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Merrick Garland

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Polar bears, Princess Diana, gun rights: The opinions of Obama’s Supreme Court nominee, Merrick Garland

The Conversation    https://theconversation.com/polar-bears-princess-diana-gun-rights-the-opinions-of-obamas-supreme-court-nominee-merrick-garland-56398

Merrick Garland, President Obama’s pick for the Supreme Court, has become the subject of enormous controversy, pitting politics against history and dueling readings of the Constitution.

But if Senate Judiciary Committee did interview him, what would they ask? We examined a selection of his 334 opinions written for the Court of Appeals for the D.C. Circuit to find out.

Judicial personality

A review of his opinions reveals a moderate, thoughtful judge with an abundance of common sense and a ready sympathy for endangered species like polar bears and arroyo toads.

Judge Garland’s opinions are models of painstaking legal analysis. He is courteous to dissenting judges – you won’t be hearing from him that an opposing view is “pure applesauce,” as Justice Scalia memorably wrote.

He has authored few dissents himself, but when he has, they have been notable. When the court barred a suit by Iraqi citizens who claimed to have been tortured by private military contractors in Abu Ghraib prison, Garland dissented. In a meticulous, 38-page opinion, he demonstrated that “no act of Congress and no judicial precedent bars the plaintiffs from suing the private contractors.” But he did not have a single harsh word for the majority. “My colleagues reach a different disposition than I do under the combatant activities exception because they employ a different test,” he wrote.

Missing from the record

Judge Garland does not appear to have written court opinions about abortion, affirmative action, same sex marriage, or the death penalty. Much of this is due to the caseload in the DC Circuit, which is heavier on agency action, federal regulations, and the like.

He has not directly taken part in cases dealing with gun control, although he voted to have a 2007 decision striking down Washington DC’s gun control law re-heard by the full Circuit. This doesn’t tell us much, as his vote to rehear was issued without an opinion, and joined by one of his conservative colleagues as well as a liberal one. But it was duly noted by the National Review, and will most likely be taken as a sign of unfriendliness towards the gun lobby.

Most of Judge Garland’s opinions don’t seem terribly controversial. He usually takes a sensible approach, like ruling that the State Department can’t fire someone for turning 65 just because they’re working abroad, or that requiring an employee to make up time spent in aerobics class does not amount to unlawful discrimination.

Because of his background as a prosecutor – most notably on the Oklahoma City bomber case – he is seen as fair, but not overly liberal in criminal cases.

The U.S. Supreme Court REUTERS/Jim Bourg

Campaign finance and free speech

Campaign finance reform remains a hotly contested topic that is likely to result in a lot of scrutiny.

In 2010, the Supreme Court ruled in Citizens United that political spending is a form of protected speech under the First Amendment. Soon after, Judge Garland joined in a unanimous decision by the DC Circuit that allowed unlimited donations by individuals to “Super PACs,” the nominally independent groups that support political candidates.

After Citizens United, the DC Circuit found the application of the law to be “straightforward.”

But this past summer, a group of contractors challenged a provision of the Federal Election Campaign Act that barred individuals and firms from making federal campaign contributions while they negotiated or performed federal contracts.

Judge Garland distinguished this ban from the situation in Citizens United. The contribution ban only operated during the period of contract negotiation and performance, the very time that the risk of corruption was at its height. This risk wasn’t speculative either, he wrote:

in the case of contracting, there is a very specific quo for which the contribution may serve as the quid: the grant or retention of the contract.”

Garland, joined by every other judge on the Circuit, upheld the restriction.

Guantanamo detainees

Judge Garland ruled on several cases brought by Guantanamo detainees, including Shawali Khan, Mashour Alsabri, and Moath Al Alwi. In all three cases, Garland agreed with the lower court that there was reliable evidence that the detainees were associated with either al Quaeda or the Taliban. Under the Authorization for the Use of Military Force, he ruled, so long as it is more likely than not that an individual is part of the Taliban or al Quaeda, their detention is legal.

But even though the standard is low, Garland at least required that it be met. Faced with a lack of reliable evidence in Parhat v. Gates, he took a much stricter approach. Hufaiza Parhat, an Uighur, a persecuted Muslim ethnic minority in China, challenged his designation as an enemy combatant.

“It is undisputed,” wrote Judge Garland, “that he is not a member of al Qaida or the Taliban, and that he has never participated in any hostile action against the United States or its allies.” The Combatant Status Review Tribunal had nevertheless designated Parhat an enemy combatant on extremely attenuated evidence.

Setting aside his usually measured tone, Garland noted that the government had argued that the allegations that Parhat was an enemy combatant were reliable because they were made in at least three different documents.

“We are not persuaded,” retorted Garland, throwing in a reference to Lewis Carroll’s 1876 poem The Hunting of the Snark for good measure: “Lewis Carroll notwithstanding, the fact that the government has ‘said it thrice’ does not make an allegation true.”

Garland had even less patience with the government argument that the State and Defense Departments would not have put the enemy combatant allegations in intelligence documents if they weren’t reliable. He wrote:

This comes perilously close to suggesting that whatever the government says must be treated as true, thus rendering superfluous both the role of the Tribunal and the role that Congress assigned to this court.

He ordered Parhat released, and in 2011, Parhat and three other Uighurs were sent to Bermuda.

FOIA requests

One issue that frequently comes up in the DC Circuit is how the government should respond to requests under the Freedom of Information Act.

Judge Garland ruled against the CIA when the American Civil Liberties Union sued to obtain records relating to the use of drones to carry out targeted killings. In classic Bourne Identity style, the CIA had refused to confirm or deny the existence of any such records. Given the fact that the President had already acknowledged the use of drone strikes in Pakistan and Afghanistan, Judge Garland was unimpressed by the CIA’s arguments. “It is neither logical nor plausible to maintain that the Agency does not have any documents about drone strikes,” he wrote.

He also had a case involving the death of Princess Diana and her boyfriend, Dodi Al-Fayed, in a car crash in Paris in 1997. Al-Fayed’s father had made a FOIA request for documents from the CIA, claiming that the NSA had recorded the Princess’ telephone conversations and that MI6, Britain’s spy agency, might have been involved in the deaths. But the case was just about getting his FOIA request expedited. Judge Garland found that he had not demonstrated a “compelling need” for faster service.

Friend to polar bears and toads

Judge Garland does have a fairly strong record of support for environmental regulations.

He upheld a move by the EPA to eliminate a loophole that let some homeowners do renovations without worrying about lead paint dust.

Arroyo toad

He joined an opinion upholding the Fish and Wildlife Service’s determination that “due to the effects of global climate change, the polar bear is likely to become an endangered species and face the threat of extinction within the foreseeable future.”

And he upheld a ruling against a real estate development company whose proposed housing project would destroy the habitat of the arroyo toad.

When the developers tried to argue that the toads themselves did not conduct economic activity and so could not be regulated, Judge Garland set them straight:

The regulated activity is Rancho Viejo’s planned commercial development, not the arroyo toad that it threatens. The Endangered Species Act does not purport to tell toads what they may or may not do.

Finally, Garland voted to uphold EPA regulations of power plant emissions to limit the dispersion of mercury and other toxins. This decision was by reversed by the Supreme Court last June, on the grounds that the EPA hadn’t considered the costs to the utilities.

The opinion’s author? Justice Scalia.

 

Merrick Garland’s long service makes him a well-vetted candidate for U.S. Supreme Court

 

Why we have the most polarized Supreme Court in history

  Professor of Political Science, Stony Brook University (The State University of New York)

The unexpected passing of Justice Antonin Scalia has had and will have enormous ramifications across the American polity.

Prior to his passing on February 13, hardly a word was mentioned about the Supreme Court in any of the presidential debates. In contrast, subsequent debates mentioned the words “court” or “justice” more than 20 times.

And barely an hour after Scalia’s passing, Senate Majority Leader Mitch McConnell declared that no replacement should be named until after the 2016 election.

As to the court itself, the impacts of Scalia’s passing could be significant, including a reprieve for affirmative action (Fisher v. Texas), an inability to prohibit mandatory union dues by public employees (Friedrichs v. California Teachers’ Association) and greater leeway under the Second Amendment to regulate guns (Voisine v. United States).

In fact, if a Democratic president gets to appoint the next justice, the doctrine that the Second Amendment provides an individual right to bear arms, and not just a right of state militias (United States v. Heller), could fall, as could the doctrine that campaign contributions by individuals and corporations are a form of speech protected by the First Amendment.

My confidence in this assertion is based on the fact that in recent times, unlike any time in our history, we are unlikely to see conservative Democrats or liberal Republicans on the Supreme Court.

That’s because the Supreme Court is more polarized politically than it’s ever been. If historical trends continue, the next Supreme Court justice will not be a moderate, but a person with strong ideological views.

Different times

For the first time in the Supreme Court’s history, every Republican on the court is to the right of every Democrat, as measured by the Martin-Quinn score.

I submit that at least part of the reason for this polarization on the court is the polarization in the Senate.

Because justices are nominated by the president and confirmed by the Senate, the impact of party on the choice of justices should roughly reflect the amount of partisan division at the time of the justices’ appointment. And indeed, we have seen this in decades past.

For example, the 94th Senate confirmed John Paul Stevens, a liberal Republican, at a time when there were many liberal Republicans in the Senate, such as Jacob Javits (New York) and Edward Brooke (Massachusetts).

Similarly, the 92nd Senate confirmed Lewis Powell, a conservative Democrat, at a time when conservative Democrats such as John Stennis and James Eastland (both Mississippi) were fairly common.

Given growing party polarization in Congress over the last 30 years, we should also expect a relatively tighter fit between party and voting behavior on the court in 2010 than we would find in 1994. But has that actually been the case?

Spreading partisanship

Consider the following evidence. I start by examining the overlap between partisanship in the 98th Senate (1983-84) and the justices serving 10 years later – that is, the 1994 term of the court. With new appointments every few years a polarized Senate would not have an immediate effect on the court, but over time the impact would grow.

As the graph below shows, there was a fair amount of overlap in partisanship in the 98th Senate as represented by ideal points, a common way to measure political leanings.

Figure 1: Ideal points (liberal to conservative) by party 98th Senate with Republican senators in black, Democratic senators in white.

Ten years later, we find, based on commonly used ideology scores of the justices, Republican Justice John Paul Stevens to be the most liberal member of the court, while Republican Justice David Souter falls to the left of Democratic Justice Stephen Breyer.

 

Figure 2. Ideal points (liberal to conservative) of the justices by party, 1994 term. Legend: nominees by Republican presidents in CAPS. Andrew Martin and Kevin Quinn

Then I look at the partisanship in the 107th Senate (2001-03) and the justices serving on the 2010-11 term. By the 107th Senate, we observe far less overlap between Republicans and Democrats.

Ideal points (liberal to conservative) by party, 107th Senate with Republican senators in black, Democratic senators in white.

The increasing homogeneity of the Republican Party since the 1980s, combined with the battle cry “No More Souters,” should make it increasingly difficult for a Republican president to nominate a Supreme Court justice who overlaps ideologically with Democratic justices.

Has this happened? While Harriet Miers’ lack of qualifications no doubt hurt her chances for confirmation, her failure was certainly aided and abetted by conservatives who were not certain about her ideological purity, given her ambiguous statements about abortion rights as well as her past political contributions to Democrats Albert Gore and Lloyd Bentsen. In fact, conservative commentator Charles Krauthammer laid out her eventual exit strategy. (She eventually withdrew her nomination.)

To a lesser extent, liberal Democrats vocally expressed some dissatisfaction that President Obama’s choice to replace Justice Stevens, Elena Kagan, was not sufficiently liberal. While Democrats had no intention of voting against Kagan, the carping about her nomination was certainly a signal from liberal Democrats to President Obama to resist further movement toward the political center in future nominations.

The make-up of today’s court does indeed reflect a partisan legislature. Ten years after the 107th Senate, and given Justice Stevens’ retirement, we no longer observe any overlap between Republicans and Democrats on the court, as seen in the chart below. The five Republicans on the court (in CAPS) place above the four Democrats.

Ideal points (liberal to conservative) of the justices, 2010 term, with nominees by Republican presidents in CAPS. Andrew Martin and Kevin Quinn, Author provided

To be sure, this complete segregation by party exists only because of the retirement of Justice Stevens in 2010. But Justice Stevens, from the moderate wing of the Republican Party, was appointed at a time when there were many moderates and even some liberals in the Republican Party.

My model of course cannot predict how long partisan-ideological aberrations such as Stevens will remain on the court. But as long as the partisan-ideological stance of the Senate remains, the Supreme Court will continue, with a certain time lag, to gain justices on either ends of the partisan spectrum.

 

Merrick Garland’s long service makes him a well-vetted candidate for U.S. Supreme Court

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/03/17/merrick-garlands-long-service-makes-him-a-well-vetted-candidate-for-u-s-supreme-court/

 

Jonathan Ernst / Reuters
Supreme Court nominee’s dissents are an exercise in restraint
Judge Merrick Garland’s dissents reinforce what is apparent from his majority opinions — that he is deferential to federal agencies, protective of press freedom and more open than some of his colleagues to a broader definition of what constitutes criminal behavior.
By Robert Barnes

Before Merrick Garland was announced as President Obama’s nominee to the Supreme Court, he was a prosecutor and the linchpin in the 1995 Oklahoma City bombing investigation and ultimate convictions of Timothy McVeigh and Terry Nichols.   Here’s a look at some of Merrick Garland’s high profile work on the Oklahoma City bombing investigation.

[Garland’s instinct for the middle could put him in court’s most influential spot]

To get a real feel for a judge, a theory goes, look not at the majority opinions he writes, which must encompass the views of others, but when he writes for himself in dissent.

Dissents allow a judge his own voice and the chance to deliver an unvarnished verdict on the law — to call out the “legalistic argle-bargle” of hopelessly misguided colleagues the way Justice Antonin Scalia did, or advise Congress to cure a particularly unwise ruling, as Justice Ruth Bader Ginsburg has done.  Judge Merrick Garland respectfully disagrees.

Moreover, he has written remarkably few — less than one a year during his nearly two decades on the U.S. Court of Appeals for the District of Columbia Circuit, and apparently none since becoming chief judge in 2013.

“I think he always sounds the same,” said Aaron L. Nielson, a law professor at Brigham Young University who closely follows the decisions of the D.C. Circuit. “Most of the time, he is very even-toned, not aggressive.”

A representative sample:

“Reasonable minds can differ about what is reasonable, and I certainly understand my colleagues’ reservations,” Garland wrote in Northeast Beverage Corp. v. National Labor Relations Board in 2009. “But I am unable to conclude that the Board’s application of Section 7 to the facts of this case was unreasonable.”

Perhaps his feistiest exchange with a colleague was in a disagreement with a man with whom he aspires to argue once again — Chief Justice John G. Roberts Jr. Then a D.C. Circuit colleague, Roberts wrote a majority opinion about the False Claims Act that drew Garland’s ire.

“That was a little bit — fiery, isn’t the right adjective — engaged,” said Nielson, who clerked for another judge on the D.C. Circuit and later for Justice Samuel A. Alito Jr.

In general, Garland’s dissents reinforce what is apparent from his majority opinions — that he is deferential to federal agencies, protective of press freedom, more open than some of his colleagues to a broader definition of what constitutes criminal behavior.

The dissents affirm his position on the court’s left — he most often disagrees when one of the court’s conservatives is writing the majority opinion. The exception is on law-and-order cases, where he has parted ways with liberal colleagues who have overturned convictions. That position seems in line with his former role as a federal prosecutor.

In Valdes v. United States, the full circuit court in 2007 overturned the conviction of Nelson Valdes, a detective for the D.C. police department. Valdes was the target of a sting operation in which he was paid in cash to search police databases to supply otherwise publicly available information.

The majority of the judges said the actions did not constitute an “official act” to which the bribery statute applied.

“A guy walks into a bar,” Garland’s dissent begins, referring to the shady aspects of the agent’s solicitation of Valdes.

The bottom line, Garland concluded: “A jury convicted the detective of accepting an illegal gratuity — to put it bluntly, a ‘payoff.’ Today, the court reverses the conviction on the ground that accepting such a gratuity does not constitute a crime. Because the court’s decision is wrong, and because it undermines the prosecution of public corruption, I respectfully dissent.”

His disagreement with Roberts was over whether former Amtrak employee Edward Totten could go forward with a whistleblower claim that two companies had delivered defective rail cars to the railway.

The False Claims Act is the government’s primary litigation tool in guarding against fraud. But Roberts and another judge on the panel said that the language of the act covers only bills presented to the government, and Amtrak is not the government.

Garland countered that the government gave Amtrak the money that paid for the railcars. Such a tight reading of the statute would leave vast sums of government money unprotected, he said.

The two dueled, in the language of lawyers.

Roberts: “The dissent literally begins and ends with legislative history. We will end as we began, too, but with the statutory language.”

Garland: “The court counters the payment to the defendants was not a payment ‘by the government’ since Amtrak — a government grantee rather than the government itself — wrote the check. The implications of the court’s argument are breathtaking.”

The two even sparred over which side the “inestimable” Judge Henry J. Friendly, a famous circuit judge for whom both clerked, would take.

“In Judge Friendly’s view, this court would do ‘pretty well to read the statute to mean’ what Congress said it meant,” Garland wrote.

Interestingly, Roberts’s decision was sharply questioned at his Supreme Court confirmation hearing in 2005 by Sen. Charles E. Grassley (R-Iowa), who is now chairman of the Senate Judiciary Committee and taking a hard stand against allowing a hearing for Garland.

“I’m happy to concede that it was among the more difficult cases I’ve had over the past two years,” Roberts told Grassley. “Any time Judge Garland disagrees, you know you’re in a difficult area. And the function of his dissent, to make us focus on what we were deciding and to make sure that we felt we were doing the right thing, I think was well-served.”

In 2005, Garland objected when the full court reviewed a three-judge panel’s decision that reporters must divulge their sources in a privacy lawsuit filed by nuclear scientist Wen Ho Lee, who alleged that federal agencies leaked defamatory information about him.

“Unless potential sources are confident that compelled disclosure is unlikely, they will be reluctant to disclose any confidential information to reporters,” Garland wrote, referencing earlier court decisions. “And if our case law has that consequence, it will undermine the Founders’ intention to protect the press so that it could bare the secrets of government and inform the people.”

As Obama pointed out when he introduced Garland to the nation Wednesday, the D.C. Circuit is often referred to as the nation’s second-highest court because it deals with important questions about government, campaign-finance law and regulations. The audience for its decisions is composed of government officials, lawyers and other judges.

It is relatively removed from controversial issues such as abortion, the death penalty and affirmative action that crowd the dockets of other courts. The language of its opinions is more technical and muted.Garland’s dissent from a court decision that shielded private military contractors at Abu Ghraib prison in Iraq from lawsuits had a bit more bite.“The plaintiffs in these cases allege that they were beaten, electrocuted, raped, subjected to attacks by dogs, and otherwise abused by private contractors working as interpreters and interrogators at Abu Ghraib prison,” Garland wrote.

He objected to the “breadth of the protective cloak [the court] has cast over the activities of private contractors.”

Alice Crites contributed to this report.   Robert Barnes has been a Washington Post reporter and editor since 1987. He has covered the Supreme Court since November 2006.

 

http://www.washingtonpost.com/politics/inside-supreme-court-nominee-merrick-garlands-crucial-role-in-the-oklahoma-city-bombing-investigation/2016/03/16/27f8373a-ebb9-11e5-b0fd-073d5930a7b7_gallery.html

http://www.washingtonpost.com/politics/inside-supreme-court-nominee-merrick-garlands-crucial-role-in-the-oklahoma-city-bombing-investigation/2016/03/16/27f8373a-ebb9-11e5-b0fd-073d5930a7b7_gallery.html

http://www.washingtonpost.com/politics/inside-supreme-court-nominee-merrick-garlands-crucial-role-in-the-oklahoma-city-bombing-investigation/2016/03/16/27f8373a-ebb9-11e5-b0fd-073d5930a7b7_gallery.html

http://www.nytimes.com/2016/03/19/us/politics/merrick-garland-supreme-court-senate-recess.html

http://www.nytimes.com/2016/03/19/us/merrick-garland-often-deferred-to-government-in-guantanamo-cases.html

http://www.nytimes.com/2016/03/18/us/politics/obama-supreme-court-senate.html

http://www.nytimes.com/2016/03/18/us/politics/merrick-garlands-record-and-style-hint-at-his-appeal.html

http://www.nytimes.com/2016/03/20/opinion/sunday/what-do-you-need-to-do-to-be-a-supreme-court-justice.html

https://www.whitehouse.gov/the-press-office/2016/03/16/remarks-president-announcing-judge-merrick-garland-his-nominee-supreme

 

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Larry H. Bernstein, MD, FCAP, Wtiter and Curator

http:///pharmaceuticalintelligence.com/5/7/2014/where_has_reason_gone?

Update 8 July 2014

 

This will be a series of presentations on the Supreme Court decision on Hobby Lobby, it’s impact, and the distamce it places on Chief Justic Roberts’ decision to go with a 5-4 majority after this year achieving a direction of concensus largely undivided decisions.  Both Justice Kennedy and Chief Justice Roberts could have taken a different position with a much appreciated decision, or the alternative was to send the case back to the lower court.  That did not happen, and the consequences are unfolding.

  1. Where has the reason gone?
  2. Justice Ginsberg written dissent
  3. The physicians’ view of Supreme Court on an issue of public health
  4.  Reason in Hobby Lobby

We are in a period of widespread instability that is bereft of  comprehensibility, not just in Asia, the Middle East, and Africa, but also imposing constrainsts on our constitutional government.  This web sight is concerned with science and also health.  Science is challenged to figure out the complexity of biology and the physical world.  But it has been challenged for centuries by an uncompromizing view of how to organize a society, driven by hatred and violence, and excused by fanatical views. We have a most advanced society in the US, self selected to be the leader of nations.  Yet we have a separation of powers in the presidency, two houses of Congress, and a judiciary that cannot function for the good of the people.  The Congress is at war within itself , unable to carry out its obligations, and only functioning to blockade the presidential authority.

But most disconcerting is a third branch, the judiciary, with Supreme Court Justices, all of whom are political appointmnt for LIFE, and half of who have shown sufficient incompetence to wonder how they can stay in office.  Perhaps, what we don’t have to keep them in line is a periodic review of performance by the American Association of Legal Constitutional Scholars.  What we have is as good as it gets, but not good enough. I refrain from saying more, and proceed to the most recent ABSURD events.   In the Hobby Lobby case, the Court’s conservative majority held that closely held corporations are entitled to some of the same religious rights as people. That means corporations can decide whether or not birth control is covered in the health plans of female employees. Corporations are not people, period. A boss’s religious views should not trump a physician’s medical judgement or a woman’s considered need .

The White House must move fast on expanding contraception coverage.

One proposal…would assign companies’ insurers or health plan administrators for contraceptive coverage… Another would give the administration itself a larger role.” Robert Pear and Adam Liptak in The New York Times.

A rare but potentially important dissent?

“Dissents to Supreme Court orders are rare, and a 17-page dissent to a curt, four-paragraph order is extraordinary. But Sotomayor is on to something: What the majority did in Hobby Lobby, was to allow the plaintiff also to determine what constitutes a ‘substantial burden’ upon it.” Daniel Fisher in Forbes.

Here’s what everyone has been missing in this debate.

“Ginsburg, in her scathing dissent…made an important point about women’s health that’s been almost entirely overlooked elsewhere: For many American women, the birth-control pill has nothing to do with controlling births. It’s a life-saving medicine….The decision…may affect millions of women who suffer from a variety of medical conditions. These women depend on the pill to regulate their hormones and do everything from ease pain to reduce the risk of cancer. These medical benefits have nothing to do with sex or the prevention of pregnancy….Even if these women never have sex once in their lives, they need to be on birth control.” Lucia Graves in National Journal.

“The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269.” Ricardo Alonso-Zaldivar in the Associated Press.

In Hobby Lobby, Supremes grant religious objection rights to for-profit corporations.

by Adam  B In a widely-awaited-but-still-85 percent-as-sucky-as-you-feared 5-4 decision this morning,the Supreme Court of the United States has held that for-profit corporations are “persons” for purposes of the Religious Freedom Restoration Act, and that their religious rights were unduly burdened by the contraceptive mandate provisions of the Affordable Care Act. Because the contraceptive mandate was not the least restrictive means available for the government to provide such coverage—in the Court’s mind, the Government could just assume the costs itself, and already provided an opt-out for religious non-profit employers—the mandate on private employers violates the law. The Court was careful to limit its opinion (in theory) to these facts.

  • It applies only to closely held corporations, and not publicly traded ones.
  • It applies to the contraceptive mandate and
  • not religious objections to all laws in general,

believing that the “compelling interest” struck a sensible balance between religious liberty and competing prior governmental interests. But … we’ll see about that. Justice Ginsburg, writing for the four dissenting Justices, refers to the decision thusly:

In a decision of startling breadth, the Court holds that commercial enterprises, including corporations, along with partnerships and sole proprietorships, can opt out of any law (saving only tax laws) they judge incompatible with their sincerely held religious beliefs.

Compelling governmental interests in uniform compliance with the law, and disadvantages that religion-based opt-outs impose on others, hold no sway, the Court decides,

  • at least when there is a “less restrictive alternative.”

And such an alternative, the Court suggests, there always will be whenever, in lieu of tolling an enterprise claiming a religion-based exemption, the government, i.e., the general public, can pick up the tab….

Religious organizations exist to serve a community of believers.

For-profit corporations do not fit that bill.

Moreover, history is not on the Court’s side. Recognition of the discrete characters of “ecclesiastical and lay” corporations dates back to Blackstone, see 1 W. Blackstone, Commentaries on the Laws of England 458 (1765), and was reiterated by this Court centuries before the enactment of the Internal Revenue Code. See Terrett v. Taylor, 9 Cranch 43, 49 (1815) (describing religious corporations); Trustees of Dartmouth College, 4 Wheat., at 645 (discussing “eleemosynary” corporations, including those “created for the promotion of religion”). To reiterate,

“for-profit corporations are different from religious non-profits in that they use labor to make a profit, rather than to perpetuate [the] religious value[s] [shared by a community of believers].”

Let’s be clear, explains Justice Alito for the five majority opinion, corporations are people too (in aggregate) (for purposes of this statute): As we will show,

  • Congress provided protection for people like the Hahns and Greens by employing a familiar legal fiction: It included corporations within RFRA’s definition of “persons.”

It is important to keep in mind that the purpose of this fiction is to provide protection for human beings. A corporation is simply a form of organization used by human beings to achieve desired ends. An established body of law specifies the rights and obligations of the people (including shareholders, officers, and employees) who are associated with a corporation in one way or another. When rights, whether constitutional or statutory, are extended to corporations, the purpose is to protect the rights of these people. For example, extending Fourth Amendment protection to corporations protects the privacy interests of employees and others associated with the company. Protecting corporations from government seizure of their property without just compensation protects all those who have a stake in the corporations’ financial well-being. And …   protecting the free-exercise rights of corporations like Hobby Lobby, Conestoga, and Mardel protects the religious liberty of the humans who own and control those companies

This statement extends the rights beyond the statement above in that it cannot apply to a closely held corporation with only the owner having fiduciary interest

Indeed, the opinion claims, you can go back over 50 years and find the Court not questioning that a for-profit corporation’s had religious rightsin that 1961 case, a kosher supermarket seeking the right to be open on Sundays despite Massachusetts blue laws. [To which the dissent counters, “The suggestion is barely there. True, one of the five challengers to the Sunday closing law … was a corporation owned by four Orthodox Jews. The other challengers were human individuals, not artificial, law-created entities, so there was no need to determine whether the corporation could institute the litigation.”]

The Court insists that this isn’t something publicly traded companies are going to get involved in. We could use corporate law principles to suss out what their religious beliefs are: HHS contends that Congress could not have wanted RFRA to apply to for-profit corporations because it is difficult as a practical matter to ascertain the sincere “beliefs” of a corporation. HHS goes so far as to raise the specter of “divisive, polarizing proxy battles over the religious identity of large, publicly traded corporations such as IBM or General Electric.” These cases, however, do not involve publicly traded corporations, and it seems unlikely that the sort of corporate giants to which HHS refers will often assert RFRA claims. HHS has not pointed to any example of a publicly traded corporation asserting RFRA rights, and numerous practical restraints would likely prevent that from occurring. For example,

  • the idea that unrelated shareholders—including institutional investors with their own set of stakeholders—would agree to run a corporation under the same religious beliefs seems improbable. In any event, we have no occasion in these cases to consider RFRA’s applicability to such companies.
  • The companies in the cases before us are closely held corporations, each owned and controlled by members of a single family, and no one has disputed the sincerity of their religious beliefs.

HHS has also provided no evidence that the purported problem of determining the sincerity of an asserted religious belief moved Congress to exclude for-profit corporations from RFRA’s protection…. HHS and the principal dissent express concern about the possibility of disputes among the owners of corporations, but that is not a problem that arises because of RFRA or that is unique to this context. The owners of closely held corporations may—and sometimes do—disagree about the conduct of business. Even if RFRA did not exist, the owners of a company might well have a dispute relating to religion…. Courts will turn to that structure and the underlying state law in resolving disputes.

So, what about the contraceptive mandate?

Interestingly, the Court concedes for sake of argument that it serves a compelling state interest. But, still, that’s not enough. By requiring the Hahns and Greens and their companies to arrange for such coverage, the HHS mandate demands that they engage in conduct that seriously violates their religious beliefs. If the Hahns and Greens and their companies do not yield to this demand, the economic consequences will be severe. If the companies continue to offer group health plans that do not cover the contraceptives at issue, they will be taxed $100 per day for each affected individual. For Hobby Lobby, the bill could amount to $1.3 million per day or about $475 million per year; for Conestoga, the assessment could be $90,000 per day or $33 million per year; and for Mardel, it could be $40,000 per day or about $15 million per year. These sums are surely substantial. … Are their religious beliefs loony? The Court’s not going to look into that.

The sincerity is what counts, and that creates a burden: …If I may ask—how do you measure sincerity?

How much it will spend on litigating its case!

The Hahns and Greens believe that providing the coverage demanded by the HHS regulations is connected to the

destruction of an embryo in a way that is sufficient to make it immoral for them to provide the coverage.

This belief implicates a difficult and important question of religion and moral philosophy, namely, the circumstances under which it is wrong for a person to perform an act that is innocent in itself but that has the effect of enabling or facilitating the commission of an immoral act by another.

Arrogating the authority to provide a binding national answer to this religious and philosophical question, HHS and the principal dissent in effect tell the plaintiffs

  • that their beliefs are flawed. …
  • we have repeatedly refused to take such a step.

See, e.g., Smith, 494 U. S., at 887 (“Repeatedly and in many different contexts, we have warned that courts must not presume to determine . . . the plausibility of a religious claim”)

Incredible!!      So, RFRA applies,   there’s a burden, and the contraceptive mandate fails the test.

The least-restrictive-means standard is exceptionally demanding, and it is not satisfied here.  HHS has not shown that it lacks other means of achieving its desired goal without imposing a substantial burden on the exercise of religion by the objecting parties in these cases. See §§2000bb–1(a), (b) (requiring the Government to “demonstrat[e] that application of [a substantial] burden to the person . . . is the least restrictive means of furthering [a] compelling governmental interest” (emphasis added)).

The most straightforward way of doing this would be for the Government to assume the cost of providing the four contraceptives at issue to any women who are unable to obtain them under their health-insurance policies due to their employers’ religious objections. This would certainly be less restrictive of the plaintiffs’ religious liberty, and HHS has not shown that this is not a viable alternative. HHS has not provided any estimate of the average cost per employee of providing access to these contraceptives, two of which, according to the FDA, are designed primarily for emergency use. Nor has HHS provided any statistics regarding the number of employees who might be affected because they work for corporations like Hobby Lobby, Conestoga, and Mardel. Nor has HHS told us that it is unable to provide such statistics. It seems likely, however, that the cost of providing the forms of contraceptives at issue in these cases (if not all FDA-approved contraceptives) would be minor when compared with the overall cost of ACA.

According to one of the Congressional Budget Office’s most recent forecasts, ACA’s insurance-coverage provisions will cost the Federal Government more than $1.3 trillion through the next decade. If, as HHS tells us, providing all women with cost-free access to all FDA-approved methods of contraception is a Government interest of the highest order, it is hard to understand HHS’s argument that it cannot be required under RFRA to pay anything in order to achieve this important goal.

HHS contends that RFRA does not permit us to take this option into account because “RFRA cannot be used to require creation of entirely new programs.”  But we see nothing in RFRA that supports this argument, and drawing the line between the “creation of an entirely new program” and the modification of an existing program (which RFRA surely allows) would be fraught with problems. And don’t worry, Justice Alito insists! This is a really, really narrow holding, and doesn’t create religious exemptions to good laws: HHS and the principal dissent argue that a ruling in favor of the objecting parties in these cases will

  • lead to a flood of religious objections regarding a wide variety of medical procedures and drugs, such as vaccinations and blood transfusions,

but HHS has made no effort to substantiate this prediction. HHS points to no evidence that insurance plans in existence prior to the enactment of ACA excluded coverage for such items. Nor has HHS provided evidence that any significant number of employers sought exemption, on religious grounds, from any of ACA’s coverage requirements other than the contraceptive mandate. …

What are the credentials for Alito and associates in the domain of medical therapies?  None!

[O]ur decision in these cases is concerned solely with the contraceptive mandate. 

Our decision should not be understood to hold that an insurance-coverage mandate must necessarily fall if it conflicts with an employer’s religious beliefs. Other coverage requirements, such as immunizations, may be supported by different interests (for example, the need to combat the spread of infectious diseases) and may involve different arguments about the least restrictive means of providing them. The principal dissent raises the possibility that discrimination in hiring, for example on the basis of race, might be cloaked as religious practice to escape legal sanction. Our decision today provides no such shield. The Government has a compelling interest in providing an equal opportunity to participate in the workforce without regard to race, and prohibitions on racial discrimination are precisely tailored to achieve that critical goal. Justice Kennedy adds an additional concurrence to remind everyone that Justice Kennedy believes in the Court, America, and his own importance:

In our constitutional tradition, freedom means that all persons have the right to believe or strive to believe in a divine creator and a divine law. For those who choose this course, free exercise is essential in preserving their own dignity and in striving for a self-definition shaped by their religious precepts. Free exercise in this sense implicates more than just freedom of belief. It means, too, the right to express those beliefs and to establish one’s religious(or nonreligious) self-definition in the political, civic, and economic life of our larger community.

But in a complex society and an era of pervasive governmental regulation, defining the proper realm for free exercise can be difficult. … “[T]he American community is today, as it long has been, a rich mosaic of religious faiths.” Town of Greece v. Galloway, 572 U. S. __ (2014) (Kagan, J., dissenting) (slip op., at 15). Among the reasons the United States is so open, so tolerant, and so free is that no person may be restricted or demeaned by government in exercising his or her religion. Yet neither may that same exercise unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling.

In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here. RFRA requires the Government to use this less restrictive means. Justice Ginsburg writes the principal dissent, and begins by reminding us of the importance of sexual autonomy, and the economic stakes for women in this litigation: “The ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.” Planned Parenthood of Southeastern Pa. v. Casey, 505 U. S. 833, 856 (1992).Congress acted on that understanding when, as part of a nationwide insurance program intended to be comprehensive, it called for coverage of preventive care responsive to women’s needs.

… The [ACA] had a large gap, however; it left out preventive services that “many women’s health advocates and medical professionals believe are critically important.” 155 Cong. Rec. 28841 (2009) (statement of Sen. Boxer). To correct this oversight, Senator Barbara Mikulski introduced the Women’s Health Amendment, which added to the ACA’s minimum coverage requirements a new category of preventive services specific to women’s health…Women paid significantly more than men for preventive care, the amendment’s proponents noted; in fact, cost barriers operated to block many women from obtaining needed care at all. See, e.g., id., at 29070 (statement of Sen. Feinstein) (“Women of childbearing age spend 68 percent more in out-of-pocket health care costs than men.”); id., at 29302 (statement of Sen. Mikulski) (“copayments are [often] so high that [women] avoid getting [preventive and screening services] in the first place”). And increased access to contraceptive services, the sponsors comprehended, would yield important public health gains. See, e.g., id., at 29768 (statement of Sen. Durbin) (“This bill will expand health insurance coverage to the vast majority of [the 17 million women of reproductive age in the United States who are uninsured] . . . . This expanded access will reduce unintended pregnancies.”). And the dissenters deride as unfounded the Court’s new recognition of religious rights for for-profit corporations: Until this litigation, no decision of this Court recognized a for-profit corporation’s qualification for a religious exemption from a generally applicable law, whether under the Free Exercise Clause or RFRA.

George Takei’s blistering response to #HobbyLobby: Could a Muslim Corp impose Sharia Law?

byVyan   THU JUL 03, 2014 AT 09:12 AM PDT “The ruling elevates the rights of a FOR-PROFIT CORPORATION over those of its women employees and opens the door to all manner of claims that a company can refuse services based on its owner’s religion,” Takei wrote. (O)ne wonders,” he said, “whether the case would have come out differently if a Muslim-run chain business attempted to impose Sharia law on its employees.” “Hobby Lobby is not a church. It’s a business — and a big one at that,” he continued. “Businesses must and should be required to comply with neutrally crafted laws of general applicability. Your boss should not have a say over your healthcare. Just as Justice Ginsberg and Mr Takei have suggested, the Hyper-Religious are already attempting to capitalize on the SCOTUS new granting of the rights of an individual to a corporate entity. In this decision the SCOTUS Majority opinion claimed that they were not granting the equal legitimacy of such follow on requests, but they’ve kicked open the door. Takei – bless his soul – also pointed out the basic hypocrisy of Hobby Lobby’s business practices in regards to religion.  Noting that… …Hobby Lobby has invested in multiple companies that manufacture abortion drugs and birth control. The company receives most of its merchandise from China, a country where overpopulation has led to mandatory abortions and sterilizations for women who try to have more than one child.

What the battle over birth control is really about

byteacherken    in a 2012 piece at Alternet by Sara Robinson. Conservative bishops and Congressmen are fighting a rear-guard action against one of the most revolutionary changes in human history. Robinson suggests 500 years from now looking back, the three great achievements of the 20th Century are likely to be the invention of the integrated circuit (without which the internet does not exist), the Moon landing (which she thinks will carry the same impact as Magellan’s circumnavigation of the globe), and the mass availability of nearly 100% effective contraception. Far from being a mere 500-year event, we may have to go back to the invention of the wheel or the discovery of fire to find something that’s so completely disruptive to the way humans have lived for the entire duration of our remembered history.

 Free Birth Control is Emerging Standard for Women

Mon, 07/07/2014 – 8:47am
RICARDO ALONSO-ZALDIVAR, Associated Press
WASHINGTON (AP) — More than half of privately insured women are getting free birth control under President Barack Obama’s health law, a major coverage shift that’s likely to advance. This week the Supreme Court allowed some employers with religious scruples to opt out, but most companies appear to be going in the opposite direction. Recent data from the IMS Institute document a sharp change during 2013. The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269. “It’s a big number,” said institute director Michael Kleinrock. The institute is the research arm of IMS Health, a Connecticut-based technology company that uses pharmacy records to track prescription drug sales. The core of Obama’s law — taxpayer-subsidized coverage for the uninsured — benefits a relatively small share of Americans. But free preventive care— from flu shots to colonoscopies —is a dividend of sorts for the majority with employer coverage. Expanded preventive coverage hasn’t gotten as much attention as another bonus for the already insured: the provision that allows young adults to remain on their parents’ policy until they turn 26. That may start to change with all the discussion of birth control. Business groups and employee benefits consultants say they see little chance that employers will roll back contraceptive coverage as a result of the Supreme Court ruling. The court carved out a space for “closely held” companies whose owners object on religious grounds. Most companies don’t fit that niche.

Read Full Post »


Curator: Aviva Lev-Ari, PhD, RN

In their discussion, the researchers argue that the U.S. Supreme Court now has a chance to shape the balance between the medical good versus inventor protection, adding that, in their opinion, the court should limit the patenting of existing nucleotide sequences, due to their broad scope and non-specificity in the human genome.

“I am extremely pro-patent, but I simply believe that people should not be able to patent a product of nature,” Dr. Mason says. “Moreover, I believe that individuals have an innate right to their own genome, or to allow their doctor to look at that genome, just like the lungs or kidneys. Failure to resolve these ambiguities perpetuates a direct threat to genomic liberty, or the right to one’s own DNA.”

http://www.sciencedaily.com/releases/2013/03/130326101614.htm

Supreme Court May Decide Whether We Own Our Genes

March 26, 2013
 
Image Credit: Photos.com

Brett Smith for redOrbit.com – Your Universe Online

They may be responsible for everything in your life, from conception to death, they may be inside every living cell in your body – but you do not own your own genes, legally speaking.

According to a report in Genome Medicine, patents essentially cover the entire human genome, hampering research and raising the question of “genomic liberty.”

The legal standing of genomic patents could change next month when the Supreme Court reviews patent rights for two key breast and ovarian cancer genes, BRCA1 and BRCA2, which include segments of genetic code as small as 15 nucleotides, known as 15mers.

“This is, so to speak, patently ridiculous,” said report co-author Dr. Christopher E. Mason of Weill Cornell Medical College. “If patent claims that use these small DNA sequences are upheld, it could potentially create a situation where a piece of every gene in the human genome is patented by a phalanx of competing patents.”

In their report, Mason and Dr. Jeffrey Rosenfeld, an assistant professor of medicine at the University of Medicine & Dentistry of New Jersey, looked at patents for two different categories of DNA fragments:

  • long and
  • short.

They revealed 41 percent of the human genome is covered by “long” DNA patents that can include whole genes. Because many genes share similar sequences within their code that are patented, the combination of all these “short” DNA patents covers 100 percent of the genome.

“This demonstrates that short patent sequences are extremely non-specific and that a 15mer claim from one gene will always cross-match and patent a portion of another gene as well,” Mason said. “This means it is actually impossible to have a 15mer patent for just one gene.”

To reach their conclusions, the researchers first looked at small sequences within BRCA1 and noticed one of the company’s BRCA1 patents also covered almost 690 other human genes. Some of these genes are unrelated to breast cancer – instead being associated with brain development and heart functioning.

Next, researchers determined how many known genes are covered by 15mers in current patent claims. They found 58 patents covered at least ten percent of all bases of all human genes. The broadest patent claim matched 91.5 percent of human genes. When the team took patented 15mers and matched them to known genes, they found 100 percent of known genes are patented.

Finally, the team also looked at “long” DNA sequences from existing gene patents, ranging from a few dozen to thousands of base pairs. They found these long sequences added up to 41 percent of known human genes.

“There is a real controversy regarding gene ownership due to the overlap of many competing patent claims. It is unclear who really owns the rights to any gene,” Rosenfeld said. “While the Supreme Court is hearing one case concerning just the BRCA1 patent, there are also many other patents whose claims would cover those same genes.

“Do we need to go through every gene to look at who made the first claim to that gene, even if only one small part? If we resort to this rule, then the first patents to be granted for any DNA will have a vast claim over portions of the human genome,” he added.

Another legal question surrounds patented DNA sequences that cross species boundaries. The researchers found one company has the rights to 84 percent of all human genes for a patent they received for cow breeding.

Source: Brett Smith for redOrbit.com – Your Universe Online

Topics: Health Medical PharmaGeneticsGene patentBiologyGeneLiving modified organismAssociation for Molecular Pathology v. U.S. Patent and Trademark OfficeBRCA1DNASupreme CourtHuman genome

SOURCE:

Human Genome: Name Your Price

Posted March 27, 2013 – 12:51 by a staff writer

Weill Cornell Medical College researchers have issued a warning that, according to the patent system, the vast majority of humans on the planet don’t ‘own’ their own genes, and in fact their biological make-up is being exploited for profit. Even seemingly innocent research into cow breeding can cover human genetic make-up.

As spotted by a Slashdot user, two researchers combing through patents on human DNA discovered that over 40,000 patents on DNA molecules have effectively declared the human genome for profit. A report in medical journal Genome Medicine said that humans may be losing their grip on “individual genomic liberty”.

Looking at two kinds of patented DNA sequences, or long and short fragments, 41 percent of the human genome is covered by DNA patents that can cover entire genes. According to the research, if all of the short sequence patents were allowed in aggregate they could cover 100 percent of the human genome.

Lead author Dr Christopher E Mason and co-author Dr Jeffrey Rosenfeld warned that short sequences from patents cover “virtually the entire genome, even outside of genes”. A Weill Cornell assistant professor asked: “How is it possible that my doctor cannot look at my DNA without being concerned about patent infringement?”

There will be a Supreme Court hearing about genomic patent rights next month that will debate the morality of a molecular diagnostic company claiming patents on key cancer genes, as well as on any small sequence of code within the BRCA1 gene. Cornell explained that at present, genes are able to be patented by researchers working in companies and institutions who discover genes that have potentially useful applications, like in testing for cancer risks. Because the patents can be held by companies or organisations, it is possible for the patent owner to charge doctors thousands of dollars for each diagnostic test.

The authors pointed out that in their studies, while engaged in research, it is common to come across a gene that’s patented “almost every day”. Their paper promises to examine how genes may have been impacted by held patents, and the extent of intellectual property on the genome. Gene patents can also relate between different species – for example, a company may have a patent for breeding cows that also covers a large percentage of human genes. They cited one company that owns 84 percent of all human genes because of a patent for cow breeding.

“There is a real controversy regarding gene ownership due to the overlap of many competing patent claims. It is unclear who really owns the rights to any gene,” Dr Rosenfeld said. “Do we need to go through every gene to look at who made the first claim to that gene, even if only one small part? If we resort to this rule, then the first patents to be granted for any DNA will have a vast claim over portions of the human genome.”

Lead author Dr Mason insisted he is pro-patent, but believes people “should not be able to patent a product of nature”.

“I believe that individals have an innate right to their own genome,” he said.

http://www.tgdaily.com/hardware-brief/70513-human-genome-name-your-price#BUKfEtjWKb3gq7X3.99 

Other related articles on Genomics and Ethics on this Open Access Online Scientific Journal include the following:

Aviva Lev-Ari, PhD, RN

20.2 Understanding the Role of Personalized Medicine

Larry H Bernstein, MD, FACP

20.3 Attitudes of Patients about Personalized Medicine

Larry H Bernstein, MD, FACP

20.4  Genome Sequencing of the Healthy

Larry H. Bernstein, MD, FACP and Aviva Lev-Ari, PhD, RN

20.5   Genomics in Medicine – Tomorrow’s Promise

Larry H. Bernstein, MD, FACP

20.6  The Promise of Personalized Medicine

Larry H. Bernstein, MD, FACP

Read Full Post »


Genomics and Ethics: DNA Fragments are Products of Nature or Patentable Genes?

Curator: Aviva Lev-Ari, PhD, RN

UPDATED 6/17/2013 – OPINIONS ON COURT DECISION of 6/13/2013

Experts say court’s decision on human gene patents is a win-win

Jun 16, 2013

Jun 16, 2013 (St. Louis Post-Dispatch – McClatchy-Tribune Information Services via COMTEX News Network) — The Supreme Court ruling Thursday that naturally occurring human genes cannot be patented effectively ended the monopoly that Utah-based Myriad Genetics had on breast and ovarian cancer tests.

The news was hailed as a victory by health advocates and medical researchers, who can now not only access the genes at issue — the BRCA1 and BRCA2 — but all other patented human genes without infringement. In the wake of the decision, several other testing companies, including Quest Diagnostics, announced it would perform the tests — and at far cheaper prices than Myriad’s.

The court’s unanimous ruling, however, was mixed. It said that naturally occurring DNA could not be patented, but synthetic DNA can still be, giving patent protection advocates and Myriad a victory, too. The decision also means that methods of isolating genes still qualify for patent protection.

The Post-Dispatch interviewed experts from a broad range of fields, from medicine to law, about the court’s ruling.

Here’s what they had to say about what was at stake and what the decision could mean.

Christopher Mason

Professor of physiology, biophysics and computational biomedicine, and author of a study showing that 41 percent of the human genome is covered by patents, Cornell University

I’d say this represents a great win for genetic liberty, both for patients and for doctors. The American Medical Association said it was a big win for patients, and I couldn’t agree more — especially for breast and ovarian cancer, but for all types of cancer. This is an important cancer gene and now it’s open for study to everyone.

(Myriad) didn’t just own a test or a method, they owned anyone’s DNA as soon as it was isolated. They didn’t say we patented a series of letters, they said we patent anything that remotely looks like that, which the court correctly said is not patentable.

It would have been great to have both the patents (on natural and synthetic DNA), but of the two this is the most restrictive one — 99.9 percent of testing is done on DNA not cDNA.

Plenty of companies aren’t scared anymore. This is going to open the floodgates on new research and ideas.

Dr. Julie Margenthaler

Associate professor of surgery and breast cancer specialist, Siteman Cancer Center

This ruling has important implications for physician scientists actively engaged in genetic research. We are on the brink of significant strides in our understanding of the genetic links to many diseases.

For those of us who care for cancer patients, personalized cancer care hinges on the ability to genetically examine the pathways that result in a normal cell becoming a malignant cell. Because some companies held patents to pieces of the genome involved when whole genome sequencing is performed, there was at least some concern over patent infringement. With this ruling, we can continue to move our research forward and benefit the lives of our current and future patients.

Michael Watson

Executive director, American College of Medical Genetics and Genomics (plaintiffs in the case), and former professor of pediatrics at Washington University

It has enormous implications for labs and the public, certainly for breast cancer and for many other cancers. Since the case was settled (Thursday), at least four labs have put the test online. Prices are about half of Myriad’s — $3,500 down to $2,000 overnight.

It’s a win-win for everybody. It used to be when you had the tests done by Myriad, you couldn’t get that test confirmed by anyone else. Now the public can confirm the test and get second opinions, and that has a lot of value for patients. And I think it’ll open up the research.

There are two aspects of this that still remain open. Because 4,000 to 5,000 genes have patents on them, many people signed licensing agreements to use the gene. One of the questions is about the contract they signed. They will probably be able to challenge their contract now.

Nathan Lakey President and CEO, Orion Genomics

I think the ruling is positive because it removes a cloud of uncertainty as to where the Supreme Court stood on patents relating to gene sequences. I appreciate the thoughtfulness that went into the ruling. Justice Thomas adds a section that talks about what the ruling did not address that’s interesting. He emphasizes that method patents, or patents covering gene sequences that apply knowledge of those sequences, are patentable. I think this is what the justices sought to do, to not limit science and to not limit innovation and improvements in patient care. I think they do a markedly good job laying out the framework by which the business of science needs to consider the issue going forward as we all seek to lower the cost of care and improve outcomes.

We’re thrilled because our patents have been crafted primarily as method patents that involve naturally occurring gene sequences, and at the same time we add on to that a novel method that was not known and is quite valuable. We have biomarkers that we believe will be able to predict the risk of an individual getting colon cancer in the future, not unlike the Myriad test, but this is for colon cancer. We feel that our path forward is actually more clear and more positive given the clear line that the Supreme Court drew around what is and what isn’t patentable.

Janet S. Hendrickson

Patent attorney, specializing in chemical, pharmaceutical and food science companies, Senniger Powers law firm

They split it down the middle, and it seems to be, when looking at the commentary, that most people agree with that. They didn’t preclude the patenting of everything related to DNA, just natural DNA.

There are so many considerations and it’s hard to know what ramifications there are going to be, and what might be the best policy. It does mean that for companies that have these claims on natural DNA in their portfolio, they need to make sure they have the other range of claims for the cDNA (synthetic DNA). For companies that have past patents, it’s going to figure into those claims for those natural DNA products.

So it’s hard to tell whether it has broader implications for other things, that when you take them out of their natural milieu we thought were patentable.

Kevin Emerson Collins Professor, Washington University School of Law and patent law expert

This is going to mean one thing for patent lawyers and another thing for biotech companies. For patent lawyers, we now have a new source of business. The court hasn’t given us precise guidelines that say exactly when in other situations do we pass from something being a product of nature to a patentable invention. That’s a new frontier that patent lawyers are going to have to advise companies on.

For biotech companies it’s going to mean they pay patent lawyers a little more. Although the Myriad Genetics ruling deals with DNA, it would seem from the language of the opinion that the ruling should also apply to nongenetic, naturally occurring materials, but exactly how is yet to be determined.

A historical example that predates the Myriad controversy is the debate over the patentability of insulin in the early 20th century. A very famous lower court opinion held that isolated and purified human insulin was patentable so long as it became isolated insulin with impurities removed and took on new commercial value. I bet that case might well come out differently under the Myriad Genetics ruling. The insulin question is moot; that patent has expired. Similarly there a number of other therapeutics which are components that nature already makes that are isolated in a way they can be used in medicine but not in their natural state. Those are the kinds of things we’re going to have to grapple with.

Josh Newby-Harpole Founder, Theresa Harpole Foundation for Metastatic Breast Cancer in Alton

We have a foundation we started this year in honor of my mom. She was diagnosed over seven years ago with stage zero breast cancer. They did genetic testing and found out she had the BRCA gene. In 2010 she got diagnosed with metastatic breast cancer after she had a lump in her neck and it had spread to her bones. I needed to get tested at that point. I had testing done in Chicago and found out that I had the BRCA gene. As a male I’m lucky she had a son and not a daughter. My mom has been on different courses of treatment, and I monitor my health as well as I can, because I have a higher risk for certain kinds of cancer such as prostate and skin cancer and a higher than 3 percent chance of breast cancer.

The cost was probably over $2,000 to have the test done, and I paid close to $1,000 for it. We’re very excited about the Supreme Court ruling. I think a lot of people are hesitant to get the test done because of the cost. It’s exciting because it means possibilities. More people are going to be motivated to do research in labs to try to find a cure. Maybe they can come up with better treatment options for women because some of them will find out they have the gene and they don’t have evidence of disease. It’s something that is really getting a lot of attention right now, and the population is maybe not as aware about things like BRCA and metastatic breast cancer.

Yvette Liebesman Assistant professor of law, St. Louis University

It’s very good for research and in fact it’s very good for health care in the sense that already today a competitor for Myriad said they would run the same test for thousands less. Already we’re seeing a good thing happening that more women are going to be able to be tested for this gene. Now we’re talking about more women being aware of their health risks. Now a company that wants to develop a drug isn’t going to have to go through Myriad to isolate this gene in order to test drugs for breast cancer.

If Myriad won this case it would be like saying while a tree is made by nature, if I find a way to pick the leaves off it, the leaf is my patented product. Myriad did win in one sense, that there is a form of DNA not found in nature that is patentable. This is very logical. I think that like with most things, the people who are doomsayers will say it’s not going to have as great of an impact. The idea that now this opens up the ability to develop treatments is going to be huge.

___ (c)2013 the St. Louis Post-Dispatch Visit the St. Louis Post-Dispatch at
www.stltoday.com Distributed by MCT Information Services

Georgina Gustin and Blythe Bernhard

Copyright (C) 2013, St. Louis Post-Dispatch

SOURCE: Comtex

http://predictwallstreet.com/news/Story.aspx?StoryID=31159b4101f28d00

UPDATED 6/13/2013, following the new Supreme Court Decision on 6/13/2013 to include it, below.

The Supreme Court ruled unanimously Thursday that human genes cannot be patented, a decision that could shape the future of medical and genetic research and have profound effects on pharmaceuticals and agriculture.The ruling was a split decision for Myriad Genetics Inc., which holds patents on genes that have been linked to breast and ovarian cancer.

Justice Clarence Thomas, writing for the court, said that merely isolating those specific genes — called BRCA1 and BRCA2 — was not worthy of a patent.

“Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes . . . patent eligible,” Thomas wrote.On the other hand, Thomas wrote, Myriad’s creation of a synthetic form of DNA — called cDNA — based on its discovery does deserve patent protection.“The lab technician creates something new when cDNA is made,” Thomas wrote.Responding to the decision, Myriad focused on the favorable cDNA ruling. “We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” said Peter D. Meldrum, company president and chief executive. “More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall health-care costs.”DNA research is a vital component of personalized medicine. The challenge to Myriad’s patents came from scientists and doctors who said that allowing patents on genes inflated the cost of testing and hindered research.

The American Civil Liberties Union praised the high court’s ruling as a victory. “Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park of the ACLU, which represented the groups that brought the challenge. “Because of this ruling, patients will have greater access to genetic testing, and scientists can engage in research on these genes without fear of being sued.”

The test that Myriad offers for determining whether a woman contains the genetic mutation that heightens her chance of cancer has received much attention lately after actress Angelina Jolie wrote about it in a letter to the editor to the New York Times. In the letter, Jolie revealed that she had a double mastectomy because the test showed she carried the defective gene.

http://www.washingtonpost.com/politics/supreme-court-rules-human-genes-may-not-be-patented/2013/06/13/9e5c55d2-d43d-11e2-a73e-826d299ff459_story.html?hpid=z1

[bold and green added by the Curator]

START QUOTE

1 (Slip Opinion) OCTOBER TERM, 2012

Syllabus

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued.The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.

SUPREME COURT OF THE UNITED STATES 

Syllabus

ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL.

v. MYRIAD GENETICS, INC., ET AL.

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

No. 12–398. Argued April 15, 2013—Decided June 13, 2013

Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a “double helix.” Each “cross-bar” in that helix consists of two chemically joined nucleotides. Sequences of DNA nucleotides contain the information necessary to create strings of amino acids used to build proteins in the body. The nucleotides that code for amino acids are “exons,” and those that do not are “introns.” Scientists can extract DNA from cells to isolate specific segments for study. They can also synthetically create exons-only strands of nucleotides known as composite DNA (cDNA). cDNA contains only the exons that occur in DNA, omitting the intervening introns. Respondent Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient’s cancer risk. If valid, Myriad’s patents would give it the exclusiveright to isolate an individual’s BRCA1 and BRCA2 genes, and would give Myriad the exclusive right to synthetically create BRCA cDNA. Petitioners filed suit, seeking a declaration that Myriad’s patents areinvalid under 35 U. S. C. §101. As relevant here, the District Court granted summary judgment to petitioners, concluding that Myriad’s claims were invalid because they covered products of nature. The Federal Circuit initially reversed, but on remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. ___, the Circuit found both isolated DNA and cDNA patent eligible. 2 ASSOCIATION FOR MOLECULAR PATHOLOGY v. MYRIAD GENETICS, INC. Syllabus

Held: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. Pp. 10–18. 

(a) The Patent Act permits patents to be issued to “[w]hoever invents or discovers any new and useful . . . composition of matter,” §101, but “laws of nature, natural phenomena, and abstract ideas”“ ‘are basic tools of scientific and technological work’ ” that lie beyond the domain of patent protection, Mayo, supra, at ___. The rule against patents on naturally occurring things has limits, however. Patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” Id., at ___. This standard is used to determine whether Myriad’s patents claim a “new and useful . . . composition of matter,” §101, or claim naturally occurring phenomena. Pp. 10–11. 

(b) Myriad’s DNA claim falls within the law of nature exception.Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U. S. 303, is central to the patent-eligibility inquiry whether such action was new “with markedly different characteristics from any found in nature,” id., at 310. Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but ground breaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new . . . composition[s] of matter,” §101. Myriad’s patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone isinsufficient to satisfy §101’s demands. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes. Finally, Myriad argues that the Patent and Trademark Office’s past practice of awarding gene patents is entitled to deference, citing J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U. S. 124, a case where Congress had endorsed a PTO practice in subsequent legislation. There has been no such endorsement here, and the United States argued in the Federal Circuit and in this Court that isolated DNA was not patent eligible under §101. Pp. 12–16. 

3 Cite as: 569 U. S. ____ (2013)

Syllabus

(c) cDNA is not a “product of nature,” so it is patent eligible under§101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA. Pp. 16–17.

(d) This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Pp. 17–18. 

689 F. 3d 1303, affirmed in part and reversed in part. 

THOMAS, J., delivered the opinion of the Court, in which ROBERTS,  C. J., and KENNEDY, GINSBURG, BREYER, ALITO, SOTOMAYOR, and KAGAN, JJ., joined, and in which SCALIA, J., joined in part. SCALIA, J., filed an opinion concurring in part and concurring in the judgment.

1 Cite as: 569 U. S. ____ (2013) Opinion of SCALIA, J.

SUPREME COURT OF THE UNITED STATES 

No. 12–398

ASSOCIATION FOR MOLECULAR PATHOLOGY, ET AL., PETITIONERS v. MYRIAD GENETICS, INC., ET AL.

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

[June 13, 2013]

JUSTICE SCALIA, concurring in part and concurring in the judgment. 

I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am un-able to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.

END QUOTE

http://www.concurringopinions.com/archives/2013/06/the-humble-justice-scalia.html

 

Evolution of the case ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL. v. MYRIAD GENETICS, INC., ET AL. priot to 6/13/2013 Supreme Court decision

Curator: Aviva Lev-Ari, PhD, RN

In an amicus brief, the Broad Institute‘s Eric Lander shares his personal view of the ongoing gene patenting case between Myriad Genetics and the American Civil Liberties Union, saying that isolated DNA fragments are products of Nature.

The central issue of the case revolves around Myriad’s patents on the BRCA1 and BRCA2 genes. In a mixed ruling, the federal appeals court found that while some of the company’s methods patents may not be patentable, its BRCA1 and BRCA2 gene patents, as they concern isolated DNA fragments, are patentable items as human intervention is needed to isolate DNA.

Lander argues that that is not true, though, as the Boston Globe points out, his brief was not filed in support of either side. Isolated DNA, he says, happens all the time in nature. “It is well-accepted in the scientific community that

(a) chromosomes are constantly being broken into DNA fragments by natural biological processes that break the covalent bonds within DNA chains;

(b) these DNA fragments can be routinely found in the human body … and

(c) these fragments cover the entire human genome and, in particular, include many of the DNA fragments claimed by Myriad’s patents,” the brief says.

The US Supreme Court announced in December that it will re-hear the Myriad gene patenting case.

 SOURCE:

Eric Lander weighs in on gene patenting case

By Carolyn Y. Johnson

 |  GLOBE STAFF

FEBRUARY 26, 2013

Late last year, the nation’s highest court said it would consider a legal challenge to patents that biotechnology company Myriad Genetics holds on breast cancer genes. Now, Eric Lander, head of the Broad Institute in Cambridge, has filed an amicus brief that he says reflects his personal opinion. Utah-based Myriad, Lander argues, has patented products of nature, and its patents are an “insurmountable barrier” to studying DNA, with serious repercussions for medical progress.
 
In the Supreme Court of the United States – On Writ of Certiorari to the United States Court of Appeals for the Federal Circuit
The Association for Molecular Pathology, et al., v. Mariad Genetics, Inc, et al.,
Brief for Amicus Curiae Eric S. Lander in support of neither party
 
SCIENTIFIC CITATIONS
Eric S. Lander et al., Initial Sequencing and Analysis of the Human Genome, 409 Nature 860 (2001)
Eric S. Lander, Initial Impact of the Sequencing of the Human Genome, 470 Nature 187 (2011)
ARGUMENT
1. THE FEDERAL CIRCUIT INCORRECTLY ASSUMED, WITHOUT CITING SCIENTIFIC EVIDENCE, THAT ISOLATED DNA FRAGMENTS OF THE HUMAN GENOME DO NOT OCCUR IN NATURE, WHEN IT IS WELL-ACCEPTED IN THE SCIENTIFIC COMMUNITY THAT THEY DO
2. MYRIAD’S COMPOSITION-OF-MATTER CLAIMS ON ISOLATED FRAGMENTS OF THE GENOMIC DNA ARE INCONSISTENT WITH THIS COURT’S SECTION 101 JURISPRUDENCE BECAUSE THEY (1) ARE DIRECTED TO PREEXISTING PRODUCTS OF NATURE (2) EXCLUDE OTHERS FROM OBSERVING, CHARACTERIZING OR ANALYZING THESE PRODUCTS OF NATURE BY ANY MEANS WHATSOEVER; AND (3) CREATE AN INSURMOUNTABLE BARRIER TO SCIENTIFIC PROGRESS AND TECHNOLOGICAL INNOVATION CONCERNING THESE PRODUCTS OF NATURE
3. A NARROWLY CRAFTED DECISION BY THIS COURT WOULD NOT UNDERMINE THE BIOTECHNOLOGY INDUSTRY AND INSTEAD WOULD FOSTER INNOVATION
CONCLUSION
It is well-accepted in the scientific community that isolated DNA fragments of the human genome – including isolated DNA fragments of the BRCA1 and BRCA2 genes – are found routinely in th human body and are thus patent-ineligible products of Nature. The biotechnology industry would not be substantially affected by a narrowly crafted decision here holding that
1) fragments of human genome DNA are patent-ineligible where the claimed molecules themselves are routinely found in Nature and where the process for purification or synthesis of such molecules iS routine and
(2) cDNAs are patent-eligible.

Susan McBee and Bryan Jones Guest

Posted Thu, February 7th, 2013 10:16 am

The Supreme Court should be mindful of naturally derived products other than nucleic acids when deciding Myriad

The following contribution to our gene patenting symposium come from Susan McBee and Bryan Jones. Ms. McBee is the Chair of the Life Sciences Intellectual Property Team for Baker, Donelson, Bearman, Caldwell, and Berkowitz, P.C. Bryan Jones is a registered patent attorney in the Washington D.C. office of Baker, Donelson, Bearman, Caldwell, and Berkowitz, P.C.  

In April, the Supreme Court will hear oral argument in Association for Molecular Pathology v. Myriad, ostensibly on the question whether so-called “gene patents” satisfy 35 U.S.C. § 101.  However, Myriad is about more than whether “genes” can be patented.  It is about what types of activities justify patent protection.  Does one need to create something that is unlike anything else that has ever existed in order to justify a patent?  Or is it enough to discover something that was previously unknown, remove it from its natural environment, and show that it has a practical application?

This is a critical question to the biotechnology industry, because many biotechnological products are not novel chemical structures, but naturally occurring products.  Between 1981 and 2006, approximately forty percent of all pharmaceuticals approved for use by the FDA were a biologic, natural product, or derived from a natural product.  Moreover, for start-up biotechnology companies, patents covering such products are incredibly important, “as they are often the most crucial asset they own in a sector that is extremely research-intensive and with low imitation costs.” Strong and enforceable patents to these core products therefore are vitally important to the healthy development of the biotechnology industry.

Before the Myriad case, the Court has not had an opportunity to consider the patentability of such products.  Therefore, this case has the potential to have an enormous impact on the viability of the business model in this industry.

In Myriad, Judge Lourie and Judge Moore both found “isolated” nucleic acids to be patentable, but for different reasons.  Judge Lourie was convinced that isolated nucleic acids are patentable because isolation “breaks covalent bonds” relative to the longer native nucleic acid, thereby resulting in a new chemical entity.  Judge Moore reasoned that, if analyzed on a blank slate, she would require the product to have a “substantial new utility” relative to its natural function in order to satisfy 35 U.S.C. § 101.  While we agree that the generation of a novel chemical entity or demonstration of a new utility would be sufficient to satisfy 35 U.S.C. § 101, we do not believe these to be necessary requirements.

Consider, for example, Taq polymerase.  The inclusion of Taq into a process called polymerase chain reaction (PCR) has often been credited as being the single most important technological advance to the modern biotechnology industry.  PCR uses repeated cycles of increasing and decreasing temperatures in the presence of a polymerase to amplify a target nucleic acid.  In the original iteration of PCR, new polymerase enzyme had to be added to the reaction mixture after each heat cycle, because the high temperature permanently deactivated the enzyme.  Taq, however, is heat stable and thus does not lose activity when subjected to high temperatures.  Because of this stability, Taq only needs to be added to a PCR reaction mixture once, thus greatly reducing the costs and the time of performing the process, and permitting easy automation.  Clearly, then, the identification and characterization of this enzyme is a significant technological advance, from which the public obtains a significant benefit.  Yet the properties of Taq that make it so attractive for PCR are a consequence of its structure and function in the natural world.  Taq is naturally produced by Thermus aquaticus, a bacterium that is naturally found in hot springs.  Therefore, in nature, just like in PCR, Taq functions as a thermostable enzyme that catalyzes the amplification of a nucleic acid.  Why should this render Taq unpatentable?

The Constitution does not require a claimed compound to have a formally “new” chemical structure or new function to justify a patent.  Article I, section 8 of the Constitution authorizes patents “[t]o promote the Progress of Science and useful Arts . . . .”  As explained by the Court:

Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available.  Innovation, advancement, and things which add to the sum of useful knowledge are inherent requisites in a patent system which by constitutional command must ‘promote the Progress of useful Arts.’  This is the standard expressed in the Constitution and it may not be ignored.

Thus, the Constitution only limits patents that “remove existent knowledge from the public domain” or “restrict free access to materials already available.”  Assuming that Taq was not previously known, a claim to it in isolated form simply cannot “remove existent knowledge from the public domain.”  Because Taq naturally exists only in the context of a living organism, claiming it in “isolated” form cannot “restrict free access to” its source.  Thus, constitutional limits cannot justify a prohibition on patents covering isolated naturally occurring products.

Nor does 35 U.S.C. § 101 clearly prohibit such patents.  The statute specifically encompasses “discoveries,” so long as those discoveries relate to processes, compositions of matter, or articles of manufacture that are “new” and “useful.”  In most cases, naturally occurring products are found in very minute quantities in complex association with other molecules inside living organisms.  The act of isolating the natural product removes them from this context, thereby inevitably resulting in a composition that is materially different than anything that exists in nature.  An “isolated” natural product therefore is “new” compared to the same product in its natural state.  Its discovery thus could justify a claim under 35 U.S.C. § 101.

Finally, Supreme Court precedent does not clearly prohibit patenting of such claims.  Under the closest Supreme Court precedent, a patent that is limited to a “non-naturally occurring article of manufacture or composition of matter” satisfies 35 U.S.C. § 101.  Although it is often convenient to describe naturally occurring compounds in terms of chemical structure or nucleotide or amino acid sequence, they rarely if ever exist in nature as isolated compositions.  Rather, they are found in complex associations with other compositions, usually within living organisms.  The removal of these products from their natural context sometimes results in distinct chemical entities, such as the isolated nucleic acids in Myriad.  Other times, the result is a highly purified form of the compound, such as isolated adrenaline or purified vitamin B12.  In each case, however, the intervention of man is required to produce the “isolated” composition.  Claims directed to “isolated” natural compounds thus are limited to purely artificial, non-naturally occurring compositions of matter.  This should make them patentable, irrespective of whether they have a novel chemical structure or new utility in isolated form.

It is our sincere hope that the Court will not only find isolated nucleic acids to be patentable, but that it will do so under a rationale which allows for other naturally derived products to similarly be patentable.  In as much as a possible test can be garnered, our recommendation is to find that a naturally derived product satisfies 35 U.S.C. § 101 as long as it is claimed in a purely man-made form (and thus is “new”), and the form in which it is claimed has a practical utility disclosed in the Specification (and thus is “useful”).  This test closely aligns with the plain language of 35 U.S.C. § 101.  Challenges to the eligibility of such claims could then focus on two clear issues: (1) whether the claim encompasses the product in its natural state; and (2) whether the claim is reasonably commensurate in scope with the disclosed utility (i.e., is the claim narrowly tailored to products that possess the disclosed utility?).  This allows overly broad claims to be invalidated without resorting to a categorical ban on a broad class of subject matter.  Moreover, it would not require courts to answer the philosophical question of whether something has enough of a structural or functional change to justify a patent.

Posted in Association for Molecular Pathology v. Myriad GeneticsFeaturedGene Patenting Symposium

Recommended Citation: Susan McBee and Bryan Jones, The Supreme Court should be mindful of naturally derived products other than nucleic acids when deciding Myriad, SCOTUSblog (Feb. 7, 2013, 10:16 AM), http://www.scotusblog.com/2013/02/the-supreme-court-should-be-mindful-of-naturally-derived-products-other-than-nucleic-acids-when-deciding-myriad/

– See more at: http://www.scotusblog.com/?p=159001#sthash.UGzQgi2x.dpuf

Appeals Court Affirms Isolated DNA Patents in Myriad Case

August 16, 2012

NEW YORK (GenomeWeb News) – A federal appeals court today has for a second time reversed a lower district court’s decision that isolated genes are not patentable, but it also partly affirmed the District Court’s decision that certain methods patents “comparing” or “analyzing” gene sequences may not be patentable.

The Supreme Court recently asked the US Court of Appeals for the Federal Circuit to reconsider its earlier decision in the case, The Association for Molecular Pathology v. the US Patent and Trademark Office and Myriad Genetics, in light of its ruling in another lawsuit, called Mayo Collaborative Services v. Prometheus Laboratories.

AMP v USPTO focuses on the patentability of Myriad Genetics’ claims on isolated gene sequences and diagnostic methods related to its BRACAnalysis test. In Mayo v Prometheus, the Supreme Court recently invalidated patents held by diagnostics firm Prometheus because they merely described laws of nature, and did not apply those laws of nature in a markedly different manner as to warrant a patent.

Despite the Supreme Court’s ruling in Mayo, the CAFC in a 2-1 decision maintained that although isolated gene sequences may be derived from naturally occurring substances, their isolation requires human intervention in order to make them useful in medical care and so are deserving of patent protection.

“We are very pleased with the favorable decision the Court rendered today which again confirmed that isolated DNA is patentable,” Myriad Genetics President and CEO Peter Meldrum said in a statement. “Importantly, the court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity.”

The decision was met with disappointment by those opposing gene patenting.

“It is extremely disappointing that despite the Supreme Court’s ruling, the appeals court has failed to fully re-consider the facts of this case,” Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project, said in a statement.

The case against Myriad was filed in 2009 by the Public Patent Foundation, American Civil Liberties Union, AMP, and others who claim that patents cannot cover natural phenomena and that Myriad’s patents, and others like them, will hinder genetics research and keep some people from accessing tests and second opinions.

“This ruling prevents doctors and scientists from exchanging their ideas and research freely,” Hansen added the ACLU statement today. “Human DNA is a natural entity like air or water. It does not belong to any one company.”

Myriad said again today what it has argued all along, that gene patents have not thwarted research, that the cost of its BRACAnalysis test is not prohibitive and is covered through most insurance for “appropriate” patients, and that second opinion testing is available in many US labs.

“Certainly, you could hear a collective sigh of relief from the biotech industry, as of this decision,” Jennifer Camacho, an attorney and shareholder with law firm Greenberg Traurig, told GenomeWeb Daily News today.

“Isolated DNA patents remain intact. We still have patent eligibility for isolated DNA,” Camacho said, explaining that the court’s decision to uphold the patentability of isolated DNA may be seen by the biotech industry as more important than its reading of the reach of the Prometheus decision.

“They did actually take [the Prometheus decision] into consideration,” Camacho said, adding that it did not change the judges’ analysis.

“This puts a narrow interpretation of Prometheus in the books, as being limited to the ‘laws of nature’ exclusion, she added.

Camacho told GWDN that she was struck by how similar today’s CAFC ruling was to the original. She pointed out that part of one judge’s opinion, which argued that whether some patents should or should not be awarded are policy questions that are best left to Congress, was the same language as in the first opinion.

For Myriad, the ruling provided mixed results, Goldman Sachs Investment Research analyst Isaac Ro said in a note today.

On the positive side for Myriad, the patent eligibility of its BRCA1 and BRCA2-based tests was upheld again based on its isolated DNA claims and screening method claims. But a potential negative is that the CAFC also upheld the District Court’s opinion that Myriad’s method claims for comparing DNA sequences are not eligible.

“The outcome is modestly disappointing,” Ro stated, adding that the critical question now is whether or not the Supreme Court will agree to hear the case next year.

US Supreme Court Agrees to Hear Myriad Patent Case Again

NEW YORK (GenomeWeb News) – The US Supreme Court decided on Friday to once again hear the American Civil Liberty Union’s case against Myriad Genetics challenging the firm’s patent rights related to BRCA1 and BRCA2 genes.

The decision by the court to hear the case — originally filed by ACLU, the Public Patent Foundation, the Association for Molecular Pathology and others in 2009 — comes a little more than three months after a federal appeals courtissued a mixed ruling in which it found that isolated genes are patentable, but that certain methods patents that compare or analyze gene sequences may not be.

The US Court of Appeals for the Federal Circuit issued its decision in August after the Supreme Court asked it in March to reconsider a decision rendered by the appeals court in 2011 in light of the Supreme Court’s decision in another case, Mayo Collaborative Services v. Prometheus Laboratories. In that case, the Supreme Courtinvalidated patents held by Prometheus, saying the patents merely described laws of nature but did not apply those laws of nature in a markedly different manner as to warrant a patent.

The appeals court originally ruled in July 2011 that Myriad’s patents covering isolated DNA are patentable under Section 101 of the US Patent Act, reversing a decision by the Federal District Court for the Southern District of New York that isolated DNA is not much different from gene sequences found in nature and therefore is not patentable.

This past September, ACLU and the Public Patent Foundation asked the Supreme Court to once again take up the issue of whether Myriad’s claims on genes that predict the risk of ovarian and breast cancer can be patented. ACLU and the foundation contend that Myriad’s BRCA1 and BRCA2 gene patents should be invalidated because the genes are products of nature and allowing Myriad patent protection stifles scientific research and patient access to medical care.

“Myriad did not invent human genes, and has no right to claim ownership of them just because they removed them from the body,” Daniel Ravicher, executive director of PUBPAT, said in a statement on Friday. “The government does not have the right to give a corporation the exclusive power to control what we know about our own genetic makeup.”

Myriad President and CEO Peter Meldrum said in a statement, however, that patent protection is necessary to drive technological innovation.

“Two previous decisions by the Federal Circuit Court of Appeals confirmed the patentability of our groundbreaking diagnostic test that has helped close to 1 million people learn about their hereditary cancer risk,” he said. “Myriad devoted more than 17 years and $500 million to develop its BRACAnalysis test. The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our US patent system is the engine that drives this innovation.

“This case has great importance for the hundreds of millions of patients whose lives are saved and enhanced by the life science industry’s products,” he said.

Read Full Post »


 

Reporter: Aviva Lev-Ari, PhD, RN

Arti Rai, J.D.

N Engl J Med 2012; 367:491-493  August 9, 2012

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch–Waxman Act, aims to strike a balance between the innovation incentives provided by patents and the greater access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the Food and Drug Administration (FDA) drug-approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Now, the tactical landscape has shifted again, with a recently decided Supreme Court case, Caraco Pharmaceutical Laboratories v. Novo Nordisk.

Under current FDA regulations, the developer of a brand-name drug must submit all patents that it deems to cover the drug to the FDA for publication in the agency’s Approved Drug Products with Therapeutic Equivalence Evaluations — the so-called Orange Book. Before marketing a generic version of a drug, the generics manufacturer must certify that all Orange Book patents for the brand-name product are invalid, are not infringed by the generic product, or have expired. Certifications that patents that are invalid or not infringed, known as Paragraph IV certifications, allow the brand-name drug maker to sue the generics manufacturer to resolve questions of validity and infringement. As a result, FDA approval of the generic drug can be delayed for up to 30 months pending legal resolution.

Orange Book listings can include both product patents on small-molecule chemicals and patents on methods of use for treating particular conditions. FDA regulations require that, in addition to patent numbers and expiration dates, method-of-use patents must have “use codes” that describe their scope.

Frequently, the main product patent on a brand-name drug expires before the use patents do. In that case, FDA regulations based on Hatch–Waxman allow generics firms the option of filing a “section viii statement,” which “carves out” from the generic label those uses on which the brand-name firm still has patents. If the FDA finds this narrower labeling acceptable from the standpoint of safety and efficacy, the generic version has a potential path to market.

Brand-name drug manufacturers have sometimes tried to sue to prevent market entry by generics companies that file section viii statements, typically arguing that although a generics firm may not be directly infringing a use patent, it should be prohibited from marketing its product because such marketing will inevitably “induce” infringement. In other words, the generic-substitution practices of doctors and pharmacists — encouraged by FDA approval of “carved-out” generics as fully substitutable for brand-name drugs and by laws in many states — will inevitably lead to prescription of generic drugs for patented uses. Moreover, brand-name pharmaceutical firms argue that generics firms should be held liable because they are well aware that their products will be prescribed and dispensed in an infringing manner.

The Court of Appeals for the Federal Circuit, the intermediate appellate court for patent cases, has held that as a procedural matter, courts may hear suits brought by brand-name firms in response to a section viii statement filing. However, it has generally rejected the substantive claim of induced infringement, holding that because inducement requires more than mere knowledge that infringement is occurring, the generics firm cannot be held liable unless it specifically promoted the drug for a carved-out use.1

In recent years, carve-out labeling has assumed a prominent role in facilitating market entry of generics. For example, in fiscal year 2010, the FDA approved 11 generic drugs with carve-out labeling. In fact, 3 of the 5 top-selling brand-name drugs that “went generic” that year did so as a consequence of such labeling.2

On occasion, brand-name drug manufacturers have attempted to defeat carve-out attempts by listing use codes that substantially exceed the scope of the use patent. This tactic can be effective, since the FDA does not evaluate representations of patent information in use codes.3

In April 2012, however, the Supreme Court issued a decision enabling generics firms to challenge the submission to the FDA of overly broad use claims. In Caraco, Novo Nordisk’s only unexpired patent covered a relatively narrow use — treating non–insulin-dependent diabetes by combining its diabetes drug repaglinide with another drug, metformin. In the Orange Book, however, Novo Nordisk listed a much broader use code that covered all methods for “improving glycemic control in adults with type 2 diabetes mellitus,” thereby denying generics firms a meaningful carve-out.

The key question in this case was whether amendments to Hatch–Waxman implemented in 2003 allowed generics firms, in the course of a patent-infringement lawsuit brought by the brand-name company, to file a counterclaim to correct overly broad listings of Orange Book use codes. The unanimous opinion of the Court, delivered by Justice Elena Kagan, held that the amendments were indeed intended to correct such overbreadth. As Kagan noted, absent the ability to correct overbreadth, a company could not market a generic drug for noninfringing uses.

As a matter of statutory interpretation, the Supreme Court decision is correct. Both the language and legislative history of the 2003 amendments indicate that Congress intended to control inaccurate Orange Book listing practices with respect to product patents and method-of-use patents. Such misleading practices had been thoroughly documented in a 2002 Federal Trade Commission report. However, as Justice Sonia Sotomayor‘s concurrence points out, the mechanism provided by Congress is far from optimal. A claim to correct overbreadth can be filed only if the generics firm chooses to provoke litigation by filing a Paragraph IV certification and the brand-name firm then sues for infringement. An administrative approach to determining the accuracy of Orange Book listings — an approach in which the FDA might, for example, consult with the Patent and Trademark Office — would clearly be more efficient.

Lurking behind these technical legal disputes over carve-outs, induced infringement, and overly broad Orange Book listings is the broader policy issue of providing incentives to search for new uses. Brand-name pharmaceutical companies argue that the pervasive distribution of generic drugs for patented uses substantially undermines the efficacy of such patents and hence the incentives for finding other uses.4

Strong incentives are probably unnecessary for purposes of generating hypotheses regarding new uses. The heavy prevalence of off-label prescribing — which accounted for more than 20% of prescriptions written by office-based physicians in 2001, according to one study5 — suggests that hypotheses are pervasive. The incentives question is important, however, because the ultimate objective, from the standpoint of both patient welfare and cost, is reliable evidence of efficacy. Such evidence, which is required before the FDA can approve labeling (or allow marketing) for a new use, is generated through investment in well-designed trials.

Such investment need not emerge, however, only from individual firms operating in secrecy and motivated by patents. Indeed, one recent study found that publicly funded research formed the foundation for almost all the new-use FDA approvals that were examined.6 Going forward, the public sector’s role is likely to increase — the new National Center for Advancing Translational Sciences at the National Institutes of Health has explicitly embraced the search for new uses in a number of the programs it is funding.

In many arenas of innovation, proprietary research models supported by intellectual property and publicly funded open research models not only coexist, they play mutually reinforcing, synergistic roles. Brand-name firms could view Caraco‘s partial restriction on their deployment of overly broad use claims as an opportunity to rely less on dubious legal tactics and more on the pursuit of opportunities to leverage public-sector investment.

Disclosure forms provided by the author are available with the full text of this article at NEJM.org.

SOURCE INFORMATION

From the Duke University School of Law, Durham, NC.

REFERENCES

    1. 1

      Warner-Lambert Co. v. Apotex, 315 F.3d 1348 (Fed. Cir. 2003).

    1. 2

      Brief for the United States as amicus curiae supporting petitioners, Caraco v. Novo-Nordisk, 2011.

    1. 3

      68 Fed. Reg. 36683 (2003).

    1. 4

      Eisenberg RS. The problem of new uses. Yale J Health Policy Law Ethics 2005;5:717-739

    1. 5

      Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021-1026

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    Stevens AJ, Jensen JJ, Wyller K, Kilgore PC, Chatterjee S, Rohrbaugh ML. The role of public-sector research in the discovery of drugs and vaccines. N Engl J Med 2011;364:535-541

 

 

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