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Archive for the ‘Patent Law in Biotech’ Category


CRISPR Patent Battle Determined on 2/15/2017 – USPTO issues a verdict in legal tussle over rights to genome-editing technology

Curator: Aviva Lev-Ari, PhD, RN

Broad Institute prevails in heated dispute over CRISPR patents

Sharon Begley sharon.begley@statnews.com
@sxbegle

In a one-sentence judgment by the Patent Trial and Appeal Board, the three judges decided that there is “no interference in fact.” In other words, key CRISPR patents awarded to the Broad beginning in 2014 are sufficiently different from patents applied for by UC that they can stand. The judges’ full 51-page decision explaining their reasoning stated that the Broad had persuaded them “that the parties claim patentably distinct subject matter.”

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

MIT

The Broad said in a statement that the decision “confirms that the patents and applications of Broad Institute and UC Berkeley are about different subjects and do not interfere with each other.”

UC, Berkeley

In a statement, the University of California said it was pleased that its patent application, which it described as covering “the invention and use of CRISPR gene editing in all cells,” can move forward. “We continue to maintain that the evidence overwhelmingly supports our position that the Doudna/Charpentier team was the first group to invent this technology for use in all settings and all cell types,” it said, “and that the Broad Institute’s patents directed toward use of the CRISPR-Cas9 system in particular cell types are not patentably distinct from the Doudna/Charpentier invention.”

UC said it is considering its legal options, including the possibility of an appeal, but it contended that anyone who wants to develop CRISPR-based treatments for human diseases would have to license not only the Broad’s patents but also those that UC expects to be awarded. “Ours,” Doudna told reporters, “is for the use [of CRISPR] in all cells,” including human ones.

PTAB appeals are heard by the US Court of Appeals for the Federal Circuit, which sits in Washington. In recent years, more than half of PTAB’s decisions have been upheld.

“The Federal Circuit heard three appeals of interferences in 2016,” said Sherkow. “All three were at least affirmed in part. It’s completely unclear whether that’s meaningful — it’s an N of 3–but there you go.” Overall, on 155 appeals since PTAB was created in 2012, the Federal Circuit affirmed 120 on every issue, dismissed or reversed 21 on every issue, and issued partial decisions (that is, upholding parts of a PTAB decision and reversing others) in the other 14.

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

Said UC attorney Lynn Pasahow:

For “all tennis balls,” read “all cells.” For “green tennis balls,” read “eukaryotic cells.”

https://www.statnews.com/2017/02/16/crispr-patent-decision-six-takeaways/

 

What will that mean for licensees of CRISPR patents?

Stanford University Voice

UC believes that any company that wants to use CRISPR to develop human therapies — we’re looking at you, Editas Medicine — will need to license not only the Broad’s patents on eukaryotic cells but also those UC expects to receive on all kinds of cells. “It looks to me as if someone wanting to use the Broad patent would also have to license the UC patent,” agreed law professor Hank Greely of Stanford University. “The UC patent (if granted) would be on any use; the Broad would be on use in eukaryotes. I think someone who wanted to do this in eukaryotes would need to have licenses to both.”

CRISPR-Cas9 is unlikely to be the last genome-editing technology ever discovered. In 2015, Zhang and his colleagues discovered a version called Cpf1, which they’ve now patented and licensed to Editas. “I continue to think the possibility of inventing around the [CRISPR] patents seems very likely,” said Stanford’s Greely. Bacteria “have certainly come up with other ways to reach the same end [of genome editing], ways that aren’t covered by UC’s or the Broad’s claims. That could make either of these patents ultimately of little importance … especially if the licensing conditions give people a strong incentive to come up with invent-arounds.” Science will march on.

https://www.statnews.com/2017/02/16/crispr-patent-decision-six-takeaways/

What does the CRISPR ruling mean for biotech?

By DAMIAN GARDE @damiangarde

FEBRUARY 15, 2017

Editas Medicine, which has aligned with the winning Broad, saw its share price rise more than 25 percent on Wednesday. Intellia Therapeutics, affiliated with UC, fell about 11 percent, while compatriot CRISPR Therapeutics dipped 24 percent.

https://www.statnews.com/2017/02/15/what-does-the-crispr-ruling-mean-for-biotech/

 

Broad Institute wins bitter battle over CRISPR patents

The US Patent and Trademark Office issues a verdict in legal tussle over rights to genome-editing technology.

15 February 2017 Updated:In December 2016, lawyers representing the University of California and the Broad Institute participated in oral arguments before a trio of patent-court judges. University of California attorney Lynn Pasahow said that the team had not yet decided whether it would appeal the verdict on 2/15/2017.

Lawyers representing the University of California filed for an ‘interference’ proceeding, in an effort to have the Broad’s patents thrown out. But on 15 February, patent judges determined that there was no interference, meaning that the Broad’s invention is distinct from that of the University of California, and the Broad patents will stand. The University of California’s patent application will now be referred back to an examiner, but legal challenges could continue.

molecular biologist Jennifer Doudna of the University of California in Berkeley, likened the situation to licensing permission to someone who wants to use green tennis balls. “They will have a patent on the green tennis balls,” she said, referring to the Broad patents. “We will have a patent on all tennis balls.” ”Doudna argued at the press conference that the patent battle had not hampered research, given the speed with which researchers had taken up the technique and companies had rushed to commercialize it.”

The University of California’s invention would cover the design of the RNA molecule that guides the key step in CRISPR–Cas9 gene editing, directing the Cas9 enzyme to a specific site in the genome. But getting that system to work in eukaryotes was an additional inventive step, Coombes says, a patent lawyer at intellectual-property specialists HGF in York, UK.

SOURCE

Nature doi:10.1038/nature.2017.21502

http://www.nature.com/news/broad-institute-wins-bitter-battle-over-crispr-patents-1.21502?WT.ec_id=NEWSDAILY-20170216%20

https://www.statnews.com/2017/02/15/crispr-patent-ruling/#decision

Related articles from nature.com

Other related articles published in this Open Acceaa Online Scientific Journal include the following:

UPDATED – Status “Interference — Initial memorandum” – CRISPR/Cas9 – The Biotech Patent Fight of the Century: UC, Berkeley and Broad Institute @MIT

Reporter: Aviva Lev-Ari, PhD, RN

 

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On Investment Platforms for Private Funds and Investment Platforms for Private Placements – SEC Update

Reporter: Aviva Lev-Ari, PhD, RN

 

SEC Update

In the last few years, we have seen a number of important developments in the securities laws related to finders and broker-dealer registration requirements. Below we provide an overview of the broker-dealer registration requirement as it relates to finders who assist in matching issuers with investors or buyers and the latest developments in this area.

Overview

The distinction between being classified as a finder and a broker-dealer can have significant consequences. An unregistered broker-dealer may face sanctions from the Securities and Exchange Commission (SEC), and it may be unable to enforce payment for its services. In addition, transactions involving an unregistered broker-dealer may create a right of rescission in favor of the investors, allowing the investors the right to require the issuer to return the money invested. One example of the consequences of an unregistered broker-dealer occurred in the Ranieri Partners SEC enforcement action. In that action the SEC brought charges against a private-equity firm, its managing director, and a consultant because of the consultant’s failure to register as a broker-dealer. The SEC’s order found that the private equity firm paid transaction-based fees to a consultant, who was not registered as a broker-dealer, for soliciting investors for private fund investments.1

The federal securities laws do not specifically define the term “finder” or outline what finders can do. Instead, finders must avoid being deemed a broker or dealer under the federal securities laws unless they register as such with the SEC and the Financial Industry Regulatory Authority (FINRA). A broker is defined as “any person engaged in the business of effecting transactions in securities for the accounts of others.”2 A dealer is defined as a person that is “engaged in the business of buying and selling securities … for such person’s own account,” but excludes a person that buys and sells securities for its own account, but not as part of a regular business.3Because the broker definition is the one that finders have the most trouble with, this discussion is focused on what activities may cause a finder to fall within the definition of a broker required to register with the SEC and FINRA.

  • M&A Brokers
  • FINRA Guidance
  • Investment Platforms for Private Placements
  • Investment Platforms for Private Funds
  • Crowdfunding
  • Potential Regulatory Action
Conclusion

A determination of whether an intermediary is acting as a finder or an unregistered broker-dealer is a very fact-specific analysis and can often be very complex. Unfortunately for unwary entrepreneurs, company executives, and equity fund sponsors, frequently a third party assisting with capital-raising will be acting as a broker-dealer, not a finder, and therefore should not be engaged unless properly registered. It is likely that we will see further clarification or new rules from regulators in the future; regardless, it is important to always carefully consider the involvement of finders or broker-dealers in any capital-raising endeavor.

If you have any questions regarding the use of finders, or capital raising in general, please contact the Venable lawyer with whom you work, one of the authors of this article, or a member of our Corporate Finance and Securities Group.

SOURCE
https://www.venable.com/finders-and-unregistered-broker-dealers-12-04-2015/?utm_source=Mondaq&utm_medium=syndication&utm_campaign=View-Original

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Forward Pharma settled with Biogen on their patent dispute on active ingredient for MS Tecfidera (dimethyl fumarate): Biogen will pay $1.25 billion upfront, level of royalties TBD

Reporter: Aviva Lev-Ari, PhD, RN

 

Biogen will pay $1.25 billion upfront, but the level of royalties will be dependent on the interference proceeding hearing decision. The royalty rate could range from 1% to 10%, and could increase to as high as 20%, depending on the outcome – Forward Pharma settled with Biogen on their patent dispute regarding the active ingredient for the blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate).

 

SOURCE

http://www.biopharmadive.com/news/biogen-settles-in-tecfidera-patent-case/434138/

Biogen’s Tecfidera faces outside pressure

http://www.biopharmadive.com/news/biogen-tecfidera-patent-forward-court/431486/

 

Biogen and Forward Pharma Agree to Enter into Settlement and License Agreement

Biogen to Pay $1.25B in Exchange for License Agreement to Forward Pharma Intellectual Property

Future Payment of Royalties Subject to Resolution of Ongoing Patent Procedures in US and EU

Category:

Tuesday, January 17, 2017 7:30 am EST
“We are very pleased to have reached this settlement with Forward Pharma. We believe this agreement will clarify and strengthen our intellectual property for TECFIDERA, the leading oral therapy for multiple sclerosis”

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Biogen Inc. (NASDAQ: BIIB) today announced that it has agreed to enter into a settlement and license agreement with Forward Pharma, subject to the approval of Forward Pharma’s shareholders and other customary conditions. The license agreement will provide Biogen an irrevocable license to all intellectual property owned by Forward Pharma.

Upon the effectiveness of the settlement and license agreement, Biogen will provide Forward Pharma a cash payment of $1.25 billion. Under certain circumstances outlined in the agreement, Biogen will pay Forward Pharma royalties on net sales of Biogen products for the treatment of multiple sclerosis that are covered by a Forward Pharma patent and have dimethyl fumarate (“DMF”) as an active pharmaceutical ingredient.

“We are very pleased to have reached this settlement with Forward Pharma. We believe this agreement will clarify and strengthen our intellectual property for TECFIDERA, the leading oral therapy for multiple sclerosis,” said Michel Vounatsos, Chief Executive Officer of Biogen.

The settlement and license agreement does not resolve the issues pending in the ongoing Interference Proceeding in the U.S. or the Opposition Proceeding in the EU. Biogen and Forward Pharma intend to permit the Patent Trial and Appeal Board (PTAB), the U.S. Court of Appeals for the Federal Circuit, the European Patent Office, and the Technical Board of Appeal and the Enlarged Board of Appeal, make a final determination in the proceedings before them.

Summary of Details and Conditions of the Agreement

The agreement to enter into a settlement and license agreement (the “License Agreement”) announced today was reached between Biogen’s wholly owned subsidiaries, Biogen Swiss Manufacturing GmbH and Biogen International Holding Ltd., and Forward Pharma A/S, a Danish limited liability company (“Forward Pharma”) and additional related parties and is subject to the approval of Forward Pharma’s shareholders and other customary conditions. The approval of two-thirds of Forward Pharma’s voting share capital is required to approve the License Agreement. Shareholders representing approximately 77% of Forward Pharma’s voting share capital have irrevocably agreed to vote in favor of the License Agreement. Forward Pharma has agreed to convene an extraordinary general meeting on February 1, 2017 to obtain the approval of its shareholders.

The License Agreement will have a perpetual term and provide for the grant to Biogen of an irrevocable, co-exclusive license to all intellectual property owned by Forward Pharma in the U.S. (the “U.S. Licensed Intellectual Property”). The co-exclusive U.S. license may be converted into an irrevocable exclusive license subject to the conditions in the License Agreement, which include the absence of legal restraints and the receipt of all necessary regulatory approvals. The License Agreement will also provide for the grant to Biogen of an irrevocable, exclusive license to all intellectual owned by Forward Pharma anywhere else in the world (collectively, the “Designated Countries Licensed Intellectual Property”).

Upon the execution and delivery of the License Agreement, Biogen will pay Forward Pharma a non-refundable cash payment of $1.25 billion which will not affect Biogen’s 2016 Non-GAAP financial results. Under certain circumstances, Biogen will also be obligated to pay Forward Pharma future royalties on net sales of Biogen products for the treatment of multiple sclerosis that are covered by a Forward Pharma patent and have dimethyl fumarate (“DMF”) as an active pharmaceutical ingredient.

Biogen will only be obligated to pay Forward Pharma royalties in the U.S. if Forward Pharma obtains patent rights covering treatment of a human for multiple sclerosis by orally administering 480 mg per day of DMF arising from the interference proceeding between the Company and Forward Pharma that is currently pending at the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (the “Interference Proceeding”). If royalties are payable in the U.S. and Biogen holds a co-exclusive license, a royalty of 1% will be payable from January 1, 2023 until the earlier of the expiration, unenforceability or invalidation of the patents included in the U.S. Licensed Intellectual Property. If Biogen holds an exclusive license, a royalty of 10% will be payable from January 1, 2021 to December 31, 2028 and a royalty of 20% will be payable from January 1, 2029 until the earlier of the expiration, unenforceability or invalidation of the patents included in the U.S. Licensed Intellectual Property.

Biogen will only be obligated to pay Forward Pharma royalties in countries other than the U.S. if Forward Pharma obtains patent rights covering treatment of a human for multiple sclerosis by orally administering 480 mg per day of DMF in the opposition proceeding against Forward Pharma’s European patent EP 2801355 (Application No. 14172398.1) (the “Opposition Proceeding”). If royalties are payable in countries other than the U.S., a royalty of 10% of Net Sales of applicable infringing products will be payable on a country-by-country basis, from January 1, 2021 to December 31, 2028, and a royalty of 20% will be payable on a country-by-country basis from January 1, 2029 until the earlier of the expiration, unenforceability or invalidation of the patents included in the Designated Countries Licensed Intellectual Property in each country.

The License Agreement does not resolve the issues pending in the Interference Proceeding or the Opposition Proceeding. Biogen and Forward Pharma intend to permit the PTAB and the U.S. Court of Appeals for the Federal Circuit, as applicable, and the European Patent Office and the Technical Board of Appeal and the Enlarged Board of Appeal, as applicable, to make a final determination in the proceedings before them.

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.

Safe Harbor

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to: Biogen’s commercial business, the obligation to make, the anticipated amount of, and the timing of, royalty payments under the License Agreement, the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to patents and other proprietary and intellectual property rights, the strength and value of intellectual property rights, and the approval of the License Agreement and the transactions contemplated by the License Agreement by Forward Pharma’s shareholders and regulatory authorities and tribunals. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: risks relating to management and key personnel changes; failure to compete effectively; difficulties in obtaining and maintaining adequate coverage, pricing and reimbursement for our products; potential future healthcare reforms; the occurrence of adverse safety events; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; uncertainty of success in developing, licensing or acquiring other product candidates or additional indications for existing products; and other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC.

These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

Contact:

Biogen Media Contact:
Biogen Inc.
Jason Glashow, 781-464-3260
or
Biogen Investor Contact:
Biogen Inc.
Matt Calistri, 781-464-2442

SOURCE

http://media.biogen.com/press-release/investor-relations/biogen-and-forward-pharma-agree-enter-settlement-and-license-agreem

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