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Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting


 

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Achievement Beyond Regulatory Approval – Design for Commercial Success

philly2nightStephen J. Williams, Ph.D.: Reporter

The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.

The meeting was divided into three panel discussions and keynote speech:

  1. Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
  2. Panel 2: Design for Market Success– Commercial Strategy Planning
  3. Panel 3: Design for Investment– Financing Each Stage
  4. Keynote Speaker: Robert Radie, President & CEO Egalet Corporation

Below are Notes from each PANEL Discussion:

For more information about the Life Sciences Collaborative SEE

Website: http://www.lifesciencescollaborative.org/

Or On Facebook

Or On Twitter @LSCollaborative

Panel 1: Design for Market Protection; Intellectual Property Strategy Planning

Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.

Panelists:

John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University

Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents

Ryan O’Donnell; Partner Volpe & Koenig

Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC

Notes:

Dr. Nag:

  • Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
  • Naked patent licenses are most profitable when try to sell IP

John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.

  • 30-40% of Princeton’s IP portfolio is related to life sciences
  • Universities will prefer to seek provisional patent status as a quicker process and allows for publication
  • Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
  • Good to cast a wide net when looking at early development partners like pharma
  • Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
  • Last 2 years many universities filing patents for startups as a micro-entity

Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.

Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective

  • Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
  • Good to make a contractual bundle of IP – “days of the $million check is gone”
  • Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR

Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act

  • Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
  • Diagnostics and genes not patentable now – Major shift in patent strategy
  • Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP

Panel 2: Design for Market Success; Commercial Strategy Planning

Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.

Panelists:

David Blaszczak; Founder, Precipio Health Strategies

Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals

Paul Firuta; President US Commercial Operations, NPS Pharma

 

Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia

 

Notes:

David Blaszczak:

  • Commercial payers are bundling payment: most important to get clarity from these payers
  • Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
  • When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area

Terri Bernacchi:

  • Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
  • Value-based contracting with manufacturers can save patient and payer $$
  • As most PBMs formularies are 80% generics goal is how to make money off of generics
  • Patent extension would have greatest impact on price, value

Paul Firuta:

  • NPS Pharma developing a pharmacy benefit program for orphan diseases
  • How you pay depends on mix of Medicare, private payers now
  • Most important change which could affect price is change in compliance regulations

Panel 3: Design for Investment; Financing Each Stage

Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.

Panelists:

Ting Pau Oei; Managing Director, Easton Capital (NYC)

Manya Deehr; CEO & Founder, Pediva Therapeutics

Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation

 

Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance

  • In 2000 his experience finding 1st capital was what are your assets; now has changed to value

Notes:

Ting Pau Oei:

  • Your very 1st capital is all about VALUE– so plan where you add value
  • Venture Capital is a PERSONAL RELATIONSHIP
  • 1) you need the management team, 2) be able to communicate effectively                  (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
  • VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
  • Best advice: show some phase 2 milestones and VC will knock on your door

Manya Deehr:

  • Investment is more niche oriented so find your niche investors
  • Define your product first and then match the investors
  • Biggest failure she has experienced: companies that go out too early looking for capital

Dr. Dutta: funding from a non-profit patient advocacy group perspective

  • Your First Capital: find alliances which can help you get out of “valley of death
  • Develop a targeted product and patient treatment profile
  • Non-profit groups ask three questions:

1) what is the value to patients (non-profits want to partner)

2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)

3) when can we see return

  • Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
  • Have a plan B every step of the way

Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

 

 

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Reported: Aviva Lev-Ari, PhD, RN

Dr. Lev-Ari agrees with Mr. Chris Gladwin:

“Chris thinks that first-to-file and the new Act will better enable new technology businesses and new technology jobs.”

Leahy-Smith America Invents Act Implementation

Beginning on September 16, 2012, the inventor’s oath or declaration provision became effective.  This provision simplifies several of the requirements for filing an inventor’s oath or declaration.  We have summarized the changes relating to the content required to be included in an inventor’s oath or declaration, the situations when an AIA-compliant inventor’s oath or declaration is required, the use of an Application Data Sheet (ADS), delayed submission of an inventor’s oath or declaration, and the process for taking advantage of a combination assignment-statement document.  Stayed tune for more guidance regarding other aspects of the inventor’s oath or declaration provision in the coming weeks concerning the use of various USPTO forms for the inventor’s oath or declaration provision, correction of inventorship, and substitute statements.

Content for an AIA Compliant Inventor’s Oath or Declaration

Section 115 of Title 35, as amended by the AIA, coupled with new USPTO rules, requires an applicant to provide less information in an inventor’s oath or declaration than required by
pre-AIA law.  Specifically, the AIA eliminated the need for identification of the inventor’s country citizenship and a statement that the inventor is the first inventor. The list below identifies the current requirements for an inventor’s oath or declaration based on the AIA:

  • Inventor’s name (in the case of joint inventorship, each inventor may sign his/her own oath or declaration provided that an ADS is filed with the application naming the complete inventive entity), residence, and mailing address;
  • Identification of the relevant application to which the oath or declaration relates;
  • Statement that the application was made or was authorized to be made by the declarant;
  • Statement that such individual believes himself/herself to be an original inventor/joint inventor of a claimed invention in the application; and
  • An acknowledgement of penalties that any willful false statement made in such oath or declaration is punishable under 18 U.S.C. 1001 by fine or imprisonment of not more than 5 years, or both

When to File an AIA-Compliant Inventor’s Oath or Declaration 

An AIA-compliant inventor’s oath or declaration is required for any application filed on or after September 16, 2012.  This covers non-provisional applications, including continuing applications (i.e., continuation, continuation-in-part, divisional, and “bypass” applications) and reissue applications.  A “bypass” application refers to an international (PCT) application filed as a continuing application under 35 U.S.C. 111(a) and 37 C.F.R. 1.53(b) and thus “bypassing” national stage entry under 35 U.S.C. 371.  For an international (PCT) application filed before September 16, 2012, and entering the national stage on or after September 16, 2012, an
AIA-compliant inventor’s oath or declaration is not required.  But for an international (PCT) application filed after September 16, 2012, and entering the national stage after September 16, 2012, an AIA-compliant inventor’s oath or declaration is required.  The table below summarizes the situations when an AIA-compliant inventor’s oath or declaration is needed.

Type of Application Filing Date AIA-Compliant Inventor’s Oath or Declaration Required?
U.S. Application
(non-provisional applications, including continuing and reissue applications)
U.S. filing on or after 9/16/2012 Yes
International “Bypass” Applications
(filed under 35 U.S.C. 111(a))
U.S. filing on or after 9/16/2012
International PCT Applications
(entering National Stage under 35 U.S.C. 371)
PCT filing on or after 9/16/2012

Use of an Application Data Sheet (ADS)

An ADS is a document containing bibliographic information regarding an application, such as the identity of the named inventors, the identity of the applicant if different from the inventors, and any foreign priority or domestic benefit information.

An ADS must be filed with an application where: (i) submission of the inventor’s oath or declaration is to be postponed; (ii) each inventor’s oath or declaration identifies only the inventor (or person) executing that particular oath or declaration and not all of the inventors; (iii) there is a claim for domestic benefit (37 C.F.R. 1.78), or foreign priority claim (37 C.F.R. 1.55)(except foreign priority for national stage applications); or (iv) there is an identification of applicants other than the inventors under 37 C.F.R. 1.46 (except for national stage applications, where the applicant is the person identified in the international stage).

As to situations (i) and (ii), the Office must know the names of all of the inventors before examination begins in order to apply the correct prior art and to make a proper double patenting determination.

As to situation (iii), the Office has centralized the location of foreign priority and domestic benefit claims to the ADS.  This benefits applicants, the public, and the Office by making it easier to find this information.  Further, the Office will recognize such claims only if they appear in the ADS.

As to situation (iv), the Office needs to know who the applicant is, particularly where a power of attorney is being submitted by other than the inventors.

Finally, even when an ADS is not required, it is a best practice to use an ADS to aid in the correct identification of bibliographic information on the filing receipt.  An ADS must be signed by the applicant or the applicant’s representative.

Postponed Submission of an Inventor’s Oath or Declaration

Where an inventor’s oath or declaration or a signed ADS is not submitted on filing of the application, the Office will mail a notice to file missing parts requiring either an oath or declaration, or an ADS.  Surcharge practice has not changed.  Submission of an inventor’s oath or declaration later than the filing date of the application will cause the Office to mail a notice to file missing parts requiring a surcharge if not already paid, even where an ADS is submitted with the application on filing.  Where an ADS has been submitted, the Office will not mail a missing parts notice requiring submission of the inventor’s oath or declaration.  The Office may, however, mail an informational notice to notify the applicant that an inventor’s oath or declaration has not been submitted for each named inventor or that the submitted oath or declaration is non-compliant.  Where the application is otherwise in condition for allowance, the Office will mail a Notice of Allowability with a 3 month non-extendable period to submit the required inventor’s oath or declaration.

Combination Assignment and Inventor’s Oath or Declaration

An assignment document may contain the statements required to be included in an inventor’s oath or declaration and thereby serve as the inventor’s oath or declaration.  The Office reference to such a dual purpose document as an “assignment-statement.”  If an applicant chooses to file an assignment-statement and reduce the number of documents to be submitted to the USPTO for a particular application, the applicant must record the assignment-statement in the USPTO Assignment Database.

To record an assignment-statement in the Office’s Assignment Database, the assignment recordation cover sheet must set forth the application number.  Additionally, the assignment-statement must identify the application to which it relates, such as by name of the inventors, title of the invention, and the attorney docket number on the specification as filed.  See MPEP 602 VI.

The best practice is to file an assignment-statement electronically per the following steps.  First, the applicant should file the application via EFS-Web and immediately obtain the application number.  Second, on the same day that the applicant files the application, the applicant should submit the assignment-statement for recording via the Electronic Patent Assignment System (EPAS).  In EPAS, the applicant should check the box on the assignment recordation cover sheet to indicate that the document is intended to have a dual purpose (i.e., as both an assignment and the inventor’s oath or declaration).  Checking the box on the assignment recordation cover sheet will trigger the Office to place a copy of the assignment-statement into the application file as well as record it in the assignment database.  If the assignment-statement is recorded on the same day that the application is filed, the applicant can avoid paying the surcharge for the delayed filing of the inventor’s oath or declaration.

SOURCE:

http://www.uspto.gov/aia_implementation/index.jsp

FORBES reported on November 13, 2012

The new patent law put into place by the America Invents Act on September 16, 2011, goes into effect Spring 2013. This marks a fundamental change in US patent protection, moving away from the current first-to-invent rule to the international standard, first-to-file.

English: United States Patent Cover from a rea...Will the new patent law endanger American entrepreneurs? (Photo credit: Wikipedia)

“Effectively, this creates a race to the patent office,” according to Patrick Richards of Richards Patent Law PC. “In a race of established, well-funded businesses with defined intellectual property protection strategies (and patent attorneys in-house or working closely with the business) versus entrepreneurs that may not have any experience with the patent system and the funds to pursue robust patent strategies, the advantage clearly goes to the businesses,” Richards said.

Although some aspects of the change are positive, including a reduced fee structure, the entrepreneur, who above all wants to “gain more certainty about their business plan at an early stage,” is likely to find the changes a net negative, Richards said.

“There are a lot of people that think (first-to-file) might favor large businesses, but no one knows how it’s going to affect” the business climate, according to Chas Rampenthal, general counsel at online legal services provider LegalZoom.com.

A solo entrepreneur who follows the rules carefully in acquiring a patent “has a pretty good leg up,” Rampenthal said, noting the law change actually reduces patent fees and possibly quickens the process.

Although companies with more resources can certainly win the race to getting in line, it “doesn’t get them a leg up on doing the inventing themselves.” He said the solo entrepreneur with a great idea remains ahead of the patent game.

What will be the impact on new business creation?

Anna Prata, an interim and turnaround executive who has worked with both Fortune 500 corporations and startups, sees trouble for entrepreneurs and investors alike. Prata says “this shift favors big companies with broad reach, resources and capabilities. They can quickly file while startups without cash on hand will not be able to protect their idea.” Prata thinks that thus far most early stage entrepreneurs didn’t need to make filing a top priority, especially not prior to fundraising, knowing they invented something and could prove it. But with the new law that’s no longer the case. “Why keep innovating if you do not have the resources to file first and claim ownership? It could really inhibit new company creation,” she said.

Prata thinks the impact of the new patent law on venture funding could also be pronounced: “VCs invest on the future promise of technology that will be patented at some point, knowing that if the start up failed they could retain the patented technology as an asset.” If that promise is threatened, she sees less investment dollars on ideas alone.

The End of Entrepreneurs?

Prata is also concerned about the potential effect on the American dream. Historically an entrepreneur could create and a large corporation would buy the entrepreneur’s company – it was cheaper to buy the little guy’s patent than attempt to re-invent it themselves. But what if corporations became a threat to entrepreneurs instead of their salvation as a rich class of buyers?  Why would a corporation buy the entrepreneur’s company if it could come up with a variation on the theme and quickly file its own patent?

Veteran Entrepreneurs Say Bring it On

Veteran entrepreneur Chris Gladwin, founder and CEO of Cleversafe, knows a thing or two about patents, having authored 300+ issued and pending patents relating to dispersed storage technology. His take is that the patent reform act is a good idea. “In addition to aligning with international patent offices that are all on a first-to-file system, it is materially easier to operate.  First-to-invent is just too hard to measure.  It is practically impossible to know if a prior invention is lurking that hasn’t yet been filed; as a result, a first-to-invent system inhibits investment in new technology areas.” Chris thinks that first-to-file and the new Act will better enable new technology businesses and new technology jobs.

Neil Kane, founder of Advanced Diamond Technologies and now CEO of GlucoSentient, agrees with Gladwin: “I think it’s a net positive. There is a huge misconception about first-to-file. People incorrectly assume that if you give a presentation about an invention or idea, someone in the audience can run to the USPTO with your idea and patent it before you do.” Kane says that’s not the case, that in fact your public disclosure becomes what is known as “prior art” and would invalidate a patent filing.

Sure There’s the Law, But What About Patent Trolls?

Venture capitalist Matt McCall of New World Ventures in Chicago is among those who think the new patent law is a net plus. “Patents are not core in our process. Patents don’t keep players out but can help from being sued.” McCall hopes the new law hinders patent aggregators, often called “patent trolls”, who sue firms they claim infringe on their patents.  “We’ve had too many companies victimized by trolls who have no intent to commercialize, just tax tech firms.”

Nancy Hill, president of the American Association of Advertising Agencies, says the new law “doesn’t solve the problem in our industry.” Ad agencies are a prime example of the creation of new intellectual property, building web-based products and services on top of open source code for clients and believing they are free and clear of patent claims. Hill says agencies believe they are building products “in the public domain” but continue to face legal challenges from patent trolls, making for an impossible situation that won’t be improved by the new law taking effect.

SOURCE:
Patent Law and Innovations in the Pharmaceutical Industry is addressed on this Open Access OnLine Scientific Journal as follows:

Lev-Ari, A., (2012O). Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers

https://pharmaceuticalintelligence.com/2012/07/30/biosimilars-intellectual-property-creation-and-protection-by-pioneer-and-by-biosimilar-manufacturers/

Lev-Ari, A., (2012P). Biosimilars: Financials 2012 vs. 2008

https://pharmaceuticalintelligence.com/2012/07/30/biosimilars-financials-2012-vs-2008/

Lev-Ari, A., (2012Q). Biosimilars: CMC Issues and Regulatory Requirements

https://pharmaceuticalintelligence.com/2012/07/29/biosimilars-cmc-issues-and-regulatory-requirements/

 

The AIA is the First Universally Equal Patent Law in the World

Written by Ken-Ichi Hattori
Partner, Westerman Hattori Daniels & Adrian, LLP
Posted: October 14, 2012 @ 9:07 pm

Tell A Friend!

 

All member countries of the Paris Convention and the PCT approve the novelty of an invention claimed in the patent application going back to the priority date in the origin country.  Therefore, as to the novelty of a claimed invention, all member countries treat foreign and domestic patent applications equally.  Still, the member countries’ treatment of the “grace period” poses a serious issue: no patent law in any country recognizes the grace period as starting from the priority date, but only from the domestic filing date.

Thus, if a U.S. inventor publishes his invention, files a U.S. patent application within one year, and files a Japanese patent application within one year from the U.S. filing date claiming priority, he will get a U.S. patent but not a Japanese patent.  This is so because the Japanese Patent Law allows a six-month grace period from the Japanese filing date, not U.S. priority date. This six-month grace period is same in the rest of world except for the United States and Korea.

The AIA broke this barrier by giving both the novelty and the grace period on an effective filing date which goes back to the original filing date, so long as there is priority claim to the original foreign application date.  Thus, under AIA, both U.S. and foreign applications are completely equal with respect to both novelty and grace period.

This is extremely unusual, since no other country provides a grace period commencing from the priority date. In this respect, the AIA is the first and sole universally equal patent law in the world.

 

 

Public Disclosure Before Filing and Its Potential Abuse

There is a new unique prior art exception (grace period) under §102(b)(1)(A), (B) and (b)(2)(B) of the AIA.

If U.S. inventor A publicly discloses his invention and files a U.S. patent application within one year, his disclosure is not a prior art against his own U.S. application (for convenience, I’ll call this grace period as a standard grace period since other countries’ patent offices also have similar (six-month) grace period). Moreover, even if a third party B publicly publishes same subject matter prior to A’s patent application, or even if B files a patent application on same subject matter prior to A’s patent application, B’s subject matter disclosed in his publication or in B’s patent application is not prior art (for convenience, I’ll call this period as an absolute grace period since this is completely different from the standard grace period).  Thus, U.S. inventor A can obtain a patent regardless of B’s prior act is either publication or patent application.

However, if U.S. inventor A files a foreign application within one year from the U.S. application date claiming priority, he cannot obtain a foreign patent since no foreign countries recognize a grace period from the priority date.

In contrast, a foreign inventor has a huge advantage created by the AIA.  If a Japanese inventor publicly publishes an invention, files a patent application in the Japanese Patent Office within six months (the standard grace period under Japanese Patent Law), and files a U.S. application claiming priority within one year, the Japanese inventor can get a patent both in Japan and in the U.S.  This is so because the AIA recognizes a grace period from the earliest effective filing date which is the priority date.

Even if the Japanese inventor publicly publishes the invention one year before his Japanese application and files a U.S. application within one year from the Japanese filing date, the Japanese inventor can still get a U.S. patent although he cannot get a Japanese patent due to his own publication.

Thus, a Japanese inventor or an inventor in any other foreign country can publicly disclose his invention almost two years before the U.S. filing date!  As such, the AIA works better for a foreign applicant than for a U.S applicant.

Moreover, the prior art exception under AIA §102(b)(1)(A), (B) and (b)(2)(B), does not specify languages for the public disclosure.  Suppose an inventor A in a remote foreign country publicly discloses an invention in an unusual foreign language, files a patent application in his county within one year, and files a U.S. application claiming priority within one year, the foreign inventor A can get a U.S. patent by removing as prior art a third party’s disclosure or U.S. patent application concerning the same subject matter disclosed which was filed immediately after the foreign inventor A’s public disclosure.  The foreign inventor A’s U.S. patent application may be filed almost two years from the foreign inventor A’s public disclosure.

And it is quite possible that someone in a remote foreign country might try to abuse this prior art exception.

There is a further unique advantage by foreign inventors. Suppose a foreign inventor files a foreign application but not files a U.S. application for some reasons. The foreign application will be published as a laid-open publication after 18 months of the filing. Then, the foreign inventor all of sudden changed his mind and files a U.S. application within one year from the laid-open publication. Will the laid-open publication be given the absolute grace period by excluding subsequent third party’s disclosure or a U.S. patent application? Since the Federal Court traditionally treats the foreign patent publication as an inventor’s own publication for the purpose of pre-AIA §102 (b), it appears it is quite likely so.

Potential Conflict with Paris Convention

As explained above, under AIA §102(b)(2)(B), once a foreign inventor publishes a subject matter, due to the absolute grace period, he can exclude subsequent U.S. patent application describing same subject matter for almost two years.  It seems that he can extend priority date for almost two years, perhaps conflicting with Paris Convention Article 11 which defines as follows:

(1)  The countries of the Union shall, in conformity with their domestic legislation, grant temporary protection (Authors’ note: grace period) to patentable inventions, utility models, industrial designs, and trademarks, in respect of goods exhibited at official or officially recognized international exhibitions held in the territory of any of them.

(2)  Such temporary protection shall not extend the periods provided by Article A (Authors’ note: one year priority period). If, later, the right of priority is invoked, the authorities of any country may provide that the period shall start from the date of introduction of the goods into the exhibition.

Article 11 (1) allows the Union countries to provide temporary protector, i.e., a grace period, however, (2) also requires that it shall not extend one year priority period as defined in Article 4.

AIA §102 (b)(2)(B)provides not just a standard grace period but the absolute grace period on the foreign filing date since the foreign investor’s public disclosures exclude subsequent U.S. application for almost two years.

Although Paris Convention Article 4 and 11 depict a particular situation in which an inventor disclosed his invention in an exhibition and then files a patent application, it is still covered by AIA §102 (b)(2)(B), and whether or not AIA §102 (b)(2)(B) conflicts with Paris Convention Articles 4 and 11 is a future question for the Federal courts.

 Hybrid Patent Law

AIA is a first-to-file system if an inventor files a patent application without disclosing his invention prior to filing the patent application since a patent is granted to the applicant who has filed the patent application having the earliest effective filing date.

However, due to the absolute grace period, AIA has essentially the nature of a first-to-publish or even first-to-invent aspect since the publication date can often be the invention date.

The USPTO publishes an examination guideline which states that the subject matter the inventor published must be identical to the subject matter disclosed by the third party to mitigate the first-to-publish effect. More precisely, it proposes that if there is “insubstantial change, or only trivial or obvious variation” in the two subject matters, the exception does not apply. Some say that, in order to apply §102(b)(1)(B), not only must the subject matter be identical, but also the disclosures (the way how the subject matter is published) must be identical as well.

I believe this is wrong in view of §102(b)(1)(B).  Section 102(b)(2)(B) concerns the situation where a first inventor publicly published a subject matter and filed a first patent application, it excludes another inventor’s second patent application disclosing the same subject matter which was filed before the first patent application.

The USPTO also proposes in the above examination guideline that if there is “mere insubstantial change or only trivial or obvious variation” in the two subject matters, the exception does not apply. Thus, the USPTO treats §102(b)(1)(B) and (b)(2)(B) same as to the sameness between the two subject matters.

However, under §102(b)(2)(B), the first inventor’s disclosure is always different from the second inventor’s disclosure since the former is either a printed publication, or public use, or on sale while the latter is always a patent specification.

Thus, unless it is the subject matter which must be identical, §102(b)(2)(B) will never be applied. Therefore, same should be true under §102(b)(1)(B).

U.S. Patent With Priority Claim is a Strong Prior Art

Under Pre-AIA §102(e), the reference date of a U.S. patent with priority claim is the U.S. filing date unless the foreign patent application is published in English.

However, under AIA §102(d), the reference date is the earliest effective filing date which should be the foreign application date. Thus, the U.S. patents with priority claim become extremely strong prior art. This is especially so, since strict §112 is not required to the description in the foreign specification.

 AIA is Tough Patent Law for the U.S. Inventors

This means that the AIA is the tough patent law for the U.S. because of the following reasons:

  • U.S. applicant cannot get benefit of the standard and absolute grace periods on the earliest effective filing date in a foreign countries whereas foreign applicant can get benefit of their own standard grace period (usually six months) and complete benefit of AIA’s standard and absolute grace periods in the U.S. on the earliest effective filing date.
  • U.S. patent claiming foreign priority becomes stronger prior art under AIA §102 (d); and
  • Prior art of public use and on sale is now worldwide activity.

Thus, unless foreign countries adapt both standard and absolute grace period at the earliest effective filing date, U.S. applicants will get less benefit.

The big question for the U.S. is whether or not the foreign patent offices will adopt the AIA grace periods. Korea Patent Office has extended its standard grace period from six months to one year  from the Korean filing date but not from the foreign priority date.  No other countries have indicated thus far that it would adapt the AIA grace period.

A Big Mystery of AIA Application

The first-to-file provision of §102 will be applied to a new patent application filed on or after March 16, 2013.

AIA provides as follows:

—Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act, and shall apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—

(A) a claim to a claimed invention that has an effective filing date as defined in section 100 (i) of title 35, United States Code, that is on or after the effective date described in this paragraph; or

(B) (omitted here)

Thus, if a new application filed on or after the effective date has one claim having the effective filing date on or after the effective date, AIA § 102 is applied to the entire application. If so, AIA § 102 is also applied to other claims having the effective filing date BEFORE the effective date and how those claims will be examined?

Suppose a Japanese applicant publicly published subject matter A on June 30, 2012, filed a Japanese application claiming subject matter A on October 30, 2012, and then files a U.S. application having claims A and B respectively on March 16, 2013, claiming priority to the Japanese application.

The U.S. application is considered as AIA application because of new matter claim B. Thus, claim A is also examined under AIA § 102.

If so, will the public publication on June 30, 2012, have effects of § 102 (b)(1)(B) and (b)(2)(B)? Will it exclude third party’s disclosure of same subject matter A or U.S. application disclosing same subject matter A which was filed after June 30, 2012, but before October 30, 2012?

If AIA § 102 takes effect ONLY after the effective date, it is possible to argue that there will be no application of AIA § 102 before the effective date for any claims.

However, how can one argue that, while AIA § 102 is applied to examine the retroactive claims, but, § 102 (b)(1)(B) and (b)(2)(B) are not applied?

USPTO’s examination guideline draft does not address on this issue. This is also a question that the Federal Court should resolve.

About the Author

Ken-Ichi Hattori is a partner in the Washington, DC law firm of Westerman Hattori Daniels & Adrian, LLP.

SOURCE:

http://www.ipwatchdog.com/2012/10/14/the-aia-is-the-first-universally-equal-patent-law-in-the-world/id=28850/

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Reporter: Aviva Lev-Ari, PhD, RN

this post was reblogged on 9/28/2012 by

http://patentbusinesslawyer.wordpress.com/2012/09/28/ucsf-appeal-of-united-states-patent-and-trademark-office-judgment-in-favor-of-insite-vision/

September 27, 2012 08:30 AM Eastern Daylight Time

Oral Arguments in the UCSF Appeal of United States Patent and Trademark Office Judgment in Favor of InSite Vision Are Scheduled for November 6, 2012

InSite Vision Along with Merck Will Vigorously Defend AzaSite® Patents

ALAMEDA, Calif.–(BUSINESS WIRE)–InSite Vision Incorporated (OTCBB: INSV) today announced that oral arguments are scheduled for November 6, 2012, in Washington, D.C. in connection with the University of California, San Francisco’s (UCSF) appeal of the November 2011 favorable judgment of the United States Patent and Trademark Office (USPTO). The USPTO panel of judges ruled in favor of InSite Vision and confirmed the inventorship of InSite Vision’s U.S. Patent Nos. 6,239,113 and 6,569,443 protecting AzaSite® (azithromycin ophthalmic solution) 1%. The appeal was filed by UCSF with the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. on December 23, 2011, and a cross appeal was filed by InSite Vision on January 4, 2012. Merck, which markets AzaSite in the U.S. for the treatment of bacterial conjunctivitis, is collaborating with InSite on the continued vigorous defense of the AzaSite patents.

“We are highly confident that the UCSF claims are entirely without merit as confirmed by the USPTO judgment last November and we will continue to collaborate actively with Merck to vigorously defend our position”

“We are highly confident that the UCSF claims are entirely without merit as confirmed by the USPTO judgment last November and we will continue to collaborate actively with Merck to vigorously defend our position,” said Timothy Ruane, InSite Vision’s Chief Executive Officer. “We anticipate results of the appeal will be announced in 2013, but we could get a verdict before the end of 2012.”

In 2009, the Regents of the University of California claimed that the inventions contained in the patents were made by a former employee of the University alone and without collaboration with InSite Vision, the assignee of all the named inventors.

About InSite Vision

InSite Vision is advancing new ophthalmic products for unmet eye care needs based on its innovative DuraSite® and DuraSite 2® platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topical drugs. DuraSite is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus and DexaSite for the treatment of eye infections, and BromSite for pain and swelling associated with ocular surgery. DuraSite 2 incorporates InSite’s proprietary bioadhesive core technology with a cationic polymer to achieve sustained and enhanced ocular delivery of drugs. The DuraSite 2 platform will be applied to InSite’s future pipeline product candidates and available through a broad licensing program for advanced ophthalmic drug development. For further information on InSite Vision, please visit www.insitevision.com.

Forward-looking Statements

This news release contains certain statements of a forward looking nature relating to future events, including InSite Vision’s expectations of a successful outcome in the appeal, the expected timing of a decision by the court, and other plans and expectations with respect to the litigation described above. Such statements entail a number of risks and uncertainties, including but not limited to: that the court may not rule in favor of InSite Vision, the inherent uncertainty of any litigation matter including the court’s decision and the timing of same; InSite Vision’s ability to continue to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others. Reference is made to the discussion of these and other risk factors detailed in InSite Vision’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption “Risk Factors” and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.

AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.

BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.

Contacts

InSite Vision
Louis Drapeau, 510-747-1220
Chief Financial Officer
mail@insite.com
or
Media and Investor inquiries
BCC Partners
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509

Source:

http://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120927005486&newsLang=en

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