Is the Myriad Case Decision and/or the DOJ Brief TRIPS Compliant?

Judge Sweet seemed to dismiss Myriad’s constitutional taking and TRIPS claims by indicating:

“Finally, Myriad’s suggestion that invalidating the patents-in-suit would constitute an unconstitutional taking in violation of the Fifth Amendment of the Constitution or a violation of the United States’ obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is unpersuasive. Myriad’s novel taking argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent. Similarly,Articles 8.1 and 27.3 of TRIPS permit governments to incorporate public health concerns into their intellectual property law and to exclude from patentability diagnostic, therapeutic, or surgical methods as well as particular inventions on the grounds of public interest. As a result, invalidation of the patents-in-suit would constitution neither a constitutional violation nor a conflict with the Untied States’ treaty obligations.” Pages 106-107. Emphasis added.

Alnylam’s Appellate Brief to the Circuit Court in the Myriad case argues that “excluding certain “compositions of matter” from patent-eligibility would violate the United States’ treaty obligations under the TRIPS Agreement.” pg. 17  The Brief goes on to discuss this legal issue as well as international policy implications.  pg. 18-19

Questions for thought:

1.  Would ‘isolated DNA’ even constitute an “invention” under TRIPS Article 27.1?  How do other nations view patentability of ‘isolated DNA’ and how does that affect a TRIPS analysis? See European Union Biotechnology Directive and WIPO’s “Information provided by WIPO Member States Concerning Practices Related to the Protection of Biotechnology Inventions.”

According to practice, a Dispute Panel would use the ordinary meaning of the word (probably from the Oxford English Dictionary) and look at common practice around the world.  Isolated DNA seems to meet the definition of ‘invention’ and the resources mentioned above seem to back up the assertion. 

2.  What about Alnylam’s “discriminatory… as to the field of technology” argument?  Does Judge Sweet’s opinion discriminate against DNA based patents and/or the Biotechnology Industry?  How does the DOJ’s Brief fare? 

Based on a WTO Dispute Panel analysis on discrimiation in a similar context (see CANADA – PATENT PROTECTION OF PHARMACEUTICAL. PRODUCTS), it seems that both Judge Sweet and the DOJ Brief are discriminating against DNA based patents and the biotechnology industry.  Judge Sweet creates a patentability exemption for ‘isolated DNA’ and DNA based inventions (to an unknown point).  The DOJ seem to create a new ‘isolation’ test which implicates much more than ‘isolated DNA’.  Both approaches specifically target the biotechnology ‘field of technology’ and have devastating effects on the industry.

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New Series: Biotechnology Companies at Forefront of Global Health Innovation – Post #1: GlaxoSmithKline & Alnylam Pharmaceuticals

On July 8 2009, GlaxoSmithKline (GSK) and Alnylam Pharmaceuticals, Inc. announced a patent pool to compile intellectual property (IP) to develop treatments for 16 tropical diseases as identified by the FDA including malaria, TB and Chagas, found in 49 Least Developed Countries as defined by the United Nations. (GSK press release)

The pool currently has two members (GSK and Alnylam) but is inviting others to participate. The donated IP will be non-exclusively licensed and royalty free for the purpose of addressing the above mentioned unmet needs. The current members of the patent pool will also provide for know-how, technical resources and training to be available to those who access the pool. The pool will also help in accessing financing where possible.

GSK has donated IP for some of its New Chemical Entities (NCEs) and Alnylam has donated its RNAi platform technology to the pool for limited field of use.　 　

For more information you can visit Alnylam and GSK websites. We will have updates as they become available.

Department of State: Foster Climate Change Solutions, Biodiversity, & Economic Development with IPR Protections

CropLife recently posted their newest video interview last week with Carrie LaCrosse, of the Office of Intellectual Property Enforcement at the U.S. Department of State.

LaCrosse discusses the value of IP for agriculture, looking in particular at new plant varieties and how IP is part of the solution in addressing the food security. LaCrosse states that intellectual property rights protections (IPR) encourages the development of plant varieties, including protected varities, at reduced or free prices — thus allowing countries to protect their biodiversity while also meeting increased demand for crops due to climate change and economic crisis.  My favorite quotation comes near the end, where LaCrosse aptly states that innovation is historically sparked by challenging times.

Don’t forget to add the Indian insect-resistant eggplant to the list of innovative plant varieties changing the world.

For U.S. Healthcare Reform and Global Health Crises, Both Public and Private Efforts Needed

This morning Laura and I attended 2 sessions about the benefits of collaborative public-private partnerships at the International Convention.

The first was the super session “Global Biotechnology Innovation: Connecting the Laboratory, the Field, and the Marketplace” with speakers from the Food & Drug Administration, National Cancer Institute, the Centers for Disease Control and Prevention – moderated by former U.S. Secretary of Health & Human Services, Louis Sullivan. The speakers discussed how discoveries created through collaborative initiatives have accelerated biotechnology innovation to address global health disparities. The second session, “Time for Action: A prescription for Health-Care Reform” was moderated by BIO’s President & CEO and included speakers from the American Cancer Society, Regence BlueCross BlueShield, and the American Medical Association. The speakers presented their association’s perspectives on how U.S. healthcare reform could become a reality under the Obama Administration after decades of Congressional failures to comprehensively address rising costs and limited access to care.

The two panels addressed what are seemingly different topics: one global heath, and the second national healthcare reform. What struck me was the need to sustain new, complex collaborations between all stakeholders in order to encourage finding solutions to “old” problems.

The old view of global health programs states that logistical issues, including a lack of needed resources and capacity, require a top-down strategy with governments leading the efforts. Yesterday’s idea about healthcare reform, taken up by many a Congress the past 20 years, asserts that only the grassroots efforts of individual Americans can encourage permanent, sustainable solutions in communities where the government is unable to keep up (and often times hurts innovation rather than helping).

The truth is, for both global health goals and national healthcare reform, innovation requires both a “grass-top” and a “grass-roots” approach. I stole that phrase from the CEO of the American Cancer Society, John Seffrin. Seffrin is also CEO of the ACS Action Network. Both branches of the ACS facilitate efforts at the individual level (encouraging prevention and wellness efforts, for example) and the national level (analyzing Congressional proposals for reform). Both entities working together help solidify the foundation upon which the war on cancer can be won.

Indeed, the driving factor of encouraging biotechnology innovation to meet health care goals comes from the individual human beings who suffer, manage, and cure their own or another’s illness. Individuals collectively bring their unique experience and knowledge as patients, physicians, researchers, venture capitalists, university administrators, and government policymakers to public discourse, and by working together, benefit each other and accelerate finding a solution to health needs.

Some examples taken from the 2 sessions:

1. Gardasil, the blockbuster cervical cancer vaccine appeared under the guidance of collaborative efforts via the CDC.

2. The hope of collaboration helped the FDA form the basis for what would become the Critical Path Initiative for clinical trials.

2. Collaboration was the key for the American Medical Association’s work to address streamlining patient care by studying inefficiencies inequalities in the healthcare system, as Dr. Patrice Harris described this morning.

3. AMA, BIO, and ACS joined together to create the “Health Economy Now” website, which puts the focus of U.S. healthcare reform efforts on the need to lower costs through health information technology, changes in the reimbursement system, and encouragement of prevention & wellness. Jason Daughn of Regence remarked that “real reform lets innovators innovate, and preserves competition through public-private partnerships.”

4. James Curran, Dean of the Rollins School of Public Health at Emory University described that when the HIV/AIDS epidemic first emerged in 1981, it was thought that we would never find the cause or be fully able to characterize the disease. Since then, we can now screen the blood supply, extend the lives of those infected with HIV with antiretroviral therapy, prevent pregnant women from passing the virus to their unborn children, and measure the viral load of an infected individual’s blood.

 Both public and private entities are needed at the table of public discourse, not one or the other. We can address health needs in both the United States and developing countries at the same time by working together via open, fair, and collaborative partnerships. It saves money, time, effort and – most important of all – lives.

This post was co-written by Margarita Noriega and Laura Sambataro at BIO.

China IP Forum to Bring Third Patent Amendment Face-to-Face with Biotechnology Concerns

Emerging markets, particularly the China market, have become a strategic area for pharmaceutical and chemical companies and law firms. China’s lawmakers adopted third revision of the law recently, which will bring a number of substantial changes to the Chinese patent system.

The third amendment of Chinese patent law was recently passed and will become effective October 1, 2009. The amendment includes a number of  changes  of particular concern  to the pharmaceutical and biotechnology companies, such as foreign filing license requirement, genetic disclosure requirement, granting compulsory licensing, etc. 

How will the third amendment of patent law impact China’s role an active participant in biotechnology innovation? This August, concerned observers will get a chance to ask the Chinese Patent Office (SIPO) themselves at the 2nd International Pharmaceutical and Chemical IP Forum, August 5-8, 2009 in Beijing. The 1st Forum in 2006 was endorsed and supported by SIPO. This time around, SIPO Commissioner, Tian Li Pu, will chair, with the Chinese Intellectual Property Society (CIPS) as co-organizer. The forum will provide an opportunity for the biotechnology community interact and network with Chinese government officials, representatives from China’s chemical and pharmaceutical industries, representatives from Chinese academia and IP attorneys from China , and facilitate an understanding of the needed checks and balances in a health, robust national intellectual property system.

China IP Forum: www.chinaipforum.net
SIPO official site http://www.sipo.gov.cn/sipo2008/ztzl/hylt/yyyhggflt/ (Chinese)

Sunny Wang is Head, Patent Search Group and Patent Agent at sanofi-aventis.

World IP Day: Special Edition of BIO IP News Weekly

Happy World IP Day!

A special edition of the IP News Weekly focuses on green technology and intellectual property policy. I’ve posted additional resources here:

Judge Randall R. Rader (US Court of Appeals for the Federal Circuit) discusses the value of a strong IP system in maintaining an innovative economy, not only for the ‘industrial giants’ but also for developing nations: http://www.youtube.com/watch?v=tB3OROLi9IM

 

Take a look at the U.S. Chamber of Commerce’s release on World IP Day, too:

“U.S. Chamber Recognizes World IP Day”, April 24, 2009: http://www.theglobalipcenter.com/index.php/news/press-releases/164.

 

World IP Day is Sunday, April 26, 2009. For more information, visit www.wipo.int.