BIO’s take on the CBD Nagoya Protocol

After several years of negotiations, the 10th Conference of the Parties of the Convention on Biological Diversity (CBD) successfully adopted the Nagoya Protocol.  The Protocol provides benefits to the biotechnology industry by creating a legal framework to regulate access to genetic resources and provide fair and equitable sharing of benefits.  In addition, the Protocol does not apply retroactively or hinder regulation or a country’s intellectual property systems.  Assuming nations implement the Protocol appropriately, we can meet the joint goals of conservation and sustainable use of biodiversity. 

The biotechnology community recognizes several important aspects of the Protocol.

Mutually Agreed Terms

Article 4.1 creates the obligation to share benefits on mutually agreed terms between the provider and user of genetic resources.  Both parties will understand their rights and obligations regarding the transfer of genetic resources which will create a synergetic relationship.

Emergencies

The Protocol recognizes the need to access genetic resources to respond to imminent emergencies that threaten or damage human, animal or plant health.  Article 6(b) answers these needs by ensuring national access and benefit sharing (“ABS”) requirements do not impede a response to a public health crisis.

Transparency

Those Parties requiring prior informed consent must take legislative, administrative or other policy measures to provide legal clarity and transparency under the Protocol.  Article 5.2 requires a “clear and transparent written decision” in a reasonable time.  These requirements enable biotechnology companies to comply with national access and benefit sharing laws. 

Prospective

The Protocol appears to be prospective and applies only to genetic resources transferred after the entry into force of the Protocol.  This particular provision however, is a bit unclear and will require more study, particularly during the implementation phase.  Retroactive application would create widespread uncertainty and litigation and should be avoided.

Intellectual Property Laws/Marketing Approval

The Protocol does not create new rules or laws for intellectual property or for marketing approval for new products.  Article 13.1(a) provides for checkpoints which will help monitor the collection of information providing transparency and respect for mutually agreed terms. 

The Nagoya Protocol represents a series of compromises with many provisions in the text still unclear.  As a result, BIO will monitor the national implementation of the Protocol and the implementation of the “global multilateral benefit-sharing mechanism” used for genetic resources existing in transboundary situations or where no prior informed consent is obtainable. (Article 7 bis)  However, we believe that the successful implementation of the Protocol is likely to result in positive relationships between the biotechnology industry, governments, and other stakeholders.

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USPTO Requesting Comments on Humanitarian Technologies

In case you missed it, on September 20 the United States Patent Office issued a request for comments on incentivizing humanitarian technologies and licensing through the intellectual property system.

 The USPTO is trying to incentivize humanitarian technologies by creating a “fast-track ex parte reexamination voucher pilot program.”  The program will give priority to humanitarian technology patents shortening the review process to six months.  The USPTO also hopes the program will reduce costs for humanitarian technology patents.

 The proposed legal standard the PTO will use to define “humanitarian use” and “humanitarian research” are as follows;

 “‘‘Humanitarian use’’ would comprise four principles: subject matter, effectiveness, availability, and access. In general terms, subject matter evaluates whether the patented technology addresses a recognized humanitarian problem. Effectiveness judges whether the technology can be used or is being used to address that issue. Availability determines whether the technology is available to an affected impoverished population. Access evaluates whether the applicant has made significant efforts to increase access to the technology among such populations.”

 “‘‘Humanitarian research’’ would comprise two principles: significance and access. Significance requires that the patented technology make a significant contribution to research on a problem that predominantly affects an impoverished population, such as the tropical diseases identified by the FDA in its priority review voucher scheme. Access determines that the patented technology was made available to researchers on generous terms. “

 The PTO asks comments to focus on the twelve questions found in the Request for Comment.    

 To make a comment to the USPTO on this issue send an email to HumanitarianProgram@uspto.gov

India Threatens European Union: ‘Don’t Stop Flow of Illegal Drugs’

India’s Commerce Ministry drew attention to the “plight” of producers of infringing copies of vaccines last week, highlighting a need to quell the dangers of swine flu, whose vaccine is in legal development and as we speak (WHO Link):

[Indian Company] Cipla has produced a generic version of the antiviral drug Tamiflu for sale to developing countries but no one, including India itself [emphasis added], has so far been willing to buy it, either because of financial constraints or concerns over violating intellectual property laws.

 The Financial Times does an excellent job of explaining the “request” :

Myth One: The World is So Challenged by Swine Flu, It Should Allow the Unapproved, Illegal Flow of Drugs:

“When the world is being challenged in another area, by swine flu, India is one of the countries that has been mandated by the World Health Organisation as ­having the capacity to develop vaccine along with other major countries,” Mr Sharma told the Financial Times on a visit to Seoul.

Myth Two: India is Producing Illegal Drugs Out of Own Heart to Meet Global Health Needs:

Mr Sharma’s comments are an escalation of a dispute over protectionism between India and one of its main trading partners… India’s pharmaceutical industry is one of the sectors of India’s fast-growing economy worst hit by the global economic downturn.

Myth Three: India Is Trying to Solve the Problem:

India’s commerce ministry declined to say when it might file a complaint at the WTO against the EU over drugs seizures… “[A resolution with the EU] might be in the process through discussions. But as of now we have no reason to change our stand,” said Rajeev Kher, a joint secretary of commerce.

This story is courtesy of the Financial Times. In order to access the article, you must register (free).

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 July 4: Let’s Thank the Inventors

For this week’s IP News Weekly, I emphasized stories about research breakthroughs and U.S. healthcare reform. In honor of this July 4, I’m taking a moment thank the researchers, business entrepreneurs and investors, and inventors who, as encouraged and protected by the U.S. Constitution, work tirelessly to create solutions to global health and environmental needs.

While I watched “The Fashion Show” on Bravo last night, one of the contestants proclaimed that “a designer is only as good as his last fashion show.” Its easy to forget that the United States’ economy (read = our jobs and homes) is only as strong as our last innovation. Further, everyone (from artists like clothing designers to high-technology workers) understands that it takes a long time to create the next “masterpiece.”

The complexity of creating biotechnology products is especially investment and time-consuming, and both the research process and the final product have a fragile relationship with human health and the environment. The intellectual property framework protects biotechnology innovators when they need it most, during the research and development process and the period of time the patent holder uses to recoop the investors funding. This protection creates a safe environment for investors that increases the possibility of the inventor producing a sustainable, high-quality product.  Americans do not prefer low-quality, high-risk solutions to the biggest problems of our time.

I hope that the current members of Congress will take it upon themselves to appreciate the need for data and patent protection for follow-on biologics, intellectual property rights and enforcement in international trade agreements, and increased funding for the NIH, FDA and PTO. No government can force innovation that comes out of the natural creative capabilities of its citizens, even in times of need.

My hope for America this July 4? I hope, in 100 years, the response time to human and environmental suffering will be immediate. Until that day arrives (thanks to scientific breakthroughs funded  by individual citizens) — let’s thank the scientists, investors, and inventors around us.

Finally, let’s also thank the founding fathers for knowing America’s innovative potential without seeing it for themselves.

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.

A Stimulated NIH Discovers the Devil in the Grant Details

In February, Congress awarded the National Institutes of Health with stimulus funds to the tune of $10.4 billion through the American Recovery and Reinvestment Act of 2009 (Recovery Act). The funding is directed towards helping the United States improve its “scientific infrastructure”: education initiatives, research, “investment in biomedical research and development, public health and health care delivery” (NIH Press Release), including $400 million for comparative effectiveness studies.

Acting National Institutes of Health Director, Raynard S. Kington, MD, has done an excellent job of diversifying the kinds of projects that funding will support, as well as looking for solutions to some of the more, well, I’ll call them opportunities for growth (read: beaurcratic red tape).

Science Magazine further describes these opportunities in the April 17 edition article “NIH Stimulus Plans Triggers Flood of Applications—and Anxiety.”

Grant applicants question whether the NIH has the capacity to manage the tsunami of applications.  Researchers in the Science article also ask if the NIH baseline funding “will grow at anywhere close to the rate needed to handle the blizzard of new ideas and expanded scientific work force” that the Recovery Act funding will produce once the stimulus funds expire. This would allow the projects to continue, if further research was recommended.

Additionally, an April 24 Burrill Report podcast (http://www.burrillreport.com/article-1311.html) interviews Reg Kelly, Director of the California Institute for Quantitative Biosciences (QB3), about whether the stimulus could slow down discoveries. University researchers, seeing state and alumni funding cuts, will spend all of their time preparing grant applications.  Researchers are forced to ignore current projects during the application process. Even if they do receive funding, they will face a technology transfer system that isn’t quite ready for a grand influx of fresh ideas just “waiting” to get picked up for further research & development. Kelly further asks if the technology transfer community is collectively incentivized (and collectively capable) of prioritizing funding for stated NIH priorities like personalized medicine, vaccines (read today: swine flu), cancer, and HIV/AIDS research.

While the stimulus created an “innovation backlog”, it can only be a good thing. For the next two years, NIH programs like “Grand Opportunities” and “Challenge Grants” will enable today’s bright minds to forge new paths into health and environmental sustainability – at least for the next 2 years, when the grant rivers run dry.  In 2012, the new challenge will be utilizing the innovation boomtown the stimulus will have inevitably created. 

If the stimulus succeeds in providing researchers enough funding to help form ideas to improve the world, it will take just as much effort for the biotechnology industry to turn that research into tangible products for a global audience.

Next question: Are the other United States federal agencies (FDA, USDA, and USPTO among them) ready to usher these innovations into the economy?