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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BIO Press Release: BIO and AUTM file Amicus Brief in Myriad Case

The Biotechnology Industry Organization (BIO) filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on Friday, October 29th, in an appeal of a lawsuit brought by the American Civil Liberties Union on behalf of a number of plaintiffs against Myriad Genetics, the U.S. Patent and Trademark Office, and others.

The brief, filed jointly with the Association of University Technology Managers (AUTM), supports the patentability of isolated DNA molecules, noting that invalidating the patentability of these molecules would discourage future biotechnological innovation.  DNA-based patents are a critical tool that help enable the fundamental research and development of new biotech products, therapies and technologies to fight deadly diseases, expand agricultural production, clean the environment, and reduce our dependence on foreign sources of oil. 

Isolating a DNA molecule, in addition to creating a new chemical molecule that does not exist in nature, imparts new utilities and functions that are not available from native DNA.  The utility of isolated DNA molecules derives from their chemical structure, which is developed by human ingenuity using complex scientific expertise and equipment. As a result, isolated DNA molecules are patentable subject matter based on decades of U.S. case law.

 “Unless reversed, the district court’s ruling will seriously harm the U.S. biotechnology industry, which consists largely of small firms that are engaged in foundational research and dependent on private investment to fund their work,” stated BIO President & CEO Jim Greenwood.  “Patent protection is critical for the ability of biotechnology firms to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental and agricultural products. This innovation will lead to domestic job creation and help sustain our country’s global competitiveness.”

 If the Court of Appeals affirms the district court’s categorical rejection of the patentability of isolated DNA molecules, it would cast a cloud of uncertainty over thousands of similar patents and compromise the ability of biotechnology firms to pursue groundbreaking discoveries in human healthcare, renewable energy, and sustainable agriculture. 

 “Patentability of isolated DNA molecules is critical to the translation of university research discoveries for the public good. Without this, many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products which improve the public health,” stated AUTM President Ashley J. Stevens.

“From the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society,” concluded BIO President and CEO Jim Greenwood. 

The joint BIO-AUTM amicus brief is available at http://bio.org/ip/amicus/BIO_AUTM_Amicus_Brief_AMP_v_USPTO_2010-1406_FedCir.pdf.  Additional background materials are available at http://bio.org/ip/genepat

Secretary Sebelius speaks at biotech meeting

Secretary Sebelius delivered a speech in California yesterday which recognized the potential of biotechnology to address unmet needs in human health, agriculture and industrial and environmental applications.  In her remarks, Secretary Sebelius stated:

“[I]nvesting in each step of the process that starts with basic scientific discovery and ends with the development and provision of better diagnostics, treatments, and preventive strategies to significantly improve health care.  I know I don’t have to tell you that because these steps are often very complex, promising scientific discoveries can move incredibly slowly toward practical application, encountering significant hurdles along the way.”

The Secretary also recognized the challenges faced by emerging companies in raising the funds necessary for research and development and the approval process: 

“While many companies may have powerful new ideas, the fact is that when those companies are young and small, they may not have access to the capital they need to get those ideas off the ground.” 

The Secretary’s stated objective to “accelerate the process of scientific discovery, and improve the health of the American people” requires a strong and predictable intellectual property system together with an efficient and flexible technology transfer system.  It is equally important to foster partnerships and collaborations between the private and the public sector to translate basic research into new medical therapies and other products. 

Without strong intellectual property protection and an efficient technology transfer system, biotech companies may have trouble attracting investment into cutting-edge products and technologies.”

Below is a transcript of the Secretary’s speech.

The Biotech Meeting

Laguna Beach, CA
October 12, 2010

Thank you Brook for that very kind introduction.

I want to thank both Brook and Steven Burrill for convening this important discussion today and for all the work you have done to advance the life sciences.

Thank you as well to my colleague and friend Congresswoman Anna Eshoo, a true champion of science and technology in the House of Representatives.

I am delighted to be here. As you know, I came to the Department of Health and Human Services as a governor where I saw firsthand the potential of biotechnology – not just to create jobs and drive growth, but also to solve some of our biggest problems: to improve health and eradicate disease, to reduce our dependence on foreign oil and keep our water clean.

When we look back over the last century, we see that biotechnology is responsible for some of our greatest progress in public health, from the discovery of penicillin to the development of effective therapies for HIV infection.

Diseases that had once been a death sentence have been eradicated or cured.  Conditions that had once been disabling are now manageable.

Today, at the beginning of a new century, we can see even bigger opportunities ahead.

And our mission at HHS is to make good on those opportunities, accelerate the process of scientific discovery, and improve the health of the American people.

That means investing in each step of the process that starts with basic scientific discovery and ends with the development and provision of better diagnostics, treatments, and preventive strategies to significantly improve health care. 

I know I don’t have to tell you that  because these steps are often very complex, promising scientific discoveries can move incredibly slowly toward practical application, encountering significant hurdles along the way. 

But with so much to gain, we can’t afford to let any good idea go to waste. We must be able to realize tomorrow’s opportunities. And that means being able to count on a robust and streamlined process to translate and carry promising ideas forward, from the microscope to the medicine chest, from initial investment to the global market.

As you may know, this very challenge was recently highlighted in an HHS report examining our nation’s medical countermeasure enterprise.

With the President’s support, we conducted a first-of-its-kind, comprehensive analysis, and its conclusions ultimately confirmed what some of you have been saying for some time: that the pipeline we rely on to provide those critical countermeasures – diagnostics, vaccines, antivirals, antibiotics – is full of leaks, choke points, and dead ends.

In an age of new threats and persistent challenges, where delays cost lives, we simply aren’t developing and manufacturing new medical countermeasures fast enough. 

So, when the review was completed this August, HHS announced it would direct nearly $2 billion in preparedness funds to help us build a medical countermeasures enterprise that is modern, flexible, and equipped to respond quickly and effectively to any threats that arise.

What I want to share with you today is that:

One, we’re already moving forward on this plan.

And two, you need to be a part of it. We intend to call on your expertise and experience to make sure we get it right.

It was in this spirit last month that the Department’s Biomedical Advanced Research and Development Authority (BARDA) announced a solicitation for one or more new Centers of Innovation for Advanced Development and Manufacturing.

Despite tireless efforts on every front during the H1N1 influenza pandemic, we needed greater capacity and more flexibility to produce enough vaccine in a timely manner.

These new centers would serve as key platforms where flexible manufacturing can take place. They may be brand-new facilities, or existing facilities that are significantly refurbished. And they will have the potential to offer a dependable and robust domestic source of vaccines and other countermeasures for pandemic influenza, unknown pathogen outbreaks, and other evolving public health priorities.

But more than that, these Centers — established as public-private partnerships — will also serve as a resource so that small biotech companies with big ideas can get the regulatory, technical, and manufacturing know-how they need to demonstrate their product’s potential and bring it to market.

And they will provide manufacturing resources so those same small companies can produce these products without the heavy burden of capital investment into their own facilities.

Going forward, we are very interested in feedback and guidance from the community we hope these Centers will serve. Comments are due no later than October 29th, and will be used to develop a formal request for proposals that will potentially be awarded by the end of 2011. So please contribute your thoughts, so that we can make these facilities as responsive and effective as possible.

At the same time and in similar spirit, we are also initiating what we call the Concept Acceleration Program at the NIH, to ensure that discoveries with great potential do not die on the vine.

The program will create so-called “Sherpa” teams to guide these concepts through early stage development with partner agencies, academic researchers, biotechnology and pharmaceutical companies.

NIH is essentially scouting the emerging science that comes from its investments then leveraging its resources to take them further still.

Now, our comprehensive review identified another key challenge as well:

While many companies may have powerful new ideas, the fact is that when those companies are young and small, they may not have access to the capital they need to get those ideas off the ground.

Right now, there’s little financial incentive for private companies to explore rare conditions like the Ebola virus infection or exposure to non-medical radiation.

Yet in the event of an Ebola outbreak or a nuclear explosion, countermeasures for these conditions would be critical.

That’s why we’re exploring a strategic investment fund.

It may be a new entity entirely or a new initiative within an established government-sponsored fund.

But I can tell you it will be an independent, not-for-profit organization whose mission is to find and nurture those organizations that have the greatest chance of making good on the public’s early investment.

And we’re not just talking about money. A good venture capital organization does not just infuse capital into key projects; it brings in executive business expertise — the vision and the guidance to take something small with big potential and find the best path to reach the next level.

At the same time, we will continue, as always, to provide direct support for the advanced development of products that are important to the public health but often unattractive to investors in private industry.  Let me give you some examples:

In 2005, the National Institutes of Health established the Centers for Countermeasures Against Radiation, where investigators developed innovative methods and tools to measure radiation exposure and evaluate potential drugs to treat radiation injury.

The program funded 130 pilot studies, and attracted many new scientists to the field, bringing with them new ideas and new perspectives.

So this summer, we announced an additional five years of funding to extend the program — $105 million in support of further research at seven institutions nationwide, building on the advances of the last five years.

On August 31, BARDA awarded a contract of up to $64.5 million for the continued development of a promising new antibiotic that may be used to fight drug-resistant organisms, including serious biothreat agents like the one that causes bubonic plague.

And late last week, we announced three new contracts that could reach $68 million focusing on a dengue vaccine delivered by a needle-free device, an anthrax vaccine delivered orally, and an anthrax vaccine delivered in conjunction with a compound that stimulates the immune system.

Clinical trials of all three vaccine products should begin within three years.

All of these investments, like many of the new initiatives highlighted in our medical countermeasure review, are about addressing risk. 

By supporting facilities and resources at the new Centers of innovation, we’re addressing the technical risk that comes with taking on uncertain, but important public health projects.

By exploring a strategic investment fund, we are addressing the risk in terms of business development.

But there’s another kind of risk, and that’s regulatory risk.

So we’re addressing that too, by improving regulatory science at the FDA.

Last week, our terrific FDA Commissioner Margaret Hamburg unveiled the agency’s new Regulatory Science Initiative, laying out a strategic framework to modernize how we evaluate and regulate product development.

For too long, we’ve underinvested in the tools, models, methods and knowledge needed for making these assessments.

Because of this underinvestment, we’re often testing and producing cutting-edge products using science that’s decades-old.

We’re going to give our world-class FDA scientists the resources they need to create clear regulatory pathways, analyze promising new discoveries faster, and help identify and solve scientific problems as they occur. And we’re going to build capacity throughout the development process to support intensive and early interaction between FDA and sponsors as well as government partners.

In the end, if a product fails to make it into our national stockpiles, it should only be based on its failure to meet our stringent standards for safety, efficacy or quality, and not because we failed to provide the needed business, regulatory and technical support for success. 

To achieve that goal we will have to work together.

Last year, less than an hour after being sworn in as Secretary, I was in the Situation Room being briefed on the H1N1 flu by John Brennan, the President’s Advisor for Homeland Security and Counterterrorism.

I was so new I didn’t even know where the Situation Room was. Someone had to show me how to get there.

During last year’s flu season, we turned to medical countermeasures, of course. But they were just one part of a much larger response.

That response depended on the strength of our health care workforce. 

It depended on our ability to collaborate across the government and to execute a national strategy on the local level. And it depended on successful public-private communication and collaboration, as well as an informed and engaged public. 

With so many factors in play at once, coordination was key.

It was a good reminder that to be ready for the next public health crisis, we need to focus on our entire end-to-end response, from how we assess and identify threats to how we distribute and administer products to counter those threats across the country.

This was one of the goals we had in mind when we passed the Affordable Care Act six months ago.  And although it is not often referred to this way, it is one of the strongest public health bills our nation has ever seen. 

The Treasury Department has already received over 5,000 applications and will soon announce recipients of the $1 billion therapeutic discovery grant and tax credit program as part of the new law, helping small businesses that are developing new and cost-saving therapies for patients suffering from serious diseases.

Investments like these create jobs and help us stay competitive as a nation.

So, too, will the new $15 billion Prevention and Public Health Fund that recently distributed nearly $43 million in grants to state, local, and tribal governments to improve their public health services.

And at the heart of so much of our prevention efforts is an understanding that vaccination is absolutely critical.

That’s why under the new consumer protections that took effect last month, Medicare and new private health plans will offer flu vaccine and other critical vaccine coverage – without co-pays or deductibles.

The elimination of cost as a barrier comes at a key moment: This is the first year in which health officials are recommending that every American older than six months get a flu shot. And there should be ample supply; over 100 million doses have already been distributed. 

I want to thank you again for having me here today — and for your partnership. Together we’re going beyond scientific discovery, and bringing its possibilities to more people and more communities.

That is our shared responsibility — to make the very most of biotechnology’s great promise: to make it work for people’s families and communities, to strengthen our economy, and to improve our quality of life.

Francis Crick said that “Big questions get big answers.” 

By pushing science in powerful new directions, we can continue to answer some of today’s biggest, toughest questions with confidence and real hope for a brighter tomorrow.

Getting to Market: The Challenges of Technology Transfer

An article about BIO’s recent Technology Transfer Symposium.

Getting to Market: The Challenges of Technology Transfer
Attendees at special symposium focus on issues of commercializing and licensing biotech discoveries

Read the post on BIOtech NOW

IPWatchdog Blog: “In Search of Technology Transfer Best Practices”

Gene Quinn of IPWatchdog.com covered the BIO-AUTM Technology Transfer Symposium this past week, on May 4, 2010 at the 2010 BIO International Convention.

The Symposium attendees were high-level experts on technology transfer policy looking to get to the “brass tacks” of issues concerning innovation, federally funded research, and creative licensing schemes for product development in the United States.

Below is a quotation from IPWatchdog’s coverage:

Last week while at the 2010 BIO International Convention, I attended the Tech Transfer Symposium, which was held on Tuesday, May 4, 2010 at the Hyatt Regency Ballroom at McCormick Place. I had previously arranged an interview with Linda Katehi, Chancellor of the University of California (Davis), a transcript of that conversation appears below. At the outset of the Tech Transfer Symposium Katehi gave an introductory presentation on technology transfer that lead into a panel discussion.  As an Electrical Engineer, Professor and now Chancellor in the UC system, Katehi has a lot of experience with technology transfer, and for those Universities struggling to figure out how to license out technology in a successful manner they could learn an awful lot from Katehi. Her presentation and the time I spent thereafter with her continued to facilitate my understanding of why some Universities succeed and others fail.

Katehi also has some interesting suggestions regarding what the Patent Office could do to help Universities, both in speeding up the patent process and in keeping costs lower.  I learned a lot from speaking with Katehi, which supplemented my knowledge based on my experiences at Syracuse University.  What I am continually piecing together suggests that there is no great surprise why most Universities do not do a better job with respect to technology transfer.  There are things that are clearly considered best practices in the private sector that seem to elude Universities for the most part.  The University of California system seems to be out in front and trying to bring the best practices of the private sector into Universities.  It is no wonder they do a better job than most with technology transfer.

Full summary of the BIO-AUTM Technology Transfer Symposium:

Today’s Technology Transfer Symposium’s panel on The Role of Universities, Biotechnology Companies and Technology Transfer in the Innovation Economy included an active debate on issues ranging from increasing the odds for a successful partnership and the pros and cons of the Bayh-Dole Act.  Andrew Cittadine, Co-founder & CEO of American BioOptics, Linda P.B. Katehi, Chancellor of the University of California (Davis), Steve Mento, President and CEO of Conatus Pharmaceuticals, Inc., and Tom Skalak, Vice President for Research, University of Virginia, all participated in the conversation, moderated by Robin A. Chadwick of Schwegman, Lundberg & Woessner.

Skalak noted during the panel that one of the keys to a successful partnership is “diverse eyeballs on the project,” which can help in making good decisions.  As an example, he pointed to a deal his university is involved in with AstraZeneca.  Cittadine underscored the importance of finding a good fit between the university and the biotech firm.

In discussing Bayh-Dole, all the panelists agreed that the Act has brought a lot of benefit to the industry, although there is room for improvement.  The Act “provides incentives to institutions to bring research to the marketplace,” explained Katehi.  Under Bayh-Dole, “ideas can emerge,” she added.  While she acknowledged that changes are needed, Katehi explained that if the Act is eliminated “there will be millions of good ideas, but no process for bringing them forward.”

Mento agreed, stating, “Bayh-Dole made the biotech industry possible.”  He noted that the system worked in the beginning, but it has now “evolved into a system where the focus is on short term return.”  It’s “impossible” to make the economics work, Mento said.

Cittadine added, the framework in Bayh-Dole is what enables new ideas to get funding.  Skalak, meanwhile, noted that without Bayh-Dole, discovery-oriented research would not happen.

Did you attend the Symposium? Interested in materials, or in joining the BIO Technology Transfer Committee? Email me at mnoriega@bio.org.

Policy Leaders Discuss U.S. Innovation Economy at BIO-AUTM Technology Transfer Symposium

Today’s Technology Transfer Symposium’s panel on The Role of Universities, Biotechnology Companies and Technology Transfer in the Innovation Economy included an active debate on issues ranging from increasing the odds for a successful partnership and the pros and cons of the Bayh-Dole Act. 

Andrew Cittadine, Co-founder & CEO of American BioOptics, Linda P.B. Katehi, Chancellor of the University of California (Davis), Steve Mento, President and CEO of Conatus Pharmaceuticals, Inc., and Tom Skalak, Vice President for Research, University of Virginia, all participated in the conversation, moderated by Robin A. Chadwick of Schwegman, Lundberg & Woessner.

Skalak noted during the panel that one of the keys to a successful partnership is “diverse eyeballs on the project,” which can help in making good decisions.  As an example, he pointed to a deal his university is involved in with AstraZeneca.  Cittadine underscored the importance of finding a good fit between the university and the biotech firm.

In discussing Bayh-Dole, all the panelists agreed that the Act has brought a lot of benefit to the industry, although there is room for improvement.  The Act “provides incentives to institutions to bring research to the marketplace,” explained Katehi.  Under Bayh-Dole, “ideas can emerge,” she added.  While she acknowledged that changes are needed, Katehi explained that if the Act is eliminated “there will be millions of good ideas, but no process for bringing them forward.”

Mento agreed, stating, “Bayh-Dole made the biotech industry possible.”  He noted that the system worked in the beginning, but it has now “evolved into a system where the focus is on short term return.”  It’s “impossible” to make the economics work, Mento said.

Cittadine added, the framework in Bayh-Dole is what enables new ideas to get funding.  Skalak, meanwhile, noted that without Bayh-Dole, discovery-oriented research would not happen.

Great Lakes Bioenergy Center

As the U.S. increasingly turns its attention—and resources—to bioenergy and biofuels, the Madison Wisconsin Region is emerging as a national leader, both in research and commercialization, evidenced in part by the siting of the Great Lakes Bioenergy Research Center (GLBRC) at the University of Wisconsin-Madison in 2007, one of only three Department of Energy (DOE) Bioenergy Research Centers in the U.S.

Funded with an initial five-year, approxmately $130 million-grant ($25 million dispersed annually), the GLBRC was launched to make transformational, game-changing breakthroughs for biofuels, and more specifically cellulosic ethanol. The GLBRC is the only academically-based Bioenergy Research Center; the other two national Centers are the JBEI (led by Lawrence Berkeley National Laboratory), and the BioEnergy Science Center (led by Oak Ridge National Laboratory).

The DOE grant to launch the GLBRC was awarded to the UW-Madison with Michigan State University as the major partner, though the University partners with other universities and private-side partners. The GLBRC has over 300 researchers on staff currently, spread between the UW Madison (roughly 200), partner Michigan State University (approximately 100), and a handful at partner institutions like Illinois State University, Iowa State University, Cornell University, and University of Minnesota.

Siting the GLBRC in the Midwest—and in the Madison Region at UW Madison particularly—was decided because of the pre-existing asset base of the area. Not only is the UW Madison rich in expertise across multiple fields (engineering, agronomy, crop sciences, sustainability, genomics, etc.), the region supports a host of natural resources used in this type of challenge. An earlier DOE “Billion Ton Biomass” study showed an excess of one billion tons of available biomass in the nation, most of which is found in Midwest (particularly Northern Wisconsin and Michigan) that could be used for fuel. Other siting factors include the presence and power of the Wisconsin Alumni Research Foundation (WARF) and the proximity of major Chicago and Detroit markets.

Now three years into their first five year grant cycle, the GLBRC continues on its initial course of research, which is diverted to four main research areas: improved plants, improved processing, improved catalysts and sustainable bioenergy practices. Researchers at the Center are doing everything from figuring out how to break down tough cell walls to answering questions like, ‘If we have a processing environment, how can we make that work efficiently, bring costs down, and make sure it’s sustainable (economically and environmentally)?’ While the GLBRC is set up to be a basic research center, there is a strong eye toward patenting and commercialization. WARFs leads the tech transfer group, and a process is in development to commercialize research breakthroughs.

The Center also embodies a strong Wisconsin Idea component, taking the science to the borders of the state and beyond for the public good. GLBRC has a large education and outreach component, which includes a number of Research Experience for Teachers (RET) programs. For example, over the summer, area high school teachers can apply to be part of the RET program, brought into research labs to work with the GLBRC scienitists to develop scientific activities to bring back to their classrooms.  Another program offers research experience for undergrads (generally targeted at underrepresented groups, or students from smaller colleges who might not have as broad a research opportunity as can be found at the UW Madison).

In many ways the GLBRC functions with a simliar outlook to the Wisconsin Institutes for Discovery (WID), bringing together researchers from across many different disciplines to make discoveries not otherwise possible; the Center facilitates this with the grant, of course, as well as things like high-throughput services and shared high-end lab equipment: the underlying shared philosophy being that the whole is greater than sum of its parts, moving smart thinking to commercialized potential in the Madison Region and beyond.

Find more information on the GLBRC on their website: http://www.glbrc.org or via Twitter @GLBioenergy.

Jennifer Smith, Thrive

jsmith@thrivehere.org | http://www.thrivehere.org | Twitter @thrivehere
Thrive is the economic development enterprise for the eight-county Madison Wisconsin Region.