Fabry Patient Law Suit and Request to NIH for March-in Petition Rehearing

An article out of the Genomics Law Report discussing the recent law suit citing violations of the Bayh Dole Act.

A second article from Patent Docs discusses the request for rehearing of the patients petition to the NIH for march-in.

AUTM’s 2010 Better World Report Highlights

 AUTM released their Better World Report for 2010 highlighting academic innovations commercially developed through technology transfer that are improving the quality of life.  Here is a quote from their press release.

A device that allows the blind to ―see‖ via electrical pulses applied to the tongue…a collagen scaffold to treat damaged joints…a new vaccine to prevent shingles…an artificial lung that provides patients with both mobility and comfort during treatment…a program that vastly improves literacy among middle and high-school age students…a device that transforms wheelchairs into all-terrain vehicles…a vaccine to prevent HPV…

These are just a few of the discoveries featured in the 2010 edition of the AUTM Better World Report, a collection of stories about technologies that originated in academic research and were brought to the public through technology transfer, the process of licensing and commercializing academic research so it can become real products that make the world a healthier and safer place.

Senator Birch Bayh writes the foreword and includes impressive evidence of Bayh-Dole’s success.

• More than 6,000 new U.S. companies were formed from university inventions.

• 4,350 new university licensed products are in the market.

• 5,000 active university-industry licenses are in effect, mostly with small companies.

• More than 153 new drugs, vaccines or in vitro devices have been commercialized from federally funded research since enactment of Bayh-Dole.

• Between 1996 and 2007 university patent licensing made:

❍ a $187 billion impact on the U.S. gross domestic product,

❍ a $457 billion impact on U.S. gross industrial output; and

❍ 279,000 new jobs in the United States.

A fairly impressive accomplishment considering before Bayh-Dole Senator Bayh states:

 “We found 28,000 government-funded inventions gathering dust on agency shelves with not a single drug commercialized when the government owned the patent.”

The report is an interesting read as it includes a small snapshot of what the academic and private sector can do when patent ownership incentives are properly aligned. 

 

IPWatchdog.com interview of Bayh-Dole insider

A great article from IPWatchdog.com giving Joe Allen’s (a Birch Bayh staffer) insider perspective on the passage of the Bayh-Dole Act. 

The Article’s Introduction:

William Shakespeare once wrote:

There is a tide in the affairs of men
Which taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.

See Julius Caesar.

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

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.

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.

From Lab to Commercialization: NIH Licenses Offer Another Path

(Original post at BIOtechNow)

If a biomedical breakthrough occurs within a federal lab, chances are your company can license use of the technology from the National Institutes of Health’s Office of Technology Transfer (OTT).

Every year, literally hundreds of biomedical breakthroughs take place in federal labs, and OTT handles licensing of such technologies for all labs within the Health and Human Services Department. NIH promotes licensing and use of these developments to create practical applications.

While NIH works to make the licensing process easy, it also seeks the development of as many products as possible that have the potential to improve public health. For that reason, it rarely grants exclusive-use licenses. In fact, the more licensees the better, in its view.

“This allows more than one company to develop products using a particular technology, products which may ultimately compete with each other in the marketplace,” OTT points out in its licensing documentation. “NIH recognizes that companies typically need an exclusive market position to offset the risk, time and expense of developing biomedical diagnostic or therapeutic products; however, companies do not necessarily need to achieve that position by exclusively licensing a government technology used to develop that product.”

The OTT website provides extensive lists and details of the technologies available for licensing. Toward its goal of improving public health, the agency breaks out licensing opportunities for neglected diseases and rare diseases in their own sections on the site. In addition to explaining the different types of licenses and research opportunities available, the site also provides examples of the forms and documents needed to apply for licenses.

NIH developments have played a role in many successful biomedical products. Determining the value of the government’s technology transfer work is tricky, the agency concedes. Typically, success is measured in patents approved and royalties received by the government.

“This approach does not depict the full scope of activities and may, in fact, distort the importance of ensuring that novel biomedical inventions are commercialized,” the agency notes in the preface to NIH Technologies in the Development of Healthcare Products, an online collection of case studies that showcase the impact of tech transfer.

Ultimately, the report notes, the most crucial factor is “the extent to which technologies developed in NIH laboratories and transferred to commercial partners are meeting the NIH mission of improving the public health.”

Based on that mission, the licensing process focuses on ensuring that licensed technology results in the creation of actual products. When applying for a license, a company must submit a business development plan, which OTT then uses to create performance benchmarks. OTT monitors each licensee’s performance and adjusts benchmarks as needed to ensure commercial development of government-derived inventions.

The Office of Transfer Technology will have a booth providing information about its programs at the upcoming BIO International Convention.

WARF: A Model of Technology Transfer Partnership

The Wisconsin Alumni Research Foundation (WARF) is the oldest technology transfer office in the United States, founded to manage a University of Wisconsin-Madison discovery that eventually eliminated the childhood disease rickets. WARF works with business and industry to transform university research into real products benefiting society at large—the Wisconsin Idea in action (see “Wisconsin Thrives“).

Over the years, the foundation has developed a model of technology transfer based on partnership with the UW-Madison and industry, an approach that today makes it one of the most successful long-term benefactors of technological innovation and public welfare in the country.

WARF played a fundamental role in the passage of the Bayh-Dole Act, giving U.S. universities and small businesses the right to own their own federally funded IP and allowing them to license that technology for commercial development.

The mission of this private, non-profit organization is to support scientific research at the UW-Madison, patenting inventions that come out of university research, licensing those technologies to companies for commercialization, and returning the licensing income to the UW-Madison to support further scientific endeavor.  Since making its first grant of $1,200 in 1928, WARF has contributed more than $915 million dollars to the UW-Madison, including monies to fund research, build facilities, purchase lands and equipment, and support a bevy of faculty and graduate student fellowships each year. Each year, WARF contributes over $45 million to fund additional UW Madison research.

Cool facts and hard numbers about WARF:

  • Manages over 800 pending and over 1,000 issued U.S. patents on UW-Madison technologies, as well as more than 2,000 international equivalents
  • Offers more than 1,000 technologies for licensing
  • Maintains more than 500 active commercial license agreements
  • Has completed over 30% of its license agreements with Wisconsin companies
  • Holds equity in 40 UW-Madison spin-off companies

Jennifer Smith, Thrive

jsmith@thrivehere.orgwww.thrivehere.org | Twitter: www.twitter.com/thrivehere
Thrive is the economic development enterprise for the 8-county Madison Wisconsin Region.

BIO Survey on Technology Transfer Shows Complexity of University-Industry Relationships

 I sat down with Cartier Esham, Director, Emerging Company Health and Regulatory Affairs at BIO, to discuss BIO’s new survey on licensing trends between universities and companies, part of a larger process of technology transfer. BIO will release the survey at this year’s BIO Investor Forum Technology Transfer Symposium, October 28, 2009. You can learn more about by visiting www.bio.org/ip/techtransfer.

 

Let’s start at the beginning – what makes the process of technology transfer interesting to those who care about innovation in America? What does technology transfer have to do with getting products out to people who want and need them?

Developing research into products and technologies for use by the public is a long and complex process. In the biotechnology sector once a company obtains a license for a discovery they will spend up to or more than a decade and hundreds of millions of dollars developing that discovery into a commercially available product that also meets all required regulatory standards.   Innovation, especially in the biotechnology sector, often requires that the public and the private sectors work together.  Since enactment of the Bayh-Dole Act in 1980 – which gave U.S. universities the right to retain rights to inventions made with government funding – more discoveries are being moved out of the laboratory into the public and providing enormous economic, health, an environmental benefits to our citizens.  Prior to this Act  only 5% of publicly-funded research were ever developed into publically available products.  It is imperative that we protect the laws and policies that have stimulated the transfer of technology and foster public and private sector interactions so that key discoveries in our laboratories are developed  into products/technologies available to the public.  We need to cultivate the dialogue among universities, the federal government and the private sector and work together to identify practices that will ensure the effective transfer of technology in the United States.

 

What’s so hard about making a deal about a technology?

There are always difficulties in public and private sector negotiations since while many of the goals are the shared some of the perspectives may differ.  And really, there is no one size fits all approach.  BIO recently conducted a  survey among its members on technology transfer and in-license agreement negotiations.  The survey showed that  monetary terms was the most difficult part of the in-license negotiation process.  We then asked several questions of our members on what types of payment structures they have for their license agreements and what metric they typically use to calculate value.  We will be unveiling this survey during BIO’s first annual Technology Transfer Symposium in California on October 28th.  It is our hope that by collecting this data we can facilitate discussions and collect information from the biotechnology industry and university and federal labs on best practices for in-license negotiations.

 

Licensing can be a pretty complicated process, from what it sounds like. You have lots of cooks in the innovation kitchen, so to speak… what wasn’t known about licensing that you hoped to understand with the survey?

I think one of the more startling findings of the survey is the lack of license agreements the biotechnology industry has with the federal government.  Given that the Unites States has some of the best research facilities and premier scientists working on break through research in the health, energy, food and environment fields, it seems critical that we work to ensure this research – where appropriate – should not sit in a lab but be developed in a way that will benefit the public.

 

Final question: if you were an inventor of a stellar, unfunded platform technology, how would you approach today’s market, given these licensing trends?

A fundamental part of successful transfer of technology is finding the right partner – this goes for universities who seek companies to license their technology and companies looking for a specific technology that fits into their research and development pipeline.  BIO would like work on how to improve communications between the public and private sectors on how to identify and find licensing opportunities.

GAO Report on Bayh-Dole: Leverage to Promote Commercialization of Federally-Funded Inventions

The General Accountability Office submitted its report to Congress today on the administration of the regulations found under the Bayh-Dole Act, the foundation of all federally-funded research in the United States and one of the key factors in the creation (and boom) of biotechnology as both a research field and industry in the 1980s.

A little background on Bayh-Dole:

Technological innovation is widely seen as responsible for much of the economic growth and increased standard of living in modern societies. Patent rights give inventors, or other patent owners, exclusive control over the use of their inventions for about 20 years, which promotes commercialization of new ideas and allows inventors to profit from their ideas. Patent rights ownership encourages the additional, and often substantial, investment of time and money needed to transform the technological innovations developed in the laboratory into goods, services, and processes available in the marketplace.

Since its enactment in 1980, the Bayh-Dole Act has provided recipients of federal research and development funding…the option to retain patents on the inventions they create, provided they adhere to certain requirements. A main goal of the act is to promote the utilization of inventions arising from federal supported research or development, and observers have judged the act a success in their regard. Prior to 1980, when the government routinely retained the patents on federally sponsored inventions, only 5 percent of these patents were ever used in the private sector. In contrast, some stakeholders, including federal and technology transfer officials, today believe that invention that arise from federally funded research are routinely commercialized, although comprehensive data are not available on how often this happens…

The report was prompted  by a single issue not many outside of legal circles understand: march-in rights, or in vernacular, the government’s ability to “march-in” and revoke ownership of federally-funded research under certain, rare circumstances:

In exchange for the right to retain ownership of federally sponsored inventions under the Bayh-Dole Act, contractors must agree to certain reporting requirements. More specifically, contractors agree to notify the funding agency within 2 months after the contractor learns that an invention has been created and to notify the funding agency within 2 years after this notification of the contractor’s decision to retain title to the invention. In addition, contractors agree to apply for a patent on the invention typically within 1 year of the election of title, attempt to commercialize the invention, and to provide additional reports. These additional reports, if requested by the agency, can provide such information as utilization of the invention and patent-related information such as the filing date, patent application number and title, and patent number and issue date for the invention in any country in which the contractor has applied for a patent. Failure by the contractor to disclose the invention, elect title to it, or file a patent application within the times specified, or failure to follow through with the patent application process, allows the relevant federal agency to obtain ownership of the invention.

The Bayh-Dole Act also reserved certain rights for the government to protect the public’s interests. Specifically, the government retains “a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world,” also known as a nonexclusive royalty-free license. In addition, the act provides the government march-in authority. Under this authority, the federal agency that funded the development of an invention has the right to require the contractor or exclusive licensee to grant a license in any field of use to a responsible applicant upon terms that are reasonable under the circumstances, if the agency determines that:

• the contractor has not made, and is not expected to make, efforts to commercialize the invention within an agreed upon time frame;

• public health or safety needs are not reasonably satisfied by the contractor or licensee;

• the use of the invention is required by the federal government and the contractor or licensee cannot meet the government’s requirements; or

• the owner of an exclusive license is not ensuring that the invention is “manufactured substantially” in the United States and has not obtained the necessary waivers to do so.

Indeed these situations are so rare they’re non-existant, as the report points out:

None of the four agencies we reviewed has chosen to exercise march-in authority under the Bayh-Dole Act. DOD, DOE, and NASA have neither discovered nor received information that would lead them to initiate a march-in proceeding or exercise their march-in authority during the last 20 years. In contrast, NIH has been petitioned formally to exercise its march-in authority three times, but in each case determined that the statutory requirements for march-in proceedings had not been met. Nevertheless, officials at three of the four agencies told us they value the authority because, together with other tools, it provides them leverage to promote commercialization of federally funded inventions. In contrast, DOE officials do not believe march-in authority has significant value as leverage, in part, because no agency has ever exercised the authority.

Specifically, the report details the history of repeated and failed attempts to use march-in rights to gain access to patented technologies after they have been commercialized, including a recent petition in 2004 regarding public health care and access to technology:

In 2004, NIH received two more petitions, in which the petitioner expressed concern that the price of two drugs—one to treat HIV/AIDS and the other to treat glaucoma—made them unaffordable for many people living with these diseases, posing a threat to their health and safety. However, NIH determined that the drugs were already on the market and widely prescribed, and therefore marching in would not alleviate health and safety needs that were not already being satisfied by the producer [italics added]. NIH also stated in its decisions that drug pricing is an issue more appropriately left to the Congress. Furthermore, as NIH noted in its decision on the 1997 petition, the agency is “wary of forced attempts to influence the marketplace for the benefit of a single company.”

Since August 2007, however, a change of administration creates cause for concern:

As a result of changes mandated by the America COMPETES Act, the Technology Administration has been disbanded and Commerce has shifted responsibility for the Bayh-Dole Act to the National Institute of Standards and Technology (NIST). Officials from two technology transfer organizations told us that, as a result of this change, the department currently has little expertise on the march-in process. Specifically, technology transfer officials told us they were concerned that NIST did not have the knowledge and experience of the Technology Administration with regard to oversight of march-in procedures and officials at one organization believed that this might cause some ambiguity in facilitating agencies’ implementation of the act.

NIST officials acknowledged that no one currently in their office has any experience with the march-in authority and said the process appears to be very time-consuming and complex. However, these officials told us that when the Technology Administration was disbanded, the same lawyers who worked on Bayh-Dole issues continued to provide their services, which allowed continuity in the overall legal aspects of oversight for the act. They also noted that most of the questions they have addressed for agencies concern aspects of the act other than the march-in authority. They also believe that because agencies are not required to contact NIST with questions related to the Bayh-Dole Act, that NIST’s role in any future march-in proceedings will likely be very limited.

For further background, you can read BIO’s response to the 2004 petition here; also; read BIO’s statement to the House Science & Technology Committee in 2007 titled, “The Bayh-Dole Act: The Next 25 Years” here .