BIOtech NOW: The Role of Intellectual Property in Global Health

The Role of Intellectual Property in Global Health

BIO is committed to increase access to biologic medicines for patients throughout the world.  As BIO President and CEO Jim Greenwood said last year when announcing our policy statement on Options for Increasing Access to Medicines in the Developing World, “We believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are mutually supportive.”

While there are frequent misguided calls to circumvent intellectual property (IP) rights in order to provide therapies to undeveloped countries, BIO and many policy experts understand that IP rights are necessary to bring innovative new therapies to market and into the hands of patients.  Medicines cannot be utilized if they are not developed, and IP rights are often the only asset emerging biotech companies can leverage in order to attract the investment necessary to fund the lengthy and expensive research and development and clinical review processes.

Bill Gates has been an ally in our efforts to increase access to medicines in developing countries.  In 2004, BIO launched BIO Ventures for Global Health (BVGH) with a start-up grant from the Bill & Melinda Gates Foundation to speed the development of medicines for unmet diseases of developing countries. 

In a recent interview with Intellectual Property Watch, Bill Gates discussed the important role of IP in his Foundation’s work on global health:

“We fund research and we actually ourselves or our partners create intellectual property so that anything that is invented with our foundation money that goes to richer countries, we’re actually getting a return on that money.”

“By doing that we have more money to devote for research into neglected diseases and the diseases of the poor,” he said. “Now when our medicines go into the poor countries, they are always going in without any intellectual property fee, at very lowest cost pricing.”

 “But,” he said, “the intellectual property system has worked very well to protect our investments so that when they are used in rich countries we get a payback and then we have the control to make sure that it is not creating any financial burden on the countries that are the poorest.”

You can read the full article on Intellectual Property Watch’s website (subscription required).

Biotech, Gates Foundation, and Global Health

Great interview by Gene Quinn with Erik Iverson, Associate General Counsel with the Bill & Melinda Gates Foundation.  A summary article is on BIOtech Now and the full interview can be found on IPWatchdog.com.

 Highlights:

Iverson told me in no uncertain terms, “[A] fundamental premise at the foundation is that we absolutely respect intellectual property rights.  We recognize their importance and we certainly recognize the importance of companies and their involvement in developing products and having them commercialized both in developed and developing countries.”  But how can the Gates Foundation balance the intellectual property rights of those who create live saving technologies and treatments while at the same time ensuring the humanitarian mission? 

According to Iverson, this requires a different approach to each situation taking into consideration the unique factual circumstances involved, such as the disease at issue, the marketability that may exist in developed countries and the need to incentivize the desired outcome.  Iverson explained, “[T]he life science community is all about helping people and saving lives… [we are] trying to figure out how to balance them to push the development of products that well, very few people historically have put much effort into…”

Bayh-Dole Podcast moderated by BIO with AUTM and patient advocate

Lila Feisee, Vice President for Global Intellectual Property Policy at BIO, moderated a podcast on the benefits of the Bayh-Dole Act and the need to maintain flexibility in our nation’s technology transfer system.  She was joined by:

  • Dr. Ashley Stevens, Special Assistant to the Vice President for Research Technology Development and Senior Research Associate at the Institute for Technology Entrepreneurship & Commercialization at the Boston University School of Management.  He  also serves as President of the Association of University Technology Managers (AUTM), a nonprofit organization with an international membership of more than 3,000 technology managers and business executives. AUTM members come from more than 300 universities, research institutions and teaching hospitals as well as numerous businesses and government organizations.
  • Betsy de Parry, a patient advocate and author of The Roller Coaster Diaries, the story of her experience with non-Hodgkin’s lymphoma.

For more information on the many benefits the Bayh-Dole Act has provided, please visit http://www.b-d30.org/.  Information on AUTM can be found at http://www.autm.net.

To listen to the podcast go to:  http://www.biotech-now.org/section/bio-matters/2011/01/12/celebrating-thirty-years-success-bayh-dole-act and press the play button at the bottom of the article.

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. 

 

Pathogens and the Nagoya Protocol of the Convention on Biological Diversity

          Some nations have argued that the recent Nagoya Protocol of the Convention of Biological Diversity (CBD) includes pathogens. The inclusion of pathogens in the Nagoya Protocol could adversely affect the world’s ability to control outbreaks of infectious disease.  The following reasons demonstrate why pathogens are not and should not be included in the Nagoya Protocol.

Contrary to the Mission of the CBD:

  1. “The conservation of biological diversity,
  2. The sustainable use of the components of biological diversity, and
  3. The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.” 

 

  • The objective for preventing pathogen-borne illness is to eliminate and not conserve the pathogen.  Therefore, conserving and sustaining pathogens seems like a tenuous application in light of the first two objectives of the CBD.  

 

  • Some might argue that pathogens fall under the 3rd objective, addressed by the Nagoya Protocol.  However, analyzing the 3rd objective requires consideration of the other two objectives.  Benefit sharing is intrinsically linked to those genetic resources worthy of protection and sustainable use.  The following points clarify why the Nagoya Protocol does not cover pathogens.

 

 Nagoya Protocol Language

Mindful of the International Health Regulations (2005) of the World Health Organization and the importance of ensuring access to human pathogens for public health preparedness and response purposes.”  

  • The reference to the World Health Organization and the importance of access to pathogens indicates the intent that the WHO, not the CBD, is the place to address human pathogens.  

 

  •  In fact, the clause reinforces the idea that access, not benefit, is paramount in an outbreak of infectious disease.  The CBD recognizes that WHO has the appropriate level of technical expertise and experience to handle pathogen access issues.   

 

  • Some might argue Article 8(b) implies the inclusion of pathogens in the Protocol. 

Parties must “pay due regard to cases of present or imminent emergencies that threaten or damage human, animal, or plant health, as determined nationally or internationally.  Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries.” 

  • If Article 8(b) were interpreted to include pathogens, the language “the need for expeditious access to genetic resources” in times of emergencies strongly argues for the circumvention or inapplicability of access and benefit sharing laws to pathogens.

 

Applying the Protocol to Pathogens is highly problematic

  • Interpreting the Nagoya Protocol to include pathogens creates numerous practical and policy problems. 

 

  • Prior drafts both included and excluded pathogens in the Protocol indicating no agreement on the inclusion of pathogens.  Including pathogens would be a disingenuous reading of the intent of the contracting parties.

 

  • How do you identify the origin of a pathogen?  Pathogens are not bound by geography, quickly spreading globally by infected persons traveling on airplanes or infected birds flying across borders.  How can we identify who owns the next HIV clade, SARS virus, or the next variation of any pathogen?    

 

  • Infectious disease outbreaks require instantaneous action.  Any delay caused by nations negotiating ‘fair’ prices for pathogens harms both the local and global population needing immediate protection. 

 

  • Including pathogens in an access and benefit sharing system rewards bad luck.  The designers of the Nagoya Protocol sought to create a monetary incentive to conserve biodiversity and sustainability; not to create a system that allows nations to profit from misfortune. 

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.

U.S. House passes Bayh-Dole 30th Anniversary Concurrent Resolution

On November 15th, the United States House of Representatives voted 385-1 for the Bayh-Dole 30th Anniversary Concurrent Resolution.  

Here are some interesting quotes from the Resolution on the need for and the successes of Bayh-Dole.

“the United States Government is one of the largest funders of research in the world, but that research does not fully benefit American taxpayers unless it contributes new products and processes to the marketplace, thereby creating new companies and jobs, and solving societal problems;”

“the commercial development of discoveries and inventions falls upon private sector entrepreneurs, often requiring millions of dollars in development funding over many years, and even then commercial success is uncertain at best”

“ before the enactment of that Act, few inventions arising from the billions of taxpayer dollars granted each year to American research universities, nonprofit organizations, and Federal laboratories were being translated into commercial products of benefit to the public and the United States economy;”

“a critical factor in developing federally funded inventions into commercial products is the continued involvement of the inventor in the process, and Government patent policies before the enactment of the Bayh-Dole Act chilled the intended incentives of the patent system in this regard;”

“the ability to obtain a reliable patent license for commercial development is needed to justify private sector investments, and Government patent policies before the enactment of the Bayh-Dole Act made negotiating and obtaining such licenses difficult, if not impossible;

“patent ownership of potentially important inventions is crucial in the formation of many start-up companies, which form vital parts of an innovation economy, and ownership rights were discouraged by Government patent policies before the enactment of the Bayh-Dole Act;”

“the success of the Bayh-Dole Act became apparent with the creation and dominance of the United States biotechnology and information technology industries, that remain largely dependent on university research;”

“the Bayh-Dole Act has been widely recognized as a best practice and is now being adopted by other countries (both developed and developing) around the world to better integrate their own research universities into their economies in order to be more competitive;”

“objective examples of how the Bayh-Dole Act has not only benefitted the United States but has also created a better world include the creation of over 150 new drugs, vaccines, or in vitro devices, including the hepatitis B vaccine, cisplatin, carboplatin and taxol anticancer therapeutics, laser eye surgery devices, the Palmaz balloon expandable stent, and many more; and

“economic activity spurred on by the Bayh-Dole Act include the formation of more than 6,500 new companies from the inventions created under the Act, an estimated contribution of $450,000,000,000 to United States gross industrial output, and the creation of 280,000 new high technology jobs between 1999 and 2007:”

“(1) it is the sense of the Congress that— (A) the Bayh-Dole Act (Public Law 96– 517), as amended by Public Law 98–620, has made substantial contributions to the advancement of scientific and technological knowledge, fostered dramatic improvements in public health and safety, strengthened the higher education system, led to the development of new domestic industries and hundreds of thousands of new private sector jobs, and benefitted the economic and trade policies of the United States;”