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Biodefense at Risk? Exploring the Impact of Gene Patents and Genomic Inventions
by Dana Perkins, PhD
Dana Perkins
Dana Perkins is a Senior Biodefense Advisor in the firm's Washington, DC office. She can be reached at (202) 496-7731
Please email the author at dperkins@mckennalong.com
with questions about this article.
McKenna Long and Aldridge LLP is recognized as the Biodefense Connection for players in the emerging biodefense industry by creating profitable partnerships between the pharmaceutical, vaccine, biotechnology, diagnostic, and other defense technology industries, the financial community, and government. The Firm's understanding of the legal challenges of biodefense, biotechnology, and infectious disease markets enables it to provide strategic government affairs and business solutions, counsel, and due diligence to investors and entities considering participation in the growing biodefense sector. Developing intellectual property (IP) - and knowing how to protect it - is a competitive cornerstone in today's complex biodefense marketplace. Recent legal changes have vitally strengthened protection of IP rights in the U.S. and internationally. At McKenna Long & Aldridge, our team of IP lawyers apply their legal knowledge, technical savvy and business acumen to help our clients leverage these changes and strategically create, manage and benefit from their IP assets.
According to the Administrative Office of the U.S. Courts the total U.S. filings for patent litigation was 2,830 in 2006 (showing a 4% increase from 2,720 cases in 2005). The growing number of biomedical patents and associated litigations has the potential of interfering with the biodefense/public health preparedness efforts and global trade and constitutes a challenge and an opportunity for the U.S. law firms to thoroughly address in order to maintain the leading role of the United States in the biotechnology and biodefense industries.
Ever since its initiation (and 2003 completion), sequencing of the human genome undertaken by the International Human Genome Sequencing Consortium (i.e. the "Human Genome Project") revealed that there are about 30,000 to 40,000 human genes (much less than what originally thought, 100,000 genes or more). The human genome is organized into 23 pairs of chromosomes consisting of deoxyribonucleic acid (DNA) and associated proteins. A gene is a DNA sequence of nucleotide bases that is transcribed into messenger ribonucleic acid (mRNA) and translated further into specific proteins. The 'code' for a specific protein thus lies into one's DNA and changes in the nucleotide sequence (mutations) are associated with human disease. A gene has coding and non-coding regions (exons and introns, respectively) and the non-coding regions (sometime called 'junk DNA') are spliced out when transcribed into mRNA. Other genetic elements such as single nucleotide polymorphisms (SNPs)-which define our genetic individuality and are used in linkage analysis, and expression sequence tags (ESTs) - which are unique occurrences in the same location of the human genome, are also significant in identifying the genetic connection to diseases (i.e. genetic testing) and designing more effective and specific drugs and treatments for these diseases.
Patent law views genes as chemicals, or "compositions of matter" and in 1980, the Supreme Court (Diamond v. Chakrabarty, 447 US 303, 206 USPQ 193) stated, in the issue whether living matter was patentable, that a patent can be issued to everything "under the sun that is made by the man". In Chakrabarty, a genetically engineered bacteria was considered an "invention" for the purposes of patent law because it was not something occurring in nature. By the year 2000, more than 25,000 DNA-based patents have been issued (Cook-Degan and McCormack, 2001 Science 293 no. 5528 pp. 217).
Like any other chemicals, DNA sequences are eligible for patents when isolated from their natural state or synthesized in a laboratory when "at least one specific, substantial, and credible utility" is disclosed (USPTO Utility Examination Guidelines, 66 FR Jan. 5, 2001). However, many consider the genes as works of nature and thus non-patentable.
By now, however, tens of thousands of human genes are now under a patent protection have patent applications pending. The Director of the Center for Genome Ethics, Law and Policy, Duke University, Robert Cook-Deegan estimated their numbers at 3,000 in US, 750 in EU and 500 in Japan. Notable patents include those owned by Myriad Genetics, Inc covering the BRCA1/2 breast and ovarian cancer genes and their use in the development of therapeutics and diagnostics and the cystic fibrosis gene patents owned by John Hopkins University (and recently licensed to Luminex Corporation to be used in test kits for screening for cystic fibrosis gene mutations and polymorphisms).
Reports of physicians avoiding the genetic testing for BRCA1/2 because they are under patent (2006 PTCJ vol. 73 no. 1794 pp 47-52) call into question the current applicability of patent law to human genes and the impact on public health. How will gene patenting affect the business strategies in the long term is also difficult to predict as the cost of acquiring multiple licenses may limit the future research and development on a specific patented matter. Nevertheless, the application of data obtained in the Human Genome Project toward the emerging field of genomic medicine is only at its infancy.
It is not then unusual that the issue of gene patenting re-emerged nowadays, this time in the form of a bill introduced (2/9/2007) by Rep. Xavier Becerra (D-CA) and Rep. David J. Weldon (R-FL), H.R. 977 "Genomic Research and Accessibility Act" aiming at banning patenting of human genetic material by amending Title 35, US Code. As of March 1, 2007, the bill was referred to the Subcommittee on Courts, the Internet, and Intellectual Property, and a sponsor is still needed to take it on the Senate floor. According to this bill, "no patent may be obtained for a nucleotide sequence, or its functions and correlations, or the naturally occurring products it specifies." If this bill makes its way through Congress, current gene patent holders will enjoy their rights to the patented genes since the provisions of the bill are not retroactive, but no new patents will be issued.
A newly emerging field, genetic control of host resistance to infection, introduces a new dimension to how we look at infectious disease in general and opportunities for "personalized" diagnostics and therapy.
A well-known example is the connection between malaria and the sickle cell trait (whereby mutant hemoglobin polymerizes under low oxygen conditions causing distortion of red blood cells and a tendency for them to lose their elasticity); about 3 million people in the US have this trait. Sickle cell trait usually is not regarded as a disease state because it has complications that are either uncommon or mild. Several polymorphisms (naturally occurring variation in the normal nucleotide sequence of the genome within individuals in a population) associated with the sickle cell trait have been shown to offer protection against malaria. For instance, people who lack the gene for the Duffy antigen are resistant to Plasmodium vivax infection. The Duffy null phenotype is most common in people whose ancestors derive from regions in Africa where vivax malaria is endemic.
Population genetic studies have led to the discovery of gene polymorphisms which directly or indirectly influence the susceptibility and resistance to HIV infection and AIDS. According to the World Health Organization, AIDS has killed more than 25 million people since it was first recognized in 1981 and about 0.6% of the world's living population is infected with HIV. In the future the study of human genes in relation to HIV-1 infection may provide the researchers to develop newer chemotherapeutic approaches to prevent or cure HIV-1 infection effectively. A mutant gene coding for a chemokine receptor (CCR5) named CCR5delta32 has already been shown to modulate the response to infection. Individuals with two mutant copies (alleles) of CCR5delta32 gene (homozygous) are resistant to HIV infection while those with a normal and mutant copy (heterozygous) have reduced susceptibility to infection and delayed progression to AIDS by about 2 years. The mutant gene conferring resistance is found in 5-14% of Europeans and Western Asians but is rare in Africans and is believed to have originated in Northern Europe and dispersed by the Vikings about 700 years ago. Some researchers have suggested that the bubonic plague that devastated Europe periodically over the past 1,000 years may have selected for this mutation by sparing those who lacked one or both copies of the gene. Moreover, it has also been suggested that the CCR5delta32 mutation may also provide protection against smallpox (Variola virus infection). However, the homozygous mutation may put people at risk for developing clinical West Nile Virus (WNV) infection (while 80% of people are asymptomatic when infected with WNV, those with clinical disease usually present with a nonspecific febrile illness lasting 3-6 days and CDC reported that 1 in 150 develop neurological manifestations). Genetic susceptibility to infection has been reported for other diseases as well such as Norwalk virus infection and Hansen's disease (leprosy)- caused by Mycobacterium leprae.
The debate over gene patenting and its impact on personalized medicine will likely continue to be in the public spotlight considering the ethical, legal, and economical issues associated with it, not to mention the polarity of views. Graham Dutfield, in a recent article in the Bulletin of the Word Health Organization (2006; 84:388-392), weighs against an outright ban on DNA patenting and urges for "purpose-bound protection", "non-intellectual property forms of legal protection" and sensitivity to the "rapidly advancing knowledge frontier".
I would like to add to that a reminder about the 1980 Cohen-Boyer patents (for recombinant DNA technology and proteins obtained using recombinant prokaryote and eukaryote DNA; expired in 1997) which led to licensing revenues of over $255 million and $3 billion in worldwide product sales establishing the biotechnology industry as we know it. Most likely the negotiation of non-exclusive, rather than exclusive, licenses at affordable prices was the pivotal decision in creating the new industry field. Stanley Cohen and Herbert Boyer are not only the founders of genetic engineering and biotechnology industry but also pioneers in the field of life sciences business based on intellectual protection issues.
Stanley Cohen and Dana Perkins
National Inventors Hall of Fame, Akron, OH 2001
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