Gene Patenting: Can Someone Else Own Your Genes?

The issue of gene patenting has been a hot topic in the medical research community for years, and now the issue will finally be addressed in the courts. The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed suit in federal court challenging the validity and constitutionality of gene patents. Ass’n for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., No.09 Civ. 4515 (S.D.N.Y. filed May 12, 2009). The case centers on patents of the BRCA1 and BRCA2 genes held by Myriad Genetics, a commercial biopharmaceutical company focused on drug development and genetic testing. Mutations of the BRCA genes are highly correlated with an increased risk of breast and ovarian cancer. The lawsuit brought by the ACLU and PUBPAT represents researchers, genetic counselors, and scientific associations as well as individual cancer survivors and female patients who wish to have access to genetic testing for the BRCA genes.

Personally, I find it unsettling that someone out there could patent a gene that exists inside my body. I was alarmed to learn that twenty percent of our genetic code has already been patented. As law students, we are taught that patents are intended to encourage innovation and to protect the time and money put into creating new ideas. In my mind, a gene cannot and should not be considered akin to an invention protectable under patent law. After all, what could be less novel than a string of genetic code that has been replicated billions and billions of times throughout human history? There can be no doubt that the methods of studying and identifying genes are useful and critically important to medical research, but should genetic researchers be able to patent our genes?

The plaintiffs have challenged the validity of Myriad’s patent on the grounds that the BRCA genes are “products of nature” which were not invented, created, or in any way constructed by Myriad. Opponents of gene patenting have also argued that patent protection is not needed to incentivize research in this field because, unlike pharmaceutical development which must rely primarily on private investments (conditioned on an expectation of a profitable return), genetic research has benefited from the use of public funds. Lori B. Andrews & Jordan Paradise, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 YALE J. HEALTH POL’Y L. & ETHICS 403, 406 (2005). In fact, Myriad received over five million dollars in government funding when researching the BRCA genes. Thus, allowing Myriad to claim patent protection for its efforts would confer a double benefit.

Aside from the seeming disconnect between the concept of gene patenting and the intended scope and rationale of patent law protection, there are hugely important health and policy questions at stake. The ACLU and its supporters have argued that gene patents should not be allowed because they enable the patent holder to prohibit others from studying or testing the patented genes. As a result, valuable research initiatives which could help to find early screening tools or even cures to genetically linked diseases are foregone or delayed while researchers seek to obtain licenses from the patent holder.

Perhaps one of the reasons that the ACLU, which is known to select its cases very carefully, chose to bring suit against Myriad is because Myriad has already demonstrated its intention to jealously assert its patent rights. Myriad has cornered the market on expensive genetic testing for the BRCA genes, insisting that all such testing be conducted only in its labs. The ACLU also implies that Myriad’s actions have hampered research efforts, an allegation which Myriad strongly denies, stating that it has broadly allowed noncommercial research on the BRCA genes. The critical distinction when it comes to gene patents is that genes cannot be “invented around,” the ability to study the genes themselves is necessary for research to advance.

Both sides argued for summary judgment before the District Court for the Southern District of New York on February 2, 2010; the judge’s decision has not yet been announced. The public health concerns related to gene patenting cannot be overstated, and are likely to be a focal point of the court’s decision. Considering that so much of our genetic code is already patented, the outcome of this case promises to have far reaching implications for genetic research and for health.