The long battle in the American courts over Myriad Genetics’ patents of BRCA1 and BRCA2, the primary diagnostic genes for hereditary breast and ovarian cancer has been well-documented in the IPilogue (see coverage by Beatrice yesterday as well as previous posts here, here, and here). Now, Myriad is poised to defend their patents at the Supreme Court for a second time, with arguments to be heard in Spring 2013. However, this time there is new information that has come to light regarding Myriad’s practices as a patentee that may further harm their case, based on public health policy.

It recently became public knowledge that Myriad has been retaining clinical data concerning BRCA1/2 mutations as trade secrets, stemming from their control over BRCA1/2 research. By claiming mutation information from clinical trials as proprietary, Myriad is failing to disclose valuable information that is secondary to their patent of the initial genes, and potentially impeding research on the genes that could result in life-saving developments. This brings concerns around the circumvention of the parameters and breadth of their initial patent, as well as the convolution of the patent as a means of shrouding their company data in trade secrecy.

Typically, patents are an alternative approach to keeping trade secrets; in exchange for disclosure of the information surrounding the invention (which is in the interest of furthering innovation), patent holders are granted legal protection from others using their patented invention. Trade secrets do not afford legal protection, and anyone obtaining the secrets (typically excluding those under contract) may use them freely. Of the greatest concern is that even if the BRCA1/2 patents are invalidated in court in the Spring, Myriad will still be privy to the clinical data collected under the invalid patent. Such unconscionable use of the patent system directly violates the public interest factors on which the system was built.

The primary public health consideration in Myriad’s decision to retain clinical data as trade secrets is the geographical inequality that has resulted from their retention of mutation information. This is a particularly great concern, as Myriad plans to enter the European market with BRACAnalysis. By retaining clinical BRCA gene mutation information in America, but not releasing it publicly, Myriad has ensured that consumers utilizing their test will receive more reliable results. At present, it has been reported that as a result of the vast mutation data and algorithms that Myriad has collected since releasing the BRACAnalysis test, only 3% of mutations will be of unknown significance. This contrasts unknown variant rates of 20% using other tests, including those presently in use in Europe. This means that Americans utilizing Myriad tests have a significantly greater chance of having their genetic variants identified, which is essential to therapeutic counseling. Further, as a result of this trade secret ‘loophole’ in the American patent system, which mirrors our own in Canada, Myriad will possess an inherent competitive commercial advantage over European BRCA tests despite not holding a BRCA patent in Europe. By allowing this type of action, a dangerous precedent is set in the field of biotechnological research, where research facilities may use patents as swords in order to protect vast trade secrets and monopolize a market, contrary to the public interest.

Beyond commercial interests, the primary function of scientific research in society is to serve the public good. This is particularly true in the case of medical research, as the ultimate goal is to benefit patients and improve diagnostics, treatment, and preventative medicine. Patents have become necessary in this competitive field, in order to encourage innovation and provide commercial protection and incentive for researchers who make significant breakthroughs. However, in the United States, it has been shown that 38% of gene patents were improper as of 2005, with most “inventors” overstating their discoveries surrounding the code, while others were granted protection for genes that had not been “discovered” yet (e.g., mutated or isoforms, with no description of the genes).

In my opinion, Myriad Genetics is a company benefitting from relatively lackadaisical biotechnology patenting standards. In addition to holding a (thus far) valid patent on the two primary diagnostic genes for breast and ovarian cancer, Myriad has created a monopoly through BRACAnalysis, which has been described as the most efficient breast cancer test commercially available. Holding the American patents for the BRCA genes has ensured that Myriad has been able to turn a profit after pouring millions of dollars into research and development, and has in turn improved the diagnostic potential of medical practitioners. However, with this advancement in medicine has come at great cost to the public. By creating geographical inequalities (resulting from the limited scope of Myriad’s services), Myriad is effectively compromising the therapeutic services provided to women worldwide, solely to advance their economic interests. Thus, despite creating an incredibly useful database of mutation information and algorithms, Myriad has effectively created a monopoly, and, in my view, has violated the promotion of innovation and discovery that the patent system is designed to serve.

Their aggressive protection against licensing, combined with what is regarded as an unreasonably high cost for the BRCA testing has led to allegations that Myriad is engaging in genetic profiteering by compromising the interests of public health in order to turn a profit. In my opinion, while the patent system certainly serves as a means of providing financial restitution to researchers and facilities that take financial risks in the interests of innovation, there comes a point when the public interest is being jeopardized out of greed. Such compromise of the public interest, especially in a medical research context, is contrary to the spirit of the patent system, which is to provide information to the public to improve transparency in innovation.

With the completion of the Human Genome Project, the United Nations identified the risk of abuse of advancing biotechnology, and the Universal Declaration of the Human Genome and Human Rights (UNESCO) took effect. Of particular importance is Article 12, which indirectly relates to gene patenting and freedom of research. It takes specific note of the unique nature of the genome, which is within all humans, and declares that the genome should be free to research in the interest of advancing bioscience and medicine. Additionally, and in my view damning to Myriad’s trade secrets and imposed geographical inequality, it declares that the benefits of advances in genetics and medical science be made available to all. Although this is not a binding legal document, it was carefully considered, is highly persuasive, and contemplates essential concepts in bioethics which may factor into the Supreme Court’s 2013 ruling.

Ryan Heighton is a JD candidate at Osgoode Hall Law School.

Posted in Blogs, Commercialization, Competition, European Union, Human Rights, Innovation, Patent Practice, Patentability, Patents, Regulatory Policy, Trade Secrets, US