US BIOTECH


affect patients’ health or risk death (see Ryan Davis’s March 20, 2012 Prometheus Blood Test Unpatentable, High Court Rules).


Prometheus is the sole and exclusive licensee of the two patents at issue, which concern the use of thiopurine drugs to treat autoimmune diseases such as Crohn’s disease and ulcerative colitis. Aſter the drugs are ingested, the body metabolises them, producing metabolites in the bloodstream. Because patients metabolise these drugs differently, doctors have found it difficult to determine whether a particular patient’s dose is too low or too high. Te patent claims at issue set forth processes embodying researchers’ findings that identify with precision correlations between metabolite levels and likely harm or ineffectiveness.


Tere are a host of issued and unexpired patents with claims similar to those in the Prometheus patents. Mayo, in 2004, began using and marketing a test to determine optimal thiopurine dosages. Te court observed this phenomenon and concluded that to hold valid patents with Prometheus-type claims would have the effect of hindering future innovation. Te court reasoned that such patents pose a threat to the development of more refined treatment recommendations.


Ryan Davis quotes Dr Robert M. Wah, chairman of the board of trustees of the AMA, who called this decision a clear legal victory for doctors and patients that will ensure scientific data will remain widely available. According to Dr Wah: “Medical innovations that provide insight into natural human biology must remain freely accessible and widely disseminated. Blocking this information from physicians and researchers inhibits future discoveries.”


Tis decision will have another effect, namely, the financing of startup companies who focus upon personalised medicine. Tese companies need to attract venture capital funding. By the court’s weakening of patent protection for innovations in this area, venture investment sensitive to risk is likely to be discouraged. On the other hand, parties aligned with Mayo believe that the court’s decision will have the effect of lowering health care costs for patients, by permitting companies to offer competing diagnostic tests.


Molecular Pathology v Myriad Genetics


Te US Supreme Court, only days aſter its decision in Mayo v Prometheus, reversed and threw out a Federal Circuit decision allowing BRCA1 and BRCA2 gene patents, and remanded the case of Association for Molecular Pathology, et al v Myriad Genetics, Inc, et al back to the lower


Michael Yee, a biotech analyst for RBC Capital Markets, is quoted by James Vicini in his March 26, 2012 Reuters article: “Biotechs have patents and intellectual property for proteins, antibodies, chemical entities and other composition of matter patents that support development of drugs.”


court for further consideration in light of its unanimous Prometheus rationale.


Justice Breyer, as in the Prometheus case, wrote the court’s opinion. Interestingly, the court’s decision conforms to the decision of Judge Robert W. Sweet of the US District Court for the Southern District of New York, who in March of 2010 issued a summary judgment opinion invalidating both composition of matter patent claims directed to these genes and methods of detecting breast cancer-related mutations in these genes. Women who test positive using Myriad’s gene test have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes. Such tests are believed to help determine therapy treatments.


Te fact that the Supreme Court reversed and remanded the case does not necessarily spell doom for Myriad’s patents. Te Prometheus and Myriad cases and their underlying facts are not identical. Unlike the Prometheus patents, the Myriad patents include product claims. Furthermore, in the event the Federal Circuit should invalidate Myriad’s patents, it will have an opportunity to appeal such a ruling to the Supreme Court.


Amicus curiae briefs were filed by, among others, Cancer Council Australia, the AMA, National Women’s Health Network, Kaiser Permanente, Knowledge Ecology International, AARP, Society Project at Yale Law School, Canavan Foundation, Association for Molecular Pathology, and academics in law, medicine health policy and clinical genetics.


Some believe that an ultimate ruling against Myriad will not upend the biotech industry.


30 World Intellectual Property Review Annual 2012 www.worldipreview.com


Te case against Myriad was initiated by the Public Patent Foundation and the American Civil Liberties Union, as well as the Association for Molecular Pathology, claiming that patents covering natural phenomena are invalid and, if held valid, would hinder genetics research. Myriad in its opposing argument holds the position that its patent has not, in fact, hindered science or research. GenomeWeb Daily News in its March 26, 2012 article, quotes Daniel Ravicher, executive director of PUBPAT and co-counsel in Myriad: “Nobody ‘invents’ genes, so no-one should be able to claim ownership of them. We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. Tat cannot, and should not, be patented.”


Clearly, the biotech industry is watching this case closely. Te ultimate outcome remains uncertain, and the Supreme Court’s decision not to rule on the merits but to ask the Federal Circuit to reconsider its ruling will mean a further delay before there is a conclusion in the case. Patent attorneys who are draſting patent claims will be best advised to recite claim language which adheres to the court’s dictates and reasoning. n


Paul Sutton is a founding partner of Sutton Magidoff. He can be contacted at: paul@suttonmagidoff.com


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