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BLOG biotech : Mar 29, 2012

Personalized Medicine Takes a Hit

  • John Sterling
The biotech industry is in the process of trying to assess the potential impact of the U.S. Supreme Court’s overturning of Prometheus’ patent claims in the Prometheus Laboratories v. Mayo Collaborative Services case. The general feeling among biofirms, especially those involved with personalized medicine, is one of negativity.

The Court ruled that two Prometheus patents that specifically cover ways of calibrating the dosage for thiopurine drugs for certain autoimmune diseases were not patentable. The diagnostic tests were designed so that dosages of the drug might be optimized for individual patients—hence the personalized medicine connection.

In its ruling, the Court noted that “laws of nature, natural phenomena, and abstract ideas’ are not patentable subject matter under §101 of the Patent Act, Diamond v. Diehr … To transform an unpatentable law of nature into a patent-eligible application of such a law, a patent must do more than simply state the law of nature while adding the words ‘apply it’…We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid.”

When asked for his opinion on the Court ruling, Gerry Elman, editor in chief of Biotechnology Law Report (http://www.liebertpub.com/blr), published by Mary Ann Liebert, Inc., responded as follows: “The Supreme Court’s Chakrabarty decision in 1980, which affirmed that even a living organism is patent-eligible subject matter, is fondly remembered to this day as having spurred widespread investment in the life sciences sector. I am fearful that the Court’s Mayo decision in 2012 may soon be decried for jerking back on the reins, bogging down in a no-man’s-land the further development of this field. Yet I am hopeful that entrepreneurs and legal practitioners will develop creative strategies that mitigate the downside of the new uncertainty as to patent protection for current and future innovations.”

To complicate matters further, the Supreme Court, in a separate decision, remanded the case of The Association for Molecular Pathology, et al. v. USPTO et al. to the Federal Circuit Court of Appeals. That court will reconsider their decision dated July 29, 2011, which upheld Myriad Genetics' gene patents. In that decision, the Federal Circuit declared that the composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible under Section 101 of the U.S. Patent Act. For a more detailed look at the ramifications of the Prometheus ruling for Myriad and the rest of the biotech industry, see the article in GEN’s online Insight & Intelligence™ section entitled “Lawyers Offer Predictions for Myriad, Diagnostic Field Based on Supreme Court’s Decision Against Prometheus.”

The Prometheus decision will certainly be a topic of discussion, among others, at a Biocom breakfast panel discussion on personalized medicine that I will be moderating in San Diego on April 11. The event will take place between 7:00 am and 9:00 am at the Hyatt Regency La Jolla. For more information please go to http://www.biocom.org/event/Bfast_Mtg_April/.