Terry Corbin (partner with Fenwich & West with extensive experience in strategic IP counseling and patent litigation for technology and life science companies) and Pauline Farmer-Koppenol’s (focusing on serving technology and life sciences clients in prosecuting patent applications) discussed the impact of recent U.S. Supreme Court’s Prometheus Decision on Patent Eligibility in areas of Personalized Medicine, Molecular Diagnostics and Human Gene Patents at www.bio2devicegroup.org .
Corbin gave the background information on the U.S. Supreme Court decision issued on March 20, 2012 that was centered around section 101 of the patent law, that remains more or less unchanged from 1793. This section requires that the patentee have invented or discovered something new and useful or a new and useful improvement on something that exists. Through various court decisions, this section of the law has also been interpreted to mean that laws of nature are not patentable. Mayo Clinic Lab and Prometheus had a court battle involving an assay for determining metabolite levels of thiopurine drugs. These are used to treat people with intestinal tract autoimmune disease. The assay in question revolved around a metabolite test which mimics naturally-occurring nucleosides, the subunits making up DNA or RNA – genetic material. Prometheus Lab is the exclusive licensee of the patents that protect a method for determining the proper dose of the drugs by measuring the levels of the particular metabolite. Mayo Clinic began using and selling its own test asserting that the Prometheus patents were around unpatentable matter and were therefore, invalid. In a unanimous decision, the Supreme Court agreed with Mayo and found that the patents claimed a law of nature and were therefore ineligible for patent protection. The court disregarded the numerous “Friends of the Court” briefs filed in favor of Prometheus, in making this ruling.
In the opinion of Corbin and Farmer-Koppenol, there could be many implications of this ruling that could potentially negatively impact innovation in the biotech industry. A looming additional concern is that the ruling was not accompanied with much guidance for future litigation in this area, thereby putting a much greater burden on the lower courts. The exclusivity versus innovation debate has always been at the center of the patent debate. In this case, Prometheus highlighted a drafting problem. In moving ahead, Corbin and Farmer-Koppenol advised, not to be greedy and not to try to grab more than what is truly invented. Farmer-Koppenol also asserted that device is a gold standard but medical device patents should seek to emphasize what they are structurally, and not just what they are capable of doing. In light of this ruling the speakers also advised to re-examine and amend claims, when necessary. The talk was followed by enthusiastic Q&A session with participants eager to discuss its many implications.