Guest Post: Are Genes Eligible for Patents in the United States?

Continuing with our coverage of the arguments in the Myriad case, we bring you another guest post from Chris Ohly, a patent litigator and partner at a leading United States law firm. Chris’ article concerns recent arguments in the United States Supreme Court concerning the eligibility of “genes” for patenting under the US Patent Act. As his article reveals, the question presented in the case is “Are human genes patentable?” 

Standard disclaimers apply, which are as follows: the views expressed in his article are entirely his own and do not necessarily reflect the views of his law firm, or of any of its other attorneys or clients. Nothing in this article is intended to provide any form of legal advice. 

Owing to Blogger’s inability to accommodate footnotes, a full copy of the article written by Chris can be downloaded from the SpicyIP website, by clicking on this link over here. Those of you interested in contacting Chris, can email him at trial_lawyer@msn.com

The procedural history of the Myriad case: The Myriad case has been on the quite the roller coaster ride through the judicial system. The case was first heard and decided by the U.S. District Court for the Southern District of New York, from where it was appealed to the Court of Appeals for the Federal Circuit (CAFC). The losing parties at this stage, the American Civil Liberties Union (ACLU) and other individual plaintiffs then sought review before the U.S. Supreme Court through a petition for a writ of certiorari. 

Like in India, review by the U.S. Supreme Court is, in most cases, not available as of right. However unlike the Indian Supreme Court which admits for hearing, literally thousands of cases, the U.S. Supreme Court hears only a few cases, when it exercises its discretion and grants a petition for a writ of certiorari (perhaps 100, less than 5% of the 10,000 petitions annually received by the Court). The votes of four of the nine Supreme Court Justices are required to grant certiorari. In the Indian Supreme Court, benches of two judges take the call on whether a petition should be admitted and honestly, nobody really knows the criteria on the basis of which such petitions are admitted. 

But getting back to the present case, the U.S. Supreme Court granted the ACLU’s petition for certiorari and set aside the judgment of the CAFC, with instructions that the matter be reheard in light of the Supreme Court’s most recent decision in the case of Mayo v. Prometheus. The CAFC reheard the matter and once again came to the same conclusions, as in its earlier opinion. The majority found that the Supreme Court’s decision in Mayo was not really relevant to the Myriad case. 

The losing party, the ACLU, again petitioned the Supreme Court for certiorari and the Supreme Court granted review for one limited question and that is “Are human genes patentable?” 

The parties’ briefs were lengthy. Dozens of briefs were filed by amicic curiae, including important briefs by the United States; Dr. James Watson, the Nobel Prize winning discoverer of the double-helix structure of DNA; Dr. Eric Lander, one of the principal leaders of the Human Genome Product; and Dr. Ananda Mohan Chakrabarty, a famed inventor whose invention of a new bacterium was challenged in an earlier, seminal Supreme Court case. Chris’ article summarizes some of the arguments made in the many briefs filed in the US Supreme Court in Myriad. 

Oral Argument before the U.S. Supreme Court, as is customary, was limited to about one hour, in total unlike the Indian Supreme Court where there is no limit. Note that in the Novartis case, the Indian Supreme Court heard arguments for over 132 hours. Given the importance of the case, the Solicitor General of the U.S. was asked to present the government’s views and if I’m not mistake, this was one of the rare cases where the U.S. Government had taken a view that was contrary to that of the USPTO. 

Chris’ article also focuses on portions of the Oral Argument Transcript, to highlight issues and arguments considered by the Court. The decision in Myriad will have profound impact in US patent law, particularly in future biologic patenting and related litigation. A final judgement is expected to be delivered by the end of the Supreme Court’s current term, in June 2013. 

A copy of the oral argument transcript can be found hereand copies of the briefs filed in Myriad case can be found here.