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FEATURED CONTENT INTELLECTUAL PROPERTY Sponsored Article The Decision: Gene Patentability The subject of gene patentability is one of the most controversial topics in the life sciences industry. On June 13, 2013, the Supreme Court reached a unanimous decision in the Association for Molecular Pathology v. Myriad Genetics case concerning gene patentability. The ruling stated that companies cannot patent parts of naturally occurring human genes. The Court also ruled that synthetically created DNA could be patented. LMG Life Sciences Editor Phillip Bausk sat down with Fitzpatrick Cella Harper & Scinto attorneys Robert Fischer, John Carlin, and Joshua Rothman to discuss the impacts of the Supreme Court’s ruling. What was your initial reaction to the Supreme Court’s ruling? Did you agree with how the Court decided to view the case? John Carlin: I was not surprised by the basic decision and I think it was in line with the government’s position on the topic of gene patentability, as stated by the Solicitor General. Robert Fischer: I completely agree. It was not a surprising decision as there was skepticism during oral argument with the idea that a segment of natural occurring DNA was patentable. From an attorney’s standpoint, it was a well-crafted decision and was very narrowly focused. It contrasts with the kind of opinions produced by the Federal Circuit, which tend to more overtly give guidance for future relevant cases. The Supreme Court was very practical about their decision. These are the facts, and this is the decision we are going to make. They are saying that we are doing our job as judges to make the decision, and we are not the ones who should be coming up with legislation on the subject. Joshua Rothman: The decision didn’t go as far as some stakeholders in the biotech community hoped it would go. I do think it provides them enough protection to permit the industry to go forward and continue to invest in their technologies. What makes this decision more interesting for those looking to produce patents in pharmaceuticals? JR: The holding in this case is that you are not allowed to patent an isolated DNA sequence that is present in the naturally occurring DNA, but if you modify that naturally occurring DNA, such as is done with cDNA, then that non-naturally occurring subject matter would overcome the section 101-issue and could be patentable. The court did not address the extent to which a new form of genetic material would be patentable under section 103. While cDNA is patent eligible from a 101 perspective, it is not clear whether cDNA would be found obvious over naturally occurring DNA in the body. As a backdrop, the obviousness analysis in the small molecule space is fairly well developed and begins with whether there is a motivation to select a lead compound. In the genetic space here, however, the Court stated that “separating that gene from its surrounding genetic material is not an act of invention.” Given this statement, it is unclear what impact the mere presence of naturally occurring genes among our 23 pairs of chromosomes may play in the obviousness analysis of genetic inventions, such as to specific cDNA. By analogy, one could argue that cDNA may be non-obvi- Robert Fischer John Carlin Joshua Rothman LMG LIFE SCIENCES 2013 31