October 6, 2014
AIPLA Hot Biotech
By Carla Mouta-Bellum, Ph.D.; Anthony C. Tridico, Ph.D.
This morning the Federal Circuit heard arguments in the case of University of Utah Research v. Ambry Genetics Corporation in which Myriad Genetics is appealing the denial of a preliminary injunction by the U.S. District Court for the District of Utah, Central Division, preventing Ambry from offering genetic tests that use the BRCA1 and BRCA2 genes.
The district court denied Myriad a preliminary injunction because, in the court's view, Myriad was unlikely to succeed on the merits of the case. The court concluded that Ambry's position that the claims at issue cover subject matter that is not patent eligible under 35 USC § 101 raised a substantial question of validity.
Jonathan E. Singer, counsel for Myriad, began by arguing that both the Federal Circuit and the Supreme Court had previously acknowledged that Myriad was entitled to patent some applications of their newly-discovered gene sequence and tools designed specifically to utilize that sequence. Chief Circuit Judge Prost asked counsel to apply the test of taking away the law of nature from the claims and then seeing if the additional steps add something significant, something that is not routine or conventional. Judge Clevenger asked counsel to show the court the result of applying two tests: (1) look at the claim as a whole made up of the non-patentable subject matter and the "rest" and (2) take way the non-patentable subject matter at issue and then ask what is left: is it non-conventional or known, routine matter? Judge Dyk added that, supposing there had only been the law of nature in the claim, why would it have been patentable to add anything conventional?
Counsel for Myriad argued that, as a whole, the method of screening for alterations on the BRCA genes involves a probe that was not conventional because it had not been done or used before. Relying on Diamond v. Diehr, he argued it is not appropriate to look at what was known before and treat it as prior art and then separately analyze the rest of the claim. He continued arguing that the Supreme Court had ruled in AMP v. Myriad Genetics that cDNA was patentable and thus the process of creating it was patent eligible. Therefore, it should follow that a method claim that uses cDNA should be patent eligible. Myriad should not have to invent a totally new way of using cDNA to support a patent eligible claim.
The discussion then turned to the primer claims. According to Myriad, the primers were a composition with a new utility, which under Funk Brothers Seed Co. v. Kalo Inoculant Co ("no species had acquired a different use") should factor towards a finding of patent eligibility. Myriad argued that man has added utility to the primers that is not found in nature, namely the utility of use in PCR. Ambry's counsel challenged Myriad on this point arguing that the issue of whether or not the primers had new utility had already been decided in the lower court against Myriad, on consideration of expert testimony from both parties. Counsel for Ambry also retorted that primers are nothing more than segments of isolated DNA, which itself has been rendered non-patent eligible by the Supreme Court in AMP v. Myriad Genetics. Ambry's counsel went on to remind the court of Justice Thomas' "proviso" in that decision that not all cDNA is patent eligible (footnote 8 in AMP). Ambry also argued that, as copies, primers should not be patentable under In re Roslin. In response to a question by Judge Clevenger, Ambry's counsel argued that, even if the probes were tagged and no one had done that before, neither the probe nor the method of using it should be patent eligible. Judge Dyk also questioned what difference it would make if the function were different, suggesting that function may not be a determinant of patent eligibility when the structure is the same.
In view of today's arguments, which, if any, of Myriad's claims are patent eligible remains unclear. It does seem certain, however, that, as a practical matter the court concluded that it will be very difficult for Myriad to obtain a preliminary injunction before the key method patent (US Patent No. 5,753,441) expires in January of 2015.
Copyright © Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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