Winter 2014
Case Name: Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 769 F.3d 1339 (Fed. Cir. Oct. 20, 2014) (Chief Judge Prost, Circuit Judges Newman, Plager, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, and Hughes presiding; per curiam opinion) (Appeal from D. Del., Burke, M.J.) (Denial of request for en banc hearing of the issue regarding use of evidence related to unexpected results in the obviousness analysis.)
Drug Product and Patent(s)-in-Suit: Baraclude (entecavir); U.S. Pat. No. 5,206,244 (“the ’244 patent”)
Nature of the Case and Issue(s) Presented: The issue here concerns whether the Federal Circuit should conduct an en banc hearing regarding the issue of whether evidence that post-dates the effective filing date of the patent may be used to demonstrate unexpected results to defeat an obviousness challenge. Baraclude tablets are used to treat chronic hepatitis B. Entecavir is a reverse transcriptase that inhibits the viral DNA replication upon infection. The challenged claim of the ’244 patent was directed at the pharmaceutical compound of entecavir.
At the district court, Teva proved by clear and convincing evidence that the challenged claim was invalid under 35 U.S.C. § 103. In particular, Teva demonstrated that one of skill in the art would use the lead compound of 2’-deoxyguanosine and make minor modifications to reach the claimed compound. The district court rejected BMS’ argument that evidence created after the effective filing date of the ’244 patent that 2’-deoxyguanosine was toxic in humans demonstrated the unexpected results of the claimed compound, which was not toxic. On appeal, a panel of the Federal Circuit affirmed the obviousness decision of the district court.
BMS requested an en banc hearing on the issue of whether evidence that post-dates the effective filing date of the patent may be used to demonstrate unexpected results to defeat an obviousness challenge. BMS asserted that the panel’s opinion created a new standard for obviousness for pharmaceutical patents and shifted the burden of proving obviousness to the patent holder. The Federal Circuit denied the request.
Why Teva Prevailed: The judges that dissented from denial of the request for en banc hearing raised at least four issues that exist in light of the panel’s decision. These four issues include (i) treatment of post-invention evidence regarding the differences between the prior art and the invention, specifically when...
