Creative Patent Claiming Strategies in Light of FDA Approval

Description

The Federal Circuit’s recent decision in Teva Pharms. v. Corcept Therapeutics reminds practitioners of the importance of claiming what was approved by the FDA and also that showing obviousness requires both a motivation to modify/combine the prior art AND a reasonable expectation of success at arriving at the claimed invention. Moreover, that reasonable expectation of success must be tied to the claim limitations, which are optimally tied to an FDA-approved product or method of treatment.

In addition, the case reminds practitioners that an obvious to try argument, for example, by a petitioner in an IPR, may be a difficult one if the changes that are allegedly “obvious to try” are not predictable solutions or if there is not a reasonable expectation of success. In such circumstances, the petitioner’s argument of obviousness may fail.

This case also highlights the importance of claim construction. Corcept’s claims were construed to require safe administration, even though that was not recited in the claims. But the Board and the Federal Circuit focused on what the clinical trials showed and what Corcept claimed. Claim construction was an important underpinning of the conclusion that the success of the claimed invention could not have been reasonably expected.

The case also brings to mind other creative claiming strategies like those in Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017), as well as using means-plus-function terminology, as prescribed by 35 U.S.C. § 112(f). See, e.g,. Ex parte Gleave, Appeal 2012-004973 (P.T.A.B. Jan. 22, 2014).

Listen as our authoritative panel of patent attorneys as they examine patent claiming and the virtues of claiming precisely what the FDA approved. The panel will discuss the recent Teva v. Corcept decision, obvious to try arguments, and the practical lessons from the recent decision. In addition, the panel will highlight a similarly successful claiming strategy employed by Sanofi in Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017). Further, the panel will explore creative claim strategies that take advantage of 112(f)’s means-plus-function terminology, particularly as a way to link an FDA-approved formulation to patent claims describing the approved formulation and literal equivalents thereof. The panel will offer best practices for patent claiming and tethering the claims to an FDA-approved product.