Obviousness, 35 U.S.C. 271(e)(4)(A) and Application of Federal Rule of Civil Procedure 60(b) in the Pharma Space

Description

Hamlet famously said: "The play's the thing." Hamlet, act-2, scene-2. Two much-ballyhooed recent Federal Circuit decisions make clear that in U.S. patent law, "The claim's the thing." The teachers for this course, Joanna T. Brougher, MPH, BioPharma Law Group, Dr. Brit Perla of Arcus Biosciences, Michelle O’Brien, Head of Life Sciences at the Marbury Law Group, and Tom Irving, Senior Partner of the Marbury Law Group, bring, combined, over 80 years of U.S. patent experience that corroborates that "The claim's the thing."

A recent decision by the Federal Circuit Court of Appeal in Salix Pharm. v. Norwich Pharm. (Apr. 11, 2024) demonstrated the complexity of cases addressing Orange Book patents and Hatch-Waxman litigation. Of course, every decision depends on its own facts and circumstances. But, this decision surprisingly invalidated Salix's Orange Book listed polymorph patents, while upholding other Orange Book listed patents. This demonstrates the importance of a pharma patentee obtaining and legitimately listing in the Orange Book as many U.S. patents as possible. After all, last year's Lundbeck v. Lupin Federal Circuit decision, Nos. 2022-1194, 2022-1208, and 2022-1246 (Dec. 7, 2023), hammered home once again that a patentee only has to prove infringement of one claim of one patent, even if ALL Orange Book listed patents are invalidated.

The decision presents a few potential issues that bear investigation and extrapolation. For example, can routine experimentation replace demonstration of a reasonable expectation of success in assessing obviousness under 35 U.S.C. § 103? Furthermore, are drugmakers who include clinical trial protocols in a patent specification walking into a trap of a court relying on those protocols when obviousness is being questioned? And, even if not disclosed, would the duty of candor require disclosure of such protocols to the USPTO? A further example from this decision is what may be the impact of a generic manufacturer's skinny labeling strategy stemming from the court's interpretation of Section 271(e)(4)(A). And an overarching theme for a patent owner is how to draft and obtain pharma claims that will dovetail with available evidence to establish non-obviousness.

In a second recent decision, Janssen Pharm. v. Teva Pharm (Apr. 1, 2024) the Federal Circuit breathed life into a generic manufacturer's claims challenging a schizophrenia drug, by finding the district court was "erroneously rigid" in its 35 U.S.C. § 103 analysis. As Yogi Berra would have said, doesn't this analysis constitute déjà vu all over again in light of the Supreme Court's KSR decision? What differences exist, if any, between Janssen and KSR?

This description merely scratches the surface of what the panel will have to say. Listen as our authoritative panel of patent professionals examines obviousness and the implications of the Federal Circuit's recent decisions. The panel will discuss the obviousness analyses of the two decisions and offer best practices for a patent owner to present claims to assist in navigating the shoals of obviousness and for a generic manufacturer to surf the waves of Section 271(e)(4)(A).