federal circuit – Duane Morris Life Sciences Law

August 19, 2024 by Duane Morris

Patent Primogeniture: Obviousness-Type Double Patenting Immunity for First-Filed, First-Issued and Later-Expiring Patent in a Family

Recently, the relationship and intersection between obviousness-type double patenting (ODP) and any awarded Patent Term Adjustment (PTA) and/or Patent Term Extension (PTE) has received significant attention. The United States Court of Appeals for the Federal Circuit held in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023), that PTA and PTE, being codified in separate statutes, are treated differently for the purposes of determining the requisite expiration dates in an ODP analysis.

The Federal Circuit’s recent holding in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 2024-1061, 2024 WL 3763599 (Fed. Cir. Aug. 13, 2024), raises the issue of when a claim can be used as a reference claim in an ODP analysis. In particular, the court addressed the question of whether “a first-filed, first-issued, later-expiring claim [can] be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date”. Id. at *4.

Read the Alert on the Duane Morris LLP website.

July 15, 2024 by Duane Morris

Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance

In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone did not, as a matter of law, recommend, encourage or promote any infringing use.

Read the full Alert on the Duane Morris LLP website.

August 8, 2022 by Duane Morris

Coordinating IP and Regulatory Filings Can Minimize the Risk of Inequitable Conduct Before the PTO

On July 29, 2022, the U.S. Patent and Trademark Office (PTO) published a Notice on the Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board. The notice was part of the PTO’s response to President Joe Biden’s July 2021 Executive Order on Promoting Competition in the American Economy. It also answered Congress’ call for PTO action following the Federal Circuit’s September 2021 ruling that a drug formulation patent was unenforceable based on a drug manufacturer’s inconsistent disclosures to both the PTO and the FDA. In view of the notice, companies should review the interface between their IP and regulatory functions to confirm that their interoperation (or lack thereof) does not run afoul of a patent applicant’s duties of disclosure and reasonable inquiry to the PTO.

To read the full text of this Duane Morris Alert, please visit the firm website.