Court Refuses to Correct Patent Error that Requires a Multi-Step Analysis to Uncover

Claim Construction

The District Court of New Jersey declined Plaintiffs’ Vifor (International) AG and American Regent, Inc. request for judicial correction of what they argued was an obvious error in a patent related to Injectafer®.  Vifor (International) AG v. Mylan Laboratories Limited, 19-cv-13955 (D.N.J. April 26, 2021).  While Vifor may still seek correction at the USPTO, the…

Amgen v. Sanofi – Federal Circuit Focuses on Functional Claim Elements in Affirming Invalidity of Antibody Patent Claims as Not Enabled

Enablement

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware holding claims covering two Amgen-owned patents invalid for lack of enablement under 35 U.S.C. § 112.  Amgen Inc., v. Sanofi, 2021 U.S. App. LEXIS 3952 (Fed. Cir. 2021).  The patents at issue are directed to antibodies that bind…

Judges Vary on Cross-Use Provisions in Protective Orders

Protective order

Judge Andrews of the District of Delaware recently provided some guidance on protective order issues in Hatch-Waxman cases.  Allergan USA, Inc. v. Aurobindo Pharma Ltd.  At issue was whether Plaintiffs should be permitted to disclose one defendant’s confidential information to another defendant. While acknowledging it was a close call, Judge Andrews ultimately rejected Plaintiffs’ position…

Clinical Trials Showing that a “Sufficient Percentage” of Prescriptions Will Practice Claimed Method Held to Prove Induced Infringement

Inducement

Judge Du of the District of Nevada recently issued findings of facts and conclusions of law in a patent trial related to the drug Vascepa®.  Amarin Pharma, Inc. v. Hikma Pharma. USA Inc.  The court ultimately held that the asserted claims were all invalid as obvious.  But first it held that defendants proposed labels would…

Petitioners Should Address Objective Indicia of Nonobviousness in Petitions Filed with the PTO

Inter partes review, IPR, PGR, Post Grant Review, Secondary Considerations

Recently, the PTAB denied Gilead Sciences, Inc.’s (Gilead) request to institute an inter partes review of two patents relating to HIV-prevention, U.S. Patent No. 9,044,509 (the ’509 patent) and U.S. Patent No. 9,579,333 (the ’333 patent). One key reason for the denial was because Gilead failed to adequately address unexpected results in its Petition. The…

Statutory Disclaimer Removes the District Court’s Authority to Invalidate Patent Claims

Declaratory Judgment

In a recent decision, the Federal Circuit held that the district court lacked authority to “disinter” and declare claims invalid where the patent owner had statutorily disclaimed the claims. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367 (Fed. Cir. 2019). The case concerns the drug cabazitaxel, marketed as Jevtanta®, which is used…

Federal Circuit Confirms Collateral Estoppel Does Not Apply to Issues that Could Have Been Raised Previously

Collateral estoppel

Recently, the Federal Circuit affirmed a decision from the United States Patent and Trademark Office Patent Trial and Appeal Board (“the Board”) finding claims of Purdue’s latest abuse deterrent, extended release oxycodone patent, U.S. Patent No. 9,034,376 (“the ’376 patent”), obvious over reference combinations including Pub. No. US 2002/0187192 A1 (“Joshi”).  Purdue Pharma L.P., et…