Court Confirms Validity of Diabetes Drug Patents, Rules Competitor’s Proposed Generics Infringe

On Monday, Chief Judge Freda L. Wolfson issued an opinion siding with the plaintiffs, several pharmaceutical companies, in a case concerning the validity and infringement of their patents concerning a pair of Type 2 diabetes drugs. The District of New Jersey determined that defendant Zydus Pharmaceuticals (U.S.A.) Inc.’s abbreviated new drug applications (ANDAs) to make and sell generic versions of the plaintiffs’ drugs infringe upon the patents-in-suit.

Judge Wolfson’s 63-page opinion explained that in July 2017, plaintiffs Mitsubishi Tanabe Pharma Corp., Janssen Pharmaceuticals Inc., Janssen Pharmaceutical NV, Janssen Research and Development LLC, and Cilag GmbH International filed the instant patent infringement action against Zydus after Zydus’s filing of the two ANDAs. In its defense, Zydus maintained that the patents-in-suit were “invalid as obvious,” and filed a counterclaim seeking a declaratory judgment so stating.

In September and October of 2020, the court held a six-day bench trial during which numerous experts testified. The two issues presented were whether the plaintiffs’ patents were invalid as obvious and whether certain claims of one patent were “invalid for obviousness-type double patenting.”

The court answered both questions in the negative. It also held that because Zydus stipulated that its ANDA products would infringe to the extent the patents-in-suit were not found invalid, its filed ANDAs infringe upon the plaintiffs’ patents.

In so finding, the court extensively reviewed the factual record, including the history of diabetes treatment and the chemistry underlying the patented methods of treatment. It also weighed the dueling experts’ credibility. Ultimately, the court found that Zydus failed to carry its burden of proof and ordered judgment in the plaintiffs’ favor, including that the effective date of Zydus’s ANDAs may not be earlier than the expiration of the patents-in-suit.

The plaintiffs are represented by Saul Ewing Arnstein & Lehr LLP, Paul Hastings LLP, and Quinn Emanuel Urquhart & Sullivan LLP, and the defendant by Saiber LLC.