Novo Nordisk and Mylan Settle Ozempic, Wegovy Patent Battles

Mylan Pharmaceuticals Inc. and Novo Nordisk A/S settled a patent lawsuit and validity challenge linked to Novo’s blockbuster weight-loss and diabetes drugs Ozempic and Wegovy.

The pharmaceutical companies asked the Patent Trial and Appeal Board to terminate Mylan’s challenge to Novo US Patent No. 10,335,462, in a motion filed Oct. 4, two days after the parties told the US District Court for the District of Delaware that they’d settled Novo’s lawsuit accusing Mylan of infringing numerous patents to create a generic version of Ozempic.

Novo sued Mylan in 2022 in a West Virginia federal court—one of a flurry of lawsuits accusing generic drugmakers of copying its profitable drug. The case was later transferred to and merged with others in Delaware federal court.

In 2023, Mylan petitioned the PTAB to cancel three of the asserted patents. The board declined to review two, but in October 2023 agreed to consider the Viatris Inc. unit’s challenge to the ‘462 patent.

Novo in July urged the PTAB to sanction Mylan for what it called harassing, duplicative litigation in its challenges to the ‘462 patent. It withdrew that motion as part of companies’ motion to terminate the proceeding. The board was set to hear the invalidity case on Oct. 8.

Novo and Mylan filed their settlement agreements with the board, and asked that the documents be treated as business confidential information accessible only to the PTAB because they “contain highly sensitive business confidential information that would substantially harm their business interests if publicly disclosed.”

The two companies asked to be notified if others request access to the settlement agreements pursuant to a statute that provides for such agreements to be made available to federal government agencies upon written request. Collaboration between the US Patent and Trademark Office and federal agencies has added to the pharmaceutical industry’s anxiety about antitrust scrutiny, as evidenced by recent proposed rulemaking in which stakeholders expressed concern about the lack of clarity around the confidentiality of agreements between drugmakers.

Groombridge, Wu, Baughman & Stone LLP represents Novo Nordisk. Perkins Coie LLP represents Mylan.

The case is Mylan Pharm. Inc. vs. Novo Nordisk A/S, P.T.A.B., IPR2023-00724, motion to terminate filed 10/4/24.