U.S. District Court Rules In Favor of Merck in Sitagliptin Phosphate Patent Lawsuit
September 22, 2022 6:40 am ET
Sitagliptin is an active ingredient in JANUVIA®, JANUMET® and JANUMET® XR
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. District Court for the Northern District of West Virginia ruled in favor of the company in a patent infringement suit against Viatris related to sitagliptin, an active ingredient in JANUVIA, JANUMET and JANUMET XR. The Court found that both Merck patents at issue were valid and infringed. The decision is subject to appeal.
Two Merck patents were involved in the suit. The first, U.S. Patent No. 7,326,708, covers the dihydrogen phosphate salt of sitagliptin and is set to expire on Nov. 24, 2026, with pediatric exclusivity extending to May 24, 2027. The second, U.S. Patent No. 8,414,921, covers the co-formulation of sitagliptin and metformin found in JANUMET and is set to expire Jan. 21, 2029, with pediatric exclusivity extending to July 21, 2029. Merck had filed infringement actions against Viatris under both patents, for which Viatris alleged non-infringement and/or invalidity.
Viatris is seeking U.S. Food and Drug Administration approval to market generic versions of JANUVIA and JANUMET in the U.S.
Viatris had previously challenged validity of the salt patent in an Inter Parties Review before the U.S. Patent Office. On May 7, 2021, the Patent Office issued a decision in Merck’s favor, finding all challenged claims valid. Viatris has appealed that decision to the Court of Appeals for the Federal Circuit, which is pending.
In addition, Merck has entered into patent litigation settlement agreements with multiple generic companies, allowing them to bring their generic versions of JANUVIA and JANUMET to the market in the U.S. in May 2026 or earlier under certain circumstances, and their generic versions of JANUMET XR to the market in July 2026 or earlier under certain circumstances.
Judge Irene Keeley presided over the trial. Merck was represented by the law firm of Williams & Connolly LLP.
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Source: Merck & Co., Inc. Merck