U.S. District Court Rules In Favor of Merck in Sitagliptin Phosphate Patent Lawsuit
Sitagliptin is an active ingredient in
JANUVIA®, JANUMET® and JANUMET® XR
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,
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
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).
version on businesswire.com: https://www.businesswire.com/news/home/20220922005340/en/
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