Sanofi SAN

• Decision unanimously affirms the United States Federal Circuit Court's opinion that Amgen's asserted U.S. PCSK9 patent claims are invalid

BRIDGEWATER, N.J., May 18, 2023 /PRNewswire/ -- Sanofi (NASDAQ: SNY) is pleased with the United States Supreme Court's ruling in Amgen v. Sanofi et. al. The decision unanimously affirms the United States Federal Circuit Court's opinion that is favorable to Sanofi and Regeneron.

This ruling reinforces our longstanding belief that Amgen's asserted patent claims are invalid and represents an unequivocal win for America's innovation economy, its scientists, and researchers. Most importantly, it is a win for patients who rely on the lifesaving discoveries made through years of research and investment by the biopharma community. The justices rejected an attempt to radically change the longstanding legal standard for patent validity under the enablement doctrine – a move that would have blocked progress for entire classes of molecules, deterred innovative competition, and led to potential increases of drug prices.

We thank the Justices and the many groups, individuals and the U.S. government who supported our defense of scientific innovation.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com   

Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com 
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com  
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com 
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com 
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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SOURCE Sanofi