Viatris Wins Court Decisions on Sanofi Appeals of Lantus® Patent Invalidations
Viatris Inc. (NASDAQ: VTRS) announced that the U.S. Patent and Trademark Appeal Board affirmed its previous rulings declaring several of Sanofi's Lantus® SoloSTAR® device patents unpatentable. This decision is a significant win for Viatris, facilitating wider access to its interchangeable Semglee® products, which are now the only interchangeable biosimilars for Lantus®. These products aim to provide affordable insulin options for diabetes patients, allowing substitution at pharmacies. Viatris' commitment to enhancing patient access is evident through its Global Healthcare Gateway® initiative.
- U.S. Patent and Trademark Appeal Board affirmed the unpatentability of Sanofi's Lantus® patents, benefitting Viatris.
- Launch of Semglee® products provides the only interchangeable biosimilars to Lantus®, enhancing patient access.
- Semglee® aids in controlling high blood sugar for diabetes patients, expanding treatment options.
- None.
PITTSBURGH, Dec. 29, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) announced that it is pleased with decisions issued today which affirm the U.S. Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus® SoloSTAR® device patents, U.S. Patent Nos. 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable.
These affirmances reinforce the company's continuing efforts to break down barriers to patient access for important medicines such as Semglee® through its Global Healthcare Gateway®. Viatris and Biocon Biologics Ltd. launched their interchangeable Semglee® products (insulin glargine-yfgn) last month, which are the first, and currently the only, interchangeable biosimilars to Lantus®, providing more affordable options for the millions of Americans living with diabetes.
The Semglee® products are available in vial and prefilled pen presentations and are interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a growing portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 38,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.
Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements about the outcome and status of ongoing litigation. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to: the scope, timing and outcome of any ongoing legal proceedings and the impact of any such proceedings; that court decisions are not yet final and are subject to further review, rehearing and appeal, which could result in an adverse outcome; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by the COVID-19 pandemic; the integration of Mylan N.V. and Pfizer Inc.'s Upjohn business (the "Upjohn Business"), which combined to form Viatris (the "Combination") and the implementation of our global restructuring initiatives being more difficult, time consuming or costly than expected, or being unsuccessful; the ability to achieve expected benefits, synergies and operating efficiencies in connection with the Combination or its restructuring initiatives within the expected timeframe or at all; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture and commercialize products; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations, including our operations in China; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management; and the other risks Viatris' filings with the Securities and Exchange Commission. Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law.
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FAQ
What recent legal decision did Viatris achieve regarding Sanofi's Lantus patents?
How does Viatris' Semglee® product relate to Lantus®?
What is the significance of the U.S. Patent and Trademark Appeal Board's ruling for Viatris stakeholders?
When were the Semglee® products launched by Viatris?
What therapeutic areas do Semglee® products address?
