Novartis Considers U.S. Supreme Court Upholds Validity of Patent on Gilenya® (fingolimod) Dosing Regimen

Novartis Pharmaceuticals AG

Ad hoc announcement pursuant to Art. 53LR

Basel, September 21, 2022 — Today, Novartis announced that the United States Court of Appeals for the Federal Circuit (CAFC) has denied its motion to rehear the negative determination regarding the validity of U.S. Patent No. 9,187,405, covering a dosage of 0.5 mg of Gilenya. Novartis plans to file a motion seeking further review of the CAFC decision with the U.S. Supreme Court.

In August 2020, the US District Court for the District of Delaware issued a favorable decision and a permanent injunction was granted against HEC Pharma until the ‘405 patent expires in December 2027 (including pediatric exclusivity). HEC Pharma was the only abbreviated new drug application (ANDA) applicant remaining to challenge this patent.

In January 2022, a panel of three CAFC judges issued a decision upholding the validity of the regimen patent. HEC then filed a motion for a rehearing with the CAFC, and in June 2022, an amended CAFC panel reversed its previous decision and declared the patent invalid.

If generics were to launch in the United States, we expect fiscal year 2022 sales to be negatively impacted by $0.3 billion. As for the full year 2022 guidance for Group sales and core operating profit growth, we continue to expect both in the mid-single digit range, at constant currencies.

Novartis intends to vigorously defend the validity of the patent and is considering all available options, including current plans to seek review of this decision by petition to the U.S. Supreme Court, a process that could take several months. to determine if the request will be granted.

Previously, Novartis entered into settlement agreements with a number of ANDA filers. Under these regulations, these ANDA registrants could have launched a generic version of Gilenya, if approved by the FDA, on an agreed date prior to the expiration of the patent on the regimen, or earlier than the agreed date under of certain conditions. With this decision, HEC and other ANDA registrants with FDA approval will potentially be able to launch a 0.5 mg generic version of Gilenya imminently, pending further legal action.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential”, “may”, “will”, “plans”, ” , or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling of the investigational or approved products described in this press release, or regarding potential future revenue from such products. should not place undue reliance on these statements. These forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to important known and unknown risks and uncertainties. If one or more of these risks or uncertainties matter ualized, or if underlying assumptions prove incorrect, actual results could differ materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indication or labeling in any particular market or time. There is also no guarantee that these products will be commercially successful in the future. In particular, our expectations regarding these products could be affected by, among other things, uncertainties inherent in research and development, including the results of clinical trials and further analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including pressures from governments, payers and the general public on pricing and reimbursement and demands for increased price transparency; our ability to obtain or maintain proprietary intellectual property protection; particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects and efforts to mitigate pandemic diseases such as COVID-19; security, quality, data integrity or manufacturing issues; potential or actual breaches of data security and data privacy, or disruptions to our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F filed with the Securities and Exchange United States Commission. Novartis is providing the information in this press release as of this date and undertakes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reinventing medicine to improve and extend people’s lives. As a world leader in medicines, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest for new medicines, we consistently rank among the top companies in the world that invest in research and development. Novartis products reach nearly 800 million people worldwide and we are finding innovative ways to expand access to our latest treatments. Approximately 108,000 people of more than 140 nationalities work at Novartis worldwide. Learn more about https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis on https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions regarding the site or required registration, please contact [email protected]

# # #

Novartis Media Relations
Email: [email protected]

Novartis Investor Relations
Investor Relations Central Line: +41 61 324 7944
Email: [email protected]

Central

North America

Samir Shah

+41 61 324 7944

Sloan Simpson

+1 862 345 4440

Nicole Zinsli-Somm

+41 61 324 3809

Alina Levchuk

+1 862 778 3372

Isabelle Zinck

+41 61 324 7188

Parag Mahanti

+1 973-876-4912

About Michael Bill

Check Also

Integrating Natural Medicines: Therapeutic Goods Administration Statement

Insight contacted the TGA regarding the episode, Integrating Natural Medicines. A TGA spokesperson provided Insight …