- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
December 2, 2024Robins Kaplan LLP Announces 2025 Partners
-
November 20, 2024Eighth Circuit Affirms U.S. Merchants Victory in Trade Dress Infringement Case
-
November 15, 2024Lauren Coppola Named an Emerging Leader by Profiles in Diversity Journal
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
December 12, 2024Strategies for Licensing AI: A Litigation Perspective
-
December 2024A Landmark Victory for Disabled Homeless Veterans: Q&A with the Trial Team
-
November 8, 2024Trademark tensions on the track: Court upholds First Amendment protections in Haas v. Steiner
-
November 8, 2024Destination Skiing And The DOJ's Mountain Merger Challenge
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
In re Entresto Patent Litigation
Entresto® (sacubitril/valsartan)
July 7, 2023
Case Name: In re Entresto (Sacubitril/Valsartan) Patent Litigation, C.A. Nos. 19-1979, 19-2021, 19-2053, 2023 WL 4405464 (D. Del. July 7, 2023) (Andrews, J.)
Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patent No. 8,101,659 (“the ’659 patent”)
Nature of the Case and Issue(s) Presented: Novartis holds the NDA for Entresto, which the FDA approved “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction,” “for treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older,” and “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.” The ’659 Orange Book-listed patent has a priority date of January 17, 2002. It claims compositions of valsartan and sacubitril and the use of those compositions to treat hypertension and heart failure. Defendants seek FDA approval to market generic equivalents of Entresto. They have stipulated that their ANDA products would infringe the ’659 patent, and assert that the claims are invalid as obvious, lacking adequate written description, not enabled, and indefinite. After a three-day bench trial, the court found that the asserted claims lacked adequate written description and were therefore invalid.
Why Defendants Prevailed: The court noted that the touchstone of written description is possession as of the priority date. Defendants argued that because sacubitril/valsartan complexes were unknown as of the 2002 priority date, Plaintiff did not possess such complexes and therefore could not have described them. Plaintiffs responded that the ’659 patent satisfied the written description requirement by disclosing valsartan and sacubitril—the structural features (i.e. chemical names and/or chemical formulas) common to the members of the claimed genus of the pharmaceutical composition containing the valsartan and sacubitril combination. Plaintiff further pointed out that physical mixtures of valsartan and sacubitril, and complexes of valsartan and sacubitril, are mere subsets of the claimed genus. But “Plaintiff’s trouble is that written description also requires that common structural features be described ‘with enough precision that a relevant artisan can visualize or recognize the members of the genus.’” The ’659 patent specification described physical mixtures only. It did not, and could not, allow a POSA to visualize the members of the entire genus sufficient to show possession of complexes, which, to a POSA’s knowledge, had not yet been discovered.
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.