- 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.
Novartis Pharms. Corp. v. Mylan Pharms. Inc.
Entresto® (sacubitril / valsartan)
July 6, 2023
Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2023 WL 4375445 (N.D.W.V. July 6, 2023) (Kleeh, J.)
Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril / valsartan); U.S. Patents Nos. 8,877,938 (“the ’938 patent”) and 9,388,134 (“the ’134 patent”)
Nature of the Case and Issue(s) Presented: Mylan filed an ANDA seeking approval to market a generic sacubitril/valsartan tablet for the treatment of heart failure. The parties dispute whether claims 1 and 11 of the ’938 patent and claim 5 of the ’134 patent are valid and enforceable. The parties also dispute whether Mylan’s ANDA product infringes the asserted claims. After a bench trial, the court found that Novartis had shown by a preponderance of the evidence that Mylan’s API is a substantially pure hemipentahydrate and Mylan’s API and ANDA products would infringe the patents-in-suit.
Why Novartis Prevailed: The patents-in-suit recited substantially pure trisodium sacubitril-valsartan (“TSVH”) hemipentahydrate in crystalline form. Mylan argued that its API was not substantially pure and that it was not hemipentahydrate.
The court construed “substantially pure” to mean that the API had at least 90% chemical purity. Mylan’s ANDA specification required that its Form II API had not more than 2.95% w/w impurities and residual solvents. Further, Plaintiff’s expert tested Mylan’s finished dosage form, finding that it had less than 0.50% w/w total impurities and residual solvents. Plaintiff’s expert also explained that although Mylan’s Form II contained amorphous material, he found that there was not a substantial amount in the final product (i.e., less than about 0.5% w/w.). Finally, the court concluded that the additional XRPD peaks not corresponding to Form II were from inactive ingredients (i.e., excipients) used to make the final formulation and did not corresponding to impure Form II.
Mylan also argued that its API was not hemipentahydrate. In so doing, it relied on a single crystal analysis performed by the DMF holder to posit that its Form II API was a trihydrate, not a hemipentahydrate. Plaintiff’s expert analyzed the Form II single crystal structure proffered by Mylan and found that the occupancies for certain water molecules were chemically impossible. Instead, when the occupancies for those water molecules were corrected based on known chemistry, Plaintiff’s expert found that the single crystal structure for Form II was hemipentahydrate. In particular, hemipentahydrate in TSVH refers to 2.5 bound water molecules per molecule of trisodium sacubitril-valsartan. As summarized by Plaintiff’s expert, Mylan’s Form II contained an estimated 4.70% to 4.71% w/w bound water, which was within 0.01% of the theoretical 4.70% w/w for 2.5 bound waters.
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.