- Acumen Powered by Robins Kaplan LLP®
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- 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
-
June 17, 2024Emily Tremblay Named IP Rising Star by Euromoney in 2024 Women in Business Law Awards
-
June 17, 2024Three Robins Kaplan Partners Named BTI Client Service All-Stars
-
June 13, 2024Brendan Johnson Named South Dakota Trial Lawyer of The Year
-
June 27, 2024Sex Abuse Litigation
-
June 10-11, 20242024 Probate and Trust Law Section Conference
-
June 11, 2024FBA 2024 Federal Practice Seminar
-
June 2024Robins Kaplan Secures Landmark $7.75 Million Verdict in Aerosol Duster Misuse Case
-
June 2024To Seize or Not to Seize: Campus Protests and Police Uses of Force
-
June 2024Communicating Your Estate Plan: A Helpful Tool, Not a Fix-All
-
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.
Astellas Pharma Inc. v. Sandoz Inc.
Myrbetriq® (mirabegron)
June 9, 2023
![GENERICally Speaking](/-/media/images/newsletters/generically-speaking-social-graphics/generic_390x160.png?la=en&h=160&w=390&la=en&hash=7C4F410F9639FA5CC4261D8C8A36AB07)
Case Name: Astellas Pharma Inc. v. Sandoz Inc., Civ. No. 20-1589, 2023 WL 3934386 (D. Del. June 9, 2023) (Bataillon, J.)
Drug Product and Patent(s)-in-Suit: Myrbetriq® (mirabegron); U.S. Patent No. 10,842,780 (“the ’780 patent”)
Nature of the Case and Issue(s) Presented: Astellas sued to enjoin a number of Defendants from marketing generic versions of Myrbetriq, an extended-release formulation of mirabegron for the treatment of overactive bladder. The ’780 patent claims overcoming “food effect,” described as a drug’s dangerous potency on an empty stomach contrasted by its inefficacy on a full one, by describing an extended-release formulation of mirabegron comprising a hydrogel-forming polymer, hydrophilic additive, and a dissolution limitation: that the dosage has dissolved no more than 39% at 1.5 hours and at least 75% after 7 hours. The parties engaged in a five-day bench trial. The court found that the asserted claims were invalid.
Why Defendants Prevailed: Defendants argued that the ’780 patent was invalid for not meeting the enablement requirement of 35 U.S.C. § 112. Specifically, Defendants argued that the patent specification did not offer sufficient clarity to enable a skilled artisan to make the invention without undue experimentation. Astellas countered that the specification directs routine activity by highly-skilled artisans in a predictable art. Taking Astellas at its word, the court found that Astellas conceded that the ’780 patent was enabled because it claimed invalid subject matter: a natural law applied via routine, conventional, and well-known methods. Relying extensively on Astellas’s expert conceding at trial that sustained release hydrogel formulations were well-known, well-characterized, not difficult to formulate, and not difficult to tune to arrive at a suitable dissolution profile, the court found that “Astellas’s zealous defense has conceded more fundamental ground. Embodying no more than the discovery of a natural law applied via well-known techniques for formulating sustained release tablets, the ’780 patent claims ineligible subject matter.”
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.