- 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 5, 2024Jake Holdreith Named to Twin Cities Business Top 100
-
December 4, 2024Robins Kaplan Obtains $10.5 Million Post-Verdict in Landmark Aerosol Dust Remover Abuse Case
-
December 2, 2024Robins Kaplan LLP Announces 2025 Partners
-
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.
Astellas Pharma, Inc. v. Sandoz Inc.
Myrbetriq® (mirabegron)
September 18, 2024
Case Name: Astellas Pharma, Inc. v. Sandoz Inc., Nos. 2023-2032, 2023-2063, 2023-2089, 2024 WL 4219374 (Fed. Cir. Sept. 18, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, J.) (Appeal from D. Del., 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: During the development of Myrbetriq, a drug that treats overactive bladder (“OAB”), Astellas discovered that immediate-release formulations of mirabegron exhibited an undesirable “food effect,” meaning that the bioavailability of the drug was affected by the presence or absence of food in the stomach. Astellas developed sustained-release formulations of mirabegron, which got around the food effect, and claimed those formulations in the ’780 patent.
On the day the ’780 patent issued, Astellas sued each of Sandoz, Zydus, Lupin, and Lek for patent infringement based on their respective submissions of ANDAs seeking to market generic versions of Myrbetriq. Sandoz raised multiple defenses, but did not pursue an invalidity defense under 35 U.S.C. § 101 during the discovery phase of the litigation. Before trial, Sandoz limited its invalidity defenses to only those arising under § 112. No other defenses were tried or raised during trial and post-trial briefing. However, the district court issued a final decision holding the asserted of the ’780 patent invalid as directed to patent-ineligible subject matter under 35 U.S.C. § 101. Following the entry of judgment, Sandoz moved pursuant to Rule 52(b) for the court to make additional findings of fact and conclusions of law on the issues actually presented at trial, which the court denied. Astellas appealed and the Federal Circuit vacated and remanded the district court’s judgment.
Why Astellas Prevailed: The principle of party presentation governs. “By rendering its decision on a ground not raised by any party at any stage of the proceedings, and by expressly declaring that it ‘sits not [as] an arbiter to resolve the disputes on the parties’ favored terrain,’ the district court disregarded the longstanding principle of party presentation and, in doing so, abused its discretion.” While, at times, it may be appropriate for a court to take a “modest initiating role” in the shape of the litigation, this was not such a scenario.
The district court interpreted Astellas’ “zealous defense” on issues of § 112 as conceding that the ’780 patent is enabled because it claims invalid subject matter: a natural law applied via routine, conventional, and well-known methods. It then used that “concession” to hold the patent invalid on a ground never advanced by Sandoz. That was an abuse of discretion. “It is for the parties—not the court—to chart the course of the litigation.” The district court believed that patent eligibility was a threshold inquiry that it had a duty to address—even if the parties did not—but the presumption of validity afforded to patents applied to that inquiry.
Next, Astellas requested that the case be reassigned to a different district court judge on remand. Astellas argued that the district court’s failure to abide by the party presentation principle is alone enough to warrant reassignment. Second, Astellas pointed to several statements that the district court made as evidencing bias toward the pharmaceutical industry that, in the district court’s opinion, has “colluded to protect weak or invalid patents and share in the startling profits.” But the Federal Circuit denied Astellas’ request. While agreeing that the statements made by the district court are irrelevant and understanding Astellas’ concern that the district court’s commentary may evidence a personal frustration with the pharmaceutical industry as a whole, the Federal Circuit trusted that the district court “can and will take an objective, measured, and thorough look into the legal issues and evidence of record to resolve only those disputes that exist between the parties.”
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.