- 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.
Intendis GMBH et al. v. Glenmark Pharms. Inc., USA
Affirming district court’s application of the doctrine of equivalents, in part, on the basis of Defendants’ representations to the FDA in their ANDA.
July 21, 2016
![GENERICally Speaking: A Hatch Waxman Litigation Bulletin](/-/media/images/newsletters/generically-speaking-social-graphics/generically-speaking-nwsltr-badge.jpg?la=en&h=160&w=390&la=en&hash=314B8432ED62E0647D7FC4565EC18B79)
Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.)
Drug Product and Patent(s)-in-Suit: Finacea® (azelaic acid); U.S. Patent No. 6,534,070 (“the ’070 patent”)
Nature of the Case and Issue(s) Presented: Appellee Bayer Healthcare markets Finacea Gel as a topical treatment for inflammatory papules and pustules of mild to moderate rosacea. Finacea’s inactive ingredients, or excipients, include triglycerides and lecithin. The ’070 patent has a single independent claim, covering Finacea Gel, requiring at least one triacylgyceride in a concentration of 0.5 to 5% by weight and lecithin. The parties agreed that the term triacylglyceride meant “triglyceride.”
Defendants filed an ANDA seeking FDA approval to market generic Finacea. That ANDA listed isopropyl myristate in place of the triglyceride and lecithin. Plaintiffs argued that isopropyl myristate met the claim elements under the doctrine of equivalents. The district court found that it did, rejecting Defendants’ arguments that the doctrine of equivalents would encompass the prior art and was barred by prosecution-history estoppel. The Federal Circuit affirmed.
Why Plaintiffs Prevailed: Defendants appealed only the district court’s finding that isopropyl myristate performed substantially the same function as triglyceride and lecithin. The Federal Circuit determined that triglyceride and lecithin served as penetration enhancers for the compounds claimed in the ’070 patent, as did isopropyl myristate. Then, the Federal Circuit held that the patent was not required to explicitly spell out a claim element’s function, way, and result for the doctrine of equivalents to apply. Further, in their ANDA, Defendants stated that “[i]sopropyl myristate was selected as [a] penetration enhancer instead of lecithin and medium chain triglyceride.” In light of these clear representations to the FDA, the Federal Circuit found no clear error with the district court’s ruling.
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.