- 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
-
April 29, 2024Robins Kaplan Mourns Death of New York Associate Waleed Abbasi
-
April 29, 2024Robins Kaplan Secures $7.75 Million Verdict in Aerosol Dust Remover Abuse Case
-
April 23, 2024David Martinez Recognized Among Top 100 Lawyers in Los Angeles by LA Business Journal
-
May 9, 2024Property Insurance Claims Group 2024 Conference
-
May 20, 2024The Present and Future of DEI
-
May 23, 202414th Annual Disability Justice Seminar
-
April 30, 2024A World Without Non-Competes: Protecting Confidential Information and Trade Secrets Following the FTC's Ban
-
First QuarterGENERICally Speaking: A Hatch-Waxman Litigation Bulletin
-
March 2024e-Commerce: Pitfalls and Protections
-
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.
CMP Development, LLC v. Amneal Pharms. LLC
CaroSpir® (spironolactone)
September 29, 2023
Case Name: CMP Development, LLC v. Amneal Pharms. LLC, Civ No. 21-549 (MN), 2023 WL 6387792 (D. Del. Sept. 29, 2023) (Noreika, J.)
Drug Product and Patent(s)-in-Suit: CaroSpir® (spironolactone); U.S. Patents Nos. 10,624,906 (“the ’906 patent”), 10,660,907 (“the ’907 patent”), and 10,888,570 (“the ’570 patent”)
Nature of the Case and Issue(s) Presented: CaroSpir is indicated for the treatment of heart failure, hypertension, and edema caused by cirrhosis. The patents-in-suit claim about 0.18% w/v to about 0.36% w/v of xanthan gum. Amneal argued that it did not infringe because it used tragacanth powder—not xanthan gum—as its suspending agent. After a two-day bench trial, the court found that CMP had not met its burden of proving infringement.
Why Amneal prevailed: The parties agreed that Amneal did not literally infringe, as Amneal’s product did not use xanthan gum. Rather, CMP argued that Amneal’s suspending agent—tragacanth powder—infringed the xanthan gum weight percent limitation under the doctrine of equivalents. Amneal did not contest that tragacanth powder performs substantially the same function to obtain substantially the same result as the recited xanthan gum. Instead, Amneal disputed that tragacanth powder worked in substantially the same way as xanthan gum.
CMP argued that tragacanth powder and xanthan gum work in substantially the same way because Amneal’s ANDA described a study examining four suspending agents and only tragacanth powder and xanthan gum prevented visually observable sedimentation. Other than this observation, CMP conducted no other scientific experiments to support its argument that each of the excipients work in substantially the same way. More particularly, the Court explained that “apart from his say-so and expertise as a polymer scientist, [CMP’s expert] offered no scientific support for the connection he made between … [the way] the two suspending agents work.” Conversely, Amneal argued that the suspending agents do not increase viscosity in substantially the same way. In particular, because of the presence of bassorin, tragacanth powder increases viscosity by a combination of swelling and polymer chain entanglement. It was undisputed that xanthan gum increases viscosity only by entanglement of dissolved polymer chains. Further, the amount of tragacanth powder in the ANDA product was 0.65% w/v, which was almost double the amount of xanthan gum recited in the patents-in-suit. CMP argued that due to the presence of bassorin, only 30-40% of the tragacanth powder will in fact be tragacanthin, and thus Amneal’s product infringed under the doctrine of equivalents. But the court found that there was no expert testimony or evidence to support this theory. In sum, there was no evidence that the amount of tragacanth powder in Amneal’s ANDA product is equivalent to the amount of xanthan gum in the patents-in-suit.
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.