- 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.
Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.
Plaintiff’s disclaimer of claims found invalid by the PTAB mooted any controversy before the appellate court associated with that patent, and a second patent-in-suit was not invalid because the district court did not err in rejecting the defendants’ obviousness challenge.
August 14, 2019
Case Name: Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., No. 2018-1804, 2019 U.S. App. LEXIS 24141 (Fed. Cir. Aug. 14, 2019) (Circuit Judges Lourie, Moore, and Taranto presiding; Opinion by Lourie, J.) (Appeal from D.N.J., Shipp, J.)
Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592 patent”) and 5,847,170 (“the ’170 patent”)
Nature of the Case and Issue(s) Presented: The ’170 and ’592 patents claim the compound cabazitaxel and its method of use. Cabazitaxel treats certain drug resistant prostate cancers and belongs to a family of compounds known as taxanes. Prior to approving Jevtana, FDA had previously approved two other taxanes, including paclitaxel and docetaxel.
While the district court case was pending, the PTAB instituted IPR of the ’592 patent and, after trial commenced, the PTAB held claims 1-5 and 7-30 invalid as obvious. Sanofi appealed the Board’s decision denying its motion to amend, but did not appeal the decision that claims 7, 11, 16-16, and 26 were invalid as obvious. Instead, Sanofi filed a statutory disclaimer of those claims. After the disclaimer was filed, the district court entered its post-trial order, finding (i) that the statutory disclaimer did not divest the court of jurisdiction and that the claims of the ’592 patent were invalid as obvious, and (ii) that the ’170 patent was not invalid as obvious.
Why Sanofi-Aventis prevailed: First, the Federal Circuit found that Sanofi’s disclaimer mooted any controversy over the ’592 patent. Defendants argued that vacating the district court’s decision would cause them to lose the possible benefit of an issue preclusion defense, should Sanofi obtain amended claims in the PTAB and later assert those claims against defendants. The Federal Circuit was unpersuaded, explaining that: (i) the relevance of the disclaimed claims to a possible issue preclusion defense was speculative; and (ii) even if relevant, defendants could not establish that the judgment pertaining to those claims was material to a possible future suit. The Federal Circuit noted that it could not issue an advisory opinion on a theoretical dispute.
With respect to the ’170 patent, the parties agreed that docetaxel was the closest prior art, but disagreed whether a POSA would have been motivated to replace the C7 and C10 hydroxyl groups of docetaxel with the methoxy groups of cabazitaxel. Defendants cited to literature contemplating this replacement, but the Federal Circuit was unpersuaded. In particular, the references investigated structurally different compounds and did not address taxanes. Further, the Federal Circuit agreed with the district court’s conclusion that Defendants’ expert cherry-picked data in the references and that a POSA would have been motivated to perform the substitution not just at the C7 and C10 position, but at any of C2, C4, C5, C7-C14, C2’, or C3’. Therefore, the district court did not err in rejecting the defendants’ obviousness challenge to the ’170 patent.
Related Professionals
Christopher A. Pinahs
Partner
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.