- 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
-
September 10, 2024Robins Kaplan Ranks Among Top Firms In 2024 American Lawyer Mid-Level Associates Survey
-
September 9, 2024Federal Judge Orders Transformative Reforms at West LA VA Campus in Major Victory for Disabled Veterans
-
September 9, 2024Robins Kaplan Partners Named to 2025 Lawdragon 500 Leading Litigators in America Guide
-
September 27, 2024Minnesota’s Largest Patent Jury Verdict: The Inside Story
-
October 9, 2024Perception vs. Reality in Trust and Estate Matters:
-
October 20, 2024License Agreement Disputes:
-
September 2024Q&A with Alan Harter, Founder of Pactolus Private Wealth Management
-
August 2024Recruiting & Retaining Diverse Attorneys: Building an Inclusive Legal Profession
-
August 22, 2024Prior Art Takeaways From Fed. Circ. Public Disclosure Ruling
-
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.
GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed Cir)
Appeal from D. Del., Andrews, J.) (District court’s finding that the written description requirement is met is affirmed because “solvates” of dutasteride are not distinguished by a particular performance property.
Spring 2014
Case Name: GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., Nos. 2013-1593, -1594, -1595, -1598, 2014 U.S. App. LEXIS 3356 (Fed. Cir. Feb. 24, 2014) (Circuit Judges Taranto, O’Malley, and Wallach presiding; Opinion by Taranto, J.) (Appeal from D. Del., Andrews, J.)
Drug Product and Patent(s)-in-Suit: Avodart® and Jalyn® (dutasteride); U.S. Patent No. 5,565,467 (“’the ’467 patent”)
Nature of the Case and Issue(s) Presented: GSK sued defendants alleging that drug products containing the molecule dutasteride that defendants propose to market fell within claims of the ’467 patent, which covers dutasteride and its pharmaceutically acceptable solvates. All defendants stipulated to infringement, but alleged that the asserted claims were invalid for anticipation, lack of utility, lack of enablement, and inadequacy of the written description. After a three-day bench trial, the district court issued an opinion concluding that defendants did not prove the asserted claims invalid. Defendants appeal the rejection of their written-description challenge. Their appeal presents only one contention: that “solvate” is not adequately described, whether as construed by defendants or the district court. The Federal Circuit affirmed.
Why GSK Prevailed: Banner asserted that the proper construction of “solvate” was limited to the crystalline form, and that the specification did not demonstrate that the inventors were in possession of that claimed invention. GSK argued that the district court’s construction of “solvate” was proper because the disclosure was not limited to just the crystalline structure. Moreover, GSK argued that the specification demonstrated the inventors were in possession of the claimed invention because it disclosed the formation of a “solvate.” The Federal Circuit’s holding was not dependent on either of the two posited claim-construction arguments. Thus, the Federal Circuit did not specifically adopt a construction.
As to the issue of adequate description for “solvate,” the Federal Circuit agreed with the district court that the specification disclosed one method of making the claimed solvate, which matched the scope of the claims. The Federal Circuit emphasized that the asserted claims did not include functional language, so the specification did not need to disclose sufficient description for a solvate created by the method functioning as claimed. Rather, the specification merely needed to disclose a solvate that had the chemical makeup claimed in the asserted claims, and which was created one of three possible ways. Because the specification included this disclosure, the asserted claims were not invalid.
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.