- 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.
Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.
Because a POSA would not have had a reasonable expectation of success that a reference disclosing increasing white blood cells also disclosed increased stem-cell mobilization, the asserted claim was not obvious.
December 18, 2017
![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: Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., No. 16-2206, -2207, 2017 U.S. Fed. Appx. LEXIS 25454 (Fed. Cir. Dec. 18, 2017) (Circuit Judges Moore, Plager, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Sleet, J.)
Drug Product and Patent(s)-in-Suit: Mozobil® (plerixafor); U.S. Patent No. 7,897,590 (“the ’590 patent”)
Nature of the Case and Issue(s) Presented: Genzyme developed a method for mobilizing and harvesting stem cells by sequentially administering two drug products. Specifically, the ’590 patent made use of a regimen comprising a combination of granulocyte-colony stimulating factor (G-CSF) and plerixafor to increase the number of stem cells in the blood for collection. Following a four-day bench trial, DRL filed a motion under Fed. R. Civ. P. 52(c) for a judgment on partial findings on its affirmative defense and counterclaim asserting invalidity of claim 19 of the ’590 patent. The district court found claim 19 not invalid as obvious and entered a final judgment enjoining DRL from commercially manufacturing, using, offering for sale, selling, or importing its generic products. DRL timely appealed, and the Federal Circuit affirmed.
Why Genzyme Prevailed: As part of its obviousness challenge, DRL relied on three prior-art references: (i) Hendrix; (ii) WO ’814; and (iii) the ’304 patent, and combinations thereof. The district court, however, found that Hendrix was not analogous art. In particular, whereas Hendrix focused on HIV treatment, the ’590 patent focused on mobilizing stem cells for subsequent harvest and transplantation. But even if Hendrix were deemed analogous art, the district court found that Hendrix would not have rendered claim 19 obvious. The district court found that a skilled artisan would not have had a reasonable expectation of success that plerixafor would mobilize stem cells, and the Federal Circuit agreed that DRL has not shown that this determination was clearly erroneous. Although Hendrix hypothesized in an isolated sentence, without explanation, that plerixafor may cause stem-cell mobilization, the rest of the seven-page article focused on the elevation of white-blood-cell counts. The Federal Circuit also found that the district court’s finding that stem-cell mobilization was highly unpredictable at the time of the invention ran counter to an expectation of success.
As with Hendrix, the Federal Circuit found that WO ’814 did not disclose information about using plerixafor to mobilize stem cells, but instead revealed the relationship between plerixafor and white-blood-cell elevation. The Federal Circuit also found that the record included ample evidence showing that an increased white-blood-cell count did not necessarily correlate with stem-cell mobilization, and that, ultimately, the deficiencies regarding Hendrix also undercut the combination of WO ’814 and the ’304 patent. “It is also significant that a gap exists between using plerixafor to enhance WBC [white-blood-cell] counts and for stem cell mobilization.”
Related Professionals
Miles A. Finn, Ph.D.
Counsel
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.