Litigation Details for Pfizer Inc. v. Zydus Pharmaceuticals (USA) Inc. (D. Del. 2017)

Pfizer Inc. v. Zydus Pharmaceuticals (USA) Inc. (D. Del. 2017)

Docket		Date Filed	2017-02-14
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	6,956,041; 6,965,027; 7,091,208; 7,265,221; 7,301,023; RE41,783
Link to Docket	External link to docket

Details for Pfizer Inc. v. Zydus Pharmaceuticals (USA) Inc. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-02-14	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,965,027 B2; 7,301,023 B2; RE41,783…February 2017 1:17-cv-00158-GJP 830 Patent None District Court, D. Delaware	External link to document
2017-02-14	133	Notice of Service	Infringement of United States Patent Nos. 6,965,027 and 7,301,023 and Reissue Patent No. RE41,783 filed by C.P… D.Sc., Regarding Infringement of United States Patent No. RE41,783 and (2) Expert Report of Leonard J…February 2017 1:17-cv-00158-GJP 830 Patent None District Court, D. Delaware	External link to document
2017-02-14	134	Notice of Service	Report of Bart Kahr, Ph.D., Regarding U.S. Patent No. 6,965,027; and (3) Opening Expert Report of Katherine…on the Invalidity of the Asserted Claims of U.S. Patent Nos. RE 41,783 and 7,301,023 filed by Cadila Healthcare…February 2017 1:17-cv-00158-GJP 830 Patent None District Court, D. Delaware	External link to document
2017-02-14	141	Notice of Service	Regarding Validity of United States Patent Nos. RE41,783 and 6,965,027, (4) Expert Report of Christopher…Regarding Objective Indicia of Non-Obviousness of Patent No. RE41,783, (2) Expert Report of Stanley B. Cohen…Regarding Objective Indicia of Non-Obviousness of Patent Nos. RE41,783, (3) Responsive Report of Stephen…February 2017 1:17-cv-00158-GJP 830 Patent None District Court, D. Delaware	External link to document
2017-02-14	145	Notice of Service	Invalidity of the Asserted Claims of U.S. Patent Nos. RE 41,783 and 7,301,023; and (5) Reply Expert Report of Ivan…February 2017 1:17-cv-00158-GJP 830 Patent None District Court, D. Delaware	External link to document
2017-02-14	151	Notice of Service	Regarding Objective Indicia of Nonobviousness of Patent No. RE41,783, (3) Reply Expert Report of Stanley B. Cohen…Regarding Objective Indicia of Nonobviousness of Patent No. RE41,783 and (4) Reply Expert Report of Christopher…February 2017 1:17-cv-00158-GJP 830 Patent None District Court, D. Delaware	External link to document

Pfizer Inc. v. Zydus Pharmaceuticals (USA) Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Pfizer Inc. and Zydus Pharmaceuticals (USA) Inc. is a significant example of patent infringement disputes in the pharmaceutical industry. This case, filed in the United States District Court for the District of Delaware (Case No. 1:17-cv-00158-LPS), involves allegations of patent infringement related to Pfizer's drug Xeljanz®.

Background

Pfizer Inc., along with its subsidiaries PF PRISM C.V., C.P. Pharmaceuticals International C.V., and Pfizer Pharmaceuticals LLC, filed a lawsuit against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. The lawsuit centers around the submission of Abbreviated New Drug Applications (ANDAs) by Zydus and Cadila to the U.S. Food and Drug Administration (FDA) for generic versions of Pfizer's Xeljanz®, a drug used to treat various autoimmune diseases such as rheumatoid arthritis and psoriatic arthritis[3].

Patents-in-Suit

The litigation involves three patents held by Pfizer:

• U.S. Patent No. 8,637,027 ('027 Patent)
• U.S. Patent No. 8,648,023 ('023 Patent)
• U.S. Patent No. RE45,783 ('783 Patent)

Pfizer alleges that Zydus's ANDA submission for generic Xeljanz® tablets would infringe at least one claim of each of these patents[3].

Claims and Allegations

Pfizer's complaint outlines several key claims:

• Direct Infringement: Pfizer alleges that Zydus's intended manufacture, use, offer for sale, sale, and/or importation of the generic tablets would directly infringe the claims of the '027, '023, and '783 patents[3].
• Inducement of Infringement: Pfizer also claims that Cadila Healthcare Ltd. is inducing infringement by Zydus Pharmaceuticals (USA) Inc. through their collaborative efforts in submitting the ANDA[3].

Jurisdiction and Venue

The court has jurisdiction over the defendants under Federal Rule of Civil Procedure 4(k)(2) due to their contacts with the United States. Specifically, Cadila Healthcare Ltd. has been shown to have sufficient contacts with the U.S. through its business activities[3].

Relief Sought

Pfizer seeks several forms of relief, including:

• Injunctive Relief: Pfizer requests an injunction to prevent Zydus from manufacturing, using, offering for sale, selling, and/or importing the generic tablets until the expiration of the patents in question.
• Monetary Damages: Pfizer also seeks monetary damages for any past infringement and a declaration that the defendants' actions constitute patent infringement[3].

Procedural History

The case was filed in June 2017, and since then, there have been various procedural developments:

• Consolidated Amended Complaint: Pfizer filed a consolidated amended complaint outlining the specific allegations and claims against Zydus and Cadila[3].
• Defendants' Response: Zydus and Cadila have responded to the complaint, denying the allegations of patent infringement and asserting various defenses[3].

Similar Litigation Context

This case is part of a broader landscape of Hatch-Waxman patent infringement suits, which are common in the pharmaceutical industry. Similar cases, such as the litigation involving Pfizer's drug IBRANCE (Palbociclib), highlight the complexities and common issues that arise when generic manufacturers seek FDA approval for drugs that are still under patent protection[1].

Implications and Analysis

The outcome of this litigation has significant implications for both Pfizer and Zydus:

• Market Exclusivity: If Pfizer succeeds in its claims, it would maintain market exclusivity for Xeljanz® until the patents expire, protecting its revenue stream.
• Generic Competition: Conversely, if Zydus prevails, it could enter the market with a generic version of Xeljanz®, potentially reducing the drug's price and increasing competition[3].

Industry Impact

This case underscores the importance of patent protection in the pharmaceutical industry. It highlights the ongoing battles between brand-name drug manufacturers and generic drug manufacturers over patent rights and market access. The resolution of such disputes can have far-reaching consequences for drug prices, patient access, and the overall competitive landscape of the pharmaceutical market.

Key Takeaways

• Patent Protection: The case emphasizes the critical role of patent protection in maintaining market exclusivity for brand-name drugs.
• Hatch-Waxman Act: The litigation is governed by the Hatch-Waxman Act, which provides a framework for resolving patent disputes between brand-name and generic drug manufacturers.
• Market Competition: The outcome of the case will influence the level of competition in the market for Xeljanz® and similar drugs.

FAQs

1. What is the main issue in the Pfizer Inc. v. Zydus Pharmaceuticals (USA) Inc. litigation?

   • The main issue is Pfizer's allegation that Zydus's submission of an ANDA for a generic version of Xeljanz® infringes Pfizer's patents.

2. Which patents are involved in the litigation?

   • The '027, '023, and '783 patents held by Pfizer are involved.

3. What relief is Pfizer seeking in the lawsuit?

   • Pfizer is seeking injunctive relief and monetary damages.

4. How does this case relate to other pharmaceutical patent disputes?

   • This case is part of a broader category of Hatch-Waxman patent infringement suits common in the pharmaceutical industry.

5. What are the potential implications of the case for the pharmaceutical market?

   • The outcome could affect market exclusivity, competition, and drug prices.

Cited Sources

1. In re Palbociclib ('730) Patent Litigation (No. II) - Casetext
2. United States District Court - Stringer v. Nissan North America, Inc. - [PDF]
3. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC., et al. v. ZYDUS PHARMACEUTICALS (USA) INC., et al. - Insight.RPXCorp.com