Litigation Details for TAKEDA PHARMACEUTICAL COMPANY LIMITED v. ZYDUS PHARMACEUTICALS (USA) INC. (D.N.J. 2018)

TAKEDA PHARMACEUTICAL COMPANY LIMITED v. ZYDUS PHARMACEUTICALS (USA) INC. (D.N.J. 2018)

Docket		Date Filed	2018-02-12
Court	District Court, D. New Jersey	Date Terminated	2021-07-26
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	Defendant	Referred To
Patents	6,328,994; 7,399,485; 7,431,942; 7,875,292
Link to Docket	External link to docket

Details for TAKEDA PHARMACEUTICAL COMPANY LIMITED v. ZYDUS PHARMACEUTICALS (USA) INC. (D.N.J. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-02-12				External link to document
2018-02-11	1		.S. Patent No. 6,328,994 (“’994 Patent”), U.S. Patent No. 7,431,942 (“’942 Patent”), U.S. Patent No. …of the ’994 Patent, ’942 Patent, ’485 Patent, and U.S. Patent No. 5,463,632 (“ ’632 Patent”) would be … (“’292 Patent”), and U.S. Patent No. 7,399,485 (“’485 Patent”) (collectively, “the patents-in- suit…enforceable claim of the ’994 Patent, ’942 Patent, ’292 Patent, or ’485 Patent will be infringed by the …Defendants for infringement of the ’994 Patent, ’942 Patent, and ’632 Patent, based, inter alia, upon Zydus’	External link to document
2018-02-11	72		(the “‘994 Patent”); (b) U.S. Patent No. 7,431,942 (the “‘942 Patent”); (c) U.S. Patent Number No. 7,875,292…‘292 Patent”); and (d) U.S. Patent No. 7,399,485 (the “‘485 Patent”) (collectively, the “patents-in-suit…directly infringed the ‘994 Patent, ‘942 Patent, ‘292 Patent, and ‘485 Patent by filing amended ANDA No…following patents which claim the formulation for the drug Prevacid® SoluTab™: (a) U.S. Patent No. 6,328,994…Zydus, alleging infringement of the ‘994 Patent and ‘992 Patent. Id. ¶ 39; see Takeda Pharm. Co. v. Zydus	External link to document
2018-02-11	168	Opinion	U.S. Patent Nos. 6,328,994 (“’994 patent”), issued on December 11, 2001, 7,431,942 (“’942 patent”), issued…wants to market a patented drug prior to the expiration of the patent, the patent owner can seek to… 5,464,632 (“’632 patent”), issued on January 25, 2011, and 7,399,485 (“’485 patent”), issued on July…Claim 1 of the ’994 patent is incorporated as a continuing reference in the other patents, and describes …sustained-release agent.” ’994 patent, col. 37 II. 43-53. All but the ’485 patent expired on May 17, 2019.	External link to document

Takeda Pharmaceutical Company Limited v. Zydus Pharmaceuticals (USA) Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Takeda Pharmaceutical Company Limited and Zydus Pharmaceuticals (USA) Inc. is a complex and multifaceted case that involves patent infringement, antitrust claims, and the intricacies of pharmaceutical market dynamics. Here, we will delve into the key aspects of this case, including the background, the main arguments, the court's decisions, and the implications of the outcome.

Background

Takeda Pharmaceutical Company Limited, a major pharmaceutical company, developed Prevacid SoluTab, an orally disintegrating tablet used to treat gastroesophageal reflux disease. Zydus Pharmaceuticals (USA) Inc., a generic drug manufacturer, sought to launch a generic version of Prevacid SoluTab. This led to a patent litigation dispute between the two companies[3][4].

Patent Infringement Claims

Takeda sued Zydus for infringing the patent related to Prevacid SoluTab. The core of Takeda's argument was that Zydus's generic formulation infringed on the '994 patent, which specifies the particle size and other characteristics of the drug. Takeda's expert testified that Zydus's reformulated particles were below the upper limit specified in the patent, thus infringing on Takeda's intellectual property rights[4].

Zydus's Counterclaims

Zydus counterclaimed, alleging that Takeda had filed a "sham suit" to maintain its monopoly power in violation of the Sherman Act and the New Jersey Antitrust Act. Zydus argued that Takeda's lawsuit was intended to delay the launch of Zydus's generic product, thereby maintaining Takeda's market dominance[1][4].

Market Definition and Competitive Effects

A crucial aspect of the case involved the definition of the relevant market and the competitive effects of Takeda's actions. Dr. Eric Gaier, an expert retained by Takeda, testified on market definition, market power, competitive effects, and damages. His testimony was pivotal in addressing Zydus's antitrust counterclaims[1].

Testing and Evidence

The case involved extensive testing of Zydus's generic formulation. Takeda conducted tests that showed Zydus's particles were within the infringing range when deagglomeration was required. Zydus argued that its ANDA (Abbreviated New Drug Application) with the FDA specified a quality control measure that would eliminate particles less than 450 μm, but the court rejected this argument based on Takeda's evidence[4].

Court Decisions

The District Court made several key decisions in this case. Initially, Takeda voluntarily dismissed its patent infringement claims after testing Zydus's generic version, but Zydus continued to pursue its antitrust counterclaims. The court ultimately found that Zydus's ANDA product literally infringed on Takeda's '994 patent, as the particles were within the infringing range when deagglomeration was considered[4].

Regarding the antitrust claims, the District Court granted Takeda's motion for summary judgment on the antitrust counterclaims. This decision was based on the lack of evidence supporting Zydus's claims that Takeda had engaged in sham litigation to delay the generic launch[1][4].

Implications and Analysis

The outcome of this case has significant implications for the pharmaceutical industry, particularly in the context of patent litigation and antitrust law.

• Patent Protection: The case highlights the importance of robust patent protection for innovative pharmaceutical products. Takeda's successful defense of its patent underscores the value of intellectual property in maintaining market exclusivity.

• Antitrust Considerations: The rejection of Zydus's antitrust claims suggests that courts are cautious about labeling legitimate patent enforcement as "sham" litigation. This sets a precedent that companies must have strong evidence to support claims of anticompetitive behavior.

• Market Dynamics: The case illustrates the competitive tensions between brand-name pharmaceutical companies and generic manufacturers. It emphasizes the strategic importance of patent litigation in delaying or preventing the entry of generic competitors.

Expert Testimony and Evidence

The role of expert testimony, particularly from Dr. Eric Gaier, was crucial in this case. His analysis on market definition, market power, and competitive effects helped to refute Zydus's antitrust claims. The extensive testing and evidence presented by Takeda also played a decisive role in the court's findings[1][4].

Conclusion

The litigation between Takeda and Zydus is a prime example of the complex interplay between patent law, antitrust law, and market competition in the pharmaceutical industry. The case underscores the importance of robust evidence and expert testimony in patent and antitrust disputes.

Key Takeaways

• Patent Protection: Strong patent protection is crucial for maintaining market exclusivity in the pharmaceutical industry.
• Antitrust Claims: Courts require substantial evidence to support claims of anticompetitive behavior.
• Market Dynamics: Patent litigation is a key strategy in delaying or preventing the entry of generic competitors.
• Expert Testimony: Expert analysis and evidence are vital in refuting or supporting claims in complex litigation.

Frequently Asked Questions (FAQs)

Q: What was the main issue in the litigation between Takeda and Zydus? A: The main issue was Takeda's claim that Zydus's generic formulation of Prevacid SoluTab infringed on Takeda's patent, and Zydus's counterclaim that Takeda filed a "sham suit" to delay the generic launch.

Q: What was the outcome of the patent infringement claims? A: The court found that Zydus's ANDA product literally infringed on Takeda's '994 patent.

Q: What happened to Zydus's antitrust counterclaims? A: The District Court granted Takeda's motion for summary judgment on the antitrust counterclaims, dismissing Zydus's claims.

Q: How important was expert testimony in this case? A: Expert testimony, particularly from Dr. Eric Gaier, was crucial in addressing market definition, market power, and competitive effects, and in refuting Zydus's antitrust claims.

Q: What are the implications of this case for the pharmaceutical industry? A: The case highlights the importance of patent protection, the need for strong evidence to support antitrust claims, and the strategic use of patent litigation in market competition.

Sources

1. Bates White, Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals, https://www.bateswhite.com/work-Takeda-Pharmaceutical-Co-v-Zydus-Pharmaceuticals.html
2. Justia, TAKEDA PHARMACEUTICAL COMPANY LIMITED et al v. ZYDUS PHARMACEUTICALS (USA) INC., https://law.justia.com/cases/federal/district-courts/new-jersey/njdce/3:2018cv01994/366455/168
3. Casetext, Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals U.S. Inc., https://casetext.com/case/takeda-pharmaceutical-company-ltd-v-zydus-pharmaceuticals-usa-inc