Litigation Details for MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (D.N.J. 2017)

MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (D.N.J. 2017)

Docket		Date Filed	2017-07-20
Court	District Court, D. New Jersey	Date Terminated	2021-04-05
Cause	15:1126 Patent Infringement	Assigned To	Freda L. Wolfson
Jury Demand	None	Referred To	Douglas Arpert
Parties	CILAG GMBH INTERNATIONAL
Patents	6,414,126; 6,515,117; 6,765,001; 7,943,788; 8,222,219; 8,785,403
Attorneys	JAY R. DESHMUKH
Firms	Lerner David Littenberg Krumholz and Mentlik LLP
Link to Docket	External link to docket

Details for MITSUBISHI TANABE PHARMA CORPORATION v. SANDOZ INC. (D.N.J. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-07-20				External link to document
2017-07-20	1	Complaint	infringement of United States Patent No. 7,943,788 (“the ’788 patent”), United States Patent No. 8,222,219 (“the…the ’219 patent”), and United States Patent No. 8,785,403 (“the ’403 patent”) (collectively, “the patents-in-suit….S.C. § 355(b)(l), the ’788 patent, the ’219 patent, and the ’403 patent are listed in the United States… THE PATENTS-IN-SUIT 19. On May 17, 2011, the ’788 patent, titled “Glucopyranoside…the ’788 patent. 21. JNV is an exclusive sublicensee of the ’788 patent.	External link to document
2017-07-20	128	Stipulation and Order	it is the owner of United States Patent No. 7,943,788 (“the ’788 patent”). WHEREAS, Sandoz has filed Abbreviated…District Court for the District of New Jersey for patent infringement based on Sandoz’s filing of ANDA …2017 5 April 2021 3:17-cv-05319 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2017-07-20	166	Trial Brief	disclosed in the ’117 patent ’126 patent U.S. Patent No. 6,414,126 …Example 10 Example 10 of U.S. Patent No. 6,414,126 FDA United States …788 patent, claim 22 of the ’219 patent, and claim 26 of the ’403 patent BMS…Seiyaku Co., Ltd. patents-in-suit U.S. Patent No. 7,943,788 (“the ’788 patent”), … U.S. Patent No. 8,222,219 (“the ’219 patent”), and U.S. Patent No. 8,785,403	External link to document
2017-07-20	173	Opinion	infringement of U.S. Patent Nos. 7,943,788 (“the ’788 patent), 8,222,219 (“the ’219 patent), and 8,785,403… (“the ’403 patent”) (collectively, “the patents-in-suit”). Compl. at ¶ 10. The patents-in-suit are… B. Local Patent Rules Pursuant to the Local Patent Rules for the District of…Local Patent Rules. Zydus contends that the “priority date” disclosure required by Local Patent Rule….D. Cal. July 17, 2015) (“Patent L.R. 3-1(f) particularly requires a patent holder to assert a specific	External link to document
2017-07-20	185	Redacted Document	the ’126 patent (U.S. Patent No. 6,414,126) was issued and assigned to BMS. The ’126 patent disclosed…......................28 U.S. Patents U.S. Patent No. 6,414,126.................................…Patents-in-Suit are the ’788 patent (U.S. Patent No. 7,943,788), the ’219 patent (U.S. Patent No. 8,222,219), and… on the ’126 patent, the ’117 patent, and U.S. Patent No. 7,129,220 [“the ’220 patent”]) that 4-ethoxy…of the two patents—the ’788 Patent or the ’219 Patent— is invalid. Here, the ’788 Patent was issued	External link to document

Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The case of Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc. is a significant patent litigation that involves complex issues of patent infringement, obviousness, and obviousness-type double patenting. This article delves into the key aspects of the case, including the parties involved, the patents at issue, and the critical legal rulings.

Parties and Background

The plaintiffs in this case include Mitsubishi Tanabe Pharma Corporation (MTPC), Janssen Pharmaceuticals, Inc. (JPI), Janssen Pharmaceutica NV (JNV), Janssen Research and Development, LLC (JRD), and Cilag GmbH International (Cilag). The defendants are Zydus Pharmaceuticals (U.S.A.) Inc. and other generic drug manufacturers. The litigation began when the plaintiffs alleged that the defendants infringed their patents through the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of MTPC’s Invokana products, which are used to treat diabetes[1][4].

Patents at Issue

The patents in question are U.S. Patent Nos. 7,943,788 (the ‘788 patent), 8,222,219 (the ‘219 patent), and 8,785,403. These patents are related to the formulation and use of canagliflozin, the active ingredient in Invokana[4].

Claims and Counterclaims

The plaintiffs asserted that the defendants’ ANDAs infringed their patents. In response, Zydus filed a counterclaim seeking a declaratory judgment that the patents-in-suit were invalid due to obviousness and obviousness-type double patenting[1][4].

Obviousness Challenge

Zydus argued that the patents were obvious over prior art, citing several reasons. The plaintiffs defended against this claim by presenting expert testimony from Dr. Gavin, Dr. Davies, and Mr. Sims, focusing on secondary considerations to demonstrate the nonobviousness of the patents. However, Zydus moved to exclude certain opinions of Dr. Gavin as factually unsupported or speculative and unreliable[2].

Obviousness-Type Double Patenting (OTDP)

A crucial aspect of the case was the challenge based on obviousness-type double patenting. Zydus contended that the ‘788 patent, which received patent term adjustment (PTA) and thus expired later than the ‘219 patent, was invalid due to OTDP. The court had to determine whether an earlier-expiring patent could serve as an OTDP reference against a later-expiring patent from the same patent family[3][4].

Court Ruling on OTDP

On March 22, 2021, the U.S. District Court for the District of New Jersey ruled that the ‘788 patent was not invalid under the doctrine of OTDP. The court rejected the argument that the expiration date of a patent governs OTDP analysis, instead relying on the Novartis decision. It found that, absent the PTA granted to the ‘788 patent, both the ‘788 and ‘219 patents would have had the same expiration date, thus there was no potential for gamesmanship by the inventors to secure a second, later-expiring patent for the same invention[3][4].

Expert Testimony and Admissibility

The court also addressed the admissibility of expert testimony. Zydus sought to exclude certain opinions of Dr. Gavin under Federal Rule of Evidence 702 and the Daubert standard. The court ruled that some of Dr. Gavin’s opinions were inadmissible, and consequently, opinions derived from those by Dr. Davies and Mr. Sims were also excluded[2].

Invention Date Disclosure Requirements

Another point of contention was whether the plaintiffs complied with the disclosure requirements set forth in the Local Patent Rules. Zydus argued that the plaintiffs failed to disclose earlier invention dates they planned to assert with their Infringement Contentions. However, the court found that the plaintiffs had timely served their Infringement Contentions and disclosed the necessary information[2].

Impact and Implications

The decision in Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc. has significant implications for patent law, particularly regarding OTDP and the role of PTA in determining patent validity. It clarifies that an earlier-expiring patent is not necessarily a proper OTDP reference against a later-expiring patent from the same family, especially when the later-expiring patent’s term is extended due to PTA[3][4].

Key Takeaways

• Patent Infringement Claims: The case involved allegations of patent infringement by generic drug manufacturers against MTPC’s Invokana products.
• Obviousness and OTDP: The defendants challenged the patents on grounds of obviousness and OTDP, but the court ruled in favor of the plaintiffs.
• Expert Testimony: The admissibility of expert testimony was a critical issue, with some opinions being excluded under Federal Rule of Evidence 702.
• PTA and OTDP: The court clarified that PTA can affect the analysis of OTDP, distinguishing this case from earlier decisions.
• Disclosure Requirements: The court found that the plaintiffs had complied with the necessary disclosure requirements under Local Patent Rules.

FAQs

Q: What was the main issue in the Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc. case? A: The main issue was whether the defendants infringed the plaintiffs' patents related to the diabetes drug Invokana and whether the patents were invalid due to obviousness and obviousness-type double patenting.

Q: What is obviousness-type double patenting (OTDP)? A: OTDP is a doctrine that prevents a patent owner from extending exclusive rights to an invention through claims in a later-filed patent that are not patentably distinct from claims in an earlier-filed patent.

Q: How did the court rule on the OTDP challenge in this case? A: The court ruled that the later-expiring patent was not invalid under OTDP because, absent the patent term adjustment (PTA), both patents would have had the same expiration date.

Q: What role did expert testimony play in the case? A: Expert testimony was crucial, but some opinions were excluded under Federal Rule of Evidence 702 and the Daubert standard.

Q: What are the implications of this decision for patent law? A: The decision clarifies the role of PTA in OTDP analysis and provides guidance on how to determine whether an earlier-expiring patent can serve as an OTDP reference against a later-expiring patent from the same family.

Cited Sources

1. Mitsubishi Tanabe Pharma Corp. v. Sandoz, Inc. - Case Law - VLEX.
2. Case 3:17-cv-05319-FLW-DEA Document 173 Filed 06/15/20 - USCOURTS.
3. Important New Decision Regarding Obviousness-Type Double Patenting - WilmerHale.
4. Federal District Court Declines to “Cut Off” Patent Term Adjustment - Wolf Greenfield.