Litigation Details for Biogen International GmbH v. Amneal Pharmaceuticals LLC (D. Del. 2017)

Biogen International GmbH v. Amneal Pharmaceuticals LLC (D. Del. 2017)

Docket		Date Filed	2017-06-26
Court	District Court, D. Delaware	Date Terminated	2020-09-22
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	Defendant	Referred To
Parties	ACCORD HEALTHCARE INC.
Patents	6,509,376; 6,926,907; 7,320,999; 7,619,001; 7,803,840; 8,399,514; 8,759,393
Attorneys	Sanya Sukduang
Firms	Duane Morris, LLP
Link to Docket	External link to docket

Details for Biogen International GmbH v. Amneal Pharmaceuticals LLC (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-06-26				External link to document
2017-06-26	1	Complaint	“the ’999 patent”), 7,619,001 (“the ’001 patent”), 7,803,840 (“the ’840 patent”) and 8,399,514 (“the …regarding the ’376 patent, the ’999 patent, the ’001 patent, the ’840 patent and the ’514 patent, has a substantial…is an action for patent infringement of U.S. Patent Nos. 6,509,376 (“the ’376 patent”), 7,320,999 (“the…the ’514 patent”) arising under the patent laws of the United States, Title 35, United States Code, §§ … FIRST COUNT FOR PATENT INFRINGEMENT (’376 PATENT) 23. Biogen realleges	External link to document
2017-06-26	166	Stipulation of Dismissal	infringement of U.S. Patent Nos. 6,509,376 (“the ’376 patent”), 7,320,999 (“the ʼ999 patent”) and 8,399,514…8,399,514 (“the ’514 patent”) (collectively, the “Asserted Patents”): Biogen MA Inc. v. Impax Laboratories, …Stipulation grants no rights to Impax under any patents or other proprietary rights. … 26 June 2017 1:17-cv-00823 835 Patent - Abbreviated New Drug Application(ANDA) Defendant	External link to document
2017-06-26	236	Memorandum Opinion	alleging infringement of U.S. Patent Nos. 6,509,376 ("the ' 376 patent"), 7,320,999 ("…x27; 514 patent") (collectively, "patents-in-suit" or "asserted patents"). …quot;the ' 999 patent"), 7,619,001 ("the ' 001 patent"), 7,803 ,840 ("the …the ' 840 patent"), 8,759,393 ("the ' 393 patent"), and 8,399,514 ("the &#…quot;It is a bedrock principle of patent law that the claims of a patent define the invention to which the	External link to document
2017-06-26	315	Stipulation of Dismissal	infringement of U.S. Patent Nos. 6,509,376 (“the ’376 patent”), 7,320,999 (“the ’999 patent”), and 8,399,514… alleging infringement of U.S. Patent No. 7,619,001 (“the ’001 patent”) by submission of Hetero’s ANDA…8,399,514 (“the ’514 patent”) by submission of Hetero’s Abbreviated New Drug Application (“ANDA”) No. 210500… Product”) prior to the expiration of the ’001 patent, i.e., June 20, 2020. 2. All claims… defenses, and counterclaims regarding the ’001 patent brought in C.A. No. 19-211 are dismissed without	External link to document
2017-06-26	317	Stipulation	4, 6, 8-13, 15, and 16 of U.S. Patent No. 8,399,514 (“the ’514 patent”) (collectively, the “Asserted …Asserted Claims” of the “Asserted Patent”) by submitting, or causing to be submitted, Abbreviated New Drug Application… WHEREAS claims 5, 7, 14, and 17-20 of the ’514 patent have not been asserted; WHEREAS, MSN’…(A)(vii)(IV) that, in its opinion, the Asserted Patent is invalid, unenforceable, or would not be infringed…Products prior to the expiration of the Asserted Patent in accordance with the labeling proposed in MSN	External link to document
2017-06-26	319	Stipulation	4, 6, 8-13, 15, and 16 of U.S. Patent No. 8,399,514 (“the ’514 patent”) (collectively, the “Asserted …Asserted Claims” of the “Asserted Patent”) by submitting, or causing to be submitted, Abbreviated New Drug Application… WHEREAS claims 5, 7, 14, and 17-20 of the ’514 patent have not been asserted; WHEREAS, Biogen…by Sandoz of the Asserted Claims of the Asserted Patent based Sandoz’s filing of ANDA No. 210414; …Prinston of the Asserted Claims of the Asserted Patent based on Prinston’s filing of ANDA No. 210512;	External link to document

Biogen International GmbH v. Amneal Pharmaceuticals LLC: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Biogen International GmbH and Amneal Pharmaceuticals LLC revolves around patent infringement claims related to Biogen's drug Tecfidera®, which is used to treat relapsing forms of multiple sclerosis (MS). Here, we delve into the key aspects of this case, including the background, the patents in dispute, the legal arguments, and the court's decisions.

Background

Biogen International GmbH and Biogen MA Inc. (collectively, Biogen) hold an approved New Drug Application (NDA) for Tecfidera®, a delayed-release dimethyl fumarate (DMF) capsule indicated for the treatment of relapsing forms of MS. Biogen owns several patents related to fumarates and their use in treating MS, including U.S. Pat. No. 8,399,514 (the ’514 Patent), which is listed in the Orange Book for NDA No. 204063[1][4].

The Patents in Dispute

The ’514 Patent is central to this litigation and pertains to a method of treating MS with a therapeutically effective amount of DMF, monomethyl fumarate (MMF), or a combination thereof, specifically at a dose of 480 mg per day. This patent was asserted against several generic pharmaceutical companies, including Amneal Pharmaceuticals LLC, which filed Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of Tecfidera[1][4].

Legal Arguments and Proceedings

Invalidity Claims

In the Northern District of West Virginia, Biogen sued Mylan Pharmaceuticals Inc. for infringement of the ’514 Patent. After a bench trial, the court found that Mylan had proven by clear and convincing evidence that the asserted claims of the ’514 Patent were invalid due to a lack of adequate written description. The court determined that the specification of the ’514 Patent did not sufficiently describe the use of a 480 mg dose of DMF or MMF for treating MS, and thus, the inventors did not possess the claimed invention as of the patent’s priority date[1][4].

Collateral Estoppel

In the District of Delaware, Biogen sued Amneal Pharmaceuticals LLC and other defendants for infringement of the same ’514 Patent. The Delaware court considered whether the judgment of invalidity from the West Virginia case should apply under the principles of collateral estoppel. The court found an "identity of issues" between the two cases and determined that the invalidity issue was "actually litigated" and "necessary for the judgment" in the West Virginia case. Therefore, the court applied collateral estoppel, holding that the claims of the ’514 Patent were invalid against Amneal and other defendants as well[4].

Court Decisions

District Court of Delaware

The District Court of Delaware, in its decision, upheld the application of collateral estoppel. It rejected Biogen's arguments that applying collateral estoppel would be unfair and inefficient due to the parallel litigation in both West Virginia and Delaware. The court emphasized that considerations of justice and equity cannot override the four requirements for collateral estoppel when they are met[4].

Federal Circuit

Although not directly addressing the Amneal case, the Federal Circuit's precedents played a crucial role. The court's decision in the Pfizer case, which was cited, supported the argument that patent term extensions do not limit the form of the product subject to the extension. However, in this case, the focus was on the written description requirement rather than patent term extensions[3].

Why Defendants Prevailed

The defendants prevailed primarily due to the lack of adequate written description in the ’514 Patent. The specification did not specifically link the 480 mg dose of DMF or MMF to the treatment of MS, which was a critical element of the claimed invention. This deficiency meant that the inventors could not be said to have possessed the claimed invention at the time of the patent application, leading to the invalidation of the patent claims[1][4].

Impact and Implications

The invalidation of the ’514 Patent has significant implications for Biogen and the generic pharmaceutical industry. It allows companies like Amneal to proceed with marketing generic versions of Tecfidera, potentially reducing the cost of treatment for patients with relapsing forms of MS. This decision also underscores the importance of ensuring that patent specifications provide clear and specific descriptions of the claimed inventions to avoid invalidation on written description grounds.

Key Takeaways

• Patent Invalidity: The ’514 Patent was found invalid due to a lack of adequate written description.
• Collateral Estoppel: The judgment of invalidity from the West Virginia case was applied to the Delaware case.
• Specification Requirements: The specification must clearly describe the claimed invention, including specific dosages and treatments.
• Generic Competition: The invalidation allows generic versions of Tecfidera to enter the market.

FAQs

What is the main issue in the Biogen v. Amneal Pharmaceuticals case?

The main issue is whether the ’514 Patent, which covers the use of DMF for treating MS, is valid given the lack of adequate written description in its specification.

What is the significance of the West Virginia case in this litigation?

The West Virginia case established that the ’514 Patent claims were invalid due to a lack of written description, and this judgment was applied via collateral estoppel to the Delaware case.

How does this decision affect Biogen and generic pharmaceutical companies?

The decision allows generic companies to market their versions of Tecfidera, reducing Biogen’s exclusivity and potentially lowering treatment costs for patients.

What is the importance of written description in patent law?

Written description is crucial as it must clearly describe the claimed invention to ensure that the inventors possessed the invention at the time of the patent application.

What are the implications for patients with MS?

The decision could lead to more affordable treatment options for patients with relapsing forms of MS as generic versions of Tecfidera become available.

Cited Sources

1. United States District Court for the District of Delaware, "Biogen International GmbH and Biogen MA Inc. v. Mylan Pharmaceuticals Inc.", 2020 WL 3317105.
2. New York State Attorney General, "Attorney General James Secures Over $270 Million Multistate Settlement in Principle with Amneal Pharmaceuticals for Its Role in the Opioid Crisis", May 3, 2024.
3. Patently-O, "Biogen International GmbH and Biogen MA Inc. v. Banner Life Sciences LLC", 2020-06-24.
4. Robins Kaplan, "Biogen Int'l GmbH v. Amneal Pharmaceuticals LLC", 2020-09-16.
5. Casetext, "Biogen Int'l GMBH v. Amneal Pharm., 487 F. Supp. 3d 254".