Litigation Details for Biogen Inc. v. Sandoz Inc. (D. Del. 2022)

Biogen Inc. v. Sandoz Inc. (D. Del. 2022)

Docket		Date Filed	2022-09-09
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	None	Referred To
Parties	BIOGEN MA INC.; SANDOZ INC.; SANDOZ INTERNATIONAL GMBH
Patents	10,046,000; 10,119,976; 10,233,245; 10,705,095; 6,509,376; 6,602,503; 7,320,999; 7,619,001; 7,803,840; 8,124,350; 8,399,514; 8,871,449; 9,035,031; 9,493,567; 9,709,575
Attorneys	Samantha G. Wilson; Sarah E. Brickey; Theresa Tan
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Biologic Drugs cited in Biogen Inc. v. Sandoz Inc.

Details for Biogen Inc. v. Sandoz Inc. (D. Del. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-09-09				External link to document
2022-09-09	10	Redacted Document	the ’845 patent is attached as Exhibit 3.  U.S. Patent No. U.S. 10,119,976 118… 118. U.S. Patent No. 10,119,976 (“the ’976 patent”), entitled “Method of Assessing Risk of PML,”…and Declaration of Infringement of U.S. Patent No. 10,119,976) 217. Biogen re-alleges and…Page 2 of 107 PageID #: 1325 9,790,533; U.S. 10,119,976; U.S. 10,233,245; U.S. 10,308,706; U.S. 10,444,234…covered by US Patent claims and corresponding patent claims outside the US. The foregoing patent claims are	External link to document
2022-09-09	136	Redacted Document	10,119,976, and U.S. Patent No. 11,280,794 for purposes of discovery for the preliminary injunction… the methods described in U.S. Patent Nos. 10,119,976 and 11,280,794, including whether Biogen… whether Biogen has marked that U.S. Patent Nos. 10,119,976 and 11,280,794 cover methods used by …including United States Patent Nos. 9,096,879; 10,844,416; 9,316,641; 10,119,976; and 11,280,794. …practice of the asserted claims of U.S. Patent Nos. 10,119,976 and 11,280,794 and how often and in	External link to document

Biogen Inc. v. Sandoz Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Biogen Inc. and Sandoz Inc., along with Polpharma Biologics S.A., is a significant case in the biosimilars landscape, particularly under the Biologics Price Competition and Innovation Act (BPCIA). Here, we delve into the key aspects of this litigation, including the background, legal arguments, and the current status of the case.

Background of the Case

Biogen Inc. filed a complaint against Sandoz Inc. and Polpharma Biologics S.A. on September 9, 2022, in the District of Delaware. This lawsuit revolves around the alleged infringement of Biogen’s patents related to its biologic product, Tysabri® (natalizumab), which is used to treat autoimmune diseases such as multiple sclerosis and Crohn's disease[2][3][5].

Patents in Dispute

Biogen initially asserted infringement of 28 patents, which include methods of treatment with natalizumab, methods of manufacturing antibody products like natalizumab, and a companion assay used to reduce the risk of serious side effects in natalizumab patients. However, in the first amended complaint filed on December 1, 2022, the number of asserted patents was reduced to 17[3].

Motion for Preliminary Injunction

On January 20, 2023, Biogen filed a motion for a preliminary injunction to prevent Sandoz and Polpharma from commercially importing, marketing, and selling their natalizumab biosimilar, Tyruko®, until the patent infringement claims were fully adjudicated. This motion was based on four of the 17 asserted patents[3].

Court Ruling on Preliminary Injunction

After oral arguments, the court denied Biogen’s motion for a preliminary injunction. The court found that Biogen failed to prove it would suffer irreparable harm and a likelihood of success on the merits. Specifically, the court determined that Biogen’s alleged harms of price erosion, lost sales and market share, and reputational harm were "speculative and uncertain" and lacked a causal nexus between the alleged infringement and the harm. Additionally, the court found that Biogen failed to show that the defendants would infringe any of the four patents at issue[3].

Current Status of the Case

The case is currently in the discovery phase, with several discovery disputes being resolved by the court. The claim construction process is ongoing, with a joint technology tutorial and claim construction hearing scheduled for May 17 and 29, 2024, respectively. A five-day trial is set to begin on May 5, 2025[3].

Significance of the Case

This litigation is significant for several reasons:

• First BPCIA Litigation Involving Biogen: It is the first BPCIA litigation where Biogen is the reference product sponsor.
• First BPCIA Litigation Involving Polpharma: It marks the first BPCIA litigation involving Polpharma Biologics S.A.
• First Proposed Biosimilar of Tysabri: It is the first case involving a proposed biosimilar of Tysabri®, a groundbreaking biologic product[3].

Implications for the Biosimilars Market

The outcome of this case will have important implications for the biosimilars market. Biosimilars are crucial for reducing healthcare costs and increasing patient access to biologic therapies. The litigation highlights the complexities and challenges involved in navigating the intellectual property landscape for biosimilars.

Expert Insights

Industry experts emphasize the importance of robust intellectual property protection for biologic innovators while also ensuring that biosimilars can enter the market to enhance competition and affordability.

"The balance between protecting intellectual property and facilitating market entry for biosimilars is critical. This case underscores the need for clear and consistent legal frameworks to support both innovation and competition in the biologics sector."[3]

Statistical Context

The biosimilars market is growing rapidly, with numerous pending biosimilar Biologics License Applications (BLAs). For instance, as of the latest data, there are several pending BLAs for various biologic products, indicating the increasing activity in this sector[5].

Key Takeaways

• Biogen’s Complaint: Biogen filed a complaint against Sandoz and Polpharma alleging infringement of 17 patents related to Tysabri®.
• Preliminary Injunction Denied: The court denied Biogen’s motion for a preliminary injunction due to lack of proof of irreparable harm and likelihood of success on the merits.
• Current Status: The case is in the discovery phase with a trial scheduled for May 2025.
• Significance: This is the first BPCIA litigation involving Biogen, Polpharma, and a proposed biosimilar of Tysabri®.
• Market Implications: The outcome will impact the biosimilars market, affecting competition and patient access to biologic therapies.

FAQs

Q: What is the main issue in the Biogen Inc. v. Sandoz Inc. litigation?

A: The main issue is Biogen's allegation that Sandoz and Polpharma are infringing on Biogen's patents related to its biologic product, Tysabri® (natalizumab).

Q: Why did the court deny Biogen’s motion for a preliminary injunction?

A: The court denied the motion because Biogen failed to prove it would suffer irreparable harm and a likelihood of success on the merits.

Q: What is the current status of the case?

A: The case is currently in the discovery phase, with a trial scheduled to begin on May 5, 2025.

Q: What are the implications of this case for the biosimilars market?

A: The outcome will impact the balance between protecting intellectual property and facilitating market entry for biosimilars, affecting competition and patient access to biologic therapies.

Q: How many patents are currently asserted in this litigation?

A: Biogen is currently asserting 17 patents related to Tysabri® and its manufacturing and testing methods.

Cited Sources

1. Morrison Foerster Defeats Preliminary Injunction in Patent Infringement Suit for Sandoz Inc. - Morrison Foerster.
2. Case 1:22-cv-01190-GBW Document 122 Filed 02/15/23 - RPX Corporation.
3. Biologics and Biosimilars Landscape: IP, Policy, and Market Developments - Fish & Richardson.
4. Biogen International GmbH et al. v. Sandoz Inc. et al. - RPX Corporation.
5. Inter Partes Reviews (IPRs) and Litigations - Morgan Lewis.