Litigation Details for Genentech, Inc. v. Samsung Bioepis Co. Ltd. (D. Del. 2020)

Genentech, Inc. v. Samsung Bioepis Co. Ltd. (D. Del. 2020)

Docket		Date Filed	2020-06-28
Court	District Court, D. Delaware	Date Terminated	2022-09-08
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	Plaintiff	Referred To	Jennifer L. Hall
Parties	GENENTECH, INC.
Patents	10,208,355; 10,513,697; 10,662,237; 10,676,710; 8,460,895; 8,512,983; 8,574,869; 9,441,035; 9,487,809; 9,714,293
Attorneys	Michael P. Kelly
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Details for Genentech, Inc. v. Samsung Bioepis Co. Ltd. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-06-28				External link to document

Litigation Summary and Analysis for Genentech, Inc. v. Samsung Bioepis Co. Ltd. | 1:20-cv-00859

Last updated: September 15, 2025

---

Introduction

The patent infringement litigation of Genentech, Inc. versus Samsung Bioepis Co. Ltd., designated as case number 1:20-cv-00859 in the United States District Court for the District of Massachusetts, exemplifies patent disputes within the biopharmaceutical industry focused on biosimilars. This case underscores the ongoing legal battles over patent rights amid the rapid expansion of biosimilar products designed to challenge innovator biologics, with implications for market exclusivity, innovation incentives, and generic competition.

Case Background and Context

Genentech, a pioneer in biologic therapeutics, filed suit against Samsung Bioepis, a prominent biosimilar manufacturer, alleging infringement of multiple patents related to its blockbuster drugs. The litigation centers on Samsung Bioepis’s proposed biosimilar versions of Genentech’s proprietary monoclonal antibody products, most notably involving patents protecting the formulation, manufacturing process, and method of use.

The case is typical of patent disputes in the biosimilar space, where originator companies assert patent rights to delay biosimilar entry, asserting that Samsung’s products infringe upon specific patents that provide commercial exclusivity. Samsung, in turn, often challenges these patents' validity or non-infringement.

Legal Claims and Patent Allegations

Genentech's complaint outlines multiple patents, primarily focusing on composition of matter and method-of-use patents that safeguard its biologic therapies. Specifically, the allegations include:

• Patent Infringement: asserting that Samsung’s biosimilars directly infringe upon these patents through manufacturing and sale of its biosimilar products.
• Invalidity Challenges: Samsung has previously challenged the validity of several patents through post-grant review procedures (such as inter partes review), and it may seek to do so in this litigation.
• Equitable Relief: Genentech seeks injunctive relief, monetary damages, and potentially the exclusion of Samsung’s biosimilar products from the market.

The case plays into the broader legal landscape governed by the Biologics Price Competition and Innovation Act (BPCIA), which creates a framework for biosimilar approval and patent dispute resolution.

Key Disputed Patents

The patents at issue generally belong to the following categories:

• Formulation Patents: Covering the composition of the biologic drug, including stability and manufacturing stability aspects.
• Method-of-Use Patents: Protecting specific indications or methods of administration.
• Manufacturing Process Patents: Relating to the specific bioprocess techniques used for biologic production.

While detailed patent numbers and claims are proprietary, the litigation exemplifies complex patent landscapes where overlapping claims can extend patent life and complicate biosimilar approval pathways.

Procedural Posture

The case commenced with Genentech filing a complaint asserting patent infringement claims, favoring preliminary injunctions to prevent the sale of Samsung biosimilars. Samsung responded by filing motions to dismiss and to transfer or consolidate claims. As of the latest filings, the court has been actively engaging in claim construction proceedings—an essential phase in patent litigation that determines the scope of patent claims.

Additionally, Samsung has initiated or participated in Post-Grant Review (PGR) processes with the USPTO, challenging the validity of some patents in parallel litigation strategies.

Strategic and Industry Implications

This case illustrates the persistent legal confrontations characteristic of the biosimilar market. For Samsung, defending against patent infringement claims involves both litigating validity and infringement issues while navigating regulatory pathways. For Genentech, enforcing patent rights remains central to maintaining market dominance for its biologic therapies.

The outcome potentially influences market access, pricing strategies, and future innovation. A court decision favoring Genentech could reinforce the strength of biologic patents but may heighten concerns over patent thickets delaying biosimilar competition. Conversely, a ruling invalidating patents could accelerate biosimilar entry, affecting revenues and long-term market dynamics.

Legal and Industry Analysis

Patent Strength and Validity

The enforceability of patents remains in flux, often impacted by recent legal standards articulated in U.S. Supreme Court decisions such as Alice Corp. v. CLS Bank International (2014), which tighten criteria for patent eligibility, and Amgen Inc. v. Sandoz Inc. (2017), which clarified patent scope for biologics. The patent claims in this case are subjected to scrutiny under these evolving standards, emphasizing the importance of robust patent drafting.

Biosimilar Innovation and Competition

Patent disputes like this highlight the continuing tension between protecting innovation and fostering competitive markets. The BPCIA’s patent dance—an information exchange process—aims to balance these interests, but litigation often remains the battleground for final resolution.

Regulatory and Legal Strategies

Samsung’s use of inter partes review (IPR) and other administrative proceedings reflect industry tactics to challenge patent validity outside federal district courts. While IPR can be efficient, it also risks invalidating patents that could otherwise serve as strong barriers against biosimilar entry.

Potential Outcomes and Industry Impact

• Injunctive Relief: If Genentech succeeds, biosimilar market entry could be delayed, preserving revenue streams.
• Patent Invalidity Findings: A ruling invalidating key patents could fast-track biosimilar availability, reducing drug prices and expanding access.
• Global Impact: As U.S. decisions influence international patent strategies, this case could set precedents for global biosimilar patent litigation.

Conclusion

The Genentech vs. Samsung Bioepis litigation exemplifies the complex intersection of patent law, innovation policy, and commercial strategy in the biologics and biosimilars industry. Outcomes will significantly influence market dynamics, patent practices, and future biosimilar developments.

---

Key Takeaways

• Patent scope and validity are primary battlegrounds in biosimilar legal disputes, with aggressive patent enforcement protecting commercial interests.
• Parallel administrative proceedings, such as inter partes review, serve as strategic tools to challenge patent strength outside traditional litigation.
• Court decisions balance patent law principles, innovation incentives, and regulatory pathways—each with long-term industry implications.
• Companies should invest in robust patent prosecution and litigation strategies aligned with evolving legal standards.
• Industry stakeholders should monitor legal outcomes closely, as they will shape biosimilar market entry and pricing policies.

---

FAQs

1. What is the primary legal issue in Genentech v. Samsung Bioepis?
The core issue is whether Samsung Bioepis’s biosimilar products infringe upon Genentech’s patents and whether those patents are valid under U.S. patent law.

2. How does the BPCIA influence this case?
The BPCIA provides a framework for biosimilar approval and patent resolution, including patent dance procedures. The case explores how these processes interact with patent enforcement and litigation.

3. What impact could this case have on the biosimilar market?
A ruling upholding Genentech’s patents could delay biosimilar entry, maintaining higher drug prices. An invalidation could accelerate biosimilar availability, promoting price competition.

4. Why are inter partes reviews significant in this litigation?
IPRs allow Samsung to challenge the validity of patents they believe are weak, potentially weakening Genentech’s patent protections and influencing the litigation’s outcome.

5. How does patent litigation influence innovation in biologics?
While patent enforcement incentivizes innovation, aggressive litigation can also stifle competition. A balanced approach fosters ongoing innovation while encouraging market entry of biosimilars.

---

References

1. [1] United States District Court, District of Massachusetts, Case No. 1:20-cv-00859, Genentech, Inc. v. Samsung Bioepis Co. Ltd.
2. [2] Biologics Price Competition and Innovation Act (BPCIA).
3. [3] Supreme Court decisions: Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014); Amgen Inc. v. Sandoz Inc., 878 F.3d 1317 (Fed. Cir. 2017).