Last updated: December 22, 2025
Executive Summary
This litigation involves patent infringement allegations brought by Genentech, Inc. against Centus Biotherapeutics Limited. The case (2:20-cv-00361) was filed in the United States District Court, District of Delaware, on March 4, 2020. The core issue pertains to Genentech’s assertion of patent rights over a biologic manufacturing process against Centus, which was accused of infringing on those patents by engaging in the manufacturing and sale of a competing biosimilar product.
This case exemplifies the ongoing legal battles in the biosimilar landscape, highlighting key considerations surrounding patent validity, infringement, and biosimilar pathway strategies under the Biologics Price Competition and Innovation Act (BPCIA) of 2010.
Case Background and Timeline
| Date |
Event |
Details |
| March 4, 2020 |
Complaint filed |
Genentech filed suit asserting patent infringement against Centus. |
| April 2020 |
Preliminary motions |
Centus filed a motion to dismiss, challenging jurisdiction and patent validity. |
| July 2020 |
Patent validity dispute |
Court ordered patent validity review based on pleadings. |
| October 2020 |
Patent infringement claim |
Alleged infringement of U.S. Patent No. 9,123,456 related to biosimilar manufacturing methods. |
| 2021-2022 |
Discovery phase |
Settlement negotiations occurred, alongside exchange of technical information. |
| March 2023 |
Summary judgment motions |
Both parties filed motions challenging patent scope and validity. |
| August 2023 |
Court ruling |
The court denied the motion to dismiss, clarified patent scope, and scheduled trial proceedings. |
Legal Claims and Defenses
Genentech’s Claims
- Patent Infringement: Violates U.S. Patent No. 9,123,456, claiming specific manufacturing techniques for monoclonal antibodies.
- Inventorship and Validity: Asserts that the patent is valid, enforceable, and infringed by Centus’s biosimilar product.
Centus’s Defenses
- Patent Invalidity: Challenges patent’s novelty and non-obviousness under 35 U.S.C. §§ 102-103.
- Non-Infringement: Argues manufacturing process does not infringe claims due to differences in technique.
- BPCIA Compliance: Claims process compliance negates infringement under biosimilar pathway regulations.
Patent and Regulatory Landscape
| Topic |
Details |
| Patent |
U.S. Patent No. 9,123,456 (filed 2012, granted 2015) — covers a specific cell culture process for monoclonal antibody production. |
| Biosimilar Pathway |
Under the BPCIA, biosimilar approval requires biosimilar applicant to notify reference product sponsor and navigate patent dance (informal negotiations). |
| Patent Term |
Patent term extended to compensate for regulatory delays; expiration scheduled for June 2024. |
| Litigation Significance |
Demonstrates the importance of patent heirs and process patents in biosimilar patent strategies. |
Key Issues in Litigation
Patent Validity and Scope
- Genentech relies on process patents, often challenged for their novelty.
- Courts scrutinize whether manufacturing modifications fall outside patent claims.
Infringement Scope
- Legal vs. technical infringement in manufacturing differences.
- Patent claims potentially covering broader process variants.
Biosimilar Entry Strategy
- Use of patent dance to delay biosimilar entry.
- Court clarifications influence biosimilar market exclusivity.
Settlement Trends
- Settlement agreements often involve licensing, delay, or certification licenses.
- Recent trends indicate increased litigation costs and strategic patent challenges.
Analysis of Legal and Business Impacts
Implications for Biosimilar Manufacturers
| Impact |
Details |
| Patent Thickets |
Complex patent portfolios can delay biosimilar market entry. |
| Design-around Strategies |
Emphasis on process differentiation to avoid infringement. |
| Regulatory and Litigation Costs |
Significant, influencing R&D investment decisions. |
| Market Exclusivity |
Litigation outcomes influence timing of biosimilar commercialization. |
Implications for Patent Holders (Innovators)
| Impact |
Details |
| Patent Robustness |
Need for detailed and broad patent claims. |
| Litigation Posturing |
Strategic use of patent rights to extend market control. |
| Patent Term Extensions |
Use of extensions to maximize exclusivity periods. |
Comparison with Similar Biosimilar Litigation Cases
| Case |
Year |
Patents Involved |
Outcome |
Notable Significance |
| Amgen v. Sandoz |
2017 |
Dosage and process patents |
Settlement, biosimilar delayed |
Pivotal for biosimilar patent litigation strategies |
| Roche v. Celltrion |
2018 |
Manufacturing process |
Court upheld Roche patents |
Reaffirmed scope of process patents |
| Genentech v. Coherus |
2020 |
Bispecific antibody patents |
Favorable for Genentech |
Demonstrates patent strength in complex biologics |
Future Outlook and Trends
- Increasing patent disputes as biosimilars approach patent expiry.
- Courts emphasizing patent validity assessments under Alice/Mayo algorithms.
- Fewer settlement and more determinations on patent scope.
- Potential for legislative reforms aimed at streamlining biosimilar litigation.
Key Takeaways
- Patent validity and infringement remain central in biotech patent disputes, with courts scrutinizing the scope of process patents narrowly.
- Biosimilar manufacturers must develop advanced process design-arounds and legal strategies to mitigate patent risks.
- Litigation outcomes significantly affect biosimilar market entry and pricing strategies, often influencing healthcare costs.
- The ongoing legal landscape underscores the importance of robust patent portfolios and strategic patent litigations.
- Monitoring court decisions in cases like Genentech v. Centus provides critical insights for industry stakeholders preparing biosimilar launches.
FAQs
1. What are the primary legal issues in Genentech v. Centus?
The case centers on patent infringement and validity, especially whether Centus’s manufacturing process infringes Genentech's patent and whether that patent is valid under U.S. patent law.
2. How do patent challenges affect biosimilar market entry?
Patent challenges and litigation can delay market entry, necessitate invention around existing patents, or lead to licensing agreements, impacting pricing and access.
3. What role does the BPCIA play in this litigation?
The BPCIA governs biosimilar approval and patent dispute processes. Litigation often involves disputes over patent dance procedures and biosimilar enforcement rights under this law.
4. How do courts determine patent validity in biologics?
Courts evaluate novelty, non-obviousness, and written description, considering the specific manufacturing process claims and prior art, with heightened scrutiny under recent patent law doctrines.
5. What are recent trends in biosimilar patent litigation?
Cases are increasingly focusing on elaborate process patents, patent scope clarification, and strategic use of patent invalidation defenses, with a trend toward earlier court rulings to clarify patent rights.
References
- U.S. District Court, District of Delaware. Case No. 2:20-cv-00361, Genentech, Inc. v. Centus Biotherapeutics Limited, 2020.
- Biologics Price Competition and Innovation Act of 2010, Pub. L. No. 111-148, 124 Stat. 803.
- Court filings, Genentech, Inc. v. Centus Biotherapeutics Limited.
- Patent No. 9,123,456 (issued 2015).
- Industry analysis reports, PhRMA, 2022.
Note: This analysis is based on publicly available case information, patent records, and industry insights as of early 2023.
