Introduction
The litigation between Genentech, Inc. and Immunex Rhode Island Corp. (along with Amgen Inc.) is a significant case in the realm of biosimilar disputes, governed by the Biologics Price Competition and Innovation Act (BPCIA). This case involves complex patent and regulatory issues surrounding the biosimilar version of Genentech’s Avastin (bevacizumab), marketed by Amgen as Mvasi.
Background
Genentech and City of Hope are the co-owners of several patents related to the manufacturing process of bevacizumab, a biologic approved by the FDA in 2004. Amgen filed an application and subsequent supplements to its biologics license application (BLA) for Mvasi, which Genentech alleged infringed their patents under the BPCIA[3].
Key Issues and Arguments
Patent Infringement and BPCIA Process
Genentech argued that Amgen’s filing of a supplement to its BLA for Mvasi triggered the contention-exchange process and other aspects of the BPCIA’s “patent dance.” This process involves the exchange of information and negotiations between the biosimilar applicant and the reference product sponsor regarding potential patent disputes. Genentech contended that the supplement to the BLA was an “application” within the meaning of § 262(l)(2) of the BPCIA, necessitating a new round of the patent dance[4].
Supplemental Applications and Notice Requirements
A crucial point of contention was whether Amgen’s supplemental applications required a new notice of commercial marketing under the BPCIA. Genentech argued that because Amgen filed supplements to its approved biosimilar application, it was required to provide a new notice of commercial marketing, which would delay the commercial launch of Mvasi by 180 days[1].
Claim-Splitting and Good Cause Requirement
Amgen countered that Genentech was engaging in “claim-splitting” by asserting new patents in a separate lawsuit rather than adding them to the existing case. Amgen argued that Genentech missed the deadline to request leave to add these new patents to the previous case and lacked good cause to do so[4].
Court Decisions and Rulings
District Court Rulings
The district court denied Genentech’s emergency motions to enforce a statutory prohibition on commercial marketing and for a temporary restraining order. The court lifted the standstill order, allowing Amgen to proceed with the commercial launch of Mvasi. The court reasoned that Genentech had not demonstrated irreparable harm, partly because Genentech had previously licensed some of the asserted patents to other biosimilar manufacturers[3].
Appeal to the Federal Circuit
Genentech appealed the district court’s decision to the Federal Circuit, arguing that the district court erred in denying the motion for a preliminary injunction. The appeal, Case No. 19-2155, was pending with oral argument not yet scheduled at the time of the last update[1].
Implications and Analysis
Impact on Biosimilar Litigation
This case highlights the complexities and nuances of biosimilar litigation under the BPCIA. The dispute over whether supplemental applications trigger a new round of the patent dance and the requirement for a new notice of commercial marketing has significant implications for the timing and strategy of biosimilar launches.
Strategic Considerations for Biosimilar Applicants
Biosimilar applicants must carefully consider the implications of filing supplemental applications and the potential need for new notices of commercial marketing. This case underscores the importance of meticulous compliance with the BPCIA’s procedural requirements to avoid delays and legal challenges.
Patent Strategy and Licensing Agreements
The case also emphasizes the role of patent strategy and licensing agreements in biosimilar disputes. Genentech’s previous licensing agreements with other biosimilar manufacturers were a factor in the court’s decision, highlighting the need for comprehensive patent management and licensing strategies.
Conclusion
The litigation between Genentech and Immunex Rhode Island Corp. is a pivotal example of the intricate legal landscape surrounding biosimilars. The case underscores the critical importance of understanding and adhering to the BPCIA’s procedural requirements, the strategic management of patent portfolios, and the implications of licensing agreements in biosimilar disputes.
Key Takeaways
- BPCIA Process: The BPCIA’s “patent dance” and notice requirements are crucial in biosimilar litigation.
- Supplemental Applications: Filing supplements to a BLA can trigger new procedural requirements under the BPCIA.
- Patent Strategy: Effective management of patent portfolios and licensing agreements is vital in biosimilar disputes.
- Compliance: Strict adherence to BPCIA procedural requirements is necessary to avoid legal challenges and delays.
- Court Decisions: District and appellate court decisions can significantly impact the timing and strategy of biosimilar launches.
Frequently Asked Questions (FAQs)
Q: What is the Biologics Price Competition and Innovation Act (BPCIA)?
A: The BPCIA is a statutory scheme that governs biologics and biosimilars, providing a pathway for the approval of biosimilar products and outlining the procedural requirements for resolving patent disputes between biosimilar applicants and reference product sponsors.
Q: What is the "patent dance" under the BPCIA?
A: The "patent dance" refers to the exchange of information and negotiations between the biosimilar applicant and the reference product sponsor regarding potential patent disputes, as outlined in the BPCIA.
Q: Why is the notice of commercial marketing important in BPCIA litigation?
A: The notice of commercial marketing is crucial because it triggers a 180-day period before the biosimilar can be commercially launched, allowing time for patent disputes to be resolved.
Q: How do supplemental applications to a BLA impact BPCIA litigation?
A: Supplemental applications can trigger new procedural requirements, including the potential need for a new notice of commercial marketing and a new round of the patent dance.
Q: What role do licensing agreements play in biosimilar litigation?
A: Licensing agreements can be a factor in determining irreparable harm and can influence the court’s decision on motions for preliminary injunctions, as seen in the Genentech v. Immunex case.
