Introduction
The litigation between Genentech, Inc. and Celltrion, Inc. is a significant case in the realm of biosimilar disputes, particularly involving Genentech's biologic drugs Herceptin (trastuzumab) and Rituxan (rituximab). This article delves into the key aspects of the litigation, including the legal framework, the disputes, and the outcomes.
Background: BPCIA and Biosimilar Litigation
The Biologics Price Competition and Innovation Act (BPCIA) of 2009 established a pathway for the approval of biosimilar products, which are highly similar to, and interchangeable with, already approved biologic drugs. The BPCIA outlines a complex process known as the "patent dance," which involves negotiations and exchanges of information between the biosimilar applicant and the reference product sponsor (RPS) to resolve patent disputes before the biosimilar is marketed[1][3][4].
The Dispute: Genentech, Inc. v. Celltrion, Inc.
In January 2018, Celltrion, Inc., along with its partner Teva Pharmaceuticals, filed two lawsuits against Genentech, Inc. in the U.S. District Court for the Northern District of California. These lawsuits sought declaratory judgments regarding the validity, enforceability, and infringement of patents related to Herceptin and Rituxan.
Herceptin (Trastuzumab) Litigation
The first lawsuit targeted 38 patents covering Herceptin, a biologic drug used to treat certain breast cancers. Celltrion and Teva argued that these patents were either invalid, unenforceable, or not infringed by their proposed biosimilar, Herzuma, which was under FDA consideration[3][4].
Rituxan (Rituximab) Litigation
The second lawsuit involved 37 patents related to Rituxan, a biologic drug used to treat B-cell lymphomas and other conditions. Celltrion sought a declaratory judgment that its biosimilar, Truxima, did not infringe these patents or that the patents were invalid or unenforceable[3][4].
Statutory Requirements and the Patent Dance
A crucial aspect of the BPCIA is the "patent dance," which requires the biosimilar applicant to engage in good faith negotiations with the RPS to identify and resolve patent disputes. Celltrion's lawsuits were dismissed because the company failed to complete the required statutory steps outlined in the BPCIA, specifically Section 262(l)(5)[1].
Court Rulings and Motions to Dismiss
District Judge Jeffrey S. White of the U.S. District Court for the Northern District of California granted Genentech's motions to dismiss both lawsuits. The court held that Celltrion was obligated to complete all required procedures under the BPCIA before filing the declaratory judgment actions. Celltrion's argument that the notice of commercial marketing lifted the ban on declaratory judgment actions was rejected, as it did not comply with other portions of the statute[1].
Discovery Disputes and Manufacturing Information
In biosimilar litigation, discovery disputes often arise, particularly regarding manufacturing information. While not central to the Celltrion v. Genentech case, other cases have highlighted the challenges in obtaining manufacturing process details. For instance, in a related case, Amgen's request to delay a summary judgment ruling until Sandoz submitted its modified manufacturing process to the FDA was denied, illustrating the complexities in accessing such information[2].
Industry Implications and Strategies
The litigation between Genentech and Celltrion underscores the strategic importance of complying with the BPCIA's procedural requirements. Biosimilar manufacturers must carefully navigate the patent dance to avoid premature litigation. Additionally, the case highlights the use of patent thickets by RPSs to forestall competition, a tactic that biosimilar manufacturers often challenge as anticompetitive[3][4].
Current Status and Future Directions
As of the last updates, Celltrion was afforded leave to amend its complaints, but the core issue of compliance with the BPCIA's statutory steps remains a barrier. The ongoing litigation in the biosimilar space continues to evolve, with courts refining the interpretation of the BPCIA and its application in various cases.
Key Takeaways
- Compliance with BPCIA: Biosimilar applicants must strictly adhere to the procedural requirements of the BPCIA, including the patent dance, before initiating declaratory judgment actions.
- Patent Thickets: RPSs often use extensive patent portfolios to delay biosimilar entry, which biosimilar manufacturers may challenge as anticompetitive.
- Discovery Challenges: Accessing manufacturing information can be a significant hurdle in biosimilar litigation.
- Strategic Litigation: Careful planning and compliance are crucial for biosimilar manufacturers to navigate the complex legal landscape.
FAQs
What is the BPCIA and how does it relate to biosimilar litigation?
The Biologics Price Competition and Innovation Act (BPCIA) is a law that established a pathway for the approval of biosimilar products. It outlines a process known as the "patent dance" to resolve patent disputes between biosimilar applicants and reference product sponsors.
Why were Celltrion's lawsuits against Genentech dismissed?
Celltrion's lawsuits were dismissed because the company failed to complete the required statutory steps under the BPCIA before filing the declaratory judgment actions.
What is a patent thicket, and how is it used in biosimilar litigation?
A patent thicket refers to a large number of patents that cover various aspects of a biologic drug, often used by reference product sponsors to delay or prevent biosimilar competition. Biosimilar manufacturers may challenge these as anticompetitive.
What challenges do biosimilar manufacturers face in accessing manufacturing information?
Biosimilar manufacturers often face challenges in obtaining detailed manufacturing process information from reference product sponsors, which can be crucial for determining infringement and validity of patents.
How does the outcome of this litigation impact future biosimilar disputes?
The outcome emphasizes the importance of strict compliance with the BPCIA's procedural requirements and highlights the ongoing legal battles over patent thickets and access to manufacturing information, setting precedents for future biosimilar disputes.
Cited Sources:
- Celltrion, Inc. v. Genentech, Inc. (N.D. Cal. 2018) - Patent Docs
- Discovery Disputes Related to Manufacturing in BPCIA Litigation - JD Supra
- Celltrion and Teva Sue Genentech Over Trastuzumab, Rituximab Patents - Center for Biosimilars
- Biosimilars 2018 Year in Review - Fish & Richardson
