Introduction
The litigation between Genentech, Inc. and Pfizer Inc., case number 1:19-cv-00638, is a significant example of the complex legal landscape surrounding biosimilars and biologic drugs. This case involves Genentech's reference biologic product Avastin (bevacizumab) and Pfizer's biosimilar version, Zirabev (PF-06439535).
Background
Genentech, a biotechnology company, developed Avastin, a monoclonal antibody used to treat various types of cancer. Pfizer, seeking to enter the market with a biosimilar, submitted an abbreviated Biologics License Application (aBLA) for Zirabev to the FDA. This triggered a series of legal actions under the Biologics Price Competition and Innovation Act (BPCIA)[3].
The Patent Dance and Initial Filings
The BPCIA mandates a "patent dance" process, which involves the exchange of information between the reference product sponsor (Genentech) and the biosimilar applicant (Pfizer). On August 21, 2017, Pfizer's aBLA was accepted by the FDA, and Genentech received a copy of the application on September 5, 2017. Genentech then identified potentially infringed patents and provided this list to Pfizer on November 3, 2017. However, Pfizer did not provide its non-infringement and invalidity positions as required by the BPCIA, and instead notified Genentech of its intention to commence commercial marketing of Zirabev on January 18, 2019[1][3].
Complaint and Allegations
On April 5, 2019, Genentech filed a complaint in the United States District Court for the District of Delaware, alleging that Pfizer's Zirabev infringed 22 patents related to bevacizumab. Genentech claimed that Pfizer had failed to provide sufficient manufacturing information as required by the BPCIA, which hindered Genentech's ability to assess potential infringement. The complaint sought a trial by jury, damages, and both preliminary and permanent injunctions against Pfizer's alleged infringement[3].
Pfizer's Response and Counterclaims
Pfizer responded to Genentech's complaint by asserting affirmative defenses and counterclaims for declaratory judgment of non-infringement and invalidity of the asserted patents. Pfizer argued that it had complied with the BPCIA's information disclosure requirements to the extent necessary and that Genentech's claims were barred because Pfizer had not fully participated in the patent dance[2].
Legal Disputes and Motions
Genentech moved to dismiss Pfizer's counterclaims, arguing that Pfizer's failure to fully comply with the BPCIA's information disclosure requirements barred its counterclaims. Genentech also contended that Pfizer's validity challenges were facially deficient because they alleged grounds broader than those disclosed during the patent dance. Pfizer opposed the dismissal, arguing that the BPCIA did not limit it to only the legal theories presented in its detailed statements[2].
Settlement and Dismissal
Before the court could address these issues, the parties jointly stipulated to dismissal in September 2019, resolving the litigation through a settlement. This settlement terminated the BPCIA litigation, and the case was dismissed[2].
Key Takeaways
- BPCIA Compliance: The case highlights the importance of complying with the BPCIA's information disclosure requirements. Failure to do so can lead to significant legal challenges.
- Patent Dance: The "patent dance" process is crucial in biosimilar litigation, and any deviations can impact the legal strategy and outcomes.
- Settlements: Many biosimilar litigations are resolved through settlements, which can avoid lengthy and costly legal battles.
- Manufacturing Information: The dispute over manufacturing information underscores its critical role in assessing patent infringement in biosimilar cases.
FAQs
Q: What is the Biologics Price Competition and Innovation Act (BPCIA)?
A: The BPCIA is a statute that governs the approval and litigation process for biosimilar drugs, including the "patent dance" mechanism for exchanging information between reference product sponsors and biosimilar applicants.
Q: Why did Genentech sue Pfizer in this case?
A: Genentech sued Pfizer alleging that Pfizer's biosimilar, Zirabev, infringed 22 patents related to Avastin (bevacizumab).
Q: What was the outcome of the litigation?
A: The litigation was resolved through a settlement, and the case was dismissed in September 2019.
Q: What role did the "patent dance" play in this litigation?
A: The "patent dance" process was central, as Genentech alleged that Pfizer did not fully comply with the BPCIA's information disclosure requirements, which led to legal disputes.
Q: How common are settlements in biosimilar litigations?
A: Settlements are relatively common in biosimilar litigations, as they can avoid the costs and uncertainties associated with prolonged legal battles.
Citations
- Fish & Richardson P.C., "The Herceptin® Battle Moves into the District Court," November 22, 2017.
- Biosimilar Development, "Biosimilar Litigation Review BPCIA Cases Settled Or Dismissed In ...," January 21, 2020.
- Center for Biosimilars, "Genentech Sues Pfizer Over Proposed Bevacizumab Biosimilar, PF-06439535," April 9, 2019.
