Introduction
The litigation between Genentech, Inc. and Amgen Inc., case number 1:2017cv01407, is a complex and multifaceted dispute involving patent infringement, biosimilars, and the Biologics Price Competition and Innovation Act (BPCIA). Here, we delve into the key aspects of this litigation, analyzing the major arguments, court decisions, and implications.
Background and Context
Genentech, Inc., along with City of Hope, filed a lawsuit against Amgen Inc. on October 6, 2017, in the U.S. District Court for the District of Delaware. The lawsuit revolves around Amgen's submission of an Abbreviated Biologics License Application (aBLA) to the FDA for approval to market a biosimilar of Genentech's biologic drug product Avastin®[4][5].
Patent Infringement Claims
Genentech alleged that Amgen's biosimilar, Kanjinti (trastuzumab-anns), infringed upon 26 patents held by Genentech. These patents cover various aspects of biologic drugs, including methods of treating cancer with specific dosage regimens[4].
BPCIA Compliance
A significant aspect of the litigation involves compliance with the BPCIA. Genentech argued that Amgen failed to meet pre-litigation production obligations under the BPCIA, specifically § 262(l)(2)(A), which requires the biosimilar applicant to provide detailed information about its manufacturing process. Amgen countered that it had provided over a million pages of technical details and batch records, fulfilling its obligations[4].
Preliminary Injunction Denial
In a pivotal decision, the court denied Genentech's motion for a preliminary injunction against Amgen's launch of Kanjinti. The court found that Genentech had delayed in filing its motion, which undermined the claim of irreparable harm. Amgen had served its notice of commercial marketing on May 15, 2018, and Genentech was aware of Amgen's intentions to launch by July 2019. However, Genentech did not file its motion until July 10, 2019, after the FDA had approved Kanjinti on June 13, 2019[1].
Irreparable Harm and Licensing Practices
The court also considered Genentech's licensing practices as evidence against irreparable harm. Genentech had granted licenses to the patents in question to other companies, such as Mylan, Celltrion, and Pfizer. This indicated that Genentech had placed a value on the patents and was willing to allow competitors into the market, suggesting that any harm could be quantified and compensated through reasonable royalty damages[1].
Declaratory Judgment Counterclaims
Amgen filed declaratory judgment counterclaims and affirmative defenses, arguing that the 26 asserted patents and two additional patents were invalid and/or unenforceable. Genentech moved to dismiss these counterclaims and strike the affirmative defenses. The court partially granted Genentech's motion, dismissing certain counterclaims for lack of subject matter jurisdiction but denying the motion in other respects[4].
Legal Standards and BPCIA
The BPCIA is a complex statutory scheme designed to foster price competition and innovation in the field of biologics. The court's decisions were guided by the BPCIA's provisions, particularly those related to the exchange of information and the timing of legal actions. The BPCIA's 180-day notice period for commercial marketing was a critical factor in the court's analysis of Genentech's delay in seeking a preliminary injunction[4].
Court Opinions and Rulings
Judge Colm F. Connolly and Judge Gregory M. Sleet played significant roles in this litigation. Judge Connolly's opinion on the preliminary injunction highlighted the importance of timely action and compliance with the BPCIA. Judge Sleet's memorandum opinion addressed the dismissal of certain counterclaims and the striking of affirmative defenses[1][2][5].
Implications and Future Directions
The denial of the preliminary injunction and the partial dismissal of Amgen's counterclaims have significant implications for both parties. For Genentech, it underscores the need for prompt action in seeking legal relief to avoid allegations of delay. For Amgen, it allows the company to proceed with marketing its biosimilar, potentially increasing competition in the biologics market.
Key Takeaways
- Timeliness in Legal Action: The court emphasized the importance of timely filing motions, especially in the context of the BPCIA's notice periods.
- BPCIA Compliance: Compliance with the BPCIA's pre-litigation production obligations is crucial for both patent holders and biosimilar applicants.
- Licensing Practices: Licensing agreements can impact the assessment of irreparable harm in patent infringement cases.
- Market Competition: The litigation highlights the ongoing battle for market share in the biologics sector, with biosimilars playing a key role in increasing competition.
Frequently Asked Questions
Q: What was the main reason for the court's denial of Genentech's motion for a preliminary injunction?
A: The court denied the motion because Genentech delayed in filing it, which negated the claim of irreparable harm.
Q: How did Genentech's licensing practices affect the court's decision?
A: Genentech's licensing agreements indicated that it had placed a value on the patents and allowed competitors into the market, suggesting that any harm could be quantified and compensated through reasonable royalty damages.
Q: What is the significance of the BPCIA in this litigation?
A: The BPCIA's provisions, particularly those related to notice periods and information exchange, were critical in the court's analysis of the case.
Q: Which judges were involved in this litigation?
A: Judges Colm F. Connolly and Gregory M. Sleet played significant roles in this case.
Q: What are the implications of this litigation for the biologics market?
A: The litigation could increase competition in the biologics market by allowing biosimilars to enter the market, potentially reducing prices and increasing innovation.
Cited Sources:
- Goodwin Law: Opinion Denying TRO/PI in Genentech v. Amgen Released on July 23, 2019.
- Justia Law: Genentech, Inc. et al v. Amgen Inc., No. 1:2017cv01407 - Document 58 (D. Del. 2018).
- Justia Law: Genentech, Inc. et al v. Amgen Inc., No. 1:2017cv01407 - Document 401 (D. Del.).
- Casetext: Genentech, Inc. v. Amgen Inc., Civ. No. 17-1407.
- Justia Dockets: Genentech, Inc. et al v. Amgen Inc. 1:2017cv01407.
