Background of the Case
The litigation between Amgen Inc. and Apotex Inc. revolves around the Biologics Price Competition and Innovation Act (BPCIA) of 2009, specifically the process for approving and marketing biosimilar products. Amgen, the manufacturer of the FDA-approved biologic Neulasta® (pegfilgrastim), faced a challenge from Apotex, which sought to market a biosimilar version of Neulasta®[1][2].
The BPCIA Process and Patent Dance
Under the BPCIA, a biosimilar applicant must engage in a step-by-step process known as the "patent dance," which involves exchanging information and channeling patent litigation. Apotex initiated this process by providing Amgen with its biosimilar application and manufacturing information. Amgen then identified three patents that could be asserted against Apotex, and Apotex responded with detailed statements on non-infringement and invalidity[1][2].
Notice of Commercial Marketing and Preliminary Injunction
A critical aspect of the BPCIA is the requirement for the biosimilar applicant to provide notice of commercial marketing 180 days before entering the market. Apotex sent a notice to Amgen on the same day it provided its patent-specific responses, but this notice was given before Apotex received FDA licensure. Amgen sought a preliminary injunction to enforce the 180-day notice period post-licensure, which the district court granted. The Federal Circuit affirmed this decision, ruling that the commercial-marketing provision is mandatory and enforceable by injunction, even for applicants who have engaged in the patent dance[1][2].
Federal Circuit's Decision
The Federal Circuit's decision in Amgen v. Apotex clarified that the 180-day notice period begins only after the biosimilar applicant receives FDA licensure. The court rejected Apotex's argument that the notice provision was not mandatory because it had engaged in the patent dance. The court held that the distinction between Apotex and Sandoz (which had skipped the patent dance entirely) was not legally material, and the notice provision applies uniformly[1][2].
Infringement Litigation
In addition to the dispute over the notice period, Amgen and Apotex were involved in infringement litigation. Amgen alleged that Apotex's proposed biosimilar product would infringe one of its patents, specifically the '138 patent. The district court conducted a bench trial and found that Amgen failed to prove infringement, both literally and under the doctrine of equivalents. The Federal Circuit affirmed this finding on appeal[4].
Claim Construction and Evidence
During the litigation, there were disputes over claim construction, particularly regarding the terms "volume" and "refold mixture." The district court construed these terms in favor of Apotex, finding that Amgen's processes did not meet the specified protein concentration requirements. The Federal Circuit upheld this construction, noting that the pre-litigation letters exchanged during the BPCIA process were not binding but could be considered as part of the evidence[4].
Personal Jurisdiction and Venue
In other related litigation, the issue of personal jurisdiction and venue was addressed. Apotex, along with other defendants, was found to have systematic and continuous contacts with the State of New Jersey, establishing personal jurisdiction. This was based on Apotex's business activities, including manufacturing, marketing, and selling pharmaceutical products in the United States, including New Jersey[3].
Key Takeaways
- Mandatory Notice Period: The 180-day notice period for commercial marketing under the BPCIA is mandatory and begins only after FDA licensure, regardless of whether the biosimilar applicant has engaged in the patent dance.
- Infringement Litigation: The litigation highlighted the importance of precise claim construction and the careful consideration of evidence in determining patent infringement.
- Personal Jurisdiction: Companies engaging in systematic and continuous business activities within a state can be subject to personal jurisdiction in that state.
FAQs
Q: What is the Biologics Price Competition and Innovation Act (BPCIA)?
A: The BPCIA is a law that outlines the process for approving and marketing biosimilar products, including a step-by-step process for exchanging information and channeling patent litigation.
Q: Why did Amgen seek a preliminary injunction against Apotex?
A: Amgen sought a preliminary injunction to enforce the 180-day notice period required under the BPCIA before Apotex could commercially market its biosimilar product.
Q: What was the Federal Circuit's decision regarding the notice period?
A: The Federal Circuit ruled that the 180-day notice period is mandatory and begins only after the biosimilar applicant receives FDA licensure, regardless of whether the applicant engaged in the patent dance.
Q: What were the key issues in the infringement litigation between Amgen and Apotex?
A: The key issues included claim construction related to the terms "volume" and "refold mixture" and whether Apotex's processes infringed Amgen's '138 patent.
Q: How did the court determine personal jurisdiction over Apotex?
A: The court determined personal jurisdiction based on Apotex's systematic and continuous business activities within the State of New Jersey.
Sources
- AMGEN INC. v. APOTEX INC. - Court of Appeals for the Federal Circuit, July 5, 2016.
- Amgen v. Apotex: Analysis of the Fed. Cir. Opinion - Big Molecule Watch, July 6, 2016.
- Case 2:23-cv-23141 Document 1 Filed 12/15/23 - U.S. District Court for the District of New Jersey.
- Amgen Inc. v. Apotex Inc., 2017-1010 - Casetext Search + Citator, November 13, 2017.
