Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act.

Shortly after Amgen received US Food and Drug Administration (FDA) approval for MVASI® (bevacizumab-awwb), a biosimilar to Genentech’s Avastin®, both parties filed competing lawsuits regarding patent infringement, as detailed in a previous LawFlash. Amgen filed a declaratory judgment lawsuit in the US District Court for the Central District of California and Genentech filed a patent infringement lawsuit in the US District Court for the District of Delaware.

In its complaint, Genentech alleged that Amgen contradicted a representation it made during information exchange negotiations (also referred to as the Patent Dance) pursuant to the Biologics Price Competition and Innovation Act (BPCIA). As a result, Genentech sought a declaratory judgment that Amgen not be allowed to market MVASI® until a particular date.[1] Amgen moved to dismiss this claim under Federal Rule of Civil Procedure (Rule) 12(b)(6) for failure to state a claim and under Rule 12(b)(1) for lack of subject matter jurisdiction.[2]

In its motion to dismiss, Amgen contends that Genentech was the bad actor during the Patent Dance negotiations. Amgen accuses Genentech of failing to respond to its detailed noninfringement, invalidity, and/or unenforceability positions disclosed as part of the Patent Dance. Additionally, Amgen contends that, despite having its detailed disclosure of defenses, Genentech intentionally delayed informing Amgen that it still intended to litigate a number of the patents it disclosed pursuant to the Patent Dance. Further, Amgen alleges that Genentech refused to take any action to remove any of its patents or claims from dispute that it previously stated it would not assert. This purportedly caused an impasse and created uncertainty as to which patents and which claims Genentech would assert against Amgen. Because of this, the time period for negotiations under the Patent Dance expired without a final agreement as to the list of patents that would be asserted in an immediate infringement action. As a result, Amgen provided its notice of commercial marketing as required under the BPCIA and filed suit to ascertain the parties’ rights and obtain certainty regarding any alleged infringement.

Amgen argues that Genentech failed to state a claim upon which relief could be granted because it is unclear what the underlying federal cause of action is to establish liability or support a declaration of rights that would preclude Amgen from marketing its biosimilar until a specific date. Additionally, Amgen asserts that Genentech failed to plausibly allege that Amgen made a legally binding enforceable representation regarding the date of first commercial marketing. In doing so, Amgen contends that Genentech mischaracterized Amgen’s “statement of future intention and the statutory language.” According to Amgen, its notice of commercial marketing states that it will begin commercial marketing of MVASI® no earlier than 180 days from October 6, 2017, not that it can begin marketing MVASI® 180 days from October 6, 2017, as Genentech contends. Amgen contends that its notice is in compliance with the BPCIA’s commercial marketing notice provision and is consistent with its stated future intent to market MVASI® at a later date. Amgen further argues that there is no evidence of any reliance, detrimental or otherwise, on its stated marketing intention.

It will be interesting to see whether the District of Delaware dismisses Genentech’s claim regarding Amgen’s allegedly misleading representation. Amgen has certainly provided a number of hooks for the court to do so. However, the parties’ competing interpretations of the facts regarding the Patent Dance negotiations suggest that neither party is blameless in causing the breakdown of those negotiations.

Regardless, these litigations show that there remains a substantial amount of uncertainty regarding the interpretation and application of the BPCIA. Parties have demonstrated that they are more than willing to litigate any disputes that arise in order to obtain clarity regarding the metes and bounds of permissible conduct under the BPCIA. Thus, it is likely that the judicial system’s work interpreting and clarifying the BPCIA has only just begun.