Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint. Perhaps more importantly, the clock still may be running against Genentech to make the next move in the patent dance.
As explained in this article, this case arose from Amgen’s November 2016 aBLA for a biosimilar version of Genentech’s Avastin® (bevacizumab) product, which Genentech describes as it “best-selling cancer drug.” However, Genentech’s complaint was not for patent infringement, but rather alleged that Amgen failed to comply with the information exchange requirements of the “patent dance” provisions of the BPCIA. Although Amgen provided a copy of its aBLA to Genentech in accordance with 42 USC § 262(l)(2)(A), Genentech alleged that Amgen failed to provide additional required information, such as informaton regarding its manufacturing process.
In a letter to the court dated February 27, 2017, Amgen argued that Genentech’s complaint should be dismissed as “procedurally improper” under the Federal Circuit decision in Amgen v. Sandoz. According to Amgen:
[That case] squarely holds that the sole and exclusive remedy for any alleged non-compliance with 42 U.S.C. 262(/)(2)(A) is a patent infringement action.
As explain in this article, the Federal Circuit ruled in Amgen v. Sandoz that if a biosimilar applicant fails to follow the “patent dance” procedures of 42 U.S.C. § 262(l)(2)(A), the only “remedy” available to the reference product sponsor is to pursue a patent infringement claim under 42 USC § 262(l)(9)(C) and 35 U.S.C § 271(e)(2)(C)(ii).
(Amgen acknowledged that it has asked the Supreme Court to reverse that decision, but noted that the decision “remains controlling authority here.”)
Since Genentech’s complaint did not assert any claims of patent infringement, Amgen argued that it was precluded under Amgen v. Sandoz.
Genentech filed a responsive letter to the court dated February 28, 2017, arguing that Amgen v. Sandoz only applies when a biosimilar applicant opts out of the patent dance altogether. According to Genentech, because Amgen opted into the patent dance by providing a copy of its aBLA to Genentech, the court should have the authority to resolve this dispute so the patent dance can go on.
Genentech also argued that biosimilar applicants who opt into the patent dance benefit considerably because it imposes certain limitations on “how and when the innovator [reference product sponsor] can exercise its patent rights.” That also means that the reference product sponsor is at a disadvantage when the biosimilar applicant withholds information needed to assess patent infringement. For example, Genentech argues that it will be forced “either to produce a list of potentially infringed patents under § 262(l)(3)(A), without the full production of materials or expert assistance that should have informed that list, or sue Amgen for infringement and wait and see whether that lawsuit was proper at some later time.”
Judge Sleet dismissed Genentech’s complaint for lack of subject matter jurisdiction without prejudice, and gave Genentech the opportunity to filed an amended complaint within 45 days (i.e., April 15). However, according to its February 28 letter, Genentech faces a March 24, 2017 deadline for serving Amgen with its list of potentially infringed patents under § 262(l)(3)(A). It will be interesting to see whether Genentech continues on with the patent dance or opts out itself by filing a declaratory judgment action under 42 USC § 262(l)(9)(C) and 35 U.S.C § 271(e)(2)(C)(ii).