By James C. Shehan –
In the latest Biologics Price Competition and Innovation Act of 2009 ("BPCIA") patent dance development, Amgen filed a lawsuit alleging that Apotex’s biosimilar of Neulasta (pegfilgrastim) infringes two Amgen patents, one about to expire composition of matter patent and one process patent expiring in 2031. This is the first lawsuit in which the parties at least initially engaged in the “intricate and carefully orchestrated set of information exchanges” known as the patent dance. But alas, this beautiful pas de deux has been marred, according to Amgen, by Apotex’s providing notification of commercial marketing prior to FDA approval of its Section 351(k) application, or Abbreviated Biologics License Applications ("ABLA"). And Amgen isn’t relying solely on its interpretation of the BPCIA – the judges of its last dance contest, also known as the Federal Circuit, have already ruled in Amgen v. Sandoz that notification of commercial marketing must come after approval (see our earlier post here). Although it is anticipated that an en banc or Supreme Court appeal will be granted in that case, while it stands, the Federal Circuit opinion should govern this case. But how that will play out in the current litigation remains to be seen, as it appears that Amgen has filed a complaint that partially follows the patent dance and partially does not.
Amgen filed suit against Apotex in the Southern District of Florida on August 6th, alleging infringement of U.S. Patent Nos. 8,952,138 and 5,824,784. Amgen states in the Complaint that Apotex and it began exchanging the information and statements required by the BPCIA in December 2014 and agreed that the two above-referenced patents would be included in patent dance litigation.
Amgen received a letter from Apotex purporting to be a notification of commercial marketing on April 17, 2015. Note that this date is roughly a month after the ruling by the U.S. District Court for the Northern District of California in Amgen v. Sandoz that notification of commercial marketing could occur before approval (the ruling that was subsequently reversed by the Federal Circuit).
Although Amgen doesn’t reveal at which stage the rest of the patent dance was at when it received the April 17th letter, from the timing it was likely somewhere in the middle. The Apotex ABLA was apparently accepted by FDA in December (see Apotex press release here) and patent dance exchanges with Amgen began that month. These patent dance exchanges take quite a bit of time - 20 days permitted for Apotex to supply the ABLA to Amgen, 60 days for Amgen to provide a patent list, 60 days for Apotex to supply its own patent list, 60 days for Amgen to respond, an unspecified amount of time for good faith negotiations on which patents to litigate over (agreed to here, at least according to Amgen), and then 30 days for Amgen to bring a lawsuit.
Amgen thus appears have allowed the patent dance to proceed otherwise unimpeded after it received the April 17th notification of commercial marketing. Nothing in the complaint indicates that Amgen told Apotex upon receipt of the letter that it was ineffective or otherwise took steps to stop the patent dance. But with the Federal Circuit opinion now in hand, Amgen appears to be hedging its bets, filing a Complaint that acts as if the patent dance is and is not still on. In other words, the complaint asks for both findings of infringement under the BPCIA patent dance (artificial acts of infringement of both patents by virtue of the filing of the ABLA) and for declaratory judgements outside of the patent dance. Amgen makes two distinct declaratory judgment requests: (1) that the court declare that Apotex will infringe the later to expire process patent (No. 8,952,138) if it manufactures, uses, offers to sell, sells or imports its pegfilgrastim product; and (2) that the court declare that Apotex’s April 17th letter is not effective notice of commercial marketing and that the Court declare that Apotex will violate 42 U.S.C. § 262(l)(8)(A) by not providing Amgen with a notice after its ABLA is approved and at least 180 days before marketing commences. Amgen also asks that the court to enjoin Apotex from taking these actions.
It will be fascinating to see how Apotex responds to the nimble steps taken by Amgen, and how this case will change in reaction to possible further developments in Amgen v. Sandoz. And with Neulasta ringing up about $4.6B of annual sales in 2014, we can be pretty certain that we will see some more interesting positions taken in this litigation, and that the FDA Law Blog will find more dance puns to use to comment upon them. According to Big Molecule Watch Blog, the case has been scheduled for a two-week trial beginning on July 11, 2016. Meanwhile, the user fee date for the Apotex product should be sometime this month, although the absence of notice of an advisory committee meeting to review the application suggests that approval may not be imminent.