By James C. Shehan –
More than one commentator predicted that the Federal Circuit’s decision in Amgen v. Sandoz interpreting the patent dance provisions of the Biologics Price Competition Innovation Act ("BPCIA") would be a fertile source of new litigation rather than a definitive decision laying out clear rules for industry to follow. But to our knowledge no one predicted that Amgen and Sandoz would themselves engage in multiple additional patent dance lawsuits, which is exactly what is occurring now after Amgen filed two suits against Sandoz on February 26th (complaint here) and March 4th (complaint here).
The first case involves an etanercept biosimilar to Amgen’s Enbrel and the second a pegfilgrastim biosimilar to Amgen’s Neulasta. Of perhaps great significance is that the first case is a patent infringement case and the second is not – it solely asks the court to interpret the BPCIA. The second case may therefore result in a court ruling on a point contested by Amgen and Sandoz – whether a decision by a reference product sponsor such as Amgen to not bring a patent infringement lawsuit within 30 days of a breakdown in patent dance proceedings will trigger 35 U.S.C. § 271(e)(6)(B) and therefore limit the reference product sponsor to the sole and exclusive remedy of a reasonable royalty in case of a later finding of infringement.
In the Enbrel case, Amgen alleges infringement of five patents covering the active ingredient, its method of manufacture, and certain therapeutic uses. According to the Amgen complaint, in October 2015, Sandoz gave Amgen its ABLA and information about the manufacturing processes for its Enbrel biosimilar. In December, Amgen provided Sandoz with a list of patents for which it believes that infringement claims could reasonably be asserted. At this point, Sandoz apparently decided to exit the dance floor. On January 27th, Sandoz sent Amgen an 86 page letter in which Sandoz agreed with the Amgen patent list and provided more information about its manufacturing processes for its biosimilar. But Amgen states that Sandoz also declared in that letter that it was “waiving” its right to receive the next documents in the patent dance, a detailed statement from Amgen under 42 U.S.C. § 262(l)(3)(C) of the grounds for infringement. Sandoz also informed Amgen that further “negotiations were unnecessary” and that Amgen under 42 U.S.C. § 262(l)(6) should file a patent infringement suit within 30 days.
Amgen protested by letter Sandoz’s exit from the dance and invoked its right under 42 U.S.C. § 262(l)(9) to seek a declaratory judgment of infringement. According to Amgen, Sandoz replied by confirming its refusal to further negotiate and stating that it “wished for patent litigation to begin as soon as possible." The eagerness exhibited in this “see you in court” statement may hearken back to Sandoz’s attempt a couple of years ago to get a judicial declaration of invalidity for two of the patents that Amgen is now asserting, an attempt that ended with the Federal Circuit dismissing the case as premature (see our post here and the decision here) In contrast to the Enbrel case, Amgen’s lawsuit against Sandoz over the Neulasta biosimilar does not allege patent infringement. Rather, it asks the court to declare that Sandoz failed to comply with the mandatory patent dance information exchanges, declare that this failure means that there can be no “immediate patent infringement action” under 42 U.S.C. § 262(l)(6), and declare that Amgen may get injunctive relief and lost profits damages in case infringement is later found,
The interactions between the parties leading up to the Neulasta lawsuit are quite similar to those in the Enbrel lawsuit. In November 2015, Sandoz gave Amgen its ABLA and information about the manufacturing processes for its Neulasta biosimilar. In January 2016, Amgen provided Sandoz with a list of two patents that Amgen believed Sandoz’s biosimilar would infringe. Then on February 2, 2016, Sandoz told Amgen why the two patents were invalid, unenforceable and/or not infringed, and also told Amgen that it would no longer follow the patent dance.
As in the Enbrel case, Sandoz declared that it was waiving its right to receive Amgen’s detailed statement of the grounds for infringement, informed Amgen that further “negotiations were unnecessary” and admonished Amgen to file a patent infringement suit within 30 days. Sandoz added that “[o]therwise, the penalty for an untimely suit—that the ‘sole and exclusive remedy’ for any infringement be limited to a ‘reasonable royalty’—applies. See 35 U.S.C. § 271(e)(6)(B).” Note that the reasonable royalty point does not appear in Amgen’s complaint in the Enbrel lawsuit, so it is unknown whether Sandoz asserted it there as well.
What can be gleaned from these multiple battles? As for Sandoz, it may be that, at least in the case of older biologics lacking exclusivity, Sandoz has decided that beginning and then abandoning the patent dance is a good strategy. As for Amgen, it seems committed to litigating to defend its biologics products but there is no indication of why it did not bring a patent infringement lawsuit over the Neulasta patents but did over the Enbrel patents. In any event, a court ruling over whether reasonable royalties are the sole remedy if a patent infringement case is not brought is likely to be at least an unintended consequence of that decision. And for both parties, it seems that there are many more turns ahead in their BPCIA patent dance saga.
And finally we wonder whether, having been jilted three times now, does Amgen feel like a shy but determined teenager who keeps on pursuing the same potential partner despite multiple rejections, hopeful that one day he or she will own the dance floor as completely as Tony Manero, Alex Owens or Ren McCormack?