With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent developments in these cases.
AbbVie v. Amgen (Humira/adulimimab)
The litigation between AbbVie and Amgen over Humira, the world’s best-selling biologic, is still in its early stages, with AbbVie having filed suit in August asserting infringement of ten patents selected for the BPCIA’s immediate litigation phase. Amgen’s application was approved on September 23, but Amgen has not announced when it plans to launch its product. Earlier this month, AbbVie filed its answer to Amgen’s counterclaims. In the answer, AbbVie disputes Amgen’s allegations that AbbVie failed to comply with its obligations during the “patent dance.” AbbVie also reaffirms its allegation that Amgen had refused to commit to observing the statutory 180-day notice period. Amgen, however, asserted in its answer that it would not launch its product for 180 days after approval.
Amgen v. Sandoz (Neupogen/filgrastim)
In contrast to the Humira dispute, the litigation between Amgen and Sandoz over Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen (filgrastim), has been going on for nearly two years. In 2015, the Federal Circuit decided Amgen v. Sandoz, 794 F. 3d 1347 (Fed. Cir. 2015), a split decision addressing procedural issues. In particular, the Federal Circuit held that initiation of the BPCIA “patent dance” is not mandatory but that the 180-day notice of commercial marketing is mandatory and must come after the approval of the biosimilar. After the 180-day post-approval notice period ended, in September 2015, Sandoz launched Zarxio. Both parties petitioned for cert in the Supreme Court (though Amgen’s cross-petition was conditional) and, on June 20, 2016, the Court called for the U.S. Solicitor General’s views on the petitions. The S.G. has not yet filed a brief with the Supreme Court.
Meanwhile, the parties are litigating Amgen’s patent infringement claims on remand from the Federal Circuit in the Northern District of California. The case has been consolidated with Amgen’s related lawsuit regarding Sandoz’s proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). Discovery is ongoing.
Amgen v. Sandoz (Neulasta/pegfilgrastim)
Before filing the California Neulasta lawsuit that has been consolidated with the Neupogen case, Amgen sued Sandoz in New Jersey over Sandoz’s Neulasta biosimilar application. In that lawsuit, Amgen alleged that Sandoz failed to comply with the BPCIA’s patent dance procedures. After the suit was filed, however, Sandoz agreed to complete the patent dance process, leading Amgen to file its patent infringement suit in California. Sandoz then moved to dismiss the New Jersey action as moot. On July 22, the district court granted the motion, holding that Sandoz’s completion of the paten dance mooted Amgen’s statutory claims and that contrary to Amgen’s argument, the issue was not likely to recur in the future. Meanwhile, the Sandoz’s parent Novartis announced in July that FDA had rejected its Neulasta biosimilar application.
Amgen v. Apotex (Neulasta/pegfilgrastim and Neupogen/filgrastim)
In addition to Sandoz, Apotex also filed applications for Neulasta and Neupogen biosimilars. Amgen filed related suits in Florida alleging patent infringement and violations of the BPCIA. In the Neulasta case, the district court enjoined Apotex from entering the market during the 180-day post-approval notice of commercial marketing period. In July, the Federal Circuit affirmed that injunction, holding that the 180-day notice period is mandatory whether or not the biosimilar applicant participates in the patent dance. While that appeal was pending, the parties continued to litigate Amgen’s patents in the district court. In September, Apotex prevailed at trial of the two consolidated actions, defeating Amgen’s claims for infringement of the sole remaining patent in suit. Amgen has filed a notice of appeal of the district court’s ruling. Meanwhile, Apotex petitioned for cert on the Federal Circuit’s 180-day ruling. Earlier this month, the Biosimilars Council and Mylan Pharmaceuticals filed amicus briefs supporting the petition. Amgen’s opposition is due on November 8. Apotex’s Neulasta and Neupogen biosimilars have not yet been approved.
Amgen v. Hospira (Epogen/epoetin alfa)
In September 2015, Amgen sued Hospira in Delaware for patent infringement and BPCIA violations relating to Hospira’s application for a biosimilar version of Amgen’s Epogen (epoetin alfa). Hospira moved to dismiss the BPCIA claims, but the district court denied the motion without opinion after the Federal Circuit decided Amgen v. Apotex and confirmed that the 180-day notice of commercial marketing period is always mandatory. Discovery is ongoing and trial is scheduled for July 2017. Notably, both patents in suit have now expired. However, Amgen is currently appealing a discovery ruling by the district court, which prevented Amgen from obtaining manufacturing information from Hospira that was not relevant to any patent in suit. Amgen contends that it needs this information (and is entitled to it under the BPCIA) in order to assess whether Hospira’s product will infringe patents it has not yet asserted. Meanwhile, earlier this month, the district court denied Amgen’s motion to add new defendants to the suit, reasoning that doing so would delay trial and thus prejudice Hospira. The court did allow Amgen to amend the complaint to add new infringement theories.
Immunex et al v. Sandoz (Enbrel/ etanercept)
In February, Immunex, along with its parent Amgen and its partner Hoffman-LaRoche, sued Sandoz in New Jersey over Sandoz’s biosimilar version of Enbrel (etanercept). The plaintiffs assert infringement of five patents as well as violations of the BPCIA. The case, which is largely proceeding under seal, is in discovery with trial set for April 2018. Sandoz’s biosimilar, Erelzi (etanercept-szzs) was approved on August 30, 2016, but Sandoz has entered into a stipulated injunction preventing it from selling the product. The duration of the injunction is not public, but under the Amgen v. Apotex ruling, Sandoz cannot market its biosimilar for at least 180 days after approval.
Janssen Biotech v. Celltrion (Remicade/infliximab)
In March 2015, Janssen Biotech sued Celltrion and its partner Hospira in Massachusetts over their biosimilar version of Remicade (infliximab), asserting statutory violations and infringement of six patents. The FDA approved the biosimilar, called Inflectra, in April 2016. Based on the Federal Circuit’s decisions in Amgen v. Sandoz and Amgen v. Apotex, the defendants agreed to remain off the market for 180-day post-approval notice of commercial marketing period required by the BPCIA. In August, the district court granted summary judgment to the defendants that one of Janssen’s patents was invalid for obviousness-type double patenting. The district court subsequently granted the defendants’ motion for partial final judgment on that patent and yesterday Janssen filed a notice of appeal. On October 17, Hospira’s parent company Pfizer announced that it would begin shipping Inflectra to wholesalers in late November 2016. Trial on the remaining patent is scheduled for February 2017. Our firm, Patterson Belknap, represents Janssen.