Genentech Was Too Slow In Trying To Halt Amgen's Herceptin Biosimilar Launch
Executive Summary
Genentech's delay in requesting an injunction, as well as its licensing deals with Mylan, Celltrion and Pfizer, show it won't suffer irreparable harm from sales of Amgen's biosimilar, judge says.
Genentech Inc. waited too long to seek a preliminary injunction to stop Amgen Inc. from launching its biosimilar to Herceptin (trastuzumab), a judge said in denying Genentech's request for the injunction.
The Food and Drug Administration approved Amgen's Kanjinti (trastuzumab-anns) on 13 June, but Genentech did not file its PI motion until 10 July, 14 months after receiving Amgen's 180-day notice of commercial marketing, three months after receiving "a fairly specific launch date," and almost one month after Amgen had FDA approval to launch Kanjinti, Judge Colm Connolly, of the US District Court for the District of Delaware, stated in a memorandum opinion.
Amgen announced the launch of both Kanjinti and Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin, on 18 July, the same day Connolly issued an order denying PI motions directed at the two oncology biosimilars. (Also see "How Risky Is Amgen's At-Risk Launch Of Herceptin, Avastin Biosimilars?" - Pink Sheet, 21 Jul, 2019.)
Connolly's memo, which became public several days later, offers some lessons for other companies engaged in biosimilar litigation. Not only do innovators need to file timely requests for injunctions, they also must be wary of the impact licensing deals with other competitors may have on their efforts to delay biosimilar entry.
"Genentech's undue delay in requesting a preliminary injunction," should be sufficient by itself to deny the motion, Connolly said. "Nevertheless, a finding of no irreparable harm is also supported by the fact that Genentech has engaged in a pattern and practice of licensing" its Herceptin dosing patents.
The opinion notes that Genentech, a unit of Roche, granted licenses for three dosing patents to Mylan NV, Celltrion Inc., and Pfizer Inc. that allow a biosimilar to enter the market. The date of entry is redacted from the ruling. It says the licenses make it reasonable to expect that Genentech can be recompensated with a royalty rather than an injunction.
"Genentech has been able to place a value on the patents and has approved competitors entering the market," the ruling says. "Under these facts, any potential damages for sales in the next four months should be quantifiable."
Launch Plans Revealed
A bench trial in Genentech's infringement suit is scheduled for 9 December. The parties had been litigating 10 patents, which include the composition patent on the trastuzumab antibody, the three dosing patents, and diagnostic and manufacturing patents.
On 17 January, Genentech and City of Hope filed a second amended complaint asserting infringement of 18 patents. At the request of both parties, the judge issued a 24 July order dismissing claims of infringement of seven patents and dismissing City of Hope as a party to the case.
Connolly's opinion provides details on the information Genentech obtained about Amgen's launch plans. It notes that Amgen served Genentech a notice of commercial launch, as required under the Biologics Price Competition and Innovation Act, on 15 May, 2018. Genentech also learned through discovery that Amgen had filed a "resubmission" to FDA on December 2018 and given the six-month regulatory review time would have understood FDA would act on it by the end of June. The ruling says Amgen produced other documents in April that permitted Genentech to see that Amgen planned to launch in July.
In a filing opposing Genentech's emergency motions for a TRO and PI, Amgen argued that Genentech failed to show that it would be irreparably harmed by Amgen's Kanjinti sales before other licensed biosimilar competitors enter the market. Mylan was the first to ink a licensing deal with Genentech in March 2017. Pfizer and Celltrion/Teva Pharmaceutical Industries Ltd. each entered into litigation settlement and licensing agreements in December, and Samsung Bioepis Co. Ltd. followed suit on 1 July. Mylan is expected be launch its biosimilar Ogivri (trastuzumab-dkst) before the other three licensees.
Amgen said it sought to obtain Genentech's licensing agreements with Mylan, Celltrion and Pfizer during discovery but that Genentech blocked their production by telling the court that it was not seeking injunctive relief.