As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a biosimilar to Amgen’s Epogen®. The approval, based on a Biologics License Application dated December 16, 2014, came after Hospira resubmitted its application twice after receiving Complete Response Letters from the FDA, most recently in November 2017.
In addition to the regulatory barriers Hospira has overcome in reaching approval, Hospira has faced legal challenges from Amgen in the form of one of the earliest litigations filed under the Biologics Price Competition and Innovation Act (“BPCIA”). We previously covered that litigation here and here.
Since our last update in early August 2017, there have been several developments in the litigation, including the Federal Circuit dismissing Amgen’s appeal regarding its denied discovery of Hospira manufacturing information on jurisdictional grounds and failure to satisfy the prerequisites for mandamus. However, the most significant development was the five day trial which took place in September 2017.
At the conclusion of trial, the jury found that Hospira had not infringed any claim of U.S. Patent 5,756,349 (“the ’349 patent”), while it did infringe two asserted claims of U.S. Patent No. 5,856,298 (“the ’298 patent”). The jury found those two claims to not be invalid for anticipation or obviousness, and further held that only a portion of the lots manufactured by Hospira fell into the BPCIA’s Safe Harbor Defense. Ultimately, the jury found that Amgen had proven $70 million in damages as a result of Hospira’s pre-approval manufacturing activities.
On September 25, 2017, the Court entered its judgment, awarding $70 million and holding the ’298 patent valid and infringed, and the ’349 patent not infringed. Soon after, the first of several post-trial motions were filed. On October 12, as both parties agreed that several counts by both parties had not yet been ruled on, a stipulated agreement was entered into the case that the judgment was not final and was not immediately appealable or executable, and it additionally stipulated a schedule for briefing post-trial motions.
Both parties then filed their initial Motions for Judgment as a Matter of Law or of New Trial on October 23, 2017. Answering briefs were filed by both parties on November 20, and reply briefs on December 8. The most recent filing in the case took place on December 15, 2017, requesting oral argument regarding the motions. Hospira’s motion requests findings that 1) its 21 manufacturing batches are protected under the Safe Harbor Defense, 2) it did not infringe the claims of the ’298 patent, 3) the claims of the ’298 patent are invalid, and 4) damages should be limited to no more than $1.5 million per batch. Amgen’s motion, meanwhile, requests a finding of infringement of the ’349 patent.
If the judgment at issue currently stands, Hospira will be on the hook for $70 million for its pre-approval manufacturing activities. However, as both the ’298 and ’349 patents are currently expired, none of the current judgment or rulings in favor of either party on their motions will prevent Hospira from bringing its now-approved Retacrit to market, and only modifications or removal of the damages award may occur.
What may remain a difficulty for Hospira, however, is that the court still has not entered judgment as to Count 1 of Amgen’s complaint regarding Hospira’s allegedly giving ineffective Notice of Commercial Marketing as required under the BPCIA. While the latest stipulation entered on October 31, 2017, indicates that the parties recognize that as time goes on, this may become, or already has become, a moot issue, it is still a factor that Hospira considers in the timing of its launch into the U.S. market.