Pfizer plans for October Remicade biosimilar launch, boosted by IP ruling
This week, the District of Massachusetts Federal Court ruled in favour of Pfizer and its biosimilar development partner Celltrion by invalidating US Patent 6,284,471 for J&J’s monoclonal antibody Remicade (infliximab).
The ‘471 patent relates to the method of action of anti-human tumour necrosis factor-alpha (hTNFα) antibodies and was set to expire in September 2018, but the ruling puts Pfizer one-step closer to launching its product Inflectra in the US.
“We are committed to bringing biosimilars to patients in the US as quickly as possible, and are continuing with the preparation of our launch plans for Inflectra for 2016,” Pfizer spokeswoman Rachel Hooper told this publication on the back of the court ruling.
The earliest Inflectra could be available is October 3, after the US Court of Appeals for the Federal Circuit ruled last month that a biosimilar applicant must provide at least 180-days’ notice to the reference product sponsor from the date of US FDA approval before a commercial launch.
But according to Kevin Noonan, a biotechnology patent lawyer and partner with McDonnell Boehnen Hulbert & Berghoff LLP, Pfizer should not be too confident of an October launch just yet.
J&J can file an appeal to the ‘471 patent ruling “both to the district court decision and to a decision before the USPTO in a re-examination that invalidated the same claims,” he told Biopharma-Reporter.com. The pharma firm has begun the appeal and is awaiting a date to be set for an oral hearing.
“Also, J&J has rights to another patent that they have asserted in the litigation that the court has not yet ruled upon,” he added, referring to US patent 7,598,083 which surrounds the culture media used to produce infliximab and as it stands expires in 2027.
And J&J has said, through its subsidiary Janssen, it “will continue to defend its intellectual property rights,” and warns “a commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch.”