Generic, Biosimilar Manufacturers Defend Apotex in Amicus Briefs

Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law.

Amicus briefs filed by three companies and one organization — Pfizer’s Hospira unit, generics giant Mylan, biosimilar producer Celltrion and GPhA’s Biosimilars Council — voiced support for Apotex’s appeal of a December federal district court ruling requiring the drugmaker to give Amgen six months’ notice before trying to market a generic version of the bone marrow drug Neulasta.

While the briefs differ in their concerns with the district court ruling, they boil down to the same complaint: Apotex is being punished for complying with a section of the Biologics Price Competition and Innovation Act that instructs companies filing an abbreviated biologics license application to inform the patent holder within 20 days.

The briefs stem from a lawsuit Amgen filed in August, contending that Apotex’s plans to market a generic version of Neulasta infringes two of the company’s patents on the drug. Apotex followed the BPCIA by informing Amgen that it was filing an ABLA to market generic Neulasta. However, it refused to give the company notice when it received FDA approval — a measure also spelled out in the BPCIA — on the grounds that Apotex considers that part of the law to be optional. Apotex argued unsuccessfully that because the law states that a company “shall” provide six months’ notice, the measure should be viewed as discretionary.

The judge in the case sided with Amgen, issuing a preliminary order Dec. 9, 2015, requiring Apotex to give six months’ advance notice before marketing generic Neulasta. Apotex appealed the ruling to the U.S. Court of Appeals for the Federal Circuit the very next day.

In identical briefs filed by Hospira and Celltrion, the companies say that the district judge’s interpretation of the BPCIA is flawed, contending that the six months’ advance notice is intended as a back-up measure to protect patent holders when generic drugmakers fail to inform them that they are filing an ABLA, not as an automatic six month-extension of patent holders’ market exclusivity.

In a separate amicus brief, Mylan contends that the Amgen v. Sandoz case is a red herring, given that the facts in Apotex’s case don’t fit. Instead, Mylan concentrated on the idea that patent holders can obtain six additional months of exclusivity simply by invoking the BPCIA, a notion Mylan rejects as “contrary to Congress’ intent.”

In its brief, the Biosimilars Council focused on the specific language of the BPCIA, noting that Congress had no reason to give patent holders an additional six months of patent exclusivity when the law already includes a remedy for dealing with patent violators: lawsuits. The group notes that another provision in the law gives patent holders the right to “bring an action … for a declaration of infringement, validity or enforcement of a patent” if a challenger fails to follow the BPCIA.

Read Hospira/Celltrion’s brief here: www.fdanews.com/01-14-16-Hospira-Celltrion.pdf.

Read Mylan’s brief here: www.fdanews.com/01-14-16-Mylan.pdf.

Read the Biosimilar Council’s brief here: www.fdanews.com/01-14-16-BiosimilarsCouncil.pdf.