Amgen v Apotex Upheld, Janssen v Samsung Bioepis Dropped

The past week has seen the resolution of 2 high-profile biosimilar patent infringement cases. In the first, a district court’s ruling was upheld, and in the second, a reference drug sponsor agreed to drop its infringement claims—with prejudice—against a biosimilar developer.

Amgen v Apotex

On Monday, the US Court of Appeals for the federal circuit upheld a district court verdict in Amgen v Apotex, in which the court ruled that Apotex did not infringe on Amgen’s patent 8,952,138 (the ‘138 patent), which covers a method of refolding proteins expressed in non-mammalian cells, when it developed its proposed filgrastim and pegfilgrastim biosimilars.

Big Molecule Watch reported that, in Amgen’s October appeal before 3 judges, most of the panel’s questions centered on whether patent infringement in Biologics Price Competition and Innovation Act (BPCIA) litigation can be demonstrated by relying on information in an abbreviated Biologics License Application (aBLA), as Amgen had argued, and whether Apotex should have been allowed to rely in court on arguments that the biosimilar developer had not raised in a timely fashion.

In the November ruling, the appellate court affirmed the court’s ruling that Amgen failed to prove direct infringement on its patents by Apotex. The court’s opinion stated that “…it was not Apotex’s burden to prove non-infringement…It was Amgen’s burden to prove that Apotex’s processes would infringe the ‘138 patent.”

Janssen v Samsung Bioepis

Johnson & Johnson division Janssen has voluntarily dropped its patent suit against biosimilar developer Samsung Bioepis in a lawsuit regarding its infliximab biosimilar, Renflexis. Janssen had filed the suit in May, claiming that Samsung Bioepis had both violated the BPCIA and infringed on 3 patents.

After the Supreme Court’s decision in Amgen v Sandoz, the district court dismissed the claims concerning the BPCIA as moot. Janssen and Samsung Bioepis continued to litigate US patents 7,598,083 and 6,900,056 (both of which cover chemically defined media) and 6,773,600 (which covers the use of a clathrate modifier to promote passage of proteins during nanofiltration).

However, on November 10, the parties filed documents to dismiss the remaining claims of patent infringement. The dismissal was filed with prejudice with respect to claims and defenses related to cell culture and downstream purification processes; thus, Janssen cannot file a future suit against Samsung Bioepis over these particular claims.

“Janssen’s withdrawal of the lawsuit marks a positive step towards improving patient access to biosimilars in the United States,” Mingi Hyun, a Samsung Bioepis spokesperson, told Reuters.

Samsung Bioepis launched Renflexis, the second FDA approved infliximab biosimilar, in the United States in July 2017.