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.
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.