The United States Patent Trial and Appeal Board (PTAB) has denied biosimilar developer Samsung Bioepis’ request for inter partes review (IPR) of a patent that Genentech holds covering reference trastuzumab (Herceptin).
The United States Patent Trial and Appeal Board (PTAB) has denied biosimilar developer Samsung Bioepis’ request for inter partes review (IPR) of a patent that Genentech holds covering reference trastuzumab (Herceptin).
This is not the first time that the board has denied a claim for review of US Patent Number 7,846,441. Previously, Hospira, owned by Pfizer, and Celltrion had also petitioned PTAB to the Genentech patent in January 2017. Initially, the PTAB denied the review, but later reversed the decision after finding that Hospira had shown each of the patent’s claims were likely invalid.
Celltrion filed its own challenge in March 2017, in which PTAB had instituted an IPR, which Hospira subsequently joined.
Samsung Bioepis had stated that Genentech’s claim was obvious, based, in part, on a research paper. The same paper had been cited in both prior claims from Celltiron and Hospira.
In the board's denial of Samsung Bioepis’ request for an IPR proceeding, it explained that Samsung Bioepis’ evidence brought nothing new to the table. The research paper that had been cited in the 2 prior claims was cited in an additional reference provided by Samsung Bioepis, and that reference was cited by yet another. “In other words, Bioepis’ arguments on the newly asserted references are substantially the same as those in the earlier cases,” said the board.
According to Genentech, this particular paper was also considered in the prosecution of the patent. “Thus, after considering the totality of the circumstances, we agree with [Genentech] that it is appropriate for us to exercise our discretion to deny the petition under 35 USC § 325(d),” stated the board.
Although the outcome was favorable for Genentech, the pharma company is taking steps to further protect its drug from competitors and has recently indicated plans to seek injunctions to stop Samsung Bioepis from selling its biosimilar trastuzumab in Europe.
Genentech has requested US District Judge Robert Sweet to order Samsung Bioepis’ counsel, White & Case LLP, to share parts of its abbreviated Biologics License Application to examine certain chemical properties of the proposed trastuzumab biosimilar.
According to White & Case, Genentech is not entitled to receive this information from the European Medicines Agency and is “fishing” for grounds to challenge the biosimilar. The judge has yet to rule.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.