PTAB Denies Samsung Bioepis' Request for IPR on Herceptin Patent

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.