Update on Samsung Bioepis’s ONTRUZANT (trastuzumab-dttb)

As we have reported, Samsung Bioepis is engaged in U.S. patent litigation and proceedings against Genentech in connection with Samsung Bioepis’s ONTRUZANT (trastuzumab-dttb) biosimilar product, which the U.S. FDA approved earlier this year.  In addition to litigating a BPCIA case in federal district court that is currently scheduled for a bench trial beginning on December 9, 2019, Samsung Bioepis is participating in appeals before the Federal Circuit of the Patent Trial and Appeal Board’s final written decisions in IPRs concerning some of Genentech’s method of use patents in its trastuzumab portfolio.

On March 21, 2019, Samsung Bioepis filed its opening brief in its appeals from the Board’s final written decisions in October 2018 that upheld the patentability of claims in U.S. Patent Nos. 6,627,196 and 7,371,379 directed to methods of treatment for cancer using dosing intervals of either every three weeks or every two weeks.  According to Samsung Bioepis, the Board erred in concluding that a person of ordinary skill in the art would have lacked a reasonable expectation of success in administering trastuzumab every three weeks by relying on conclusory or irrelevant testimony, a “made up” graph, and/or post-priority date art, and by ignoring the state of the art or teachings of the prior art.  In addition, Samsung Bioepis argued that the Board failed to articulate any rationale for finding the two-week dosing interval claims to be patentable and, instead, wrongly applied its analysis for the three-week dosing claims to the two-week dosing interval claims in disregard of the prior art.

Genentech’s responsive brief in this appeal is due by April 30, 2019, absent any extension of time. Genentech is separately appealing the Board’s final written decisions in October 2018 that found the challenged claims of U.S. Patent Nos. 7,846,441 and 7,892,549 to be unpatentable.  Genentech’s opening brief in that appeal is not due until May 17, 2019.

Also on March 21, Samsung Bioepis announced findings of a three-year follow-up study comparing its trastuzumab biosimilar and the reference product (HERCEPTIN) in early or locally advanced HER2-positive breast cancer.  According to Samsung Bioepis, the data show comparable overall survival and cardiac safety.

Stay tuned to Big Molecule Watch for further developments.