Genentech Alleges Infringement by Samsung Bioepis

San Francisco, California-based Genentech filed a complaint against Samsung Bioepis in the District of Delaware, claiming Samsung Bioepis infringed 14 patents by submitting an abbreviated Biologics License Application (aBLA) for its bevacizumab biosimilar candidate (SB8).

Genentech markets the originator bevacizumab Avastin, which generated over $7 billion in revenues for 2019. The company has fought numerous court battles over biosimilar commercialization plans, which would erode those sales revenues.

Genentech has requested a court injunction to prevent the marketing of Samsung Bioepis’ biosimilar on grounds that it would infringe Genentech’s patents. It also requested a permanent injunction blocking any further infringing behavior during the life of Genentech’s patents.

Details of the Complaint

In addition to allegations of patent infringement, Genentech alleges that Samsung Bioepis violated “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA). The patent dance is intended to be an organized exchange of critical information between the originator and biosimilar companies that occurs prior to commercialization of the biosimilar. Genentech alleges that Samsung Bioepis failed to supply sufficient information during that process.

Genentech contends that although Samsung Bioepis provided a copy of the aBLA in accordance with the BPCIA, it failed to provide other information on the manufacturing process for the biosimilar and insisted that its aBLA copy fulfilled the company’s obligations for an exchange of information.

Additionally, Genentech lists a number of patents that it believed Samsung Bioepis would be in violation of if it brought the bevacizumab biosimilar to market. Previously, Samsung Bioepis denied infringement of all identified patents and contended that the patents were invalid, unenforceable, or would not be affected by the marketing of SB8. Genentech alleged that Samsung Bioepis should have provided a claim-by-claim detailed statement of the basis for that opinion.

Lastly, Genentech claims that although Samsung Bioepis gave notice of its intent to market SB8, the biosimilar developer appeared likely to begin marketing the biosimilar sooner than allowed. A biosimilar applicant has to provide notice to the reference product company no later than 180 days prior to the date of the first commercial marketing of the licensed biosimilar.

Genentech alleges that Samsung Bioepis may begin to market its biosimilar shortly after receiving FDA approval, before the 180 days following notice have elapsed. Genentech sought an injunction to prevent the marketing of the biosimilar during the notice period.

Other Biosimilar Litigations

This is the third BPCIA litigation against a bevacizumab biosimilar developer that Genentech has brought forward.

Earlier this week, the US Court of Appeals for the Federal Circuit sided against Genentech in favor of Amgen over its bevacizumab biosimilar, Mvasi. The litigation began in 2017, and Mvasi launched on the US market in July 2019.

In April 2019, Genentech sued Pfizer over an aBLA for Zirabev, which ended in a settlement later that year.

Genentech has also filed several patent dispute lawsuits over Herceptin (trastuzumab) biosimilars. Samsung Bioepis, Mylan, Pfizer, Celltrion, and Teva have all reached settlements with Genentech over their biosimilar products.

In the case of Amgen’s version (Kanjinti), Genentech actually waited too long to file the preliminary injunction motion after Amgen served its commercial marketing notice for its trastuzumab biosimilar.