Published December 5, 2023

In a recent legal matter, Genentech, Inc., Hoffmann-La Roche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) have officially reached a settlement agreement in a patent dispute related to the Tocilizumab drug (Case No.: 1:23-CV-11573) with Biogen MA Inc. and Bio-Thera Solutions, Ltd. (“Biogen”). 

The resolution of this dispute took place through the filing of a Joint Stipulation of Dismissal with Prejudice before the District of Massachusetts. This joint stipulation signifies the consensus reached by both parties, stating their mutual agreement to voluntarily dismiss all claims asserted in the aforementioned case with prejudice.

This litigation can be traced back to July 2023, when Genentech initiated a lawsuit against Biogen and its business partner, Bio-Thera Solutions, Ltd., in the District of Massachusetts under the provisions of the Biologics Price Competition and Innovation Act (BPCIA). This lawsuit stemmed from the alleged infringement of certain patents associated with Genentech’s product Actemra®, a Tocilizumab anti-IL-6 antibody.

The legal action unfolded as a reaction to Biogen’s submission of an abbreviated Biologics License Application (aBLA) to the US Food and Drug Administration (FDA). Biogen sought approval for a biosimilar version of Actemra® (Tocilizumab). In response to these actions, Chugai, Roche, and Genentech jointly filed a patent infringement lawsuit against Biogen and Bio-Thera Solutions, Ltd., which had been responsible for the development of biosimilar products as part of Biogen’s aBLA submission. 

The legal claims presented encompassed the infringement of various US patents held by Chugai, Roche, and Genentech, all within the framework of the BPCIA. These patents encompassed but were not limited to, methods of utilizing Tocilizumab in intravenous form and methods of manufacturing Tocilizumab.

In its complaint, Genentech contended that Biogen was seeking FDA approval for a proposed biosimilar known as “BIIB800,” intended to compete with Genentech’s Actemra® (Tocilizumab). Additionally, Genentech asserted that Bio-Thera Solutions, Ltd. was involved in manufacturing BIIB800 and its importation into the US.

It is important to note that the parties initially engaged in the so-called “patent dance” as required by the BPCIA. However, Genentech alleged that Biogen had failed to provide sufficient information concerning the processes used for manufacturing the biological product outlined in its aBLA. Genentech further claimed that the detailed statements furnished by Biogen lacked the requisite level of detail mandated by the BPCIA. As a result, Genentech had to assess Biogen’s infringement with incomplete information. Genentech harbored concerns that the manufacture, use, sale, offer for sale, or importation of BIIB800 would infringe upon 20 patents associated with methods of using Tocilizumab and methods of manufacturing Tocilizumab.

In light of these alleged infringements, Genentech sought various legal remedies, including a judgment of infringement, statutory relief under 35 USC §271(e)(4)(D), including but not limited to a permanent injunction, damages such as lost profits, not less than a reasonable royalty, a declaration of willful infringement, enhancement of damages, an accounting of damages, a preliminary and permanent injunction, a declaration of the cases exceptional nature, and an award of attorney’s fees, costs, and expenses. Genentech also demanded a jury trial for this matter.

It is noteworthy that this lawsuit represented Genentech’s first legal action involving Tocilizumab under the BPCIA. In a related development, Genentech had previously entered into a settlement agreement last year concerning Fresenius’s Tocilizumab biosimilar. However, Genentech had not initiated a BPCIA complaint in that instance.

On September 29, 2023, Biogen received FDA approval for its Tocilizumab biosimilar under the name TOFIDENCE (Tocilizumab-bavi). 

“In the United States, the majority of biosimilar patent litigations culminate in settlements prior to the court rendering its decision. This trend is primarily attributed to patent settlement agreements between innovator pharmaceutical companies and biosimilar manufacturers. Out of the 44 biosimilars that have received approval in the United States, only a select few have advanced to the stage where a court issues a final verdict.” 

The settlement between Genentech and Biogen represents a positive step in the world of Biosimilar patent disputes. Complex issues surrounding intellectual property can often lead to lengthy and costly legal battles, and the willingness of both parties to reach an agreement is commendable. It will be interesting to see how this resolution may set a precedent for upcoming tocilizumab biosimilars.”

Darshan Jadav

Written by Darshan Jadav

Registered Indian Patent Agent

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