Genentech Defends Patents on Bevacizumab, Rituximab in US, Japanese Courts

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.
The Center for Biosimilars Staff
January 13, 2018
Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

Genentech Holds That Amgen Infringed on Avastin Patents With Mvasi
On Thursday, a California federal judge paused Amgen’s lawsuit that sought to invalidate 27 patents covering Genentech’s innovator bevacizumab, Avastin. The judge will await further action in another case, filed by Genentech, in a Delaware district court.

In October 2017, Amgen filed its California lawsuit, seeking a judgment that Amgen’s FDA-approved bevacizumab biosimilar, Mvasi, did not and will not infringe on the 27 patents at issue for Genentech’s Avastin. It also claimed that it had complied with the information exchange process provided for under the Biologics Price Competition and Innovation Act (BPCIA). Amgen argued that not only did Genentech fail to state a claim on which relief can be granted, but it also mischaracterized Amgen’s statements concerning when it may begin marketing Mvasi.

Genentech, for its part, filed a patent infringement lawsuit against Amgen in a Delaware district court, saying that the biosimilar developer did not provide information required by the BPCIA, other than its abbreviated Biologics License Application, to Genentech, and that Amgen refused to negotiate the scope of litigation concerning patent infringement.

Genentech Sues Sandoz and Kyowa Hakko Kirin Over Rituximab
Genentech has also filed suit against Novartis division Sandoz in a Tokyo District Court, according to The Pharma Letter. Genentech has alleged that the biosimilar developer has infringed on 3 of its patents for Rituxan.

Sandoz’s biosimilar (Rixathon, Riximyo) was approved by Japan’s Ministry of Health, Labor and Welfare in September 2017. In January 2016, Sandoz entered into an exclusive license agreement with Kyowa Hakko Kirin for the distribution and promotion of its biosimilar in the Japanese market.

Under the terms of the agreement, Kyowa Hakko Kirin paid Sandoz an up-front fee and subsequent payments for the regulatory filing and approval of the drug, and will take responsibility for all sales, marketing, and promotional activities within Japan.
 

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