Fustibal LLC challenges Bayer’s Stivarga patent


A biotech startup has mounted a challenge against the validity of Bayer’s Stivarga patent. Fustibal LLC filed a petition on the 25th July in order to attempt to reverse the patent.

Stivarga is a drug typically used to treat colorectal cancer, and has had a large market share since its approval by the Food & Drug Administration (FDA) in 2012. Global sales figures in 2016 are expected to exceed $343 million. Bayer announced in May that it expects that Stivarga is one of their “big five” drugs, which will drive the future growth of the company.

However, things took an interesting twist when therapeutic biotech startup Fustibal LLC recently announced that it had filed an IPR (inter partes review) petition for Bayer patent #8637553 with the Trial & Appeal Board of the US Patent & Trademark Office. According to Fustibal LLC, the patent makes Stivarga exclusive until February 2031 – something the firm believes to be invalid.

Spirit of innovation

David Tran, a founding scientist at Fustibal, believes that the patent “thwarts the spirit of innovation”, citing his belief that oncology medications should be “accessible to all cancer patients” as opposed to simply “those who can afford [Stivarga]”.

At the time of its launch, Stivarga cost $9350 for a monthly dose, and San-Franciso based generic pharmaceutical industry startup Fustibal wants to see a relaxation of regulations which would bring the cost down to more reachable levels for those in lesser-developed areas.

Strong beliefs

However, a spokesperson for Bayer told Bloomberg in an email that they believed “strongly” that the patent will remain valid, adding that Bayer is “committed to defending intellectual property rights” and that the drugs giant will be pursuing its legal options. In the same email, the spokesperson defended the decision, stating that pharmaceuticals patents help companies to continue to invest in research to create new medicines and advance healthcare.

Monopoly vs oncology

The current legal quandary essentially comes down to the ethics behind treatment for all versus business development. On one hand, companies like Fustibal want the generic pharmaceutical industry to have greater opportunities to produce life-saving drugs like Stivarga. On the other, companies who control the patents want to ensure maximum profits. Of course, profits are often in turn used to fund essential research, so it’s never quite as black-and-white as first impressions can seem.





Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.com

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