Biotech Startup Challenges Validity of Bayer's Stivarga Patent

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By John T. Aquino

July 27 — A biotech startup July 25 said it's challenging the validity of Bayer's patent covering its colorectal cancer medicine Stivarga ( Fustibal LLC v. Bayer, P.T.A.B., No. IPR2016-01490, petition filed 7/25/16 ).

Stivarga (regorafenib), which the Food and Drug Administration approved in 2012, had global sales of $343 million in 2015, and in May 2016, Bayer announced that Stivarga is one of five drugs that will drive its future growth.

Fustibal LLC, a targeted therapeutics biotechnology startup, announced that it has filed an inter partes review (IPR) petition for Bayer's U.S. Patent No. 8,637,553 with the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB). According to Fustibal, the '553 patent provides Stivarga with exclusivity through Feb. 16, 2031.

“We believe that the patent in question is invalid and thwarts the spirit of innovation,” David Tran, founding scientist at San Francisco-based Fustibal, said in a statement, adding, “We believe oncology products should be developed and accessible to all cancer patients, not only for those patients who can afford it.” Stivarga was launched in 2012 at a price of $9,350 for a monthly regime.

A Bayer spokesman told Bloomberg BNA in a July 27 e-mail, “We believe strongly that the patent is valid. Bayer is committed to defending its intellectual property rights, and we are pursuing our legal options. It is essential that pharmaceutical patents are recognized and honored so that we may continue to invest in research and development activities that help bring new medicines to the people that need them.”

Candidate for Fustibal's Platform

The America Invents Act created the IPR process to give third parties an administrative path to challenge the validity of existing patents. The PTAB reviews IPR petitions and makes a decision about whether to deny the petition or let the case proceed to trial.

According to a Bloomberg BNA analysis, biopharma patent challengers stand about a 50-50 chance of having the PTAB grant an IPR petition (10 LSLR 11, 5/27/16).

Stivarga is an oral multikinase inhibitor that has been approved by the FDA for treating select patients with colorectal cancer and gastrointestinal stromal tumors.

In May, Bayer announced that a phase III study of Stivarga in patients with unresectable liver cancer had met its primary endpoint. It indicated that it was preparing to file for additional indications for Stivarga.

According to Fustibal, regorafenib is a leading drug candidate for its drug targeting platform.

Tran said, “The IPR process is being utilized to clear questionable intellectual property rights that would unduly delay the development of our novel antibody-based drug for multi-targeted cancer therapy. We look forward to the uninterrupted development of medicine, whether innovative or generic, and the submission of New Drug Application (NDA) and Abbreviated NDA (ANDA) for future formulations.”

Ancient Bazooka

According to its website, Fustibal is focused on fostering affordable health care through simpler science.

Fustibal says: “To evolve the medical industry, our team dissects life science big data through scientific investigation, reverse engineering, data mining and computational modeling. In synergy with our drug targeting platform, we design genomic- and proteomic-driven pharmaceuticals. Our mission is to develop economical and accessible molecular diagnostics and therapeutics.”

Fustibal is a resident company of qb3, one of four Governor Gray Davis Institutes for Science and Innovation created by the University of California in 2000 to drive the state’s economy and improve the quality of life for its residents. Bayer is a qb3 partner.

The fustibal or fustibalis was a medieval weapon, a sling that has been called “the bazooka of the ancients.”

To contact the reporter on this story: John T. Aquino in Washington at

To contact the editor responsible for this story: Randy Kubetin at

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