Shire Goes to Court to Stall Hemlibra Impact

Legal dispute between Shire and Roche over “patent infringement” began in May

Shire has asked a federal court to restrict Roche AG from creating, transporting, and marketing its recently approved hemophilia drug Hemlibra (emicizumab-kxwh, Genentech) in the U.S., according to a BioPharma Dive report.

The request came in the form of a motion for preliminary injunction filed with the U.S. District Court in Delaware. Shire expects the court to make a decision on the motion by mid-2018, according to a December 14 statement by the company.

While the injunction is sealed, a Roche spokesperson explained in an email to BioPharma Dive that the motion seeks to prevent the Swiss pharma company from providing Hemlibra to hemophilia patients in the U.S.—a move resulting from an ongoing legal dispute between the two companies over whether Hemlibra infringes on a key Shire patent.

Shire foresees Hemlibra eroding about half of its Feiba (anti-inhibitor coagulant complex) franchise by 2022. Losing that revenue won't cripple Shire (the company estimates Feiba sales will account for about 5% of its 2017 earnings), but it's still hundreds of millions of dollars that the Irish drug-maker isn't keen on letting go without a fight, according to the report.

In May, Shire subsidiaries Baxalta, Inc., and Baxalta GmBH filed a lawsuit against Roche's Genentech claiming the company's development of Hemlibra infringed on a patent—known as the '590 patent—for an isolated antibody or antibody fragment that binds factor IX or factor IXa. This most recent motion for injunction is the latest development in the suit, and timely given that Hemlibra recently gained FDA approval.

"Patent infringement lawsuits are lengthy. It can take years for a court to issue a judgment," a Shire spokesperson wrote in an email to BioPharma Dive. "If granted, the preliminary injunction will immediately protect the value of our '590 patent and will allow us to continue to reinvest, innovate and provide value to hemophilia patients."

Shire maintains that, until the court decides on its motion, there won't be any impact on hemophilia patients. The company says it has proposed allowing those who are already taking Hemlibra or who wouldn't adequately respond to bypassing treatments to have access to the drug. Roche, however, discredits the motion and contends that Shire would essentially close off patients from treatment who, in its mind, are in need of Hemlibra.

"Shire and Baxalta have demonstrated a profound disregard for patient well-being by seeking this preliminary injunction that prevents patients who may benefit from Hemlibra from receiving it," a Roche spokesperson wrote in an email to BioPharma Dive. "These actions harm the hemophilia community. We believe it is also inappropriate for Shire to dictate which patients should or should not receive Hemlibra. That decision rests with treating physicians and patients, and is supported by the FDA approval of Hemlibra for all people with hemophilia A with inhibitors."

Hemlibra gained an FDA thumbs-up last month as a therapy for hemophilia A patients with factor VIII inhibitors. With a once-weekly dosing regimen, Hemlibra is part of a recent string of longer-acting drugs for the rare blood disorder to become available to patients. Market researchers expect the drug to bring in billions of dollars annually and make waves throughout the hemophilia space.

Source: BioPharma Dive; December 18, 2017.