• Teva seeking FDA approval for biologic to treat episodic and chronic migraine
• Struggling company says Eli Lilly’s competitor product, also under FDA review, infringes two patents
Teva Pharmaceuticals International GmbH says an Eli Lilly and Co. yet-to-be-approved migraine drug infringes patents on its own putative migraine product as the Israeli drugmaker seeks to pull out of a tailspin.
Eli Lilly’s galcanezumab biologic infringes Teva’s U.S. Patent Nos. 9,884,907 and 9,884,908, which cover the fremanezumab biologic, Teva said in a lawsuit filed Feb. 6. Both drugs await Food and Drug Administration approval.
Teva said in its suit it has “invested heavily” in its biologic and “the potential benefit to the public is enormous.” More than a billion people deal with migraine headaches worldwide, including 38 million in the U.S., the company said. Teva may need fremanezumab to take off; a $41 billion acquisition of Allergan Plc’s generics unit has fizzled, and a new CEO announced plans to cut its workforce by 25 percent in a bid to turn the company around.
Lilly Targeting Same Peptide
Teva’s Labrys Biologics Inc., which the company bought in 2014, developed a biologic product with fremanezumab as the active ingredient, the company said. It’s an antibody that targets calcitonin gene-related peptide (CGRP), which plays a role in migraines. Teva filed a Biologics License Application (BLA) with the FDA in October 2017, seeking approval for treating episodic and chronic migraine. Teva announced the agency accepted it for review in December.
The active ingredient in Eli Lilly’s biologic, galcanezumab, is an antibody that also targets CGRP, according to the suit. Eli Lilly announced in December the FDA had accepted its BLA, which the company had also submitted in October. The company said the product is the first of three investigational, nonopioid treatments being developed as part of an overall pain medication portfolio.
Eli Lilly’s product will directly infringe or induce infringement of the ’907 and ’908 patents, Teva said in the suit. The case is ripe for litigation because Eli Lilly’s product launch is imminent, Teva argued. Eli Lilly has said publicly FDA approval is likely and it will market and sell its galcanezumab product as soon as the agency does so, Teva said.
Eli Lilly knows its product infringes Teva’s U.S. patents, as revealed in filings in a European patent fight with Teva, according to the suit. Eli Lilly disclosed that Teva’s European patent broadly encompasses anti-CGRP antagonist antibodies that may have therapeutic utility, Teva said.
New Teva Chief Executive Officer Kare Schultz announced in December that the company, the world’s largest generic drugmaker, would slash 25 percent of its workforce of 56,000. The restructuring plan includes a goal to cut costs by $3 billion by the end of 2019. The company carries a $35 billion debt burden.
Teva paid almost $41 billion last year to acquire Allergan Plc’s generics unit, but the deal didn’t provide the sales boost Teva’s previous CEO, Erez Vigodman, said it would. The company also lost its monopoly on Copaxone (glatiramer acetate), a multiple sclerosis injection that at one point generated half of Teva’s profits.
Representatives for Teva and Eli Lilly declined to comment on the suit.
Goodwin Procter LLP represents Teva. Attorneys for Eli Lilly aren’t yet listed on the case docket.
The case is Teva Pharm. Int’l GMBH v. Eli Lilly and Co., D. Mass., No. 18-cv-10242, 2/6/18.
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For More Information
The complaint is available at http://src.bna.com/weX.