Teva sues Eli Lilly again after FDA approves migraine drug

Teva has once again taken Eli Lilly to court over a migraine drug, just hours after Eli Lilly gained Food and Drug Administration (FDA) approval to market Emgality (galcanezumab-gnlm).

On Thursday, September 27, Teva filed the lawsuit at the US District Court for the District of Massachusetts, accusing Eli Lilly of infringing nine patents covering Teva’s migraine biologic Ajovy (fremanezumab), which gained FDA approval on September 19.

The suit came just hours after two developments in the dispute.

First, a US judge had dismissed a pair of patent infringement claims filed by Teva that had been seeking to block Eli Lilly from bringing Emgality to market.

District Judge Allison Burroughs, at the Massachusetts district court, dismissed both claims after finding that the suits failed to raise an actual controversy that would allow her to rule on patent infringement in advance of the FDA’s approval of Eli Lilly’s drug.

In the suits, Teva claimed that its affiliate company Labrys Biologics had made a major breakthrough in the research of migraine treatment concerning the role that calcitonin gene-related peptide (CGRP) plays in the headaches.

Labrys then developed a biologic product with an active ingredient, fremanezumab—a humanised monoclonal antibody that targets CGRP. But Eli Lilly’s competing biologic product has the active ingredient galcanezumab, which also targets CGRP.

Second, and later on September 27, Eli Lilly received approval for Emgality for the preventive treatment of migraine in adults.

This prompted Teva to file another suit against Eli Lilly.

In the latest claim, Teva alleged that Eli Lilly has already created a case and controversy regarding the validity of six of the nine patents-in-suit by initiating inter partes review proceedings against them.

Teva is seeking a judgment that the launch of Emgality will infringe its patents, plus an injunction and damages.

In the US, 39 million people are affected by migraines, according to the Migraine Research Foundation.

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