Complaint for Declaratory Judgment and Injunctive Relief, Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, No. 1:17-cv-12087 (D. Mass., Oct. 24, 2017), complaint hosted by FDAnews.com.
On October 24, 2017, Teva Pharmaceuticals International GmbH (“Teva”) brought a patent infringement action for a declaratory judgment against Eli Lilly and Company (“Lilly”). The lawsuit seeks damages and an injunction that would block Lilly from manufacturing and selling products containing its new migraine drug galcanezumab. Teva argues that Lilly’s planned medication would infringe U.S. Patent Nos. 8,586,045; 8,597,649; 9,266,951; 9,340,614; and 9,346,881 (“Patents-in-Suit”), which cover fremanezumab, an active ingredient used by Teva in products used for the treatment of episodic and chronic migraine.
On October 16, 2016, Teva submitted a Biologics License Application (“BLA”) to the Food and Drug Administration (“FDA”) seeking approval to market fremanezumab, an antibody that targets calcitonin gene-related peptide (“CGRP”) receptors. CGRP is known to play a key role in migraine headaches. Eight days later, on October 24, Lilly submitted a BLA for galcanezumab, which also targets CGRP. The BLA is a request for permission to introduce a biologic product into interstate commerce, regulated under the Code of Federal Regulation, 21 C.F.R. § 600–680.
In the complaint, Teva asserts that its cause of action is ripe for consideration by the courts in light of Lilly’s completion of Phase III clinical trials and its BLA submission to the FDA. Moreover, Teva remarks that Lilly has expended substantial marketing efforts to raise awareness of migraine treatment, built a sales force for the launch of the galcanezumab product, and developed an online presence specifically to promote CGRP-based migraine therapies, including Twitter account @LillyMigraine. Lilly has also launched a website directed at US healthcare professionals which promotes the link between CGRP and migraines. Teva argues that allowing Lilly to pursue FDA certification via a BLA will immediately lead to lost profits.
Teva’s suit further claims that Lilly is familiar with Teva’s patents on migraine treatment. The complaint bases this allegation on a suit brought by Lilly and Alder BioPharmaceuticals (“Alder”) in opposition to a European patent (No. 1957106 B1) on CGRP-targeting antibodies. In November 2016, the European Patent Office (“EPO”) revoked all claims in the patent. Several Teva patents for related inventions had been published prior to Lilly’s opposition; Teva alleges that Lilly must therefore have been aware of Teva’s migraine patents before filing a BLA for galcanezumab.
This complaint constitutes the latest stage of a race involving several pharmaceutical companies as they compete to develop new products to treat migraines. For instance, in addition to Teva’s fremanezumab and Lilly’s galcanezumab, California-based Amgen has developed yet another GCRP-targeting drug, known as Erenumab. This quest for innovation (and profits) is not surprising, given that migraine, according to the Migraine Research Foundation, currently affects 39 million people in the United States and 1 billion people worldwide, of which only 12 percent are receiving preventative treatment. The World Health Organization estimates that less than half of migraine and tension-type headache (“TTH”) sufferers are even diagnosed. Given the scarcity of preventive therapeutic options, the market potential for innovative CPGR-based drugs for the treatment of migraine–such as fremanezumab and galcanezumab–is estimated at around $8 billion to $10 billion.
Riccardo Tremolada, Ph.D., is an LL.M. Candidate at Harvard Law School and a Fulbright Fellow.