In a New Twist in Restasis Legal Battle, Teva Sues the FDA

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.

The suit hinges on the fact that the FDA Reauthorization Act of 2017 (FDARA) established a possible 180-day exclusivity and expedited for abbreviated New Drug Application sponsors who seek to market “competitive generic therapies.” This exclusivity was seen as a way to increase competition and drive down drug prices—a key goal of the Trump administration.

Drug makers can request competitive generic status at the time of or before submission of their Abbreviated New Drug Application (ANDA). Generics that qualify for the exclusivity period are those competitive generic therapies that are the first approved applications for innovator products that have no more than 1 approved ANDA for the reference product.

Generally, the FDA has adopted one approach to determining which generic was the first to file: a generic sponsor had to submit a substantially complete application with a paragraph IV certification (a certification stating that a patent on a drug is invalid, unenforceable, or will not be infringed), and to give timely notice to the reference product’s sponsor.

Now, the FDA has signaled in a separate decision, regarding an unrelated generic, that it is changing its approach. In the decision letter, the FDA indicated that therapies that may gain exclusivity are the first to submit a substantially complete application with a paragraph IV certification, regardless of whether the applicant maintains the certification or provides timely notice.

Teva’s complaint, filed last month, signals that it fears another generic developer could be given 180-day exclusivity under the new interpretation. The complaint seeks to keep the FDA from applying this new understanding of a first applicant, and “bar FDA from depriving plaintiff Teva…of its statutory right to 180 days of marketing exclusivity for its generic version of the brand-name drug Restasis. Teva earned that reward because it was the first generic applicant that complied with the Hatch-Waxman Act’s requirements for challenging at least one of the patents covering Restasis.”

Teva asks the court to declare that the FDA’s decision letter in the separate case is “arbitrary, capricious, an abuse of discretion and not in accordance with law,” to declare that Teva’s ANDA is entitled to exclusivity, and to bar the FDA from approving any other ANDAs for Restasis generics.

In response, the FDA called Teva’s demands baseless, premature, and full of conjecture, noting that Teva’s generic has not been approved, may not be approved, and could forfeit exclusivity for the product for statutory reasons other than those related for first-to-file status.