FDA Seeks Public Comments on 180-day Exclusivity and Forfeiture Issues for Generic Restasis (US)

Practical Law UK Legal Update 4-617-8085 (Approx. 3 pages)

FDA Seeks Public Comments on 180-day Exclusivity and Forfeiture Issues for Generic Restasis (US)

by Practical Law Life Sciences

The FDA is asking for public comments on 180-day exclusivity and forfeiture issues for generic Restasis products, eye drops that increase tears in patients with chronic dry eyes.

Speedread

On July 28, 2015, the FDA asked for public comments on a matter concerning 180-day exclusivity and forfeiture issues for cyclosporine ophthalmic emulsion (generic Restasis) applicants. The FDA is asking whether any applicant that submitted a paragraph IV certification but did not receive an FDA acknowledgement letter before the relevant patent expired is a "first applicant," and whether 180-day exclusivity was forfeited when that patent expired. As the FDA explains in its letter to applicants, there are multiple ANDAs and patents in play.

The FDA is asking for public comments on 180-day exclusivity and forfeiture issues for cyclosporine ophthalmic emulsion products (generic Restasis), eye drops that increase tears in patients with chronic dry eyes.

The FDA's Office of Generic Drugs (OGD) has opened a public docket on a letter to abbreviated new drug application (ANDA) applicants with complex facts that raise Hatch-Waxman issues. The so-called dear applicant letter describes multiple patents for Restasis listed in the Orange Book, and multiple applicants' paragraph IV certifications to one or more of those patents stating that those patents are invalid or will not be infringed by the applicant's sale of the generic. Because the facts are unusual, OGD asks the applicants (and the public) to weigh in on whether anyone is eligible for 180-day exclusivity.

Under the Food, Drug and Cosmetic Act (FDCA):

ANDA applicants that submit paragraph IV certifications run the risk of patent infringement litigation in exchange for possible 180-day marketing exclusivity, a delay in FDA approval of other ANDAs that benefits the first applicant.
The first applicant is an applicant that, on the first day on which a substantially complete application containing a paragraph IV certification is submitted for approval of a drug, submits a substantially complete application that contains and maintains a paragraph IV certification for the drug.
An applicant that submits a paragraph IV certification must notify the patent holder (and the NDA holder), but not before receiving an acknowledgement letter from the FDA indicating that the ANDA is sufficiently complete for substantive review.
The relevant FDCA exclusivity provisions were revised by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) to add several conditions or provisions under which an applicant loses, or forfeits, its eligibility for 180-day exclusivity. One of those forfeiture provisions is where all of the patents to which the applicant has submitted a paragraph IV certification expire. If all first applicants forfeit under this provision, no applicant gets 180-day exclusivity.

(See 21 U.S.C. §355(j).)

The relevant facts in this matter include the following:

Restasis US patents in the Orange Book include 4,839,342 (the '342 patent) that expired in 2009 and 5,474,979 (the '979 patent) that expired on May 17, 2014.
On January 14, 2014, another Restasis patent, US Patent 8,629,111 (the '111 patent), was listed in the Orange Book. On the same day, one or more applicants submitted a paragraph IV certification to the '111 patent.
One or more ANDAs (or patent amendments) with paragraph IV certifications to the '979 patent were submitted after the '342 patent expired, but before January 14, 2014.
The '979 patent expired before the FDA sent an acknowledgement letter to any applicant.

The FDA is asking for comments on:

Whether any applicant that submitted a paragraph IV certification to the '979 patent after the '342 patent expired, but before January 14, 2014, and did not receive an FDA acknowledgement letter until after the '979 patent expired is a first applicant.
Whether 180-day exclusivity was forfeited when the '979 patent expired, meaning that no applicant gets exclusivity.

Comments are due August 28, 2015.

Source: FDA: Docket No. FDA-2015-N-2713: Letter to Cyclosporine Ophthalmic Emulsion ANDA Applicant(s), 28 July 2015.

End of Document

Resource ID 4-617-8085

Published on 05-Aug-2015

Resource Type Legal update: archive

Jurisdiction

United States