Hearing in October on Hi-Tech's generic exclusivity on Cosopt
This article was originally published in Scrip
Hi-Tech Pharmacal has filed a complaint against the US FDArequesting a declaratory judgement relating to the company's ANDA for a generic version of Merck & Co's Cosopt (dorzolamide plus timolol ophthalmic solution). Hi-Tech seeks confirmation that it is entitled to 180 days of exclusivity as the first applicant to submit an ANDA containing a paragraph IV certification challenging the validity of the Orange Book-listed patents for Cosopt.
In the suit, filed in late August with the US District Court for the District of Columbia, Hi-Tech also seeks "the issuance of an injunction preventing FDA from granting final marketing approval to any other ANDA for 180 days after Hi-Tech begins marketing its generic version, which is expected to be on October 28th, 2008". A hearing on the preliminary injunction has been tentatively scheduled for October 2nd, according to the court docket.
The generics firm has filed the suit because it believes it has been denied a decision unfairly. It says it has learned that the FDA will render no decision on the 180-day exclusivity until the agency approves an application, which Hi-Tech expects to be no earlier than October 28th.
At issue are some "failure to market" forfeiture provisions which came about as Hatch-Waxman modifications through the Medicare Prescription Drug Improvement and Modernization Act of 2003 ("MMA"). MMA provides for the forfeiture of the 180-day exclusivity period for a first ANDA filer that does not launch in a timely manner under some circumstances.
Hi-Tech claims that, under MMA, the approval of a second ANDA containing a paragraph IV certification may not take place until 180 days after the first applicant begins commercial marketing of the drug unless the first applicant has forfeited the right to exclusivity. Hi-Tech believes it is entitled to 180-day exclusivity under Hatch-Waxman, as amended by the MMA. Furthermore, Hi-Tech claims that the FDA "has failed to promulgate procedures for determining if or when a forfeiture has occurred" and has adopted "an arbitrary and capricious policy of making exclusivity forfeiture decisions only on the very day that FDA determines that exclusivity is lost, thereby permanently, irrevocably, and instantaneously adversely affecting the market and depriving ANDA applicants from any opportunity of meaningful judicial review".
The patent arena for Cosopt and Trusopt – which involves three Orange Book-listed patents (the '413, '735 and '443 patents) - is not discussed in the suit, but Hi-Tech has lost its 180-day market exclusivity for being the first ANDA filer to the '413 patent – Merck prevailed in a patent suit on that patent. But because Merck chose to disclaim the '735 and '443 patents, Hi-Tech "prevailed" as to those patents; Hi-Tech thus potentially retained 180 days of exclusivity on those patents.
Hi-Tech claims in its suit that the FDA's tentative approval letter to the company "failed to address the question of whether Hi-Tech is entitled to 180-day generic drug exclusivity, which could commence on October 28th, 2008, when FDA approves [the Cosopt application]".
Hi-Tech further claims in its suit that the FDA has granted tentative approval to Apotexfor its generic version of Cosopt, but the approval letter "is silent with respect to the date on which Apotex is entitled to final approval".
The complaint goes on to say that the FDA, by postponing any decision on exclusivity until October 28th, 2008, and then simultaneously approving two ANDAs for immediate marketing, "will permanently destroy the economic value of exclusivity and permanently deprive Hi-Tech of those profits".
Apotex recently lost a bid to provoke forfeiture by Hi-Tech. The forfeiture-triggering event would have been a decision in Apotex's favour that the '735 and '443 patents are invalid and not infringed, and Hi-Tech's failure to launch (since it could not launch until Merck's marketing exclusivity was to expire on October 28th; Scrip Online, September 3rd, 2008).