Source: http://www.fdalawblog.net/2009/06/teva-sues-fda-over-generic-cozaar-and-hyzaar-180day-exclusivity-forfeiture-and-patent-delisting-rule/
Timestamp: 2019-03-18 19:31:44
Document Index: 138643210

Matched Legal Cases: ['§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505', '§ 505']

Teva Pharmaceuticals USA, Inc. (“Teva”) recently filed a Complaint and a Motion for Preliminary Injunctive Relief (and a memorandum supporting the company’s motion) in the U.S. District Court for the District of Columbia against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & Co., Inc.’s (“Merck’s”) blockbuster angiotensin II receptor antagonist drugs COZAAR (losartan potassium) Tablets and HYZAAR (hydrochlorothiazide; losartan potassium) Tablets. Teva’s lawsuit is the latest challenge to FDA’s interpretation of the “failure to market” 180-day exclusivity forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I), and in particular with respect to FDA’s interpretation of the patent information withdrawal provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC). The 180-day exclusivity forfeiture provisions were added to the FDC Act in December 2003 by the Medicare Modernization Act (“MMA”).
Under the FDC Act, an ANDA applicant who is a “first applicant” (i.e., “an applicant that, on the first day on which a substantially complete [ANDA] containing a [Paragraph IV certification] is submitted for approval of a drug, submits a substantially complete [ANDA] that contains and lawfully maintains a [Paragraph IV certification]”) is eligible for 180-day exclusivity, but forfeits such exclusivity if there is a “failure to market” under FDC Act § 505(j)(5)(D)(i)(I). Specifically, FDC Act § 505(j)(5)(D)(i)(I) states that a first applicant forfeits 180-day exclusivity if it fails to market the drug by the later of two dates:
(CC) The patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the application approved under [FDC Act § 505(b)]. [(Emphasis added)]
FDA’s Letter Decision was challenged in the U.S. District Court for the District of Columbia; however, the challenge was abandoned after the court denied a generic applicant’s motion for a temporary restraining order.
In October 2008, FDA once again applied its interpretation of FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) when the Agency issued a Letter Decision ruling that Hi-Tech Pharmacal Co., Inc. (“Hi-Tech”) forfeited 180-day exclusivity for a generic version of Merck’s COSOPT (dorzolamide hydrochloride; timolol maleate) after the information on two exclusivity-qualifying Orange Book-listed patents covering the drug had been withdrawn by Merck. (See our October 28, 2008 post here.) FDA issued its Letter Decision after the U.S. District Court for the District of Columbia decided not to grant Hi-Tech’s preliminary injunction motion seeking to prevent FDA from granting final ANDA approval to any subsequent ANDA applicant during Hi-Tech’s period of 180-day exclusivity and to obtain a prompt exclusivity decision from FDA to allow Hi-Tech to seek judicial relief in case of an adverse FDA decision. Hi-Tech challened FDA’s Letter Decision in the U.S. District Court for the District of Columbia, but was ultimately unsuccessful in its lawsuit. (Teva submitted an amicus brief in that case.)
According to Teva’s Complaint, the company believes it is a first applicant with respect to both COZAAR and HYZAAR based on ANDA submissions in 2003 and 2004. There are three patents listed in the Orange Book for both drug products. Teva reportedly submitted a Paragraph III certification with respect to two of the patents, which expire in February and April 2010, and a Paragraph IV certification with respect to U.S. Patent No. 5,608,075 (“the ‘075 patent”), which expires in September 2014. Subsequent to Teva’s Paragraph IV certification, Merck reportedly requested that FDA withdraw (or “delist”) the ‘075 patent information from the Orange Book for both COZAAR and HYZAAR. Thus, according to Teva:
Read together, as statutory provisions must be, it thus is clear that these twin
Amendments – the delisting mechanism, on one hand, and the delisting trigger, on the other – were not remotely intended to open the proverbial floodgates to manipulative, exclusivity-divesting patent delistings by brand manufacturers, and thus sub silentio to abrogate the longstanding prohibition against such delistings that Ranbaxy recognized. To the contrary, these interlinked provisions merely provide that when a first applicant secures a court-ordered patent delisting that clears the last remaining hurdle to generic competition, it cannot indefinitely delay generic competition by refusing to sell its product for more than 75 days after the court-ordered delisting. Beyond that, however, the delisting trigger does not remotely authorize manipulative patent delistings that take place apart from, and wholly outside the confines of, the statute’s new delisting mechanism. FDA has no answer to this simple point, and it is dispositive. [(Emphasis in original)]
Although originally assigned to Judge Gladys Kessler, the Teva case has been reassigned to Judge Rosemary M. Collyer. FDA’s response, originally due on June 26th, will likely be due on July 1st once Judge Collyer rules on an unopposed motion for extension of time for FDA to respond to Teva’s preliminary injunction. We will certainly be watching this case closely and will update FDA Law Blog readers on important developments.