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In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb (NYSE:BMY) sued Apotex for infringing the Orange Book-listed patent, U.S. Patent No. 4,847,265, thereby initiating an automatic 30-month stay of FDA approval of Apotex's ANDA.

With the patent litigation still pending, the stay expired in May 2005. In January 2006, FDA granted final approval to Apotex's ANDA. The litigation was proceeding toward trial when, on August 8, 2006, Apotex launched its generic clopidogrel bisulfate product at risk, starting its 180-day exclusivity period. 23 days later, the U.S. District Court for the Southern District of New York preliminarily enjoined (pdf file) Apotex from continuing to sell its generic version of Plavix. Thus, Apotex was enjoined, but its exclusivity continued to run.

The Federal Circuit affirmed the preliminary injunction in December 2006. After a bench trial, in June 2007, the district court ruled that Apotex failed to prove that the '265 patent is invalid and entered a permanent injunction. Apotex appealed that decision to the Federal Circuit, which heard oral argument on March 3, 2008. A decision from the Federal Circuit could come at any time.

Meanwhile, other generic drug companies were pursuing their own ANDAs for generic Plavix. Dr. Reddy's (NYSE:RDY), Teva (NYSE:TEVA) and Cobalt each filed ANDAs with paragraph IV certifications and were sued by Sanofi and BMS. Teva and Cobalt are permanently enjoined, pending the outcome of Apotex's appeal. Dr. Reddy's, however, is not enjoined. Instead, according to Apotex, Dr. Reddy's agreed with Sanofi and BMS that it would provide ten days' notice before launching its generic product. Presumably, such notice would allow Sanofi and BMS sufficient time to prepare and file a motion for a preliminary injunction against Dr. Reddy's. On January 14, 2008, FDA granted final approval to Dr. Reddy's ANDA, thereby clearing Dr. Reddy's for a commercial launch.

On February 13, 2008, Apotex filed a Petition for Stay of Action with FDA, seeking

only to stay the effective date of Dr. Reddy's formal approval in a manner that would protect Apotex's remaining 156 days of generic exclusivity but would permit unrestricted generic competition at the end of that exclusivity period.
See FDA Law Blog. Apotex asked FDA to respond no later than March 15, 2008. FDA has not yet responded, and therefore, last Wednesday, Apotex filed suit against FDA in the U.S. District Court for the District of Columbia, requesting declaratory and injunctive relief.

In its complaint (pdf file), Apotex seeks "to set aside FDA's refusal to stay the effectiveness of" Dr. Reddy's final approval. According to Apotex,

[a]bsent a stay, Dr. Reddy's will be permitted to distribute generic clopidogrel bisulfate tablets during the remainder of the 180 days during which Apotex is entitled to be the sole generic manufacturer of that drug under the [Hatch-Waxman Act].

Apotex alleges that FDA's action violates the Food, Drugs and Cosmetics Act and must be set aside by the court as "arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law," in violation of the Administrative Procedure Act. Specifically, Apotex asserts that the language of the Hatch-Waxman Act

demonstrates a clear congressional intent to provide the first ANDA applicant to file a paragraph IV certification for a listed patent with the economic benefit of 180 days of generic marketing exclusivity to encourage prompt challenges to questionable or inapplicable patents. The "not earlier than" language provides a safety valve to ensure that the 180-day period will not be unfairly curtailed by, for example, an improvidently granted injunction issued during the period of marketing exclusivity against a first filer who commences commercial marketing prior to a determination that a listed patent is invalid or not infringed.

Apotex further asserts that unless the district court grants the relief sought, "Dr. Reddy's would be able to commence marketing almost immediately in the event of a CAFC decision of invalidity, while Apotex would remain bound by injunction until the mandate issues." If the Federal Circuit invalidates the '265 patent (which is a pretty big "if," given that it previously affirmed the preliminary injunction), Sanofi/BMS would certainly file a request for rehearing or rehearing en banc, which would likely delay the issuance of a mandate for several weeks. Thus, according to Apotex,

[n]ot only would Apotex be denied its remaining 156 days of exclusivity, but Dr. Reddy's would have a significant head start over Apotex in the marketplace, a marketplace that would be made available only by Apotex's challenge to the '265 patent.

Source: Apotex Sues FDA to Recover Its 180-Day Exclusivity on Generic Plavix