In Pfizer v. Mylan Labs (02cv1628) a patent infringement action was brought by Pfizer under U.S. Pat. Nos. 4,572,909 and 4,879,303, which cover an amlodipine besylate product sold under the trade name Norvasc®.

Mylan filed an Abbreviated New Drug Application (“ANDA”) for approval to sell generic amlodipine besylate. Mylan certified pursuant to 21 C.F.R. 314.94(a)(12)(i)(A)(4) ( paragraph IV certification) that it was seeking approval to market its generic copy of Norvasc® prior to the expiration of the ’909 and ’303 patents. The application stated that to the best of Mylan’s knowledge neither the ’909 nor the ’303 patents would be infringed by the manufacture, use or sale of the proposed generic amlodipine besylate.

Pfizer sued Mylan for infringement of both patents and sought “[a]n order preliminarily enjoining and permanently enjoining [Mylan] from making, using, selling, offering to sell, or importing into the United States the Mylan Amlodipine Tablets described in ANDA No. 76-418 until after the expiration of the ‘909 patent term, . . ., and after the expiration of the ‘303 patent term . . .”

Mylan argued that Pfizer’s claims for inducing infringement and infringement of the ‘909 patent should be dismissed for lack of subject matter jurisdiction. According to Mylan, since the ‘909 patent expired on July 31, 2006, there is no longer a case or controversy with respect to the ‘909 patent. Pfizer responded that the district court retains jurisdiction over a patent infringement case when the patent has expired but the period of pediatric exclusivity remains at issue. Because the ‘909 patent expired on July 31, 2006, the court found that the rights secured by the patent are no longer protectable and entitlement to injunctive relief becomes moot because such relief is no longer available.

Pfizer had sought to continue to include the '909 patent in the litigation in an attempt to reinstate pediatric exclusivity as to Mylan. The FDA has confirmed that Mylan was the first generic company to file on all strengths of Norvasc(R) Tablets and is therefore eligible for 180 days of market exclusivity. The FDA has indicated that the exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a final court decision concerning the pending litigation between Pfizer and Mylan.