Alphagan Ruling Would Limit Need For Patent Certifications

ANDA applicants are not required to certify to patents other than those covering the compound or the method of use being pursued, a Los Angeles federal court ruling in Allergan's Alphagan patent litigation against Alcon states.

Judge David Carter granted Alcon's motion for summary judgment of noninfringement May 8, finding that because Allergan's Alphagan (brimonidine) patents cover a use that is not in Alcon's ANDA, Alcon did not have to file a Paragraph IV certification.

If Paragraph IV certification is not required, there can be no grounds for a suit, the ruling finds. "It does not withstand scrutiny to conjecture that Congress intended to design a system where a patentee could bring suit to prevent the approval of an ANDA in cases where it did not require the ANDA applicant to notify the patentee," the court noted.

Allergan holds two patents (6,194,415 and 6,248,741) covering the use of brimonidine as a neuroprotective agent in the treatment of glaucoma, which is an unapproved indication. The company does not hold a patent on the drug itself, nor on its approved use as an intraocular pressure reduction agent.

Judge Carter declared that the two patents should not have even been listed in the "Orange Book" because they do not claim an indication for which Alphagan has an approved or pending NDA.

The judge also denied Allergan's claim that Alcon's application would induce infringement by enabling off-label generic use for the neuroprotective function.

Under Waxman/Hatch, a patent holder is only entitled to sue for infringements that happen before the ANDA filing, Carter ruled. The "Bolar" amendment allows for use of a patented drug by a generic company for the purpose of developing a generic, the judge noted, with an ANDA filing defined as an act of infringement.

"The result is to bar a patent holder from suing for infringing use during the development and testing stage, but allow the patentee to sue under an expedited process once the infringer files for approval of the drug," the ruling notes. "The court must therefore conclude that the type of claims that accrue upon the filing of an ANDA are limited to those claims that would have accrued earlier, when a generic drug maker used the patent to develop its generic drug."

"Viewed as such, a patent-holder cannot bring a claim" under Waxman/Hatch "that the generic drug maker will, upon approval of the patent, induce others to infringe," the ruling adds.

In throwing out Allergan's inducement claim, the court rejected unpublished decisions from two ongoing patent cases involving Pfizer's Neurontin (gabapentin) and AstraZeneca's Prilosec (omeprazole).

Judge Carter's decision quotes a 1999 district court decision in the Neurontin suit, later cited in a Prilosec ruling, which states that "[n]owhere does the statute require that the proposed use of the generic drug be within the scope of the uses claimed in the patent in question for infringement to occur."

The L.A. court, however, maintained that "this statement is plainly erroneous. Although it is not specifically stated in Sec. 271(e)(2), the Hatch-Waxman Act includes exactly this requirement."

If Carter's decision is upheld, it would remove a major concern of generic firms about the patent certification process which has driven pressure on Congress to reopen the Waxman/Hatch Act.

The Neurontin patent situation in particular was discussed at a Senate Health Committee hearing May 8 (¹ (Also see "Neurontin Patent Defense Takes Center Stage In Senate Hearing" - Pink Sheet, 13 May, 2002.), p. 5).

The decision, however, may not stand long enough to attract political attention. Allergan plans to file an expedited appeal with the Federal Circuit court, and expects that a decision could come before an ANDA approval (² 'The Pink Sheet' May 13, In Brief).

The company hopes that the Federal Circuit ruling in the Neurontin suit will provide a precedent for overturning the L.A. district court's decision. Briefing should be finished by the end of May, with a ruling "expected as early as the summer," Allergan said.

Even in the worst case scenario, Allergan does not expect approval of generic brimonidine "until some time after the first quarter of 2003," the company said, citing an average 21-month approval time for ANDAs.

The 30-month stay on Alcon's ANDA will expire in April 2004.