LIIBULLETIN-Patent

Yamanouchi Pharm. Co. , Ltd. v. Danbury Pharmacal, Inc., Docket No. 99-1521, 231 F.3d 1339 (Fed. Cir. Nov. 3, 2000).

OBVIOUSNESS - MOTIVATION TO COMBINE PRIOR ART - ATTORNEY FEES - GENERIC DRUGS - ABBREVIATED NEW DRUG APPLICATION - ANDA - HATCH-WAXMAN ACT - JUDGMENT AS A MATTER OF LAW - 21 U.S.C. § 355(j)(2) - 35 U.S.C. § 271 (e)(2)(A) - 35 U.S.C.§ 285

ISSUE & DISPOSITION

Issue(s)

1. Whether a patent is invalid due to obviousness where the party asserting invalidity fails to show that one of ordinary skill in the art at the time of the invention would have been motivated to combine elements from the relevant prior art to arrive at the claimed invention.

2. Whether the filing of an Abbreviated New Drug Application ("ANDA") containing a baseless Paragraph IV certification that claims the patent for a previously approved drug is "invalid or will not be infringed" by a proposed generic drug, constitutes an exceptional case and therefore warrants an award of attorney fees to the patent holder.

Disposition

1. No. When a party attacks the validity of a patented chemical compound on the grounds of obviousness, that party must show that the claimed invention and the prior art have similar structures and that the prior art would provide one of ordinary skill in the art with motivation to make the claimed invention or combination of prior art references.

2. Yes. The Hatch-Waxman Act authorizes a court to award attorney fees in exceptional cases, including an instance of the filing of baseless and unjustified certification in an ANDA.

SUMMARY

Yamanouchi Pharmaceutical Co. , Ltd. and Merck & Co. ("Yamanouchi") filed suit against Danbury Pharmacal, Inc., Schein Pharmaceutical, Inc., and Mansam Pharmaceuticals, Inc. (collectively "Danbury") in the U.S. District Court for the Southern District of New York. 21 F.Supp.2d 366. Yamanouchi alleged that Danbury, a generic drug manufacturer, had infringed claim 4 of U.S. Patent No. 4,283,408 ("the '408 patent"). The '408 patent is directed to the chemical compound famotidine, a histamine sub2 antagonist used to treat heartburn and ulcers.

Prior to Yamanouchi's suit, Danbury had filed an ANDA to obtain FDA approval to market generic famotidine. The Hatch-Waxman Act allows a generic drug manufacturer to file an ANDA to expedite FDA approval of a generic version of a previously approved drug. In the ANDA, Danbury asserted a paragraph IV certification, claiming that Yamanouchi's '408 patent was invalid on obviousness grounds. The district court granted Yamanouchi's motion for judgment as a matter of law ("JMOL") under Fed.R.Civ.P. 52(c) after finding that Danbury had not shown that claim 4 of the '408 patent would have been obvious at the time of the invention. The district court specifically noted that Danbury had failed to show any motivation for one of ordinary skill in the art to combine the prior art references to arrive at the claimed invention. Furthermore, because the district court found Danbury's case for obviousness lacked adequate foundation, it held that Danbury had willfully infringed Yamanouchi's patent. Therefore, the district court found the case to be "exceptional" and awarded attorney fees to Yamanouchi.

The Federal Circuit affirmed the district court's grant of JMOL that claim 4 of the '408 patent was valid. Because Danbury failed to show sufficient motivation for one of ordinary skill in the art at the time of the invention to make the claimed compound by combining the prior art, the Court held that Danbury had failed to make a prima facie case for structural obviousness.

Additionally, Danbury argued that the district court had abridged its right to be fully heard by rejecting its request to examine the inventor of the '408 patent. The Federal Circuit held that the district court did not abuse its discretion in excluding the witness because the testimony Danbury sought would not bear on the district court's dispositive finding that Danbury had failed to show sufficient motivation to combine the prior art to arrive at the claimed invention. Thus, the testimony would not have aided Danbury in meeting its burden of proof.

Finally, the Federal Circuit held that the district court did not abuse its discretion in awarding attorney fees to Yamanouchi. The Court ruled that Danbury's misconduct in filing a wholly unjustified paragraph IV certification in its ANDA warranted the district court's finding that the case was "exceptional," and therefore, an award of attorney fees under the Hatch-Waxman Act and 35 U.S.C. § 285 was appropriate.

Prepared by the liibulletin-patent Editorial Board.