Docket No. 2012-1040, -1054
RADER, BRYSON, WALLACH
January 28, 2013
Brief summary: Affirmed DC determination that Allergan acted as its own lexicographer and the claimed compound was not obvious in view of prior art, based in large part on expert testimony.
Summary: Barr (with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.) and Sandoz (“Barr”) appealed USDC DE decision that their proposed products infringed claim 10 of Allergan’s US 5,668,819 and that the claim was not invalid. Allergan’s product is Lumigan® (bimatoprost ((cyclopentane N- ethyl heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3,5-dihydroxy, [1α,2β,3α,5α])) for reducing intraocular pressure in people with hypertension or glaucoma. Prostaglandin F2a (PGF-2a) is known to reduce intraocular pressure. Bimatoprost introduced a phenyl ring and replaced a carboxylic acid group with a non-acidic substituent (ethyl amide) to provide a compound with reduced side effects as compared to PGF-2a. Claim construction arguments in front of the DC turned on whether substituent -N(R4)2 (as in ‘819 claim 5) requires identical R4 substituents (bimatoprost uses nonidentical R4 substituents (hydrogen and ethyl)). The DC determined that Allergan had acted as its own lexicographer to permit nonidentical R4 substituents and that Barr’s product infringed the claim. The FC panel agreed, citing Phillips (FC 2005) ((“Properly viewed, the ‘ordinary meaning’ of a claim term is its meaning to the ordinary artisan after reading the entire patent.”)) The DC also determined the claim was valid in view of the alleged prior art describing PG derivatives, in part because the expert witness was discredited (e.g., incorrectly drew bimatoprost, contradictory testimony in another case). The FC panel agreed, finding that the DC “did not err in finding that common sense and logic were not sufficiently illuminating in this case” and that expert testimony was required (e.g., not incorrect to decline to independently review the references (Wyeth, FC 2010; Proveris Scientific Corp., FC 2008)). The FC panel determined that the only credible expert testimony was Allergan’s expert who “the prior art did not teach or motivate one of skill in the art to substitute an amide at the C-1 position to create a glaucoma drug.” Thus, the DC decision was affirmed.