Eli Lilly and Co., v. Teva Pharmaceuticals USA, Inc., 2010-1005, -1033 (Fed. Cir. Sept. 1, 2010)

The patentee asserted various patents directed to the drug raloxifene hydrochloride used to treat postmenopausal osteoporosis. The district court found that the alleged infringer’s generic product infringed four of the patents, which were found to be non-obviousness and enabled. The district court also found that two other patents were invalid for lack of written description. Both parties appealed the district court’s findings.

The Federal Circuit affirmed on all issues because there was no “definite and firm conviction” that the district court made a mistake. As to non-obviousness, the district court concluded that known bioavailability concerns with raloxifene would have precluded a reasonable expectation of success that the drug could be used to treat postmenopausal osteoporosis. In light of this, the Federal Circuit agreed that the alleged infringer presented no evidence that would “teach, suggest, or motivate or supply any common sense reason for a person of ordinary skill in the art to reject the bioavailability concerns and routinely, simply, or easily arrive at the inventive result.”

The Federal Circuit also affirmed as to the issue of enablement. The alleged infringer argued that if the asserted patents were in fact non-obvious in view of the prior art, then the same patents could not be enabled because of the prevailing view that raloxifene would not work in humans. The alleged infringer cited the court’s previous holding in Rasmusson v. SmithKlein Beecham, which stated “[i]n the context of determining whether sufficient utility as a drug… in human therapy has been alleged, it is proper for the examiner to ask for substantiating evidence unless one with ordinary skill in the art would accept the allegations as obviously correct.” While agreeing that the Rasmussen case set forth the proper standard to be applied, the Federal Circuit found the alleged infringer’s argument unavailing because the specification of the patent-in-suit disclosed additional information – “two sets of information not found in the prior art.” First, the patents described the results of previous raloxifene studies and explained how the drug could be effective in treating human bone loss. Second, the patents also described in detail a human clinical study, which was ongoing at the time the application was filed, but for which results were not yet available. Based on these disclosures, the court found no clear error in the district court’s conclusion that the asserted patents enabled the alleged utility of raloxifene.

The Federal Circuit also affirmed as to the issue of lack of written description, finding no clear error with the district court’s conclusion that the specification did not “reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.”

A copy of the opinion can be found here.