Narrative Opinion Summary
In this case, Barr Laboratories, Inc. filed an ANDA to market fluoxetine hydrochloride, prompting Eli Lilly to sue for patent infringement under U.S. Patent Nos. 4,314,081 and 4,626,549. The district court upheld the patents' validity, determining compliance with the best mode requirement and rejecting obviousness-type double patenting claims. However, Barr appealed, arguing that claim 7 of the '549 patent is invalid due to obviousness-type double patenting over the '213 patent. The appellate court, sitting en banc, vacated the panel's initial opinion, reassigning it for revision and ultimately reaffirming the district court's best mode compliance decision while reversing the double patenting ruling. The court found claim 7 inherently anticipated due to the serotonin uptake inhibition property of fluoxetine hydrochloride, thus lacking patentable distinctiveness. The court vacated the district court's grant of a jury trial on the validity issue, holding that summary judgment was appropriate. Consequently, claim 7 was deemed invalid for double patenting, while the best mode requirement was satisfied, leading to a partial reversal and affirmation of the district court's judgment, with each party bearing its own costs.
Legal Issues Addressed
Best Mode Requirement under 35 U.S.C. § 112subscribe to see similar legal issues
Application: The court found that the patents complied with the best mode requirement, as the undisclosed synthesis method and recrystallization solvent were not required disclosures for the claimed invention.
Reasoning: Evidence presented does not establish a best mode violation, as it concerns production factors such as costs and resources, which are not necessary for best mode disclosure.
Doctrine of Obviousness-Type Double Patentingsubscribe to see similar legal issues
Application: The court determined that claim 7 of the '549 patent is invalid for obviousness-type double patenting over claim 1 of the '213 patent, as the claims were not patentably distinct.
Reasoning: The court affirmed in part and reversed in part, holding that claim 5 of the 081 patent and claim 7 of the 549 patent meet the best mode requirement, but claim 7 is invalid for double patenting.
Hatch-Waxman Act and Patent Infringementsubscribe to see similar legal issues
Application: Barr's ANDA filing under the Hatch-Waxman Act constituted patent infringement, leading to Lilly's lawsuit concerning Prozac's active ingredient.
Reasoning: Barr had filed an ANDA under the Hatch-Waxman Act in December 1995 to market fluoxetine hydrochloride, the active ingredient in Eli Lilly's Prozac.
Inherent Anticipation in Patent Lawsubscribe to see similar legal issues
Application: Claim 7's limitation of blocking serotonin uptake is an inherent property of fluoxetine hydrochloride, thus failing the patentable distinctiveness test.
Reasoning: Consequently, the limitation in claim 7 of the '549 patent, which pertains to blocking serotonin uptake via fluoxetine hydrochloride, is an inherent characteristic of its administration for any purpose, including anxiety treatment.
Patent Validity and Summary Judgmentsubscribe to see similar legal issues
Application: The district court's summary judgment was affirmed for the best mode compliance but reversed for double patenting, as the latter did not present a genuine issue of material fact.
Reasoning: Summary judgment is appropriate when there is no genuine issue of material fact, with the moving party required to demonstrate the absence of evidence supporting the nonmoving party's case.