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BY Jeffrey S. Ginsberg
May 02, 2015

Fed. Circ.: Brand Pharmaceutical Company Entitled to 50% Of Generic Drug Maker's Profits During Patent Term Only

On April 7, 2015, a Federal Circuit panel of Judges O'Malley, Clevenger, and Bryson issued a unanimous opinion, authored by Judge Bryson, in Astrazeneca AB v. Apotex Corp., Case No. 2014-1221. The panel affirmed-in-part the district court's damages award to Astrazeneca AB (Astra) for 50% of Apotex's profits made during the patent term, but reversed Astra's damages award based on Apotex's profits made during the period of pediatric exclusivity, holding that 35 U.S.C. '284 only provides for reasonable royalty damages for patent infringement-based sales as opposed to sales made after a patent expires. See, Slip op. at 31'35.

The appeal resulted from a dispute between Astra, owner of U.S. Patent Nos. 4,786,505 and 4,853,230 (collectively, “the patents-at-issue”) and Apotex. The patents-at-issue relate to pharmaceutical formulations containing omeprazole, which is the active ingredient in Astra's drug, Prilosec, used in the treatment of gastrointestinal disorders. See, id. at 2. Previous litigation between the parties resulted in a finding of infringement, affirmed by the Federal Circuit on appeal. See, In re Omeprazole Patent Litig., 536 F.3d 1361 (Fed. Cir. 2008). Following In re Omeprazole, the district court held a bench trial to determine Astra's damages award and found that, “in a hypothetical negotiation, Astra and Apotex would have agreed upon a license to Astra's patents in exchange for a royalty rate of 50[%] of Apotex's profits from the sales of its infringing omeprazole product during the period of its infringement, 2003 to 2007.” Id. at 11. Astra was awarded over $76 million in damages. Apotex appealed.

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