• Aug 9 2019
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  • Category: CAFC Updates

Hospira and Dr. Reddy’s appeal from two judgments of the district court in two infringement suits brought by Eli Lilly under the Hatch-Waxman Act. The district court held in each case that the defendant’s submission of a New Drug Application infringed U.S. Patent 7,772,209 (relating to methods of treatment with antifolates, particularly pemetrexed disodium, through supplementation with a methylmalonic acid lowering agent and folic acid) and entered orders prohibiting FDA approval of the products at issue until the expiration of the ’209 patent. The CAFC reverses the district court’s finding of literal infringement as clearly erroneous in light of the court’s claim construction of “administration of pemetrexed disodium,” noting that Hospira has only sought approval to market pemetrexed ditromethamine, and that neither its proposed product nor methods of administering it will constitute administering the pemetrexed disodium salt. However, the CAFC finds that the district court did not err in its application of the doctrine of equivalents and holds that the particular type of salt to which pemetrexed is complexed relates only tenuously to the reason for Lily’s narrowing amendment made during prosecution, and was merely tangential to pemetrexed ditromethamine because the prosecution history, in view of the ’209 patent itself, strongly indicates that the reason for the amendment was not to cede other, functionally identical, pemetrexed salts. The CAFC also holds that the disclosure-dedication rule is inapplicable to this case because the ’209 patent does not disclose methods of treatment using pemetrexed ditromethamine, and, as a result, Lilly could not have dedicated such a method to the public. Accordingly, the CAFC affirms the judgment of infringement.

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