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Doctrine Of Equivalents Trips Reddy’s And Pfizer On Pemetrexed

 
• By Aidan Fry

Hybrid 505(b)(2) rivals to Lilly’s Alimta from Dr Reddy’s and Pfizer do not literally infringe a key method-of-treatment patent protecting the pemetrexed brand until May 2022. But their alternative salts infringe under the doctrine of equivalents, the US Court of Appeals has confirmed.

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Using a vaguely similar, but not identical, salt form is enough to infringe, even if the patent identifies a specific salt, the US Court of Appeals says • Source: Shutterstock

Pemetrexed ditromethamine formulations for which Dr Reddy’s and Pfizer’s Hospira are seeking approval through the US hybrid 505(b)(2) regulatory pathway infringe the sole listed patent protecting Eli Lilly’s Alimta (pemetrexed disodium) lung-cancer treatment under the doctrine of equivalents, the US Court of Appeals for the Federal Circuit has found.

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