Doctrine Of Equivalents Trips Reddy’s And Pfizer On Pemetrexed
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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FDA approval for a hybrid 505(b)(2) new drug application referencing Alimta has been awarded to Teva’s Actavis, with a key patent expiring in May 2022 proving a barrier to market entry. Teva was itself shot down over attempts to launch an ANDA product several years ago.
The US Supreme Court has refused a certiorari petition to review a decision involving Dr Reddy’s and Pfizer over Eli Lilly’s Alimta that revolved around the doctrine of equivalents.
Sandoz’ unsuccessful attempts to show a lack of inventive step in a Swiss vitamin regimen patent leave Lilly’s Alimta pemetrexed brand protected until 2021.