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A bipartisan group of senators has written to the US Patent and Trademark Office, urging it to tackle the impact of patent thickets on the generic and biosimilar drug industries.
Dr Reddy’s is in line for a $72m payout after settling US patent and antitrust litigation over Suboxone with Indivior.
China’s HEC Pharm, the last ANDA filer for fingolimod standing in patent litigation, has won a key invalidity challenge against a dosing-regimen patent shielding the multiple sclerosis treatment. However, the Federal Circuit was split on whether it had applied a heightened standard for negative claim limitations.
Aurobindo has settled US patent litigation with Teva over Austedo, giving the Indian company an April 2033 launch date for generic deutetrabenazine, matching the date gained by Lupin in an earlier settlement.
Chugai has seen its attack on Sawai and Nichi-Iko over their generic eldecalcitol rivals to the originator’s Edirol brand dismissed by a Tokyo district court.
Following patent expiry on 24 May, Alimta ANDA products have reached the US market, eating into a product that generated more than $1.2bn in sales last year.
A “lack of co-ordination” between the US FDA and PTO has allowed patent thickets to grow via the granting of flawed patents that do not meet legal requirements, senators Maggie Hassan and Bill Cassidy have complained.
Teva has capitalized on a recent legal victory in the UK by claiming the first launch of a generic apixaban rival to BMS’ Eliquis.
One Copaxone (glatiramer acetate) ANDA sponsor is suing another for alleged patent infringement, with Momenta filing a lawsuit against Viatris and its partners in a US district court.
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