Tuesday, 1 April 2008

Carbatrol (Carbamazepine ) Litigation: Claim construction

A federal judge delivered a mixed ruling in Shire Lab's patent infringement lawsuit against generics maker Corepharma over Shire's anti-seizure drug Carbatrol (Carbamazepine ), accepting Corepharma's proposed construction of one disputed term and rejecting its constructions of three others. Carbamazepine ((Z)-5H-dibenzo[b,f]azepine-5-carboxamide) is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy and bipolar disorder. It is also used to treat ADD, ADHD, schizophrenia and trigeminal neuralgia.
Shire Lab and Defendant Corepharma, have filed an application for claim construction to resolve disputes over the construction of four claim terms in US5326570. Court Ordered that the term “unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman v. Westview Instruments, as a single thing or entity that is a constituent or isolable member of a more inclusive whole, being the least part of the whole to have a clearly definable existence separate or different from other parts of the whole; and the term “immediate release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman , as a unit, as defined above, which begins to release the carbamazepine upon ingestion; and the term “sustained release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, as a unit, as defined above, which provides for a gradual release of carbamazepine over time in the gastro-intestinal tract; and the term “enteric release unit” in claims 1 and 18 of the ‘570 patent shall be construed in all future proceedings, pursuant to Markman, as unit, as defined above, which provides for a delayed release of carbamazepine in the lower gastro-intestinal tract. (Source: inputs from AMIT)





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