Johnson & Johnson has expressed its disappointment over a decision by a US court which will allow Barr Laboratories to market its generic version of the Alzheimer’s drug Razadyne.
J&J’s Ortho-McNeil Neurologics division says that it will appeal a ruling by the US District Court of Delaware, which ruled that the patent for Razadyne (galantamine) is invalid.
A favourable decision would have provided protection for the drug until the patent expires on December 14, 2008.
In her ruling, Judge Robinson found that the ‘318 patent is invalid for lack of enablement. And she also denied J&J’s request for a temporary restraining order which would have prevented Barr from marketing its product. The decision ends the 30-month stay with respect to the latter’s generic Razadyne plus an extended-release version of the drug.
Barr filed an Abbreviated New Drug Application with the FDA for generic Razadyne on February 28, 2005, J&J sued some three months later and the subsequent trial took place in May 2007. As for Razadyne ER, J&J still claims that Barr’s copy infringes the ‘559 patent, which is scheduled to expire on December 20, 2019 but the generics firm says that patent was not listed at the time Barr’s original application was filed.
Christine Mundkur, chief executive at Barr Labs, said that the company, which is in the process of being acquired by Teva Pharmaceutical Industries of Israel, intends an ‘at risk’ launch of its generic Razadyne product “immediately following receipt of final Food and Drug Administration approval, which we expect imminently”. She added that “we also are evaluating our options regarding a launch of our generic version of Razadyne ER”.
According to Barr, sales of Razadyne ER reached $112 million in the 12 months ended June 2008, while Razadyne brought in $102 million. Six other generic firms are thought to be waiting to launch their versions of the drug.
