Sun Pharma backs out of Forest patent row

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New Delhi: The largest domestic pharma firm by market value, Sun Pharma, is no more in the running to challenge the patent of Forest Lab’s over $700-million alzheimer drug, Namenda (adamantane). The Mumbai-based drug firm has settled the matter with Forest Labs and has opted out of the case going on in the district court of Delaware, USA. It has admitting that the abbreviated new drug application it filed with US Food and Drug Adminstration to market the Alzheimer drug was a "technical act of infringement" of Forest’s patent coverage in this case.

The district court order has dismissed all claims and counterclaims in the case and the matter stands resolved between Forest Labs and Sun Pharma.

Sun Pharma also agreed that it would not manufacture or market 5 mg or 10 mg tablets during the life of the patent, unless all asserted claims of the patent have been established as invalid.

The patent of the product is scheduled to expire in April 2010. However, Forest has said it would try to prolong the life of the patent till 2013 and has already applied for a grant of extension to the USFDA.

A company spokes person refused to comment on the issue.

In January 2008, Forest Laboratories and German firm Merz Pharma, to which it had licensed the patent, sued a host of generic companies, including Indian firms Lupin Ltd, Orchid Chemicals & Pharmaceuticals Ltd and Wockhardt Ltd. The other companies that faced the lawsuit include Cobalt Laboratories, Teva Pharmaceuticals, Upsher-Smith Laboratories and Barr Laboratories.

These companies had applied to USFDA to obtain the manufacturing and marketing approval for adamantane (Namenda).