Patent infringement case against Ranbaxy
POSTED June 18, 2009 - 16:56 | POSTED BY Pankhuri Kapoor
Last edited by Harpreet Bhagrath on June 18, 2009 - 20:52
According to the filed petition, Ranbaxy has infringed one or more claims of Medicis’s U.S. patent number 5,908,838 for an acne curing method that was issued in June, 1999.
The patented drug
Ranbaxy had recently submitted a patent to the U.S. Food and Drug Administration (FDA) for a new 135 mg version of Solodyn, an acne treatment drug that contains ‘Minocycline hydrochloride’.
The drug recorded sales of $365 million for Medicis in the U.S. for the year-ended Jan. 31, 2009, and is their main revenue-generating drug.
So Medicis seeks a settlement that should stop Ranbaxy from developing and selling the product before termination of the patent. It also proposes that only after expiry of the copyright should Ranbaxy be permitted to release its product in the market.
Ranbaxy’s justification of the infringement
Ranbaxy, in response to the petition, has filed an Abbreviated New Drug Application (ANDA) with FDA to manufacture and sell the ‘Minocycline hydrochloride’ containing drug, with a Para IV certification that challenges Medicis’s patent.
According to the U.S. law, a company has to sue an ANDA applicator with Para IV certification within 45 days of the warning and request FDA from restraining the sale of the new drug before expiry of the patent or at least for the next 30 months.
Normally, an out-of-court settlement is preferred in most such cases.
Medicis involved in similar infringement case
Medicis was involved in a similar case with Teva, an Israel based pharmaceutical company, which was first to challenge the patent on the 'minocycline hydrochloride' containing tablets.
Medicis Pharmaceutical and Teva settled the litigation in March this year. Under the settlement, Teva can sell its generic version from November 2011, when the patent on ‘Solodyn’ ends.
Ranbaxy has little to gain from the ANDA litigation and can only be allowed to sell the drug after Teva’s patent expires and so it can be hoped that Medicis and Ranbaxy also go in for an out-of-court settlement.
