Generic Drugmaker Challenges FDA

     WASHINGTON (CN) – The Food and Drug Administration is exploiting a loophole that allows brand-name drugmakers to strip exclusivity rights from generic drugmakers that have successfully challenged a patent, Teva Pharmaceuticals claims in Federal Court.




     Teva claims that after it obtained FDA certification to sell generic forms of Merck’s hypertension drugs Cozaar and Hyzaar, Merck voluntarily “delisted” the patents, inviting competition against Teva, potentially costing it hundreds of millions of dollars in sales.
     Teva sued the FDA, Secretary of Health and Human Services Kathleen Sebelius and Commissioner of Food and Drugs Margaret Hamburg.
     The first companies to challenge patents may expose themselves to patent-infringement lawsuits and the costs of drug research and development, so Congress encourages the process by promising 180-day exclusivity to the first successful generic applicant for a drug. The 180-window is a tremendous marketing advantage, not just for those 6 months, as it accustoms the public to the chosen brand name of the generic.
     Teva demands immediate declaratory and injunctive relief. It claims its loss of exclusivity will be irreparable once the FDA approves another drugmaker’s application to market the drug as a generic.
     Teva is represented by Gregory Skidmore with Kirkland & Ellis.

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