1 December 2010Patents

Pfizer takes on generic rivals

Pfizer filed the patent infringement case in the US District Court for the Southern District of New York on October 29. Actavis, Amneal Pharmaceuticals, Apotex and Mylan—all generic drug companies operating in the US—were named as defendants in the complaint.

Pfizer states in its complaint that the defendants filed Abbreviated New Drug Applications (ANDA) seeking approval from the US Food and Drug Administration (FDA) to sell generic copies of Viagra, despite the continuing validity of its rights over the drug.

The generic drug companies wanted FDA approval, under the Federal Food, Drug and Cosmetic Act, to market and sell 25 mg, 50 mg and 100 mg tablets of sildenafil citrate, or “generic copies of Viagra”.

Patent 6419012, or Pyrazolopyrimidinones for the Treatment of Impotence, was granted by the US Patent and Trademark Office in 2002. Its inventors assigned the patent to Pfizer.

Each generic drug company also demonstrated knowledge of the patent by notifying Pfizer of the pending ANDAs, according to the complaint.

They told Pfizer that its patent was invalid, unenforceable or unlikely to be infringed by their respective ANDA products.

Pfizer believes that this knowledge shows that the defendants were aware of the patent’s expiry date, and so should be liable for infringing it.

Pfizer is seeking a judgment from the court that would not allow the generic drug companies to “make, use, offer for sale, market or distribute” the ANDA products before the expiration of its patent.

Actavis declined to comment on the pending litigation.

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