The IP Factor

In a 54-page ruling, Judge Michael Kelen, a Canadian federal judge, upheld the validity of the Canadian patent for Viagra, a pill for treating impotence, dismissing a bid by Novopharm Ltd. (part of Israel based Teva Pharmaceutical Industries Ltd.) to introduce a generic version of the drug.

The move, subject to appeal, prevents the Canadian Minister of Health from approving a generic version of Viagra until New York-based Pfizer’s patent expires in 2014.

Sildenafil-citrate molecule

The power of viagra - Magic!

 Kelen rejected Novopharm’s argument that it was obvious that sildenafil, the main ingredient in Viagra, would be effective in treating erectile dysfunction, stating that it wasn’t obvious in 1994, when Pfizer first developed the treatment.

 “It was the ‘holy grail’ of impotence therapy,” Kelen wrote in today’s ruling. “When it was finally learned that Pfizer had developed sildenafil for the treatment of impotence, experts wrote this was a ‘revolutionary concept.’”

“We believe intellectual property protection is vital to supporting the enormous investments required to develop life- saving new medicines,” Pfizer said in an e-mailed statement. “We will continue to take appropriate action to defend our intellectual-property rights.”

With the enormous sums of money riding on the Viagra patent, there is little doubt that Pfizer will continue to take appropriate action to defend their rights. That said, Viagra is not, and cannot be described as being a life-saving medicine since erectile disfunction, though apparently embarrassing, unpleasant and perhaps disruptive to normative physical expression of love, is nevertheless, not life-threatening.

 Viagra’s effectiveness in enabling obtaining and maintaining an erection was discovered as a valuable side effect to a research program designed to combat coronary pulmonary arterial hypertension (PAH).

Pfizer’s worldwide patents on sildenafil citrate will expire in 2011–2013. The UK patent held by Pfizer on the use of PDE5 inhibitors as treatment of impotence was invalidated in 2000 because of obviousness; this decision was upheld on appeal in 2002.

Novopharm also claimed Pfizer’s patent was invalid because it doesn’t provide enough information about the invention. The patent covers 10¹⁸ compounds, including a large number that haven’t been found effective in treating erectile dysfunction. This objection is essentially one of failure to meet the requirement of enabling disclosure, to enable the skilled person of the art to implement without undue experimentation.

 Kelen ruled that he was bound by precedents that have allowed companies to patent classes of compounds. “The patent shouldn’t be invalidated by such an objection, 13 years after it was opened for public inspection“, wrote the judge. Nevertheless, the judge criticized the practice in an obiter, writing of his discomfort with current practice allowing patents to be described in such a way that “the skilled reader must undertake a minor research project to determine which claim is the true invention.”

“The patent plays ‘hide and seek’ with the reader.”

Pfizer Canada Inc. and Novopharm Ltd. File No. T-1566-07. Federal Court of Canada (Ottawa).