Pfizer’s Patent on Viagra is being invalidated by the Supreme Court of Canada

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Canada’s Supreme Court is invalidating Pfizer’s patent on Viagra, the world-famous
little blue pill for Erectile Dysfunction.  Reason: Canadian intellectual property law requires the open disclosure of the active ingredients of the drug, and Pfizer has failed to do that.

The Canadian Pfizer patent for Viagra normally expires in 2014. This decision underscores the major difference of the Canadian and United States courts in the interpretation of patent laws.

Both Canada and the United States have in place a ‘patent bargain’ that requires pharmaceutical companies to disclose the active ingredients/chemical compounds of a drug in enough detail. This requirement is for the benefit of scientists to enable them to use the information to replicate the formulae, learn from these creations, with the ultimate aim of benefiting society.

The gift for this exchange is the exclusive rights, in this case, Pfizer, to market the product for a determined period of time.

The Canadian High Court ruled that “…sufficiency of disclosure lies at the very heart of the patent system…” and that “…adequate disclosure in the specification is a precondition for the granting of a patent.”

According to the Canadian Court, Pfizer based in New York, did not live up to that bargain. A lawsuit brought by Israeli-based Teva Pharmaceuticals Industries, led to this ruling. According the justices of the Canadian Supreme Court, Pfizer failed to disclose the active ingredient in the formula, Sildenafil. The other listed ingredients in the patent were ineffective in the treatment of erectile dysfunction.

The Canadian Court’s decision is vastly different from the US Courts that do not invalidate patents for the same reason.

In another lawsuit brought about by Teva to invalidate the patent held by Pfizer for Viagra, due to expire in 2019, a US Federal Judge in Virginia upheld the patent. Teva argued that the remedial discovery for erectile dysfunction was not patent-worthy. In addition, Pfizer had with-held that information from the US patent office.

In another case in the same year, the US Court of Appeals for the Federal Circuit ruled in a precedent-setting decision that patents may only be declared unenforceable if the undisclosed information affected the patent’s office to grant a patent.

Harry Cox