There is no longer one ruler of the Viagra market, following a decision from the Supreme Court of Canada.
In a rare occurrence, the top court weighed in on a patent dispute in
Teva Canada Ltd. v. Pfizer Canada Inc.Teva appealed to the SCC, claiming that Pfizer did not properly disclose its invention when it obtained the patent for Viagra. The Supreme Court allowed the appeal and voided the patent, permitting Teva to launch a generic version of Viagra.
David Aitken, counsel for Teva, says through its ruling, the court has upheld the importance of the patent bargain.
“What the court has done is reaffirm the basic obligation of a patent owner to fully and correctly disclose the invention in the patent in exchange for getting a monopoly on the invention,” he says.
On behalf of a unanimous bench, Supreme Court Justice Louis LeBel wrote: “[T]he public’s right to proper disclosure was denied in this case, since the claims ended with two individually claimed compounds, thereby obscuring the true invention. The disclosure failed to state in clear terms what the invention was. Pfizer gained a benefit from the Act — exclusive monopoly rights — while withholding disclosure in spite of its disclosure obligations under the Act. As a matter of policy and sound statutory interpretation, patentees cannot be allowed to ‘game’ the system in this way.”
Aitken says Pfizer should have identified sildenafil as the effective compound to treat erectile dysfunction but instead it listed it as one of many possible compounds.
“The patent covering Viagra did not identify the fact that the compound that Pfizer had actually tested in clinical trials and found to be effective in treating [erectile dysfunction] was sildenafil,” he says.
Aitken says disclosure is essential for innovation.
“The reason why disclosure is important is because one of the purposes of the patent system is to promote innovation, and that is done in part by disclosing new and useful inventions to the public so that the public can take the benefit of those inventions for further research and development,” he says.
In the decision, LeBel referenced a ruling on patents from 1989, the SCC’s
Pioneer Hi-Bred Ltd. v. Canada: “The applicant must disclose everything that is essential for the invention to function properly. To be complete, it must meet two conditions: it must describe the invention and define the way it is produced or built.
“The applicant must define the nature of the invention and describe how it is put into operation. A failure to meet the first condition would invalidate the application for ambiguity, while a failure to meet the second invalidates it for insufficiency.”
