Lipitor Canada

In the Lipitor case, Ranbaxy Laboratories had alleged non-infringement of the patent covering crystal Form I of atorvastatin calcium. The dispute centred on the intermediates used in the process to make Ranbaxy?s active pharmaceutical ingredient. Justice Snider held that the intermediates included all of the elements of the claims.
Ranbaxy argued, however, that its product would be made in India and therefore the use of the patented intermediates would not infringe the Canadian patent. The issue turned on the application of the so-called Saccharin Doctrine. In the Saccharin case (a U.K. case), the defendant made saccharin in a foreign country, employing a certain process and intermediate. Saccharin Corp. owned a U.K. patent covering the process to make the intermediate. The defendant made the intermediate using the patented process, then converted the intermediate to saccharin and imported the saccharin into the United Kingdom.
Even though the process was carried out entirely outside the United Kingdom, the Court held that the patentee is deprived of some part of the invention when the saccharin (made using an infringing process) is imported and that the defendant had infringed the patent.
In the Lipitor case, Ranbaxy argued that the Saccharin Doctrine did not apply and that its application would require an ?extension of a legal principle.? Ranbaxy argued that the Saccharin Doctrine is limited to process claims. It went on to argue that, as the intermediate in this case was covered by a product claim and not a process claim, there could be no infringement. Justice Snider rejected this argument and upheld the application of the Saccharin Doctrine in Canada, finding that there was no reason to limit the application of the Saccharin Doctrine to process claims. She concluded that the focus of the analysis was on whether the patentee had been deprived of any part of the invention.
This decision reaffirms the application of the Saccharin Doctrine in Canada. Ranbaxy is prohibited from obtaining marketing approval for its generic version of Lipitor until the expiry of the patent in 2016. The decision is subject to appeal.
As a result of this decision, pharmaceutical manufacturers, particularly generic drug manufacturers, will not be allowed to avoid infringement of Canadian patents by using patented intermediates or patented processes offshore, then importing the active ingredient or finished product to Canada. Like the Viagra decision, the Lipitor decision is further recognition of the importance of inventions.