Federal Court Strengthens the Extraterritorial Reach of Canadian Patent Law

The Federal Court, in its recent decision in Pfizer Canada Inc et al v The Minister of Health et al [2007 FC 898], has extended the extraterritorial reach of Canadian patent law. The case involves an application brought by Pfizer Canada Inc (Pfizer) under the Patented Medicine (Notice of Compliance) Regulations to prevent the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Limited (Ranbaxy) for the anti-cholesterol drug atorvastatin calcium (Lipitor®). Central to the dispute was the issue whether Ranbaxy infringed Canadian Patent No 2,220,018 (the "˜018 Patent), which claims a crystalline form of atorvastatin calcium (Form I). Form I is an intermediate used in the production of the amorphous form of atorvastatin calcium, which is the form marketed by Pfizer and the subject of Ranbaxy's Abbreviated New Drug Submission. Ranbaxy manufactures the amorphous atorvastatin in India, using the patented Form I substance as an intermediate. It asserted that it does not infringe the "˜018 Patent, because it uses the patented Form I substance only in India and this form is not contained in the amorphous form for which it seeks marketing authorization. The Court disagreed with Ranbaxy's assertion, finding that it had infringed the "˜018 Patent, holding that the Saccharin doctrine (derived from the 1900 English Chancery case of Saccharin Corp Ltd v Anglo-Continental Chemical Works Ltd) extends to product patents. The Saccharin doctrine holds that a process patent may be infringed when the patented process is used in a foreign country to produce a substance that is then imported into Canada for sale. While the jurisprudence does not address the foreign use of product patents, the Court held that it was logical to extend the doctrine to product patents because the doctrine's main aim is to prevent the deprivation of the patentee's full right to the monopoly conferred by the patent. Ranbaxy argued that this extension could lead to absurd results, especially when the product is not contained in the final product sold in Canada. It gave the example of the use of scissors that are protected by a Canadian patent, to cut the cloth for an Indian-made suit that is imported into Canada. Could the sale of the suit possibly infringe the scissor patent? To avoid such a result, the Court held that there must be a "strong link" between the use of the patented product and the product sold in Canada. It listed the following factors to consider when assessing whether this link exists:

• the importance of the patented product to the final product sold in Canada;
• whether the product actually contains all or part of the patented product;
• the stage at which the patented product or process is used; and
• the number of instances of use made of the patented product or process.

Ranbaxy's use was considered to infringe largely because it used the patented Form I in multiple steps in the production process, particularly at late stages, and the Court ruled that the amorphous form could not be produced without it. For the full decision, see: http://decisions.fct-cf.gc.ca/en/2007/2007fc898/2007fc898.html Summary by: Michael Migus