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SEALING ORDER)

Intellectual property – Patents – Medicines – AstraZeneca’s patent for omeprazole found to be valid and infringed by Apotex’s generic version of drug – Whether conflicting authority in law of patent construction to make sure that the public can rely on language used in a patent to assess lawfulness of proposed activity, and so as to allow doctrines of insufficiency, ambiguity and overbreadth to function to protect the public from misleading and/or overreaching patents requires resolution – Whether acts that occur within a province leading to the export of goods from that province is activity that occurs other than within a province within the meaning of the Federal Courts Act, R.S.C., 1985, c. F-7, ss. 39.

The respondents (collectively, “Astra”) are the owners of the 693 Patent for omeprazole, a medicine useful in the treatment of gastrointestinal diseases. Omeprazole was discovered to be a difficult pharmaceutical ingredient to formulate as it has low solubility and is very acid and moisture sensitive. Astra’s solution in the 693 Patent was to finely balance the incompatibility between alkalinity necessary for acceptable storage stability and the preservation of the enteric coating necessary for good gastric acid resistance. Astra commercialized the preparation under the brand name, Losec. Apotex sought to work around the 693 Patent and thought it had successfully done so by employing a different process than the one covered by Claim 17 and described in the disclosure of the 693 Patent. In January 2004, Apotex received a Notice of Compliance from Health Canada to market its generic version of the drug. Astra’s scientists conducted tests on Apotex’s version of the drug and established that its preparation of omeprazole had a core containing omeprazole and an alkaline reacting compound, an outer enteric coat and a subcoat containing an inert layer of polymeric film as a barrier between the core and the enteric coat. Apotex’s subcoat was formed by a chemical reaction between the enteric coating and the core when the enteric coating was applied during manufacture. In Astra’s omeprazole product, the subcoating was applied to the core. Astra brought an action for patent infringement and Apotex counterclaimed, claiming that the 693 was invalid on a number of grounds.