Drug: LOSEC® omeprazole
AstraZeneca sued Apotex for infringement of its patent relating to the formulation of the drug omeprazole. Apotex argued invalidity and non-infringement. The Court found several claims valid and infringed.
The patent described that omeprazole needed to be protected from the acid in the stomach, but an enteric coating would degrade the omeprazole. The invention included an inert subcoating that was applied between the omeprazole and the enteric coating.
The construction of claim 1 was a key issue. AstraZeneca argued that as long as all the elements were present and formed a viable formulation, it does not matter how the inert subcoating is formed. So, AstraZeneca said that a subcoating that forms in situ from a reaction between the core and the enteric coating is a matter of process that does not circumscribe or limit the claim to the product. Apotex disagreed.
The Court found that although an in situ subcoating may not have been in the minds of the inventors, all they had to do was disclose one viable method of manufacture and not limit their claim drafting to a single embodiment. The Court further stated that a patentee is not obligated to teach its competitors how to avoid infringing.
As for infringement, Apotex criticized AstraZeneca’s testing, but did not perform any testing of its own. The criticism was not found to sway the Court. Also, while the testing was performedex parte, the work was found to be appropriately recorded and the results were subject to review and criticism. Furthermore, where the work could be easily reproduced, the Court rejected any suggestion the results he obtained were anything other than he has reported.
Some additional issues were discussed, including: whether AstraZeneca had standing to bring the claim (it did); whether foreign issue estoppel should be applied (it was not); whether Apotex had deceived AstraZeneca in the NOC application where it put forward a formulation that was not ultimately used (no deception found); the applicable statute of limitations (the Federal 6 years was allowed over Ontario’s 2 years); and the allowance for AstraZeneca to claim an accounting of profits.
This decision only related to liability, as the proceeding was bifurcated. The issue of costs and the accounting of profits remains to be decided.