Apotex v. Allergan

Drug: brimonidine/timolol

The Federal Court of Appeal (FCA) upheld the granting of an order of prohibition against Apotex. However, the FCA also held that it was not open for the Federal Court judge to grant a prohibition order in order to seek clarification of the jurisprudence. The Federal Court decision can be found here, and our summary here.

The FCA held that prohibition can only be granted if the conditions set out in the NOC Regulations are met, and in this case, they were not. Nevertheless, the Federal Court did issue the prohibition order, and thus the case was appealed to the FCA. In considering the doctrine of comity, the FCA held that it is a manifestation of the principle of stare decisis, and only applies to determinations of law, not factual findings, as in theory, there can only be one correct answer to a question of law. The FCA held that a finding that an invention is obvious because the solution proposed was plain to see is one of fact. However, construing the patent for an inventive concept is a question of law.  

In this case, the Federal Court judge did not identify any error, or rely on distinct evidence to explain his diverging view of the previous construction of the patent. The FCA held that construing a patent is no less a determination of law merely because the document being construed is drafted by the patentee rather than Parliament. However, since there are now contradictory decisions on construction, the FCA must determine which is correct.  

The FCA considered the reasons of the Supreme Court of Canada in the recent Teva v. Pfizer decision, and held that the entire specification must be considered to determine the nature of the invention. Thus, in this case, the improved safety profile forms part of the claimed invention. The FCA considered the remainder of the factors in the test for obviousness, and found the allegations as to obviousness not justified.