Appeal of a judicial review; 2009 FCA 183; ramipril; June 1, 2009

The Court of Appeal upheld the decision of the trial judge holding that the generic company was not required to address the patents listed on the patent register against submissions filed after it had purchased its comparator drug.

The generic company had purchased its comparator drug and submitted an ANDS on the basis of asserted bioequivalence. It withdrew its ANDS in respect of one of the strengths due to a lack of stability but then refiled it two and a half years later. During the intervening timeframe, additional patents had been listed on the Patent Register. The Minister tried to require the generic company to address these patents. The Court found that this was not appropriate under the Supreme Court decision in Astra Zeneca.

The Minister argued that the generic company should be required to address any patent that is notionally available for early marketing, which means any patent listed prior to the ANDS or SANDS. However, the Court of Appeal did not accept this argument, finding that it is the Minister’s responsibility to conduct a patent-specific analysis and identify the precise patents that are relevant to the generic manufacturer’s early working of a copycat product. The date the comparator drug was purchased is the starting point. The Minister must then evaluate the evidence to determine whether the generic company is taking advantage of any of the teachings of any after listed patents.

As the Minister failed to conduct this analysis, it was open for the trial judge to do so. In this case, the Court found that Pharmascience had never sought approval of the new uses claimed in the after-listed patents. Thus, they did not need to be addressed.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2009/2009fca183/2009fca183.html