Sandoz Federal Court Decision Also Released

A decision in the second case before the Federal Court that I had written about in my early May posting (Sandoz v Attorney General of Canada) has also been issued by the Federal Court.

The Sandoz case was also heard by Mr. Justice O’Reilly and its reasoning and decision mirrors the Ratiopharm case below in that he rejected the PMPRB Board’s decision that Sandoz was a “patentee” subject to the Board’s jurisdiction.

The immediately noteworthy aspect of the Sandoz case is that it expands our understanding of the limits that the Federal Court would place on the PMPRB definition of patentee.

Whereas in the Ratiopharm case, the generic company was truly an arm’s length third-party that had acquired its rights to sell ratio-salbutramol HFA via a contract from GSK that clearly stipulated that GSK retained all intellectual property rights to the drug, Sandoz was and is a wholly owned subsidiary of parent company and patent holder Novartis (and its relationship and dealings with Novartis regarding generic products were not subject to any formal written contract).  Nevertheless, the Federal Court still did not think that Sandoz could reasonably be considered a patentee.

I would not have been astonished if the Federal Court had concluded that Sandoz was a patentee within the jurisdiction of the PMPRB because the factual differences just noted supported a conclusion that Sandoz was in essence a corporate extension of the Novartis parent, and therefore Sandoz did in fact enjoy sufficient benefit of the patents held by the parent company.

This was clearly not the case, and the Federal Court in these two decisions certainly appears to be saying that the PMPRB’s jurisdiction is limited for usual and normal purposes to only those companies that are actually the patent holders, whether they be generic or innovator companies.

As stated below, both of these decisions will likely be appealed so there’s definitely more to come.

Leave a Reply