Amendment to Canada’s Drug Patent Rules Closes a Loophole

Jul 03 2008

A recent amendment to Canada’s drug patent “linkage” rules removes a risk faced by originator drug companies that their patents on the Patent Register could be summarily “de-listed”. Patents that were previously considered vulnerable to removal at the instance of the Minister of Health now have a more secure future on the Register. As well, administrative proceedings against generics can no longer be dismissed on the basis that the underlying patent was improperly listed. This amendment relates only to so-called “grandfathered” patents that were listed on the Register before June 17, 2006.

The Patent Register, generally equivalent to the U.S. “Orange Book”, permits drug manufacturers to list patents relevant to their drugs as a mechanism to delay generic competition. The listed patents provide the basis of an administrative law proceeding to block introduction of a generic drug in a reasonably expeditious fashion. However, recent Supreme Court of Canada jurisprudence exposed a weakness in this mechanism, in that listed patents could be removed if they were found not to be “relevant” to the underlying Notice of Compliance of the originator’s drug. As well, an administrative action against a generic could be summarily dismissed for this reason.

Prior to June 17, 2006, the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) permitted a drug manufacturer to list any patent (that the manufacturer owned, exclusively licensed, or had consent to list) on the Patent Register. The patent had to claim the approved medicine or its use or formulation. However, the patent was not required to claim the identical use or formulation as that of the approved drug. After June 17, 2006, the requirements were tightened such that patents could be listed only if they were relevant to the specific wording of the drug approval. For example, a patent claiming a drug formulation could only be listed on the Register if it claimed the same formulation described in the drug approval. Patents that were listed on the Register before June 17, 2006 were “grandfathered” and were permitted to remain on the Register even if they did not meet the new, stricter “relevancy” requirement. However, the grandfathering of older patents was put into question by AstraZeneca Canada Inc. v. Canada1 a Supreme Court of Canada decision rendered shortly after the coming into force of the 2006 amendment, which judicially imposed a “relevancy” requirement similar to that required for newly-listed patents. This decision was followed in several subsequent decisions which removed patents from the Register and dismissed actions against generics on the basis of improper listing of patents, with the result that some drugs have faced generic competition sooner than expected.

The recent amendment to the PMNOC Regulations is intended to restore the original intent of the “grandfathering” provisions, namely to ensure that patents that do not meet the current “relevancy” standard may remain on the register and that an action against a generic cannot be dismissed solely for a lack of relevancy of the patent to the drug. As well, any patent that was removed from the Register or refused a listing may be placed back on the Register. However, the manufacturer must apply to Health Canada by July 12, 2008 in order to place such a patent on the Register.

Please contact us if you require any further information regarding the new amendment to the Patented Medicines (Notice of Compliance) Regulations.

This article is for information purposes only and does not constitute legal or professional advice.

1 [2006] S.C.J. No. 49;

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Tags: Patents, Pharmaceutical, PM(NOC)