PM(NOC) Regulations

Proposed amendments to the PM(NOC) Regulations have been published in the Canada Gazette Part I, relating to the listing of patents claiming single medicinal ingredients found in combination drugs. The government indicated its plans to make these amendments in the fall of 2014, following Court decisions in Gilead and Viiv.

The Canada Gazette publication indicated that recent decisions are contrary to the intention of the regulations:

Two recent decisions of the Federal Court and Federal Court of Appeal have reinterpreted the requirements of section 4 of thePatented Medicines (Notice of Compliance) Regulations [the PM(NOC) Regulations] regarding the eligibility for listing on the patent register of patents claiming one or more medicinal ingredients in a manner that conflicts with the intent of the Governor in Council in making the Regulations.

The decisions referred to are:

  • Gilead Sciences Canada Inc. v. The Minister of Health and The Attorney General of Canada 2012 FCA 254 (an appeal from Mosley in 2012 FC 2) – which held in part that “the relevant claims in the ‘475 Patent do not meet the requirements of paragraphs 4(2)(a) as they lack strict product specificity with regards to the three medicinal ingredients listed in the NDS.”
  • ViiV Healthcare ULC v. Teva Canada Limited, 2015 FCA 93 (a recently issued appeal from Justice Hughes in 2014 FC 893 and Prothonotary Milczynski in 2014 FC 328) – which in part, ” In our view, both the Prothonotary and the Federal Court judge correctly concluded that Gilead applies to the facts of this case. In Gilead, this Court found that paragraph 4(2)(a) of the Regulations sets an exacting threshold of specificity between what is claimed in the patent and what has been approved in the NOC—a patent that does not explicitly claim all of the medicinal ingredients contained in the drug for which the NOC was issued cannot be listed against that drug.” The Minister had argued that Gilead was wrongly decided.

The proposed regulations provide that patents are eligible to be listed under the following conditions, as set out in the proposed new section 4(2.1):

(a) for the purposes of paragraph (2)(a), a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients;

(b) for the purposes of paragraph (2)(b), a patent that contains a claim for the formulation is eligible if the submission includes the non-medicinal ingredients specified in the claim, if any are specified, even if the submission contains any additional non-medicinal ingredients; and

(c) for the purposes of paragraph (2)(d), a patent that contains a claim for the use of the medicinal ingredient is eligible if the submission includes the use claimed in the patent, even if

(i) the submission includes additional medicinal ingredients,

(ii) the submission includes other additional uses of the medicinal ingredient, or

(iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.

Transition provisions would permit patents removed pursuant to the Court’s interpretation of 4(2) to be added within 30 days of the making of the Regulations and deals with NOC proceedings started now, or which are pending.

See my earlier post on this issue. Interested parties have 30 days to submit comments to Industry Canada.