Overrun by nettles: Government to prune the PM(NOC) Regulations

Industry Canada has announced its intention to amend  the Patented Medicines (Notice of Compliance) Regulations. These proposed changes focus on the issue of “combination drugs”, which are therapies using multiple medicinal ingredients in combination.

Under current jurisprudence, for a patent to be properly listed on the Government’s patent register, all medicinal ingredients in a combination therapy must be claimed in at least one claim. Where a patent claims only a subset of the approved medicinal ingredients, any prohibition application based on that patent may be vulnerable to a summary dismissal motion under s. 6(5) of the Regulations.

The proposed amendments are due to “recent Federal Court and Federal Court of Appeal decisions relating to patents claiming single medicinal ingredients found in combination drugs.” These decisions are likely Gilead Sciences Canada, dealing with a fixed dose combination of emtricitabine/rilpivirine/tenofovir disopoxil fumarate (COMPLERA), and ViiV Healthcare ULC dealing with a fixed dose combination of abacavir sulfate/lamivudine (KIVEXA).

In Gilead, the Court construed the inventive concept of Canadian Patent No, 2,512,475 as “…combinations and formulations of two medicinal ingredients plus a third one…”. Because the third one, riliprivine, was not specifically claimed in any claim of the 475 Patent, the Court of Appeal concluded that patent was not eligible for listing against COMPLERA (see our previous post here).

In ViiV, Prothonotary Milczynski granted Teva’s 6(5) motion that Canadian patent No. 2,289,753 directed to abacavir hemisulfate was not eligible to be listed against a fixed dose combination containing two approved medicinal ingredients (see our previous post here). This decision was upheld by Justice Hughes largely following COMPLERA  (see our previous post here). ViiV has appealed Justice Hughes’ judgment in the Teva KIVEXA matter and in a companion case involving another generic, Apotex.

Industry Canada’s language suggests the amendments will allow patents to be listed on the patent register even where those patents do not claim all medicinal ingredients in a combination drug. It remains to be seen whether the Government will take this opportunity to maintain a balance between brand and generic rights by amending other aspects of the Regulations, such as the scope of the Court’s discretion under s. 8(5). Interested stakeholders will have an opportunity to comment when the proposed amendments are pre-published in Part I of the Canada Gazette.

Note: David Aitken and Scott Beeser of Aitken Klee LLP successfully represented Teva Canada Limited in the ViiV KIVEXA matter.

Industry Canada’s notice of forthcoming amendments to the PM(NOC) Regulations is available here.