Patent containing claim to single medicinal ingredient not eligible to be listed against combination product

 On April 3, 2014, Prothonotary Milczynski granted Teva’s 6(5)(a) motion finding that Canadian Patent No. 2,289,753 is not eligible to be listed on the Patent Register against ViiV’s KIVEXA^®product, a fixed dose combination containing abacavir sulfate and lamivudine.

The specification of the 753 Patent discloses that abacavir sulfate may be combined with other therapeutic agents from several classes, including, but not limited to nucleoside reverse transcriptase inhibitors (NRTIs). The disclosure of the 753 Patent identifies lamivudine as a possible NRTI.

Claim 2 of the 753 Patent claims abacavir hemisulfate per se. Claim 32 provides:

32.       A pharmaceutical formulation as claimed in any one of claims 25 to 31, additionally comprising one or more therapeutic agents selected from the group consisting of nucleoside reverse transcriptase inhibitors,  non-nucleoside reverse transcriptase inhibitors, protease inhibitors, immune modulators and interferons.

Prothonotary Milczynski, following the Court of Appeal in Gilead (see our previous post here) Purdue and Bayer and the recent decision of the Federal Court in Eli Lilly, held that the Regulations require precise matching between the patent claims and the approved medicinal ingredients.  Prothonotary Milczynski rejected ViiV’s and the Minister’s submissions that paragraph 4(2)(a) permits a patent containing a claim to a single medicinal ingredient to be listed against a fixed dose combination containing the claimed medicinal ingredient in combination with other medicinal ingredients:

 Similarly, in the case of KIVEXA^®, no claim of the 753 Patent specifically claims the combination of the two medicinal ingredients that are the subject of the NOC for KIVEXA^®, namely abacavir sulfate and lamivudine.  There is nothing in the 753 Patent that requires lamivudine.  The 753 Patent claims only abacavir in combination with another unnamed medicinal ingredient. Section 4(2)(a) of the PMNOC Regulations, as held in Gilead, requires all of the medicinal ingredients identified in the submission that results in the issuance of the NOC to be claimed in the patent for that patent to be listed on the Patent Register.  In the same manner, the specific formulation identified in the submission that led to the issuance of the NOC must be claimed in the patent.  In the case of the 753 Patent, it is not enough that it encompasses the medicinal ingredient lamivudine (among others) in combination with abacavir for the purposes of section 4(2)(b) of the Regulations.

Teva was represented by Aitken Klee LLP.

A copy of Prothonotary Milczynski’s Reasons for Order may be found here.

ViiV’s appeal of Prothonotary Milczynski’s Order was dismissed by Justice Hughes on Spetember 18, 2014.  See our post here.