LMG Life Sciences - Page 166

FEATURED CONTENT CANADA Featured Article The Same But Different: Patent Linkage in Canada Same drugs, similar patents, different strategies. Vik Tenekjian, Emily Kettel, and Jamie Goodman, Gilbert’s LLP, Toronto S imilar to the US, Canada has a patent linkage system that requires generics to address certain patents before obtaining regulatory approval of drugs. Although in theory the two systems are similar, in practice there are nuances that make them different, resulting in the emergence of different brand and generic strategies on either side of the border. Some of the key differences explained more fully below relate to the scope of the proceedings, the availability of appeal, the nature and availability of damages, and different incentives, all of which result in different cross-border strategies for both brands and generics in the litigation. Patent Linkage North of the Border At its most basic, linkage requires that certain patents related to innovative drugs be listed on a registry, and addressed by generic manufacturers before regulatory approval is granted. In Canada, this system is established by the Patented Medicines (Notice of C ompliance) Regulations, or the “PM(NOC) Regulations”. The Minister of Health maintains the “Patent Register”, similar to the Orange Book. Brands can seek to have patents listed on the Patent Register in connection with their drug products. Eligible patents must contain a claim to the approved medicinal ingredient, approved formulation, approved dosage form or approved use of the medicinal ingredient. The PM(NOC) Regulations are triggered when a generic files a regulatory submission that compares its drug with, or makes reference to, another drug marketed in Canada (including a biologic), in respect of which patents are listed on the Patent Register. In its submission, the generic manufacturer must, in respect of each patent listed on the Patent Register for the comparison drug in question, agree to await patent expiry before obtaining regulatory approval, or allege that the patent is invalid or will not be infringed by the generic product. The generic’s allegations are contained in a “Notice of Allegation”, or “NOA,” which is served on the brand any time after the generic’s regulatory submission has been filed. Similar to the “Notice Letter” in the US, the NOA provides notice to the brand that a generic is seeking to enter the market, and triggers the brand’s right to commence proceedings to prevent the generic’s entry prior to patent expiry. In Canada, litigation under the PM(NOC) Regulations is by way of application, in which the brand seeks an order from the court (a “Prohibition Order”) prohibiting Health Canada from approving the generic’s product and granting it a Notice of Compliance. The Application is designed to be summary in nature, and factual and expert evidence is tendered by way of affidavit only. Like in the US, the commencement of this litigation triggers an automatic stay of approval of the generic product (although Health Canada continues its review of the regulatory submission) – in this case, for a period of 24 months, as opposed to 30 months. decisions tie to the patent(s) at issue, PM(NOC) decisions tie only to the NOA. An invalidity finding in a PM(NOC) proceeding is only effective as between parties and is not a declaration in rem of patent invalidity. By contrast, in the US, a finding of invalidity in a linkage proceeding is effectively a declaration of invalidity of the patent for all purposes. This leads to some important distinctions between the two systems. Perhaps most notably, in Canada, later-to-the-game generics will not automatically benefit from the success of an earlier generic that succeeds in its invalidity allegation in the PM(NOC) proceeding. Notwithstanding, if a brand seeks to prohibit the entry of a second generic, the PM(NOC) Regulations do allow for a later-to-the-game generic to bring a motion to dismiss the application on the basis that the brand is engaging in an abuse of process, and this provision is often Differences Explained Although the Canadian and US systems of linkage serve the same broad purpose, there are nuances of the systems that differently drive brand and generic strategies. Perhaps most notably, in a PM(NOC) case, the litigation does not address the infringement or validity of the patent(s) in general, but rather, only in connection with the specific allegations contained in the NOA that triggered the litigation. As a result, unlike in the US where Hatch-Waxman Although in theory the two systems are similar, in practice there are nuances that make them different, resulting in the emergence of different brand and generic strategies on either side of the border. LMG LIFE SCIENCES 2013 153