Developing a solid patent strategy is key to the success of many businesses but especially for pharmaceuticals and biologics. This article provides a brief overview of some key elements of a successful strategy with many of the areas discussed in greater detail in subsequent articles.
Data Protection and Patent Protection
Innovators can protect data that supports regulatory approval for innovative compounds. Regardless of patent rights, this protection applies for a maximum of eight years and six months from the time of issuance of the first Notice of Compliance (NOC) for a new medicinal ingredient (six years of data package exclusivity, two years of market exclusivity, and potentially a six-month pediatric extension).
However, the patent portfolio of a drug product remains the first line of defence to recoup research and development investment. The innovator must align its regulatory submissions with its patent portfolio since data protection is limited for certain drug products. For example, therapeutic combinations may have little or no data protection where the medicinal ingredients were previously approved by NOC. The Minister may deny innovative drug status to a product at any time. Consequently, patent enforcement remains essential for rights holders and the PM(NOC) Regulations (linkage) remain the best vehicle for protecting the innovator's market.
The Timing Requirement
Patents in respect of a drug must be submitted for listing upon filing of the related New Drug Submission (NDS) or a supplement to the NDS. If the patent is still pending at regulatory filing, the patent list must be filed within 30 days of issuance of the patent in respect of all submissions to which it pertains.
Moreover, the patent must have a Canadian filing date that precedes the filing date of the NDS or of the supplement to the NDS to which it relates. These timing requirements serve the sole purpose of limiting the opportunity for listing and enforcing innovator patents. No extensions of time are granted for meeting fi ling requirements.
The Relevance Requirement
Prior to 2006, a patent was relevant and could be listed in respect of a drug if the patent claims could cover a competing product. In 2006, the Minister changed the law to require specificity of the patent claims to cover the innovator's product, based upon the submissions filed.
Recent jurisprudence of the Federal Court suggests an additional requirement not addressed in the Patent Act or in the Patented Medicines (Notice of Compliance) Regulations. Arguably the claims of the patent must not only cover the innovator's product, but also specifically recite the subject matter for which a Notice of Compliance was granted in the claim. This undue narrowing of patents that may be listed restricts the innovator's ability to maintain market exclusivity by virtue of its patent portfolio. To improve the likelihood for listing, the innovator should, where practicable, include language in the patent specification that specifically (or narrowly) recites the commercial product and/or its commercial use.
Claims relating to processes of manufacture, key intermediates or metabolites remain ineligible for listing. Where an innovator uses a claimed invention to manufacture its product, the generic infringes those claims when comparing its product to the innovator's. However, linkage currently provides no relief for this patent infringement.
The linkage regulations provide that a generic entrant may freeze the Patent Register before the innovator is able to list all of its patents, ensuring that delays in listing a patent prejudice the innovator. The Patent Register is frozen by filing an abbreviated New Drug Submission, such that the generic need not address any subsequently listed patents. Consequently, enforcing patents requires rapid and diligent prosecution to secure listing as early as possible.
Based on current jurisprudence, filing a patent list prior to the generic filing of an Abbreviated New Drug Submission (ANDS) is not sufficient to prevent the patent freeze. The Minister requires the innovator to have obtained an actual listing of the patent on the Patent Register prior to a generic filing of its ANDS. The Court does not currently recognize the filing date of the patent list, only the date of listing. Unless the innovator's product has data package exclusivity, a generic ANDS may be filed at any time, triggering the patent freeze.
Once a NOC for an innovative product has been received, essentially all related patents should be issued, and patent lists filed and listed, especially where there is no data package exclusivity, or where data protection is about to lapse.
Since interlocutory injunctions are unavailable in patent infringement actions in the pharmaceutical industry, innovators must understand that failure to engage linkage allows generics to cannibalize an innovator's market share upon issuance of a NOC for a competing product. Linkage provides a warning of oncoming generic early working of a product, and remains the best means of protecting that market.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.