Canada is taking steps to improve drug patent owners’ ability to enforce their patents.

Proactive Patent Enforcement - the NOC Regulations

The Canadian Patented Medicine (Notice of Compliance) Regulations ("NOC Regulations") allow a patent owner to apply to Federal Court to keep a generic company’s potentially infringing medicine off the market before the generic company receives Health Canada approval to sell its medicine. Health Canada is the Canadian counterpart to the US FDA. The Health Canada approval for a brand name company or generic company to sell a medicine is called an NOC. Prior to the NOC Regulations, the patent owner often had to chase the generic company after the medicine was already on the market. Since interlocutory injunctions are difficult to obtain and it takes a long time to bring a patent infringement case through to trial, there are significant benefits to a patent owner in keeping a generic company from entering the market.

The NOC Regulations operate by allowing a patent owner to request an order prohibiting the government from issuing an NOC to the generic company. In order to take advantage of the NOC Regulations, the patent owner must list its patents on a Health Canada “Patent Register” within strict time limits. If the patent owner cannot add its patent to the Patent Register, then there is no trigger for the NOC Regulations, and the patent owner is back to suing for conventional patent infringement after the generic company is on the market. Therefore the issue of whether a particular patent can be listed on the Patent Register is often hotly contested between brand and generic companies.

Combination Drugs

Health Canada’s practice had been to list patents containing a claim for an approved medicinal ingredient on the Patent Register in respect of any approved drug that includes that medicinal ingredient, even if the patent is for only one drug and the approved product contains multiple drugs.

The Problem

A couple of recent court decisions required a patent to claim all the medicinal ingredients that are in the approved drug. In Gilead Sciences Canada Inc. v Canada 2012 FCA 254, the Federal Court of Appeal refused listing to a patent that claimed only two of three medicinal ingredients in the approved drug.

In Viiv et al v. Teva et al, 2014 FC 328 and 2014 FC 893. the Federal Court followed the Gilead case’s incorrect example and held that for a patent to be eligible for addition to the Register, it must specifically claim all of the medicinal ingredients in the approved drug containing more than one medicinal ingredient. This decision is under appeal, but the government has moved forward with its amendments to avoid delay, since the Federal Court of Appeal is likely to decide consistent with its earlier decision.

Following these cases, Health Canada refused to list some patents against drugs with multiple medicinal ingredients. Health Canada was also under pressure to reconsider the listing of some patents already on the Register that covered less than all medical ingredients in a combination drug.

The Solution - Amendments to the NOC Regulations

On May 2, 2015, the federal government issued draft regulations to improve brand name companies’ ability to list patents on the Patent Register to protect combination drugs. These regulations are in response to two recent Federal Court decisions that took a narrow approach to the NOC Regulations. According to Health Canada, the Courts’ narrow approach to listing eligibility requirements conflicted with the intent the Regulations, necessitating the amendments. The Canadian brand name companies’ association, called Rx&D, had been actively advocating for these amendments.

The new amendments allow relevant product, formulation and use patents to now be listed against combination drugs. This saves Health Canada from punting a bunch of patents off the Register. There is a transition period for previously refused patents to be reconsidered for listing.

Comments on the new regulations must be filed by June 1, 2015.

This position by Health Canada makes good sense. If there is a clinical benefit to combine a drug with another drug, a company should be encouraged to make this combination. Reducing patent protection would discourage such combinations, and patients could lose out.