Canada's Patented Medicines (Notice of Compliance) Regulations (the "Regulations") have become the de facto means of protecting patented pharmaceuticals in Canada. Some companies list their patents on the Patent Register maintained by the Minister of Health and then wait for a generic challenge. Follow these steps and you will be better prepared to fend off generic challengers and keep within your budget.
Begin at the Beginning
- Good patent protection starts before the patent issues:
- Be familiar with the types of patents that are eligible for listing on the Patent Register and make sure that your patent applications contain claims that will make them eligible for listing.
- Be aware of developments in Canadian law. For example recent jurisprudence has suggested that:
The basis for a sound prediction of utility must be shown in the patent. This may require data to be included in Canadian patents that would not be required in other countries.
A patent applicant’s failure to act in good faith when communicating with the Patent Examiner can lead to later invalidation of an issued patent. A generic challenger may allege that mistakes or omissions in an applicant’s statements to the Patent Examiner are evidence of bad faith.
- Ensure that all relevant patents are listed on the Patent Register:
- Patents must be added to the Patent Register in accordance with the strict timing requirements of the Regulations and must meet the new eligibility criteria.
- Make sure that all relevant issued patents are included on the patent list when filing a new drug submission.
- Review all Canadian patents that are relevant to your company’s products, not just those on the Patent Register:
- Is your product’s exclusivity at risk because of unknown problems with your patent portfolio? For example, do claims in two patents overlap, putting them at risk for a double-patenting attack? Are the claims too broad, putting them at risk for an overbreadth attack? Potential problems with issued patents can sometimes be corrected via re-issue (which is time-limited), disclaimer or dedication. However, recent jurisprudence suggests that corrective steps must be taken before a generic challenges the patent by way of a notice of allegation (NOA).
- Ensure that your company has a procedure to deal with generic notices of allegation as soon as they are received:
- Your company has forty-five days after receipt of a generic NOA to start a proceeding in the Federal Court. That deadline cannot be extended.
Your company receives a notice of allegation – now what?
- Deal with it immediately:
- Unless you plan to handle the matter internally, send a copy of the NOA and envelope (the postmark or courier waybill number may be critically important) to outside counsel. They will confirm whether the NOA meets the requirements of the Regulations, and can advise whether, and on what basis, the NOA can be challenged.
- Establish an effective working relationship with your outside counsel:
- Set a budget early and consider innovative approaches to budgeting. Remember to account for expert witnesses who can eat up a large chunk of your budget.
- Arrange for regular updates from counsel. This ensures that matters stay on schedule (and within budget) and that potential problems are caught early.
- Contact employees, such as inventors or regulatory affairs managers, who may need to provide evidence early on. Start looking for required documents, such as lab reports or regulatory filings, well ahead of time.
- Keep an eye on the big picture:
- Choose your battles wisely. Assess the merits of interlocutory motions, their importance to the overall litigation strategy and cost. Many interlocutory skirmishes can be avoided through reasonable compromise.
- Re-evaluate strategy as the case evolves and consider settlement if changing circumstances warrant it. If you do consider settlement, keep the Competition Act in mind.
- Generic challenges to a product often come in waves. Consider how future generic challenges can be dealt with efficiently.
- Prepare for the hearing early:
- Your written argument is usually due months before the hearing. At the hearing, the parties may also submit written outlines of oral argument, a compendium of evidence and visual aids. Allow adequate time for preparation and approval of everything that will be used at the hearing.
- Prepare for bad news:
- Identify the window during which the court’s decision can be released. If the court rules against your company, you may be facing generic competition within days. Ensure that the company is ready to react quickly.
- A successful generic can sue for damages it suffers by being kept off the market during a proceeding under the Regulations. Inform management of this possibility.
How can you deal with all of these issues?
10. Get the right people for the job:
- Ogilvy Renault LLP’s pharma team has been dealing with every aspect of the Regulations since before they came into force in 1993. You can benefit from our experience and expertise at every stage of the process, from patent prosecution to listing to litigation. We also understand the need for innovation and flexibility when your legal budgets are under unprecedented pressure.
- Be pro-active. Don’t wait for that envelope to land on your desk.