Canadian patents: what savvy businesses need to know

Where to pursue patent protection for an invention is always an important question, as patents are enforceable only in the jurisdictions where they issue and budget constraints are limiting. Although Canada may be a relatively small market for many technologies, there are several overriding reasons to file a patent application in Canada.

Canada’s closest neighbour is the United States, which has the largest economy and consumer market in the world. However, patent litigation costs are significantly lower in Canada than in the United States. If an invention is being made in Canada and exported to the United States, a successful Canadian patent infringement action may achieve benefits in both countries. In addition, Canada is rich in natural resources, so patents for inventions related to, for example, the oil and gas, forestry, agriculture and mining industries can be valuable assets for parties wishing to partner with established Canadian companies.

The patent regime in Canada is flexible, which allows for good opportunities to form advantageous strategies. First, Canada is one of the few countries in the world where a one-year grace period is available for disclosures made by the inventor or applicant. Therefore, a Patent Cooperation Treaty (PCT) application or national Canadian application may be filed within one year of, for example, a journal article published by the inventor or a talk given at a trade show by the applicant.

Additionally, there is no limit to the number of claims that may be included in a Canadian patent application, including independent claims and multiple-dependent claims. Unlike in several other countries, there are also no excess claim fees in Canada. Some Canadian patents include hundreds of claims, which can impose a large burden on a potential infringer to prove non-infringement or invalidity.

Canada offers procedural flexibility during the prosecution of applications, meaning that amendments to any part of the specification can be filed voluntarily at any time during examination of the application and can be filed more than once. Supplemental responses can also be filed after filing responses to office actions. There are no official limits to the number of office actions that may issue in respect of an application and final actions are encountered only when a real impasse is reached with the examiner.

Finally, there are no opposition proceedings in Canada, so once a patent is granted it is presumed to be valid until challenged in the courts. However, it is possible for a third party to file a protest against a pending Canadian patent application.

Ways to expedite Canadian patent prosecution

The typical prosecution of a patent application can be a slow process, with the time to a first office action approaching two years in some fields of technology and the time from filing to issuance ranging from two to five years, or even more. In some cases, expeditious issue of a patent may be desired and there are several mechanisms by which this can be accomplished in Canada. These mechanisms are useful if an issued patent is desired quickly in order to assert it against potential infringers. In addition, a quickly issued Canadian patent can be leveraged to secure speedy grants elsewhere in the world.

Advanced examination

The examination of any application can be advanced at any time by asserting that failure to do so will prejudice the requesting person’s rights (eg, there may be impending infringement or licensing agreements that depend on an issued patent). No evidence or details are required to support the assertion. Advanced examination can be requested by the applicant or a third party, and is granted automatically in response to payment of a fee (C$500) and the assertion of prejudice. In addition, the application must already be published or its early publication must be requested. Advanced examination leads to the issuance of a first office action within 12 weeks of the request, but often within about two months.

Patent Prosecution Highway

The Patent Prosecution Highway (PPH) is another mechanism by which to accelerate examination of an application. In this case no fee is required, but the PPH request must be made before examination of the application begins and there must be allowable claims in another jurisdiction. At present, the following countries have PPH agreements with Canada: Australia, China, Denmark, Finland, Germany, Hungary, Iceland, Israel, Japan, Korea, Mexico, Norway, Portugal, Russia, Spain, Sweden, the United Kingdom and the United States. There is also a PCT-PPH agreement, so if claims are identified as allowable at the PCT level, they can be pursued in a PPH request in Canada. Again, a two-month window can generally be expected for issuance of each office action, if required. Many PPH applications go straight to allowance within a few months of the request being made. If a Canadian patent is issued quickly, either through the PPH or otherwise, PPH agreements in other countries can be taken advantage of to obtain other national patents more quickly as well.

Green and clean technologies

Applications directed to ‘green’ inventions can be examined more quickly without an additional fee by filing a declaration indicating that the application relates to “commercial technology that would help to resolve or mitigate environmental impacts or conserve the natural environment and resources”. This programme currently offers around a two-month turnaround time for each office action.

Ways to delay Canadian patent prosecution

On the other hand, it may be advantageous to delay prosecution of an application until an invention is more commercially accepted or is ready for commercialisation at all. In this regard, there are several ways to delay filing and examination of applications in Canada:

• National phase PCT applications in most countries must be filed within 30 or 31 months of the earliest priority date. In Canada, the 30-month deadline for national phase entry can be extended to 42 months after the earliest priority date on payment of a nominal fee.
• As mentioned above, there is a 12-month grace period for public disclosures made by the inventor or applicant wherein the disclosure will not be a bar to patentability.
• There is no ‘on sale’ bar in Canada, so there is no need to rush a Canadian filing because of a secret (or otherwise) offer for sale (although the 12-month grace period for disclosures by the applicant should be kept in mind).
• Unlike in many other jurisdictions, examination of a Canadian application does not happen automatically. Examination must be requested within five years of the Canadian filing date. This delay can be useful, as within those five years one will often have a good idea how prosecution is going elsewhere in the world, thus avoiding ‘reinventing the wheel’ in Canada by adopting arguments and amendments made elsewhere.

Post-grant amendments

Issued Canadian patents can be amended in three ways – disclaimer, reissue or re-examination:

• Disclaimer – by this mechanism a patentee may amend a patent to claim less than that which was claimed. A disclaimer is not limited to a whole claim or claims. A part of a claim may be disclaimed, provided that the disclaimer does not extend the scope thereof or any claims depending thereon. A disclaimer cannot be used to broaden the claims of a patent.
• Reissue – by this mechanism a defective patent can be corrected. It may result in broader or more restricted protection, depending on the nature of the correction. A patentee may apply within four years of the date of issue of a patent for the reissue of a patent that “is deemed defective or inoperative by reason of insufficient description and specification, or by reason of the patentee’s claiming more or less than he had a right to claim as new, but at the same time it appears that the error arose from inadvertence, accident or mistake without any fraudulent or deceptive intention”. It is fairly difficult to prove that the error was truly through “inadvertence, accident or mistake”, and it has been found time and again that simply realising something else could have been claimed, but was not, is insufficient to meet this bar.
• Re-examination – by this mechanism anyone may request re-examination of any claim or claims of a patent issued after October 1 1989 at any time during the life of the patent, on the basis of prior art only. The prior art shall consist only of patents, patent applications open to public inspection and printed publications and the requester must set forth the pertinence of the prior art and the manner of applying it to the claim(s) for which re-examination is requested.

Claims may be broadened only in reissue cases and only the patentee can file a disclaimer. Reissue can be requested by the patentee or “the person for the time being entitled to the benefit of a patent for an invention”. Anyone can request re-examination of an issued patent.

Enforcement and remedies

The Canadian test for patent infringement establishes the claim language as the focus, requiring it to be read in an informed and purposive way, interpreted within the four corners of the specification and without resort to extrinsic evidence. Experts may be consulted, but construing the claims is a matter of law. In doing so, the court seeks fairness for the patent holder and predictability for the public, including competitors.

Unlike in the United States, there is no doctrine of file wrapper estoppel in patent cases, whereby statements made on the record by the applicant or its patent agent can be used to interpret the meaning of the claims. The prosecution history may nonetheless be admissible for other reasons.

A typical infringement action in Canada lasts from three to five years and may cost from C$500,000 to C$2 million. A successful party is presumed to be entitled to an award of costs from the other side in accordance with a court tariff. A successful party usually recovers a small portion of the fees it has paid its own counsel and reimbursement of the vast majority of out-of-pocket expenses necessarily or reasonably incurred in the litigation.

In addition, a successful patentee is entitled to the damages that it can prove were caused by the infringing acts. The party claiming damages has the burden of proving the nature and extent of the damages suffered, and damages are calculated as lost profits or what would have been considered a reasonable royalty had the infringer requested a licence. The patentee may instead request the court to allow it to recover the infringer’s profits derived from the infringing acts. There are no provisions for treble damages in Canada. While punitive damages may be awarded, this is exceedingly rare, even in cases of demonstrated deliberate and intentional infringement.

Interlocutory relief is available in the form of an interim or temporary interlocutory injunction preventing the continuation of infringement before trial. These are rare in Canada because it is difficult to satisfy the irreparable harm criterion.

Patent Register

Canada has a legislative scheme – the Patented Medicines (Notice of Compliance) Regulations – that links drug regulatory approval to patent protection. If the regulations are engaged, a pharmaceutical patentee may delay regulatory approval for a second party (usually a generic) to sell the patentee’s medicine, sometimes for as long as the life of its patents. This is particularly important in Canada, where interlocutory relief in a patent infringement action is almost impossible to obtain and where data protection legislation (which can also delay generic market entry) has been found to apply in only limited situations.

In order to benefit from the regulations, a patent must be listed on the Patent Register maintained by Health Canada within 30 days of issuance. A patent can be listed only if it contains a claim for the medicinal ingredient”, “the formulation that contains the medicinal ingredient”, “the dosage form”, or “the use of medicinal ingredient”, and the medicinal ingredient, formulation, dosage form, or use has been approved through the issuance of a notice of compliance (NOC). This determination is generally easy, since many pharmaceutical patents have at least one listable claim to a new chemical compound or a new use of a known chemical compound (eg, “use of drug X for treating disease Y”), or claim only non-listable processes of manufacture or intermediates having no therapeutic value as drugs. However, in other cases the determination is less clear.

It may be possible during the prosecution of a patent application to add or amend the claims to improve the chances of having a resulting patent listed. A good strategy is to ensure that at least one claim specifically recites the active ingredient for which regulatory approval has been or will be obtained. In addition, use claims reciting each utility for which approval has been or will be sought should be added.

Double patenting

Divisional applications are problematic in Canada and deserve special note. Divisional applications can be filed at any time up until the day before the parent application issues. However, double patenting can be an insurmountable problem in Canada and, as such, the voluntary filing of divisional applications is not recommended. On the other hand, if a unity of invention rejection is raised by the examiner during prosecution of an application and the applicant chooses to proceed with claims directed to one of the inventions, the applicant is free and clear to pursue claims directed to the other inventions in divisional applications without fear of a subsequent double patenting rejection.

Where a double patenting rejection is raised in Canada, the question sometimes posed by practitioners familiar with US law is whether a terminal disclaimer can be entered to overcome the double patenting rejection. Unfortunately, Canadian law does not include a terminal disclaimer practice or continuation practice. Therefore, where an applicant has new claims that might be filed in a divisional or continuation application in the United States, such claims should be added to the parent application and the applicant should wait to see whether there is a rejection that requires the claims to be divided out, rather than voluntarily filing a divisional application that may be subject to a double patenting rejection.

Conclusion

Canada offers many advantages to patentees and Canadian patents can be leveraged to obtain patents more quickly and inexpensively elsewhere in the world. The cost of obtaining a patent in Canada is much less than that in many other jurisdictions, particularly when time and cost-saving programmes, such as the PPH, are taken advantage of.

Sim IP Practice

6th Floor, 330 University Avenue

Toronto, ON, M5G 1R7

Canada

Tel +1416 595 1155

Fax= +1416 595 1163

Web www.simip.com

Erica Lowthers

Patent agent

[email protected]

Erica Lowthers is a patent agent at Sim IP Practice in Toronto, Canada. She graduated with a PhD in pharmacology from Dalhousie University in Halifax, Canada. Her practice focuses on the life sciences and she drafts, files and prosecutes patent applications directly in Canada and the United States, and coordinates patent prosecution for clients worldwide. Dr Lowthers is also involved in critically reviewing disclosures, products and patents with an eye to infringement and validity.

Lola Bartoszewicz

Patent agent

[email protected]

Lola Bartoszewicz specialises in patent drafting and prosecution, strategic portfolio management, patentability and freedom-to-operate analysis, re-examination proceedings and due diligence investigations. Her practice spans a broad range of scientific sectors, including biotechnology, medical devices, diagnostic, pharmaceutical and agricultural biotechnology, as well as vaccine and food technologies. She counsels a wide array of organisations, from universities and non-profit research institutions to small start-up biotech companies to large and long-established global companies.

Dr Bartoszewicz collaborates closely with attorneys on a global basis to ensure that her clients obtain IP protection in several jurisdictions. She has presented at the Royal Society of Chemistry, London, where she discussed the Canadian perspective on IP enforcement around the world in the chemical arts.