Late Report of Patent Grant leads to Irretrievable Loss of Drug Patent Register Listing Rights

By Claire Palmer & Osman Ismaili, September 14, 2021

Merck Canada Inc. v Canada (Health), 2021 FC 345

The grant of a patent containing a claim that relates to a medicine or use of the medicine approved by Health Canada triggers a 30-day deadline from the date of payment of the final fee to list the patent on the Patent Register maintained by the Therapeutic Products Directorate. A careful review of the timing of the grant after payment of the Final Fee (i.e., Issue Fee) in this case and the Canadian Intellectual Property Office’s service standards offers valuable lessons.

In this decision, the Federal Court (the “FC”) dismissed an application for judicial review brought by Merck Canada Inc. (“Merck”) over the refusal by the Minister of Health (the “Minister”) to add Canadian Patent No. 2,830,806 (the “‘806 Patent”) to the Patent Register pursuant to section 4(6) of the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”).

Background

Merck markets KEYTRUDA®, a biologic drug for the treatment of certain advanced-stage cancers. The ‘806 Patent was issued on May 12, 2020, and contains claims that are directed to a formulation of the drug KEYTRUDA®.

The issuance of the ‘806 Patent was not reported by the Canadian patent agent retained by Merck’s American parent company (“Merck USA”) until June 15, 2020, more than a month after the patent had issued. Merck USA had however independently learned of the issuance on June 12, 2020 and immediately instructed Merck to take the necessary next steps. Patent lists were submitted the same day, but after the close of business, and were therefore deemed to have been filed on Monday, June 15, 2020.

On June 19, 2020, the Minister informed Merck of the preliminary determination that the patent lists relating to the ‘806 Patent were ineligible for being submitted outside of the 30-day window stipulated in section 4(6) of the PM(NOC) Regulations. Merck replied with written representations and affidavit evidence.

The Minister later confirmed on November 6, 2020 that the patent lists relating to the ‘806 Patent were ineligible for inclusion on the Patent Register holding, among other elements, that the Time Limits and Other Periods Act (COVID-19) (the “Time Limits Act”) does not extend the deadline within which first persons may submit patent lists in accordance with s 4(6) of the PM(NOC) Regulations; and that the 30-day deadline in section 4(6) of the PM(NOC) Regulations is not discretionary.

Analysis

Merck argued that the Minister’s refusal would deprive the patent holder of substantial protections available under the PM(NOC) Regulations. Additionally, Merck said it would suffer prejudice because a subsequent entrant would be able to file a drug submission after the expiry of the six-year “no file” period for KEYTRUDA®, on May 19, 2021.

The issues, in this case, were a) was the Minister’s determination reasonable that the Time Limits Act cannot be applied here and as a result cannot suspend the 30-day time period specified in section 4(6) of the PM(NOC) Regulations? And b) was the Minister’s determination reasonable that she had no discretion to extend the 30-day time period specified in section 4(6) of the PM(NOC) Regulations?

The FC determined that the Minister’s decision would be subject to review against the standard of reasonableness, meaning the FC would only intervene if “there are sufficiently serious shortcomings in the decision such that it cannot be said to exhibit the requisite degree of justification, intelligibility and transparency.”

With regard to the reasonableness of the Minister’s determination, that the Time Limits Act did not cause suspending of the 30-day time period specified in section 4(6) of the PM(NOC) Regulations, the FC found that the Time Limits Act applied in only three circumstances: limitation or prescription periods for commencing a proceeding before a court; time limits for doing something in a proceeding before a court; and time limits where a party makes an application for leave of a court, either to commence a court proceeding or to do something in relation to a court proceeding. Merck asserted that section 4(6) of the PM(NOC) Regulations functions as a “gateway” to the summary litigation provisions that begin at section 6(1), and therefore Merck argued that the 30-day period specified in section 4(6) of the PM(NOC) Regulations is a “limitation period within a limitation period.” The FC concluded that the listing of a patent on the Patent Register pursuant to section 4(6) of the PM(NOC) Regulations is too remote from the commencement of a court proceeding under section 6(1) to constitute a “limitation period within a limitation period” for the purpose of section 6(1) of the Time Limits Act.

With regard to the Minister’s determination that she had no discretion to extend the 30-day time period specified in section 4(6) of the PM(NOC) Regulations being reasonable, Merck relied on a previous FC decision to argue that the Minister may add a “late” patent list to the Patent Register. The FC was not convinced of this argument though, maintaining that it is well established that the timelines prescribed by the PM(NOC) Regulations are exact. The FC further added that the 2017 amendments to the PM(NOC) Regulations also did not confer any new discretionary powers to the Minister.

The FC concluded that the Minister’s decision was justified, intelligible and transparent, and therefore reasonable. No costs were awarded by agreement of the parties.

Commentary

A patent will only issue in Canada following payment of the Final Fee. The Client Service Standards at CIPO for grant of a patent after payment of the Final Fee is stated as being within 12 weeks (Client Service Standards - Canadian Intellectual Property Office).

The Final Fee for the ‘806 application was paid on March 20, 2020. The ‘806 patent granted 53 days later (about 7½ weeks) well before the 12 weeks service standard. A brief review of recently issued patents in Canada indicates that the quick grant of the ‘806 patent was not an anomaly and that patents are regularly granting within 6 to 8 weeks of payment of the Final Fee.

A key takeaway from this case is that once the Final Fee is paid for applications that are eligible for listing on the Patent Register, the CIPO database should be monitored closely for grant of the patent. To help with that, CIPO now also lists “Forecast Issue Date” on the Administrative Status page for each patent application and further sends a notification by email that the patent has granted. Please note that this is also applicable when filing a divisional application after payment of the Final Fee.

For more information please contact:

Claire Palmer, Ph.D., Senior Patent Agent
T: 613.801.0450
E: This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

Osman Ismaili, Patent Agent & Lawyer
T: 613.801.1054
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This article is general information only and is not to be taken as legal or professional advice. This article does not create a solicitor-client relationship between you and MBM Intellectual Property Law LLP. If you would like more information about intellectual property, please feel free to reach out to MBM for a free consultation.

Conference Posters and Materials: Beware! They Can Constitute Prior Art

By David Fraser, November 15, 2021

In the academic world, it is common for researchers to attend and present their findings at conferences. Papers presented will typically end up as part of conference handouts or available online for future use. PowerPoint slides used in presentations are also sometimes published or distributed. Posters are often set up where attendees may view them. Conversations between researchers happen after presentations, and at numerous coffee breaks and networking events. In the publish or perish world of academia, conferences provide one of the best venues to present your ideas and research and meet with like-minded people.

Similarly, in the corporate world tradeshows are often used to show off products and demonstrate their features and capabilities to potential customers. Trade show booths often include demonstration systems, brochures, and marketing presentations that are only available for the two or three days of the show. Copies of brochures and presentations may be saved or may be destroyed afterwards.

Unfortunately, what is good for the sharing of information is often not good for the patenting of inventions that arise from the research and products presented at these conferences. The subject matter of a patent claim must not have been previously disclosed, and the invention must not be obvious to a person skilled in the art or science to which it pertains[1]. Conference presentations, presentation slides, and posters can all be prior art, whether they come from an inventor or someone else, and can prevent you from patenting your inventions.

Posters are an interesting case in that they may often be displayed for just a few hours, be viewed by passersby, and usually do not become part of the published conference proceedings. They are often untraceable or destroyed later. They often will not contain enough information to prevent an invention from being novel, but nevertheless may form part of the state of the art that must be considered when determining if an invention contains an inventive step.

In Biogen Canada Inc. v. Taro Pharmaceuticals Inc., 2020 FC 621, a poster was presented at a conference in Baltimore in 2002, 18 years previous. The poster was available to the court but had only been presented for a short time at the conference, and in the intervening years could not have been found even with a reasonably diligent search. Nevertheless, expert testimony established that the poster was indeed genuine and therefore its contents formed part of the state of the art in 2002 for determining obviousness of the patent claims in question. The poster, together with information found in other sources of prior art, were enough to find the patent claims in question obvious and invalid. This case is interesting since a poster, only presented for a short time at the conference and thereafter not being available, was used to establish the state of the prior art 18 years ago.

In Mediatube Corp. v. Bell Canada, 2017 FC 6 the plaintiff alleged that the defendant’s Fibe TV service could be modified to infringe its patents. Bell argued that all limitations of the relevant patent claims had been disclosed in a number of sources, including brochures and prototype systems that had been presented at the SuperComm tradeshow in June 1998, 19 years previous. Brochures were available to the court. Mediatube argued that the brochure was only disclosed at the tradeshow and could not be considered to have been available to the public as it could not later be found in a reasonably diligent search by a skilled person. With the help of expert testimony, the court decided that the brochures and presentations of the systems, despite only being available for a short time, were part of the state of the art at the time and could be considered when determining the validity of Mediatube’s patent claims.

On the other hand, in Valence Technology, Inc. v. Phostech Lithium Inc., 2011 FC 174, the defendant was challenging the validity of plaintiff’s patents. Phostech asserted that conference publications, presentations, and posters presented twelve years previous were prior art to at least some of the patent claims. The presenter had also had discussions while at the conference. The poster had since been destroyed and could not be presented to the court. When defining the common general knowledge at the key date the judge decided to exclude the presentations, posters, and any discussions that may have happened. Though not stated, this may have been because the poster had been destroyed and that there were no experts to testify to its contents or importance.

It is difficult to determine in advance if a poster will later be found to form part of the state of the art when considering patent validity. For prior art, such as a poster, that may only be presented for a few hours at a scientific or industry conference, it is uncertain whether it can be considered part of the body of prior art of which a person skilled in the art could be said to possess, especially since it may not be found later even through a reasonably diligent search. Like any disclosure, the best practice is to:

1. Review all public disclosures, even those that are short-lived and will be unavailable later.

2. Be careful what kind of information you put on a poster. Try to use more general information on all conference materials if possible.

3. If you must disclose detailed information, restrict any disclosures to individuals or groups in a non-public space under NDA.

4. File a provisional or utility patent application before the event.

5. Review and document what others present. Smartphones make it easy.

Better to be safe than sorry!

If you are considering filing a patent and worried about your conference/event disclosure, please feel free to contact MBM for a free consultation.

Important CIPO Update - Date Announced for Amendments to Canadian Patent Rules

By Claire Palmer, June 10, 2022

Canadian Intellectual Property Office (CIPO) just announced that the new amendments to the Canadian Patent Rules to ‘streamline examination', including excess claim fees, will be coming into effect on October 3, 2022. The changes will include a $100/per claim fee for applications with more than 20 claims and a fee for continued examination after three office actions equal to the original examination fee. The amendments also add steps such as 'notice of conditional allowance'.

As a result of these changes, we advise our clients to review their patent portfolios to determine which patents have over 20 claims and request examination for these patents before the October 3, 2022 date to avoid paying the access claim fees, as they would apply at the examination stage after this date.

We will follow up this announcement with more comprehensive coverage of the new changes to Canadian Patent Rules - stay tuned!

For more information please contact:

Claire Palmer, Ph.D., Senior Patent Agent
T: 613.801.0450
E: This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

This article is general information only and is not to be taken as legal or professional advice. This article does not create a solicitor-client relationship between you and MBM Intellectual Property Law LLP. If you would like more information about intellectual property, please feel free to reach out to MBM for a free consultation.