Important CIPO Update – Amendments to Canadian Patent Rules

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: cpalmer@mbm.com

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.

Health Canada to Draft New Patented Medicine Prices Review Board Guidelines in the Wake of Pharmaceutical Victories

Canada’s Patented Medicine Prices Review Board (PMPRB) is a quasi-judicial body that has authority under the Patent Act to protect and inform Canadians “by ensuring that the prices of patented medicines sold in Canada are not excessive and by reporting on pharmaceutical trends”.[1]

Two recent decisions[2] from Canadian appellant courts surrounding the scope of the PMPRB’s authority under the Patent Act represent victories for the pharmaceutical industry, sending a strong signal that the PMPRB does not have the jurisdiction to consider consumer protection or general regulations of drug pricing in its determination of “excessive” pricing.

In response to these recent appellant decisions, the Canadian Minister of Health announced in April that there will be “a new and different set of guidelines” prepared for consultation in the coming months. Notably, these amendments will not include the proposed economic, regulatory factors for drug pricing nor the net price disclosure requirements held to be unconstitutional by the Quebec Court of Appeal.[3] The Minister of Health also stated that Health Canada will be implementing the “new basket of comparator countries” as an amendment to the Patented Medicines Regulations, which will come into force on July 1, 2022.[4] This amendment removes the US and Switzerland and adds Japan, Norway, Belgium, Australia, and the Netherlands as comparator countries.[5]

Importantly, while rights holders will need to begin reporting price information in accordance with the new comparator countries beginning on July 1, 2022, there will be a temporary period during which no guidelines will be in effect. During this period, the PMPRB will be holding expedited written consultation on what price tests should be applied, the details of which will be communicated once the new draft guidelines have been published in the Canadian Gazette. Once the new guidelines are finalized, rights holders will be provided with a reasonable period to become compliant.[6] Although the PMPRB is aiming to have these new draft guidelines published in a timely manner, no firm time frame has been established.

This response by the Canadian government should benefit pharmaceutical companies by ensuring that the PMPRB does not exceed its authority by considering consumer protection or general pricing regulations in its determination of “excessive” pricing. In the meantime, we anxiously await the release of the new PMPRB guidelines.

 

For more information please contact:

Claire Palmer, Ph.D., Senior Patent Agent
T: 613-801-0450
E: cpalmer@mbm.com

Carly Horvath, Associate Lawyer
T: 613-801-0456
E: chorvath@mbm.com

 

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.

 


[1] http://pmprb-cepmb.gc.ca/home

[2] Alexion Pharmaceuticals v. Canada (Attorney General) 2021 FCA 157
Merck Canada Inc. vs. Attorney General of Canada 2022 QCCA 240

[3] “Update – PMPRB Response to the April 14, 2022 statement from Minister of Health on the Coming-into-Force of the 2019 Regulations Amending the Patented Medicines Regulations” (April 22, 2022).

[4] Office of Honourable Jean-Yves Duclos, Minister of Health, “Statement from Minister of Health on the Coming-into-Force of the Regulations Amending the Patented Medicines Regulations” (April 14, 2022).

[5] “Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements): SOR/2019-298” Canada Gazette, Part II, Volume 153, Number 17.

[6] Office of Honourable Jean-Yves Duclos, Minister of Health, supra note 4.

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

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 are worried about your conference/event disclosure, please feel free to contact MBM for a free consultation.

T: 613-567-0762
E: patents@mbm.com

Author: David Fraser, Patent Agent

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.

[1] Canadian Patent Act 28.2 and 28.3. https://laws-lois.justice.gc.ca/eng/acts/P-4/page-10.html#docCont

The Impact of CIPO’s New Guidance on the Prosecution of Patent Applications Directed to Diagnostic Methods

The Federal Court in Choueifaty v. Canada (Attorney General), 2020 FC 837 decision found that CIPO’s problem and solution framed “purposive construction” was inconsistent with the principles set forth by the Supreme Court of Canada (for more background information, please see our previous article). The CIPO has now issued examination guidance in light of this decision. The updated guidance will be applied effective immediately to applications currently in prosecution as well as those presently before the Patent Appeal Board.

We believe that the impact of this change in CIPO’s practice with respect to claim construction will positively impact the prosecution of many diagnostic method patent applications. In particular, a number of claims which were found to be directed to non-statutory subject matter when incorrectly construed using the problem solution approach may now be found to be directed to statutory subject matter when construed correctly using purposive construction.

To illustrate this impact, the following claim (from the examples included in CIPO’s notice) has been construed using CIPO’s incorrect problem solution approach and the correct purposive construction approach.

Claim:

1. A method of diagnosing whether a human subject is at risk for developing cancer, comprising:

a. measuring the level of X in a biological sample from the subject; and

b. comparing said level to the level of a non-cancerous reference sample, wherein an increase in the level of X relative to said reference indicates the subject is at risk for cancer.

Under CIPO’s Incorrect Problem-Solution Claim Construction:

The typical problem CIPO would have identified for this type of claim under the problem-solution approach is a data analysis problem (i.e. relating the level of X to cancer risk). The solution to the problem CIPO would likely have identified would have been a correlation between cancer risk and the level of X and accordingly the steps related to measuring the level of X and comparing the level would have been regarded as non-essential. As such, the only element CIPO would have identified as essential would be the correlation between cancer risk. Such a correlation step is a disembodied idea and therefore the CIPO would have found that the claim is directed to non-statutory subject matter.

Under Purposive Construction:

There is no language in the claim indicating that any of the steps are optional. Accordingly, all the steps (including the steps related to measuring X and comparing the level of X) are essential.

As the essential elements are not limited to a disembodied idea, CIPO would find that the claim is directed to statutory subject matter.

Given this change in CIPO’s practice, we recommend reassessing any cases directed to diagnostic methods that were impacted by CIPO’s incorrect problem-solution claim construction methodology.

Please feel free to reach out to MBM if you need help regarding reassessing any cases directed to diagnostic methods.

For more information please contact:

Kay Palmer, Ph.D., Senior Patent Agent
T: 613-801-0452
E: kpalmer@mbm.com

Claire Palmer, Ph.D., Senior Patent Agent
T: 613-801-0450
E: cpalmer@mbm.com

 

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.

 

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