Industry: Biotechnology & Pharma

CETA agreement and the Canadian patent landscape

Posted on by Debbie Malek

On September 21, 2017, The Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA) came into force.

Three areas part of the CETA agreement relating to a range of issues in Canadian patent protection are worth noting:

1. Certificate of Supplementary Protection Regulations

2. Regulations Amending the Patented Medicines (Notice of Compliance)

3. Amendments to the Patent Rules

1. Certificate of Supplementary Protection Regulations: the Certificate of Supplementary Protection Regulations (CSP Regulations) were created to provide additional protection for patent-protected pharmaceutical products. The new Certificate of Supplementary Protection (CSP) regime will provide additional period of patent-like protection for drugs containing a new medicinal ingredient or a new combination of medicinal ingredient. The CSP Regulations provide various timelines, requirements and procedures needed to carry out the regime and are defined in sections 104-134 of the Patent Act. The additional protection term under CSP can be calculated as the difference between the patent filing date and the Notice of Compliance date, reduced by 5 years, up to a maximum of 2 years (i.e. CSP term = [Notice of Compliance date – Patent filing date] – 5 years, with a cap of 2 years). The additional protection period under this regulation will take effect from the patent expiry date.

2. Regulations Amending the Patented Medicines (Notice of Compliance): These amendments were made to address a number of issues described below and to meet Canada’s obligations under CETA:

  • to resolve a number of problems by replacing summary prohibition proceedings with full actions to determine patent validity and infringement;
  • to expand the scope of the PMNOC Regulations to cover relevant Certificate of Supplementary Protections by providing an additional period of protection for new patented pharmaceutical products;
  • to help expedite proceedings by introducing a limited number of procedural rules, while still leaving the Court broad discretion to manage proceedings;
  • to address concerns about how damages arising from delayed generic drugs market entry are currently addressed; and
  • to remove barriers that may prevent innovators and generics from litigating certain patents outside the PMNOC Regulations prior to generics entering the market.

3. Amendments to the Patent Rules: Based on the recent amendments, section 29 of the Patent Act is being repealed and those provisions under the Patent Rules that refer to appointment of the representative under this section of the act are also being removed. The repealed provisions under the Patent Rules are section 78, clause 94(2)(b)(ii)(I), subparagraph 94(3)(b)(vi) and paragraph 148(1)(d). As a result, information regarding appointment of a representative is no longer required for completion of a patent application or the national phase of a patent application. To reflect the change, Form 1 (Application for Reissue) and Form 3 (Petition for a Grant of Patent) are also replaced to delete references to representative appointment required under section 29 of the Patent Act.

For more information, please contact:

Randy Marusyk, Co-Managing Partner
T: 613-801-1088
E: rmarusyk@mbm.com

Co-Author: Hyun Woo Choi

 

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.

New LCBO Subsidiary to Control Cannabis Sales in Ontario

Posted on by Debbie Malek

In response to the imminent legalization of recreational use of cannabis in Canada as proposed by the Parliament in Bill C-45, the Cannabis Act, the Ontario government released a detailed plan on distribution system and usage regulations of recreational marijuana in a document titled “Ontario’s Safe and Sensible Framework to Federal Cannabis Legislation” on September 8, 2017.

The centerpiece of this proposal is to create a subsidiary of the Liquor Control Board of Ontario (LCBO) to hold monopoly over cannabis retail and online sales in Ontario. This approach, as Attorney General Yasir Naqvi said, will focus on ensuring “a safe and sensible transition” to federal legalization. However, the LCBO operated subsidiary will be the single buyer of marijuana producers and the exclusive distributor to consumers. This inevitably puts it at a dominant position to make decisions on market entrance credentials, quality controls, retail prices and geographical accessibility. Private investors will not be allowed to open and operate cannabis retail stores and consumption premises in Ontario for the time being. The monopoly will also make smaller marijuana producers difficult to compete with powerhouses as Aphria Inc. (TSX: APH) and Canopy Growth (TSX: WEED), two of the country’s biggest marijuana producers.

WHAT ARE THE KEY ELEMENTS OF THE PROPOSED FRAMEWORK?

  • The LCBO will establish a new subsidiary to exclusively oversee the distribution of cannabis in Ontario through retail stores physically separate from existing LCBO liquor stores and an online order service.
  • Approximately 150 retail stores will be opened by 2020, including 40 in July 1, 2018 and another 80 by July 1, 2019. The stores will run similar to tobacco sales as behind-the-counter model and there will be no self-service.
  • The locations of these retail stores will be determined in consultation with municipalities. The guideline is to target areas with illegal marijuana dispensaries to crush black market.
  • The LCBO operated website for online orders will be available by July 1, 2018. It will make recreational marijuana accessible to residents far away from retail stores.
  • Pricing and taxation decisions will come later. The anticipated profits will be modest, especially at the beginning stage with necessary infrastructure and personnel training costs.
  • The use of recreational marijuana will only be permitted in private residences. The consumption of any form of recreational cannabis in public places, workplaces or when inside a motor vehicle will be prohibited.
  • The Ontario Government will explore the feasibility and implications of introducing designated establishments where recreational cannabis could be consumed.
  • Cannabis dispensaries currently operating in Ontario are not and will not be legal retailers. These shops will be shut down through a coordinated and proactive enforcement strategy with municipalities and police forces.
  • Ontario will set the minimum age for possessing or consuming recreational cannabis at 19, same as the current alcohol restrictions. The Government of Canada in Bill C-45 proposed the age of 18. Other rules and restrictions for distribution of cannabis will be strictly in keeping with federal rules and regulations.

HOW WILL THIS FRAMEWORK AFFECT CANNABIS INVESTORS, PRODUCERS AND CONSUMERS?

  • The safety concern is legit and marijuana should still be a tightly controlled substance after its legalization. However, the proposed monopoly model may not benefit interested parties except the Ontario government, LCBO and labour unions. This framework may deter potential investors, hamper smaller producers and drive consumers to black market.
  • Private-owned retail stores and cannabis lounges will not be allowed in Ontario according to the proposed framework. For investors, the investment opportunity is limited to marijuana production. Therefore, if some other provinces and territories present less stringent rules and regulations, Ontario would be less attractive to potential investors.
  • For marijuana producers, the monopoly model strongly favours giant corporations who have financial resources, lobbying power and business expertise to strike a supply contract with LCBO. Smaller producers may face obstacles to put their products on the shelves of legal retail stores, same as what happened to small craft brewers in Ontario under the current alcohol distribution monopoly.
  • The shut down of currentprivate-owned stores selling cannabis and business premises will make many people lose the only source of income. If the new LCBO subsidiary is not able to accommodate these people into the system, many of them may not leave cannabis business and choose to go underground. That, in return, will significantly increase the law enforcement costs and endanger the public.
  • For consumers, forty stores at the beginning stage made accessibility a big concern, especially for those who are unable to travel without assistance and having difficulty to put an online order. Furthermore, if the retail prices in legal stores are significantly higher than the black market, many consumers may simply pick the cost-effective way. It is hard for the law enforcement to tell illegal marijuana products from those purchased from legal retail stores

 

For more information, please contact:

Randy Marusyk, Co-Managing Partner
T: 613-801-1088
E: rmarusyk@mbm.com

Co-Author: Yang Wang

 

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.

The Supreme Court of Canada Knocked Down the “Promise Doctrine” for Determining Utility

Posted on by Debbie Malek

Today, the Supreme Court of Canada, in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, has determined that the Promise Doctrine is not the correct method of determining whether the utility requirement under s. 2 of the Patent Act is met, and upheld the utility of the appelants’ 2,139,653 patent.

The Promise Doctrine holds that if a patentee’s patent application promises a specific utility, only if that promise is fulfilled, can the invention have the requisite utility, but where no specific utility is promised, a mere scintilla of utility will suffice.

The Court has found that the Promise Doctrine is excessively onerous in two ways: (1) it determines the standard of utility that is required of a patent by reference to the promises expressed in the patent; and (2) where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid.

First, the Court found that the Promise Doctrine conflates s. 2 of the Act (which requires that an invention be “useful”) and s. 27(3) (which requires disclosure of an invention’s “operation or use”), by inappropriately requiring that to satisfy the utility requirement in s. 2, any disclosed use (by virtue of s. 27(3)) be demonstrated or soundly predicted at the time of filing. If that is not done successfully, the entire patent is invalid, as the pre-condition for patentability — an invention under s. 2 of the Act — has not been fulfilled.

Second, the Court found that the Promise Doctrine runs counter to the words of the Act by requiring that where multiple promised uses are expressed, they all must be satisfied for the patent to meet the utility requirement in s. 2.

The Court established the correct approach to utility as follows:

  • [54] To determine whether a patent discloses an invention with sufficient utility under s. 2, courts should undertake the following analysis. First, courts must identify the subject-matter of the invention as claimed in the patent. Second, courts must ask whether that subject-matter is useful — is it capable of a practical purpose (i.e. an actual result)?
  • [55] The Act does not prescribe the degree or quantum of usefulness required, or that every potential use be realized — a scintilla of utility will do. A single use related to the nature of the subject-matter is sufficient, and the utility must be established by either demonstration or sound prediction as of the filing date.

With respect to the ‘653 patent, the Court stated that the utility of the optically pure salts of the enantiomer of omeprazole as a proton pump inhibitor to reduce production of gastric acid (the subject matter of the ‘653 patent) was soundly predicted. The ‘653 patent is therefore not invalid for want of utility.”

Today’s long-awaited decision places Canada back in-line with international standards, and provides greater certainty to patentees and to patent prosecutors and litigators.

 

For more information, please contact:

Suzanne Hof, Senior Patent Agent
T: 613-801-0510
E: shof@mbm.com

Poonam Tauh, Partner, Patent Agent
T: 403-800-9018
E: ptauh@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.

 

A balance between confidentiality orders and the open court principle in patent litigation

Posted on by Debbie Malek

Canadian courts have recently revisited the issue as to whether a confidentiality order in pharmaceutical patent litigation should be granted notwithstanding the open court principle to ensure the public access to court proceedings.

In Teva Canada Ltd. v Janssen Inc., 2017 FC 437, an action was brought by Teva to recover damages from Janssen pursuant to section 8 of the Patented Medicine Regulations. A confidentiality order was originally issued by the Federal Court, allowing both parties to file materials under seal but only for the purpose of motions to compel.[1] However, both parties had misused the confidentiality order to improperly file materials under seal, which is common in pharmaceutical patent litigation. After the Court issued a direction requiring the parties to explain, Teva made a motion to allow the (1) supply contract between Teva and its supplier, and (2) excerpts of Teva’s ANDS (Abbreviated New Drug Submission) to remain under seal. This motion is relying on affidavits submitted by Teva that the Court eventually deemed as incomplete, insufficient, and misleading.[2] Teva claimed that: (1) ANDS filing are treated confidentially by Health Canada; (2) its competitors could obtain an unfair competitive advantage by accessing to the information.

Teva’s motion to maintain the confidentiality of the materials is dismissed. The Registry of the Federal Court should unseal and place on the public record the majority of the parties’ materials except a small portion.

Confidentiality orders inherently comprise the open court principle, and thus should be granted cautiously. A court has to be satisfied that the confidentiality order is necessary to prevent a serious risk of harm to an important interest. The moving party has the onus to establish that the information is actually confidential, rather than bold assertions and subjective belief. [3]

The Court found that the proposed confidential information regarding Teva’s supply chain is on the financial aspect of the agreement, and not on the identity of the supplier.[4] Therefore, the name and location of the supplier should be disclosed. To answer Teva’s first claim, the Court held that “while a pharmaceutical company may assert that the information contained in its ANDS as to the composition and method of manufacture of its products is treated as confidential, this information may lose its confidentiality once the product is publicly sold.”[5] The Court also recognized the fact that regulatory regime in Europe is different from the Canadian regime. Some of the information as to a pharmaceutical product’s supplier is public disclosed in Europe but not required to disclose in Canada. The fact that Teva manufactured and marketed its product in multiple European countries and already disclosed certain information contradicts with its affidavit that “is not merely that the precise identify of the manufacturer if the API that goes into Canadian is not public known, but, sweepingly, that the Teva global group of companies keeps information related to the location or identity of entities that supply their products confidential.” [6]

For Teva’s second claim, the Court found it was speculative and Teva failed to show it would actually suffer serious harm if the identity of its supplier were to be disclosed publicly.[7]

In patent litigation, Canadian courts are inclined to uphold the open court principle to ensure the public access to court proceedings. Unless the moving party for a confidentiality order can establish that it is necessary to prevent a serious risk of harm rather than bold assertions and subjective belief.

For more information, please contact:

Randy Marusyk, Co-Managing Partner
T: 613-801-1088
E: rmarusyk@mbm.com

Co-Author: Yang Wang

 

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] Teva Canada Ltd. v Janssen Inc., 2017 FC 437 at para 8.

[2] Ibid at para 32.

[3] Ibid at para 6.

[4] Ibid at para 16.

[5] Ibid at para 36.

[6] Ibid at para 28.

[7] Ibid at para 29.

Innovative Medicines in Canada: Important Patent Questions to Ask

Posted on by Debbie Malek

THE INTERPLAY OF DATA PROTECTION, PATENT REGISTER & PMPRB IN PATENT PROSECUTION & MAINTENANCE DECISIONS IN CANADA

Patents directed to medicines, and in particular, innovative drugs are impacted by a number of legislative regimes in Canada. The impact of these regimes should be fully considered when decisions are made with respect to obtaining and maintaining patent rights in Canada.

A number of key questions need to be fully considered prior to obtaining or maintaining patent protection relating to innovative drugs in Canada are discussed below. These questions relate to the Canadian patent regime, data protection provided under Canada’s Food and Drug Regulations, Canada’s Patented Medicines Notice of Compliance Regulations and the Health Canada’s Patent Register and the Patented Medicines Price Review Board. Only after answering the questions below should decisions regarding Canadian patent rights covering medicines be made.

FIRST QUESTION: Does the drug in question fall under the definition of an “innovative drug”?

Under the Food and Drug Regulations, an innovative drug is “a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, or polymorph”. Innovative drugs are provided eight years of data protection from the issuance of the first drug approval (i.e. Notice of Compliance issued by the Minister of Health) with a pediatric extension for qualifying drugs. This data protection prevents a subsequent manufacturer from relying upon the data in the innovator’s drug submission for the first six years of the eight-year period.

If the answer to the first question is yes, the following question should be answered:

When would data protection for the innovative drug expire? i.e. Does the data protection outlast any patent protection for the drug?

SECOND QUESTION: What are all of the Canadian patents and applications (including PCT applications anticipated to enter Canada) that relate to the innovative drug and how do they relate?

For example, do the claims of the patents or applications directly cover the drug or linked to the drug by the merest slenderest thread.

THIRD QUESTION: When would each of these patents or patents resulting from these applications expire? i.e. Do the patents expire before or after the anticipated end of data protection?

FOURTH QUESTION: Does the patent term end before or after the term of data protection?

As patent applications related to innovative drugs are often filed well before drug approval, the effective patent term can be significantly reduced – some studies suggest that the post-Health Canada approval patent term is ten years or less in Canada. Accordingly, for some innovative drugs the patent term ends prior to data protection.

If the answer is no, the following question should be answered:

Does the patent whose term ends after the end of the term of data protection impact a competitor from entering the Canadian market either in terms of the Patent Register (see below) or Infringement proceedings?

FIFTH QUESTION: Is the patent eligible for listing on Health Canada’s Patent Register?

The PM (NOC) Regulations allow innovative drug manufacturers that have patents listed on Health Canada’s Patent Register to seek an order prohibiting the Minister of Health from issuing a Notice of Compliance (the regulatory safety approval issued by Health Canada) to a second-entry wishing to rely on the innovator’s drug product for regulatory approval, until after the expiration of the patents in question.

Not all patents that relate to a drug are eligible for listing on Health Canada’s Patent Register. There are specific requirements to list a drug. Accordingly, it is important to determine if each patent related to the drug is eligible for listing on the Health Canada Patent Register.

 SIXTH QUESTION: Does the PMPRB have jurisdiction?

The PMPRB regulates the “factory gate” price for all patented drug products in Canada including those sold by Special Access Programs. The PMPRB does not have jurisdiction if there are no issued patents or the patents have expired. The PMPRB has jurisdictions if the patent has a nexus to the drug by the merest slenderest thread. This is in contrast to Patent Register listing eligibility requirements.

If PMPRB does have jurisdiction, the price at which the drug can be sold will be impacted.

CONCLUDING COMMENTS:

The above questions are simply a sampling of the questions which must be answered when determining the best strategy to protect your innovative drug. Other considerations include for example whether the drug is a biologic. Given the complexity, it is critical to obtain the advice of Canadian council.

For more information please contact:

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

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