Update: CASL Private Right of Action Suspended, But Be Careful, Other CASL Provisions Are Still Alive

Since our last CASL updated on March 27th, the Canadian federal government announced on June 7, 2017, that it is suspending the private right of action provision in Canada’s Anti-Spam Legislation (CASL). This provision was originally scheduled to come into effect on July 1, 2017. The private right of action provision allows anyone to sue individuals and organizations that violate CASL by either their action or omission. Under CASL’s private right of action, Plaintiffs were able to claim compensatory damages as well as statutory damages. Compensatory damages cover the plaintiff for losses or damages that they have suffered, on the other hand, statutory damages, are provided where no actual harm is proven and can be as high as $1 million per day.

Businesses, charities, and not-for-profit organizations raised concerns that a number of class action lawsuits could result from the private right of action provision. As a result, the federal government suspended the private right of action coming into force and will send this provision to parliamentary committee for review to ensure it balances the individual’s rights with the burden businesses and others will bear as a result of compliance. No date was announced when the committee will render the results of this review.

CASL’s intent is to prohibit businesses and individuals from sending commercial emails to Canadians without their consent. When CASL was introduced on July 1, 2014, it provided a 3-year grace period where implied consent, acquired prior to CASL coming into force, was sufficient. This implied consent must meet two criteria to be valid: the sender had an existing business relationship prior to July 1, 2014 and the sender and recipient had communicated through commercial electronic messages (CEMs) as a part of this relationship. These transitional provisions for implied consent come to an end as of July 1, 2017, and even though the federal government has suspended the private right of action, these other CASL provisions remain in force and are subject to enforcement. As a result, businesses and individuals must obtain express consent and provide unsubscribe methods and electronic communication practices and marketing strategies that comply with CASL.

For more information, please contact:

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

Daniel Lanfranconi, Associate Lawyer
T: 613-801-1056
E: dlanfranconi@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.

Upcoming Amendments to the Patent Rules, Industrial Design Regulations, and the Trademarks Regulations

The Canadian Intellectual Property Office (CIPO) has just announced that it will be conducting a series of consultations on proposed regulatory amendments to the Trademarks Regulations, Industrial Design Regulations and Patent Rules.

The amendments are being proposed to bring Canada’s intellectual property (IP) legal framework in line with international standards. In particular, Canada is in the process of joining five international IP treaties: the Madrid Protocol, the Singapore Treaty, the Nice Agreement, the Hague Agreement, and the Patent Law Treaty.

Amendments to the Trademarks Act, the Industrial Design Act and Patent Act were previously amended to comply with the requirements of these treaties. In order to complete the changes to Canada’s IP legal framework, the accompanying Regulations and Rules must also be amended.

CIPO will be consulting with the IP legal community starting on June 19, 2017 for the Trademarks Regulations and the Industrial Design Regulations. Consultations regarding the Patent Rules are scheduled to start in early August 2017. The proposed amendments will be disclosed during this consultation period, and there will be an opportunity to ask questions and submit questions or comments.

Amending the IP Rules and Regulations is the final step in a major makeover of Canada’s IP legal framework that will bring us closer to the developing international standards. From an IP owner’s point of view, these changes will make it more efficient to obtain patent protection in Canada based on foreign originating applications, and similarly will make it more efficient for Canadians to obtain foreign patent protection based on Canadian originating applications.

For more information, please contact:

T: 613-567-0762
E: general@mbm.com

Author: Etienne de Villiers, Of Counsel

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.

Lifting the Cloak of Anonymity of Copyright Infringers Online

While internet connects people thousands of miles apart and accelerates knowledge distribution, it also creates a cloak under which anonymous users can illegally download and distribute copyright protected materials, such as movies, songs and novels. Previously, copyright owners were unable to protect and vindicate their rights unless internet service providers (ISPs) were willing to disclose the identity of suspected copyright infringers.

The recently modified copyright regime allows copyright owners to seek a disclosure order that compels an ISP to reveal the identity of the suspected copyright infringers.[1] The purpose of which is “to allow copyright owners to protect and vindicate their rights as quickly, easily and efficiently as possible while ensuring fair treatment of all.” [2] Whether or not copyright owners should reimburse the ISPs for the cost related to a disclosure order was left undecided.

In Voltage Pictures LLC v John Doe, the Federal Court of Appeal reviewed the trial judge’s order that Voltage has to pay a fee of $100 per hour of work plus HST to Rogers, the ISP, before the disclosure of identifying information. Voltage appealed this order and contested this fee as it was far too high and thus unreasonable.

The Court allowed the appeal and ordered Rogers to disclose identifying information to Voltage without seeking compensation. The concern is if ISPs are allowed to charge a fee without restriction before the release of identifying information, the purposes of the Copyright Act would be frustrated. A large service fee could effectively dissuade copyright owners from obtaining the information they need to protect and vindicate their rights.

The Court held the subsection 41.26(1) of the Copyright Act has imposed an obligation that the ISPs “must maintain records in a manner and form that allows it to identify suspected infringers, to locate the relevant records, to send the notices to the suspected infringers and the copyright owner, to translate the records (if necessary) into a manner and form that allows them both to be disclosed promptly and to be used by the copyright owners and later the court to determine the identity of the suspected infringers, and finally, to keep the record ready for prompt disclosure. ”[3]

Furthermore, the Court divided the total cost into two categories: (1) the work necessary to assemble, verify and forward the identifying information to copyright owner pursuant to the subsection 41.26(1) of the Copyright Act; and (2) the actual, reasonable, and necessary cost of delivery or electronic transmission of the information.[4]

For the first category, the Court took a position pursuant to the “no regulation and, thus, no fee” default rule in subsection 41.26(2) of the Copyright Act for the subsection 41.26(1) obligations. It held that the decision of leaving the cost of with ISPs can push them to limit the cost of compliance with their obligation “more automatic, more efficient and less expensive.”[5] For the second category, the Court found that the cost does not fall within the subsection 41.26(1) and thus ISPs can charge this fee. However, it is usually negligible (e.g. $0.5 per IP address in 2012). [6]

The Court also recognized that ISPs can plead their economic case to the Minister to set up a regulation to allow ISPs charge a fee for performing the subsection 41.26(1) obligations. Until then, ISPs rather than copyright owners should bear the cost of assemble, verify and forward the identifying information pursuant to the Copyright Act and the Copyright Modernization Act.

 

For more information please contact:

Scott Miller, Co-Managing Partner, Head of the Litigation Department
T: 613-801-1099
E: smiller@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] Copyright Act, R.S.C. 1985, c. C-42, ss. 41.25-27 (added by the Copyright Modernization Act, S.C. 2012, c. 20, s. 47).

[2] Voltage Pictures LLC v John Doe, 2017 FCA 97 at para 27.

[3] Ibid at para 40.

[4] Ibid at para 61.

[5] Ibid at para 52.

[6] Ibid at para 76.

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

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.

A Ticket to Success: Ontario Launches its Scale-Up Vouchers Program for Innovative Technology Companies

Last November, the province of Ontario committed to help small businesses become more globally competitive. In doing so, the Ontario government promised a Scale-Up Vouchers program that would provide high potential SME’s (small and medium-sized enterprises) with access to additional resources to support critical business activities. Ontario has now made good on that promise.

On April 28, 2017, Ontario’s Ministry of Research, Innovation & Science (MRIS) and Ministry of Economic Development and Growth (MEDG) launched the Ontario Scale-Up Vouchers Program, a four-year, $32.4 million initiative. Details of the program can be found at http://www.ontarioscaleupprogram.ca/.

The program is intended to foster the growth of SMEs in Ontario to become sustainable Canadian companies. Although Canada generates world class research, and there are many start-ups based on this research, we continue to lag behind other industrialized nations in successful technology commercialization. Canada spends a lot of public money on R&D, however, to date, resources directed at supporting commercialization of the resulting innovative technologies have been largely ineffective.

In order to address this shortfall, while at the same time maximizing the likelihood of meaningful return on investment, the Ontario government has decided to target the Scale-Up Vouchers program to a subset of Ontario SMEs identified as “high-growth”. More specifically, the program is directed to companies in the high value fields of Information and Communications Technology, Advanced Materials and Manufacturing, Clean Technology, and Life Sciences. In order to be considered “high growth”, and consequently eligible to apply to the program, a company must:

  • have an annual revenue of between $1 and 50 million; and
  • should already be experiencing a 20% annual growth rate in revenue, sales or employment over the most recent fiscal year; and/or
  • have secured private investment of at least $2 million in the previous two years

The program will be delivered by three Ontario Regional Innovation Centres; MaRS, Invest Ottawa and Communitech. Each application will be reviewed and scored by a selection committee to identify those companies considered to have a high potential for exponential growth in Canada and globally.

Companies successful in the application process will be provided access to growth coaches, who are senior executives and professionals with proven expertise in talent management, sales and revenue growth, IP protection and innovation, and/or financing. Successful applicants will also be eligible to work with their coaches to apply for a voucher to offset eligible expenses for supporting growth by:

  • increasing sales
  • securing and nurturing talent
  • developing and protecting intellectual property and/or
  • accessing capital

Voucher values correlate to the size of company revenue, as follows:

  • $150,000 voucher value – for companies with revenues between $1 million and $5 million (with an expectation for the company to match 33% of the voucher value)
  • Up to $250,000 voucher value – for companies with revenues over $5 million (with an expectation for the company to match 50% of the voucher value)

It is important to highlight the value of this program in championing Ontario’s innovative technology companies and, importantly, in recognizing the value of encouraging intellectual property protection of Canadian technologies. Strong intellectual property protection is inextricably linked to access to capital and ongoing commercial success, particularly for early stage companies. We are hopeful that similar programs will become available for pre-revenue, start-up companies with valuable technologies, so that we will continue to see fresh cohorts of applicants over the four year lifetime of this Scale-Up Vouchers Program.

For more information, please contact:

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

Authors: Stephanie White, Partner &  Yang Wang, Summer Law Student

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.

 

 

Innovative Medicines in Canada: Important Patent Questions to Ask

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.

 

In for a penny, in for a pound…

I hear it all the time … “I can’t afford to protect my intellectual property.” Let me tell you that the reverse is true for a startup … you can’t afford NOT to protect your intellectual property! If you’ve decided to take the leap and embark on a start-up adventure, then you will want to do everything in your power to succeed.

Early stage companies are typically built on a great idea and a lot of hope. These companies have not yet had the opportunity to acquire tangible assets or to build significant sales revenue (if any!). Consequently, the value in these companies is often in their ideas and their ability to create products/services from those ideas. Potential investors and partners won’t take a second look at a company if those ideas are not protected, or protectable. The assumption is that all new companies have a great idea, however, investors and partners alike need to know that they will have a defensible competitive advantage over other companies before they join in developing and growing such early stage endeavors. It’s all about mitigating risk.

Market exclusivity typically requires strong intellectual property protection. But what does that mean for a start-up, with limited resources and a nascent technology? I have identified below four general areas of focus for valuable IP protection that are important to early stage companies.

Avoid costly complications:

  • Know the competitors’ IP so you know where or what the company has freedom to practice without risk of infringement;
  • Ensure that employees and contractors assign their IP rights to the company upfront;
  • Scrutinize all third party agreements, including so-called “standard” agreements (e.g., confidentiality agreements), to ensure that they do not restrict or damage the company’s IP rights
  • Teach employees about IP

Be proactive:

  • Create a working environment that fosters innovation
  • Identify inventions early and keep quiet until they are protected
  • Reassess IP regularly to ensure it remains consistent with the company’s commercial and business plans

Use appropriate IP protection:

  • Don’t rely solely on patents: consider trade secret protection and remember the value of brand protection through trademarks
  • With respect to patents, invest in quality applications rather than a lot of applications
  • Invest in IP protection in as many jurisdictions of commercial relevance as possible, while also considering strength of protection available in each jurisdiction

Look for opportunities to fund IP:

  • Government grants for startups that support IP expenditures
  • Monetize company IP (e.g., in non-commercial fields of use, or jurisdictions; or IP that has become irrelevant)

Finally, talk to your intellectual property advisor! For early stage companies in particular, it can be beneficial to select an advisor who can act as a virtual in-house professional, with a good understanding of the company’s business goals. This provides both the company and the IP advisor the opportunity to proactively and strategically grow the value of the company’s IP portfolio.

Ultimately, because of their limited resources, early stage companies may need to be even more tactical than large corporations in how they handle their IP. However, investing the time and money to ensure that the company’s IP is properly protected will pay dividends in the long run!

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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