Effective Consent Made Easier Under the NOC Regulations

 

Case introduction:

The Patented Medicines (Notice of Compliance) Regulations (“NOC Regulations”) permit the Minister of Health (“Minister”) to issue a notice of compliance (“NOC”) to a generic company where a patentee’s effective consent is obtained. Effective consent under the NOC Regulations requires the patentee’s consent for the making, constructing, using or selling of a drug in Canada (“Activities”). This was at issue in Fresenius Kabi Canada Ltd. v. Canada (Health), 2020 FC 1013 in which the Federal Court of Canada (“Court”) determined that effective consent under the NOC Regulations requires the patentee’s consent for only one of the Activities and not all Activities.

Case background:

Fresenius Kabi Canada Ltd. (“the Applicant”) brought an application for judicial review of the Minister’s refusal to issue a NOC. The Applicant had sought an NOC for its drug adalimumab, IDACIO, which is a biosimilar of the drug, HUMIRA, owned by AbbVie Biotechnology Ltd. (“AbbVie”). AbbVie also owns a number of patents (“Patents”) in respect of HUMIRA. In seeking an NOC, the Applicant had relied on AbbVie’s consent to comply with the NOC Regulations. AbbVie had provided immediate consent to the making and constructing of IDACIO, and a delayed consent, until after February 15, 2021, to the using and selling of IDACIO. The Minister refused to issue a NOC because AbbVie’s consent was only effective after February 15, 2021, when consent to all Activities had been provided.

The Court decision:

The Court found the Minister’s refusal unreasonable partly because the Minister erred in interpreting the word “or” as conjunctive “and” in the NOC Regulations, which recites “consent to the making, constructing, using or selling of the drug in Canada.” The Court reasoned that “the word ‘or’ is presumed to be disjunctive, but inclusive, such that, as in this case, a patent owner could consent to each or a combination of the activities listed - making, constructing, using or selling - to meet the [consent] requirements” of the NOC Regulations. The Court found AbbVie’s consent as unequivocal to all Activities, despite the temporal nature of the consent. The Court overturned the Minister’s decision and ordered the Minister to issue the NOC.

The Court based its reading of the word “or” on the NOC Regulations’ dual purpose, “to balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower-priced generic competitors.” The Court noted that an NOC is essential for the timely launch of a biosimilar product, which is critical for biosimilars to remain competitive and establish their market position.

Key takeaway:

The Court’s interpretation of the word “or”, as disjunctive, but inclusive, clarifies that requirements of consent, under the NOC Regulations, are met so long as the patent owner consents to at least one of the Activities.

Please feel free to reach out to MBM with regards to any Intellectual Property matters in Canada.

 

For more information please contact:

Jamal Hakimi, Patent Associate
T: 613.801.0509
E: jhakimi@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.

Common Patent Misconceptions - Myth #5 - Provisional Applications

 

This article is part of a series on commonly held misconceptions about patents. Many prospective patentees often have unfounded reservations about patenting their inventions. The aim of this series of short articles is to debunk these common myths around patent protection.

Patent Myth #5: Even if my invention is in an early stage of development, I can still file a “quick and dirty” U.S. provisional application

A U.S. provisional patent application can be filed as a “place holder” to secure an early priority date and allows you to disclose or discuss your invention with potential investors.  A provisional application needs to be converted into a full application by the one-year mark and has to be filed individually in each country you are interested in.

Despite the fact that the formality requirements for U.S. provisional patent applications are fairly relaxed in comparison to non-provisional applications, there are still a number of good practices that inventors should keep in mind. In this article, we will explore some reasons why inventors should NOT cut corners when filing provisional patent applications.

Quality of the Provisional Application Drafted

One often hears that a provisional patent application can be as simple as sending the photograph of an idea scribbled on a napkin to the United States Patent and Trademark Office (“USPTO”). While these may still serve as stopgaps at the USPTO, their robustness and efficacy as patent applications are largely problematic.

It is generally an accepted good practice in the industry to file provisional patent applications to be as much like formal applications as possible. When inventors choose to file their provisional patent applications themselves (oftentimes by submitting presentations or academic papers), they might include language that could limit the invention, or generally set themselves up for obstacles down the road.

Enabling Disclosure in Provisional Applications

Another aspect to keep in mind is the fact that provisional applications must still provide an enabling disclosure. That is, they are held to the same standard as non-provisional applications for being able to adequately teach the invention they protect. This is in fact a key requirement in all jurisdictions. For example, section 27(3) of Canada’s Patent Act states that the “specification of an invention must correctly and fully describe the invention and its operation or use as contemplated by the inventor.”

A provisional application which only spells out an idea, but does not teach how to properly implement it, may run into problems later on, including at the formalization stage. Patent Examiners may also assign later claim dates to concepts that did not appear in the provisional application, and only appeared later in its formalization. This is why it is a good practice to ensure that that provisional application describes the invention as fully as possible.

Conversion to Formal Applications

As the provisional applications must be converted into regular applications before the 12-month time period runs out, another important point to remember is that a very rudimentary provisional patent application may be much more difficult to convert into a full patent application than a provisional application that is well-drafted. The rudimentary provisional will undoubtedly require more time, effort and money than if the starting point was a robust provisional patent application drafted by a patent professional. So while the photograph of a napkin with an idea on it may seem appealing initially, it can end up costing inventors a lot more down the road.

At a very minimum, a provisional patent application should be a robust detailed description of the invention. It should teach those skilled in the relevant art how to implement and practice the invention. The description should also describe the invention as fully as possible so that a meaningful set of claims may be drawn from it at the formalization stage, if not at the provisional stage.

Patents are not cheap, but they can turn out to be your business’s biggest assets, so it is worth investing in them and drafting them properly from the start. It is equally important to remember that patent law isn’t simple. It is one of the most complex areas of the law, with numerous potential pitfalls if you aren’t careful. That’s why hiring a professional from the start, who is trained and experienced in navigating the intricacies of patent law, can end up saving inventors a great deal of time, money and trouble in the long run.

If you have an idea that you are considering patenting, please feel free to reach out to MBM for a free consultation.

For more information please contact:

Osman Ismaili, Patent Associate
T: 613.801.1054
E: oismaili@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.

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.

CIPO Updates Patent Examination Practice In Light of Recent Federal Court Decision

The Federal Court in Choueifaty v. Canada (Attorney General) (2020 FC 837) found that CIPO’s problem and solution framed “purposive construction” was inconsistent with the principles set forth by the Supreme Court of Canada.  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 this is a positive development and recommend a reassessment of cases that were impacted by CIPO’s incorrect past position. For more background information, please see our previous article.

For more information please contact:
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.

 

Enforcing Copyright Outside the Courtroom – The New Notice Regimes

 

With the ever-increasing presence of social media, including websites like YouTube where content can generate income, copyright infringement is escalating at alarming rates. Unfortunately, it is no secret that the cost of enforcing copyright through the courts is expensive. To mitigate these costs, this article will provide some tips on how to enforce copyright outside the courtroom.

Enforcing Copyright

The traditional pre-litigation enforcement tool is a demand letter. However, consideration should also be given to the Copyright Act ‘Notice and Notice Regime’ and where applicable, the social media platform(s) internal notice systems.

Traditional Pre-Litigation Demand Letters

Obviously, the stronger the identity of a right is explained in a demand letter the more likely the letter will have an effect. Fortunately, obtaining a copyright registration is extremely quick and relatively inexpensive. As such, consideration should be given to whether to register a copyright before the delivery of a demand letter.

Pre-Litigation Notice Letters

To avoid litigation, the federal government and social media platforms have created an alternate pathway to enforce copyright and settle disputes.

Notice and Notice Regime

To deal with growing copyright infringement that occurs via intermediaries without initiating litigation, the federal government added section 41.25, to the Copyright Act, which sets up the Notice and Notice Regime.

The Notice and Notice Regime is a voluntary-industry based system in which copyright owners can notify an intermediary, including social media platforms, that they are hosting copyright infringing material. The social media platform would then notify the copyright violator, usually by forwarding the letter they have received. Additionally, intermediaries are obligated to retain records about the alleged copyright infringement for six months after the notice is issued. Intermediaries commonly include internet service providers (ISPs).

Automatic Forwarding

Unfortunately, the original system was subject to abuse as social media platforms tended to forward all copyright notices they received in order to limit their liability. Copyright trolls and other nefarious entities would bulk mail, and email, standardized letters to social media platforms, which they would forward to the alleged infringers. These letters were used to effectively extort settlement money from alleged infringers.

To prevent this abuse, the federal government amended section 41.25 (3) of the Copyright Act to prohibit these notices from containing:

• An offer to settle the claimed infringement;
• A request or demand, made in relation to the claimed infringement, for payment or for personal information;
• A reference, including by way of hyperlink, to such an offer, request or demand; and
• Any other information that may be prescribed by regulation.

If a notice containing any of the above is sent to an intermediary, they are no longer obligated to forward the notice or maintain any records of it. However, in practice, social media companies often still forward these notices without reviewing them. Therefore, it is important to determine the actual source of the notice and its content.

Internal Notice System

Virtually all social media platforms have developed their own copyright notice systems and policies to deal with and notify alleged copyright violators. However, YouTube and other social media platforms send out many different types of notices. Each different type of notice can result in different consequences. Thus, it is important to identify not only: (a) who is sending the notice (e.g. a lawyer, social media platform or alleged copyright holder); but also (b) what type of notice is being sent. Only after knowing both, who the sender is and what type of notice it is, can a recipient better understand the proper actions to take.

It is important to remember that regardless how far a copyright holder is along the notice path, copyright holders can still initiate legal action separately and independently at any time. The copyright holder always has the option to initiate legal proceedings.

If you are considering sending a cease and desist letter relating to intellectual property infringement, or if you have received such a letter, please feel free to reach out to MBM for a free consultation. Also, stay tuned for a separate article discussing specifically YouTube’s internal controls for IP infringement.

For more information please contact:

Osman Ismaili, Patent Associate
T: 613.801.1054
E: oismaili@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.

High Stakes: Protecting Your Cannabis Intellectual Property

It has been almost two years since the federal legalization of cannabis, and Canada’s legal cannabis market is quickly blossoming into a massive industry. The market is constantly growing with many US states (e.g., Illinois) and Europe embracing regulatory change. Market research predicts that the global legal cannabis market could reach CAD $100 billion by 2027[1].

While medical cannabis has traditionally been a source of intellectual property (IP), legalization is sure to bring an influx of applications in the coming years. Therefore, understanding and deploying your IP toolbox to its fullest potential is the best means of ensuring strong protection of your IP assets. This article will briefly discuss some of the tools that cannabis businesses should consider when creating a robust IP moat around their products and services.

Patents in the cannabis industry can include novel or modified active ingredients, methods for the isolation of novel cannabinoids, novel formulations of active ingredients, genetically modified cells, and the use of compositions comprising cannabinoids for treatment.

In addition to patents, Plant Breeders Rights (PBRs) are an excellent complement and can be used to protect new cannabis plant varieties. PBRs are a form of intellectual property that specifically protects new plant varieties and offers exclusivity in terms of the sale, production, reproduction, import and export of the variety. This protection can be further extended beyond Canada by filing an international application.

While higher life forms are not patentable subject matter in Canada[2], genetically modified cells and methods of producing such cells are patentable[3]. New plant varieties that have been produced by traditional breeding methods are not patentable and as a result, are only eligible for protection under PBR. As such, businesses should take advantage of both regimes by obtaining a patent to protect genetically modified cells and PBRs to extend protection to the resulting plant variety.

In order to be granted protection under PBRs, the variety must meet the following criteria:

• New: the variety may not have been sold longer than 1 year in Canada and 4 years outside Canada;
• Distinct: the variety must be distinguishable from varieties whose existence was common knowledge on the date of filing;
• Stable: the variety must express a stable set of characteristics throughout propagation; and
• Uniform: the variety must exhibit characteristics that are consistent between plants within the variety.

Industrial designs are another useful tool in your IP arsenal and can be used to protect the three-dimensional features of a shape and configuration, as well as the two-dimensional features (patterns and ornaments) of finished products intended to be sold (e.g., cannabis cigarettes). Once granted, an industrial design offers protection for up to 15 years. Businesses should also be aware that Health Canada has strict regulations surrounding the packaging design for cannabis products.

Trademark registration is another available tool cannabis businesses should employ to protect their brand. It is important to be mindful that, for example, cannabis products or any related service cannot be promoted by depiction of a person, character, or animal, whether real or fictional. For additional information, check out our recent article about how to properly protect your cannabis-related trademarks. Canadian businesses should also be aware that American companies might choose to register their trademarks in Canada due to some difficulty in obtaining a cannabis-related trademark in the US.

Utilizing and deploying the proper tools in your IP toolbox is the best way to maximize the value of your cannabis business. Consult a professional at MBM to discuss how to best protect your IP portfolio.

For more information please contact:

Poonam Tauh, Ph.D., Senior Patent Agent

T: 403.800.9018

E: ptauh@mbm.com

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[1] https://www.grandviewresearch.com/press-release/global-legal-marijuana-market

[2] Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76.

[3] Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34.

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.

Federal Court Finds CIPO Examination Practice Out of Line with Supreme Court Precedents

 

The Federal Court in a recent decision found a wide-reaching examination practice respecting purposive construction that was introduced by The Canadian Intellectual Property Office (CIPO) 7 years ago, to be against principles of purposive construction set forth by the Supreme Court and damaging to the prosecution of patents in several technology areas.

CIPO issued practice notice PN2013-02 entitled “Examination Practice Respecting Purposive Construction” on March 8, 2013 that instructed Examiners to frame their purposive construction of the claims through a problem and solution lens. In particular, it was CIPO’s position in this practice notice that “identification of the problem and the solution provided by the invention informs the purposive construction of the claims” and that only those elements that solved the identified problem were essential.

A second practice notice (PN2013-03) entitled Examination Practice Respecting Computer-Implemented Inventions was also issued that detailed using the problem and solution framed “purposive construction” for the examination of applications directed to computer implemented methods.

Two subsequent practice notices (PN2015-01 and PN2015-02) were also issued that detailed using the problem and solution framed “purposive construction” for the examination of applications directed to medical uses and medical diagnostic methods.

These CIPO practices significantly and negatively impacted prosecution in many areas of technology including computer implement methods, personalized medicine, diagnostics and biotechnology. In fact, to date, there have been 31 Patent Appeal Board decisions that referenced practice notice PN2013-02, ten of which included statutory subject matter objections. Of these ten, seven were refused outright.

There were also 84 Patent Appeal Board decisions that referenced practice notice PN2013-03 and 8 Patent Appeal Board decisions that reference practice notice PN2015-01.

The Federal Court in the recent Choueifaty v. Canada (Attorney General) decision (2020 FC 837) turned their eyes to CIPO’s practice of using the problem and the solution approach to inform purposive construction of the claims. This decision specifically reviewed Patent Appeal Board decision 1478 that specifically referenced PN 2013-03. Although Choueifaty v. Canada does not specifically reference the practice notices, the Court referenced the Manual of Patent of Practice 13.05.02 which incorporated the content of practice notice PN2013-02. The Court found:

[31] It is evident on a reading of the MOPOP that the Commissioner, notwithstanding stating that the patent claims are to be construed in a purposive manner, does not intend or direct patent examiners to follow the teachings of Free World Trust and Whirlpool. …

[37] The Appellant submits, and I agree, that using the problem-solution approach to claims construction is akin to using the “substance of the invention” approach discredited by the Supreme Court of Canada in Free World Trust at para 46. …

[40] For these reasons, I find that the Commissioner erred in determining the essential elements of the claimed invention by using the problem-solution approach, rather than the approach Whirlpool directs be used. (Emphasis added)

MBM welcomes this decision from the Federal Court that affirms our longstanding position that CIPO’s problem and solution framed “purposive construction” was inconsistent with the principles set forth by the Supreme Court of Canada.

For more information please contact:
Claire Palmer, Senior Patent Agent
T: 613.801.0450
E: cpalmer@mbm.com

Kay Palmer, 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.