In a recent Federal Court decision, Justice Fothergill dismissed AbbVie’s applications for judicial review of the following decisions of the Minister of Health (the “Minister”): that JAMP was not a “second person” for the purposes of s 5(1) of the PM(NOC) Regulations; and to issue NOCs to JAMP for its SIMLANDI Presentations. Background AbbVie's drug HUMIRA first received approval in Canada in 2004 as a 50 mg/mL concentration of adalimumab. HUMIRA is widely used to treat numerous medical conditions including rheumatoid arthritis, adult and pediatric Crohn’s disease, and psoriasis. In 2016, high-concentration (100 mg/mL) HUMIRA was approved in Canada in a 40 mg/0.4 mL pre-filled syringe (DIN 02458349), and as a 40 mg/0.4 mL pre-filled auto-injector pen (DIN 02458357). In fact, AbbVie has marketing authorization in Canada for a variety of concentrations, but is actively selling only: the original (lower) 50 mg/mL concentration in 40 mg/0.8 mL strengths in both auto-injector pen and pre-filled syringe presentations, and the newer (higher) 100 mg/mL concentration in a 20 mg/0.2 mL pre-filled syringe. In December 2020 or January 2021, JAMP sought regulatory approval in Canada for its SIMLANDI drug, a “biosimilar” of AbbVie’s HUMIRA, in some of the strengths not actively sold by AbbVie (i.e., a 40 mg/0.4 mL pre-filled syringe, a 40 mg/0.4 mL auto-injector pen, and an 80 mg/0.8 mL pre-filled syringe). In its NDS, JAMP relied on three HUMIRA drug products having the same exact dosage forms, strengths, and routes of administration as the drugs to be marketed as SIMLANDI. None of these formulations of HUMIRA was marketed in Canada by AbbVie at the time JAMP submitted its NDS. Hereinafter, these drugs (DINs 02458349, 02458357, and 02466872) are referred to as the “referenced HUMIRA products”. In its correspondence with Health Canada’s Office of Submissions and Intellectual Property (“OSIP”), and after being told that their NDS was incomplete, JAMP submitted Form Vs on a “without prejudice” basis, yet took the position that it was not required to comply with s 5(1) of the PM(NOC) Regulations, as they were not a “second person” as defined therein because the referenced HUMIRA products had not been marketed in Canada for several years and therefore they were not drugs “marketed in Canada” as required by s 5(1). 5 (1) If a second person files a submission for a notice of compliance in respect of a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the submission the required statements or allegations set out in subsection (2.1). [Emphasis ours] Health Canada’s Office of Patented Medicines and Liaison (“OPML”) later advised AbbVie of its preliminary view that the referenced HUMIRA products were indeed not currently being marketed in Canada. Therefore, the referenced HUMIRA products did not trigger s 5(1) of the PM(NOC) Regulations. However, AbbVie argued that JAMP nevertheless made reference to a drug product they marketed in Canada, thus falling within s 5(1) of the PM(NOC) Regulations. Namely, AbbVie argued that JAMP SIMLANDI indirectly made reference to their HUMIRA 20 mg/0.2 mL pre-filled syringe because both products had the same drug concentration (i.e., 100 mg/mL). Hence, the issue was to determine whether a second person seeking approval for a drug with a specific dosage strength could be considered to indirectly refer to a “drug marketed in Canada” with another dosage strength but having the same concentration. The Minister’s Decision After reviewing submissions from both parties, the OPML issued its final decision on December 23, 2021, in which it confirmed its preliminary determination that JAMP was not a second person for the purposes of s 5(1) of the PM(NOC) Regulations, and the corresponding obligations did not arise unless the second person’s NDS “directly or indirectly compares the drug with, or reference” to “another drug marketed in Canada”. The OPML found that “another drug marketed in Canada” must be interpreted to be specific with respect to strength, dosage form, and route of administration (i.e., it is DIN-specific).” The Minister found that the “indirect” comparison of s 5(1) did not expand the scope of the drugs for which a second person must address the patents listed on the Patent Register beyond the DIN-specific “another drug”. Hence, the HUMIRA 20 mg/0.2 mL pre-filled syringe marketed by AbbVie was not a proper reference product for JAMP’s 40 mg/0.4 mL pre-filled syringe, 40 mg/0.4 mL auto-injector pen, and 80 mg/0.8 mL pre-filled syringe. Accordingly, on January 5, 2022, the Minister issued NOCs to JAMP and JAMP launched its products on April 13, 2022. Subsequently, AbbVie sought judicial review of these two related decisions of the Minister, the result of which is the presently-discussed Federal Court decision. Ultimately, the Federal Court agreed with the Minister. Specifically, the Federal Court concluded that inter alia the following findings by the Minister were reasonable: that the term “another drug” in s 5(1) of the PM(NOC) Regulations is confined to the drug products identified by Health Canada, and that these products must have an identical dosage form, strength, and route of administration to the drug product of the second person. that s 5(1) of the PM(NOC) Regulations applies only where a second person files a submission for an NOC that (1) directly or indirectly compares its drug, or makes reference to “another drug”, (2) that other drug is marketed in Canada under an NOC issued to a first person, and (3) that other drug is a drug in respect of which the first person has submitted a patent list; that a drug that is not marketed is not eligible for the protections under the PM(NOC) Regulations; and that JAMP was not a second person under s 5(1) for the simple reason that AbbVie was not marketing in Canada the HUMIRA drugs that JAMP relied on for its NDS. Conclusion The Minister's decisions, as well as the Federal Court's finding that they were reasonable (pending any appeal), emphasizes one of the statutory objectives of the PM(NOC) Regulations, namely to provide a patent enforcement mechanism only in relation to products that are in fact available to Canadians. This also clarifies certain practical effects of this statutory objective, namely that the enforcement mechanism of the PM(NOC) Regulations is only available to an innovator that markets its innovative drug in Canada, and that s 5(1) of the PM(NOC) Regulations applies only to reference drug products that are identical down to a DIN-specific level with the drug to be approved. However, this does not mean that innovators are entirely without recourse when it comes to drugs they are not marketing in Canada. Under such circumstances, while innovators may not be able to utilize the PMNOC Regulations to prevent a NOC from being issued to a competitor, it can nonetheless commence normal patent infringement proceedings in Federal Court.   A copy of this decision, AbbVie Corporation v. Canada (Health), 2022 FC 1209, is available here.   Our intellectual property team would be happy to help you with any questions you may have regarding the PM(NOC) Regulations.

This year’s World IP Day is upon us, with the theme “IP and Youth: Innovating for a Better Future”. In honor of this theme (and at the risk of making our adult readers feel a bit less accomplished), we thought it would be appropriate to highlight some of these wonderful inventions of young, innovative minds. US 8,371,246: Device for drying pets  In 2011, 9-year-old Marissa Streng invented a device to more effectively dry her pet dog Mojo after his baths. The product is now apparently sold under the brand Puff-N-Fluff. US 7,726,080: Under-floor storage   At the age of 14, Rebecca Hyndman patented an under-floor storage system intended for use in locations where tile floors are normally used, such as in kitchens and in bathrooms. As a result of this achievement, she was given the honor of introducing President Obama at the Thomas Jefferson High School for Science and Technology, immediately prior to his signing the America Invents Act into law. US 6,029,874: Article carrying device for attachment to a bicycle for carrying baseball bats, gloves and other sports equipment or objects   Biking to baseball practice can be quite the challenge when one has to carry both a bat and a glove simultaneously. From this problem sprang the “Glove and Battie Caddie”, invented by Austin Meggitt at the age of eleven. The Glove and Battie Caddie holds a baseball, bat, and glove on the front of a bike. US 7,374,228: Toy vehicle adapted for medical use   At the age of 8, young Spencer Whale invented a toy vehicle adapted for transporting a child and their required medical equipment. According to the patent, the toy allows children who are hooked up to medical equipment to move more freely around a hospital, with the intention of making their stay more enjoyable. US 5,231,733: Aid for grasping round knobs   One of the youngest people to obtain a patent was Sydney Dittman of Houston, Texas. In 1992, when Sydney was only 2 years old, she invented a tool out of parts of her toys in order to open kitchen drawers that her parents had told her to stay out of. Upon noticing that the device would be great for handicapped people to use, her father started the patenting process, and the resulting patent issued when Sydney was only 4 years old. Please join us to celebrate youth innovation on this World IP Day!

In the third and final entry of this three-part article series, we share with you the last set of intellectual property (IP)–related mistakes (mistakes #10 to #13) that we regularly see with startups. We hope you will find it useful for your business. Please be sure to read our first and second entries in this series, where we go over mistakes #1 to #5 and #6 to #9, respectively. Happy reading! Part 3 of 3 Mistake #10:       Assuming that your invention is unpatentable One common mistake we see business owners make is that they assume their technology is not patentable. This frequently applies to computer-related inventions, such as software. Even though there is no outright ban on patenting software in Canada, many inventors are under the impression that software is unpatentable. This is most likely due to the fact that many patent applications for computer-implemented inventions are initially refused because the Patent Office determines that the invention in question is merely a disembodied series of mental steps and/or a mathematical formula (both of which are not considered patentable subject matter). However, it is important to remember that, while certain types of subject matter are not patentable in Canada (e.g., disembodied mental steps and mathematical formulae, as mentioned above), that does not mean that technology involving such unpatentable subject matter (e.g., computer software) is completely void of patentability. Often, it simply means that another aspect of the technology should be the focus of the patent application. For example, with regard to computer-implemented inventions, one strategy to increase the likelihood of patentability is to draft the patent application in such a way so as to emphasize that the computer hardware is essential, or to draft the application in such a way that it is clear that the invention creates an output comprising discernible effects or changes (e.g.: this can be as simple as generating distinct groups in a classification method). It is also worth noting that many inventors are under the mistaken impression that a new piece of technology has to be all but revolutionary in order to be patentable. However, improvements over existing technology are also patentable as long as they are sufficiently new and inventive. Accordingly, it is important to speak to a patent agent to properly determine if and how your invention may be patented. Mistake #11:       Believing that your patent automatically gives you the right to use and/or commercialize your invention One common misconception regarding patents is that they give the owner thereof the right to use and/or commercialize the patented technology without fear of infringing third-party patents. However, what a patent actually does is allow its owner to exclude others from using and/or commercializing their patented technology. It is not a shield against potential infringement of third-party IP rights. For example, if you obtain a patent for a piece of technology you developed, that does not necessarily mean you have the right to use or commercialize that technology. Specifically, if your technology incorporates patented technology owned by another company, then that company can actually prevent you from using or commercializing your own invention. This is an important aspect of “patent protection” that all entrepreneurs should be aware of. Mistake #12:       Not informing yourself about the criteria for recognition as an inventor or owner of an invention, and not training your employees on these criteria Many types of intellectual property disputes can arise within a business. Most of the time, they are the result of misconceptions, such as: An employee believes they are the inventor of an invention, when they are not; An employee believes that as the inventor of an invention, they are necessarily entitled to consideration (monetary or otherwise); the invention belongs to them rather than to the company; they are free to use the invention, for example upon leaving the company to become a competitor; or An employer believes that their company can use the specific results of a researcher’s work obtained from a previous job. It’s easy to imagine how messy such issues can get! An ounce of prevention is certainly worth a pound of cure. Get informed! Also, clarify these issues with new employees as soon as you hire them, and set down in writing who will own the rights to intellectual property developed during the course of employment. A quick training session before such problems arise can set the record straight and avoid conflicts based on unrealistic expectations. Mistake #13:       Not having an intellectual property protection strategy After reading this three-part article, we hope you now have a better understanding of the importance of developing an intellectual property strategy for your company. While such strategies can be very complicated, we have provided three broad questions that you should consider at all times (not just when starting out).  What intellectual property is my company using? This first question tasks you with identifying intellectual property that your company uses. This would include any technology that you are using or selling; any brand names/logos; and any works you are currently using (e.g., logos, slogans, website layouts, website texts, pictures, brochures or computer programs). Is there a risk that I am infringing a third party’s IP? Once you have identified the above intellectual property, you should ask yourself if your activities might infringe a third party’s IP rights. Obtaining a response may involve the following: Hiring a patent agent to perform a freedom to operate search for any technology you plan on using. Hiring a lawyer specialized in IP to perform a trademark search and opinion for any brand names/logos you use, as well as to negotiate and prepare an assignment of IP rights. How can I expand my own IP portfolio? This question involves determining, for each piece of IP you have identified, if and how it can be protected. This can include asking yourself the following additional questions: Is any of the technology I use or commercialize worth protecting? If so, should I file a patent application or keep the technology a trade secret? In which countries do I want IP protection? Are any of my company’s brand names or logos worth protecting by filing a trademark application? What’s important is not necessarily that you protect each and every piece of intellectual property your company owns, but that you have properly evaluated your company’s IP and have come up with an effective strategy that suits your business. In order to properly optimize your company’s IP portfolio, we naturally recommend speaking with your IP professional, whether it be a patent agent, a trademark agent, or a lawyer. Conclusion Lavery’s intellectual property team would be happy to help you with any questions you may have regarding the above or any other IP issues. Why don’t you take a look at our Go Inc. start-up program? It aims to provide you with the legal tools you need as an entrepreneur so you can start your company on the right foot. Click on the following links to read the two previous parts. Part 1 | Part 2

In the second entry of this three-part article series, we share with you the next set of intellectual property (IP)–related mistakes (mistakes #6 to #9) that we regularly see with startups. We hope you will find it useful for your business. Please be sure to read our first entry in this series, where we go over mistakes #1 to #5. Happy reading! Part 2 of 3: Mistakes concerning trademarks, industrial designs, copyrights, and trade secrets Mistake #6: Launching your product on the market without having verified the availability of your trademark Choosing a trademark can be a long and expensive process. People sometimes focus on the attractive qualities of a trademark, forgetting that its primary function is to distinguish a company’s products or services from those of others. To properly fulfil this function, the trademark must not be confusing with other trademarks, trade names, and domain names. In order to avoid conflicts with existing rights, an availability search should be conducted prior to a trademark’s adoption and the launch of a new product, service, or business. Furthermore, it may not be possible to register a trademark if it doesn’t have certain necessary intrinsic qualities, and a trademark may not be usable if it conflicts with the rights of third parties. A search will make it possible to determine where your desired trademark stands in terms of these two aspects; if necessary, a different mark may need to be adopted. Conducting a pre-adoption trademark search may prevent you from having to change trademarks after sales have begun or after the marketing development of your products or services is underway. Redesigning your advertising campaign; modifying your documentation, website, and packaging; and developing a new marketing strategy to transfer and retain the goodwill surrounding your initial trademark will be an expensive task, taking up time that could have been invested elsewhere. Such a process also carries the risk of tarnishing your reputation or losing your goodwill. Mistake #7: Not having your software or graphic designer sign a copyright assignment Many people think that a copyright is intended to protect a work with exceptional artistic qualities. However, such thinking is erroneous. As long as a text, drawing, graphic design or computer program is a creation that required a certain amount of effort and is not a copy of an existing work, it constitutes a “work” and is automatically protected by copyright. As a general rule, in Canada, the author is the first copyright owner; thus, just because the work was created in exchange for remuneration doesn’t mean that its copyright was transferred. For a startup business owner to ensure that they own a copyright, they should ask the artist or author to sign a written transfer of copyrights, thereby ensuring that the business can publish and use the work as it sees fit. It is also important to have the author of a work sign a waiver of moral rights or to outline the terms and conditions that will apply to the work’s authorship and integrity. If these steps are omitted, you’ll be limited in the use of such works. They won’t be part of your assets and will therefore not increase the value of your portfolio. In addition, you’ll be dependent on the consent of the actual holders of the rights to commence actions for infringement, should that ever be necessary. Mistake #8: Not having your employees, officers, and contractors sign confidentiality agreements (before entering into a business relationship) The sooner the better! Your company should see to having an agreement intended to preserve the confidentiality of its information signed by all those whom it mandates to perform work that is significant for its development, including its employees. The type of information that can be protected is virtually unlimited; at a minimum, it includes information related to R&D, market studies, prototypes, ongoing negotiations, marketing research of any kind, and lists of target customers. Ideally, in an employer-employee relationship, when an employee or officer leaves, a company should make sure to remind them of the confidentiality obligations that will continue to apply despite the end of the relationship. Applying these principles reduces the risk that an employee or partner will publicly share or independently use your strategic information at your company’s expense. Mistake #9: Not protecting your original products’ shapes and ornamentation within the prescribed time limit Many are unaware of the benefits of protecting an object’s shape, form, and ornamentation through the Industrial Design Act, or they learn of such benefits too late. In Canada, such protection has two key requirements: The industrial design must not have been published more than one year before the date on which an application for registration is filed; and The protection must be acquired by registration to exist. This type of protection is more effective than one might think and should not be overlooked. For example, a search of the industrial design register will reveal how many industrial designs tech giants have obtained. Some industrial designs have even been the subject of high-profile disputes, including one between Apple and Samsung over the shape of tablets. Apple Inc. uses such protection to prevent the presence of competing products that copy its designs on the market. As an example, in Canada, the shape of the headphones shown below was protected in 2021 and the shape of the phone shown below was protected in late 2020. For more detail on the protection of each of these articles, see Registration 190073 and Registration 188401. Conclusion Lavery’s intellectual property team would be happy to help you with any questions you may have regarding the above or any other IP issues. Why don’t you take a look at our Go Inc. start-up program? It aims to provide you with the legal tools you need as an entrepreneur so you can start your company on the right foot! Click on the following links to read the two previous parts. Part 1 | Part 3