IP protection – a vital foundation for the development of medical devices
For medical device innovators, the need to properly protect intellectual property is becoming increasingly urgent as the industry experiences a proliferation of innovation and a shifting global demographic driving demand. IP protection has been essential for advances in medical devices, due to the high R&D costs and the risk of counterfeiting and copying by competitors.
To safeguard a medical device’s potential for societal and economic benefits, it is vital for innovators to identify and protect IP assets such as R&D, trade secrets, designs, trial systems, manufacturing processes, and consumer goodwill and recognition. These make up a large part of a company’s value and must be protected from potential threats that exist in this highly competitive arena.
As a new device moves from an idea through the development process to market and commercialization, it is important to align the process with business and IP strategy from the earliest stages. Continuous review through the medical device development lifecycle will protect innovators and inventors from infringing on the large number of existing patents and registered design rights, and ensure that the strongest protection is in place for their own innovative medical devices.
Canadian strength & innovation
With a focus on innovation and new technologies in the field of medical devices, Canada’s current strengths and future potential for growth in the medical technology industry should not be underestimated.
Canadian universities, research institutions, and hospitals are conducting world-class research, and with a stable economy, the support of government, and one of the strongest regulatory systems in the world, Canada is a key investment opportunity for world technology leaders.
Canada’s medical devices industry is highly diversified, and imports and exports are on the rise. Canadian export is concentrated in such areas as diagnostic imaging, patient aids, orthopedic and prosthetic products, dental products, consumables, and equipment including, wheelchairs, ophthalmic instruments, anaesthesia, endoscopy, and dialysis apparatus, and blood pressure monitors.
Smart & Biggar is actively involved in the evolution of Canadian intellectual property policy and legislation and plays an active and engaged role in developing and promoting industry and innovation for leading organizations in Canada.
Smart & Biggar technical expertise
The complex technology, fierce competition, and interdisciplinary nature of the medical device industry make having highly specialized strategy and protection essential. With technical backgrounds in sectors such as pharmacology, chemistry, biochemistry, biotechnology, biophysics, molecular biology, and genetics, our lawyers deliver focused and relevant IP strategies that integrate technical depth and the current industry trends and regulations both in Canada and internationally to keep our clients on the cutting edge of medical innovation.
Smart & Biggar legal expertise
In the fast-paced medical device market, company success is built on the strength of intellectual property that is meticulously and strategically handled. We prepare, draft, and prosecute patents, and provide strategic counselling on patent validity, patent infringement, and patentability.
We have expertise in all manner of IP transactions, including licensing and asset purchase agreements, manufacturing and supply agreements, research collaboration agreements, sale and distribution agreements, related due diligence, and regulatory matters. Our powerful combination of legal expertise and advanced technical training in relevant subspecialties enable us to offer outstanding services for the protection of medical devices and innovation.
Medical devices are a global necessity
The medical device sector has far-reaching implications for the health and well-being of populations in countries around the world. The economic growth of the fiercely competitive field of medical devices is accelerating in the global marketplace and is expected to continue.
Without adequate IP protection and laws, the misuse, unlawful reproduction and counterfeiting of medical devices is a significant issue for global companies. Regulatory controls and strong international intellectual property laws are necessary to control the unlawful reproduction, importation, and use of counterfeited medical devices. IP protection differs in jurisdictions around the globe and with a vast network of foreign associates, our lawyers give targeted advice on how best to navigate international IP rights and the global economy.
Our depth of experience is unmatched
With our depth of IP and industry-related experience, our clients have a focused team behind them to develop and implement IP management and strategy to strengthen and protect their business objectives and corporate strategy.
Our services include:
- Drafting and prosecuting patents
- Patentability, validity and infringement opinion
- Patent searching and whitespace analysis
- Patent monitoring
- Trademark searches and filing
- Copyright and industrial design registration
- IP audits and due diligence
- Technology transfer
- Licence agreements
- Patent infringement litigation
- Regulatory issues
- Strategic advice on intellectual property portfolios
Key Contacts
Client Success
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Fasken v Getemed
2022 TMOB 217Successfully defended international client’s trademark registration in Canada.Read More -
Cook Incorporated v Medical Resources Corporation
2011 TMOB 151Successfully opposed a trademark application for the mark SILHOUETTE which was found likely to be confusing with the client’s prior used mark.Read More -
Healthcare compliance, regulatory, and grey market issues for pharmaceutical and device companies
OngoingMultinational pharmaceutical and device clients on various regulatory, healthcare compliance (including liaising with US counsel on FCPA), grey market and access to information / freedom of informatio...Read More -
Pharmaceutical industry guidance on marketing, advertising and privacy matters
OngoingMultinational pharmaceutical and device clients on various marketing, advertising and privacy matters, including disputes with competitors, PR activities, DTC advertising campaigns, advertising by hea...Read More -
IP advisor to perinatal safety company PeriGen Inc. in acquisition by Halma plc for US$58M
IP advisory counsel to perinatal safety company PeriGen Inc., defending the value of the company's patent portfolio value during and IP Due Diligence in its acquisition by Halma plc in an deal va...Read More -
Reimbursement, pricing and market access issues for pharmaceutical and device companies
OngoingMultinational pharmaceutical and device clients on various reimbursement, pricing and market access issues (including rebate, interchangeability, procurement matters and agreements with public and pri...Read More -
Regulatory disputes for therapeutic products, innovative drugs, controlled drugs and substances, competitor claims
OngoingMultinational pharmaceutical and device clients in disputes or interactions with regulators, including how therapeutic products are classified (including from a controlled drugs and substances perspec...Read More
Related Publications & Articles
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Updated and new draft Health Canada guidance documents related to medical devices
On August 30, 2023, Health Canada opened consultation on its draft pre-market guidance for machine learning-enabled medical devices (MLMD).Read More -
In-house counsel primer: Managing IP and compliance risks in artificial intelligence and a digital world
This article provides a summary of key insights and takeaways from the panel, with strategies for in-house counsel to leverage and protect a company’s valuable portfolio, both offensively and defensiv...Read More -
Health Canada paving the way for more AI/ML medical devices
On October 27, 2021, Health Canada, the US Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly published the Good Machine Le...Read More -
Regulatory amendments provide permanent measures to address therapeutic product shortages
On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments ar...Read More -
Proposed amendments to Food and Drug Regulations and Medical Devices Regulations would modernize the regulatory system for therapeutic products
On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are...Read More -
Patentability of diagnostic methods – has the Canadian Patent Office drawn the line?
The importance of medical diagnostic technologies has been brought to the fore with the COVID-19 pandemic.Read More -
Canada’s patent office speeding examination of COVID-19 med-tech applications, cutting company costs
David Schwartz spoke to Bioworld about the new pilot program designed to reduce the time it takes to approve patent applications for inventions supporting health-related response to COVID-19.Read More -
Do Ontario regulatory laws apply to BC retailer’s online sales to Ontario residents? Ontario Court of Appeal overturns lower court ban on online sales of prescription eyewear to Ontario residents
On April 4, 2019, the Ontario Court of Appeal overturned the Ontario Superior Court of Justice’s finding that online sales of prescription eyewear by Essilor Group Canada Inc. (Essilor) to Ontario res...Read More
Related News & Media
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Sheldon Hamilton participates in webinar to address second medical use infringement, as part of LSPN Connect
Smart & Biggar partner Sheldon Hamilton will moderate a live webinar for LSPN Connect on Tuesday, December 1, 2020.Read More -
Smart & Biggar welcomes Natalie Galley as a new associate in Montreal
Smart & Biggar, Canada’s leading firm for intellectual property law and agency services, is pleased to share that Natalie Galley has joined our Montreal patent practice as a new associate.Read More -
Andrea Berenbaum joins Smart & Biggar bringing her patent expertise to Vancouver
Smart & Biggar is pleased to announce that Andrea Berenbaum has joined the firm as a senior associate in Vancouver.Read More -
Smart & Biggar builds on strength as an IP litigation powerhouse with the additions of Noelle Engle-Hardy and Ryan Evans in Toronto
We are proud to welcome Noelle Engle-Hardy and Ryan Evans as the newest members of Smart & Biggar’s highly skilled IP litigation team.Read More -
Alice Tseng is awarded ‘Canadian Regulatory Attorney of the Year’ by LMG Life Sciences
On September 18th, 2019 the Legal Media Group (LMG) Life Sciences Awards took place at Essex House in New York, NY.Read More -
Abigail Smith joins the Canadian Bar Association’s National IP Section Executive
Smart & Biggar is pleased to announce that Toronto senior associate, Abigail Smith, has been elected to the Canadian Bar Association’s (CBA) National Intellectual Property (IP) Section Executive a...Read More -
Keltie Sim Luft and Nancy Pei named in the world’s 'Top 250 Women in IP'
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Smart & Biggar sponsors Toronto Medical Device Playbook 2019
Smart & Biggar is pleased to be a sponsor of Medical Device Playbook 2019, Canada’s largest medtech event for entrepreneurial companies and medical device professionals.Read More