Right here in Canada, fashion companies big and small have done their part to contribute to bettering the circumstances surrounding the pandemic. Canada Goose has used its facilities in Toronto and Winnipeg to produce . Meanwhile, Toronto designers and began creating non-medical grade masks in response to the pandemic. In the midst of what has proven to be an exceptionally challenging time for many communities globally, the fashion industry has stepped up to provide resources where possible.

However, as homemade and factory-made masks have become a growing means of supporting the public and healthcare workers in times when resources may be scarce, health authorities have cautioned that there are foundational requirements that must be met in order for any mask to be as effective as N95 respirators, surgical masks, or other personal protection equipment (PPE).

America’s Center for Disease Control (the CDC) and the Food and Drug Administration (the FDA) have released informing the public that there is a significant difference between “surgical” and “non-surgical masks”, and accordingly, the labeling of these products must reflect this difference.�� The regulation of surgical masks by the FDA generally includes standards relating to the use of specific medical-grade textiles and coating technologies that aid in filtration to ensure that the masks block minuscule airborne particles. Other regulatory guidelines also include the manufacturing and storage of the masks in an environment that meets the legally defined “quality system requirements”. Similarly, in Canada, various PPE, such as masks and respirators, are as medical devices by Health Canada. However, meeting the regulatory standards within Canada, the United States, or other regulatory bodies around the world can prove to be difficult for small and independent fashion designers.

Given the rapid progression of COVID-19, Health Canada has worked towards streamlining the approval process for medical devices. On March 18, 2020, the Minister of Health, pursuant to subsection 30.1(1) of the , made an setting out that device licensing provisions of the do not apply to necessary devices if certain procedures are followed. Similarly, as indicated in a , the FDA stated that given the circumstances surrounding the COVID-19 Public Health Emergency, it will “not object to the marketing and distribution of” certain face masks without the “usually-required prior-clearance”. These temporary regulatory changes and relaxed standards may better assist American and Canadian fashion brands in producing PPE. Regardless, fashion companies must properly assess and consider whether the products they are producing meet their government’s current regulatory measures.�� Though brands such as New 91��ɫ’s Christian Siriano have that they intend to make masks that meet FDA standards as soon as they can acquire approved materials, meeting these standards may not be a feasible option for some designers. In these cases, proper product labeling as outlined by regulatory bodies must be followed.

The FDA has that companies may produce non-surgical masks if the product labeling respects the following requirements: it may be used when FDA cleared masks are unavailable; it recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected; it makes no claims of antimicrobial or antiviral protection; it makes no claims of infection prevention or reduction; it makes no claims regarding flammability; the labeling contains a list of the body contacting materials; and the mask is not labeled as a “surgical mask”; rather it may be labeled as a “face mask”.

Health Canada has also advised the public and healthcare professionals on various important considerations for the use of homemade masks to protect against the transmission of COVID-19. Specifically, Health Canada has : “Homemade masks are not medical devices, and consequently, are not regulated like medical masks and respirators. Their use poses a number of limitations, [including] they have not been tested to recognized standards, they may not provide complete protection against virus-sized particles, the edges are not designed to form a seal around the nose and mouth, the fabrics are not the same as used in surgical masks or respirators, [and] they can be difficult to breathe through and can prevent you from getting the required amount of oxygen needed by your body”.

As fashion companies continue to reallocate resources in order to make essential products throughout the current global health pandemic, it remains crucial that independent designers and global fashion companies alike understand the various regulatory considerations and distinctions between surgical and non-surgical masks.

Written by Alessia Monastero, IPilogue editor and articling student at Deeth Williams Wall LLP.

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Thomson-Reuters’ forecast is supported by the People’s Republic of China State Intellectual Property Office’s����(the Strategy), a document that was published November of last year containing tactics to significantly increase the nation’s patent production. The Strategy aims to reach 2 million patent filings per year by 2015 and to double both domestic and overseas applications. The document outlines approaches to achieve this, such as increasing patent examination and approval efficiency by cutting waiting times down to as little as 3 months and doubling patent examiners to 9000, as well as enhancing benefits of utilizing patents and protecting the rights of patent holders by improving patent law and regulations.

The Strategy is certainly ambitious, especially considering that China did not even have a patent law system in place until 1985.������noted their skepticism towards this pending patent explosion, expressing concerns that there may be a major quantity versus quality discrepancy.

Firstly, there are three types of patents in China: invention, utility model, and design. Chinese patent law allows double patenting where an applicant is able to simultaneously apply for an invention patent and a utility model patent. The utility model patent, which provides protection for a product’s shape or structure, requires no substantive examination and is typically granted very quickly. In some sense, it acts as a placeholder “mini-patent” before the invention patent, which does involve a potentially lengthy examination, is granted. A utility model patent must be abandoned before the invention patent is granted for the same product. These utility model patents are also often used to protect new ideas applied to pre-existing products. Hence, China’s numbers may have been artificially inflated. Three years ago, a legal expert proclaimed that the standard is so low that��. Since then, amendments have been made to the law in an effort to raise the quality of Chinese patents to meet international standards but we have yet to see evidence of a genuine technical innovation burst.

The second issue with patent quality is the use of state incentives for filing patents,including cash bonuses, residence permits, tenure, fee waivers, substantial tax breaks, and government contracts. These inducements then trickle down companies to its individual employees��. While these strategies technically work to aggressively increase numbers, they are misleading in painting China as an inventive nation. The problem is that these incentives are granted for patents, and not innovation.

The Strategy suggests that China is aware of these concerns, promising to enhance patent quality, as well as “”. The approach they appear to be taking is to establish themselves as global patent leaders in numbers first and then gradually refine quality. It is possible that what China will end up with is a mountain of useless patents but��. For example,��.

Nancy (Meng Xiao) Situ is a JD candidate at Osgoode Hall Law School and was enrolled in Professor Mgbeoji’s Patents class in Fall 2011. As part of the course requirements, students are asked to write a blog on a topic of their choice.

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Many commentators and policymakers have expressed serious concerns about the exclusionary potency of patents on communications protocols and interface designs for information and communications technologies (ICT).�� Among the proposed policy responses to potential harms arising from the exercise of such interface patents are excluding interfaces from patent protection, immunizing use of patented interfaces when necessary to achieve interoperability, tailoring certain patent rules to foster greater interoperability, withholding injunctive relief for infringement of interface patents, and treating refusals to license interface patents as abuses of intellectual property rights or violations of competition or antitrust laws.

This Article is the first comprehensive assessment of the twenty-some proposed policy responses to the exclusionary potency of interface patents.�� It makes four main points.�� First, there is less need for
strong regulatory measures, such as barring patents on interface innovations or treating the exercise of interface patents to block interoperability as misuse of the patents, than some commentators seem to believe.�� Second, insofar as interface patents do emerge as more serious impediments to interoperability than they have been to date, there are adequate policy responses in place in various countries that can be used to address them.�� Third, some tailoring of patent rules and patent reforms may be advisable in order to promote greater interoperability among ICT systems.�� Fourth, patents are often less of an impediment to interoperability than secrecy of interface information, which may be difficult or impossible to reverse engineer, ambiguity about precise details of the interface, and/or changes to interfaces that may accompany new versions or features of an ICT system.�� This Article explains why it may be difficult to bring about more interoperability by mandating more substantial disclosures of interface information or regulating what kinds of changes firms can make to their interfaces.

Professor Pamela Samuelson's article "Are Patents on Interfaces Impeding Interoperability?"��is available for download on SSRN .�� It is forthcoming in the Minnesota Law Review.

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While such lock-ins act as an incentive for the company that can procure them, it has the potential to harm the competitiveness of the marketplace by creating barriers to entry for newcomers and by causing complacency in the incumbent market leader. ��This leads to a fear that there may be a lack of innovation in that space. ��

As such, there has been a movement to establish open standards that level the playing field for the marketplace.�� These movements have played out in a variety of different ways, but perhaps the most pervasive illustration of standards today is those set by the World Wide Web Consortium () which aims to “allow��any hardware and software used to access the Web to work together.”�� To the extent that standards is said to enable innovation, the existence of open and clear web standards is an exemplary example because it facilitated a vibrant marketplace for online innovation. ��

While it is generally recognized that open standards is increasingly necessary in our age of global cross-platform communications, how exactly this policy goal intersects with holders of patent rights is unclear.�� For example, what if the implementation of a standard is covered by a patent? Will this not create the possibility of exorbitant royalties and undermine the purpose of creating standards in the first place? These were the issues that formed the subject of a WIPO panel .��

The panelists had several suggestions to mitigate the potential impact of patents on standards: the involvement of government through implementing a requirement for disclosing relevant IP information on standards; modifying TRIPs so as to introduce an interoperability provision for standards, just as there is for public health; and using competition authorities to monitor the development of standards to ensure that anti-competitive practices are not employed.��

It is the last of these which highlight a more general tension between intellectual property rights (IPRs) and competition law. ��Whereas IPRs provide a paper monopoly by means of a private right to exclude all others from utilizing an invention or work, such a concept is antithetical to competition law because it restricts otherwise capable parties from entering a market.�� Ultimately, the setting and implementation of standards is as much a competition concern as it is an innovation concern because the two are inextricably linked in the area of hi-tech.�� Nevertheless, one must not discount the effect of IPRs in providing an economic incentive for private parties to develop robust and useful standards.����

As the dialogue around this issue continues to grow, it will be interesting to see how the policy initiative of achieving optimal innovation in society will be achieved while taking into account the tension in the two legal regimes.��

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