Emily Xiang is an IPilogue Writer, a Senior Fellow with the IP Innovation Clinic, and a 3L JD Candidate at Osgoode Hall Law School.

For the first time in decades, the US Supreme Court will engage with enablement in patent applications. On November 4th, 2022, the Supreme Court to review the Federal Circuit’s decision in Amgen v Sanofi, against the . Specifically, Amgen seeks to appeal a , in which the court found Amgen’s patents invalid for lack of enablement.��

The requirement of enablement in US patent law is codified in , which requires that the specification of a patent application “enable any person skilled in the art…to��make and use” the invention in question. The in Amgen v Sanofi is whether this statutory requirement governs enablement (that the specification teaches those skilled in the art to “make and use” the claimed invention) or whether it must instead enable those skilled in the art “to reach the full scope of the claimed embodiments” without “undue experimentation” (characterized by substantial “time and effort”).��

In 2014, Amgen sued Sanofi for infringing on its patents concerning drugs for lowering cholesterol. The genus patents specifically cover that bind to the PCSK9 protein in the body. The patents disclose the amino acid sequences for 26 antibodies that bind to one or more of 15 residues found on the PCSK9 protein. Importantly, the claims at issue are considered , in which the antibodies are not claimed based on their structural components but rather on what they do.��

On January 3rd, 2023, many interested parties submitted to offer the Supreme Court their take on the issue to be considered. For instance, in a brief submitted by a group of , it was argued that the Federal Circuit’s standard imposes “an impossible burden” on patentees and that such a decision represents “a categorical shift in thinking away from teaching the PHOSITA and towards a precise delineation of the boundaries of the claim”. The professors further submitted that such a heightened requirement would be especially burdensome for patentees seeking to protect their innovations in the fields of chemistry and the life sciences, as “a chemical genus with any decently large number of species will never be able to satisfy the new enablement standard”.��

Other parties in support of Amgen presented some other reasons as well. In their amicus brief, the stated that the court’s reasoning “leaves patent practitioners guessing about how to advise client-inventors regarding the extent of disclosure required”. The , warned of the adverse impact that the new enablement requirement might have on the effectiveness of patent incentives for investors to contribute towards research and development, especially in the case of startups and smaller companies.

Moreover, the has filed a motion for leave to participate in oral argument, claiming a “paramount and unique institutional interest and perspective” – that is, the perspective of individuals and companies working in the chemical, pharmaceutical, and biotechnology fields. CHAL asserts that the Federal Circuit’s enablement standard potentially jeopardizes the benefits of many modern innovations and that adhering to the plain meaning of 35 USC s. 112 should continue to be the prevailing approach.

The Supreme Court’s decision regarding the enablement standard for functional claims could also have wide-reaching implications that spill over into other fields, such as technology and computer-implemented inventions. By too narrowly focusing on the “full scope of the claim” and “undue experimentation” instead of on what those skilled in the art could determine from the specification, it is unclear how broader claims for (such as those that describe the desired result to be achieved by the AI rather than its structural components or any specific software solutions) might fare in the face of such a standard.��

Amgen v Sanofi is scheduled to be heard by the US Supreme Court in the upcoming Spring Term.

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Meena Alnajar is an IPilogue Senior Editor and a 3L JD Candidate at Osgoode Hall Law School .

A protects your intangible property from others’ use, but what happens when patent protection operates in a way that ensures no other innovators can build upon a patented invention? When IP and competition clashes, authorities will step in to regulate as demonstrated in a recent dawn raid.

On September 13, 2022 the Swiss Competition Commission (“COMCO”) the pharmaceutical company Novartis’ headquarters in Switzerland at . A rather unusual visit, COMCO proceeded to raid the company’s headquarters for all information related to an unidentified . According to the regulator, the drug’s patent could be a blocking patent used to prevent competing products’ entry into the market. Novartis is allegedly protecting its dermatology drug by using one patent to launch proceedings against possible competitors in the market. Here we see IP and competition law colliding with blocking patents wielded as an anti-competitive tool.

A blocking patent can prevent another inventor from using the patent’s technology or improving it. A blocking patent is often cited by during the patent application examination phase to block a patent application or a patent’s challenger (such as those claiming an existing patent should be invalid). On July 22, 2021, held in Chemours v. Daikin that “[a] blocking patent is one that is in place before the claimed invention because such a blocking patent may deter non-owners and non-licensees from investing the resources needed to make, develop, and market such a later, ‘blocked’ invention.” A blocking patent is therefore broad in scope to deter people from innovating in any way related to the blocking patent. Overall, these patents are a helpful business tool, blocking a competitor to conserve the patent’s commercial success while also observing where competitors are attempting to . But when too successful, the blocking patent has a on competition. Innovators’ fear of overtakes their willingness to build on the invention and the blocking patent becomes an anti-competitive red flag to regulators.

In the Novartis , authorities are questioning whether Novartis is acting appropriately with its drug patent. The investigation is still in its and in the company have slightly fallen after the raid was announced. Regulators unexpectedly taking a business’ commercially sensitive information is not ideal. The investigation thus raises a further question, when does a business’ patent portfolio become anti-competitive and subject to a raid?

Patent rights and anti-competitive practices can overlap. Patent holders should take action to ensure that their IP use does not violate their jurisdiction’s competition law. Balance must be maintained in the patent system through the : setting strict patent content boundaries, preventing exclusive licensing that stops other competitors from market entry, and preventing restrictive selling practices where patent rights are used to price fix. While blocking patents can close the doors to competitors, these patents can open the doors for someone else, like regulators, to come in and conduct their information raids.

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Anita Gogia is a IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

iRobot Corp was recently issued a against its competitor SharkNinja Operating LLC for . The product in question was the innovative Roomba robotic vacuum and floor cleaning device. While the final decision is yet to be given in , the recent holding recommends an of any infringing SharkNinja devices. Once approved by ITC commissioners in February, this remedy will be enforced regardless of any appeals.

Such a decision is important as it provides credence to the work and intellectual property of iRobot engineers in revolutionizing home cleaning products. The iRobot portfolio consists of other technology innovations and ideas in .

It was found that SharkNinja was infringing two out of the four patents claimed by iRobot. The court found SharkNinja to infringe on two out of four of iRobot’s relevant patents, specifically for . While SharkNinja also infringed a patent for autonomous floor cleaning, there was no determination of a violation as the Patent Trial and Appeal Board had . The fourth patent for map-based training was . SharkNinja based their defence on the invalidity of iRobot’s patents. They that the patents were revisions of known technology and that such protection supresses innovation. For example, regarding the mapping patents, SharkNinja says, “”.

In the past, iRobot has applied their patent protections to . The iRobot advanced technologies have justified the high price for their products but have seen a largely due to competition from SharkNinja. In selling their vacuums for below half the price of the Roomba, SharkNinja has grown to be the in North America. According to representatives from iRobot, “”. Shark’s “plan” may work despite this decision, as the ban may not take place until February 2023, well beyond the holiday season when many household gifts such as robotic vacuum cleaners are purchased.

iRobot has revolutionized the home cleaning devices industry. However, a monopoly is typically considered contrary to public interest. One may argue that it is not reasonable for consumers to have no choice but to purchase an expensive robotic vacuum or not have one when a lower-quality and affordable one exists that offers the technology to navigate cleaning areas, autonomous charging, and map floor layouts. Perhaps if a consumer is willing to sacrifice quality to save money in their household, they should be able to.

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Emily Chow is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

On June 10, 2022, Adidas launched its first federal lawsuit against its main competitor, Nike, at the US District Court in Eastern Texas. Demanding a jury trial, the alleges that Nike has conducted nine counts of patent infringement relating to Adidas’ GPS, sensor and wearable technologies.

Both retailers are at the forefront of the sportswear/sporting goods industry, although Nike substantially exceeds Adidas in global sales with a profit of compared to The are Puma ($5.72B), Under Armour ($5.22B) and Lululemon Athletica ($3.75B).

The global sneaker industry, valued at by the end of 2027. According to , a large proportion of Nike’s income comes from footwear, with an estimated revenue of $28 billion USD in 2021 compared to Adidas’ $12.84 billion.

In its complaint, Adidas claims that Nike induced infringements of nine patents through their development of the , , and mobile applications. Adidas also takes issue with shoe line, which launched in 2016 and features self-tightening laces according to the wearer’s foot. The company claims that this is an infringement of Adidas’ existing patent for an that senses and adjusts the comfort of the shoe when worn. was announced in 2004 and released in 2005, touted as the world’s first intelligent running shoe.

In addition to selling sneakers, Adidas and Nike have both developed various mobile applications and exercise companions. According to , features of Nike’s apps – such as location-based GPS run tracking, the creation of training plans, audio feedback, and integration with third party devices – are direct infringements of Adidas’ intellectual property and its app. ��

Furthermore, Adidas points to similarities between its app, launched in February 2015, and , introduced a few days later. Both apps claim to make buying exclusive products easier and fairer for users, . The patented technology in question is , “systems and techniques for computer-enabled geo-targeted product reservation for secure and authenticated online reservations,” which allows Adidas to confirm a and prevent a bot from reserving the product in advance of the launch.

Adidas seeks a declaration from the court that Nike has infringed its patents, a permanent injunction, and compensatory damages, that “unless enjoined by this Court, [Nike’s] acts of infringement will continue to damage adidas irreparably.”

This new lawsuit comes at the and corresponding lawsuit filed in Oregon in December 2021. Nike sought to ban the import of shoes, accusing Adidas of appropriating Nike’s patented technology – a special knit weave made up of recycled and reclaimed yarn that creates a sock-like fit for the wearer.

The in Washington is often a forum for companies competing in the global market. Given the ITC’s relatively faster decisions – 15 to 18 months – , the ITC offers an expedited, comprehensive mechanism for addressing patent infringements.

Back in 2005, Nike also sued Adidas in East Texas. However, the companies It will be interesting to see how the ITC and Oregon verdicts will affect both companies’ strategies moving forward.

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Tianchu Gao is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

On June 8, 2022, the Department of Justice of the United States announced the official withdrawal of (2019 Statement). As a result, there is now no official written government policy ��setting out infringement remedies for Standards-Essential Patents. Instead, courts are now responsible for case-by-case regulatory scrutiny.

Significance of this Withdrawal

��, or SEPs, are patents that serve to ensure compliance with technical standards. Holders of SEPs are often required to grant licenses to their patents on fair, reasonable, and non-discriminatory (FRAND) terms. When disputes arise, SEP holders would need to do more work to demonstrate good faith and to move the negotiations forward. ��According to the , the withdrawal of the policy is intended to “create incentives to generate more innovation” and “strengthen the ability of U.S. companies to engage and influence international standards.”

The Policy Statement on Remedies for SEPs was initially launched by USPTO in . It was harshly by many in the IP community and thus was replaced with a more SEP-holder-friendly version in . The policy statement faced another transition in July 2021 when President Biden issued an to promote a “fair, open, and competitive marketplace.” In response to it, the USPTO and National Institute of Standards and Technology proposed a and solicited .

The new draft statement strengthened restrictions on SEP remedies again. Supporters of the draft argued that it provides a more handling of the rights of patent holders and implementers. The global corporation, Canon, that the draft would improve the predictability of SEP enforcement and facilitate the participation of potential SEP holders and implementers.

Yet, overall, criticism of the draft outnumbered the applause among the public. Many businesses and innovators found the policies unfair and disfavored the dictating role of the government. Senator Thom Tillis that it “diminishes patent holders’ statutory rights and undermines the judicial process by substituting the courts’ judgement for its own.” Another comment that the 2019 policy gave US companies an edge in 5G, artificial intelligence, biopharmaceuticals, and robotics sectors. The draft statement would subject American tech-companies to a less advantageous position in patent disputes. Apparently, these comments persuaded the US government that “withdrawal best serves the interests of innovation and competition.”

Looking into the future, the law regarding SEP injunctions inevitably becomes in the US. IP attorneys will have to watch more closely on how the courts rule cases involving requests for injunctions based on SEPs. It will also have ripple effects on smaller businesses and institutions, in the US and across the world, whose operations relies on SEPs implementation.

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Jaime Zorrilla is an IP Innovation Clinic Fellow and a 2L JD/MBA Student at Osgoode Hall Law School & the Schulich School of Business. This article was written as a requirement for Prof. Pina D’Agostino’s Directed Reading: IP Innovation Program course.

After inviting public and stakeholder feedback in 2020, the Ontario Government commissioned the . The Report found significant deficits in IP related outcomes. While the Ontario government has introduced courses to raise IP awareness, making these courses at least partially mandatory might better address the Panel’s Recommendations.

The report identified several issues in Ontario’s attempt to become a hub for IP creation. Further, of the patents that are assigned to Canadian inventors, a significant percentage are subsequently assigned to foreign entities. ��

So far, the province has taken meaningful steps to address these deficits in education and governance contexts. Notably, . The Ontario Government has worked with the University of Toronto and the Centre for International Governance Innovation to launch . Missing, however, is the second part of the Expert Panel’s recommendations – that engaging with these modules or curricula be “”.

On the one hand, requiring founders to take a course can delay and complicate the launch of a successful venture. Failing a module could play a detrimental role in determining whether a particular venture gets access to additional resources from universities, accelerators or even funding partners. Additionally, the length of such a module could dissuade innovators from seeking out resources or help from these institutions.

Still, the potential payoffs are significant. The report identified benefits in proliferating IP in the province:

• Canadian small/medium enterprises (SMEs) holding registered IP rights are .
• SMEs that are aware of IP at all are .

The easiest way to promote IP awareness would be ensuring the module is simple to take; however, a course which is too rudimentary may prevent innovators and SMEs from being well appraised to best spot opportunities to commercialize new IP within their own businesses.

A two-pronged strategy might be preferable. Requiring that SMEs who receive government funding from grants or loans or who participate in commercialization aides such as accelerators or university programs take the existing module could meaningfully promote a baseline level of IP awareness. In addition, the Ontario Government could promote even greater familiarity with IP concepts by setting and enforcing targets for completion of levels two and three of these modules, potentially contingent on some degree of support by the province and its related agencies. The module established at the University of Toronto has, for example, developed additional modules on the value of various types of IP and the process of actually applying for a patent.

The latest development from the Expert Panel’s Report came in March when based in no small part from a recommendation by the panel’s Report. The new agency has so far identified IP education and awareness as one of its priorities. By working alone or with the province, implementing some form of mandatory training can go a long way to promoting IP awareness among inventors.

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Michelle Mao is an IPilogue Writer and an incoming 2L JD candidate at Osgoode Hall Law School.

Soon, manufacturers will be able to use NIH-licenced technologies to develop COVID-19 technologies for sale and distribution to low and middle-income countries. This is because the has finalized its its NIH-owned COVID-19 technology patents to the and the ’s (WHO) ). There will be a total of shared, including technologies supporting vaccine development, drug and diagnostic development, and prospective vaccine candidates. These technologies will be brought under a global and non-exclusive licence. Additionally, under the agreement, the NIH for products licensed in the United Nations’ .

While it may feel like the pandemic is ending in higher socioeconomic countries like the United States and Canada, vaccination levels in low-income countries are still , at around 15.9% first-dose vaccination rate. This continues the trend of COVID-19 pandemic leaving low-income countries in the face of expensive, patented COVID-19 vaccines and drugs. Allowing manufacturers to access previously patented technologies to develop their own products can dramatically decrease the cost of accessing COVID-19 technologies. A wider pool of manufacturers creating their own products to supply to lower and middle-income countries means they must compete with other manufacturers to keep the cost of products low.

During the early stages of the COVID-19 pandemic, scientists across the globe raced to develop life-saving medicines that could end the global crisis. Those efforts are by intellectual property laws, allowing scientists to securely make scientific advances without the worry of another competing lab “stealing” their discoveries. Now, due to a combination of a well-developed COVID-19 scientific field and the global obligations of the United States, the NIH feels ready to agree to a global non-exclusive licence for several of its patented COVID-19 technologies.

This agreement finally comes after from scholars in public health, intellectual property, and scientists about potential global inequalities that could arise in vaccine and drug development in a global pandemic. Due to the lack of economic resources for lower-income and middle-income countries for vaccine doses and a to manufacture their own COVID-19 medicines, it was predicted that lower-income countries would be hardest hit. Additionally, from the beginning of the pandemic, health-advocacy organizations have for pharmaceutical companies to share their patent knowledge so that lower-income countries can produce their own generic versions of COVID-19 drugs.

While the sharing of NIH-licensed COVID-19 technologies comes as good news for lower and middle-income countries still grappling with the pandemic, this licensing agreement may have come too little, too late. The pandemic has already swept through a majority of nations where many lives may have been saved if there was quicker and wider access to the life-saving COVID-19 vaccines that the higher income countries had first access to.

In future global crises, the problem of balancing intellectual property protections with global cooperation and socioeconomic inequality will continue. Hopefully, the COVID-19 pandemic can shed some light on how future policy considerations can be made to protect scientific innovation while minimising the sacrifice.

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Jenny Peng is an IP Innovation Clinic Fellow and a 2L JD Candidate at Osgoode Hall Law School. This article was written as a requirement for Prof. Pina D’Agostino’s Directed Reading: IP Innovation Program course.

In an age of increasing globalization, the ripple effect of a single event resulting in unintended consequences is nothing new. Amidst the ongoing Russia-Ukraine conflict, the Russian government has recently announced a series of measures related to IP rights and payments in response to sanctions from foreign governments and corporations. One such measure was a , which stated that patent holders of foreign countries that commit unfriendly actions against Russia would be subjected to a compulsory licence of their inventions, utility models and industrial designs with 0% royalty to the owner of the intellectual property.

What is compulsory licencing?

is when a government permits another party to produce a patented product without the consent of the patent owner.

Under the World Trade Organization (WTO)’s Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), compulsory licencing is a flexibility in the field of patent protection. lists out conditions under which a compulsory licence may be granted, and specifically under Article 31(b), member nations are allowed to do so “in the case of a national emergency or other circumstances of extreme urgency”. has further loosened this provision and confirmed that “each member [nation of the WTO] has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted”.

What does this mean in the current context of the world?

In most cases, compulsory licences are granted to meet the demand for a patented product in a domestic market. During a global health crisis, compulsory licences would facilitate knowledge sharing across nations and maximize efficiency in R&D and production.

, India and South Africa have led the proposal for a TRIPS Waiver that would temporarily suspend IP protection on medical products required to treat COVID-19. Fast forward to present day, these talks are still ongoing with no resolution to be reached between the push for scaling up production and increasing access to critical medicines on one side of the table, and the desire to protect intellectual property on the basis of sufficient production on the other.

Conclusion

��ܲ�������’s compulsory licence policy seems to be a direct response to international sanctions, and while it does not particularly target the pharmaceutical industry, this decision has certainly affected discussions of the COVID TRIPS Waiver. International cooperation is weakening, and Russia has set an example of its own national enforcement of compulsory licencing. As events continue to unfold, the “emergency” context surrounding compulsory licencing will likely continue to be a source of ambiguity and a point of debate.

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Anita Gogia is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

Pessimism is to innovative culture as heat is to ice. It slowly destroys but can be remedied by its polar opposite. On April 28, Halimah DeLaine Prado, the general counsel at Google, wrote about her optimism for innovative culture in an online post. She outlined reforms and recommendations that .

Google’s contribution to the US patent system

Healthy patent systems can sometimes be as a way to incentivize creative inventions, encourage building on existing ideas, and avoid frivolous litigation. Google has created a space that incentivizes innovation by being one of the first companies to . Google has invested in patenting and licensing their engineers’ inventions (), and has sold patents to smaller companies to help strengthen their portfolios. Google also helped the License on Transfer Network. This Network protects members from patent trolls’ claims, these ‘patent trolls’ are described as companies that bring patent claims for profit and to supress competition.

Concern with the US patent system

Patent litigation has been on the , with 46% more patent litigation lawsuits in 2021 than in 2018.

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Patent trolls and opportunistic companies, as DeLaine Prado describes, weaponize patents against competitors which deters innovation and harms the quality of new products. Most notably, says the American “prized ‘culture of innovation’ is being undermined by a ‘culture of litigation.’” ��Such litigation wastes court resources and are a shakedown tactic or to “stretch patents beyond recognition.” Resources spent on wasteful litigation is better used in research and development for new products. In contrast, Google has a history of confronting overreaching patent claims and defending their users and products. Smaller companies “nascent technologies” are unable to fight these lawsuits without raising costs for consumers or harming their ability to create new products.

Google’s recommendation

Google proposes 3 developments: support for the US Patent Trademark Office (PTO), Judiciary review of forum shopping, and congressional changes to address patent abuse.

The PTO receives . The evaluation process has not been streamlined because PTO employees are under-resourced despite the PTO working on AI solutions. Such inefficiency leads to possible issuances of invalid patents, inventors may then be unable to protect their inventions confidently. Others end up having to defend infringement claims against patents that . Google that investing in the patent office can help prevent such issues and are that “important work can finally begin” by the new director of the PTO, Kathi Vidal.. Google also funding the PTO by increasing fees for larger patent filers (including themselves).

At the judicial level, Google Chief Justice Roberts urgently investigates the judicial imbalances caused by abusive forum shopping. DeLaine Prado recommends ending forum shopping as many companies suing patent claims may damage the integrity of the judicial process. In a year-end report on the federal judiciary, Justice Roberts pledged to direct the judicial conference to address patent venue rules and that the . The extreme concentration of patent cases in Waco, Texas in Judge Alan Albright’s court has concerned Senators. To illustrate, approximately 20% of all US patent litigation is filed in Judge Albright’s court.

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Senators have also raised concern that Judge Albright has . have raised concern that this patent-owner friendly policy attracts patent trolls. Senators also note that current case assignment procedures may allow the plaintiff to select a specific judge to hear their case.

Google supports legislation before congress that reduces abusive patent litigation, restoring access to inter partes review, and increasing accountability. Inter partes review was a created by Congress as part of the America Invents Act that helps companies cost-effectively invalidate low-quality patents. This program was created to provide expert review of patents with the greatest impact on the US economy, however changed PTO rules created some barriers to use the program that could be reduced.

Overall, Google’s concern with the lack of promotion of innovation and creativity by the US patent system will likely spark debate and potential reform in the near future.

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Photo by Tina Hartung ()

Pankhuri Malik is an IPilogue Writer and an LL.M Candidate at Osgoode Hall Law School.

As , Russia is now responding to sanctions by removing the protection of IP rights in its territory for owners from “unfriendly” countries. On , Russia released an executive order acknowledging the unfriendly actions of the United States of America and its allies, including Canada, the UK, and all EU states.

��ܲ�������’s of Ukraine elicited a show of solidarity from the western world. As several countries imposed political and economic sanctions on Russia, the United States of America and its allies banned the export of luxury goods into Russia. Various USA-based companies like also responded by winding down their operations in Russia. The value of the Russian ruble dropped to ,. In retaliation, starting with the list of “unfriendly” countries, Russia proceeded to worth of property from sanctioning states.

Suspension of Association with Russian Patent Offices

On , the United States Patent and Trademark Office announced that it would no longer associate with the Russian and Belarusian Patent Offices. This announcement closely followed a similar one from the .

President Putin responded by suspending the operation of IP rights in Russia for owners either residing in or operating in “” countries. As a result, US-based companies can no longer enforce their IP rights in Russia. Included in the scope of these rights are protections flowing from patents, trademarks, and copyright.

Putin announced compulsory licensing, without any remuneration, of patents held by sanctioning states. Following this order, a Russian Court the trademark rights of Hasbro Inc. in its “Peppa Pig” and “Daddy Pig” marks, stating that the sanctions imposed on Russia “prejudice” the dispute. Russia has also suspended the operation of IP rights for “certain goods”, the ambit of which is unclear.

Russia has been accused of of IP rights in the past. Unsurprisingly, ��ܲ�������’s suspension of IP rights has only aggravated the situation. for various deceptive ��marks have emerged, bearing similarity to renowned MNCs such as McDonald’s, Starbucks, Instagram, and Ikea. Russian entities will be able to like McDonald’s, Ford, and General Motors at their existing manufacturing facilities in Russia.

Going Forward

With the events in Russia and Ukraine still unfolding, it is difficult to say if we can expect IP rights to be restored in Russia anytime soon. Even if they are, Putin’s actions appear to have changed ��ܲ�������’s relationship with the rest of the world. US and Canadian companies do not have any way to enforce their IP rights in Russia. In this situation, the best move may be to restrict Russian-made infringing goods in foreign markets through .

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