Every year on January 1, works protected under copyright law enter into the public domain due to their copyright protection expiring. Thus, as a new year approaches, those in the field of copyright look to see which works will expire at the end of the year. As the world entered January 2023, many excitedly anticipated that Disney’s copyright protection of Mickey Mouse in the United States (US) would expire at the end of 2023, allowing Mickey Mouse to . This means that  reproduced, adapted, published, publicly performed, and publicly displayed by anyone in the United States without infringing upon Disney’s copyright.

As a general rule in the U.S., for works created after January 1, 1978,  for the life of the author plus 70 years. However, for works created before January 1, 1978, the duration of copyright protection depends on several factors as set out by  in the United States. Mickey Mouse  in the US in 1928 with the film “Steamboat Willie,” so its copyright protection term was dictated by several factors outlined in chapter 3.Additionally, the expiration of the copyright term only applies to the original version of Mickey Mouse displayed in Steamboat Willie; later versions of Mickey Mouse will still be protected by copyright. This original version of Mickey Mouse is a black and white rat-like depiction with a long snout and black eyes, whereas later versions of Mickey Mouse include the version of Mickey with his signature red shorts and white gloves.  

Copyright law in the US has evolved many times in part as a result of Disney lobbying for copyright term extension. Originally, the Mickey Mouse copyright was supposed to expire in 1983 because when Mickey Mouse was first debuted to the public in 1928, copyright law only protected works for 56 years. However, in 1976 Congress passed the  which extended the copyright term to 50 years after the death of the author or 75 years after the death of the author if the author was hired by an employer to create the work. As a result, the Mickey Mouse copyright was then set to expire at the end of 2003.

Starting in 1990, Disney pushed hard for an extension of copyright protections. This resulted in the  which extended copyright protection to 70 years after the death of the author. This extension is why Mickey Mouse’s copyright protection is set to expire at the end of 2023. The extreme lobbying from Disney to extend copyright protections earned the 1998 act the nickname of the “Mickey Mouse &�Բ�����;������.”

Although the original Mickey Mouse’s copyright protection will expire at the end of 2023, Disney will still be able to protect the Mickey Mouse brand through trademark law. Mickey Mouse is  as Disney’s property because . Trademark protection can theoretically last forever if Disney can continually show that Mickey Mouse is associated with its company.  Disney will likely be able to continually show an association with Mickey Mouse. In 2007, Walt Disney Animation Studios  to incorporate the original version of Mickey Mouse. Therefore, although someone may use the original version of Mickey Mouse in a work, they are not able to use this version of Mickey Mouse for any branding purposes or any purpose that would cause consumers to be confused about the source of the Mickey Mouse product. These intersections between trademark and copyright law may stop Mickey from strolling into public use for the coming years.

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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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Serena Nath is an IPilogue Writer and a 2L JD candidate at Osgoode Hall Law School.

Controversy and uncertainty in the field of patent eligibility have resulted in decade-long fights over what can be patented and what cannot be, especially regarding diagnostic tests. There is currently a congressional push to let drug companies patent diagnostic tests in the United States. This push comes from Senator Thom Tills. On August 2, 2022, Senator Tills introduced Bill , titled the Patent Eligibility Restoration Act of 2022, which, in part, aims to change currently existing US federal patent law regarding patent eligibility for different classes of inventions. ��

History of Patenting Diagnostic Methods

The bill was largely motivated by several Supreme Court rulings over the past decade, which have created exceptions to patent eligibility in biotechnology and pharmaceuticals. Traditionally, an inventor can gain patent protection for their invention if it is novel, non-obvious, and has utility. However, in 2012, the court in ruled that diagnostic tests that reflect naturally occurring biological phenomena cannot be patented because one cannot have a monopoly on a relationship based on natural principles. This ruling was then reaffirmed later in . This exception in the eligibility of diagnostic tests led to widespread confusion regarding patent eligibility. In particular, the chief judge of the US’s top patent court, Kimberly A. Moore, saying that Federal Circuit judges are now unsure of how to apply the patent eligibility provision. Additionally, these exceptions have led to patents being rejected in the United States but approved in other jurisdictions with similar patent laws, such as Europe, thus discouraging biotech companies from investing in diagnostic methods. In response, Bill S.4734 is being presented to address this confusion and increase innovation in the United States via more specific patent eligibility standards that are likely to expand the ability to patent modified genes and pharmaceutical processes, including diagnostic methods.

The Debate over S. 4734

This proposed bill has drawn much debate. On the one hand, , such as the American Civil Liberties Union, have expressed concern that this bill will allow pharmaceutical companies to take advantage of this expanded patent eligibility by creating monopolies over essential diagnostic methods resulting in decreased access to these methods and overall harm to the health of Americans. However, , such as the Council of Innovation Promotion, argue that the bill will increase investment into diagnostic research, which decreased significantly after the Mayo decision. These groups point to the pharmaceutical industry’s response to COVID-19, arguing that patents were the basis for creating the vaccines.

If the bill can clarify patent eligibility in the US, it may be worth pursuing further. However, I also question the idea that patent eligibility is the driving force behind biotech innovation.�� The Invention-Induced Theory, argued by proponents for S.4734, posits that patents are an incentive for inventors and that absent patents, there will be no inventions. However, this theory fails to account for inventions induced by the market, scientific curiosity, accident, or ego. Additionally, have shown that patents are not a significant driver of most innovations. Thus, there may be a better way to both reward biotech companies for their creation of diagnostic methods and prevent harmful monopolies over essential lifesaving inventions.

Regardless of which side of this debate you fall on, it is still being determined if S. 4734 will be further explored. When this bill was introduced in August 2022, the Tillis planned to hold hearings focused on this legislation if the Republicans took the senate in the November midterm elections. However, with the , the future of this matter remains uncertain.

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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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Meena Alnajar is an��IPilogue��Writer, IP Innovation Clinic Fellow,��and a 2L JD Candidate at��Osgoode��Hall Law School

On October 15, 2021, the U.S Patent and Trademarks Office (USPTO) on the contentious topic of patent eligibility. provided contrasting viewpoints on the matter, with some corporations urging legislative reform, and others quite pleased with the current state of law. To understand these varying opinions, it is important to examine patent eligibility’s current state, recent changes, and what changes could be made to the patent eligibility laws.

Calls for Reform

Tillis, Hirono, Cotton, and Coons requested a study by the on the state of patent eligibility jurisprudence in the U.S. The study aims to examine the current jurisprudence’s in the fields of quantum computing, artificial intelligence (AI), and pharmaceutical treatments, among others. The USPTO requested public input to complete the study, as to gain perspective and anecdotal evidence on the jurisprudence’s effects on innovators and patentees.

The law outlines what innovators can and cannot patent in the United States. Patent eligibility is codified under , which states that any “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” may be patented. However, many industry sectors have been pushing the bounds of what a manufacture, machine, or composition of matter could mean. Abstract ideas like AI or algorithms have sparked debate as to whether this codification of patent eligibility accurately encompasses everything that innovators should be able to patent.

Current State

While a vast realm of things can be patented, software and medical devices are frequently hot topics when discussing patent eligibility. Software including algorithms and AI technology have often been excluded from patent eligibility on account of s”, unless they are rooted in something tangible, like a computer.

Diagnostic techniques and medical devices historically garner mixed court reactions. On the one hand, diagnostic techniques may be construed as finding something that occurs in nature; but, at the same time, the technique could be construed as a “new and useful process” meeting the section 101 eligibility criteria. In , the District Court rejected patent claims related to methods of isolating fetal DNA from maternal blood plasma that was based on a discovery that fetal DNA is shorter than maternal DNA. The District Court found that this discovery and subsequent method are invalid as the claims are directed to natural phenomena, therefore excluded from patent eligibility. On appeal in March 2020, the Federal Circuit reversed this decision and found that the method had and thus the methods were patent-eligible subject matter. The back and forth highlights the ongoing debate on patent eligibility in the realm of medical methods and devices.

Significant U.S. Precedent: Alice/Mayo test ��

The U.S Supreme Court has established a two-step inquiry to section 101 patent validity challenges. The inquiry is referred to as the . The asks whether the contested claim is directed at a patent ineligible concept, like an abstract idea. If it is, then deems a claim eligible for a patent if it contains an inventive concept. Inventors are as to whether this test has clarified patent eligibility, or if it has created a complicated and costly barrier to patent production.

While differing patentee viewpoints will be studied in a subsequent article, many companies take issue with the application of the Alice/Mayo two-step inquiry for patent eligibility. So, it is important to examine these cases ( and ) and the rationale in their application.

Potential Impacts of the Study

The study made no guarantees that the U.S. law regarding patent eligibility will change, but its creation acknowledges that industries are evolving, and legislators and intellectual property experts alike should evaluate the law.

The study’s publication may also become a useful reference for the judiciary when evaluating patent claims and their validity. Therefore, the study could potentially aid in fostering more consistency in the decisions regarding complex industries like medical devices and software. The line between eligible and ineligible patents in these fields is thin, and courts are not sure when an innovator will cross it. This study could be the first of many initiatives to bolden and solidify these patent eligibility lines for innovation in the future.

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

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Brief History of Insulin

In 1921, Dr. Frederick Banting, Charles Best, and James Collip successfully isolated the hormone , discovering a new life-saving treatment for managing diabetes in humans. By 1923, insulin was widely-produced and available to the general public.

Dr. Banting and research facilitator Dr. Macleod, refused to put their names on the patent for the drug, with Banting stating Thus, the first patent application for an insulin patent was filed under Best and Collip’s names. However, as all the co-inventors believed that the medicine should be widely available and not restricted by costs, they sold their intellectual property rights to the University of Toronto for Today, contrary to the co-inventors’ intentions, insulin is highly unaffordable for individuals around the world who rely on the lifesaving treatment, including in the United States.

Insulin Price Rise

Over 30 million people in the U.S. live with diabetes and around a third of them require insulin to survive. From 1960 – 2019, the price of a vial increased from , over forty times the rate of U.S. inflation. Soaring prices have left many with few options besides rationing or skipping doses altogether, a practice that has harmful and To put it in perspective, a carton of insulin costs . Many researchers and doctors attribute these price hikes to lax regulatory measures on drug-pricing in the U.S. How do patents play into this? Only a handful of companies control the market and those companies are increasingly modifying their insulin products, improving them, and typically protecting them with additional patents. It’s a practice that some call the “cost of innovation”. However s for the consumer. Most patients are prescribed the newer, modified formulations, instead of the older ones. Unfortunately, no true affordable generic is currently available. Enter : a group of individuals who hope to make insulin more accessible for everyone. ��

Insulin Bio-hackers

is essentially a do-it-yourself (DIY) approach to biology. works to create insulin that is , easily replicable, and most importantly, affordable. The group is comprised of volunteer scientists and community advocates. The . Di Franco himself lives with Type-1 diabetes and was motivated to create the project after witnessing the rising prices of insulin in the U.S.

The project is not limited to the U.S. and, if successful, seeks to provide insulin to other parts of the world where patients similarly struggle to access insulin. To date, the project has made some strides in their discoveries. They announced their first major milestone at the end of 2018, . Open Insulin estimates that they may be able to develop a version of insulin that - a stark difference in price from what is currently available. While optimistic, the project faces various regulatory obstacles. The group will not be able to produce market insulin without the approval. They may, however, publish their findings to help support other biohackers around the globe.

Even if they are unable to release generic insulin to market, their innovative research and goals are making waves, increasing awareness, and inspiring others to push for solutions to the insulin cost problem. Check them out at !

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Tiffany Wang is an IPilogue Writer, IP Innovation Clinic Fellow, and a 2L JD Candidate at Osgoode Hall Law School.

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In 2019, Microsoft and the Pentagon signed a via deploying cloud technology. One man was not too happy with the agreement. , Jeff Bezos, persisted in fighting for the lucrative contract, especially after the Biden Administration began work at White House.��

Amazon Web Services, . Amazon’s efforts have not gone unnoticed.

, ending the feud between the two technology giants over the ten-year commercial contract. The DoD did not explicitly name the feud as the motivating factor for cancellation. Instead, the DoD announced that the ��John Sherman, acting Pentagon Chief Information Officer, stated that the inevitably call for novel strategies.

The JEDI deal has long been controversial. In 2019, Amazon suggested that the Pentagon award the contract to Microsoft due to . Moving away from a Microsoft monopoly, the current Biden administration welcomes bids from which satisfy the government’s standards. , and others have joined the ranks.

Companies anticipate competing for the new contract: . Attempting to canvass by military personnel.

The JEDI deal aims to upgrade the More than a contract duel, the JEDI deal acknowledges the rapid growth of the —and the pace at which the U.S. military needs to work to match this evolution.

Considering the forests rather than the trees, the Pentagon may have set its sights on competition from China instead of the clash amidst domestic technology titans. . In this cross-border military cloud computing race, the U.S. does not want China to win. If China wins the cloud computing marathon, the DoD will not celebrate on cloud nine.

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Tiffany Wang is an IPilogue Writer, IP Innovation Clinic Fellow, and a 2L JD Candidate at Osgoode Hall Law School.

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Chips are the hotspot in the current . By stymieing Huawei’s reach of international customers’ communications and leading the 5G race, the Biden administration has fronted a in chipmaking and research. Beijing, swimming against the current, has committed more than to high-tech developments, particularly in the semiconductor industry.

Samsung leads its competitors in the during the pandemic has led the Chinese government to invest in domestic semiconductor supply chains. and carved a local talent pool. Reducing dependency on outside markets is in part due to domestic demand since . Internal supply chain security will curb shortage risks for the country.

Production will not be a quagmire for Beijing. Their reservoir of . In fact, China’s share of the global semiconductor production capacity may rise from . .

President Xi positions China for . The restricted Huawei and other players in the Chinese market’s access to American technology. US , have pushed China to bite back in its For Beijing, technology and innovation self-sufficiency have inevitably turned into a matter of survival. Chinese firms .

As the net importer of semiconductors, . This figure continues to rise. In China’s race with the US, no one is safe. These two giants in the global economy threaten their mutual destruction. For one, the Chinese semiconductor industry considers leveraging rare earth minerals in this geopolitical war.

Who will win the semiconductor race—the eagle or the dragon? One thing remains certain: no one is backing down.

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Ryan Erdman is an��IPilogue��Writer and a 2L JD Candidate at��Osgoode��Hall Law School.��

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In a truly monumental achievement in scientific innovation, there are now authorized COVID-19 vaccines around the globe. However, present inequities in global distribution plague the achievement and ultimate success of these vaccines in ending the pandemic. show that 87% of the over 1 billon doses administered worldwide have been in high-income countries, compared to only 0.2%��of doses administered in low-income countries. As world case numbers continue to rise, the presence and likelihood of variant strains only prolong the immediate harms and long-term impacts. If current trends persist, COVID-19 will continue to devastate countries with less developed and more permeable borders long after developed countries reach majority levels of immunization. At the current pace, it is some low-income countries will not see significant percentages of the population vaccinated until 2023.

The trends in inequitable global access to new medicines are not novel and have long been tied to the intellectual property (IP) rights granted to drug manufacturers in return for taking on the “risk” of research and development (R&D). In general, by awarding a period of limited exclusive rights during which the developer can set non-competitive prices, IP protections inherently and negatively impact affordability. At the beginning of the pandemic, costs and public sector investment affected the ability of high-and upper-middle-income countries to around 6 billion doses through advanced purchase agreements. In October, South Africa and India submitted a to the World Trade Organization (WTO) calling to temporarily waive the Trade-Related Aspects of the Intellectual Property Rights (TRIPS) Agreement provisions relevant to COVID-19 related technology, citing historical and present barriers in affordable and timely access to new medicines created by IP rights. Specifically, they call for a waiver of sections outlining the rights and obligations in the areas of copyright, industrial designs, patents, and the protection of trade secrets relating to “the preventing and treatment of COVID-19.”

The breadth of the original proposal is important in light of the Biden Administration’s recent supporting a waiver of IP rights. The announcement, however, does not directly support the waiver initially proposed 7 months ago. The scope of the initial waiver proposal was purposefully broad, looking to eliminate barriers created by IP protections related to accessibility of not just vaccines, but also other necessary technology in the areas of diagnostics, P.P.E., and other therapeutic drugs. The scope and duration of a waiver comprise many key issues that will need to be agreed to and countries have shown a to come to the negotiating table in light of the US announcement. Canada has that it will not block a waiver, and that the government is committed to work towards a “consensus-based” solution.

But where time is at a premium, the complexity and length of negotiations is an obvious cause of concern. Given the likelihood of COVID-19 becoming , including the persistent threat of variants, any waiver may significantly affect future innovation in COVID-19 “booster shots” and other vaccine technology. This is part of why Big Pharma has met the Biden Administration’s announcement with continuous and skepticism for the efficacy of any waiver in meeting the objective of timely increases in global production. The most prominent of these criticisms doubts that a waiver will effectively address the true bottlenecks, which is to be the scarcity of raw materials and ingredients and the lack of technical know-how.

This is particularly important in determining the scope of the waiver, as a vaccine “patent waiver”, as the media consistently calls it, is simply underinclusive of the knowledge transfer necessary. While a vaccine patent waiver could help alleviate obstacles around technology fragmentation, where different parties own multiple patents related to one vaccine, scaling up production in developing countries also requires the transfer of technical processes. This would involve numerous types of IP and requires technical expertise to build and implement. Some this is why, even though Moderna has long not to enforce certain COVID-19 patent rights during the pandemic, there has been “no flourishing of factories pumping out “generic” messenger-RNA vaccines.” New manufacturers would also need to generate a novel and comprehensive “”, as they cannot rely on the safety and efficacy clinical trial data of originators like with small molecule drugs. The original waiver addressed both copyright and trade secrets, but there are clear that any waiver is certainly going to be narrower than that originally proposed. Any “consensus-based solution”, if at all, will take months and not include the time for new producers to build production capacity and meet regulatory hurdles. WTO Director-General Ngozi Okonjo-Iweala recently expressed “hope” that a waiver could be agreed upon by .

Nonetheless, while accepting that a waiver may not be a “silver bullet” solution, the announcement has certainly reflected optimism for a critical shift in the status-quo, with the head of the WHO calling it a “monumental moment in the fight against COVID-19.” We could look back on this as the moment where high-income nations finally move-away from strong notions of “vaccine nationalism.” Timely access requires a unified effort and immediate, continued support from developed nations for global initiatives like the UN-backed , which plans to deliver billions of vaccines to low-income countries. Members on both sides of the waiver debate advocated for vaccine-producing nations increasing production and reducing restrictions on the export of vaccines (and materials). Interestingly, some that the threat of a waiver could also be a tactic to push companies into greater licensing strategies and persuade them to exhaust production capacity and sell extra supplies to poor countries. The perceived threat of compulsory licensing has pushed companies to make broader global pledges in the .

Where a pandemic is truly a “” every second matters, yet there are many reasons to believe that we will not feel the effects of any negotiations for a long time. Waiver discussions are sure to intensify ahead of the WTO’s next formal meeting in early June.

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DRAMATIS PERSONAE: ����������������������

Justice R. Bitter, judge (J)

Sue N. Ewon, plaintiff (P)

Wigmore Cross, plaintiff’s counsel (PC)������������������������������������������������������������������������������������

Chick Fowler, defendant (D)

Ms Chiff Maker, defendant’s counsel (DC)

PARTIAL TRANSCRIPT OF CROSS-EXAMINATION OF PLAINTIFF SUE N. EWON:

DC: So, Ms Ewon, you say the defendant’s chicken-plucker infringes claim 1 of your patent?

P: Yes.

DC: Because it includes chicken-pluckers with a widget, and the defendant’s plucker has that widget?

P: Yes.

DC: Did you ever tell anyone that claim 1 doesn’t include chicken-pluckers with a widget?

PC: I object, what plaintiff thinks her claim means is irrelevant. That’s for the judge.

J: Yes, I think that’s right. Ms. Maker, I decide questions of law.

DC: All right. (To P:) When you applied for your Canadian patent, did your patent agent write to the examiner to say that pluckers with widgets were excluded?

P: I’ve no idea.

DC: I show you Exhibit K. You recognize that letter from your patent agent to the examiner?

P: Yes, she sent me a copy.

DC: You see where it says “Enclosed is a new claim 1 that corresponds substantially to the claim submitted in prosecution of the related United States patent application”?

P: Yes.

DC: You did have such an application in the United States, didn’t you?

PC (to J): With respect, Your Ladyship, I have no idea where this is all heading.

J: Nor do I, but I’ll cut Ms. Maker some slack for the moment.

DC: Thank you. (To P:) I repeat, you did have an application filed in the United States for the same invention as in this case, didn’t you?

J: Yes.

DC: Are you aware that the attorney handling your American application wrote to the American examiner, saying that a new claim 1 he was submitting would overcome the examiner’s objection that chicken-pluckers with widgets were known to the prior art?

PC (to J): I object most strenuously to that whole question. Even if my client personally wrote to the American examiner saying that, it is inadmissible here.

J: Why? Because it wasn’t said in Canada to a Canadian examiner?

PC: Yes.

J: Would it have been admissible had your client written the same thing to the Canadian examiner?

PC: I don’t believe anything said anywhere else than in a Canadian prosecution has anything to do with this case. May I draw Your Ladyship’s attention to the Court of Appeal’s reasons in CanMar at paragraph 70? The Court there said you should be “wary” about allowing anything other than Canadian prosecution history in. And then at paragraph 71, the Court went on to say you should “tread carefully” in admitting extrinsic evidence to interpret a patent claim. And once again in that paragraph, “Opening the door to allowing foreign patent prosecution history into the analysis might lead to overly contentious and expensive litigation.”

J: Well, I am treading carefully and warily, and I haven’t turned the door knob yet. Hasn’t this litigation been contentious and expensive enough anyway? Aren’t you making it more expensive and contentious by raising these sorts of objections? I can’t see why a statement that would be admissible and relevant if made in Gatineau becomes inadmissible and irrelevant if made in Alexandria. What happens in Virginia doesn’t have to stay in Virginia.

PC: With respect, it is not Your Ladyship’s role to question the wisdom of Parliament. Both Justice Manson and the Court of Appeal said very clearly that section 53.1 applies only to communications to the Canadian Patent Office.

J: I am not questioning Parliament’s wisdom, only the awkward statutory language used to translate it. Hasn’t one of my colleagues just decided that even Canadian history isn’t admissible if it’s the licensor rather than the patentee who sues, even where the patentee is a defendant (Allergan Inc v Sandoz Canada Inc, at [126])? Why couldn’t section 53.1 just have said that any prosecution history from wherever is admissible, but its weight is for the court? Is section 53.1 based on any other country’s legislation?

PC: Not that I know, Your Ladyship. It is homegrown, although I accept there may be a few weeds among the roses.

J: What I am saying, I guess, is much what Justice Manson said in CanMar. Here we have the extraordinary circumstance that the Canadian communication expressly refers to the corresponding US application and the clear inference is that the Canadian claim is being replaced precisely to overcome the actual or anticipated citation of the same prior art against the Canadian application.

PC: With respect, that is exactly the same situation as in CanMar, and the Court of Appeal explicitly overruled Justice Manson’s admission of the American file.

J: We have this anomaly then, haven’t we? If the Canadian patent had been granted unchanged and without reference to the US application, your client could have asked for it to be reissued with the changed claim under section 47 of the Patent Act because of an inadvertent mistake. Foreign prosecution history has long been admitted on a reissue application to show there was a mistake and that the reissued patent would be for the same invention. Why allow the foreign file to be admitted to show the reissue was justified, but exclude it to show what the claims now mean?

PC: If that was the position before section 53.1 took effect, then I submit that such foreign history can no longer be admitted in reissue.

J: What do you say, Ms. Maker?

DC: Section 53.1 states that it specifically applies to reissue and no intent to change current Patent Office practice appears. Nor is there any apparent attempt to overrule long-standing cases such as Northern Electric Co v Photo Sound Corp, , where the whole case depended on foreign prosecution history. If foreign history is admissible in reissue to determine the scope of the invention, as I submit it was before and is after s. 53.1, then I cannot see why it is inadmissible where an ordinary patent is involved.

J: Well, it’s a brave trial judge who says the Court of Appeal has decided something per incuriam and should not be followed.

DC: May I make one further point? The Court of Appeal in CanMar relied on a decision of the United States Federal Circuit Court of Appeals to say that the reference in the plaintiff’s letter to the Canadian examiner to “a related United States patent application” wasn’t specific enough to incorporate the corresponding US file. The point on how specific a cross-reference must be to allow another document to be read has not been decided by the US Supreme Court, and I would point out that the Federal Circuit Court of Appeals is a court with one of the highest reversal rates before the US Supreme Court, and especially so in patent cases.

What our Court of Appeal should have done was to apply the general law in Canada on when documents can be looked at together. Cases on the Statute of Frauds are the most obvious source. The Statute requires contracts, such as guarantees or sales of land, to be evidenced by a memorandum in writing, and ever since the 19th century, it has been held that two or more documents can form a single memorandum. Supreme Court of Canada authority going back a century says, and I quote, “parol evidence may be given to connect two documents together which do not expressly refer to each other, but which connection and reference is a matter of fair and reasonable inference:” Doran v McKinnon, , 53 SCR 609 at 611. I can say that is also the law in most Commonwealth countries and state courts of the United States. Not to put too fine a point on it, the US Federal Circuit has gone rogue by making up its own rule of incorporation and ignoring the general law of the majority of state courts.

I submit that in our case the reference to the US application is plain enough in the letter to the Canadian examiner. It is also distinguishable from CanMar in two respects. First, our letter refers to “the” US application, whereas the Canmar letter referred only to “a” related application. We are very specific. Second, the US application in CanMar was abandoned, whereas here the plaintiff’s application specifically claims priority from the corresponding US application which was granted. It is open to the Court to hold the US history admissible on either of these distinctions, since the Court of Appeal specifically refused to express any “firm view on the broader issue of whether foreign prosecution history can be considered under section 53.1.” I ask for Your Ladyship’s firm views now. ��

PC: I submit this case is covered exactly by the Court of Appeal in CanMar and the foreign history cannot be looked at.

D (intervening): You mean Sue can lie to a Canadian judge where she wouldn’t dare to an American one? [Scuffle breaks out.]

J: Ms. Maker, could you kindly restrain your client? [Order resumes.]

Thank you, counsel.

I propose to admit the statement in the US patent file into evidence. I shall not at this stage indicate what weight it deserves or what use I may make of it. This case is not covered by CanMar because the Canadian patent here relies for its priority on a stated US patent. The plaintiff cannot blow hot and cold by then dismissing the very patent from which it claims priority and on which it may well depend for validity in Canada.

The Court of Appeal thought it “a stretch” to incorporate a US patent file on language as general as that which points to “a” related United States application. There is no “stretch” at all here since, as defendant’s counsel submitted, the letter to the Canadian examiner points to “the” related US application, not merely “a” related one. I nevertheless must say that, at a time when we are all urged not to subject patents to “the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge” (Catnic Components Ltd v Hill & Smith Ltd, [1982] RPC 183, 243 (HL)), I would be reluctant to have to read the documents leading to the grant of a patent more meticulously than I would read the patent itself.

I am also not sure that incorporation is the mot juste for the ability to follow a signpost and explore the destination to which it points. There is no difficulty in identifying that destination off the face of the Canadian file. Canadian patent law is no Alsatia where the general law stops, nor is it one where the US Federal Circuit’s writ runs. To adapt L.P. Hartley’ s words in The Go-Between, patent law should not be a different country where they do things differently. Law under the Statute of Frauds lets two documents be read together where their “connection and reference is a matter of fair and reasonable inference:” Doran v McKinnon, , 53 S.C.R. 609, 611, which I note was recently applied to a series of emails in Druet v Girouard, at [34]. Canadian patent law should let patent files be cross-referenced that way too. The location of the second file should not matter, any more than it does under the Statute of Frauds. If a multimillion dollar guarantee or land contract can be interpreted and enforced by means of such a connection, so should a patent.

None of the parade of horribles trotted out by the Court of Appeal (CanMar at [71]) is present here. There is no translation problem with the US file, and the Court of Appeal specifically said at [72] that “one should not underplay the public interest in keeping those who have previously disclaimed elements from their patent from re-claiming them in future infringement cases.” I do not expect that the plaintiff will ask me to take such a course, which Locke J (now JA) in Pollard Banknote Ltd v BABN Technologies Corp, at [237] described as “breathtaking.”

I would only add in passing that, when the Court of Appeal comes to take a “firm view” on foreign prosecution history and section 53.1, it may well have to take account of the long-standing practice, sanctioned by consistent Supreme Court authority, of relying on evidence of such history to decide when the reissue of a defective or inoperative patent under section 47 of the Patent Act is warranted or valid.

Ruling accordingly

Prof David Vaver is a Professor of Intellectual Property Law at Osgoode Hall Law School and Emeritus Professor of Intellectual Property & Information Technology Law at University of Oxford. This is an abridged version of a Comment that will appear in the Intellectual Property Journal.

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