Gregory Hong is an IPilogue Writer and a 1L JD candidate at Osgoode Hall Law School.

This past summer, I had the privilege, as my final act as a graduate student, to attend a major magnetic resonance imaging (MRI) conference in London, UK (ISMRM). At this conference, GE Healthcare used its plenary session to . The other major MRI manufacturers, and , also have AI suites. Computed tomography (CT) had joined the AI party even earlier than MRI, with , , and products. The widespread adoption of AI in medical imaging products is significant because it is one of the first commercial applications of AI in healthcare.

What are MRI and CT?

MRI and CT are the workhorses of most hospitals’ radiology departments. CT and MRI both allow for a 3D image to be taken of internal anatomy, making them invaluable for diagnosing many diseases. Unfortunately, they both have at least one critical downside. CT is an extension of x-ray and thus exposes patients to ionizing radiation, with a CT image often depositing more than 10x the effective radiation dose of an x-ray image. MRI is lauded for, among other benefits, avoiding this radiation; however, MRI is both expensive to run and comparatively very time-consuming.

How does AI come into play?

The primary goal of AI in MRI and CT applications is mitigating the downsides – radiation dose in CT, and scan time in MRI. In both cases, this goal is achieved by “training” an AI through machine learning – or, more specifically, deep learning algorithms – by feeding it an enormous amount of data consisting of previously acquired images. Trained AI allows MRI and CT to acquire less data as the AI is used to fill in the data shortfall – almost analogous to the Hollywood idea of zooming in on a pixelated picture and seeing a clear image. Acquiring less data means less views in CT, leading to less radiation dose and shorter MRI scan times. The resulting AI-enhanced images are used for diagnostic purposes in the same way that conventionally acquired images are.

Why does it matter?

Directly related to healthcare, Canadian , and any improvements to MRI and CT will aid in alleviating that pileup to some extent. It is also significant that radiologists and medical physicists approve of AI in diagnostic imaging. There may not be any group in the medical field more qualified to have at least some grasp of the (disclaimer: I do not fully understand the title of this thesis). It also represents one of the first applications of AI that directly affects medical decisions, which may open the door for other AI applications in healthcare. Lastly, using AI in a commercially available product is interesting on its own – the pathway toward deploying AI in such a high-stakes application may be a useful example for future AI-based products.

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Gregory Hong is an IPilogue Writer and a 1L JD candidate at Osgoode Hall Law School,

Many of you are likely familiar with 3D printing. The process is as follows:

1. Add a digital model of a 3D model to a slicer;
2. The slicer “slices” the model and generates toolpaths layer by layer;
3. Upload the toolpaths to the 3D printer; and
4. Start the machine and wait!

Within hours, you will have a physical rendition of the object you modelled. During the early days of the pandemic, supply issues forced society to adopt any available means to source medical supplies. 3D-printing was able to fill some of the supply gaps faced in medicine, in an important but limited capacity. ��It began with simpler things like ��face shield holders, but over time, the 3D-printing community expanded its applications to things like , , and even a whole .

A mounting concern, however, was that the ability for anyone to download a physical 3D object may pose problems for IP rights. While the pandemic made it , it was important to consider possible avenues to ensure that IP does not hinder emergency response.

I will summarize here two published views on existing solutions to this IP problem: in a May 2022 article in The Journal of World Intellectual Property, explored exceptions that potentially allow IP to be freely used in emergencies: the right to repair exception, the private and noncommercial use exception, and the experimental use exception, while in a in International Review of Intellectual Property and Competition Law (IIC), Ballardini et al. examined two existing ways to tackle the problem: compulsory licensing and voluntary licensing.

Compulsory licensing is the straightforward authorization of licensing by force outlined in the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights . It is regarded, as it should be, as a last resort — administrative burdens make this route largely unviable as a fast way to enable and deploy an emergency response. Voluntary licensing, then, should be ��the best existing means of promoting patented ideas in an emergency. Ballardini et al. looks specifically at IP pools and IP pledges as successful means in the response to the pandemic. Two very important examples of IP pools include the and the , which includes 3D-printing repositories. An IP pledge is effectively a patent holder announcing a limited-time public license of their patent. A prominent example of this is the , where many large technology companies have pledged “to make our intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.” While IP pledges are powerful tools, it is still limited by patent holder goodwill. This is a problem because pledges are conditional and limited in scope, leading to confusion and uncertainty.

The right to repair exception is the right of an owner of a patented article to make repairs to preserve its useful life. Abbas argues that “A more robust and explicit right to repair exemption needs to be incorporated in patent law in response to the COVID-19 health emergency… This clear exemption is important so that consumers of medical devices and 3D maker communities can confidently engage in humanitarian efforts to repair critical life-saving medical equipment without risking patent infringement.”

The private and noncommercial use exception varies and is generally intended to prevent a patentee’s rights from restricting non-commercial activities that don’t conflict with the legitimate interests of the rights holder. Abbas also asked WTO Member-States to “adopt a reasonably broad noncommercial use exception to make it practically significant,” so as to allow medical device users to repair their devices without undue concern for IP problems.

The experimental use exception exists to support the advance of science and technology. Unfortunately, in Madey v. Duke, the Court ��limited this exception’s scope significantly. Furthermore, as a common-law rule, experimental use is not defined by international agreement. Abbas calls for WTO members to clarify the experimental use defense and extend coverage to repairs, arguing that “facilitating increased experimental and repair activity by creating a safe harbor for experimentation with medical devices will better prepare countries to deal with a future pandemic.”

The pandemic has shown possible benefits to relaxing patent enforcement in emergency situations. It is thus imperative to explore how the IP system can avoid standing in the way of saving lives. The ideas outlined by Ballardini et al. and Abbas are a start – hopefully more ideas will be expressed and adopted going forward.

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Pankhuri Malik is an IPilogue Writer, IP Innovation Clinic Fellow, and an LLM Candidate at Osgoode Hall Law School.

On May 31, 2022, the Federal Court of Canada in favour of the plaintiffs, Janssen and Actelion Pharmaceuticals ("Janssen”) in their action against Sandoz. The Court held that Janssen’s combination therapy patent is valid. is often used to treat ailments and medical conditions where treatment through single-agent therapy has proven to be challenging.

Background

The present case concerns the validity of claims 21 to 31 of Janssen’s Canadian combination therapy patent for treatment of diseases involving , including pulmonary arterial hypertension (PAH). The patent seeks to treat the ailments through a combination of Macitentan (sold under the brand name Opsumit) and phosphodiesterase type-5 inhibitor (PDE5-1).

Sandoz sought permission from Health Canada to market generic medicine containing 10mg of Macitentan as the active pharmaceutical ingredient (API) for use alone, or in combination with PDE5-Is. Janssen filed an action before the Federal Court claiming that Sandoz’s generic medicine will infringe upon claims 21 to 31 of the plaintiffs’ patent.

Defences

Sandoz conceded that its proposed medicine does infringe the alleged claims, but defended against Janssen’s claims by raising four different grounds of invalidity. However, the Court rejected Sandoz’s arguments that the combination therapy invention was obvious, lacked a sound prediction of utility, and that the patent was overbroad, and the specifications were insufficient.

1. Obviousness

The Court in held that whether an invention is “obvious” depends on if the skilled person (without any inventiveness), in view of the state of the art and the common general knowledge on the date of publication, would have directly or without difficulty come to the same conclusion as the patent. Plainly, the test can be understood as:

1. Identify the person of skill in the art (“POSITA”), and their common general knowledge;
2. Identify the inventive concept;
3. Identify the difference between the inventive concept and the “state of the art”; and
4. Determine if the difference is obvious or if it requires inventiveness.

The Federal Court followed the test down to the T and held that the available evidence and prior art do not indicate that the POSITA would have considered the combination of Macitentan with PDE5-I to show effectiveness in treatment of ailments involving vasoconstriction, where monotherapies have failed.

Since Sandoz raised the defence of invalidity, Sandoz had the onus to establish obviousness, which it was unable to do.

2. Utility

The requirements to establish a sound prediction of utility were set out in the case of as:

1. A factual basis for prediction;
2. An articulable and sound line of reasoning; and
3. Proper disclosure.

The Court, having considered the POSITA’s common general knowledge and the test results provided in the patent, concluded that the plaintiffs met the requirements of sound prediction of utility.

3. Overbreadth

Here, Sandoz recycled its argument of utility in claiming that the patent does not disclose a sound line of reasoning and claims overtly broad protections. However, the Court relied on its own analysis under Utility and concluded that a sound line of reasoning is present, thereby invalidating the overbreadth argument.

4. Sufficiency

A patent specification is required to provide sufficient disclosures to enable the POSITA to use the invention. Sandoz claimed that the specification of the patent does not enable the POSITA to put the invention to use. The Court reasoned that Sandoz’s “sufficiency” argument contradicted its “obviousness argument.” Further, Sandoz failed to explain the lacunae in the specification that needed filling for the disclosure to be sufficient.

The Judgment

Unable to find merit in Sandoz’s arguments, the Court declared that Sandoz would infringe the asserted claims if granted permission to market its generic medicine in Canada. As of July 20, 2022 Sandoz has filed an against Federal Court’s judgment. ��

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On January 10, 2022, the Canadian Competition Bureau (the Bureau) and Health Canada’s Health Products and Food Branch (the HPFB) issued a����to stakeholders on their continued collaboration to support Canadians’ access to safe, effective, and affordable pharmaceuticals and biologics.

Although the Bureau and HPFB are independent entities, they have complementary mandates in the pharmaceutical sector. The Bureau is responsible for administering and enforcing the��Competition Act, which includes addressing competition issues for the pharmaceutical industry. While the HPFB regulates, evaluates, and monitors therapeutic products available in Canada under the��Food and Drugs Act. This overlap has led to past collaboration on several issues, including mergers and acquisitions, deceptive and misleading claims, and claims of abuse of dominance.

As part of their goal for continued collaboration, both entities plan to maintain a channel of communication to ensure the mutual success of their policy objectives. This includes having the Bureau report to the HPFB on aspects of the pharmaceutical regulatory framework that may impact competition, and the HPFB providing feedback to the Bureau when competition-related issues may result in problems for access to medicines.

The Bureau and HPFB have also committed to working together on Bureau-led enforcement actions, such as when generic pharmaceutical companies report having difficulty obtaining reference samples from branded drug manufacturers. These samples are necessary for generic companies to perform testing for regulatory approval and any difficulties in obtaining samples would delay market launch, with corresponding impact on drug availability. Both the Bureau and HPFB have released guidance for providing access to reference samples and plan to continue working together to monitor and address issues in this area. Based on the extent of guidance documents made available from both entities, branded drug manufacturers are advised to anticipate that the Bureau will treat any explanation for delay in supplying reference products with a high degree of skepticism.

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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.

The post Evolving Perspectives: USPTO Call for Comments on Patent Eligibility Comes to a Close (Part 1) appeared first on IPOsgoode.

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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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Photo Credits: healthline.com (https://www.healthline.com/health/cancer/cancer-ribbon-colors)

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

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Janssen Inc. (“Janssen”), a Canadian pharmaceutical company, sells ZYTIGA under Patent No. 2,661,422 (“422 Patent”). ZYTIGA, Janssen's abiraterone acetate (“AA”) product, can be combined with prednisone (“PN”) to treat prostate cancer together, rather than using the two drugs separately. In 2017, Apotex Inc. (“Apotex”), another leading Canadian pharmaceutical corporation, brought forward . Pursuant to section 5 of the (“PM(NOC) Regulations”), a notice of allegation is a submission that states a patent is invalid for one of many reasons.

Apotex was seeking approval to create a generic version of ZYTIGA called APO-ABIRATERONE, which uses therapeutically-effective amounts of AA and PN to treat prostate cancer. Their NOA alleged that if the 422 Patent was invalid, APO-ABIRATERONE could not infringe upon it, and that the combined use of the two medications was not patentable primarily due to a lack of evidence showing the benefits of combining AA and PN versus using them separately. Additionally, Apotex argued that their generic drug was not for the same use as ZYTIGA; APO-ABIRATERONE was intended to treat the adverse side effects of taxanes, a class of chemotherapy drugs.

In response to the NOA, Janssen brought an application under and prohibiting the Minister of Health from issuing Apotex a notice of compliance (NOC). An NOC, as defined under section C.08.004 of the under the PM(NOC) Regulations, essentially enables the Minister of Health to grant Apotex permission to create a generic version of ZYTIGA following a successful examination. Janssen submitted that Apotex’s allegations under the NOA were invalid and therefore they should not be issued an NOC until the 422 Patent expires. ��

In 2019, the ruled in Janssen’s favour, ordering the Minister of Health to not issue a notice of compliance to Apotex at least until the expiry of Janssen’s 422 Patent. Apotex appealed the decision to the who, on January 14, 2021, ruled to dismiss the appeal on all four of Apotex's arguments, ruling on: (1) patentable subject matter; (2) obviousness; (3) inutility; and (4) infringement.

(1) Patentable Subject Matter

Apotex stated that the lower court erred in finding that the 422 Patent amounted to a new patentable subject matter, compared to AA and PN independently. Apotex noted that the combined drug did not produce a better result, and the lack of evidence sufficiently supports this claim. Referring to the jurisprudence, the Court of Appeal stated that determining patentable subject matter depends on whether the patent provides the public with something previously unavailable within cancer treatment. It is not concerned with the efficacy of the combined drug. ��

(2) Obviousness

Apotex alleged that the lower court erred in issuing the test of obviousness to determine patentability: specifically, the “more or less self-evident that it ought to work” aspect. Assessing Apotex’s argument of lack of evidence, the Court of Appeal reaffirmed that the patent's applicant need not meet all aspects under the test. They agreed with the lower court’s decision that the test of obviousness was fulfilled because it was not self-evident to combine AA and PN to treat prostate cancer.

(3) Inutility

Apotex argued that the lower court erred in its reasoning because it could not prove that the combination of drugs was more effective than each drug separately. Apotex relied on Janssen’s results when applying the Supreme Court’s test for utility from . The Court ruled that the lower court did not err. A claimant for a patent must only establish suggestive utility, which Janssen successfully did in 2007 when establishing their 422 Patent.

(4) Infringement

Apotex's last argument, a defence, was that neither their Product Monograph nor their product’s marketing infringed Janssen’s product. They stated that their product did not infringe on the 422 Patent because it was marketed for alternative use. The Court of Appeal stated that the lower court did not err in their decision that the product still imposed an infringement. Although Apotex was not currently producing a direct infringement, the Court found that it would eventually lead to an infringement of the 422 Patent.

What’s to Come

The Federal Court of Appeal’s decision to uphold the lower court’s decision and dismiss the appeal broadens Canadian patent law's future at a very pivotal time. Janssen’s success for ZYTIGA allows them to monopolize on their effective prostate cancer treatment. Most importantly, the reaffirmation of the “obvious to try” test guidelines and the updated definition of “utility” greatly enhance patent law during the COVID-19 era . A patent does not have to meet every criterion for the “obvious to try” test and must only demonstrate suggestive utility results. With new corporations striving to be at the forefront of medical technology and produce effective treatments for the ever-mutating COVID-19 virus, this decision creates a less stringent threshold for obtaining and defending a patent.

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What is CRISPR?

Some scientists believe the design and development of new biomolecules is as much an art as it is science. The ��discussed, and used, by Dr. Pearlman capitalizes on an adaptive immunity system found naturally in bacteria and archaea that uses clustered, regularly interspaced short palindromic repeat (CRISPER) DNA segments to fend off invading viruses. In naturally adapting to a virus invading the cell, CRISPR associated proteins (Cas proteins) will create a spacer unit of genetic code that is unique to the invading virus and incorporate this spacer into the CRISPR region of the cell’s genome. This unique spacer unit will then be transcribed (that is, converted from double stranded DNA to RNA), associate with Cas proteins to form a functional complex, and then target and inactivate the very same type of virus that led to the creation of the spacer unit.

In the laboratory, genome editing uses the functional complex found in this adaptive immunity mechanism to insert or remove genetic code from the genome of a cell. By attaching a synthetic, guiding portion of RNA (sgRNA) to Cas proteins they can be directed to a portion of the genome, through complimentary base pairing with the sgRNA, where Cas will recognize a portion of the genome and cut it to either insert a new region or to remove a portion and disrupt the expression of a gene. By cutting out sections of DNA a gene can be disrupted and lose its functional expression in the cell. In other words, it will no longer be able to produce the molecular products responsible for its former physical trait. By inserting new regions of DNA, the genome can be expanded to confer resistance to invading pathogens, such as viruses, or to express new protein products that can add or enhance the cell’s function. For example, a new portion of DNA may be inserted that codes for a digestive protein not normally found in the cell and, consequently, grant a new molecular digestive mechanism.

What does Genome Editing have to do with Law?

Dr. Pearlman noted that there has been an explosion of scientific literature covering the CRISPR system of genome editing since 2010 and it appears that the momentum will only grow in the coming years. The ability to edit genomes can allow for the expression of new protein products that can be of great commercial value as well as pave the way for new medical treatments that circumvent traditional pharmaceuticals. Additionally, Dr. Pearlman noted that the CRISPR system can be used to produce heritable traits – that is, changes that can be transferred from a parent to their offspring. With this sort of molecular modification becoming more pragmatic, it becomes paramount to have a thorough understanding of the biochemical expression pathways that govern genomic expression to keep an eye on the ethical implications of modification. If human genome editing were to become available, should those with advantageous genomic modifications be treated differently by public health systems? To whom should these technologies be made available, if ever? These questions are beyond the scope of current genomic technology but, with the growing pace of CRISPR methodologies, designs may soon start to reach more readily into the macroscopic domain.

What Makes Scientific Designs Different?

With the cost of biochemical research and development increasing and a billion-dollar entry fee for the drug and biomolecular development market it follows that when an industrially relevant molecule is finally created the developer should be able to recuperate their investment and benefit from their work. Normally, the boundaries of property rights require contextual understanding: what is the nature of comparable products, if the new product’s design is generic or obvious, and if the new product can have a place in its intended market. The differentiating criteria of the sciences become pronounced when considering the esoteric nature of the discipline. How can one reasonably expect a thorough consideration of the distinguishing criteria for obscure scientific concepts, like base pair fidelity, when the requisite knowledge is held only by a few people, like Dr. Pearlman, who have committed years, if not decades, to the study? The nuanced nature of genetics can make innovations in genome editing or CRISPR technology appear to be near imitation; however, the modification of a single nucleotide in the genetic code can have a profound impact on the success and possible application of a biotechnology.

Synthesis, Structure, and Industry

What amount of scientific knowledge is sufficient in legal practice? that a special breed of IP lawyer will arise to confront the high demands of contemporary science and technology patents. Considering the high financial stakes and the significant likelihood that a new molecule or molecular technique will fail the requisite safety tests at any of a multitude of stages, a lot of designs are left in the laboratory. A re-engineering of the approach or scrapping the project in its entirety may follow, meaning product patents should not be initiated until after the molecule has been proven safe for its regular use instead of when it is first designed or synthesized in the lab. Additionally, research and development can indirectly prioritize self-benefit over scientific collaboration since scientists rely on design details to learn about their ever-developing field and most details are kept secret until after a patent has been granted.

This is where innovation becomes conservative and structure becomes especially important. Does a single elemental substitution in the genetic code constitute a new product if the application remains the same? What about changing a single gene to modify a physical characteristic that relies on multiple genes? While certain business practices, such as non-competition deals, are commonly found outside of the sciences, unique can arise from small chemical modifications which effectively extend a patent beyond its expiry date through the issuing of a new patent for a highly similar molecule. Furthermore, patents may be sought for generic parts of biotechnology procedures that are nonessential to its action, prohibiting competitors from including strategies in their approach and significantly , or even demolishing, a competing synthesis. Lastly, meeting the testing and safety demands of different communities poses an for introduction into a global market due to different national regulatory standards.

So, What Makes It My Molecule?

The same fundamental concepts that apply to patents outside of genome engineering also apply to those inside the discipline but with a stringent demand to understand the nuances of molecular design. An integration of mechanistic knowledge may prove to be key when evaluating possible distinguishing criteria among patents filed for similar compounds but it is ultimately up to practicing lawyers to integrate sufficient scientific knowledge to accurately capture the scope of their client’s designs.

Dominic Cerilli is the Content Editor for the IPilogue and a JD Candidate at Osgoode Hall Law School.

[1] Dr. Pearlman's talk was organized by The 91��ɫ Collegium for Practical Ethics and The 91��ɫ Centre for Public Policy and Law under the leadership of Ian Stedman.�� Support for the event was provided by IP Osgoode, McLaughlin College, 91��ɫ - Faculty of Health, 91��ɫ - Faculty of Science, and 91��ɫ's Office of the VPRI.

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Let’s start with a little background about the regulation of medical products: Following the thalidomide disaster in the 1950s, countries around the world implemented regulatory systems for vetting the safety and efficacy of drugs before they were available for sale on the market. For a long time, information about the safety and efficacy of drugs was held in confidence between the regulator and the manufacturer of the product. However, a number of highly publicized cases in the early 2000s involving drugs like Paxil® and Vioxx® revealed that this confidential relationship between regulators and manufactures might not serve the public interest, or worse, result in actual harm to patients. Take the example of Paxil, a drug belonging to a class of drugs called “SSRIs.” In an analysis recently published by the , one of us (MH) explained how Health Canada’s decision to delay disclosure of safety and efficacy information precipitated misinformed off label prescribing by physicians:

Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada also did not publicly disclose that evidence, and by 2004 SSRIs were being widely prescribed for teenagers. Physicians had no idea they were invoking their discretion to prescribe “off label” on the basis of incomplete information — the balance of which Health Canada had in hand.

It is difficult to know how frequently such misinformed off label prescribing occurs. But it only takes one blockbuster drug to become a : tens of millions of Americans were estimated to be using Vioxx for pain relief when knowledge of increased risks of heart attack and stroke began to surface. The selective publication behaviours of researchers and manufacturers combined with the publication bias toward statistically significant results amongst journals suggests that regulators are in possession of relevant safety and efficacy data that is not in the public domain for every drug they review.

In the wake of the Paxil and Vioxx scandals, several jurisdictions implemented changes to make safety and efficacy information as well as regulatory decision-making more transparent.�� The United States’ Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are leading the way.�� Health Canada, in sharp contrast, has been slow to change.�� An initiative known as the “” project has, by Health Canada’s own account, been an abject failure given the limited value add it provided to information that is already in the public domain. Instead, Health Canada’s approach to transparency remains largely reactive, in response to requests for information made under the

Merck was an appeal from the Federal Court of Appeal concerning the disclosure of Merck’s New Drug Submission (NDS) of Singulair and Supplementary New Drug Submission (SNDS) under the ATI Act. Under the s. 4 of the Act, the government is obligated to release any record under the control of a government institution subject to certain exemptions such as personal privacy. Here, the set of exemptions at issue were the “third party” (in this case, Merck) information exemptions, which encompass information that is owned by (i.e. trade secrets or confidential business information) or could harm the competitive or financial interests of a third party.

When Health Canada received an access to information request for documents pertaining to Singulair, it undertook a review of the NDS documents and found 550 relevant pages. Of those pages, it found 30 pages contained confidential information and found that 15 pages did not contain any confidential information and released them without notice to Merck. It requested submissions from Merck for the balance. For the SNDS request, it found 300 pages, refused to disclose 60 pages and released 8 pages without notice. Merck objected to the disclosure of pages that Health Canada sought submissions on. After two rounds of correspondence, Health Canada redacted an additional 55 pages and decided the release the balance of the document subject to Merck’s right to seek judicial review, which Merck invoked, leading to extensive proceedings at the Federal Court and the Federal Court of Appeal.

Justice Cromwell, writing on behalf of a majority of six, characterized the ATI Act as a balance between “openness and commercial confidentiality.” He stated that balance was achieved in the form of two kinds of protection, which he framed as the “procedural protection” afforded to third parties in terms of notice of disclosure and so forth, and the “substantive protection” of information that falls within the scope of the third party exemptions. In the end, Cromwell J. supported Health Canada’s decision to disclose information on the facts of this case. But the ways in which he interpreted the substantive and procedural protections available to third parties seem likely to further undermine access to information under the legislation in the future.

Consider first the “procedural protections” conferred under the ATI Act. The Court focused on two issues embedded in the legislation’s s. 27(1) notice requirement: What is the threshold for notice and what type of efforts must be expended by the agency prior to disclosure or notice? While the Cromwell J. rejected Merck’s assertion that notice should be automatic, he held that the threshold for notice is nevertheless very low: the institutional head must have “no reason to believe that the information might fall within the exemptions under s. 20(1).” In almost the same breath, Justice Cromwell emphasized that the third party will generally be “better position[ed] than the head of the institution to identify information that falls within one of the s. 20(1) exemptions.” Practically speaking, then, Health Canada has to be absolutely certain that the information is not exempt under s. 20(1) without checking in with the third party. The Court also held that it is incorrect to place a burden on the third party to prove that the documents they object to being disclosed falls under s. 20(1), at least until judicial review.

In terms of what efforts must be made by the regulator before deciding whether to give notice and/or disclose, Cromwell J. held that governmental agencies such as Health Canada must conduct a “sufficient review.” He stressed that the duty to disclose and the duty not to disclose are “equally important” and should be taken “equally seriously.” In principle, each of these moves by Justice Cromwell follows from the language of the statute. However, they also have the potential to further delay transparency.

So too with the principles articulated by Justice Cromwell with respect to the “substantive protections” from disclosure contemplated under the ATI Act.�� To begin, the majority noted that the Federal Court of Appeal erred by holding Merck to a “heavy burden” to establish that the pages in question contained trade secrets. Rather, the appropriate burden on the third party attacking Health Canada’s decision to disclose is the civil balance of probabilities standard. What’s more, characterizing trade secrets as narrow or broad in scope was deemed unhelpful. Whether something qualifies as a trade secret instead turns on the evidence: Is it secret in an absolute or relative sense? Did the alleged owner of the information treat it as secret? Was it capable of industrial application? Does the owner have an economic interest in the information? While these questions derive from the jurisprudence (not to mention Health Canada’s own internal operational guidelines), the fact-driven nature of the test further exposes Health Canada’s decision-making to negotiation, uncertainty, and challenge by the third party meanwhile delaying access to information by others.

Justice Cromwell’s remarks around the scope of “confidential business information” (CBI) under s. 20(1)(b) of the ATI Act are illustrative of the same. Provided the information in question is of a financial, commercial, scientific or technical nature and not simply administrative details (e.g. page numbers), it may amount to CBI.�� Cromwell J. noted that the fact of relying upon studies that are publicly available (provided the reliance isn’t known through, for example, the FDA’s website or stated in the Product Monograph), and the manufacturer’s evaluation of a published study could all be shown to be within the sphere of CBI. Observations and analysis by regulators is not likely CBI, but correspondence that reveals information supplied by the manufacturer could be. Each is a question of evidence to be determined on the facts of each case.

Form the perspective of enhancing transparency, the most helpful passages from the Court surround s. 20(1)(c), which exempts information that could result in financial or competitive harm to the third party. ��Cromwell J. found that Health Canada applied too high of a standard under s. 20(1)(c). ��The third party must show that harm is more than merely possible or speculative, but need not demonstrate that harm is more likely than not to ensure. Justice Cromwell accepted that any release of information that could give competitors a head start in product development might fall under the definition of harm under s. 20(1)(c). Yet, at the same time, he held that there must be a “direct link between the disclosure and the apprehended harm and that the harm could reasonably be expected to ensue from disclosure.” And he dismissed Merck’s argument that the prospect of public misunderstanding the information should be equated with harm under s. 20(1)(c), quipping: “The point is to give the public access to information so that they can evaluate it for themselves, not to protect them from having it.”

In this concluding statement and at the outset of the judgment where he quoted Brandeis’ famous statement about “sunlight” being the “best of disinfectants,” Justice Cromwell gestured at the broader importance of transparency. Yet it seems to do little work in the main analysis. We think the parameters that Justice Cromwell (the minority dissented on other grounds) placed upon the substantive and procedural protections under the ATI Act ignore the temporal dimension of transparency, that is, the importance of timely access to information. The Court referenced the time requirements codified in the legislation, but showed no awareness of Health Canada’s in meeting those timeframes. In fairness, that is an issue for the executive branch or Parliament, not the judiciary. The Court also didn’t have the benefit of hearing why timely access to information beyond Health Canada’s doors is critical. BIOTECanada, a trade association aligned with Merck’s position, was the only intervenor in the case. Where was the Canadian Medical Association? Where were consumer protection groups? The Court made a passing reference to the importance of access to information given pharmaceutical industry practices. But regulatory failures like Paxil and Vioxx did not inform the analysis. At worst, the decision in Merck will exacerbate problems under the access to information legislation by lowering the threshold for notice and endorsing a case-by-case, fact-intensive approach to disputes over the scope of trade secrets and confidential business information protection. At best, it confirms what many already suspected: the ATI Act is no answer to the need for timely transparency within and without Health Canada.

William Wong is a JD Candidate at Dalhousie's��Schulich School of Law and a Judicial Clerk at the Supreme Court of Nova Scotia.

Matthew Herder is an Assistant Professor in Dalhousie's Faculty��of Medicine who has been cross-appointed to the Schulich School of Law.

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