Image by Philip Ezze ()Ěý

Emily Xiang is an IPilogue Writer, President of the Intellectual Property Society of Osgoode, and a 2L JD candidate at Osgoode Hall Law School.

Ěý

What is Bioprinting?

is an innovative technology that uses cells, organic materials, and biological molecules to create complex models and structures. Its is forming organic tissue constructs with a high degree of repeatability, flexibility, and accuracy. Since its first breakthrough in the health and pharmaceutical industries in the 2010s, the application of 3D bioprinting has grown to include , , , , and . In 2021, the global 3D bioprinting market was valued at and is expected to grow from there.

3D Bioprinting in the Cosmetics Industry

The use of bioprinted tissue by cosmetics companies has seen tremendous growth in recent years. In Europe, following the which banned animal testing for cosmetic purposes, cosmetics companies have had to seek alternative methods of ethical testing on varying skin types that would also produce accurate results. ĚýMoral advantages are not the only kind of benefit that bioprinting technologies can offer. Since human skin is multilayered and comprised of various cell types, 3D bioprinting presents the unique ability to deposit cells in meticulous arrangements that closely resemble actual human skin, resulting in and faster, cheaper, and more effective testing procedures. Since 3D bioprinting entered the marketplace, global cosmetic leaders such as and have invested significantly into the R&D of bioprinting technologies, with a view to revolutionize the practice of dermatology in the future.

3D Bioprinting & Canadian Patent Law

From an intellectual property law perspective, could 3D bioprinted material be patented? While the scope of patentable subject matter in Canadian patent law is generally considered Ěýquite broad, products and techniques related to bioprinting between the living and the non-living, which could complicate matters. In , the Court held that “higher life forms,” such as genetically modified plants or animals, were not patentable but affirmed the patentability of the genetically modified genes in question. Since the decision, the Canadian Patent Office has more clearly delineated the distinction between higher and lower life forms in the , which defines lower life forms as unicellular and higher life forms as being multicellular. In Chapter 17.02.02 of the MOPOP, the Patent Office states that “[a]rtificial organ-like or tissue-like structures that are distinct from true tissues and organs and that have been generated by human intervention through the combination of various cellular and/or inert components may be considered, on a case-by-case basis, to be manufactures or compositions of matter with the scope of section 2 of the Patent Act.”

While some ambiguity remains regarding the patentability of bioprinted materials, there has been some success in patenting associated with bioprinting. Despite these patents, however, bioprinting technology can still be said to be distinct from, for example, more cutting-edge , for which the core of the technology can be patented and can thereby lead to intellectual property disputes. In contrast, the core elements of bioprinting derive from that are already free from patent protection, providing innovators working with bioprinting technology some more leeway to appropriate the existing methodologies in the field.

Conclusion

While cosmetics companies constitute some of the more recent actors to leverage the new technology, bioprinting has gained in the industry in recent years, with interest no longer being restricted to academic circles but also gaining traction in the marketplace. As the research and development of 3D bioprinting continues to evolve, the need for the law to take a more explicit stance on the subject matter will become increasingly apparent.

The post Easy, Breezy, Bioprintable: 3D Printing in the Cosmetics Industry appeared first on IPOsgoode.

In Canada, methods of medical treatment are unpatentable subject matter. This prohibition originated from an old provision of the Patent Act (Section 41) interpreted by the Supreme Court of Canada in . The statutory provision has since been repealed but the subject matter prohibition survives as a common law doctrine. The justification for the prohibition is agreeable: fear of patent infringement should not deter medical practitioners from applying their exercise of skill and judgment (see ). However, the scope of the prohibition is less agreeable. To this day, the definition of a “method of medical treatment” remains unclear, especially in the context of pharmaceutical use patents. Phelan J. in admitted that the jurisprudence on this matter “is not entirely consistent” (also see Manson J’s comment at ).

For example, consider the following two types of claims:

• “the use of compound X to treat disease Y in a dosage range of A to B mg”
• “the use of compound X to treat disease Y, at a dosage of A mg”

The first claim is invalid because the dosage range encompasses a choice to be made by a medical practitioner prescribing compound X. The second claim specifies a fixed dosage rather than a range and is therefore patentable. The Federal Court made this distinction in . There are many problems with this rule. One problem is that this distinction does not serve the primary goal of unimpeded medical practice, even if a claim for a fixed dose can theoretically be infringed by a physician and therefore interfere with physicians’ exercise of skill and judgment. Furthermore, an interesting is that the distinction is purely formal, as a patentee could simply split a claim with a dosage range into multiple claims with fixed doses. While I agree that courts have fixated too much on form over substance, I am curious about whether a court would treat multiple claims with different doses the same as one claim with a dosage range. Another interesting is that invalidating a claim for encompassing a physician’s exercise of skill and judgment is difficult to reconcile with the Supreme Court’s decision in where a claim for the use of a compound at an “effective amount” was held patentable. Surely, a physician deciding an “effective amount” exercises the same (if not more) skill and judgment required to choose a dosage within a dosage range. Ěý

In a case from this year, , the common law doctrine became even more convoluted. The Federal Court held that a fixed dose claim, similar to the example above, was unpatentable because the specified dose was “not appropriate for all patients” (partly due to potential adverse effects) and a prescribing physician would need to exercise skill and judgment in deciding whether to prescribe at the claimed dose amount (Manson J at ). This illustrates another problem with the earlier distinction, that a claim with a fixed dose would still encompass a choice to be made by a medical practitioner – the choice to prescribe at the fixed dose or at a different one (or not at all).

So, what is the solution to this confused area of law? Could not courts create a common law defence for medical practitioners against patent infringement claims? Obviously, some caveats would be needed. One should be that courts must assess whether an infringement action could deter medical practitioners from their duty of care to patients. But a common law solution may be preferable to waiting indefinitely for legislative change. Currently, patents do not pose a serious threat to medical practice because medical practitioners are not targeted by pharmaceutical patentees which prefer going after the generic companies which directly compete with them.

Courts have already virtually created a common law defence, but a needlessly complex and roundabout one that depends on seemingly arbitrary claim-by-claim rulings on patentability. If the jurisprudence remains as it is or continues to develop along these lines, the public could be deprived of some valuable potentially life-saving inventions.

The post What is a Method of Medical Treatment? appeared first on IPOsgoode.

“You are not feeling well and need to see a doctor.Ěý You have two options: (i) you can be treated by a human doctor, or (ii) you can be treated by an AI doctor, but not both.Ěý Which do you choose and why?”

1. Introduction

This question is so open-ended that a scope-narrowing discussion is needed. As such, I make three assumptions. The first overarching assumption I will make is that there exists a trade-off of capabilities between AI and humans such that a weighing of their relative benefits is required to render a decision. This assumption births further assumptions, namely that AI doctors are technically superior, that humans possess some intangible positive factor, and that I have zero information regarding my affliction. .

1. Setting the Stage with Necessary Assumptions

#1 – AI doctors have technical superiority

Current research suggests AI doctors are to or than their human counterparts at diagnostic accuracy. For the purposes of this discussion, I will assume that AI doctors possess, across the board, technical superiority. Otherwise, what are they providing us that humans do not?

#2 – Humans possess some intangible factor of positive, albeit uncertain, value

For the question, ‘AI or human?’ to be worth asking, there must be a trade-off. What advantage does the human possess? The , something that is undoubtedly beneficial in a patient-doctor relationship.

A to the use of AI in medical settings is “the belief that AI does not take into account one’s idiosyncratic characteristics and circumstances”. The more ‘unique’ one perceives herself to be, the stronger the preference will be for a human doctor. However, this reliance on ‘uniqueness’ is, at least in part, unjustified because there is a limit to how ‘unique’ medical conditions can be. To some extent (greater or lesser, depending on the specific ailment), sickness X afflicting person A is equivalent to sickness X in person B for diagnostic and treatment purposes. For example, a doctor does not need to know about a diabetic’s personality and emotions in order to create a treatment plan.

This trade-off then begs the question: what is the relative value of the ‘human factor’ versus the superior diagnostic ability of an AI in a doctor-patient setting? It depends on the patient’s specific needs.

#3 – I have zero information regarding my affliction (i.e., it can be benign or fatal)

The third assumption I must make involves the nature of the malady requiring medical intervention. In a scenario in which I have knowledge of my condition, my decision would be predicated on the following considerations. If there is a chance I could be dealing with a hard-to-detect, serious disease, the presence of the ‘human factor’ would be of limited value. In this case, what I need is the superior technical capabilities of the AI doctor.

On the other hand, I may be dealing with a condition that is mostly, or even exclusively, psychological in nature. I imagine that a human doctor would be desirable in dealing with a patient’s depression, anxiety, or any other condition in which the patient may derive some benefit from ‘being heard’. In particular, the need for human intervention (as opposed to a robot therapist) can be , such as flashbacks and nightmares from PTSD. This ties in with the above discussion on ‘uniqueness’ as a source of resistance to AI doctors. Psychological disorders, I believe, possess a greater degree of uniqueness than ones of a primarily physiological nature, which supports the assertion that human doctors are better equipped to deal with them.

The only context provided by the question is that ‘you are not feeling well’. I can only assume, then, that the mystery condition is equally likely to be physical or psychological in nature, and equally likely to be serious or non-serious. In simple language, ‘it could be anything’.

III. Assessing the Trade-off

I don’t feel well, and that’s as specific as I can be

The above considerations are summarized as follows: AI doctors provide superior diagnostic service that is preferred in situations involving hard-to-detect, potentially life-threatening conditions. Human doctors, while not as technically savvy, possess an intangible ‘human factor’ that is of increased utility in a psychological/psychiatric setting.

With reference to my contextualization above of the words ‘you are not feeling well’, I must assume the worst-case scenario. For me, that consists of a hard-to-detect, life-threatening condition. This is based on an implicit premise that a life with psychological unrest is preferable to no life at all. Therefore, in a situation of zero information, I would opt for the AI doctor.

Additional considerations

Pragmatically speaking (discounting for a moment the ambiguity of the statement ‘you are not feeling well’), it would not be difficult to distinguish a psychological condition from a physiological condition. A stomach pain is likely to be primarily physiological, in the same way that auditory hallucinations are probably psychological in origin. Given the trade-offs between diagnostic accuracy and the ‘human factor’ discussed above, even a small amount of information about my condition would assist in making the optimal choice between an AI and human doctor.

Another consideration I set aside until the end is that of the coincidence of physiological and psychological trauma. I deliberately separated the two in the above discussion to give due consideration to each factor; but it is true that physical maladies are often accompanied by psychological distress (see and for examples). However, does this change the above calculus? In my mind, it does not. The mental toll exacted on a cancer patient notwithstanding, her primary focus remains detecting and combating the cancer itself. Benefits accrued from the ‘human factor’ are secondary to the AI doctor’s superior ability to protect the patient from the actual disease.

In summary, I prefer an AI to a human in the vast majority of medical scenarios.

Daniel Joseph is a second-year JD student at Osgoode Hall Law School and a Fellow at the IP Osgoode Innovation Clinic.

The post AI or Human Doctor? appeared first on IPOsgoode.

The problem of SFFCs has been by WHO as having a broad international impact. All varieties of medication are at risk of being counterfeited and this concern applies to both brand name and generic drugs. The results of fake packaging and improper ingredients include unsuccessful treatment as well as accidental consumption of toxic substances.

While it is difficult to paint an accurate statistical picture of the SFFC problem due to the constant evolution of illegal techniques and distribution methods, the WHO notes that the problem is most prevalent in developing nations in Africa, Asia, and Latin America and that less than 1% of the market value is from industrialized countries.Ěý This dichotomy is evidenced by a number of the cited by WHO. First of all, the high costs of medication often drive consumers to seek cheaper illegal sources. Similarly, in many developing nations, supplies at regular health facilities are often limited and illegal suppliers may be the only alternative option. Further, many jurisdictions lack legislation to combat SFFCs and are unable to address the increasing issues arising from the growth of international trade.

The WHO resolution aims to promote the Thus, the goal of the resolution is effectively to target the contributory factors and recognize how these factors shape the situation in developing countries. The resolution advocates for a “global strategy” involving public health, innovation and intellectual property. Part of this strategy is intended to address the lack of sufficient financing which is presently hindering WHO’s progress in combating SFFCs.

The resolution also outlines a through which all member states may take part in combating SFFCs. This mechanism reflects the contribution of international trade to the increasing prevalence of counterfeit medicine by stressing the importance of international collaboration regarding sharing of information and best practices. The intended result is to strengthen both regional and national supply chains, particularly in developing nations. In order to achieve this, existing WHO structures will be incorporated, as well as regional and subsidiary groups. The overarching perspective is to be that of a public health initiative, however, as opposed to being one of trade or intellectual property.

The resolution will be submitted for approval to the 65th World Health Assembly scheduled to meet in Geneva next May.

Nora Sleeth is a JD candidate at Osgoode Hall Law School.Ěý

The post WHO Resolution Intended to Address Global Counterfeit Drug Market appeared first on IPOsgoode.