Life Sciences

Biotechnology projects rely on sensitive genetic data and biological material Nowadays, innovation-driven companies involved in life sciences, research and biotechnology handle some of the most legally sensitive assets: human tissue, biological material and genetic data. Innovation models involving tissue engineering, biobanks or AI-based analytical technologies are now based on the transfer and use of biological data with high scientific and commercial value. Yet, many organizations still prioritize the scientific and operational aspects of their projects without giving sufficient consideration to the legal restrictions that arise when a project involves a person’s DNA or biological material. From a business standpoint, the risk is that an organization—whether a private company or a public institution—might develop a technology, but then be unable to market that technology because it does not hold the necessary rights to use the biological material and information involved. In Canada, and particularly in Quebec, laws that protect personal and health information have become central to such projects.1 We are no longer simply dealing with typical cybersecurity or privacy concerns. These laws directly affect how biological material is:  collected used transferred stored altered and potentially leveraged for commercial or collaborative research purposes2. Why DNA and human tissue are subject to a particular legal protection The highly sensitive nature of DNA and genetic data is no longer disputed. Canadian case law has long recognized the highly personal and private nature of this type of information.3 It also emphasizes the fact that human tissue and genetic data play a unique role in research and innovation projects because of the identification risks they carry, their scientific value, and the ethical and commercial concerns related to their use.4 This perspective is evident in section 2 of the Act respecting health and social services information5, for example, which defines health information as any information that concerns “any material taken from [a] person,” including biological material. Section 5 and following of this act set out the conditions under which such information may be used, disclosed or transferred in the context of research or collaboration involving third parties6  These obligations supplement those set forth in the Act respecting the protection of personal information in the private sector,7 which requires in particular that personal information be collected for specific and legitimate purposes, and that it be used in a manner consistent with the purposes for which it was originally collected.8 Artificial intelligence, genetic data and the risk of re-identification From a biotechnology perspective, the matter becomes particularly touchy when human tissue or genetic data, which was initially collected for clinical or scientific purposes, is then used for technology or artificial intelligence projects. In fact, many projects that utilize artificial intelligence require not only biological samples and DNA, but also phenotypic data, health information and family history information from the patients from whom the biological samples were obtained. As such, there is a real risk of data cross-referencing here that must be managed with full awareness of the potential impact on those individuals. In certain projects, combining DNA with family information could compromise the privacy of not only the individuals from whom the biological material was collected, but also their family members. This problem has already been raised in relation to genetic genealogy.9 Consent, health information and secondary uses tend to be overlooked A project that was initially intended for research purposes can quickly drift into secondary uses that extend beyond its original scope. However, consent obtained at the outset does not necessarily cover all future uses, particularly where derived data or analysis results are integrated into technology platforms or used to develop analytical tools.10 Research agreements and biological material transfer agreements constitute an essential governance mechanism Agreements have thus become the key governance mechanism. Biological material transfer agreements, collaborative research agreements and data-related provisions are no longer solely intended to protect intellectual property or commercial confidentiality. They also serve to define the processes involved in transferring biological samples, ensuring data traceability, imposing restrictions on reuse and meeting anonymization requirements.11 The rights relating to intellectual property, DNA and personal information are interconnected The interplay between biotech innovation, intellectual property and personal information protection raises complex legal issues. A genetic database or a biological model derived from it can be both a strategic business asset AND a collection of highly sensitive personal information. However, any intellectual property rights that may apply to the results, algorithms or analytical methods do not exempt organizations from the obligations set out in Quebec laws regarding the protection of personal and health information12. On the contrary, in order to market a technology, organizations must hold not only the necessary intellectual property rights but also the rights required under the legal framework governing health and personal information. The commercialization of a technology begins long before it is brought to market As organizations increasingly seek to leverage data from scientific research, issues related to the governance of human tissue, DNA and biological material should no longer be treated as a secondary consideration addressed only at the end of a project. They are becoming an integral part of the legal, operational and commercial framework of modern biotechnology projects and therefore deserve careful consideration from the outset. Summary 1. From a legal standpoint, DNA is considered to be health information In Quebec, biological material and genetic data are not merely instruments of research. Under the law, they are defined as highly sensitive “health information”. The collection, use and transfer of this type of information is strictly regulated and requires explicit, informed consent. 2. Intellectual property does not confer all rights to the holder Just because a company develops a high-performance AI algorithm or an innovative biological model does not mean it can circumvent Quebec’s privacy laws. Bringing biotech products to market requires holding the necessary intellectual property rights AND complying with the legal framework governing the use of health data. 3. The pitfall of project drift (secondary uses) Consent obtained at the outset of a clinical research project usually does not extend to future uses, such as the integration of data into AI platforms. Organizations that fail to establish a solid contractual framework (e.g., transfer agreements, anonymization clauses) from the start may never be able to market their technology. Act respecting health and social services information, CQLR c R-22.1, ss. 1, 2, 5, 44 to 49 and 77. Act respecting the protection of personal information in the private sector, CQLR c P-39.1, ss. 4, 5, 8, 12 and 14. R. v. Dyment, 1988 CanLII 10 (SCC), [1988] 2 SCR 417 Marie Hirtle and Bartha Maria Knoppers, Le stockage des éléments du corps humain, les droits de propriété intellectuelle et les autres droits de propriété, Industrie Canada, 2014. Act respecting health and social services information, supra, note 1, s. 2. Id., ss. 5, 44 to 49 and 77. Act respecting the protection of personal information in the private sector, supra, note 2. Id., ss. 4, 5, 8, 12 and 14. Clausius, K., Kenny, E. & Crawford, M. J. (2023). BILL S-231: The Ethics of Familial and Genetic Genealogical Searching in Criminal Investigations. Canadian Journal of Bioethics / Revue canadienne de bioéthique, 6(3-4), 44–56.  Act respecting health and social services information, supra, note 1, ss. 44 to 49; Act respecting the protection of personal information in the private sector, supra, note 2, ss. 12 and 14. Act respecting health and social services information, supra, note 1, ss. 48 and 49; Act respecting the protection of personal information in the private sector, supra, note 2, ss. 18.3 and 23. Act respecting health and social services information, supra, note 1, ss. 5 and 49; Act respecting the protection of personal information in the private sector, supra, note 2, ss. 12, 17 and 18.3.

Recently,1 Justice Isabelle Germain of Quebec’s Superior Court ruled on a case involving insurance fraud in the matter of Paul-Hus v. Sun Life Canada, compagnie d’assurance-vie2. This ruling illustrates that applicants must answer the insurer’s questions honestly; should an applicant try to mislead the insurer, he will have to face the consequences. In this case, the plaintiff Daniel Paul-Hus (Paul-Hus) claimed an amount of $150,000 from Sun Life Canada by way of benefits as set out in the serious illness insurance policy taken out by his company (of which he was the sole shareholder and director) in 2015, along with $50,000 for the trouble and inconvenience caused by Sun Life’s refusal to honour its contractual undertakings. Paul-Hus claimed that he suffered from amyotrophic lateral sclerosis (ALS) diagnosed on February 1, 2018. The claim form was submitted by him on August 16, 2018. Sun Life refused his claim since an assessment of his medical records revealed that his prior medical history was inconsistent with the information he had provided during a telephone interview on March 17, 2015. Sun Life considered the contract null and void due to Paul-Hus’s false declarations while filling out the questionnaire he was required to complete when taking out the policy. Essentially, it was Sun Life’s position that Paul-Hus had not answered certain questions correctly in the questionnaire and that, if he had, the insurer would not have issued the serious illness policy. It was brought into evidence that, during the telephone interview of March 17, 2015, Paul-Hus had to answer questions on his lifestyle habits, his current health condition and his prior medical history. Some of the questions in Sun Life’s medical questionnaire sought to ascertain whether Paul-Hus felt weakness in his arm and whether a doctor had ever recommended any tests or if he was awaiting any test results. These questions were answered in the negative by Paul-Hus. However, a review of the file reveals that these answers were inaccurate. The insurance policy was issued on March 17, 2015, while the evidence indicated that Paul-Hus had consulted his neurologist a few weeks before, on February 24, 2015, due to weakness in his left hand, the symptoms having appeared progressively since August 2013. At that time, additional tests were prescribed (cervical and brain imaging, magnetic resonance imaging and numerous blood tests). Nonetheless, in his Originating Application, Paul-Hus asserts that, at the time the policy was issued, he had not noticed or suspected any symptoms of disease and contends that, according to the doctors, the disease had developed suddenly. In her judgment, Justice Germain reiterated the principles governing declarations of risk in the insurance sector, pointing out that false declarations can result in the nullification of the contract.3 However, in this case, the policy had been in force for over two years at the time of the claim for indemnification, so that the insurer was required to prove fraud in order to nullify the contract4 (Paul-Hus’s intention to hide his true health condition). Justice Germain found that Sun Life had discharged the burden of demonstrating Paul-Hus’s fraudulent dealings. In addition to his medical records, Sun Life produced a recording of the telephone interview held on March 17, 2015, as well as a transcription of the interview. In the Court’s view, it was clear that Paul-Hus was under neurological investigation due to weakness in his left arm at the time he was completing the questionnaire. Although in his testimony at trial,5 he claimed not to know that this information could have had an impact on the insurer’s decision, Justice Germain did not side with this version. For Justice Germain, the evidence presented by the insurer demonstrated that it had been Paul-Hus’s intention to deceive Sun Life. This being said, in accordance with the requirements of article 2408 C.C.Q., Sun Life had to demonstrate not only that it would not have covered this risk had it been aware of the new information resulting from the claim, based on its own underwriting standards, but that any reasonable insurer would have refused to issue the serious illness insurance policy under the circumstances. Sun Life also discharged this burden and completed this “evidence of materiality” by presenting the testimony of an underwriting expert. Finally, and in addition to the above, Paul-Hus claimed that he had been diagnosed with amyotrophic lateral sclerosis (ALS), which he was unable to support with evidence. Under cross-examination, Paul-Hus admitted that he had never received any such diagnosis. Instead, he suffered from a lower motoneuron disease, which did not qualify as a “serious illness” under the policy. In conclusion, in the Court’s opinion, the policyholder knowingly misled the insurer and falsified his risk assessment in order to obtain coverage. Moreover, given that Paul-Hus was not insurable for serious illness coverage in the eyes of a reasonable insurer, the Court concluded that the contract should be nullified ab initio and terminated. This decision reminds us of how important it is for policyholders to answer insurers’ questionnaires honestly when making their initial declaration of risk : [TRANSLATION] [55] In the Court’s opinion, Paul-Hus failed to answer the questionnaire sincerely. He did not act as would have a reasonable insured. He was aware of the importance of giving honest answers to the questions asked during the telephone interview. An insurance contract is one requiring the utmost good faith, particularly as far as the assessment of risk is concerned. It is of interest that in this matter, Paul-Hus gave his testimony at the hearing by way of videoconference, which Justice Germain comments as follows: [TRANSLATION] [49] One notes that, while giving his testimony via videoconference at the hearing, Paul-Hus referred to a document, which would be obtained and filed by Sun Life. The document is Sun Life’s letter of refusal of December 28, 2018, which he annotated with the words “good faith” and “answered no in all good faith I was not awaiting anything no results”. It seems odd, to say the least, that he should make the effort to write down these words as a reminder and should feel the need to repeat them several times during his testimony and when cross-examined.   [50] However, it is not enough to repeat that one acted in good faith to justify such omissions. Paul-Hus appealed Justice Germain’s decision. Sun Life filed a Motion to Dismiss the appeal, which was dismissed on January 15th, 20246. We will therefore have to wait and see what happens before the Court of appeal.  To sum up… Insurance contracts are essentially characterized by the risks they cover and by what risks the insurer is willing to tolerate for a given premium. The Civil Code of Québec recognizes two specific instances in which the actual declaration of risk is fundamental: the initial declaration of risk before the contract is drawn up7 and any increase in the risk level during the term of the contract.8 The declaration of risk is essential to the insurer when it comes to accurately determining the extent of the risk and the premium that will be charged if the insurer agrees to provide coverage. As a general rule, the policyholder’s utmost good faith should be in evidence during the initial declaration stage given that this declaration paves the way for the prospective contractual relationship and its various terms and conditions. A policyholder will be deemed to have properly met their obligation “if the representations are such as a normally provident insured would make, if they were made without material concealment and if the facts are substantially as represented.”9 Since Policyholders are responsible for informing the insurer about any relevant factors that might change its risk assessment, i.e., a positive disclosure requirement, it stands to reason that the Civil Code sets out consequences in the event that this requirement is not fulfilled by the policyholder. A policyholder who makes false statements can therefore see his insurance contract nullified ab initio.10 In other words, the contract would be deemed to have never existed because the basis on which it rests, the initial declaration of risk, was flawed. It should also be noted that nullification will only be relative and that the insurer may elect not to assert it. Consequently, the Court, after having heard the evidence, cannot rule ex officio that the contract is null and void. The insurer has two (2) years after the effective date of the contract to request nullification ab initio based on false statements or unwillingness to fully disclose risk.11 Set against that backdrop, the insurer’s burden of proof amounts to demonstrating that the policyholder made false statements or concealed relevant facts. Insurance fraud Once the two (2) year window of opportunity has closed, the insurer faces an additional burden of proof: it must also demonstrate that the policyholder committed fraud.12 Fraud is distinguished from false declarations or concealment. Among other things, it results from the misrepresentation or omission of a fact in the knowledge that, if the truth were disclosed, the insurer would not issue the policy under the negotiated conditions. Therefore, the policyholder must have intentionally deceived the insurer in order to obtain an advantage that would not have otherwise been obtained. Insurers, therefore, have a heavy burden of proof if the two-year threshold has been crossed. This is because fraud cannot be presumed; it must be established on the balance of probabilities. Burden of proof Whether or not the two (2) year period is still running, the insurer must (1) demonstrate that it would not have entered into the contract based on its own underwriting criteria; and (2) that a reasonable insurer in the same circumstances (i.e., dealing with false declarations, concealment or fraud) would have also declined to issue coverage.13 To recap, before the expiry of the two (2) year period, insurers seeking a contract’s nullification ab initio must prove that: The policyholder made false declarations or concealed information when making the initial declaration of risk. The insurer would not have entered into the contract based on its own underwriting criteria if it had been apprised of the concealed information. A reasonable insurer in the same circumstances would have also declined to take on the risk. After the expiry of the two (2) year period following the effective date of the policy, insurers requesting the contract’s nullification ab initio must prove that: The policyholder made false declarations or concealed information when making the initial declaration of risk AND intended to deceive the insurer. The insurer would not have entered into the contract based on its own underwriting criteria if it had been apprised of the concealed information. A reasonable insurer in the same circumstances would have also declined to take on the risk. Judgment handed down on October 3, 2023; the hearing was held on May 25 and 26, 2023. 2023 QCCS 3890; this ruling was appealed from (200-09-010693-239) and the appeal was dismissed on January 16, 2025 (2025 QCCA 41). Art. 2410 C.C.Q. Art. 2424 C.C.Q. Via videoconference.  Paul-Hus v. Sun Life Canada, compagnie d'assurance-vie, 2024 QCCA 46 Arts. 2408 and 2409 C.C.Q. Arts. 2466 et seq. C.C.Q. Art. 2409 C.C.Q. If the false statement deals exclusively with the policyholder’s age, the contract cannot be declared null and void (art. 2410 C.C.Q.) unless the policyholder’s actual age is outside the insurable range established by the insurer (art. 2411 C.C.Q.). Art. 2424 C.C.Q. Civil Code, art. 2424, para. 1 C.C.Q. CGU compagnie d’assurance du Canada v. Paul, 2005 QCCA 315, para. 2 and art. 2408 C.C.Q.

In a recent Federal Court decision, Justice Fothergill dismissed AbbVie’s applications for judicial review of the following decisions of the Minister of Health (the “Minister”): that JAMP was not a “second person” for the purposes of s 5(1) of the PM(NOC) Regulations; and to issue NOCs to JAMP for its SIMLANDI Presentations. Background AbbVie's drug HUMIRA first received approval in Canada in 2004 as a 50 mg/mL concentration of adalimumab. HUMIRA is widely used to treat numerous medical conditions including rheumatoid arthritis, adult and pediatric Crohn’s disease, and psoriasis. In 2016, high-concentration (100 mg/mL) HUMIRA was approved in Canada in a 40 mg/0.4 mL pre-filled syringe (DIN 02458349), and as a 40 mg/0.4 mL pre-filled auto-injector pen (DIN 02458357). In fact, AbbVie has marketing authorization in Canada for a variety of concentrations, but is actively selling only: the original (lower) 50 mg/mL concentration in 40 mg/0.8 mL strengths in both auto-injector pen and pre-filled syringe presentations, and the newer (higher) 100 mg/mL concentration in a 20 mg/0.2 mL pre-filled syringe. In December 2020 or January 2021, JAMP sought regulatory approval in Canada for its SIMLANDI drug, a “biosimilar” of AbbVie’s HUMIRA, in some of the strengths not actively sold by AbbVie (i.e., a 40 mg/0.4 mL pre-filled syringe, a 40 mg/0.4 mL auto-injector pen, and an 80 mg/0.8 mL pre-filled syringe). In its NDS, JAMP relied on three HUMIRA drug products having the same exact dosage forms, strengths, and routes of administration as the drugs to be marketed as SIMLANDI. None of these formulations of HUMIRA was marketed in Canada by AbbVie at the time JAMP submitted its NDS. Hereinafter, these drugs (DINs 02458349, 02458357, and 02466872) are referred to as the “referenced HUMIRA products”. In its correspondence with Health Canada’s Office of Submissions and Intellectual Property (“OSIP”), and after being told that their NDS was incomplete, JAMP submitted Form Vs on a “without prejudice” basis, yet took the position that it was not required to comply with s 5(1) of the PM(NOC) Regulations, as they were not a “second person” as defined therein because the referenced HUMIRA products had not been marketed in Canada for several years and therefore they were not drugs “marketed in Canada” as required by s 5(1). 5 (1) If a second person files a submission for a notice of compliance in respect of a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the submission the required statements or allegations set out in subsection (2.1). [Emphasis ours] Health Canada’s Office of Patented Medicines and Liaison (“OPML”) later advised AbbVie of its preliminary view that the referenced HUMIRA products were indeed not currently being marketed in Canada. Therefore, the referenced HUMIRA products did not trigger s 5(1) of the PM(NOC) Regulations. However, AbbVie argued that JAMP nevertheless made reference to a drug product they marketed in Canada, thus falling within s 5(1) of the PM(NOC) Regulations. Namely, AbbVie argued that JAMP SIMLANDI indirectly made reference to their HUMIRA 20 mg/0.2 mL pre-filled syringe because both products had the same drug concentration (i.e., 100 mg/mL). Hence, the issue was to determine whether a second person seeking approval for a drug with a specific dosage strength could be considered to indirectly refer to a “drug marketed in Canada” with another dosage strength but having the same concentration. The Minister’s Decision After reviewing submissions from both parties, the OPML issued its final decision on December 23, 2021, in which it confirmed its preliminary determination that JAMP was not a second person for the purposes of s 5(1) of the PM(NOC) Regulations, and the corresponding obligations did not arise unless the second person’s NDS “directly or indirectly compares the drug with, or reference” to “another drug marketed in Canada”. The OPML found that “another drug marketed in Canada” must be interpreted to be specific with respect to strength, dosage form, and route of administration (i.e., it is DIN-specific).” The Minister found that the “indirect” comparison of s 5(1) did not expand the scope of the drugs for which a second person must address the patents listed on the Patent Register beyond the DIN-specific “another drug”. Hence, the HUMIRA 20 mg/0.2 mL pre-filled syringe marketed by AbbVie was not a proper reference product for JAMP’s 40 mg/0.4 mL pre-filled syringe, 40 mg/0.4 mL auto-injector pen, and 80 mg/0.8 mL pre-filled syringe. Accordingly, on January 5, 2022, the Minister issued NOCs to JAMP and JAMP launched its products on April 13, 2022. Subsequently, AbbVie sought judicial review of these two related decisions of the Minister, the result of which is the presently-discussed Federal Court decision. Ultimately, the Federal Court agreed with the Minister. Specifically, the Federal Court concluded that inter alia the following findings by the Minister were reasonable: that the term “another drug” in s 5(1) of the PM(NOC) Regulations is confined to the drug products identified by Health Canada, and that these products must have an identical dosage form, strength, and route of administration to the drug product of the second person. that s 5(1) of the PM(NOC) Regulations applies only where a second person files a submission for an NOC that (1) directly or indirectly compares its drug, or makes reference to “another drug”, (2) that other drug is marketed in Canada under an NOC issued to a first person, and (3) that other drug is a drug in respect of which the first person has submitted a patent list; that a drug that is not marketed is not eligible for the protections under the PM(NOC) Regulations; and that JAMP was not a second person under s 5(1) for the simple reason that AbbVie was not marketing in Canada the HUMIRA drugs that JAMP relied on for its NDS. Conclusion The Minister's decisions, as well as the Federal Court's finding that they were reasonable (pending any appeal), emphasizes one of the statutory objectives of the PM(NOC) Regulations, namely to provide a patent enforcement mechanism only in relation to products that are in fact available to Canadians. This also clarifies certain practical effects of this statutory objective, namely that the enforcement mechanism of the PM(NOC) Regulations is only available to an innovator that markets its innovative drug in Canada, and that s 5(1) of the PM(NOC) Regulations applies only to reference drug products that are identical down to a DIN-specific level with the drug to be approved. However, this does not mean that innovators are entirely without recourse when it comes to drugs they are not marketing in Canada. Under such circumstances, while innovators may not be able to utilize the PMNOC Regulations to prevent a NOC from being issued to a competitor, it can nonetheless commence normal patent infringement proceedings in Federal Court.   A copy of this decision, AbbVie Corporation v. Canada (Health), 2022 FC 1209, is available here.   Our intellectual property team would be happy to help you with any questions you may have regarding the PM(NOC) Regulations.

Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them. These include plants (roots, bark, leaves), micro-organisms (terrestrial and marine), toxins, venoms and other natural biological agents.  In the current race to develop a drug and/or vaccine against COVID-19, natural products or derivatives are surely worth considering as a starting point. The harvesting of natural resources for use by the pharmaceutical industry is usually carried out by partners such as traditional healers, farmers, academics or businesses. Thus, the process usually involves several stakeholders, including providers and users of natural resources and associated traditional knowledge, which are often located in different parts of the world. Fair and equitable collaboration in such a context requires well-developed collaboration agreements and access and benefit-sharing agreements. Various instruments of international law encourage the signing of such agreements, including: The Convention on Biological Diversity (CBD), which recognizes the sovereignty of states over their natural resources. The CBD sets out fundamental principles to regulate access and benefit-sharing, including that access to natural resources, their use and the sharing of benefits arising from them should be based on “mutually agreed terms.”2 The Nagoya Protocol covers the sharing of the results of research and development, the payment of royalties and joint ownership of intellectual property (IP) rights.3 The World Intellectual Property Organization (WIPO) has developed a guide to assist providers and users of natural resources and associated traditional knowledge in the negotiation and establishment of IP clauses in access and benefit-sharing agreements. The guide describes how IP rights can be exploited and managed to achieve the desired objectives, and how the benefits arising from the use can be created and shared in a fair and equitable manner, thereby promoting the conservation and use of biodiversity.4 Furthermore, research and development activities in the pharmaceutical industry are known to be associated with high risk and high investment costs. Indeed, it is widely recognized that the process to develop a drug can take up to 15 years, only about 16% of molecules entering the clinical phase will be approved, and only 1 in 5 marketed drugs generates revenues equal to or greater than the research and development costs involved.5  In the pharmaceutical industry, intellectual property, especially patents and data protection, is thus considered an essential instrument for securing the economic benefits of an innovation. Efforts in this intense period of development of a drug/vaccine against COVID-19 are of course focused on the technical aspects directly related to research and development. Nevertheless, those involved should not lose sight of the importance of collaboration agreements and access and benefit-sharing agreements.  When it comes to natural products in particular, concluding agreements with solid clauses on possible innovations and patents is key for providers of natural resources and traditional knowledge. The same applies to users of these resources and knowledge. We explore some of these clauses below. Initial consideration – deciding whether or not to patent Factors to be considered include the nature and purpose of the project, the expected value of the project results, business objectives, and the ability to manage acquired patents. The decision to apply for a patent, or not to do so, depends largely on whether the benefits of patent protection will outweigh the cost of obtaining it. Confidentiality What information must be kept confidential to ensure that its disclosure does not jeopardize the chances of obtaining patent protection? Agreements should include clear clauses on information management (publication of scientific articles, presentations at conferences, press releases, etc.). The parties may agree to make public disclosures only after mutual approval and the filing of a patent application. Some jurisdictions (Canada, United States, Japan) offer a grace period after a disclosure of the innovation, but for other jurisdictions (Europe, China) there is virtually no such grace period. Where patent protection is desired, the US Provisional Patent Application is a key tool for managing the confidentiality of an innovation under development. Patentability of research and development results While a natural substance as such generally cannot be patented, some results derived from the use of natural resource and associated traditional knowledge can be protected by patent, provided that the innovation is new, useful and not obvious. Parties obtaining the patents Should a general principle applicable to all innovations resulting from the use of natural resources obtained from providers be adopted? Should users have the obligation of reporting all developed innovations? Should they have the obligation of agreeing on the terms for obtaining a patent? Countries where patent protection can be obtained Countries where patents can be obtained are determined by taking into account key markets, strategic locations for drug manufacturing and other considerations, such as the country of origin of natural resources and the traditional knowledge associated to them. Depending on the number of countries ultimately chosen, a strategy involving a Patent Cooperation Treaty (PCT) international application could be considered.  Inventors It is important to name the “real” inventors in a patent application—the validity of the future patent could depend on this. Those who participated only in collecting natural resources or verifying use results may not qualify as inventors. The extent of scientific contribution is one of the main factors to consider. Ownership of future patents The Nagoya Protocol mentions joint (provider-user) ownership of patents as a possible benefit-sharing mechanism. However, companies in the pharmaceutical industry are not keen on this practice. They try to avoid the complications and legal uncertainties associated with joint ownership. Although most countries, including Canada, require the co-owner of a patent to obtain the consent of the other co-owner in order to grant a license, this is not the case in the United States, where a co-owner can grant a license without the consent of the other party and without having to give any justification with respect to royalties or other payments. One commonly adopted solution allows the user to retain ownership of the patent while the provider is granted a royalty-free license. However, some providers consider this option unfair because the patent is not co-owned. In cases of joint ownership, it will of course be necessary to determine how responsibilities will be divided between the provider and user. The parties must decide who will be responsible for filing the patent application and for maintaining the continuing effect of the patent, and who will provide the resources necessary for performing these actions. Patent exploitation What is the most appropriate model for exploiting a patent and disseminating innovation? Which among a license, assignment or joint venture is preferable? Who will negotiate and approve the terms of any subsequent patent exploitation agreement? Should licenses be granted free of charge, or should preferential conditions be granted to entities in the provider’s country or to other partners? Benefit-sharing How, when and between whom will the monetary or non-monetary benefits arising from the commercial exploitation of a patent be distributed? What benefit-sharing mechanisms can be applied in this case? Management of conflicts between provider and user It is important to determine what jurisdiction will apply and how possible conflicts will be resolved (mediation, binding or non-binding arbitration, civil action, etc.). Disputes Only a patent owner can sue for infringement. If the patent is owned only by either the provider or the user, the other party’s cooperation can be negotiated. End of collaboration A collaboration can end for a number of reasons, for example, as a result of problems with the flow of natural resources (volume, quality). What happens to acquired patents then? Conclusion Providers and users of natural resources and associated traditional knowledge should carefully consider their relationship ahead of time. It is very likely that research and development using natural resources will lead to patentable innovations. If there are no plans for patent co-ownership, it is important to include relevant clauses in agreements that ensure a fair and equitable distribution of monetary or non-monetary benefits resulting from the commercial exploitation of patents.   Newman D. et Cragg G., “Natural products as sources of new drugs over 30 years from 1981 to 2014”, Journal of Natural Products (2016), 79.3, 629-661. Convention on Biological Diversity. Nagoya Protocol. World Intellectual Property Organization (WIPO) (2018), A Guide to Intellectual Property Issues in Access and Benefit-sharing Agreements. Report of the Meeting of the Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches (UNEP/CBD/WG-ABS/7/2).