Today, the World Intellectual Property Organization (“WIPO”) finished the preparatory session for the draft International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources (the “Instrument”), which will be discussed and adopted at a diplomatic conference in 2024.

At the heart of the Instrument is the introduction of a new disclosure obligation for companies seeking to apply for patents for inventions that are “materially/directly based on” genetic resources (“GRs”) and associated traditional knowledge (“TK”).  Such companies will potentially need to disclose information regarding the source or origin of the GRs and associated TK as part of the patent application.  Failure to do so may lead to the refusal of the patent application.

Attempts to introduce a similar disclosure regime were first made under the TRIPS Agreement in 2008, and then later during the negotiations on the Nagoya Protocol for access and benefit-sharing from GRs, where the introduction of “compliance checkpoints and mandatory transparency disclosure information requirements” was ultimately unsuccessful.  Nevertheless, these type of disclosure obligations have since been introduced under nearly 30 national regimes, such as in India, Spain and Switzerland.  The WIPO Instrument now intends to introduce such a disclosure obligation globally, and potentially, non-compliance may be sanctioned with the possibility of a patent application being refused.

In this blog we summarize some of the key provisions of relevance to companies.

Scope of the new disclosure mechanism

The new disclosure mechanism explicitly covers the following three groups:

  • Genetic Resources” – meaning “any genetic material of actual or potential value.”  This definition is aligned to the one provided in the Convention on Biodiversity (“CBD”), and presumably excludes human genetic resources. 
  • Associated Traditional Knowledge” – currently the Instrument provides three different definitions, placing the accent on the traditional knowledge of the GRs being developed over time by indigenous people(s) and local communities, and where the new invention would not have been possible to create without the use of the TK.
  • GRs obtained in areas beyond national jurisdiction – notably, the new regime could potentially apply also to GRs obtained in areas beyond national jurisdiction, such as marine GRs obtained at the high seas.

One question not addressed by the Instrument is whether it also covers Digital Sequence Information (“DSI”) of GRs.  While “DSI” is not explicitly mentioned in the current draft of the Instrument, older proposed drafts explicitly required that the applicant has access to the “physical samples” of GRs.  However, this text was ultimately removed due to differing views and leaving the question open.  This uncertainty could potentially also be explained by the fact that the Global Mechanism for benefit-sharing from the use of DSI is currently being created after COP 15, and the WIPO may wish to align with the new mechanism and their definition of DSI.

When is the obligation to disclose triggered?

One of the major unsolved issues by the current draft Instrument is the lack of a clear trigger. Due to diverging views by WIPO’s members, the Instrument currently states that the obligation to disclose will be triggered only when the invention is “materially / directly based on” GRs or Associated TK.  This means that the GRs and / or Associated TK must “have been necessary or material to the development of the claimed invention, and that the claimed invention must depend on the specific properties of the GRs and/or Associated TK.”

In essence, this trigger indicates that there must be a causal link between the invention and the GR, meaning information only for those GRs without which the invention could not be made, should be disclosed.  An obvious concern to companies may be the use of research tools, such as animals and plants, yeasts, bacteria, plasmids, and viral vectors  which would be considered GRs.  However, according to the explanatory notes to the draft Instrument, GRs which may be involved in the development of the invention, but which are not material to the claimed invention, should not trigger the disclosure requirement.  This, it states, includes in particular research tools, which are often standard consumables and can be purchased from commercial suppliers. They do not form part of the claimed invention, and therefore need not be disclosed.

Notably, the instrument foresees justifiable exceptions and limitations to the disclosure regime for special cases laid down at national level to protect the public interest.  The text however remains silent and there is no further guidance by way of explanatory note, whether this should cover public health emergencies, thus leaving the issue open whether patent applications for vaccines, therapeutics and diagnostics based on pandemic pathogens will be covered.

What needs to be disclosed?

Once the obligation has been triggered, applicants will need to disclose:

  • either the “country of origin of the GRs” / “the indigenous peoples or local community that provides the Associated TK”; or
  • if this information is not available to the applicant – the “source of the GRs” / “source of the Associate TK”.  

The Instrument defines “Source of the GRs” as:

any source from which the applicant has obtained the GRs, such as a research centre, gene bank, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of GRs (emphasis added),

while “Source of Traditional Knowledge Associated with Genetic Resources” is defined as:

any source from which the applicant has obtained the traditional knowledge associated with genetic resources, such as scientific literature, publicly accessible databases, patent applications and patent publications (emphasis added).

These definitions are very broad and provide a non-exhaustive lists as to from where GRs and associated TK may have been sourced.

If none of this information is available, the applicant may produce a declaration to that effect, which will allow companies to still apply for patents if for justified reasons the relevant information is not known to them.  However, this is an exception and applied in very exceptional circumstances, e.g., the origin of the GRs cannot be identified anymore due to the relevant documents having been destroyed by force majeure.

Once disclosed, patent offices will not have the obligation to verify the authenticity of the information.  However, since this information will be made publicly available in accordance with national patent procedures, and a special “Information system” on GRs and associated TK will be created under the Instrument, such disclosures could still trigger Access and Benefit-Sharing (“ABS”) compliance reviews.

Consequences of a failed disclosure?

The new mechanism poses one crucial question:

Would patents be refused if applicants fail to disclose the required information?

The short answer is – it will depend on the implementation into national law. 

Contracting Parties will put in place “appropriate, effective and proportionate legal, administrative, and /or policy measures”, which could include pre-grant sanctions (e.g., suspending the further processing of a patent application until the disclosure requirement is met, withdrawing/lapsing the application if the applicant fails or refuses to provide the minimum information, etc.) or post-grant sanctions (e.g., fines for wilfully failing to disclose the required information, publication of judicial rulings, etc.).

However, the Instrument at least explicitly states that patents, which have already been granted, cannot be rendered unenforceable solely on the basis of the applicant’s failure to disclose the information, unless the applicant had fraudulently failed to make the disclosure.

Other questions that remain open

There are further aspects of the proposed regime that remain unanswered.  What will be the implication of the patent disclosure formality requirement to the substantive patentability analysis carried out by the patent offices?  One of the underlying objectives of the Instrument is to not grant patents erroneously for inventions that are not novel or inventive with regard to GRs and Associated TKs, thereby improving legal certainty and patent quality.  However how will the information that is disclosed by the applicant be used during the prosecution process? The Instrument provides no guidance beyond the formalities requirements.  The disclosure may though impact on prior art and inventorship/co-inventorship, in particular in jurisdictions where prior art disclosure requirement exist and where correct inventorship can impact patent enforceability.

How confidentiality will be dealt with is another open question.  According to the draft Instrument, the patent office needs to make the disclosed information available in accordance with patent procedures, however this is without prejudice to the protection of confidential information.  It will be interesting to see what justification is required from the patent applicant for the relevant patent office to preserve confidentiality.  Interestingly,  no further discussion of this provision is provided in the draft Instrument.

Next steps

The Instrument will be discussed and potentially adopted at a diplomatic conference in 2024 by all WIPO members.  WIPO has currently 193 members, and, while the European Union, as a single entity, is not a member, each EU member state is a member of WIPO.  Once the text is adopted, it will be open for signatures and enter into force three months after 20 countries have signed it.  

At this stage, it is not expected that the Instrument will have retroactive application, however, given the long duration of research and development needed in some life sciences sectors, companies are advised to consider some measures already at this point.  If you find that the Instrument may affect your business, due diligence activities relating to ABS under the Nagoya Protocol may be helpful.

Covington’s unique practices on Access and Benefit-Sharing from Biodiversity and IP law stand ready to assist you.

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.

Photo of Yuliya Gevrenova Yuliya Gevrenova

Yuliya Gevrenova is an associate in the Life Sciences Practice Group.

She advises clients across a wide range of regulatory, compliance and procedural issues in the food and pharmaceutical sectors, focusing on EU and Public International regulatory advice.

Inga-Marlene Pietsch

Inga-Marlene Pietsch is an intellectual property lawyer in Covington’s Life Sciences Transactions team assisting clients in protecting and enforcing their most valuable assets. She works closely with other teams across the firm in particular the Corporate and Regulatory teams.

Inga has an extensive…

Inga-Marlene Pietsch is an intellectual property lawyer in Covington’s Life Sciences Transactions team assisting clients in protecting and enforcing their most valuable assets. She works closely with other teams across the firm in particular the Corporate and Regulatory teams.

Inga has an extensive contentious and non-contentious IP practice advising companies from the Life Sciences and Technology sectors on complex IP issues with a particular focus on patents. Her previous experience in patent litigation gives Inga a unique perspective on IP issues that arise.

Inga’s clients include start-up companies as well as large corporations advising throughout the company life cycle.

Inga regularly advises clients on:

  • IP aspects in transactions
  • IP strategy and landscaping
  • Third party IP risk assessments
  • IP ownership and entitlement
  • IP validity assessments
  • Cross-border IP issues
  • Supplementary Protection Certificates

Inga also advises clients on managing and protecting their trade secrets and confidential information, assisting clients in auditing and identifying their trade secrets and putting procedures and processes in place to establish good trade secrets and confidential information handling practices.

Prior to her legal career Inga completed a PhD in Organic Chemistry and worked for a custom synthesis start-up company.

Photo of Max Jerman Max Jerman

Max Jerman is an associate in the Life Sciences Practice group. Max advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU and Italian regulatory advice. He is a native…

Max Jerman is an associate in the Life Sciences Practice group. Max advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU and Italian regulatory advice. He is a native Italian and Slovenian speaker.