Introduction
In decision T2510/18, the European Patent Office's (EPO) Board of Appeal addressed critical issues surrounding the patentability of compounds derived from traditional knowledge and the impact of public morality on patent eligibility under Article 53(a) of the EPC. This case highlights the tensions between traditional knowledge, inventive step, and the moral aspects of patenting natural products.
Summary of the Invention
The patent application in question, EP 2443126, owned by the Institut de Recherche pour le Développement, describes a molecule known as Simalikalactone E (SkE), which is extracted from the plant Quassia amara and has antimalarial properties. The application includes claims for the molecule, a pharmaceutical composition containing it, and a specific isolation process that uses mature, dried leaves of Quassia amara.
Key Aspects of the Decision
Opponent’s Arguments: The opponents, including Danielle Mitterrand Foundation - France Libertés, argued that:
- The patent violated Article 53(a) EPC, asserting that the invention’s use of traditional knowledge without indigenous community consent was contrary to public morality and good practices. They claimed that this patent failed to respect indigenous rights and lacked an equitable benefit-sharing agreement.
- The novelty of the molecule SkE was questioned, citing prior art (documents D2, D3, and D5) involving traditional antimalarial remedies derived from Quassia amara, suggesting these preparations might already contain SkE.
- The inventive step was challenged, asserting that knowledge from traditional remedies reduced the inventive contribution of isolating and using SkE.
Patentee’s Arguments: The patent holder contended that:
- The claimed invention does not contravene Article 53(a) because the SkE molecule, as isolated and used for antimalarial treatment, serves a legitimate public health purpose and is not harmful to public order or morality.
- The molecule SkE is novel because none of the prior art explicitly discloses SkE as a distinct compound; prior art merely describes general preparations from Quassia amara without specific identification of SkE.
- The inventive step is supported by the complex isolation process and the distinct properties of SkE compared to other compounds within Quassia amara, showing a high level of innovation and practical contribution to medicine.
Board’s Analysis and Conclusion:
- On Public Morality (Article 53(a) EPC): The Board ruled that there was no sufficient basis to conclude that the commercial exploitation of SkE as a medication would violate public morality or good practices, especially since no evidence was provided of direct harm to the indigenous communities or their practices. Citing case law such as decision T 356/93, the Board emphasized that patent exclusion under Article 53(a) EPC is based on the invention’s commercial exploitation itself, not on prior research methodologies.
- On Novelty (Article 54 EPC): The Board found the SkE molecule to be novel, ruling that prior art failed to explicitly or implicitly disclose SkE. Although SkE might theoretically be present in traditional Quassia amara extracts, it was not proven to be identifiable or accessible without inventive effort, thus preserving novelty.
- On Inventive Step (Article 56 EPC): The Board upheld the inventive step, acknowledging the patentee’s specific isolation technique for SkE and its therapeutic efficacy, which exceeded general knowledge in traditional remedies. The detailed extraction and purification methods were deemed inventive, and the resulting isolated molecule had unique antimalarial potential not obvious from existing knowledge.
Lessons to be Learned
Respect for Traditional Knowledge: This case emphasizes the importance of obtaining consent and acknowledging the role of indigenous knowledge, particularly when accessing biological resources from local communities. While the EPO's assessment focuses on commercial application rather than acquisition methods, applicants should consider partnerships with indigenous groups and equitable benefit-sharing agreements to strengthen ethical aspects of their applications.
Public Morality and Patent Law: Decision T 2510/18 clarifies that for an invention to be excluded under Article 53(a), its commercial use must inherently conflict with public morality or order. This decision reinforces a narrow interpretation of Article 53(a), focusing on the invention’s market impact rather than the research approach taken by the applicant.
Inventive Step and Novelty in Biologically Derived Compounds: For patents based on natural products, explicit and precise isolation and characterization methods are critical to establish novelty and inventive step. This decision illustrates the high threshold for opponents to disprove novelty based on the hypothetical presence of compounds in traditional formulations without direct evidence of prior access or disclosure.
Documentation and Evidence Standards: The Board’s decision underscores the importance of substantial evidence when challenging novelty, especially in cases involving compounds derived from traditional plants. Opponents need clear analytical proof of a claimed compound's existence in the prior art to successfully argue a lack of novelty.
Conclusion
Decision T 2510/18 is a reminder for patent applicants of the complex interplay between patent law, ethics, and traditional knowledge. It also offers valuable guidance on the importance of evidence and specificity in patents involving biological and natural resources. This case reinforces the need for robust documentation in disputes and highlights a cautious approach to applying public morality restrictions under Article 53(a).
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Legal Disclaimer
The information provided in this blog post is for generalinformational purposes only and does not constitute legal advice. The summary and analysis of the EPO case are based on publicly available information and are intended to offer insights into the decision and its implications. This content should not be used as a substitute for professional legal advice tailored to your specific circumstances. For advice related to any specific legal matters, you should consult a qualified attorney.