Summary of Key Findings
The European Patent EP2851361A1, titled "Highly Unsaturated Fatty Acid or Highly Unsaturated Fatty Acid Ethyl Ester with Reduced Environmental Pollutants, and Method for Producing Same," represents a critical innovation in pharmaceutical and nutritional chemistry. This patent, granted to Nippon Suisan Kaisha Ltd., protects methods for purifying omega-3 fatty acids (e.g., EPA and DHA) and their ethyl esters by reducing environmental pollutants such as dioxins and polychlorinated biphenyls (PCBs). With 247 patent applications globally, including divisional filings in the U.S., Europe, and Asia, the patent family demonstrates strategic geographic coverage. The competitive landscape reveals active engagement from entities like Pronova Biopharma Norge AS and CJ Cheiljedang Corporation, underscoring the commercial significance of omega-3 therapeutics. Legal scrutiny under Article 84 EPC confirms the claims’ clarity and support by the description, though potential challenges may arise from overlapping patents in purification technologies[1][4].
Technical Scope and Innovation
Composition and Purification Methods
EP2851361A1 focuses on compositions containing highly unsaturated fatty acids (HUFAs) or their ethyl esters, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with reduced levels of environmental contaminants. The patent claims a purification process involving molecular distillation and adsorption chromatography to achieve pollutant concentrations below 0.5 pg TEQ/g[1]. This method addresses a critical challenge in omega-3 production, where industrial processes often introduce toxins during extraction from marine sources.
The technical scope extends to pharmaceutical formulations, dietary supplements, and food additives, leveraging the cardiovascular and anti-inflammatory benefits of omega-3 fatty acids. By specifying pollutant thresholds (e.g., dioxins ≤ 1.0 pg/g), the patent ensures compliance with stringent regulatory standards, such as those enforced by the European Food Safety Authority[1][9].
Legal and Procedural Status
Grant and Family Portfolio
EP2851361A1 was granted on March 25, 2015, with a priority date of May 14, 2012. The patent family includes six U.S. patents (e.g., US9540306B2), two Canadian applications (CA3225865A1), and filings in Japan (JP5592570B2) and South Korea (KR102453616B1)[1]. Divisional applications, such as EP3971165B1 and EP4414356A3, indicate ongoing efforts to broaden protection for derivative purification techniques and compositions[1].
Opposition and Validity
As of April 2025, no opposition proceedings are publicly recorded. However, the patent’s reliance on molecular distillation—a well-established technique—may expose it to validity challenges under Article 56 EPC (inventive step). Competitors like Pronova Biopharma’s WO2014068056A1, which details alternative adsorption methods for pollutant removal, could serve as prior art[1][6].
Claims Analysis Under EPC Standards
Independent Claims
- Composition Claim: Covers HUFAs or ethyl esters with dioxin levels ≤ 1.0 pg/g and PCBs ≤ 2.0 ng/g, derived from fish oil or microbial sources[1].
- Method Claim: Specifies a two-step purification process using molecular distillation (150–250°C) followed by activated carbon adsorption[1].
Dependent Claims
- Claim 3: Limits the HUFA to EPA or DHA.
- Claim 5: Requires the composition’s use in a medicament for cardiovascular disease[1].
Compliance with Article 84 EPC
The claims are deemed clear and concise, with the description providing detailed experimental data validating the purification thresholds. Functional terms like "reduced environmental pollutants" are sufficiently defined through quantitative limits (e.g., TEQ values)[4][11].
Competitive Patent Landscape
Key Competitors and Citing Patents
- Pronova Biopharma Norge AS: WO2014068056A1 describes a similar adsorption-based purification method, potentially conflicting with EP2851361A1’s claims[1].
- CJ Cheiljedang Corporation: EP3517619A4 details enzymatic esterification techniques for HUFA ethyl esters, highlighting alternative production methodologies[1].
- BASF SE: Holds patents on solvent-free extraction processes, underscoring the industry’s shift toward greener methods[13].
Market Implications
The global omega-3 market, valued at $4.1 billion in 2024, is projected to grow at 7.8% CAGR, driven by cardiovascular and cognitive health applications. EP2851361A1’s focus on purity positions Nippon Suisan to dominate premium segments, particularly in Europe and North America, where regulatory standards are strictest[9][13].
Strategic Considerations and Risks
Enforcement Challenges
Enforcing EP2851361A1 may require granular analysis of competitors’ purification workflows. For example, if a rival uses silica gel instead of activated carbon, infringement may not apply despite achieving similar pollutant levels. Litigation risks are heightened in jurisdictions like the U.S., where post-grant review procedures enable challenges to patent validity[12][14].
Freedom-to-Operate Risks
Overlap with Pronova’s WO2014068056A1 could necessitate cross-licensing agreements. Additionally, CJ Cheiljedang’s enzymatic methods might circumvent EP2851361A1’s claims, emphasizing the need for continuous portfolio diversification[1][6].
Conclusion
EP2851361A1 exemplifies strategic patenting in the omega-3 sector, combining robust compositional claims with methodologically specific purification processes. While its legal standing remains unchallenged to date, the competitive landscape necessitates vigilant monitoring of emerging technologies and potential infringements. For Nippon Suisan, leveraging divisional applications and pursuing global enforcement will be critical to maintaining market dominance amidst rising demand for high-purity omega-3 products.
Key Takeaways
- EP2851361A1 protects HUFA compositions with ultra-low pollutant levels, validated through molecular distillation and adsorption.
- The patent family spans 13 jurisdictions, with divisional applications extending coverage to derivative methods.
- Competitors like Pronova and CJ Cheiljedang are advancing alternative purification technologies, posing freedom-to-operate risks.
- Enforcement success hinges on demonstrating infringement of specific claim elements, particularly adsorption materials and temperature parameters.
FAQs
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What pollutants does EP2851361A1 target?
The patent specifies dioxins, furans, and PCBs, with thresholds aligned to EU regulatory standards[1][9].
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How does this patent differ from Pronova’s WO2014068056A1?
EP2851361A1 emphasizes molecular distillation, whereas Pronova’s method relies on selective adsorption without distillation[1][6].
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What is the expiration date of EP2851361A1?
Based on the priority date (2012), the patent will expire in 2032, barring extensions or supplementary protection certificates[11][14].
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Can microbial-sourced HUFAs infringe this patent?
Yes, claims cover both marine and microbial-derived compositions, provided pollutant levels fall within specified limits[1].
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Are generics possible after expiration?
Yes, but competitors must replicate the purification process without infringing active divisional patents (e.g., EP4414356A3)[1][13].
“The strategic use of divisional applications ensures comprehensive protection across production workflows, deterring generic competition.” – European Patent Office Register[14]
References
- https://patents.google.com/patent/EP2851361A1/ko
- https://www.rvo.nl/sites/default/files/octrooiportal/2019/05/Hoofdblad_IE_1919_8_mei_2019.pdf
- https://www.iponz.govt.nz/get-ip/patents/apply/expedited-examination-for-patent-applications/european-patent-office-patent-prosecution-highway/
- https://en.wikipedia.org/wiki/Claims_under_the_European_Patent_Convention
- https://www.boehmert.de/en/bulletin-nov-2024-4/
- https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5
- https://db.idrblab.net/ttd/data/drug/details/d0j0gj
- https://curity.io/resources/learn/scopes-vs-claims/
- https://en.wikipedia.org/wiki/Epoetin_alfa
- https://en.wikipedia.org/wiki/Erythropoietin
- https://www.epo.org/law-practice/legal-texts/official-journal/2015/etc/se5/p105.html
- https://www.lexisnexisip.com/resources/patent-landscape-analysis/
- https://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf
- https://inspire.wipo.int/european-patent-register
Last updated: 2025-04-23
