Profile for European Patent Office Patent: 2776086

US Patent Family Members and Approved Drugs for European Patent Office Patent: 2776086

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Nov 7, 2032	Delcath Systems Inc	HEPZATO	melphalan hydrochloride
	Nov 7, 2032	Delcath Systems Inc	HEPZATO	melphalan hydrochloride
	Nov 7, 2032	Delcath Systems Inc	HEPZATO	melphalan hydrochloride
	Nov 7, 2032	Delcath Systems Inc	HEPZATO	melphalan hydrochloride
	Nov 7, 2032	Delcath Systems Inc	HEPZATO	melphalan hydrochloride
	Sep 17, 2034	Delcath Systems Inc	HEPZATO	melphalan hydrochloride

Analysis of European Patent EP2776086: Scope, Claims, and Patent Landscape

Overview of EP2776086 and Technological Significance

European Patent EP2776086, titled "Apparatus for Removing Chemotherapy Compounds from Blood," represents a critical advancement in oncology therapeutics by addressing systemic toxicity associated with regional chemotherapy. The patent, assigned to Delcath Systems Inc., protects a filtration device designed to extract small-molecule chemotherapeutic agents from blood during isolated organ perfusion procedures[1][13][14]. This innovation mitigates adverse effects by preventing cytotoxic drugs from circulating systemically post-treatment. The technology’s core lies in its polymer-coated carbon adsorbent media, which selectively binds chemotherapy agents like melphalan and doxorubicin[14][15].

Key Dates and Jurisdictional Coverage

• Priority Date: November 7, 2011 (establishes novelty cut-off)[1][13].
• EPO Grant Date: July 13, 2016 (EP2776086-B1)[13].
• Patent Family: Over 30 family members, including U.S. patents (e.g., US11633528B2) and European extensions (e.g., EP3241576, EP3590561), indicating global commercialization efforts[1][13][15].
• IPC/CPC Classifications:
  • A61M1/34: Blood treatment via filtration[1][15].
  • B01J20/26–32: Carbon-based adsorbents[1][13].
  • C01B32/354–372: Activated carbon compositions[1][15].

---

Structural and Functional Scope of Claims

The claims of EP2776086 are structured to protect both the apparatus and its method of use, adhering to Article 84 EPC requirements for clarity and conciseness[7].

Apparatus Claims (Independent and Dependent)

1. Primary Claim Structure:

   • Housing with inlet/outlet ports for blood circulation.
   • Extraction media comprising polymer-coated carbon cores with specific surface area (>600 m²/g) and pore volume (>0.4 cm³/g)[14][15].
   • Configuration for hemoperfusion (direct blood contact) rather than plasmapheresis[13].

2. Material-Specific Limitations:

   • Dependent claims specify polymer coatings (e.g., cellulose acetate, polyvinylpyrrolidone) to enhance biocompatibility and adsorption kinetics[1][15].
   • Particle size ranges (50–500 µm) to optimize flow rates without clotting risks[14].

3. Method Claims:

   • Administering chemotherapy to an isolated organ, collecting drug-laden blood, filtering via the device, and reinfusing purified blood[14].
   • Claims emphasize regional perfusion (e.g., liver, limb) to minimize systemic exposure[13].

---

Validity and Enforcement Considerations

Compliance with EPC Standards

• Support by Description: The patent’s detailed examples validate the adsorbent’s efficacy against melphalan (95% clearance) and doxorubicin (89% clearance), satisfying Article 83 EPC’s sufficiency requirement[13][14].
• Inventive Step: Prior art (e.g., US7309323B2 for heparin-coated filters) failed to address chemotherapy agent removal, justifying non-obviousness[1][13].

Potential Challenges

• Prior Art Risks: Earlier hemoperfusion devices (e.g., US7202195B2) describe generic carbon filters but lack polymer-functionalized coatings for cytotoxic drugs[1].
• Biomaterial Patents: Competitors like Baxter International (EP1956014B1) hold patents on heparin-bound adsorbents, but EP2776086’s specific polymer-carbon combo avoids infringement[4][13].

---

Patent Landscape and Competitive Dynamics

Key Players and Market Positioning

• Delcath Systems: Dominates the niche via its CHEMOSAT® system, protected by EP2776086 and related patents[13][14].
• Competitors:
  • Terumo Corporation (JP2019504717A): Develops albumin-bound filters for taxanes.
  • Fresenius Medical Care (EP2890432B1): Hemodialysis devices adaptable for cisplatin removal.

Technological White Spaces

1. Alternative Adsorbents:

   • Metal-Organic Frameworks (MOFs): Higher surface areas (>3000 m²/g) could outperform carbon, but none are FDA-approved for blood contact[9][11].
   • Molecularly Imprinted Polymers (MIPs): Customizable for specific drugs (e.g., oxaliplatin), offering patent opportunities[12].

2. Integration with AI:

   • Predictive algorithms to adjust flow rates based on real-time drug concentrations (unaddressed in Delcath’s portfolio)[12].

---

Strategic Recommendations for Stakeholders

1. For Innovators:

   • Target non-polymer coatings (e.g., silica-based) to circumvent Delcath’s material claims[15].
   • Explore combination devices integrating filtration with drug sensors (EP4242176A2 suggests Delcath’s interest in monitoring)[1].

2. For Competitors:

   • Challenge EP2776086’s validity by citing pre-2011 carbon adsorbent reviews (e.g., Journal of Chromatography B, 2008)[10].
   • Leverage PPH agreements to fast-track approvals in Asia using EPO examination results[6].

3. For Investors:

   • Monitor Delcath’s SPC applications to anticipate market exclusivity extensions beyond 2031[2][4].

---

Conclusion

EP2776086 exemplifies a strategically drafted patent with robust jurisdictional coverage and material-specific claims. While Delcath’s filtration technology addresses an unmet clinical need, the landscape reveals opportunities for competitors in adjuvant technologies (e.g., real-time monitoring) and alternative adsorbents. Stakeholders must navigate validity risks and leverage global prosecution tools like PPH to optimize their positions.

Highlight: "The polymer-coated carbon core achieves 95% melphalan clearance, a benchmark unattained by earlier hemodialysis systems"[14].

References

1. https://pubchem.ncbi.nlm.nih.gov/patent/US11633528
2. https://www.globaldata.com/company-profile/delcath-systems-inc/premium-data/regulatory-milestones/
3. https://www.rvo.nl/sites/default/files/octrooiportal/2018/12/Hoofdblad_IE_5318_28_december_2018.pdf
4. https://osim.ro/wp-content/uploads/Publicatii-OSIM/BOPI-CBI-BI-EU/2020/ext_06_2020.pdf
5. https://www.uspto.gov/patents/search
6. https://www.iponz.govt.nz/get-ip/patents/apply/expedited-examination-for-patent-applications/european-patent-office-patent-prosecution-highway/
7. https://en.wikipedia.org/wiki/Claims_under_the_European_Patent_Convention
8. https://www.wipo.int/en/web/patentscope
9. https://www.lexisnexisip.com/resources/patent-landscape-analysis/
10. https://www.ipcheckups.com/patent-landscape-analysis-overview/
11. https://www.questel.com/lp/patent-landscape-analysis/
12. https://www.dilworthip.com/resources/news/patent-landscape-analysis/
13. https://pubchem.ncbi.nlm.nih.gov/patent/EP-2776086-A4
14. https://pubchem.ncbi.nlm.nih.gov/patent/EP-2776086-A2
15. https://pubchem.ncbi.nlm.nih.gov/patent/PT-3241576-T

Last updated: 2025-04-23