Soteria Biosciences
Foreign Filing Considerations
Novelty
*Claimed subject matter must be NEW
*Not be in the prior art (either directly or inherently), public use or known by others
Novelty Requirements
*Publication of inventor’s own work before filing can destroy novelty
*Disclosures made in confidence usually will not constitute prior art (non-disclosure agreements)
*Grace period different for different countries
Novelty in view of NuHumor
High Omega-3/Omega-6 Oil (high oil)
*Inherent Disclosure Issues from NuHumor
*Composition
*Methods of extracting the Oil
*Uses/Methods Of Use
Novelty in view of NuHumor Cont.
NoPainNoGain
*Process of extracting the HBD/isoprenoid fraction
*Use of plant to obtain fraction
*Extracted Composition
*Use to treat pain without weight gain
Soteria Provisional Filings
*Rolling provisional applications
*Article 4 of Paris Convention-right of priority
-Co-pending provisionals can destroy EP priority claim
-Problematic with intervening prior art
Absolute Novelty
*Countries with absolute novelty-filing date before any prior disclosure anywhere in the world, including by inventor
*Grace periods under certain conditions (relative novelty)
Foreign Filing Options
Where to File?
Direct National Filing
*If only small number of countries may be less expensive
*Limit third-party notifications
*Disadvantage-each application independently examined
*Some countries not PCT contracting states and thus need to file directly--TW
PCT*Allows protection simultaneously in a large
number of countries by filing an international application
*Have up to 18 months more than non-PCT filings to determine countries to proceed in
*PCT application cannot be rejected on formal grounds by any designated office during the national phase
*ISR/WO
*Publication creates prior art for others
Regional Filings
*European Patent Office
-National validation vs. UPC
*ARIPO (African Regional Industrial Property Organization)
*OAPI (African Intellectual Property Organization)
*EAPO (Eurasian Patent Organization)
*Translation cost savings
*Substantive examination regionally
Foreign Filing License Requirements
*US
*Taiwan/Argentina
*Italy
*China
Some Specific Country Information
*India-no method of treatment or use claims; no methods of agriculture or horticulture
-Section 3(d) India Patent Act
*China-claims tend to be limited to working examples; Article 20
*Brazil-ANVISA issue
*Colombia/Argentina –treatment claims and secondary/formulation cases severely limited
Costs and Market Considerations
*PCT vs. Direct and Regional filings
*Major manufacturing locations including for competitors
*How large the market is for a particular country