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