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