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Globally Protecting Intellectual Property for Emerging Companies

CHOOSING THE IMPORTANT COUNTRIES: 

CHOOSING THE IMPORTANT COUNTRIES U.S. EUROPEAN JAPAN CHINA (ASIA) INDIA CANADA AUSTRALIA KOREA ISRAEL MAINTENANCE FEES

THE ONE SIZE FITS ALL PATENT: 

THE ONE SIZE FITS ALL PATENT U.S. Description issues Limitations on drug claiming Disclosure of prior art Limitation on medical uses Amending specification Markush Table Provisos – thinking negatively Checking the Box U.S. Provisional Application Legal and technical experience

GLOBALLY PROTECTING INTELLECTUAL PROPERTY FOR EMERGING COMPANIES: 

GLOBALLY PROTECTING INTELLECTUAL PROPERTY FOR EMERGING COMPANIES Typical Emerging Company: Limited resources Uncertain Market for Product Product in Early Stages of Development Efficacy of Product May be Uncertain Most companies do not want to spend large sums researching prior art, patentability or global marketability of product at the early stages when patent protection must be sought

BASIC STRATEGY AT EARLY STAGES OF PATENT PROSECUTION -- 2 Prongs --: 

BASIC STRATEGY AT EARLY STAGES OF PATENT PROSECUTION -- 2 Prongs -- Lay groundwork for protecting as broad a scope of patent protection as possible Defer costs of patent filing and prosecution for as long as possible to allow client: To raise money to support invention To determine whether invention is marketable To determine where the market will be for the product

MOST IMPORTANT CONSIDERATION AT EARLY STAGES OF PATENT PROSECUTION : 

MOST IMPORTANT CONSIDERATION AT EARLY STAGES OF PATENT PROSECUTION Manage client expectations regarding costs! Many clients are unaware of the costs of obtaining patent protection Internationally Costs can escalate exponentially as prosecution progresses Filing Fees for Various Stages of International Patent Prosecution: U.S. Provisional Application $80 (small entity) U.S. Utility Application $395 PCT International Application $1,000-2,000 National Stage Application $500-5,000 (per country) European Validation $50,000 -500,000 (all countries) Estimates do not include fees for professional legal services

RECOMMENDED COURSE OF PROTECTION FOR INVENTION MADE IN U.S.: 

RECOMMENDED COURSE OF PROTECTION FOR INVENTION MADE IN U.S. Provisional U.S. Patent Application “Conversion” at 1 Year Anniversary of Provisional (a) Regular U.S. Utility Application (b) PCT International Application (c) Direct National Applications in Selected non-PCT countries PCT National Phase (30 months from Provisional filing) Regular Applications in all Desired PCT countries, depending on corporate finances and projected markets

PROVISIONAL U.S. PATENT APPLICATION: 

PROVISIONAL U.S. PATENT APPLICATION Defers prosecution for 1 year before filing regular U.S. Utility Application Establishes priority for all foreign countries that are members of the Patent Cooperation Treaty and most other foreign countries Can be filed without claims Caveat: some cases suggest that certain European countries may not uphold priority to Provisional Applications that do not have claims

CONSIDERATIONS FOR PROVISIONAL APPLICATIONS: 

CONSIDERATIONS FOR PROVISIONAL APPLICATIONS Provide as much detail as possible Draft set of claims of broad, intermediate and narrow scope; then make sure specification provides written description and enablement for the entire range of claims, anticipated alternatives and generally for a range of equivalents Non-U.S. countries often require more literal support for claims than U.S., especially Asian countries

CONSIDERATIONS FOR PROVISIONAL APPLICATIONS (Con’t): 

CONSIDERATIONS FOR PROVISIONAL APPLICATIONS (Con’t) Patent Offices in many countries don’t permit, e.g. provisos by amendment without written description support for proviso One solution we use is “Markush Table” Clients often want to skimp on the Provisional Application, but this can lead to problems later if inadequate support for claims or if scope of invention changes To keep costs down: Work together with client to identify areas that they can write or prepare, such as Invention Background and Experimental Examples Sections Have client provide prior art references and summary of relevance for practitioner’s use when drafting the application

“Conversion” at 1 Year Anniversary of Provisional: 

“Conversion” at 1 Year Anniversary of Provisional A. Regular U.S. Utility Application If Provisional was well-prepared, there should be little to do at this point; if not get it into good shape as described above Make sure any new data generated in the past year is added to the application

“Conversion” at 1 Year Anniversary of Provisional (Con’t): 

“Conversion” at 1 Year Anniversary of Provisional (Con’t) B. PCT International Application All PCT contracting states are now automatically designated For modest cost, gives additional 18 months before entering filing Non-U.S. National Phase Applications PCT Application is not examined, but now get International Search, Preliminary Examination Report and Opportunity to Amend before entering National Phase International Search can be more thorough than U.S. Strategic consideration: List most important claims first; if there is a Unity of Invention Objection at the International Stage (equivalent to a restriction requirement), only the first claimed invention will be searched

“Conversion” at 1 Year Anniversary of Provisional (Con’t): 

“Conversion” at 1 Year Anniversary of Provisional (Con’t) C. Direct National Applications in Selected Non-PCT Countries Most countries are members of the PCT New countries are continually being added, so get a current list

“Conversion” at 1 Year Anniversary of Provisional (Con’t): 

“Conversion” at 1 Year Anniversary of Provisional (Con’t) Non-PCT Contracting States (as of 12-04) Argentina Bahamas Bahrain Bangladesh Bermuda Bolivia Brunei Cayman Islands * Chile Dominican Republic El Salvador GCC (Gulf Co-op Council) Guatemala Honduras ** Hong Kong (usually file registration based on EP or CN, so not necessary to file separate application in Hong Kong) ** Indicates most important/frequently filed * Indicates secondary importance/less often filed ?? Becoming more important; more companies considering Iran Iraq Jamaica Jordan Kuwait Lebanon Libya Malaysia - ?? Malta Nepal Nigeria Pakistan - ?? Panama Paraguay * Peru Saudi Arabia Syria ** Taiwan Thailand * Venezuela

PCT National Phase (30 months from Provisional filing) Regular Applications in All Desired PCT Countries: 

PCT National Phase (30 months from Provisional filing) Regular Applications in All Desired PCT Countries Deadline for Filing Applications in each Country and paying filing fees of typically $2,000-5,000 per country Prosecution will usually begin shortly thereafter, based on the patent laws of each country, but may be deferred for several years (e.g. Japan) Begin to incur foreign associate fees for legal services Includes EP (see procedure below) By this time, company should have better idea as to marketability of product in various countries; should have developed a global marketing strategy and raised capital

Currently 124 PCT Contracting States: 

Currently 124 PCT Contracting States EP Albania Austria Belgium Bosnia and Herzegovina Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Hellenic Republic (Greece) Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Monaco Netherlands Poland Portugal Romania Serbia and Montenegro (formerly known as the Federal Republic of Yugoslavia) Slovakia Slovenia Spain Sweden Switzerland & Liechtenstein The former Yugoslav Republic of Macedonia Turkey United Kingdom Top Tier (non-EP) Australia Canada China Israel Japan New Zealand Russian Federation Republic of Korea Second Tier Brazil Colombia Egypt India Indonesia Mexico Philippines Singapore South Africa United Arab Emirates Third Tier Algeria Antigua and Barbuda Armenia Azerbaijan Barbados Belarus Belize Benin Botswana Burkina Faso Cameroon Central African Republic Chad Congo Costa Rica Côte d'Ivoire Cuba Democratic People's Republic of Korea Dominica Ecuador Equatorial Guinea Gabon Gambia Georgia Ghana Grenada Guinea Guinea Bissau Kazakhstan Kenya Kyrgyzstan Lesotho Liberia Madagascar Malawi Mali Mauritania Mongolia Mozambique Namibia Nicaragua Niger Oman Papua New Guinea Republic of Moldova Saint Lucia Saint Vincent and the Grenadines San Marino Senegal Serbia and Seychelles Sierra Leone Sri Lanka Sudan Swaziland Syrian Arab Republic Tajikistan Togo Trinidad and Tobago Tunisia Turkmenistan Uganda United Republic of Tanzania Uzbekistan Viet Nam Zambia Zimbabwe

European Patent Protection: 

European Patent Protection Can file direct National applications in each country More typically, file EP patent application (by designation on PCT) Single application is searched and examined by the european patent office Examination costs and legal fees reduced Once patent granted by EPO, must be validated in each country where protection is desired ($$$), but these costs are deferred until AFTER patent is granted Validation costs include filing fees and translation into National language of each country China Patent

Our Global Reach: 

Our Global Reach Los Angeles Orange County Atlanta Stamford New York Tokyo London Hong Kong Shanghai Paris San Diego San Francisco Washington Brussels Beijing

Our Offices: 

For further information, you may visit our home page at www.paulhastings.com or email us at info@paulhastings.com. Our Offices EUROPE Brussels Avenue Louise 480, Boîte 5B 1050 Bruxelles Belgium Telephone: +32 2 641 7460 Facsimile +32 2 641 7461 Paris 30, avenue de Messine 75008 Paris France Telephone: + 33 1 42 99 04 50 Facsimile: + 33 1 45 63 91 49 London 88 Wood Street London EC2V 7AJ United Kingdom Telephone: + 44 207 710 2000 Facsimile: + 44 207 796 2233 NORTH AMERICA Atlanta 600 Peachtree Street, N.E. Atlanta, GA 30308 Telephone: + 1 404 815 2400 Facsimile: + 1 404 815 2424 Los Angeles 515 S. Flower Street Los Angeles, CA 90071 Telephone: + 1 213 683 6000 Facsimile: + 1 213 627 0705 New York 75 East 55th Street New York, NY 10022 Telephone: + 1 212 318 6000 Facsimile: + 1 212 319 4090 Orange County 695 Town Center Drive Costa Mesa, CA 92626 Telephone: +1 714 668 6200 Facsimile: +1 714 979 1921 ASIA Beijing Suite 2406 2410 China World Tower 2 No. 1 Jian Guo Men Wai Avenue Beijing, 100004 China Telephone: +86 10 6505 3383 Facsimile: +86 10 6505 3459 Hong Kong 22/F Bank of China Tower 1 Garden Road Hong Kong Telephone: +852 2867 9988 Facsimile:+ 852 2868 1017 Shanghai 2301 Hong Kong New World Tower 300 Huai Hai Middle Road Shanghai, 200021 China Telephone +86 21 6335 3930 Facsimile +86 21 6335 3940 Tokyo 27F Ark Mori Bldg 12 32 Akasaka 1-Chome Minato-Ku, Tokyo 107 6027, Japan Telephone: +81 3 3586 4711 Facsimile: +81 3 3586 4705 San Diego 3579 Valley Centre Drive San Diego, CA 92130 Telephone: +1 858 720 2500 Facsimile: +1 858 720 2555 San Francisco 55 Second Street, 24th Floor San Francisco, CA 94105 3441 Telephone: +1 415 856 7000 Facsimile: +1 415 856 7100 Stamford 1055 Washington Boulevard Stamford, CT 06901 Telephone: +1 203 961 7400 Facsimile: +1 203 359 3031 Washington, D.C. 1299 Pennsylvania Avenue, N.W. Washington, D.C. 20004 Telephone: +1 202 508 9500 Facsimile: +1 202 508 9700