costa rica pharma and biotech patent update aipla spring meeting seattle, washington may 2013 costa...
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Costa RicaPharma and Biotech Patent
Update
AIPLA Spring MeetingSeattle, Washington
May 2013
Costa Rica
Luis Diego [email protected]
Castro & Pal Abogadoswww.castropal.com
Costa Rica
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Costa Ricais also...
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Central
America
Central America
•CAFTA-DR
•Data Exclusivity
•Patent Term Extension
•Others Similar
Variations per country
•US - also bound by CAFTA-DR
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Costa Rica
•Patent Exclusions
•Patent Law
•Biodiversity Law
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Patent Law - Exclusions• Plants - Except through Plant Varieties
Law (UPOV)
• Animals
• Microorganisms as found in nature
• Methods of treatment of Humans or Animals
• Essentially biologic processes for the production of plants or animals, that are not non-biologic or non-microbiologic processes
• Inventions which commercial exploitation must be prevented to protect public order, moral, health, animal and human life or to preserve plants or avoid damage to the environment
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Biodiversity Law - Exclusions
• Sequences of DNA, nucleotides and amino-acids as found in nature or that do not comply with the patentability requirements in the Patent Law
• Natural processes or cycles per se
• Inventions from traditional biological or cultural practices in public domain
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Biodiversity Law
• CONAGEBIO - National Commission for Management of Costa Rican Biodiversity
• Issues required certificate of origin for patents and plant varieties from Costa Rican biodiversity
• May block patents and plant varieties considered to endanger Costa Rican biodiversity
• Excludes human biochemical and genetic material
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Biotech Patents
•Plant Varieties
•Antibodies
•Stem Cells and Other Genetic Material
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Plant Varieties
• Law based on UPOV
• Application
• National Office of Seeds (Ministry of Agriculture)
• Spanish
• Online filing - digitally signed
• Examination - National Office of Seeds or recognized international authorities (Community Plant Variety Office)
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Plant Varieties•Agricultural Exception
•Medium and small farmers may keep plant products from protected variety - only for family sustenance
•Compulsory Licenses
•Public interest - State of emergency
•Shortage of basic needs
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Antibodies
•Allowed - Not as found in Nature (?)
•Description
•Not solely on function
•Sequence
•Affinity of active site
•Pharmacological effect
•CDR must be fully identified
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Stem Cells / Genetic Material
•Allowed - Not as found in Nature (?)
•None Granted Yet
•Should be allowed if complies with novelty, inventive step and industrial applicability
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Pharma Patents
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• Patent Term Adjustments• Data Exclusivity• Patent Linkage• Patent Use
Biologics = PharmaMedicaments/Drugs
Patent Term Adjustment
•Compensates delays from Patent Office or from Health Regulatory Authority (Pharmaceuticals - Marketing Approval)
•Does not compensate delays from applicant
•Available only for patents filed after April 25th 2008
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Patent Term Adjustment
•Patent Office
•Grant > 5 years from application
•Grant > 3 years from examination request (?)
•Regulatory Authorities
•Marketing Approval > 3 years from application
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Patent Term Adjustment
•Adjustment
•One day extension per day of delay
•Maximum of 18 months of extension
•Remaining patent life may not exceed 12 years
•Must be requested within 3 months from patent grant or marketing approval
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Data Exclusivity
•Pharmaceuticals = 5 years
•Available only for new pharmaceuticals
•New = chemical entity not previously approved for marketing in Costa Rica
•Agrochemicals = 10 years
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Data Exclusivity
•Application - Sworn Statement before Notary Public identifying data to be protected
•Third party may request “Provisional Marketing Approval” 12 months prior to expiration for generics or biosimilars
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Biologicals and Biosimilars
•Special Rules for Marketing Approval of:
•Recombinant DNA medicaments
•Hemoderived products
•Vaccines and combines vaccines
•Antivenoms
•Antitoxins of animal origin
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Patent Linkage
• Health Regulatory Authority must publish in its website list of approved pharmaceuticals with info about patents covering product
• Patentee - must give notice of patent existence to Health Regulatory Authority
• Biosimilars and generics must file sworn statement that product is not protected by patent according with list on website
• Controversy may arise when patentee does not apply for marketing approval of product - No Linkage
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Requirement to Use Patent
•All patents must be used within 3 years of grant
•Use = use or commercially exploit product or process in a permanent and stable form
•Pharma - 3 year term from date of marketing approval
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THANK YOU
Luis Diego [email protected]