1. Costa Rica Pharma and Biotech Patent Update AIPLA Spring Meeting Seattle, Washington May 2013 Costa Rica Luis Diego Castro Ldcastro2@castropal.com Castro & Pal Abogados www.castropal.com

2. Costa Rica www.castropal.com

3. Costa Rica is also... Costa Rica www.castropal.com

4. Costa Rica www.castropal.com Central Americ a

5. CAFTA-DR Data Exclusivity Patent Term Extension Others Similar Variations per country US - also bound by CAFTA-DR Costa Rica www.castropal.com

6. Costa Rica Patent Exclusions Patent Law Biodiversity Law Costa Rica www.castropal.com

7. 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 Costa Rica www.castropal.com

8. 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 Costa Rica www.castropal.com

9. 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 Costa Rica www.castropal.com

10. Biotech Patents Plant Varieties Antibodies Stem Cells and Other Genetic Material Costa Rica www.castropal.com

11. 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) Costa Rica www.castropal.com

12. 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 Costa Rica www.castropal.com

13. Antibodies Allowed - Not as found in Nature (?) Description Not solely on function Sequence Affinity of active site Pharmacological effect CDR must be fully identified Costa Rica www.castropal.com

14. 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 Costa Rica www.castropal.com

15. Pharma Patents Costa Rica www.castropal.com Patent Term Adjustments Data Exclusivity Patent Linkage Patent Use Biologics = PharmaMedicaments/Drugs

16. 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 Costa Rica www.castropal.com

17. Patent Term Adjustment Patent Office Grant > 5 years from application Grant > 3 years from examination request (?) Regulatory Authorities Marketing Approval > 3 years from application Costa Rica www.castropal.com

18. 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 Costa Rica www.castropal.com

19. Data Exclusivity Pharmaceuticals = 5 years Available only for new pharmaceuticals New = chemical entity not previously approved for marketing in Costa Rica Agrochemicals = 10 years Costa Rica www.castropal.com

20. 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 Costa Rica www.castropal.com

21. Biologicals and Biosimilars Special Rules for Marketing Approval of: Recombinant DNA medicaments Hemoderived products Vaccines and combines vaccines Antivenoms Antitoxins of animal origin Costa Rica www.castropal.com

22. 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 Costa Rica www.castropal.com

23. 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 Costa Rica www.castropal.com

24. THANK YOU Luis Diego Castro Ldcastro2@castropal.com