© 2011 Leonardos & Licks Latest Developments of the Brazilian Patent System Prepared for the 2011 Tongji Global Intellectual Property Forum Otto Licks Partner; Former Adjunct Professor at George Washington Law School and advisor to the Brazilian government on the implementation of the WTO TRIPS Agreement

Brazil is the 5th largest country in the world (larger than the continental U.S.), but +/- 200M people China and Brazil have a long relationship with no problems in the far past, recent past or present China is Brazil’s # 1 client for exports The U.S. was the first country to recognize Brazil’s independence from Portugal. Brazil has been a republic since 1889 with a legislature called National Congress (Senate and House of Representatives) Brazil is an original signatory of the Paris Convention and its patent law dates from 1809 Brazil is a founding member of the United Nations, OAS, GATT, WTO, etc Host for the World Cup of 2014 and Olympic games of Carnival happens once a year… The Federative Republic of Brazil 2 | © 2011 Leonardos & Licks

Brazilian Public-Private Partnerships PPP 3 | © 2011 Leonardos & Licks Brazilian IP system – Take a look…

International treatise are law of the land if signed and approved by the Brazilian Congress: Paris Convention, Bern Convention, WTO-TRIPS, etc. Domestic municipal legislation with TRIPS-Plus standards: Industrial Property Law, of 1996: patents of invention and utility models; industrial design; trademark; repression of false geographical indications; and the repression of unfair competition. Copyright and Neighboring Rights Law, of 1998 Computer software protection law, of 1998 Several other statutes, such as Microchips, Plant Variety (UPOV); Genetic Resources, Traditional Knowledge & Folklore, Data Exclusivity Protection, etc… Brazilian Public-Private Partnerships PPP 4 | © 2011 Leonardos & Licks Brazilian IP system – laws in the books

5 | © 2011 Leonardos & Licks Legal systems in Brazil Brazil has two independent judicial systems: Federal and State. Unlike in the U.S., patent infringement cases are brought in the State courts. Patent invalidity lawsuits are only brought before the Federal courts. During litigation there no U.S.-style trials, but rather a series of short hearings, more like Japan, each of no longer than a day. It is common practice to submit expert witness opinions and affidavits. Invalidity is a statutory defense. However, any decision from a infringement lawsuit on validity issues only affects the parties. It does not render the patent invalid vis a vis third parties (erga omnes). The patent holder has the right to seek injunctive relief and damages. Injunctive relief can be obtained at the beginning of the litigation, via an ex parte ruling, or at any time before the end of the trial. Evidence is generally available to plaintiffs, although Brazil does not have U.S.-like discovery. There is a reversal on the burden of proof for infringement of method claims. Severe provisions against grey market goods and no international exhaustion. China might be able to export, but Brazil cannot import…

6 | © 2011 Leonardos & Licks 15 years of patent protection 1994 The WTO TRIPS Agreement was implemented into the Brazilian legal system (Decree 1,355) Mailbox applications (without implementation of section 70.2 of the WTO TRIPS Agreement) Pipeline patents (extra time to claim priority, same novelty in addition to commercial novelty) Pharmaceutical products and processes as patentable subject matter (Law 9,279): No patents for medical treatment or diagnostic (Art. 10, VIII); No patents for natural living organisms, biological material (even if isolated), and natural biological processes (Art. 10, IX); No patents for parts or whole living beings, except for genetically modified microorganisms and plants (Art. 18, III). Statutory doctrine of equivalence, no international exhaustion, infringement as criminal felony. 1999Regulatory review exception and political prior approval for pharmaceutical patents (Law 10,603) taking public health and economic factors in consideration. 2002Brazilian PTO guidelines for pharmaceutical and biotech inventions.

7 | © 2011 Leonardos & Licks 15 years of IP protection Two government agencies involved in the examination and grant of pharmaceutical patents: The Brazilian Patent Office, INPI (1970) and The Brazilian Food and Drug Agency, ANVISA (1999). First-to-file system, 20 years from filing or 10 from grant. Law on obviousness is not settled. a Swiss type claims, selections and polymorphs allowed. INPI strict with applicants deadlines but takes approx six seven years to examine applications. Very large backlog. Examination lacks quality, transparency and rule of law. Limited ability to rely on post-filing data. Obtaining a patent is still a problem. Enforcement not as difficult. Injunctions widely available. Patent infringement is a felony. Penalty: 3 months to 1 year imprisonment, or a fine. No specific law on patent linkage in Brazil: no patent listing; no public database listing patents for a specific product (e.g. Orange Book); no certification requirement that patents are not being infringed or “paragraph IV” certification; no notice requirement. ANVISA is not required by law to respect third parties patent rights (Memo 197/GGMED/ ANVISA of Dec 2, 2003).

Thank You. Otto Licks