Bills to amend the Brazilian Patent Statute, Federal Law 9,279 of May 14th, 1996

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Bills to amend the Brazilian Patent Statute, Federal Law 9,279 of May 14th, 1996 All the bills included in the timeline seek to amend the patent statute. This timeline does not include bills removed by their sponsors or already approved and signed into laws. Current as of March 2, 2015

1996 1997 1999 2000 2001 MAY 14TH APRIL 1ST MARCH 2 AUGUST 22 SEPTEMBER 13 DECEMBER 13 The Brazilian Patent Statute enters entirely in force. Law 9,279/96, which regulates rights and obligations relating to industrial property, was approved after intense discussion in Congress. During the legislative process of the Patent Statute, which lasted nearly five years, more than 1,300 amendments were submitted. 1. Bill 2920 H Introduced by Rep. Jovair Arantes (PSDB/GO) 9,279/96 to ensure the employee fifty percent of net profit from commercialization of inventions resulting from its personal contribution. Status: Reinstated on Feb. 2, 2. Bill 139 H Introduced by Rep. Alberto Goldman (PSDB/SP) 9,279/96, modifying provisions on the rights conferred by patent and on the grant of compulsory license. Status: Reinstated on Feb. 2, MARCH 18 4. Bill 3478 H Introduced by Rep. Paulo Paim (PT/RS) Summary: Provides new wording for item II of article 202 of Law 9,279/96 to destine seized counterfeit goods to non-profit social assistance agencies. the legislature in 2014. 5. Bill 3562 H Introduced by Rep. Raimundo Gomes de Matos (PSDB/CE) 9,279/96 to include provision on the compulsory license for the exploitation of pharmaceutical patents. Status: Reinstated on Feb. 06, 6. Bill 282 S Introduced by Senator Carlos Summary: Changes article 12 of Law 9,279/96, specifying the cases in which the previous disclosure by the inventor does not affect the patent application. legislature in 2002. 3. Bill 333 H Introduced by Rep. Antonio Kandir (PSDB/SP) 9,279/96 to increase the penalties for crimes against trademarks and for unfair competition crimes. Status: Awaits discussion of the Senate s substitute amendment by the Plenary. Bill pending in the House of Representatives Bill pending in the Senate Bill currently shelved H S President s political party (PT) and political parties supporting the Administration Bill originated in the House of Representatives Bill originated in the Senate 2/12

2002 2003 MARCH 12 JUNE 13 JULY 1 FEBRUARY 18 MARCH 12 DECEMBER 10 7. Bill 48 S Introduced by Senator Carlos 9,279/96 to establish the registration of advertising expression or sign before the BRPTO. legislature in 2006. 8. Bill 172 S Introduced by Senator Carlos Summary: Changes articles 57 and 175 of Law 9,279/96 to include the BRPTO as defendant in invalidity lawsuits. legislature in 2006. 9. Bill 7066 H Introduced by the Participative Legislation Committee Summary: Changes article 207 and 208 of Law 9,279/96 regarding the possibility of the aggrieved party file civil lawsuits and compensation resulting from infringement of industrial property rights. 10. Bill 22/2003 H Introduced by Rep. Roberto Gouveia (PT/SP) 9,279/96, including the invention of medicine for prevention and treatment of Acquired Immunodeficiency Syndrome AIDS and its process of obtaining as nonpatentable subject matter. Status: Awaits decision on 11. Bill 303/2003 H Introduced by Rep. Dr. Pinotti (PMDB/SP) Summary: Changes article 68 of Law 9,279/96, providing for compulsory licensing in case of no manufacturing of the patent subject matter in national territory. Attached to PL 139/1999. 12. Bill 2729 H Introduced by Leonardo Picciani (PMDB/RJ) 9,279/96, among others, to aggravate the punishment of the crime of counterfeit and other crimes against industrial property. Status: Referred to the Senate after the approval of the substitute amendment in the the appeal submitted to the House. Presiding Officer of the House of Representatives. 3/12

2004 2005 2006 2007 APRIL 15 MAY 19 MARCH 29 NOVEMBER 21 APRIL 4 NOVEMBER 29 13. Bill 3378 H Introduced by Participative Legislation Committee 9,279/96 to establish rules on the private criminal prosecution in crimes against industrial property. Status: Ready for consideration by the Plenary. 14. Bill 3609 H Introduced by Participative Legislation Committee 9,279/96 to set forth that lawsuits for trademark adjudication will be filed before the Federal Court, with the intervention of the INPI. Status: Shelved on Jan. 31, 15. Bill 4961 H Introduced by Rep. Antonio Carlos Mendes Thame (PSDB/SP) Summary: Amends article 10 of Law 9,279/96, establishing that substances or materials extracted from natural living beings and biological materials found in nature, which comply with the patentability requirements, will be considered an invention or utility model and can be patented. Status: Shelved on Jan. 31, 16. Bill 308 S currently in the House under No. 3074/2011 Introduced by Senator Antonio Carlos Valadares (PSB/SE) 9,279/96 to restrain parasitic competition. Status: Awaiting Opinion by the Rapporteur of the Constitution, Justice and Citizenship Committee (CCJC). 17. Bill 654 H Introduced by Rep. Nazareno Fonteles (PT/PI) 9,279/96, prohibiting the patenting of genetically modified organisms. Status: Attached to Bill 4691/2005. 18. Bill 2511 H Introduced by Rep. Fernando Coruja (PPS/SC) Summary: Amends Law 9,279/96, establishing that the therapeutic indication of pharmaceutical products and processes is not patentable. 4/12

2008 2009 JULY 9 SEPTEMBER 3 MARCH 24 APRIL 22 MAY 6 OCTOBER 27 19. Bill 3709 H Introduced by Rep. Rafael Guerra (PSDB/MG) Summary: Changes article 229- C of Law 9,279/96, establishing that the grant of patents for pharmaceutical products and processes, in accordance with articles 230 and 231, will depend on the prior approval by the ANVISA. 20. Bill 3995 H Introduced by Rep. Paulo Teixeira (PT/SP) and Dr. Rosinha (PT/PR) Summary: Changes article 10 of Law 9,279/96 to restrict patentability of the second medical use and new forms of substances, also known as polymorphs. Status: Reinstated on Feb. 6, Attached to Bill 2511/2007, which is attached to Bill 139/1999. 21. Bill 4890 H Introduced by Rep. Carlos Summary: Changes article 125 of Law 9,279/96 to establish the highly renowned trademark registration at the request of interested. 22. Bill 5088 S Introduced by Rep. Carlos 9,279/96 to establish the imprescriptibility of trademark invalidity lawsuit when the registration is obtained in bad faith. APRIL 22 23. Bill 156 S currently in the House of Representatives under No. 8045/2010 Introduced by Senator José Sarney (PMDB/AP) Summary: This Bill modifies articles 199 and 210 of Law 9.279/96. It also modifies several other laws, aiming more specifically at reforming the Penal Procedure Code, revoking Decree-Law No. 3.689. Status: On March 23, 2014, the President of the House of Representatives determined the creation of a Special Committee to analyze Bill 8045/2010. The members of such committee were not appointed yet. 24. Bill 171 S currently in the House of Representatives under No.7241/2010 Introduced by Senator Valdir Raupp (PMDB/RO) 9,279/96, aggravating the penalty for the crime of unfair competition and including a new paragraph in article 195. Status: Waiting for the assignment of a Rapporteur in the Constitution, Justice and Citizenship Committee (CCJC). MAY 6 25. Bill 5176 H Introduced by Rep. Rodrigo Rollemberg (PSB/DF) 9,279/96, providing for compulsory licensing of patents in the lack of continued use medicine in the market. Ensures non-exclusive compulsory license and for an indefinite time. Status: Reinstated on Feb. 6, Attached to Bill 3562/2000, which is attached to Bill 139/1999. 26. Bill 6287 H Introduced by Rep. Carlos 9.279/96 to regulate the registration of technology transfer contracts. 5/12

2010 2011 2012 JUNE 29 NOVEMBER 30 FEBRUARY 10 NOVEMBER 17 DECEMBER 6 MAY 16 27. Bill 194 S Introduced by Senator Valdir Raupp (PMDB/RO) Summary: Changes article 128 of Law 9,279 to compel the legal entity of private law to prove the use of the trademark for obtaining its registration and for its renewal. the legislature in 2014. 28. Bill 7965 H Introduced by Rep. Moreira Mendes (PPS/RO) Summary: Amends article 229- C of Law 9,279/96, establishing that the grant of patents for pharmaceutical products and processes, in accordance with articles 230 and 231, will depend on the prior approval by the ANVISA. Status: Reinstated on Feb. 6, Attached to Bill 3709/2008, which is attached to Bill 139/1999. 29. Bill 357 H Introduced by Rep. Júlio Lopes (PP/RJ) Summary: Aggravates the penalty of crimes against patents, modifying articles 183, 184, 196, 199, 202 and 207 of Law 9,279/96. the legislature in 2014. 30. Bill 689 S Introduced by Senator Vital do Rêgo (PMDB/PB) 9,279/96 to establish the progression of the annual fee for patents. Status: Bill with the Rapporteur (Economic Affairs Committee). 31. Bill 2846 H Introduced by Rep. Manato (PDT/ES) Summary: Amends articles 68 and 74 of Law 9,279/96, regarding the compulsory licensing of patents, and revokes article 69, which establishes the cases in which the compulsory license will not be granted. 32. Bill 158 S Introduced by Senator Ciro Nogueira (PP/PI) 9,279/96 to give priority to the examination of green patents applications. Status: Waiting for public hearing in the Environment, Consumer Rights, and Inspection and Control Committee. 6/12

2013 MAY 24 JUNE 28 DECEMBER 18 APRIL 18 AUGUST 6 33. Bill 3943 H Introduced by Rep. Jandira Feghali (PCdoB/RJ), José Linhares (PP/CE), Elcione Barbalho (PMDB/ BA) and others Summary: Changes article 229- C of Law 9,279/96, establishing criteria for examination and grant of patents in the chemicalpharmaceutical field. This Bill also and sets forth ANVISA s statutory authority to analyze patentability requirements during the prior approval examination. Attached to Bill 3709/2008. MAY 24 34. Bill 3944/2012 H Introduced by Rep. Jandira Feghali (PCdoB/RJ), José Linhares (PP/CE), Dr. Paulo César (PSD/RJ) and others Summary: Revokes article 40 s sole paragraph of Law 9.279/96, which guarantees a 10-year term from the date of grant whenever the examination takes more than a decade. MAY 24 35. Bill 3945 H Introduced by Rep. Jandira Feghali (PCdoB/RJ), José Linhares (PP/CE), Dr. Paulo César (PSD/RJ) and others Summary: Changes articles 18 and 68 of Law 9,279/96, establishing the nonpatentability of drugs used in the diagnosis and therapy of neglected diseases; and determining that the patent of such drugs is not subject of remuneration in case of compulsory license. Status: Reinstated on Feb. 6, Attached to Bill 3562/2000, which is attached to Bill 139/1999. 36. Bill 4139 H currently in the Senate under No. 118/2014 Introduced by Rep. Benedita da Silva (PT/RJ) Summary: Changes article 202 da LPI, allowing the donation of counterfeit goods to cooperatives or customization ateliers. Status: Awaits the assignment of a Rapporteur in the Economic Affairs Committee in the Senate. 37. Bill 461 S currently in the House of Representatives under No.6292/2013 Introduced by Senator Valdir Raupp (PMDB/RO) 9,279/96, extending the term of secrecy of the industrial design application during its prosecution. Status: Waiting the end of term for submission of amendments to the substitutive proposed by the Rapporteur of the Economic Development, Industry and Trade Committee. 38. Bill 5402 H Introduced by Rep. Newton Lima (PT/SP) and Dr. Rosinha (PT/PR) Summary: Intends to implement important changes in Law 9,279/96, such as revoking article 40 s sole paragraph, establishing the non-extension of patent term in Brazil; prohibiting second medical use patents; adopting a pre-grant opposition mechanism; strengthen ANVISA s powers to deny pharmaceutical patents in the prior approval examination. 39. Bill 316 S Introduced by Senator Paulo Paim (PT/RS) 9,279/96 to establish the maximum term of 180 days for the examination of trademark and patent applications by the BRPTO. Status: Waiting for public hearing in the Environment, Consumer Rights, and Inspection and Control Committee. 7/12

NOVEMBER 12 40. Bill 8090 H Introduced by Social Security and Family Committee. Summary: Changes article 68 of Law 9,279/96 to set forth the compulsory license of patented goods for manufacturing and exportation to countries that have insufficient or inexistent capacity of production in the pharmaceutical field, in accordance with TRIPS Agreement. NOVEMBER 12 41. Bill 8091 H Introduced by Social Security and Family Committee. Summary: Changes articles 43 and 184 of Law 9,279/96 to apply the exhaustion of patent rights to goods put in the external market. 8/12

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