NEW PROVISIONAL RULING MODIFIES PATENTABLE SUBJECT MATTER OF PENDING CHEMICAL, PHARMACEUTICAL AND
FOODSTUFF APPLICATIONS AND PATENTABILITY REQUIREMENTS FOR PHARMACEUTICAL PATENTS.
Just two weeks before the date of application of the WTO’s TRIPS Agreement, according to the Brazilian
government, Provisional Ruling 2.006 of December 14, 1999, (hereinafter PR 2.006/99) was published in
the Federal Register making several changes to the Brazilian patent law. PR 2.006/99 was effective on
December 15, 1999.
The new piece of legislation changes the patentable subject matter of regularly filed pending
applications before the Brazilian Patent Office (BPTO) in the chemical, pharmaceutical and foodstuff
arts. Apparently, no application filed after May 15, 1997 will be affected by PR 2.006/99, as far as
patentable subject matter is concerned.
Provisional rulings have the same importance as ordinary laws under the hierarchy of the laws in
Brazil. They are issued by the President using his or her legislative powers under special
circumstances provided for in article 62 of the 1988 Brazilian Constitution. Provisional rulings can
only be issued in relevant and urgent circumstances. Without Congressional approval, they lose effect
30 days after being enacted. However, the President may reissue as many times as he or she desires,
until it is formally rejected by Congress.
PR 2.006/99 also introduces Article 229-C into the patent law, altering the patentability
requirements for pharmaceutical patents to include the following: “The granting of patents in
connection with pharmaceutical products or processes shall be dependent on prior consent from the
National Sanitary Supervision Agency (Agência Nacional de Vigilância Sanitária - ANVS).” The ANVS is
the Federal regulatory agency that approves pharmaceutical products for marketing.
Besides adding a new patentability requirement for pharmaceutical patents, PR 2.006/99 changes the
patentable subject matter of regularly filed patent applications pending before BPTO in the chemical,
pharmaceutical and foodstuff arts, according to the following table:
Patent applications claiming PRODUCTS filed before December 12, 1994. Patent applications claiming
PRODUCTS filed between January 1, 1995 and May 14, 1997.
Applications claiming substances, matter or products obtained by chemical means or processes and alimentary
and chemical-pharmaceutical substances, matter, mixtures or products and medicaments of any type -
where the applications were not converted into a "pipeline" application until May 15, 1997, shall be
considered as rejected for all purposes.The criteria for patentability established in this law shall
be applied to the applications relating to pharmaceutical products and chemical products intended for
agriculture, having been filed between January 1, 1995 and May 14, 1997, from the effective date of
filing of the application in Brazil or of the priority, where applicable, the protection being
assured from the date the patent is granted, through the remaining term counted from the filing date
in Brazil, limited to the term provided in the caput of Article 40 of the patent law.
Patent applications claiming PROCESS filed before December 12, 1994.Patent applications claiming PROCESS
filed between January 1, 1995 and May 14, 1997.
The patent law (Law 9.279/96) shall be applied to all pending applications claiming processes for
obtaining or modifying substances, matter or products obtained by chemical means or processes and
alimentary and chemical-pharmaceutical substances, matter, mixtures or products and medicaments of
any type.The patent applications relating to processes filed between January 1, 1995 and May 14,
1997, and whereto no protection was provided by Article 9, Subparagraph "c" of Law No. 5,772 of
December 21, 1971, (foodstuff, chemical, pharmaceutical and medicines) shall be deemed rejected at
the BPTO.
This table reflects a possible interpretation to be given to PR 2.006/99. However, no official
statement was issued by the BPTO before this newsletter was sent to print.
Should you need further information, please contact any of our attorneys or email us at
momsen@leonardos.com.br.
PROVISIONAL RULING No. 2,006, OF DECEMBER 14, 1999
(Federal Register of December 15, 1999, Section I, page 46)
Amends and adds provisions to Law No. 9,279, of May 14, 1996, which regulates rights and duties in
connection with industrial property, and provides other measures
THE PRESIDENT OF THE REPUBLIC, using his prerogative as provided in Art. 62 of the Constitution,
hereby enacts the following Provisional Ruling, which shall produce the effects of a Law:
Article. 1. Law No. 9,279, of May 14, 1996, will hereinafter be effective with the following amendments:
"Article 229. The provisions of this Law shall be applied to all pending applications, except with
respect to the patentability of applications filed until December 31, 1994, where the object for which
there is being sought protection comprises substances, matter or products obtained by chemical means
or processes and alimentary and chemical-pharmaceutical substances, matter, mixtures or products and
medicaments of any type, and where the applicants have not used the right provided in Articles 230
and 231 of this Law, and in which case those applications shall be considered as rejected for all
purposes, the BPTO (Brazilian Patent and Trademark Office) being due to publish the notices
concerning the cited rejections.
Sole Paragraph. The criteria for patentability established in this law shall be applied to the
applications relative to pharmaceutical products and chemical products intended for agriculture,
having been filed between January 1, 1995 and May 14, 1997, from the effective date of filing of
the application in Brazil or of the priority, where applicable, the protection being assured from
the date the patent is granted, through the remaining term counted from the filing date in Brazil,
limited to the term provided in the caput of Article 40."
"Article 229-A. The patent applications relative to processes filed between January 1, 1995 and May
14, 1997, and whereto no protection was provided by Article 9, Subparagraph "c" of Law No. 5,772 of
December 21, 1971, shall be deemed rejected and the BPTO (Brazilian Patent and Trademark Office)
shall be due to provide the publication of the notices concerning the cited rejection decisions."
"Article 229-B. The patent applications relative to products filed between January 1, 1995 and May 14,
1997, to which no protection was granted in Article 9, Subparagraph "c" of Law No. 5,772 of December
21, 1971, and in connection wherewith the filing applicants failed to avail themselves of the right
provided in Articles 230 and 231, shall be decided until December 31, 2004, pursuant to this Law."
"Article 229-C. The granting of patents in connection with pharmaceutical products or processes shall be
dependent on prior consent from the National Sanitary Supervision Agency (Agência Nacional de
Vigilância Sanitária - ANVS)."
Article 2. Pursuant to Item IX of Article 37 of the federal Constitution, the National Institute
of Industrial Property (Instituto Nacional da Propriedade Industrial - INPI) (The Brazilian Patent
and Trademark Office) is hereby authorized to hire personnel on a provisional basis for a period of
twelve months.
Paragraph 1. For the purposes of the caput of this Article, there are considered to be temporary
needs of exceptional public interest those activities related to implementation, follow-up, including
juridical, and evaluation of activities, projects and programs within the scope of competence of the
BPTO (Brazilian Patent and Trademark Office).
Paragraph 2. The number and the remuneration of provisionally hired personnel shall be defined in a
joint act by the BPTO (Brazilian Patent and Trademark Office) and the Management Secretary Office
of the Ministry of Planning, Budget and Management.
Paragraph 3. There shall be applied to the personnel provisionally hired by the BPTO (Brazilian
Patent and Trademark Office) the provisions of Articles 3rd, 5th, 6th, of the sole paragraph of
Article 7th, of Articles 8th, 9th, 10, 11, 12 and 16 of Law No. 8,745, of December 9, 1993.
Article 3. This Provisional Ruling is effective from the date of publication hereof.
Brasília, December 14, 1999; 178th Year of Independence and 111th Year of the Republic.
