Sunday, 4 October 2015

Brazilian Politicians will vote for new Pharma Laws

Last month IP Tango was delighted to host a guest post from our Brazilian friend Magda Voltolini, on the topic of sham litigation.  Now we are pleased to welcome her back with her perspective on the chances of Brazil applying the flexibilities of the Doha Declaration. This is what she writes:
Are Brazilian politicians applying the flexibilities on the basis of the Doha Declaration?  The Brazilian National Congress is apparently ready to reform Law N. 9279 of 14 May 1996 (Law 9279/96) regulating rights and obligations relating to industrial property.  In fact, the Committee on Constitution, Justice and Citizenship (CCJC) will soon vote Bill N. 139 of 2 February 1999 (Bill139/99) and its annexes, which aim at modifying the provisions concerning rights awarded by the patent and conditions that grant compulsory licenses including those relating to pharmaceutical products and processes.

On 17 September Deputy Andre Moura, Rapporteur of the Bill 139/99 voted to amend Law 9279/96 repealing the sole paragraph of art. 40, altering arts. 10, 13, 14, 31, 43, 68, 195 and 229-C and adding arts. 31-A and 43-A to art. 4 of the Law 9279/96. However, the Brazilian Fine Chemicals, Biotechnology and Specialty Industries Association (Abifina) and the Pharmaceutical Research Industry Association (Interfarma) support opposite views. If the proposed Bill passes, Abifina ideas will prevail and the Brazilian generic industry will certainly benefit from the new law.

For instance, the proposed Bill is also expanding the grounds of Government non-commercial use of patents and patent applications on the basis of public interest. In its article 43.A(6), it forbids the Judiciary Branch to decide on matters concerning whether the objectives of public interest were established to justify the Government authorization of the non-commercial use of the object of a pharmaceutical patent or patent application. However, as a fundamental right and guarantee,  the Brazilian Constitution stipulates that  “the law shall not exclude any injury or threat to a right from the consideration of the Judicial Power”. (art. 5, XXXV)

The table below illustrates a snapshot of the changes proposed by Bill 139/99 amending Law 9279/96.


Law 9279/96
Bill 139/99
40. An invention patent shall remain in force for a period of 20 (twenty) years, and a utility model patent for a period of 15 (fifteen) years from the date of filing.

Sole Paragraph. The term shall not be less than 10 (ten) years for an invention patent and 7 (seven) years for a utility model patent, beginning on the date of granting, unless the INPI has been prevented from examining the merits of the application by a proven pending judicial dispute or for reasons of force fmajeure.


10. The following are not considered to be inventions or utility models: I. discoveries, scientific theories, and mathematical methods;
………………………………………………………

10. ........................................................................... .............................................................................................
X.  any new property or new use of a known substance or mere use of a known process, unless such known process results in a new product;
XI. new forms of known substances, which do not result in the enhancement of the known efficacy of the substance.

Single paragraph. For the purposes of this article, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other known substance derivatives should be regarded as the same substance, unless they differ significantly in properties as regards efficacy. (NR)

13. An invention is endowed with inventive step provided that, to a technician versed in the subject, it is not derived in an evident or obvious way from the state of the art.

13.  An invention is endowed with inventive step provided that, to a person skilled in the art, it is not derived in an evident or obvious way from the state of the art, and since it represents a significant technical improvement over the state of the art. (NR)

14. A utility model is endowed with inventive act provided that, to a technician versed in the subject, it is not derived in a common or ordinary way from the state of the art.

14. A utility model is endowed with inventive act provided that, to a person skilled in the art, it is not derived in a common or usual manner from the state of the art, and since it represents a technical improvement over the state of the art. (NR)

31. After publication of the application and up to the end of the examination, interested parties may submit documents and data to assist the examination.
Sole Paragraph. The examination shall not begin before 60 (sixty) days from the publication of the application.

31. After publication of the patent application and up to the end of the examination, any person may submit an opposition.

(1) The applicant will be notified of the opposition, through publication in the official gazette, and may respond within sixty (60) days from the publication date of the opposition.

(2) In cases where an opposition to a patent application has been submitted, INPI is allowed to request technical opinions from the Public Administration, organizations recognized by the Government as consultation bodies and members of the faculty and students of higher education universities.

(3) After a complaint is filed, the examiner may, on the basis of a grounded requirement, request any further clarification as it deems necessary, as well as the submission of additional documents.

(4) The examiner must necessarily give an opinion on every filed opposition, indicating the reasons why it accepts or rejects the information there presented ...................................


43. The provisions of the previous Article do not apply:
………………………………………………………
IV. to a product manufactured in accordance with a process or product patent that has been introduced onto the domestic market directly by the patentholder or with his consent;


43.  ................................................................................. ......................................................................
IV.  to a product manufactured in accordance with a process or product patent that has been introduced to the domestic or international market directly by the patent holder or with his consent;

68. The titleholder shall be subject to having the patent licensed on a compulsory basis if he exercises his rights derived therefrom in an abusive manner, or by means thereof engages in abuse of economic power, proven pursuant to law in an administrative or judicial decision.

(1) The following also occasion a compulsory license:

I. non-exploitation of the object of the patent within the Brazilian territory for failure to manufacture or incomplete manufacture of the product, or also failure to make full use of the patented process, except cases where this is not economically feasible, when importation shall be permitted; or

II. commercialization that does not satisfy the needs of the market

(2) A license may be requested only by a person having a legitimate interest and having technical and economic capacity to effectively exploit the object of the patent, that shall be destined predominantly for the domestic market, in which case the exception contained in Item I of the previous Paragraph shall be extinguished.


68. ............................................................................... .............................
(1) .........................
I. non-exploitation of the object of the patent within the Brazilian territory for failure to manufacture or incomplete manufacture of the product, or also failure to make full use  of a patented process; or

II. .............................................................................
(2) A license may be requested only by a person having a legitimate interest and having technical and economic capacity to effectively exploit the object of the patent, that shall be destined predominantly for the domestic market.

195. A crime of unfair competition is perpetrated by anyone who:
.............................................................................
XIV. divulges, exploits, or utilizes, without authorization, results of tests or other undisclosed data whose preparation involves considerable effort and that were submitted to government agencies as a condition for obtaining approval to commercialize products.
Penalty—imprisonment, for 3 (three) months to 1 (one) year, or a fine.

195.  ...........................................................................

.............................................................................................
(3) The provisions of item XIV do not apply to the use of results of tests or other undisclosed data, by government agencies, for marketing approval of equivalent products to the product for which they were originally presented.



229. The provisions of this Law shall apply to pending applications, except as regards patentability of substances, materials or products obtained by chemical means or processes, and alimentary or chemical-pharmaceutical substances, materials, mixtures or products, and medications of any kind, as well as the respective processes for obtaining or modifying them, which shall only be privileged under the conditions established in Articles 230 and 231.


229-C.  The granting of patents for pharmaceutical products and processes shall depend on the prior consent of the National Health Surveillance Agency - ANVISA, which shall examine the object of the patent application in the light of public health.

(1) It is considered that the patent is contrary to public health, according to regulation, when:

I. a product or pharmaceutical process contained in the patent application presents a risk to health; or

II. an application for a product patent or pharmaceutical process is of interest to medicines or pharmaceutical care policies within the Unified Health System - SUS
and does not meet the patentability requirements and other criteria established by this law

(2) Following the examination of prior consent and published the result,  Anvisa shall return the request to the INPI, which shall carry out the technical examination of the approved application and shall shelve permanently the non-approved applications.

4. The provisions of treaties in force in Brazil are equally applicable to natural and legal persons who are nationals of or domiciled in this country.

31-A. The INPI must offer intuitive electronic channel, easily accessible, interconnected to the global computer network, wherewith anyone can, free of charge, present evidence or proof of previous existence, in Brazil or abroad, of the claimed invention or state of art.

Single paragraph. Even after the possible grant of the patent, and especially during the process of opposition and administrative nullity proceedings, it is authorized the submission of evidence or proof of previous existence, in Brazil or abroad, of the claimed invention or state of art.

43-A. The Government, through an Ordinance of the Ministry of State concerned, may make non-commercial use of the object of patents or patent applications without the consent or authorization of the patent holder or the patent applicant, directly or by hiring or by authorization to third parties for the purposes of public interest, including those of national defense and social interest.

(1) If the invention is a process, the public non-commercial use of the patent or patent application will cover the use in connection with any product that can be obtained by the process that is protected object  by the patent or patent application;

(2) The Government shall notify the holder of the patent or patent application when making non-commercial use;

(3) The non-commercial public use will meet the following conditions:

I. it will not prevent the full exercise of other rights of the holder of the patent or patent application;

II. it will not be exclusive, sublicensing not being permitted;

III. it will be made exclusively to meet the objectives of the Ordinance that authorized the use, being forbidden any other use, not related to the non-commercial public use,
matter contrary to Art. 42 of this Law;

(4) The remuneration for non-commercial public use, which will be fixed by the Government according to the circumstances of each case, take into account the percentage that could be routinely determined in a voluntary license between independent parties, applied to the cost for the Government resulting from the use of the object of the patent or patent application and weighted by the contribution made by the holder in the transfer of technology of manufacturing or employment;

(5) In the case of patent applications, the amount of compensation will be deposited in escrow until the grant of the patent;

(6) The Judicial Branch is forbidden in the case of public non-commercial use to decide whether the purposes related to the general interest are established;

(7) Non-commercial public use will not be suspended, limited or interrupted by a  judicial dispute concerning the fixed remuneration.










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