Brazilian Ministry of Health advocates for the end of prior consent for pharmaceutical patents and proposes a new remedy for delays in patent prosecution

The prosecution of the Direct Plea of Unconstitutionality No. 5529 (ADI 5529) before the Supreme Court has been causing an intense debate on the long delays in the patent examination and the consequences of the inefficiency of Brazilian Patent Office. Amid such debate, the Brazilian Ministry of Health has recently submitted a brief with pieces of information on patents for pharmaceutical products and processes which revealed that the Ministry is ready to present a bill proposing the amendment of the current wording of the Brazilian Industrial Property Act (Law # 9,279/1996) in order to end prior consent for pharmaceutical patents and proposing a new remedy for delays in patent prosecution.

The prior consent is provided by article 229-C of the Brazilian Industrial Property Act (Law # 9,279/1996), which reads as follows:

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 included by Law nº 10.196, of 02.14.2001) -Note: the agency is currently known as Anvisa.

The bill drafted by Brazilian Ministry of Health reads as follows:

I, THE PRESIDENT OF THE REPUBLIC hereby inform that the National Congress decrees and I sanction the following Law:

Art. 1 This Act updates the Industrial Property Act, in the sense of inserting guarantees of predictability to innovators and economic agents, adapting the regulation to the best international practices, with the aim of:

I – guaranteeing greater legal certainty about intellectual property rights;

II – reducing the time for examining patents and the resulting expenses with public tenders;

III – preserving ongoing international agreement negotiations;

IV – adjust Brazilian regulation to the best international practices; and

V – minimizing damages to competition resulting from excessive and unpredictable extensions of time during the validity of patents.

Art. 2. Art. 40 of Law No. 9,279, of December 14, 1996, is effective with the following amendments:

"Art. 40. ………………………………………… …………………………………………..

§ 1 If the granting of the patent suffers unreasonable delays during the administrative process, its term shall be adjusted in such a way that each day of delay in issuing the patent will be compensated with an additional day in its term in addition to those defined in the head of this article.

§ 2 For the purposes of § 1, unreasonable delays for granting a patent are considered to have occurred:

I – 10 (ten) years after the filing of an invention patent or 8 (eight) years after the request for examination of an invention patent, whichever occurs last; and

II – 7 (seven) years after the filing of a utility model patent or 5 (five) after the request for examination of a utility model patent utility, whichever comes last.

§ 3 The adjustment in the term of the patent resulting from unreasonable delays during the administrative process, as provided for in § 1, will be limited to the maximum additional of 5 (five) years beyond the terms defined in the head of this article.

§ 4 Delays caused by the Applicant will be discounted in the calculation of the adjustment within the term of the patent.

§ 5 For the purposes of § 4, the regulation will define the delays attributable to the Applicant.

 

 

 

Such bill reinforces that the Brazilian Government is committed to comply with the international duties the country has undertaken before the World Trade Organization, and that the country wishes to provide legal certainty to investors.

By the same token, the Ambassadors of the United Kingdom, Belgium, Denmark, France, Japan and Sweden sent a joint letter to the Brazilian Government expressing their concerns on the outcome of ADI 5529 and underlying their view that any questions concerning the term of protection for patents should be addressed by the Brazilian Congress after a democratic debate with the society.

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