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Patents – New decision from the Brazilian Supreme Court in favor of Patent Term Adjustment (PTA) cases

Patents – New decision from the Brazilian Supreme Court in favor of Patent Term Adjustment (PTA) cases

By Antonella Balbo y Rosario Mauro.

Last November 16, the Brazilian Supreme Court issued a favorable decision on behalf of patent holders regarding patent term adjustment in Brazil, due to the BPTO’s unreasonable delay to study patent applications.

It should be recalled that as a result of the Direct Plea of Unconstitutionality 5,529 (ADI) filed by the Attorney General in May 2021, the Brazilian Supreme Court declared Article 40 of the Industrial Property Law No. 9,279/96 as unconstitutional, which guaranteed that the term of a patent would not be less than 10 years counted from the date it was granted.

The Attorney General had argued that this automatic extension provided by Article 40 was contrary to the principle of temporary patent protection (Article 5, XXIX, Federal Constitution) since it implied that the term of the patent would be unpredictable, which reflected in uncertainty and consequently in an obstacle for potential economic competitors.

Even if the Attorney General’s request was based on avoiding alleged de facto monopolies, the ruling in ADI 5,529 was detrimental to the interests of patent holders, especially for pharmaceutical and telecommunications sectors, considering that over 3,000 pharmaceutical patents were granted the extension by invoking Article 40.

This decision triggered a wave of legal actions before the Brazilian federal courts.

Last November 16, the Brazilian Court established a new position by ruling that the decision of the Supreme Court in the Direct Plea of Unconstitutionality 5,529 (or ADI) does not prevent the Courts from authorizing PTA for a particular and reasonable term, if there are circumstances that demonstrate an unreasonable, unjustified and exceptional delays by the BPTO.

Said decision was issued in Constitutional Complaint 56.378/DF (RCL) filed by Bristol-Myers Squibb, against the denial of its request for an injunction to maintain in force patent PI 0212726-1, which expired on September 17, 2022.

Considering all of the above, the decision issued last November 16, 2022, in RCL 56.378/DF represents a turning point when it comes to PTA. It establishes a Supreme Court’s new interpretation, admitting the possibility for the Courts to adjust patent terms on a case-by-case basis, according to the circumstances of the case and based on unjustified delays by the BPTO.

However, while this latest interpretation may be encouraging for patent holders, especially those currently in litigation, the issue is not settled just yet. The Court’s ruling will be reviewed by a five-judge panel on a case-by-case basis. Anyhow, given this new interpretation of PTA in Brazil, patent holders may be inspired to believe.

For further information please contact: abalbo@ojambf.com y/o rmauro@ojambf.com.

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