La Belgique a récemment modernisé sa législation sur les brevets, transposant la directive 98/44 EC grâce à l’Acte du 28 avril 2005. Cette révision, qui a suivi de longs débats parlementaires, vise à aligner le droit belge sur les exigences de la directive relative aux inventions biotechnologiques. Deux nouvelles dispositions notables ont été introduites : l’article 11, qui élargit l’exception pour la recherche scientifique, et l’article 13, qui établit un régime de licence obligatoire pour des raisons de santé publique. Cette licence obligatoire, prévue par l’article 31bis, a pour but de protéger la santé publique en facilitant l’utilisation d’inventions biotechnologiques potentiellement risquées. Elle s’applique à une large gamme d’inventions, y compris les tests diagnostiques et les inventions médicales. Bien que critiquée par certains lobbies pharmaceutiques, cette réglementation ne fait que réguler l’utilisation des droits de brevet, sans impacter leur brevetabilité. Le processus de demande de licence obligatoire est accessible et ne nécessite pas l’accord préalable du titulaire du brevet, ce qui est crucial en situation de crise sanitaire. Les conditions d’exploitation de la licence, notamment sa durée et son champ d’application, sont déterminées par le Roi, garantissant ainsi une approche flexible et réactive aux enjeux de santé publique. Avec l’ajout récent d’une réglementation européenne sur les brevets liés à l’exportation de produits pharmaceutiques, la Belgique renforce son engagement envers la santé mondiale tout en préservant les droits des inventeurs.
A. The Implementation in Belgian Patent Law
Belgium transposed lately the directive 98/44 EC with the Act of 28th April 2005 modifying the Act of 28th March 1984 on Patents on Inventions . This has been the result of a long parliamentary debate and an attempt to adjust national patent law with the new requirements settled in the biotechnological inventions directive . A first attempt occurred in 1998 but the federal elections of 1999 led to a governmental change with a “rainbow” majority – that is to say a coalition of liberal, socialist and ecologist parties. Under Verhofstad I, the proposal of an act transposing the directive contained several exceptions to the directive regime. But the majority changed in 2003 with a “violet” majority composing the Verhofstad II government– including liberal and socialist parties, i.e. a more laic coalition . After the ECJ’s judgment of 2004, Belgium finally transposed the directive in 2005. The Act added to the 1984 Act two provisions that weren’t in the directive – for the rest, it simply transposed the provisions of the directive.
The first provision is article 11 of the 2005 Act which modified article 28, §1, b of the 1984 by enlarging the scope of the exception for scientific research:
“Art. 28. § 1er. Les droits conférés par le brevet ne s’étendent pas : […]b) (aux actes accomplis à des fins scientifiques sur et/ou avec l’objet de l’invention brevetée.) […]”
This was not a limitation to the scope of the protection by the patent right that existed in the directive. The Belgian legislator nuanced the scope of this protection.
The second provision is article 13 of the 2005 Act which inserted an article 31bis in the 1984 Act. This article concerns the compulsory license for public health reasons. This specific license is examined in the next section.
B. The compulsory license for public health reasons
The aim of this compulsory license is to reduce the risks that biotechnological invention may cause to public health throughout their patentability . Article 31bis, §1 of the 1984 Act on Patents on Inventions underlines that it is the public health interest which motivates the grant of this compulsory license.
The list of the biotechnological inventions concerned by this specific regime is settled in the article 31bis, §1. The list is quite large because it covers both patented tests and methods of diagnostic applicable outside the human body or the animal and medical inventions . This has been criticized by pharmaceutical lobbies because, according to them, it creates a discrimination between the medical sector and the other economical sectors which are not subject to this kind of compulsory license regime. The argument is weak since article 31bis regulates the use of patent rights and not the patentability of biotechnological inventions .
The exclusion of the in vivo diagnostic methods – on the human body and the animal – is logical because article 7, §2 of the 1984 Act forbids their patentability .
Article 31bis, §2 states that the demander of the compulsory license has to prove that has all the means for a serious and continuous fabrication and/or application in Belgium of the patented invention. This is justified by the fact that the invention is related to public health interests . This article echoes to article 31, §2, 2° of the 1984 Act which provide the same requirements for the grant to a compulsory license. Article 31bis, §11 prescribes that the King can take the license back if, after a certain delay, the invention has been used under the conditions mentioned above. The Council of Ministers has, then, to fix that delay according to article 31bis, §6 in fine .
The procedure for the demand of a compulsory license for public health reasons in settled in article 31bis. Article 31bis, §6 doesn’t exclude anybody to demand the grant of the license. The demander addresses his or her demand to the minister – i.e. the minister for economical affairs – and sends a copy to the Consultative Comity of Bioethics. This comity has only the power to deliver a non-binding opinion to the minister. Contrary to article 31, §2, 1° which concerns compulsory licenses, the demander of a compulsory license for public health reasons doesn’t have to ask the holder of the patent rights for a contractual license. The holder can, according to article 31bis, §6, express his or her point of view after he or she has been informed by the minister about the demand. The decision to grant the license is taken by the King through a Royal Decree, which show that it is an individual decision. The deliberation in the Council of Ministers is a good way that create a debate, especially between the ministers for economical affairs, health and social affairs, who are all concerned by the question of the compulsory license for public health reasons . An accelerated procedure exists in the case of a health crisis.
Between the demand and the grant of the compulsory license, certain acts of exploitation may have been done. Article 31bis creates at its third , sixth and seventh paragraphs a specific regime.
The conditions of exploitation of the invention are settled in article 31bis. Article 31bis §5 prescribes that the license can be time-limited and its scope of application too . An additional condition is the aforementioned delay of exploitation. The question of the remuneration is an essential condition of the exploitation and is evoked in article 31bis, §6. Again, the conditions of exploitation are settled by the King.
The license is non exclusive according to article 31bis, §4. It is also non-transferable, even if article 31bis doesn’t mention this: it seems quite logical because the license is an individual decision . Furthermore, the license can be subject to a revision according to article 31bis, §10 .
Finally, all claims concerning the administrative decisions will not take place before the Council of State but before the tribunals of first instance, according to article 73, §2 of the 1984 Act .
Very recently, the Belgian legislator implemented a European regulation concerning the grant of compulsory licenses on patents on the fabrication of pharmaceutical products destined to the exportation to countries having public health problems. An article 31ter has been inserted in the 1984 Act, creating a specific regime. Biotechnological inventions may be subject to this specific regime since biotechnological inventions can concern the fabrication of pharmaceutical products. The doctrine has not commented this new provision
Annexes
Directive 98/44/EC
file_download Télécharger l'annexeBelgian Act of April 28, 2005
file_download Télécharger l'annexe
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