IDS discusses relevant issues on second medical use patents at event celebrating World Intellectual Property Day

IDS discusses relevant issues on second medical use patents at event celebrating World Intellectual Property Day

Last Thursday (25), the Dannemann Siemsen Institute (IDS) organized another IDS Agenda, this time in celebration of World Intellectual Property Day and with the theme ‘Second medical use patents: enforcement and skinny labelling’. The event, presented in English, discussed issues related to second medical use patents, such as: the protection and enforcement of these patents; the practice of skinny labelling; how Brazil and the UK regulate the subject and how the courts in these two countries have resolved disputes on the subject, among other topics.

The debate was introduced by IDS’s academic coordinator, Patrícia Porto, and welcomed as guests English lawyer Amy Cullen, who specializes in patent disputes in the pharmaceutical, telecommunications and consumer products sectors; and Bernardo Marinho, a partner at Dannemann Siemsen, a lawyer and engineer who focuses on patents and works in both strategic litigation and administrative proceedings.

The presentation began with Bernardo Marinho, who first gave a regulatory timeline of patents for second medical use inventions in Brazil. He said that the INPI has allowed the patenting of second medical use inventions since 2002. Regarding skinny labelling – the act of removing the indication of the patented use from the package leaflet of the generic medicine – Bernardo pointed out that Federal Law 9.787/1999, which regulates generic medicines, does not accept this practice, since it determines that a generic medicine must have the same therapeutic indications of its reference medicine. However, he said that in recent years generic companies have been applying incorrect interpretations of ANVISA resolutions in order to adopt the practice of skinny labelling (albeit irregularly) and commercialize medicines that infringe second-use patents, a practice that has led to infringement lawsuits. Bernardo commented on a court decision by the TJ/RJ that condemned a generic company for infringing a second-use patent, despite the practice of skinny labelling in an attempt to avoid infringement. The decision held that the practice of removing the patented use from the package leaflet is not enough to prevent infringement. Bernardo also said that ANVISA published a resolution this year allowing the practice of skinny labelling in Brazil. However, he believes that the correct way to allow or prohibit the practice is by amending the law, since ANVISA is going against the provisions of Federal Law 9.787/1999.

From this perspective, Amy Cullen began her speech by commenting on a decision by the UK Supreme Court in the context of an action for infringement of a second medical use patent for skinny labelling. She noted at the outset that this decision was not binding on the lower courts. She said that the judgement focused only on direct infringement. Regarding this type of infringement, the Court differed on the criteria to be used to verify it. The majority of the judges (3-1) agreed that, in the specific case, the most appropriate test to be applied was that of ‘external presentation’ – that is, whether the packaging and package leaflet of the allegedly counterfeit medicine adequately present the permitted uses and those that are excluded by patent protection. However, this understanding was not unanimous, and there was disagreement that the potential infringer’s intention in commercializing and using the drug on the market should also be taken into account. In this sense, two judges (including one who voted for the ‘external presentation’ test) agreed that the subjective intention of the potential infringer in using the product is also relevant when assessing cases of second-use patent infringement by skinny labelling.

Amy then went on to raise questions about the limitations on the practice of skinny labelling, as well as mentioning judgements in other European countries and citing differences between the health systems in each country, which imply significant changes in litigation on the subject. Bernardo concluded the debate by presenting the Brazilian view and emphasizing the importance of dialogue between public institutions, drug manufacturers and health agents in order to resolve these conflicts.

IDS takes this opportunity to congratulate professionals in the field on World Intellectual Property Day and to reinforce its commitment to bringing more and more debates to promote IP knowledge.

The recordings will be made available later on the IDS website.

Note: For quick release, this English version is provided by automated translation without human review.