A recent judgment by the Federal Supreme Court concluded that the rule provided for in the Industrial Property Law (LPI) which granted a minimum exclusivity period from the effective registration of a patent and not upon the submission of the application for patent registration to the National Institute of Industrial Property, is unconstitutional ( INPI).
The rapporteur, Minister Dias Toffoli, defended that the Constitution would require the legal establishment of a certain, inflexible deadline. The questioned provision (the sole paragraph of article 40) of the law determined that the term of validity would not be less than ten years from the moment the patent is registered, which is uncertain. The STF decided that the unconstitutionality reaches patents already in force for medicines and health equipment. Patents on medicines with more than 20 years from the date of submission to Inpi will lose protection.
The extended term, declared unconstitutional by the STF, was justified. Inpi takes an absolutely unusual time to analyze an order. In 2018, for example, the average time to review a patent in the US was two years. Already at Inpi, 10.5 years. The institute’s review period varies according to the industry. In 2018, the most time-consuming division was pharmaceuticals, with a 13-year wait from filing a patent to approving its registration.
According to the rapporteur, Minister Dias Toffoli, in the event that Inpi takes 15 years to grant a patent, for the additional guarantee of ten years since the grant, at the end, the period of protection will have been 25 years. By the winning understanding in the Supreme Court, the extended term would give excessive advantage to patent holders and would prevent the entry of competitors, entailing high prices to the detriment of consumers and the health system.
The court’s decision made a correct diagnosis, but had the wrong prognosis. There is a problem in the time that Inpi takes to register patents, something without parallel internationally. And there is pressure to ease drug patents at a time of pandemic. These are correct findings.
But to end the rule of the single paragraph of Article 40 is to give the wrong medicine to the patient.
Patents cannot be eternal, it is a fact. But neither can they be uncertain and precarious, as follows from the STF decision. Between presentation and registration, the inventor is not properly protected. As Minister Luís Roberto Barroso recalled, what you have is a weakly protected expectation. The constitutionally guaranteed exclusivity is only effective after registration. As the INPI does not have a deadline to register, by making the legal term of protection flow in this period of low protection, the decision weakened patents in Brazil. It was against the encouragement of science, innovation and invention.
The pandemic situation can and must be faced with effective solutions, not with a setback in a system that has existed for decades and has worked. Those most interested in a reliable and stable patent protection regime are not the companies that exploit them. They are researchers and inventors. It’s science. In the apparent conflict between the pharmaceutical multinationals and the national generic industry, the universities lost. Lost science. A feather.
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