At the next Wednesday 22th, it will happen the trial of the largest action in the history of the Brazilian Federal Supreme Court (STF, acronym in Portuguese) involving the medicine industry.
Pipeline patents are one of the biggest legislative mistake in our recent history, which has resulted in wastage of public resources through irrational and unconstitutional monopolies on medicines.
STF now has the opportunity to correct this mistake, if it judges in favor of the Direct Action of Unconstitutionality (ADI, acronym in Portuguese) 4234, proposed by the Brazilian Attorney General’s Office (PGR, acronym in Portuguese) in April 2009, after the GTPI proposal made in 2007. The appeal points out the unconstitutionality of Articles 230 and 231, inserted in 1996 in the Brazilian Industrial Property Law, the Federal Law 9.279 / 96.
WHY ARE PIPELINE PATENTS A MISTAKE?
By definition, pipeline patents revalidate patents granted in another country. This revalidation was marked by a series of serious problems:
– The patent pipeline device granted patents without any type of examination, taking into account only the results of examinations carried out in the countries of origin, which jeopardizes national sovereignty.
– Patents have been granted to medicinal products which were already in the public domain, infringing the basic principles that justify the existence of the patent system.
– The patent pipeline device was a “gift” of the Brazilian Congress to the pharmaceutical industry at the cost of a huge loss to the Brazilians. Brazil was never obliged to adopt the pipeline mechanism when it had to amend its patent law in 1996 to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). The pipeline was an unnecessary concession of Brazilian parliamentarians after intense lobbying of the pharmaceutical industry.
– During the negotiation of the TRIPS Agreement at the WTO, a similar proposal was launched by the US, but it was rejected by several negotiating countries, which already exposes it as a controversial mechanism.
WHAT DOES THIS HAVE TO DO WITH YOU?
The pipeline mechanism granted 814 patents in Brazil, mostly in the area of food, medicines and other essential goods. A study conducted by the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI /Rebrip) identified 259 medicines covered by pipeline patents, which 54 medicines are distributed in the public health system.
These patents were responsible to block the entry of generics, allowing the pharmaceutical industry to charge extremely high prices, thus generating big impact in the budget of the Ministry of Health and the quality of care to the Brazilian population. The pipeline is one of the main difficulties in ensuring universal coverage of treatment, causing interruptions, damages to untreated patients or even death, as well as compromising the quality of life of millions of Brazilians.
In practice, pipeline patents have enabled the misappropriation of medicines that are on the Brazilian National List of Essential Medicines and are provided by the Unified Health System (SUS, acronym in Portuguese) for the treatment of cancer, cholesterol, schizophrenia, Parkinson’s disease, autoimmune diseases and HIV / AIDS.
Among them are medicines used to treat many types of cancer (imatinib, bevacizumab, rituximab, trastuzumab); of arterial hypertension (bosentan, sidelnafil); heart disease (clopidrogel, simvastatin, tenectaplase); psychiatric disorders (olanzapine, quetiapine, ziprasidone), high cholesterol (atorvastatin, the best-selling medicine of all time), and against HIV / AIDS (nelfinavir, lopinavir / ritonavir, efavirenz, abacavir), and others.
There are also medicines which are not distributed by the SUS but they are among the most purchased medicines by the population. The list is vast with emphasis on the antihistamine fexofenadine; the loperamide that fights the daily; the contraceptive drospirenone / ethinyl estradiol; prucalopride for constipation and tiotropium bromide for the treatment of lung diseases.
UNCONSTITUTIONALITY CAN AFFECT THE FUTURE
The STF’s declaration of unconstitutionality, besides correcting a historical mistake, is extremely relevant in order to brake an agenda of patent proliferation and abuses committed by pharmaceutical companies.
The decision for unconstitutionality also contributes to block the advance of new unconstitutional proposals such as the automatic approval of patents, currently under discussion in the Executive.
The advance of neoliberal policies around the world has created zones of exception in the Law, sometimes under the argument of supposed modernity, defense of innovation and the arrival of new technologies. Regarding this, large corporations work to influence governments, legislators and lawmakers to facilitate their interests even if contrary to the legal system. Thus, the ‘illegalism’ advances in the absence of the Law of the country and of the people. Faced with so many attacks on the 1988 Brazilian constitution and its precepts, the STF decision will be crucial to support or stop this behave.
If the ADI is judged as appropriate, it will be a great victory of the Brazilian people against the big pharmaceutical companies that will contribute to reaffirm the commitment of the State with access to medicines for all.
CIVIL SOCIETY PROTAGONISM
Due to the great impact caused by the pipeline patents in Brazil, the GTPI/REBRIP decided to challenge this patent mechanism. On November 28, 2007, the National Federation of Pharmacists (FENAFAR, acronym in Portuguese), representing the GTPI, presented to the Attorney General’s Office (PGR) a questioning regarding the constitutionality of pipeline patents seeking to annul the pipeline device. The questioning generated a Direct Action of Unconstitutionality (ADI/4234), currently underway in the STF.
Since 2009, the GTPI has demanded the judgment of the case through events, mobilizations, petitions and impact studies in partnership with universities. In this process, the GTPI has been the voice of people affected by these patents, especially in the field of HIV/AIDS, because several medicines used to treat AIDS were protected by the pipeline mechanism, thus consuming resources that could have been destined to other actions. In the judgment of next Wednesday 22th, the GTPI will make a speech, in which will be represented by the lawyer Renata Reis, former coordinator of the group and legal representative of the GTPI in the action.