Pipeline patents – Brazilian Supreme Court decides on the present and the future

On Wednesday 22 May, the largest trial in the history of the Brazilian Federal Supreme Court (STF) involving the pharmaceutical industry will commence.

Story first published by ABIA: Global AIDS Policy Watch

UPDATE: The hearing – along with justice and lower drug prices – has been delayed.
We will keep you updated, and please follow @GTPI on Twitter.

ABIA describes pipeline patents as one of the biggest legislative mistakes in Brazil’s recent history, one which wastes public resources by allowing unconstitutional monopolies on medicines.

The Court now has the opportunity to correct this mistake. If it judges in favor of the Direct Action of Unconstitutionality (ADI) 4234, proposed by the Brazilian Attorney General’s Office in April 2009, after a proposal made by GTPI in 2007. The appeal points out the unconstitutional nature of Articles 230 and 231, inserted in the Brazilian Industrial Property Law in 1996.

Why are pipeline patents a mistake?

Pipeline patents revalidate patents granted in another country. This presents serious problems:

  • The patent pipeline device grants patents without any type of examination, taking into account only the results of examinations carried out in the countries of origin.
  • 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’ from the Brazilian Congress to the pharmaceutical industry at the price of a huge loss to 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 World Trade Organization (WTO), a similar proposal was launched by the US. It was rejected by several negotiating countries, which already exposed it as a controversial mechanism.

What’s the impact?

This pipeline mechanism has allowed the granting 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 People (GTPI /Rebrip) identified 259 medicines covered by pipeline patents, of which 54 medicines are distributed in the public health system.

These patents are responsible for blocking the entry of generic medicines, allowing the pharmaceutical industry to charge extremely high prices. This has a big impact on the Ministry of Health’s budget and a knock-on effect on the quality of care provided to the Brazilian population. 

The pipeline, and the associated unmerited monopolies, is one of the main barriers in ensuring universal coverage of treatment. The treatment gap, as well as interruptions to treatment, compromises quality of life for millions of Brazilians, and results in unnecessary deaths.

It affects medicines that are on the Brazilian National List of Essential Medicines and are provided by the national health service (SUS) for the treatment of cancer, cholesterol, schizophrenia, Parkinson’s disease, autoimmune diseases and HIV.

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 HIV (nelfinavir, lopinavir/ritonavir, efavirenz, abacavir), and others.

It also affects medicines which are not distributed by the SUS but are commonly purchased directly by the public, including antihistamines, contraceptives, diarrhoea and constipation medicines and treatment for lung diseases such as asthma. 

Unconstitutionality can affect the future 

If the Court declares the Articles as unconstitutional, not only would it correct a historical mistake, but it would also help to put the brakes on over-patenting and patent abuse by pharmaceutical companies.

It could also help block further, new unconstitutional proposals around the automatic approval of patents, currently under discussion in the Executive.

The advancement of neoliberal policies around the world has seen some decisions being taken that are contrary to the law, with large corporations working to influence governments, legislators and lawmakers to facilitate their interests. The 1988 Brazilian constitution has faced many attacks in this way. The Court’s decision will be crucial in opposing this aggressive, corporate behaviour.

If the Court backs the ADI proposal, it will be a great victory for the Brazilian people over multinational big pharmaceutical companies, and help reaffirm the State’s commitment to access to medicines for all.

Civil society’s central role

Due to the impact caused by pipeline patents in Brazil, GTPI/REBRIP has been challenging this patent mechanism since 2007. The National Federation of Pharmacists (FENAFAR), representing the GTPI, presented a proposal to the Attorney General’s Office (PGR) seeking to annul the pipeline device. The proposal generated the Direct Action of Unconstitutionality (ADI/4234), which is now underway in the Court.

Since 2009, GTPI has been demanding that the case be judged, and has taken action though public events, petitions and carried out impact studies in partnership with universities. 

Throughout this process, GTPI has been the voice of people affected by these patents, especially for HIV medicines.

GTPI will make a speech in Court on 22 May, represented by the lawyer Renata Reis, former coordinator of the group and legal representative of the GTPI in the action.

Follow @GTPI on Twitter for updates.

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