The international humanitarian medical organisation Médecins Sans Frontières (Doctors Without Borders/MSF) considers the lawsuit presented by the Brazilian Attorney General challenging the pipeline mechanism (articles 230 and 231) in the Brazilian Industrial Property Act (Act #9.279/96) a positive step towards the protection of public health.
In 2007, the Brazilian National Federation of Pharmacists (Fenafar), on behalf of the Brazilian Network for the Integration of Peoples (Rebrip), presented a proposal in the Supreme Court of a Direct Case of Unconstitutionality (ADI) against the pipeline mechanism. The pipeline mechanism makes it possible to retroactively patent, in Brazil, products that have been previously patented in other countries. This has led to patent protection for food items, medicines and other products.
During the period between May 1996 and May 1997, 1.182 patent applications were filed, in Brazil, through the pipeline mechanism, hundreds of which have been granted by now, including for essential drugs for HIV/Aids patients. These patents were granted based exclusively on the fact that other countries had granted patent to the same drugs, without being submitted to a national analysis. Therefore, Brazilian patentability criteria of novelty, inventiveness and industrial application were not applied in these cases.
Granting patents in the absence of any examination leads to the granting of invalid patents, especially because they did not fulfilled the novelty requirement anymore. As a result generic introduction of these products is not possible which leads to higher drug prices than needed.
The exclusivity rights allowed through the current international patent system is presented as a reward to the investment made on drug innovation. However, in principle, exclusivity rights are granted only if the invention to be protected fulfils the three patentability requirements: novelty, inventiveness and industrial application.
The patent protection of essential medicines which do not fulfil anymore the novelty requirement and result in the so called revalidation patents represents an undue appropriation of inventions already in the public domain. For this reason, the pipeline mechanism could be considered as a TRIPS-plus provision. According to the TRIPS Agreement, Brazil was only required to grant patents after 1995.
According to the recently approved World Health Assembly Resolution 61.21 – the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual property, led by the Brazilian government - countries are required to:
"Take into account, where appropriate, the impact on public health when considering adopting or implementing more extensive intellectual property protection than is required by the Agreement on Trade-Related Aspects of Intellectual Property Rights, without prejudice to the sovereign rights of Member State"
(WHA 61.21, 5.1b)
MSF has been monitoring the competition with generic medicines and considers it as the best way to effectively have price reduction. As an example, from 2000 to 2008, there was fall in the price of first-line combination of stavudine (d4T), lamivudine (3TC), and nevirapine (NVP), from more than US$ 10,000 to US$ 87 per patient per year, thanks to the generic competition. Currently, 80% of the anti-retrovirals (ARVs) procured by MSF are generic versions.
If the pipeline mechanism had not been incorporated into the Brazilian legislation, several medicines which take up an important share of the national health budget, such as the ARVs lopinavir/ritonavir, abacavir, nelfinavir and efavirenz generic could have been bought, in generic presentations, directly from India, paying a much lower price.
The challenge of the pipeline mechanism comes in fact in a moment when the whole patent system is being increasingly questioned by international organizations and countries, including Brazil. The step taken by the Brazilian Supreme Court, in accepting this case, demonstrates coherence with the advances of the international health agenda regarding public health innovation and intellectual property. MSF supports the Attorney General's move, which is certainly a step forward in favour of public health.