Pipeline patents put the Brazilian commitment to provide universal access to AIDS treatment under severe strain by granting unjustified patents on medicines, shutting out generic competition and keeping the price of drugs high.
But in a case with far-reaching consequences, the Supreme Court is looking at whether this measure is constitutional or not.
What are pipeline patents and how did they come about in Brazil?
In 1995, the World Trade Organization gave developing countries ten years to bring their laws into line with the TRIPS Agreement and grant patents on pharmaceutical products. Brazil, unlike India, chose to forego this ten year breathing space, and introduced patents on medicines as a part of its Industrial Property Act in 1996.
Under articles 230 and 231, the Act introduces what is known as the ‘pipeline mechanism’. This allowed drug companies to apply for patents on medicines that were invented prior to 1995, when the TRIPS Agreement came into force, provided such products were not marketed anywhere, and provided that there had not been no attempt to market the product in Brazil. With this measure, patents on medicines filed in another country well before TRIPS came into force are therefore also entitled to protection in Brazil.
What is the impact?
A period of one year was given for companies to apply for patent protection. During the established one-year period, 1,182 patent applications were filed in Brazil through the mechanism, many of which are considered essential medicines for diseases such as HIV/AIDS (the drugs lopinavir/ritonavir, efavirenz, abacavir, nelfinavir and amprenavir) or cancer (imatinib, sold under the brand name Gleevec).
This has led to patent protection on at least 340 medicines, keeping many of them well at artificially high prices by preventing competition from generic manufacturers.
The impact of pipeline patents on the Brazilian public health system is undeniable. Brazil is one of the few countries to offer universal access to antiretrovirals (ARVs), and pipeline patents have become a threat to the sustainability of this policy.
Patented medicines mean expensive medicines, so the purchase of over-priced medicines swallow up a large part of the public health budget. This jeopardises the sustainability of Brazil’s universal access to HIV treatment policy, by preventing the production or purchase of more affordable generic medicines.
Economists have estimated that the impact of purchasing five different treatments for HIV/AIDS, patented in Brazil thanks to these provisions, reaches up to US$519 million in extra, unnecessary expenditure, compared to the price of more affordable generic versions of the same medicines.
Why are pipeline patents controversial?
Firstly, because Brazil was not obliged to do this under international trade rules. Pipeline patents are a ‘TRIPS Plus’ mechanism, that is they introduce intellectual property barriers to accessing affordable medicines over and above what is the international minimum standard.
Secondly, granting pipeline patents means granting patents on medicines without actually examining whether they consisted in an inventive, novel step or not – in other words, a patent is granted in Brazil as long as a medicine was patented in another country. There was no attempt to assess whether the patent application meets the conditions set by the Brazilian patent authorities. The result is that patents were granted on medicines that don’t have the full novelty requirements to merit a patent in Brazil.
So what is happening to fight pipeline patents?
In 2007, the National Federation of Pharmacists (Fenafar) – on behalf of the Brazilian Network for the Integration of Peoples (Rebrip)- requested the Prosecutor General consider overturning the pipeline mechanism as unconstitutional. They argue that these patents should not be granted in Brazil because they had not gone through the regular analysis process for patent applications and because they go against the public interest.
In 2009, the Prosecutor General lodged a case for unconstitutionality with the Supreme Court. MSF-Brazil is actively following the case.
The Brazilian Supreme Court should revoke patents granted in an unreasonable manner. If the pipeline patents are ruled as being unconstitutional, the country’s public health authorities may immediately start purchasing, or locally producing generic versions of the drugs: a fundamental step in assuring patients a guaranteed access to essential medicines.