from the keep-taking-the-medicine dept
Last week Techdirt reported on an important decision in India to allow the production of a generic version of a kidney and liver cancer drug, with huge savings for the Indian health system, and major effects in terms of lives likely to be saved. Now Intellectual Property Watch has news of a court case in Brazil that could have equally important consequences for the local use of generics:
Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS drug, effectively allowing less expensive generic versions into the country, and calling into question other such patents.
Here's why the case is setting a precedent:
A leading feature of the case is that the patent was granted under the "pipeline" process, which allowed "revalidation" of patents granted in other countries while Brazil was modifying its patent law for certain new areas including pharmaceuticals.
The "pipeline" process refers to a mechanism for granting patents in technological fields that had earlier been excluded under Brazilian law, using the date of the first filing for patents elsewhere. This allowed companies to extend the reach of patent monopolies already obtained outside Brazil without needing to go through that country's patent application process.
The judge in this case ruled that the pipeline process was unconstitutional, according to sources.
Lack of constitutionality had been raised back in 2008 because of the way that pipeline patents diminished the public domain:
"The concession of pipeline patents also violates the acquired right of the collectivity by removing from the public domain knowledge belonging to everyone, which once again goes against society’s interest," said Renata Reis, an attorney at the non-governmental Brazilian Interdisciplinary AIDS Organization.
Among the drugs that were removed from the public domain by the pipeline process is the ritonavir/lopinavir combination, the subject of the judge's order annulling Abbott Laboratories' patent. Not surprisingly, the company has said that it will appeal the decision. But if the ruling is upheld it may lead to other patents granted to drugs through the pipeline process being invalidated too.
Taken together with the Indian decision, this latest ruling emphasizes the increasingly important role of generics in global healthcare. That's another reason why both ACTA and the Trans-Pacific Partnership agreement are problematic.
ACTA, for example, allows generics to be seized in transit on the basis of complaints about names that are "confusingly similar" to a brand-name drug. TPP, meanwhile, would bring in a range of measures to make it substantially harder for companies to produce generic versions of patented drugs in signatory nations. The divergence between what the BRICS countries are doing in this area, and what plurilateral treaties like ACTA and TPP seek to mandate, is another reason why it is unlikely the former will ever sign up to the latter.