A new online resource is now available to help the public and patient groups in developing countries challenge "unwarranted" drug patents.
The online 'Patent Opposition Database' has been launched by international aid agency Medecins Sans Frontiers (MSF), whose director of policy advocacy for its Access Campaign, Michelle Childs, said drug companies "routinely apply for patents or are granted monopolies on medicines even when these aren't actually deserved. It's a myth that every patent application that is filed is valid - when you look closely, a patent application may fail one or more of the legal tests it needs to pass," she says.
The idea behind the new database - which is accessible at www.patentoppositions.org - is to help the public and patient groups stop what MSF are calling unwarranted patents, that they say are blocking people's access to more affordable medicines. The agency points out that it relies on affordable drugs for its medical work in over 60 countries and that, in the case of HIV treatment, more than 80% of medicines used in developing countries are generics.
A "patent opposition" is a legal challenge to prevent or overturn the granting of an unwarranted patent, and is permitted under international trade rules as a way to keep checks and balances on pharma patenting, says MSF. In countries such as Thailand, Brazil and India, patent oppositions have successfully prevented undeserved patent monopolies from being granted and allowed generic competition to bring the prices of medicines down, it adds.
For example, successful patent oppositions by groups in India have enabled MSF to use affordable generic versions of key HIV treatments like lopinavir/ritonavir (Abbott Laboratories' Kaletra), it notes.
"Due to the volume of applications, local patent examiners can miss information and grant unjustified patents," says Vikas Ahuja, president of the Delhi Network of Positive People.
"Just putting two or three separate pills into one, or using known industry practices to formulate a drug, should not be considered innovative enough to warrant a new 20-year patent, for example. By filing patent oppositions, we can highlight this information and the possibility of invalid patents being granted is reduced," he says.
Examples include the opposition by Indian groups to GlaxoSmithKline's patent application in India on the HIV fixed-dose combination Combivir (zidovudine/lamivudine), on the grounds that it was not a new invention, but simply the combination of two existing drugs, says MSF, which points out that the combination is now widely used in HIV treatment in developing countries.
Also, a pre-grant opposition filed by the Cancer Patient Aid Association was the spur for rejection of Novartis' patient application on the salt form of Glivec (imatinib), on the basis that the medicine was merely a new form of an old medicine.The move, which is now the subject of a challenge before India's Supreme Court, opened up generic competition to Glivec, which is used in the treatment of chronic myeloid leukaemia and brought the price down by 92%, from over $2,158 to $174 per month.
"An unwarranted patent not only delays the entry of price-lowering competition, it also undermines the drive for genuine innovation," says Childs. "With very few innovative new drugs in their product pipelines, pharmaceutical companies desperately want to stave off generic competition by trying to get more patents on old molecules, or on processes that are not new."