In an attempt to delay launch of low priced generic medicines, multinational drug makers have asked the government to create a registry providing information about all drug applications pending manufacturing and marketing approval.
The proposal, if accepted by the government, will help the Big pharma pre-emptively challenge generic drug makers in court for allegedly infringing upon their patents and in turn blocking or delaying the entry of the low cost version of the drug in the market.
The health ministry has vehemently opposed the proposal on grounds that it will not only be “unfair to local drug manufacturers to disclose their product strategy” but also has “the potential to substantially increase healthcare costs for the public” as launch of generic products will get delayed through litigation, a senior official said. He added, such information about product applications filed for approval are not disclosed anywhere in the world.
However, the proposal is still pending with the Department of Pharmaceuticals (DoP) – another wing of the government that looks into pharmaceutical industry under the Ministry of Chemicals and Fertilizers.
“… it is pertinent to point out here that inadequate information in respect of pending applications for such market authorisations/manufacturing licenses and grants on the CDSCO website poses a significant challenge for the innovators in tracking potential infringers and obtaining timely reliefs from the appropriate Court of law,” the Organisation of Pharmaceutical Producers of India (OPPI) said in its proposal, reviewed by TOI.
OPPI – which represents multinational pharmaceutical companies and advocates issues related to research and protection of intellectual property rights – recently tabled the proposal in an industry consultation meeting with the drug regulator. The meeting was also attended by DoP secretary Jai Priye Prakash.
“OPPI is seeking to outsource its task of finding potential patent infringers to the drug regulator. The regulator’s mandate is to work towards effective and safe medicines and not to be a tool in the hands of innovator pharma for the sake of ‘pre-emptive patent litigation’,” says Malini Aisola of All India Drugs Action Network – a public health group advocating access to medicines.
According to Aisola, OPPI’s proposal is against the present legal framework that categorically excludes linking marketing approval of drugs with patents.
In the past, the Supreme Court has prohibited multinational pharma companies from blocking regulatory approvals to low cost versions by linking their marketing approvals with the patent status of original products.
The latest proposal from OPPI do not directly talk about ‘patent linkage’. However, it says information about drug applications filed with the regulator for approval will “put the innovator on a constructive notice and help alleviate some of the concerns that the research-based” industry faces in India.
“Interim injunctions in cases involving biopharmaceuticals are possible only in cases when the innovator is able to move the Court prior to the infringing products being launched in the market or else they are generally denied on the grounds of public interest or lack of prima facie case,” the OPPI said.
The Indian pharmaceutical market is pegged at over Rs 1,27,000 crore annually. Only around 9% of this market is patented medicines.
“OPPI’s proposal has no legal foundation nor does it bring in any health benefits to patients. It is simply trying to use public resources towards the protection of patents which are private rights,” Aisola said. – The Times of India