85% drug patents granted sans scrutiny

The cost of drugs for grave illnesses has gone through the roof, and the Indian Patent Office (IPO) has reportedly been granting patents not just for minor tweaks on pre-existing drugs but also without proper scrutiny.

A recent report by a tri-continental non-profit titled 'Pharmaceutical Patent Grants in India: How our safeguards against evergreening have failed, and why the system must be reformed', shows immense irregularities in the grant of patents in the country.

The Innovation & Access to Medicines in India, Brazil and South Africa, or accessibsa, analysed 2,293 patents granted by the IPO between 2009 and 2016 for drugs to tackle tuberculosis, diabetes schizophrenia and obesity among others. Of these, 1,654 patents were 'secondary', that is, granted for marginal improvements over known drugs for which primary patents exist. Up to 1,405 of these were granted without proper scrutiny, the report claims.

Secondary patents are claimed on different dosage formulations or production methods of a drug which has already been granted a primary patent for innovation.

Only a small fraction (15%) of the secondary patents granted were subjected to elaborate scrutiny, accompanied by a detailed order of the IPO controller, the report states. In most cases, the final order did not clearly cite what the innovation was that warranted a patent, it states.

After the Supreme Court blocked pharma giant Novartis's seven-year-long attempt to patent cancer-treatment drug Gleevec in India, it also put in place stringent rules for patentability, which the latest report shows have not been followed by the IPO.

After the Novartis case closed in 2013, as many as 217 patents were submitted. In 50 of these, questions were raised about whether the drug had any proven therapeutic efficacy.

"No applicant made relevant submissions of clinical data to demonstrate therapeutic efficacy as stipulated by the SC decision in 2013 relating to Novartis' secondary patent," the report states.

Poor Checks 

Of 1,654 ‘secondary’ patents granted by the IPO between 2009 and 2016, as many as 1,405 were granted without proper scrutiny, the report by a tri-continental non-profit claims.