Details of patented drugs to be made public

Details of patented drugs to be made public

Mumbai: To increase transparency, India’s patent regulator will soon make public details about patented drugs which include whether domestic demand for these medicines is met at a reasonable price.

Patent holders in the country are required to submit once every year the so-called working details which include the quantity and value of a product that is sold, manufacturing base, quantity of production or imports, and a statement on whether public requirement has been met partly, adequately or to the fullest extent for a particular drug at a reasonable price in a statutory format called Form 27.

“We will put all the details compiled from Form 27s filed by the patent holders on our website from June onwards," P.H. Kurian, India’s controller general of patents, designs and trademarks, said on Friday.

Many companies, which sell high-value drugs under patent protection, are lax in disclosing mandatory data about the working status of their patents in the local market, Mint reported on 7 April.

“Since most of the patented drugs are costly and the access is a critical issue, it is very important for the public to have this information," said Shamnad Basheer, a professor in intellectual property law at Kolkata-based National University of Juridical Sciences.

The data on the working status of patents is also useful for companies capable of producing the same products in the local market because they can then apply for compulsory licences in case a patent holder is unable to meet domestic demand.

India allows generic versions of some patented medicines to be produced and sold by third parties without the consent of the right’s owner to ensure availability of the drug at a reasonable price in case of public health emergencies and some other circumstances, such as a company abusing its dominant position in the market.

“It’s an important move and will certainly help the generic industry to come up with compulsory licence applications based on the information, which is filed by patent holders themselves," said Dilip G. Shah, secretary general of Indian Pharmaceutical Alliance, an industry lobby of local drug makers.

“Making such information available to public through official websites or not is the discretion of the government," said Tapan Ray, director general of Organisation of Pharmaceutical Producers of India, the lobby of foreign drug makers, which hold most patent rights on drugs in the local market. “Even otherwise, it is available to the public through the RTI (Right to Information Act)."

An RTI disclosure in April had revealed that some large multinational drug makers, including Pfizer Inc., Bristol Myers Squibb Co., F. Hoffmann-La Roche AG, Bayer AG and Schering (currently owned by Merck and Co. Inc.), did not disclose all mandatory information about the working status of their patents and some filed the returns only occasionally.

The companies involved had denied any wrongdoing.

The RTI was filed by a group of lawyers, including Basheer, last year to access the information on seven life-saving drugs sold in India under patent protection.

Failing to submit Form 27 and furnishing inadequate or wrong information are punishable offences under India’s Patents Act. It attracts a penalty of up to 10 lakh per patent.