India considers more compulsory licences
A government-appointed panel in India is preparing to evaluate more patented drugs for local generic pharmaceutical companies to mimic, according to reports.
A Bloomberg report said that the panel will consider assessing drugs for the treatment of HIV and diabetes, a move away from the cancer drugs it studied last year. The drugs would come under compulsory licence orders, the report said.
The panel will study 20 drugs and recommend that the government assigns about three compulsory licences, the report said, citing unnamed sources.
The products include Merck’s diabetes drug Januvia (sitagliptin) and HIV medication Isentress (raltegravir), and Bristol-Myers Squibb's medicine for diabetes Onglyza (saxagliptin) and arthritis drug Orencia (abatacept).
As laid out in the TRIPS agreement, countries may issue compulsory licences without the patent holder’s consent if they are in the public interest.
So far, one compulsory licence has been issued in India, which allowed local pharmaceutical company Natco Pharma to make its own version of Bayer’s kidney cancer drug Nexavar.
Bayer has unsuccessfully challenged the compulsory licence on two occasions.
Tarun Gandhi, a patent attorney at Chadha & Chadha in New Delhi, said that the issuance of compulsory licences affects how branded pharmaceutical companies price their products: “A lot of pharma majors like Roche (Herceptin’s price dropped by 30 percent in India) have already slashed prices of their drugs,” he said.
He added: “I believe the issuance of compulsory licenses has created a sense of scepticism in the minds of branded pharmaceutical companies regarding the enforcement of their patent rights in India. They fear dilution of IP laws would be atrocious for innovation. They have been forced to review their strategy in India and discouraged to file patent applications in India.
“However, the recent decisions (especially the Dasatinib compulsory license decision) in this respect have clearly reflected that every case is decided on merits and they need not fear compulsory licenses. This must boost their confidence in the Indian patent regime.”
Neither Merck nor Bristol-Myers responded to LSIPR’s requests for comment.
