As first reported in FE on Tuesday, a clutch of additional safeguards to allay domestic concerns in this regard were incorporated in the Bill before it was put to vote in the House.
In the Bill, the scope Of patentability has been restricted by elaborating on Trips-mandated terms namely inventive step and new invention. A patentable pharmaceutical substance has been changed to any new entity involving one or more inventive steps. It has been made clear that new use of a previously known entity will not qualify for patents.
Facility for pre-grant opposition considered to be weaker after the Ordinance than before the Ordinance was passed has been retained as it was before the December amendment with all eleven grounds. Generic producers of possible patents arising out of Mailbox filings (a transitional mechanism for seeking product patents in the relevant sectors for 1995-2005 inventions) can continue to manufacture and sell those drugs, if they had begun the activities prior to January 1 05. Such producers, however, will have to pay reasonable royalty to the patent-holder to escape infringement proceedings.
Commerce and industry minister Kamal Nath who moved the amended Bill also agreed to refer two contentious issues pertaining to new chemical entities and micro-organisms to an expert committee. If the expert committee finds more safeguards and flexibility was needed on these, the government would bring in necessary amendments to the Bill, he said.
In what could facilitate export of patented drugs produced under compulsory licence, procedures for such exports permitted under Doha Declaration have been eased. Also, exports under such licence which is Trips-complaint tool to meet domestic as well as global public health exigencies will now be allowed even as the licence is meant predominantly for domestic supply. The patent holder will now be required to respond to a request for initiation of CL under a specified clause within six months in ordinary cases.
Domestic drug industry welcomed the amended Bill with certain qualifications. We are happy that many of our concerns including that on patentability and pre-grant opposition have been addressed. However, compulsory licensing procedures should have been made simpler and easier. Patent-holders right to oppose CL invocations should have been curtailed, said G Wakankar, executive director of Indian Drug Manufactures Association. It would have been better had the patent-holders right to scuttle R&D work did not accrue to it prior to patent grant, said DG Shah, secretary-general, Indian Pharmaceutical Alliance.
Curiously, multinationals, however, pointed out that the restricted scope of patentability would in fact be to the detriment of domestic companies than theirs. In the short to medium, few Indian companies can discover new chemical entities (NCEs), which continue to be more or less an exclusive domain of large MNCs like Pfizer. Indian scientists and companies are however capable of incremental inventions which the re-definitions have now excluded from patenting, pointed out S Ramakrishna, senior director, Pfizer India.