Pharma companies who want to have patent rights for specific products must fulfil all the efficacy test criteria. This is mandatory as per Section 3(d) of Patent Act for pharmaceuticals, said Dr S P Subrahmanian, assistant controller of patents and designs, government of India.

Dr Subrahmanian was delivering a lecture on ‘Impact of Section 3(d) in the pharmaceutical patent act’, at the one-day seminar organised by IPA-Tamil Nadu branch and the Tamil Nadu Pharmaceutical Sciences Welfare Trust in Chennai last Saturday.

He said if the manufacturers give attention to new chemical entities, the patent rights granted to them will help for future business growth. On the manufacturing side, India can go high and expand the country’s business in the developed nations also. Once the patent is granted, the company will have the monopoly for the product for the next 20 years, not only in the country, but also all over the world, he said.

According to him, after the introduction of Section 3(d) in the Patent Act 2005 amendment, more attention is being paid to the process of granting patent rights. Section 3(d) refers to chemical substances, more particularly pharmaceutical substances. This clause, which is in force only in India, gives additional conditions for granting patents. As per Section 3(d), the new form of a known substance must fulfil efficacy test criteria.

The Patent Act was enacted in India in 1970. Till then India was following the British system of granting patent rights. On the basis of 1970 provisions, patent for process or method of manufacture of medicines and food was being granted. India signed WTO and TRIPS agreements in 1995. Between 1970 and 1995, several pharma companies flourished largely in several parts of the country with many generic manufacturing. The provision of process patents helped anyone to make the same product with different process. The product patent came into force in 2005 amendment, which allows only the person who has the patent, to manufacture the product anywhere in the world, said Dr Subrahmanian.

He further said, in order to compete with pharmaceutical companies in the developed nations, the Indian pharma companies should concentrate on innovation of new drugs in addition to their work on generics. Similarly, focus should be given to research and development activities. Or else, Indian companies cannot survive.

J Jayaseelan, secretary of Tamil Nadu IPA, welcomed the audience and presented papers for discussion.