Generics face uniform patent norms threat

Patients suffering from swine flu in India have a choice of buying the medicine oseltamivir from Natco Pharma, Hetero Drugs and Strides Arcolab, etc all of whose brands are available in the market.

This would not have been possible had the Delhi Patent Office in April granted a patent to the US based Gilead Science Inc’s oseltamivir, which is marketed as Tamiflu.

Had the patent been allowed, Roche, to whom Tamiflu is licensed, would have had the
sole rights to sell the drug through its Hyderabad based licensee Hetero Drugs.

The patent application was rejected on basis of a pre-grant opposition by generic drugmaker Cipla that Tamiflu did not have inventive step which is a pre-requisite to get patents in India.

Likewise, patents for other drugs like Pfizer’s Caduet (for high cholesterol and high blood pressure), GSK’s rosiglitazone salt (diabetes), Novartis’ alpha crystalline form of Glivec (chronic myeloid leukaemia), Gilead’s Hepsera (hepatitis B) and tenofovir (HIV/AIDS) and Tibotec Pharma’s darunavir (HIV/AIDS) were rejected in the recent past on grounds that the drugs did not meet all requirements of Indian patenting.

Section 3 (d) of the Indian Patent Act, 1970 — which holds that mere discovery of new form of known substance which does not result in the enhancement of known efficacy of that substance shall not be treated as an invention — has played a key role in patent rejections for some of the above drugs.

However, the provisions like section 3 (d), pre-grant opposition, etc which have prevented “frivolous” patenting, thereby making generics easily available in the market, could get watered down if intellectual property (IP) harmonisation efforts at the World Intellectual Property Organisation (WIPO) fructify.

At WIPO, which is a specialised agency of the United Nations, developed countries are pressing for a harmonised IP infrastructure, which would imply a harmonised patentability criteria and patent examination procedures.

Says an IP expert from New Delhi who was present at the WIPO general assembly in Geneva last month, “It would lead to a one-size-fits-all approach towards granting of patents as the scope and coverage of patent protection would become uniform globally.”
He says the provisions of the Patent Act are a reflection of the ground realities of the country. “India has pre-grant safeguards in the patent law to protect the public health needs and also provisions to curb frivolous patenting. But a harmonised IP system can change all this.”

If IP harmonisation takes shape, the Patent Office in India would have to take into consideration the patent examination reports of developed world like US, EU, etc while deciding on a patent grant in India, says a healthcare and legal expert.

“Tamiflu is patented in US, but not in India. Due to harmonisation, while deciding on the patent for Tamiflu or any other drug,

the Patent Office here would have to take into account the fact that the drug holds a patent in US or any other developed country,” says the expert.

Furthermore, experts also say that IP harmonisation goes beyond what is mandated by the trade related aspects of intellectual property rights (TRIPS) agreement of the World Trade Organisation (WTO), which India is a signatory to.

Says the Delhi based IP expert, “TRIPS allows countries some leeway in moulding their patent systems according to their domestic needs and state of development. TRIPS leaves it to individual countries to decide their patentability criteria within the norms of novelty, inventive step, and industrial application,” says the expert, adding that TRIPS only requires countries to have a 20 year patent term and product patent regime, both of which India has already implemented.

However, the multinational pharma lobby, Organisation of Pharmaceutical Producers of India (OPPI) feels that in order to facilitate India’s further integration into the international economy while at the same time protecting our national interests, the government should support efforts for reforms at the WIPO.

Says Ranjit Shahani, president, OPPI, “IP harmonisation could possibly make available almost parallely all new global introductions related to niche indications (unmet medical needs) to Indian patients. Moreover, possibilities of Big Pharma investing in R&D infrastructure for TB, leprosy, would increase if there is meaningful implementation and harmonisation of IP.”