INDIA BUSINESS WORLD - FEBRUARY 2007
The Month that was ...

COPYCAT DRUG COS CONVERT, BACK MNCS ON PATENTS

Once known for trashing patents and denouncing prohibitive pricing by big pharma, Indian generic companies have changed their stance. Many have now begun siding with the multinationals to support the grant of patents for incremental inventions in India.

The main reason behind the change is that companies are themselves working on incremental innovations like new forms, derivatives and new drug delivery systems of existing molecules, for which they will seek patent protection in India. Also, as Indian companies bid aggressively for overseas assets and tie-up with global pharma companies for manufacture and research, there is a pressing need for them to change their image of 'copycat manufacturers'.

Under pressure from domestic companies, the government in 1970 had abandoned the idea of a product patent regime, allowing only process patents. There are globally three types of patents: patents on the molecule, on the process of manufacturing or on the drug delivery system. Today, these same companies are encouraging the grant of patent not only for new molecules, but also for incremental inventions molecules which have been slightly modified from their original form, or to which a new substance has been added.

"We are of the opinion that incremental innovations in terms of developing new forms, new derivatives and new delivery systems of existing drug should be granted patent protection provided they are new, involve an inventive step and have commercial utility," said Ranbaxy Labs in an annex to Dr RA Mashelkar's report on the patent bill. "This will provide the necessary fillip to development of novel drug delivery system in our laboratories." The company continues to maintain its stance though the Mashelkar report has now been withdrawn.

After the amendment was introduced in Parliament in March 2005, the commerce and industry minister referred it to an expert committee, headed by Dr RA Mashelkar, for detailed examination. In an annex to Dr RA Mashelkar's report on the patent bill, the Indian Pharma Alliance (IPA), one of the industry's largest trade bodies, has taken the position that patents should be granted exclusively to new molecules.

It cannot be argued that incremental innovation is not innovation and is therefore not patentable. Restricting patents only to new chemical entities could hurt both MNCs and Indian companies.

Nicholas Piramal is working on a new version of Novartis' cancer drug Gleevec (known in India as Glivec). "We are shooting ourselves in the foot. Incremental inventions should be patented in India. If not, we will not be able to patent and launch in India our version of Gleevec, although our drug will be much more affordable than Novartis' for cancer patients," said a company official.

The grant of patents has however opened the door in the West to a phenomenon referred to as 'ever greening', whereby the patent holder files a fresh patent on trivial modifications made on the molecule to extend its monopoly beyond the 20-year period granted for the original patent.

In order to prevent pharma companies to unfairly extend their product's patent life, the Indian government has introduced in the Indian patent law a legal provision -section 3 (d)- that stipulates that modifications of already known medicines cannot be patented, unless they make the drugs significantly more effective.

However, most domestic companies still feel that section 3(d) is necessary to prevent any abuses. Patents should not be given to cosmetic modifications and improvements that do not fundamentally alter the clinical profile and therapeutic value of the drug. Seeking patents for such modifications aims at evergreening.

However, section 3(d) has many gray areas. There is a need to define and provide guidelines for understanding the term 'efficacy' in the rules so that frivolous inventions do not get patents. Examination will have to be rigorous and follow the guidelines to be given in the rules.

A large section of the domestic pharma industry also still claims that allowing patents for incremental innovations, regardless of efficacy, will have a negative impact on access to healthcare in India.