Leave formula in lab is activists’ prescription for drug companies

Leave formula in lab is activists’ prescription for drug companies

Crystal modification of a nphenyl-2-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use created history in Indian patent law.

If you are wondering what’s this mumbo-jumbo, here’s a hint: The invention relates to a new crystalline form of the methanesulfonic acid addition salt of 4-(4-methyipiperazin-1-ylmethyl)-N-[4-methyl-3- (4-pyridin-3-yl)pyrimidin-2-ylamino) phenyl]-benzamide of formula 1, which may be used for tumour therapy. Still befuddled?

Glivec’s filing is just one example of the many contorted or vague descriptions given by the innovators in the drug patent filings, complain public health activists. And the Indian generic industry is asking the government to lobby at the World Health Organization’s (WHO) health assembly in December to ensure transparency in the patent-filings procedures. The industry and the patients’ groups are demanding that the generic chemical name of the drug should be clearly spelt out in the title of the application itself.

“Prima facie, it appears trivial, but it is of vital importance for lifting the veil on the patent applications. The patent applicants now use complex chemical/molecular formula as title to hide identification of molecule," said D. G. Shah, secretary general of Indian Pharmaceutical Alliance, an industry lobby.

He wants the patent rules to insist that International Nonproprietary Name (INN or the generic name) be indicated in the title itself. For a completely new drug that does not have an INN—it should be added in the title of the patent application within 30 days of the grant of INN, says Shah who has written to the ministry of health and family welfare.

The ministry is a part of WHO’s Inter-Government Working Group on Intellectual Property Rights & Public Health and can take up the issue at the health assembly forum. If the WHO assembly stamps its approval, the matter could be taken up before global patent body World Intellectual Property Organization. Individual member nations can simultaneously go about changing their own patent rules to make INN mandatory.

The Indian law doesn’t demand chemical names of drugs but public health groups say this leaves room for drug companies dodging possible pre-grant oppositions. The patent office officials, meanwhile, say they can’t force disclosure of names by companies at the time of filing.

“We have found applications with no reference at all. It is almost impossible to identify the drug because there is so much vagueness (in the filing). The process thus becomes extremely tedious and lots of applications could slip through and get patents," said Kajal Bharadwaj, a lawyer with public health group Lawyers Collective who has first-hand experience of sifting through patent applications—an experience she describes as “beating your head against the wall."

India has provided for online filing of patents since July. Databases of the last two years are available on the website but give only the title, extract and brief description of the innovators. Any further information has to be paid for—Rs4 per page of filings that can range between 25 and 7,000 pages. And these databases are not searchable online.

Patent offices in the US, Australia, Japan and the EU nations give clear, detailed information on patent filings, free of charge.

“It is fairly ridiculous to claim that an application has been published when all the title says is ‘a novel pharmaceutical compound’ and the abstract is missing!" said drug price activist Amit Sengupta, general secretary, All India People’s Science Network. Sengupta is conducting a study on patents in India for WHO. Mint looked at the weekly online patent manual and found applications with titles such as “Delayed Release Dosage Forms," a “Topical Drug Delivery System" and an “Anti-microbial and Antiviral Product."

The Indian Patent Office, however, doesn’t see an issue there. “A common man is anyway not supposed to know the meaning of the abstract and title. Moreover, the published portion of the filing is just an indication and the whole document can be obtained at a fee. If the law tells us to provide it free, we will do that," said an official at the patent office who didn’t wish to be named. Moreover, drug names may not have been decided upon as patents are filed long before the drug is developed or launched commercially, he added. Patent controller general V. Ravi couldn’t immediately be reached for comment.

What is adding to the problem is the sheer number of applications. In 2005-06 alone, 3,736 drug and biotechnology patent applications were filed, roughly 4.25 times of the number filed in 2001-02, according to the annual report of the Office of Controller General of Patents, Designs, Trade Marks and Registrar of Geographical Indicators.

“We have to approach doctors, scientists and patients’ groups to make sense of the filings. That’s the reason, civil society has managed to file so few pre-grant oppositions," explained Bharadwaj of Lawyers Collective, which has so far acted as legal representatives in two post-grant and 13 pre-grant oppositions.

More than 9,000 drug applications are pending and more are being filed, “in a non-transparent" manner, she alleges, making the task costlier and harder.