Pharmaceutical companies appear to be aggressively pursuing—and securing—patents for drugs that would fall under India’s “frivolous patenting” guidelines that bar such incremental innovations from getting patent protection.
Several drug firms, mostly large multinational companies, have filed more than one application for a single drug, already patented, by making minor modifications. They are filing such applications at different patent offices in India.
India’s four regional patent offices are located in Mumbai, Delhi, Kolkata and Chennai. Since these offices operate independently without a coordinated single system to process these applications, many such patent applications on incremental innovations have already been granted patents, claims Anand Grower, a senior lawyer with Lawyers Collective, a Mumbai-based non-governmental organization that deals with issues related to health care and access to medicine.
The Indian Patent Act specifies that incremental innovations should not be granted product patents unless its efficacy is proved to be significantly superior to its generic product.
Indeed, just last week, a Madras high court panel rejected an appeal from Novartis AG over the Indian patent office’s rejection of the Swiss drug gia-nt’s patent application for its blood cancer drug Glivec, a beta crystal form of an existing molecule—Imatinib Mesylate—on the ground that it was only an incremental innovation. That high-profile legal challenge was seen by many as a test case for India’s new patent laws. But notwithstanding that decision, at least seven foreign pharmaceutical companies, including Merck & Co., GSK Plc., Hoffman La Roche, Boehringer-Ingelheim, Bayer Healthcare AG and Janssen Pharmaceutical NV, have filed two to three patent applications each for existing molecules with minor changes, according to Lawyers Collective.
A list of patent filings by these multinational firms revi-ewed by Mint shows that most of these applications are made for anti-AIDS drug molecules.
Prominent among these are the ones filed by Merck for its drug Raltegravir at the Delhi and Chennai patent offices; GSK’s three applications for its anti-AIDS drug Amprenavir filed at Delhi, Mumbai and Kolkata; and two filings of Roche for Saquinavir, another HIV drug, at Chennai.
Others include two filings by Boehringer for BILR 355 BS, a novel non-nucleoside reverse transcriptase inhibitor, filed at the Mumbai and Delhi offices, and two applications from Janssen for its anti-retroviral drug Rilpivirine filed at Mumbai and Delhi offices.
German drug maker Bayer has also filed two patent applications for its anti-tuberculosis drug Moxifloxacin at the Mumbai patent office.
According to Y.K. Sapru of Cancer Patients Aid Association, a health care NGO, this is a tactic used by the innovator companies to secure patents for various forms of the same molecule from different patent offices in the country.
“By doing this, they make sure that at least one patent is granted despite all the oppositions they anticipate in India,” Sapru says.
Prabudha Ganguly, a leading patent attorney in Mumbai, says drug firms are taking advantage of the current law, which allows companies to make their filings at any of the four patent offices provided they have an office in that part of the country. This was not possible earlier as the filing was restricted to the place of the company’s registered office only.
“Even if there are slight modifications in the form of the drug, it will make these applications technically different,” says Ganguly, who is an independent intellectual property consultant to pharmaceutical companies.
Girish Talang, managing director, Roche Scientific Co. (India) Pvt. Ltd, the Indian subsidiary of Holfman La Roche, declined to comment on the company’s patent filings. An email query to GSK India did not evoke any response. Officials from Merck and Bayer couldn’t be reached for comment.
According to Ranjit Shahani, president, Organization of Pharmaceutical Producers of India, a body which represents local subsidiaries of multinational firms, any innovation that enhances the efficacy of a drug should be recognized and it will ultimately improve quality of health care. Shahani is also head of Novartis in India.
Even as foreign drug companies lead the pack in filing applications for patents, Indian companies are not far behind.
While India’s largest research-based drug company Dr Reddy’s Laboratories Ltd has applied patents for two forms of Moxifloxacin, an antibiotic for treating tuberculosis, the Mumbai-based Lupin Ltd has filed six patent applications for the age-old tuberculosis drug Rifampicin and its combinations at the Mumbai patent office.
A Lupin spokesman said each of these applications are for different combinations of Rifampicin. An official from Dr Reddy’s Lab, who is not allowed to speak to the media and so did not want to be named, said the company’s patent application for Moxifloxacin is for the crystal form.
According to the data available with the pharma industry, there are about 9,000 drug patent applications currently pending with the four patent offices. A majority of the applications are filed by multinational companies.
While the US Food and Drug Administration approved only 327 new drugs for marketing during 1995-2005, the number of drug patent applications filed in India is several times that.
“About 95% of these 327 drugs are pre-1995 molecules, which are not patentable in India. So the actual number of basic molecules to get products patents here are only 16,” says K.M. Gopakumar, a research officer at the New Delhi-based Centre for Trade and Development, an agency that deals with trade practices related to health care.
This essentially means that most of the 9,000 applications are modified forms of new and existing molecules. “All these applications should come under the scanner of Section 3 (d) of the Indian Patent Act, which specifies that incremental innovations should not be granted product patents unless its efficacy is proved to be significantly superior to its generic product,” says Gopakumar.
Public health activist Amit Sengupta, who has campaigned for lowering of drug prices and is currently investigating drug patent applications as part of a study for the World Health Organization and the ministry of health and family welfare, says that “out of 9,000 applications that are in the mailbox, serious applications may be less than 100”. The mailbox mechanism was devised to store all the drug patent applications for the 10-year transition period, starting from 1995. These were opened on 1 January 2005 when the product patent law was implemented.
“There are a large number of duplicate applications filed as the same application has been filed in all the four regional patent offices. A lot of applications are merely for incremental innovations, combinations etc which can be struck down under Section 3(d),” said Sengupta.
The third category of frivolo-us applications are those that are on the same drug molecule but for newer therapeutic indications. Last of all, a drug molecule is fenced with multiple patent applications, creating what experts in this field called a “patent estate” or “patent thicket”, covering almost every aspect of that drug and thereby, making it harder for any patent challenger to break it.
Bhuma Shrivastava in New Delhi contributed to this story.