J&J gets patent for ARV drug Etravirine [India]

US major Johnson and Johnson (J&J) has been granted a patent for its anti retroviral drug (ARV) Etravirine in India—the second anti-ARV drug to be patented in India. Pfizer, the world’s largest drug maker, received a patent for Maravoric last year, which made it the country’s first patented ARV drug. The drug got the US Food & Drug Administration’s (FDA) approval in January 2008. J&J received the Indian patent from the Mumbai patent office recently.

The drug already has a US patent and is used in combination with anti-HIV drugs to treat patients who develop resistance to multiple HIV drug medication. The drug is marketed by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson, under the brand name Intelence. It is not immediately known the kind of impact J&J’s approval will have in India which has 3 million HIV patients in the country. Experts say that the drug could help prolong the use of a particular drug in a patient.

However, being a new drug its efficacy and relevance in developing countries like India is yet to be tested. NGOs and patient groups are studying the possible impact of the patent before deciding whether to file a post patent opposition against the drug. Interestingly, industry sources claimed out that J&J may use the approval not only to target the Indian market but also as a tool to stop any Indian generic competitor from manufacturing cheap copies of the drug and exporting it globally. Similarly, a patent in India will also make J&J case much stronger when it seeks patent in other developing countries. Since India became Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant in 1995, manufacturers can patent their products in India and enjoy a monopoly over marketing that product for 20 years. Global pharma companies have been aggressively filing patent applications across the country and some of them have been successful in getting patent protection in the country. However, patient groups and NGOs have been strongly opposing many application saying that the drugs are not new products but mere innovations.

Drug makers concerned over compulsory licensing [India]

Local units of multinational drug makers — who make billions of dollars of revenues from drugs protected by patents — say they are increasingly worried over a vigorous push by Indian peers to revoke such protection through what are called compulsory licences, and questioned such efforts in the absence of a national emergency.

Local drug makers, who make most of their revenues from sales of non-patented or generic drugs, are exploring the use of a controversial public health provision in global trade laws called compulsory licence that allows the World Trade Organization’s member-nations to override patents and permit cheaper versions of patented drugs. This provision can be invoked if a drug maker is willing to make and supply copies of patented drugs in a medical emergency or to export to least developed countries, which are yet to be covered by the TRIPS, or the Trade-Related aspects of Intellectual Property Rights, regime and entitles the patent holder to an “adequate remuneration”.

It was reported on 29 January that Hyderabad-based Natco Pharma Ltd’s request for compulsory licences on two patented cancer drugs could emerge as a larger trend. Natco Pharma is seeking licences for Sutent, a renal cancer drug of Pfizer Inc. and Swiss F. Hoffmann-La Roche Ltd’s lung cancer medication, Tarceva, which costs Rs1.5 lakh for a month’s treatment—nearly four times the Indian per capita annual income. Sutent, awaiting a patent grant in India, is likely to be priced at $4,000 (Rs1.57 lakh) for a six-week treatment.

Expressing concern that patent provisions could be misused to make products available illegally in the Indian market, Pfizer Ltd’s managing director Kewal Handa said in an email response, “This would be a clear disregard of Indian patent laws.” He added that if continued, this would take the country back “to the pre-product patent era.” He expects the judiciary and the Indian government to “uphold the spirit of innovation.”

The top executive at Novartis India Ltd said the move was unjustified in the absence of a national emergency for which compulsory licensing is designed. “Generic drug makers talk of evergreening of patents but this is (cutting short) patents. What signals are we giving to the global drug makers?” asked Ranjit Shahani, managing director of the Novartis unit. Makers of patented drugs are often accused of trying to extend the life of patents beyond 20 years, a tactic commonly called patent evergreening.

Roche Scientific Co. (India) Pvt. Ltd’s managing director Girish Telang declined comment.
Cipla Ltd, one of country’s largest drug makers, is fighting Roche over the latter’s patent in India for Tarceva in the Delhi high court, though the Indian firm is not asking for a compulsory licence on it.

Foreign drug makers also point out that they run patient access programmes to deliver their patented drugs to those who can’t afford it, though patient groups argue the reach of such initiatives is limited. Pfizer, for instance, has recently put together a Sutent Patient Access Programme that will partly or fully subsidize treatment options for patients in India and expects to extend it to Nepal.

Novartis’ Glivec International Patient Assistance Programme helps some 7,000 patients of myeloid leukaemia, the company says on its website. Novartis is fighting in court and at an appeals tribunal the rejection of a patent for the cancer drug by Indian authorities.

Indian drug majors in line for patent protection

It’s not just global drug discovery majors that are seeking patent protection. Out of the 8,000 drug patent applications in India filed between 1995 and 2004, about 40% are from Indian pharma companies. Domestic majors such as Ranbaxy Laboratories, Dr Reddy’s Laboratories and Cipla have filed over 100 patent applications each.

Between 1995 and 2004, the Indian patent office received over 8,000 patent applications related to medicine. Ranbaxy Laboratories, India’s largest drug maker, has claimed protection for 112 drugs during the period, including few which are at various stages of clinical development. In addition, Ranbaxy has also filed 30 patents in 2006, including seven for new drug delivery systems (NDDS), which are in advanced stages of development.

Similarly, other pharma majors such as Cipla and Dr Reddy’s Laboratories have each sought protection for over 100 drugs, says Dr Amit Sengupta who reviewed the mailbox applications in India in collaboration with the health ministry.
However, many of these applications, both from global MNCs and Indian companies, are frivolous which may not qualify as a candidate for a patent. According to Professor Carlos M Correa, a former member of the World Health Organisation (WHO) Commission on Intellectual Property, Innovation and Public Health (CIPIH), many of the patent applications worldwide are merely ‘new laboratory techniques’ and therefore would not qualify for patents.

“The pipeline of discovery drugs are drying up. While there are around a million applications in the US, only 20 new chemical entity (NCE) got US Food and Drug Administration’s approval in 2005 compared to 51 in 1997,“ he said.
Companies are now merely tinkering with the existing drug and seeking patent applications for the same. Only 2-3 application from each of the Indian companies are serious contenders for a patent, Dr Sengupta added.

However, some innovator companies feel that there are many innovations which deserve patent protection. “Innovations are either patentable or non-patentable. Patent offices are getting mature to weed out those inventions which do not merit a patent and one should look at the actual data of patents rejected before a claim like this is made, “ Novartis India vice-chairman and MD Ranjit Shahani said.

Since India became trade-related aspects of intellectual property rights (TRIPS)-compliant in 2005, both global and Indian companies have rushed to claimed protection for new drugs or innovations. If drugs get patented, the innovator company will get exclusive marketing right for 20 years. Few global companies have already got patent for drugs in cancer, anti-Aids and other therapeutic areas.