Report from India

Patent applicants seem to be facing a conflicting approval environment in India. The Delhi High Court recently turned down a plea by Bristol-Myers Squibb (BMS, New York) to stop Ranbaxy Laboratories (Gurgaon, Haryana) from selling the generic version of its patented anti-hepatitis B drug Baraclude (entecavir), Enteca, in India. The landmark decision is viewed by industry experts as helping other domestic Indian companies such as Ahmedabad's Cadila and Hyderbad's Natco pursue the development and manufacture of generic drugs.

(PHOTO: IMAGE SOURCE, GETTY IMAGES)

At the same time, the Madras High Court restrained Matrix Laboratories (Secunderabad, Andhra Pradesh) from selling the generic version (Tarceva) of Roche's (Basel, Switzerland) cancer drug, Tarceva (erlotinib hydrochloride).

Although several Indian pharmaceutical manufacturers have won legal disputes with global firms over patents, it remains unclear whether Indian courts and governmental bodies are ruling in favor of domestic players.

Many recent court decisions have sided with Indian companies. Cipla (Mumbai) won a patent infringement case against Bayer (Leverkusen, Germany) regarding its kidney cancer drug, Nexavar (sorafenib). Ideal Cures, an excipient manufacturing company based in Mumbai, won a patent revocation case against Colorcon (Harleysville, PA). And Novartis (Basel) continues to fight for its claim on its cancer drug Gleevec (imatinib mesylate) in India's Supreme Court after being challenged by Cipla and Natco Pharma (Hyderabad, Andhra Pradesh).

In early October, India's Department of Industrial Policy and Promotion (DIPP) rejected proposals from the Organization of Pharmaceutical Producers of India (OPPI), a multinational lobbying group of drug manufacturers, to amend the Indian Patent Act. DIPP is the country's administrative department for patent issues and plays a key role in deciding the future of intellectual property regulations in India. OPPI, which supports multinational companies' ability to repatent drugs (known as ever-greening), had sought a review of a specific section of the Act that disallows patenting of incremental innovations without significant advantages. DIPP's decision seemed to favor domestic firms.

"OPPI presented its case before the Prime Minister's Office in August 2010,'' said Tapan Ray, the organization's secretary-general. "India is seen to have great potential to many big drug firms. That could be the main reason why there has been an increase in the number of applicants approaching the courts to enforce their patents or challenge the validity of patents," he said.

Added Ranjit Shahani, vice-chairman and managing director of Novartis India (Mumbai), "A patent is a reward for innovation, not a monopoly. All products that have had patents rejected here have patents globally. Clearly, there is something amiss."

Although Novartis' Shahani is an aggrieved party (his firm's Gleevec drug patent is protected in 36 countries but not in India), and OPPI aims to create and sustain an environment conducive to innovation and growth, the jury is out on whether the Indian government is outrightly siding with domestic drug majors. Tarun Shah of Mehta partners, an investment research and strategic advisory firm that caters to the pharmaceutical industry, countered, "Not all Indian companies come out smelling roses. It is the law of the land and judgments are given in a very impartial manner. These are not favoring Indian companies or multinationals. Judgments have gone in favor of either party."

Shah believes the numerous patent litigation cases pending in the courts represent a misinterpretation of the Patents Law of 1995 and the TRIPS agreement, the World Trade Organization's 1994 intellectual property rights law. "When we signed on, India decided to honor true and real discovery, not isomers and different salts. Most of the cases continue to argue on that score,'' he said.

A recent study by the Indian Pharmaceutical Association (IPA), a Mumbai-based industry group, points out that the Indian government has granted 86 patents since 2005 for drug products that were not breakthrough inventions, but rather, were a variation of existing products. IPA's secretary-general D.G. Shah says many of the patent claims, and especially those from multinational companies, do not necessarily enhance the efficacy of drugs already on the market. "It is an ever-greening strategy, to merely extend the period of patent,'' says Shah.

Added Novartis' Shahani, "Globally, the patent law has been honed for several years. In India, patent courts are learning the process.''

Despite the cases noted above which tend to favor domestic firms, the Indian patent office has also rejected many domestic applications during the past several years. The office rejected 14 oppositions filed by Cipla (the highest number among generic companies), 12 by Ranbaxy, 10 by Torrent Pharma (Ahmedabad), and 6 by Natco, according to G.G. Nair, patent expert and ex-president of the Indian Drug Manufacturers Association, a body formed to help Indian drug manufacturers and consumers.

"India cannot have a cake-walk in the patent courts, though the trend might look in favor of Indian companies,'' explains Nair. "But, take the US and Europe.... Both are taking extraordinary precautions to protect their own markets and are adopting measures which are construed [as going beyond WTO and TRIPPS protections.] Why then, point a finger at India? It is every country for itself."

A. Nair is a freelance writer based in Mumbai.