The End of R&D in India?

by buildingpharmabrands

The battle lines between the Big Pharma and Generic Companies are getting distinct by the day, as the turf war is escalating and extending form hitherto restricted areas such as exorbitantly priced lifesaving drugs for cancer and HIV to other chronic ailments like diabetes. What affect it will have on the rapidly growing pharmacy of the world, that is the US $13-billion-large Indian pharma market is not clear, but it may not going to be positive.

Two of the most recent cases on two successive days amplify the point of view of Indian Patent law clearly. One is yesterday’s rejection of Glivec patent to Novartis the International drug major, and the other is today’s report in Times of India of Glenmark’s launch of a more affordable version of the US-based Merck’s blockbuster anti-diabetes drug Januvia.

Rejection of Glivec’s Patent by Supreme Court of India

Pharma Times today, reported that in a landmark case, the Supreme Court of India has rejected Novartis’ application to patent an updated version of its cancer drug Glivec (imatinib), ruling that the product fails the tests of invention and patentability requirements of India’s patent law. “This decision now makes it clear that patents on medicines that we desperately need are less likely,” said MSF (Medicines Sans Frontiers) International president Dr. Unni Karunakara.

“The Glivec decision sets a precedent that would prevent international drug makers from obtaining fresh patents in India on updated versions of existing drugs. Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug, said Pratibha Singh, a lawyer for Indian drug maker Cipla, which makes a generic version of Glivec reported Pharma Times.

Glenmark’s Launch of Zita and Zita-Met  

Glenmark’s launch of Zita and Zita-Met, branded generic versions of Januvia, the Merck’s blockbuster anti-diabetic drug could also throw up a different patent challenge and it remains to be seen whether it would also take the compulsory license route used in case of anticancer drugs. The only difference is that the cost savings for patients in case of Glenmark’s anti-diabetic drugs is only 30 per cent or ₹ 5,000 a year, whereas in case of anticancer drugs it is quite substantial at US$ 2,600 a year for a generic version of Glivec as opposed to US $70,000 a year for the branded version.

An MSD India official has asserted that they will vigorously defend the patents of their anti-diabetic drugs, Januvia and Janumet as their patents are valid and enforceable. Furthermore, MSD has a comprehensive strategy for India, where there are over 65-million people with type 2 diabetes, to help address the challenge of reducing disease burden and to increase access to our medicines, including India-specific responsible pricing for these products.

Research-Based Pharma Responds

“We’ll continue to build our business, but we will be cautious in investments in R&D and innovation in India. And until the climate for intellectual property and the ecosystem is fully in place, I don’t think any investment in R&D will take place here,” Ranjit Shahani, Novartis India Chief told Bloomberg.

“Henceforth multinational pharma companies are likely to want their patents are first recognized in India before launch of patented products,” Ameet Hariani, a prominent attorney told Reuters.

Chip Davis, the executive vice president of advocacy at the Pharmaceutical Research and Manufacturers of America said in an interview to New York Times “ It really is in our view another example of what I would characterize as a deteriorating innovation environment in India. The Indian government and the Indian courts have come down on the side that doesn’t recognize the value of innovation and the value of strong intellectual property, which we believe is essential.”

The UK Outlook to Innovation and R&D

Contrast the current Indian scenario with the UK, where R&D has been languishing for quite sometime. Bio-industry Association has been able to persuade the government and herald the arrival of the patent box effective today and got a lower rate of corporate taxation. What is more, the government has also announced an above-the-line R&D tax credit of 10% offer. The outcome? GSK decided to invest a half-billion pounds in a new manufacturing facility and Astra Zeneca too committed an equally large sum to create a new R&D center in Cambridge.

Outlook for Indian Pharmaceutical Industry

What would be the outlook for Indian pharma industry that has been growing not only in India but also internationally at breakneck speed? What would happen to the research alliances and CRAMS opportunities? Would the perceived inadequate intellectual property protection discourage the research-based pharmaceutical industry and dissuade them from forging further alliances and affect its growth? Would there be any road blocks and access issues to highly regulated markets?

The initial responses of the multinational sector indicates clearly that they would think twice before investing in R&D and innovation in India.

The battle lines are clear and distinct. Which ever side you’re on this patent flight, the next few years should offer a clear example of the Rewards and Penalties associated with each strategy of a stronger or weaker IPR protection.

Will it mean an end of the road for R&D in India or a new road to Indigenous innovation?