Ground Report

The recent statement made by Ranjit Shahani, Vice Chairman and MD, Novartis India Ltd, to a scientific magazine clearly indicates that Indian patent laws do not encourage world-class research. It is noteworthy that the most important step that India took was to move from a process patent to product patent after 35 long years. But many now questions this to make it world –class, WTO and TRIPS agreement compliant. These are no other than the major MNC in Pharmaceutical and Drug discovery and Research business. Novartis is one of them, which had spat with Indian Patents Office for getting the patent denied for Glivec. The disagreement is over the Section 3(d) of Indian Patent laws which states that incremental innovation is not patentable.

Glivec is used to treat chronic myeloid leukemia. This drug is highly priced and Novartis sells it in for $26,000 per year; whereas generic-drug manufacturers offer the drug at less than one tenth of that price. However, the company emphasizes that 99% of Indian patients now receiving the drug as free through the company’s patient-assistance program

The Indian Patent Law is challenged by Novartis in Chennai High Court since 1st January, 2005, stating that this is not the incremental innovation rather it is the patentable innovation because this is the innovations, which has a tremendous impact on healthcare outcome. It might not be a breakthrough innovation but whatever steps are taken, it can have a positive impact on healthcare. It is suggested in the case of Glivec, the original salt imatinib mesylate by itself has no value but the beta crystalline salt, which later becomes Glivec, a potent drug to cure chronic malign Leukemia.

The 1993 patent was for synthesizing the molecule of imatinib and represented the first step in the process to develop Glivec. It is important to understand that this molecule was not suitable to be taken by patients in the form of pills. Therefore, it was necessary to develop first the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take the medicine in pill form. This beta crystal form of imatinib mesylate is the active ingredient of Glivec, which is the only medicine that has ever been marketed by Novartis worldwide as Glivec.

Reportedly Glivec has been given a patent in 40 countries. It is a breakthrough research and a therapy which has changed the direction in which research is done in the area of cancer. Time magazine called it the magic bullet and FDA had held a press conference when it was launched which it rarely does.

At this juncture as lauded by most of the innovator companies of the world, which are in true sense pharma giants, Indian laws are not world-class compliant and do not encourage world class research. This is not innovator friendly country as seen  from the fact that the product patent came to India in 2005 and between 2005 and 2008, there were five MNC companies who invested in R&D in China like Novartis, AstraZeneca, GSK, Sanofi Aventis and Pfizer but not a single investment came to India.

Innovation is the life blood for pharmaceutical companies. If there is no innovation there will be no new drugs and all the unmet medical needs will be pending. India has a great opportunity both in terms of scientific pool, demographic dividend, the cost structure, the patient pool. However, in terms of WTO and TRIPS,  Indian Government need to oversee the interest of the domestic manufacturer of the drugs, which has been catering the need of the medicines not only for the domestic patients pool at an affordable price but have also contributed largely the cheap export of the drugs throughout globe including USA. Indian drug manufacturer produces mostly generic drugs which is ten times cheaper than the labeled medicine product, which is not affordable by all even in USA.

On data protection front, a committee has deliberated that companies have a caliberated approach to data protection. India had a let-down period of 10 years from 1995-2005 and the recommendation was that companies have a calibrated approach up to 2015, which was the date given to the least developed countries (LDCS). But India is a developing country and it cannot be equated with LDCS. It is argued that today we have data protection for agro chemicals, in IT but for pharma there is no such law.

As claimed by the drug innovator companies, miles of data is now available to a generic company, which uses it as its own and launches a product for commercial interest. But Article 39.3 of the TRIPS agreement clearly says that data generated by Innovator Company cannot be used by third parties for commercial interest. The data can be available for information, but not to use it and say that it is exclusive to the company. All countries across Asia-Pacific have a minimum data protection of at least five years. Jordan has it for 15 years. India is not even going in that direction. Data protection across countries ranges between 5-10 years. India is pitching for five years.

Accoriding to pharma major China is seen as better market than India which has growth rate of 30-40% compare to 10-12 % by India. China has 80 percent hospital sales exactly reverse of India (80 percent market sales and 20 percent hospital sales). This helps MNC market their product better in an organized way and reduce counterfeits in the market. But on the other hand patient always end-up paying higher price for the drug.

As the Drug Innovator Company looks at India, they suggest having a creative alliance with them to get its product globally. It is feasible in the long run that global and Indian companies ally to share the risk and rewards, the capabilities, and assets. They also suggest having progressive pricing policies including those for patented products, regulatory reforms, and rationalization of the multiple-tax system. There should also be a deterrent legislation against counterfeit drugs, reduction in import tariffs on life saving and other essential drugs, regulatory and administrative reforms, flexible labor laws and last but not the least, a world-class infrastructure.

But all said than done, every aspect of these have to be seen in the light of existing WTO, TRIPS aligning judiciously with the national law which should take care of Indian patients, manufacture and country as a whole. It is because on the contrary, WTO is not the demigod. It does have rules and laws which favours the mighty moghals. Therefore, saving the interest of its own will be India’s prime interest.