Earlier this week, the Indian Supreme Court rejected a patent sought by Novartis for its Gleevec cancer medication, a move that will allow lower-cost generic versions of to continue to be sold. The decision ends a seven-year battle that both Novartis and patient advocates expect will have far-reaching consequences for prices and access to a wide array of important medicines (back story). Drugmakers argue the decision sends a chill down their corporate spines and will discourage some of their efforts, notably in India. Consumer advocates maintain the ruling will force drugmakers to double down on truly innovative R&D and make expensive meds more affordable for the poor. In a bit of point-counterpoint, we asked John Castellini, the ceo at PhRMA, the industry trade group, to argue the case for the drugmakers...
India’s Supreme Court on Monday issued the latest in a troubling pattern of decisions that could severely impact the ability of innovators to deliver new, life-saving drugs to millions of Indians who need them. The court’s decision that denied a patent to Novartis for Gleevec, a groundbreaking drug to treat leukemia, is disappointing but not surprising given India’s recent actions. Whenever this happens, it’s the responsibility of government, industry and stakeholders alike to push back and uphold the importance of existing and future innovation.
In its ruling, the court claimed that Gleevec did not meet the standards of a true invention. A curious determination given that this week the New York Times described Gleevec as: “widely recognized as one of the most important medical discoveries in decades” -- a sentiment that many patients who rely on medical breakthroughs to improve or extend their lives would certainly share. Moreover, global recognition of Gleevec as a breakthrough medicine for certain cancers has resulted in patents being granted in nearly 40 countries. Digging a little bit deeper, it’s easy to see the ruling as par for the course from a government that is systematically infringing on the intellectual property rights of foreign innovators as part of a broader effort to spur India’s own domestic industries.
The Gleevec case is not the first case of this type, nor have the Indian Government’s actions been limited to the biopharmaceutical industry. Denial of patents, compulsory licensing, and patent revocation of innovative medicines have all occurred recently in India. And in the information technology, electronics and energy sectors, preferential market access rules and forced localization of manufacturing have prevented new technologies from reaching Indian consumers.
Research, progress and hope are the building blocks of our industry. They are also a promise to the patients we serve. The first pillar, research, requires a large, risky investment and is resource-intensive. Prior to gaining FDA approval for a new medicine, an innovating company will, on average, invest $1.3 billion and spend10-15 years in development. Research, in turn, fuels progress in finding cures for diseases and hope for the world’s patients -- according to a recent report by the Analysis Group there are more than 5,000 potential new medicines in the pipeline with 70% possibly first in class.
Certainly the cost of innovation factors into pricing, but innovation is also why the HIV virus is not the death sentence it was 30 years ago. It’s why cancer patients have access to more effective medicines than ever before and why millions of people suffering from conditions like Parkinson’s and Alzheimer’s can have real hope that an innovative, life-extending treatment is possible. To promote continued progress, reasonable intellectual property protection is essential.
Our industry recognizes the challenges the Indian Government faces in extending healthcare to a vast population. Still, we cannot sacrifice existing and future innovations that many patients rely on and that will be critical to meeting the unmet medical needs of the future. At the same time, there must be a focus on ensuring access to essential medicines, many of which are readily available as generics. After all, India is a leader in the production of low-cost, generic medicines.
PhRMA member companies have also made significant investments in the research and development of new medicines to address important unmet healthcare needs of Indian patients. Indeed, last year, eight pharmaceutical companies and four research institutions working with the Bill & Melinda Gates Foundation launched a groundbreaking partnership aimed at speeding-up the discovery of essential new treatments for tuberculosis, which affects two million new patients each year in India.
Additionally, biopharmaceutical companies are working to help build healthcare capacity in India. For instance, one company’s foundation supports 12 programs in India to increase hepatitis awareness among the population and health care workers, especially in remote, rural areas. These efforts include disease education, vaccination and programs to help prevent mother-to-child transmissions, which are the most common means of transmission of hepatitis.
But when you look at the bigger picture, India’s actions in the Gleevec case and other instances of intellectual property infringement mean that innovative biopharmaceutical companies seeking to invest in India face far greater risk and uncertainty than ever before. While Indian generics manufacturers will profit in the short term, in the long run these decisions mean that India’s patients could face delays in gaining access to the newest medicines. At the end of the day, if our collective end goal is to continue providing life-saving innovative medicines to all patients, it’s clear that the Indian Government’s view is myopic at best. This is a time when we must all do more to support development of major breakthroughs to fulfill patients’ hopes for health and better address the world’s most pressing medical challenges.