Indian law says a drug can be protected by patent when it is a new invention or improved significantly from an existing one. The law denied patent protection on the leukemia drug Gleevec made by Novartis -Swiss drug company-. On 2006, Novartis, in its petition, challenged the validity of Indian patent law, arguing that it violated trade rules. The court dismissed a petition on the grounds that Gleevec was insufficiently different from the previous version. The ruling was hailed as a victory for the rights of patients. Because there are millions of patients in developing countries who depend on affordable medicines from India. However, the Novartis warned that the ruling would “have long-term negative consequences for research and development into better medicines” because it would discourage drug companies’ efforts to invest in innovation of the products.
Developing countries and NGOs argue that TRIPS(Trade-Related Aspects of Intellectual Property Rights) raises the price of the drugs and makes new, better drugs available only in wealthy countries. Poor counties have to wait until the patent expires so the generic industries can make the cheaper version. In addition, the WHO has declared that there is little to no evidence that patent rules encourage research and development for medicines that are benefit to poor people.
The research-based pharmaceutical companies argue that the profit incentive made during the patent term is necessary for the pharmaceutical industry to invest in the very costly research and development process for new drugs. Consumers might have a financial benefit from the lower-cost generics, but would suffer in the long term if research and development for the new drugs that meet the public’s needs stops.
All people have the right to access to the adequate drugs to be healthy. However the pharmaceutical industries which make the drugs are subject to market force and seek profit. The pharmaceutical industries are now face the pressures from insurers and the government to cut price. In addition, FDA has become stricter, generic drug industries have increased. So there is a part of a shift in their business. They are moving beyond the blockbuster drugs and investing in the most profitable area such as personalized medicine. For example, Pfizer’s crizotinib attacks a protein encoded by a gene found in fewer than 5% of non-small-cell lung cancer patients. Provenge treating prostate cancer costs $93,000 for a course of treatment with extending life by an average of four months. They offer small benefit at an extreme price and, moreover, they are not for public but for few who would clearly benefit. This is not what public health wants. It seems that finding balance between providing proper incentives for scientific inventions of innovative drugs and meeting public’s needs with universal access to drugs is challenging.