Should pharmaceutical patents—which result in monopolistic pricing of medicines—apply to any new drug, regardless of how it was made and whether it offers anything new?
This question was answered recently in a courageous decision by the Intellectual Property Appellate Board of India (IPAB), in a suit brought by Open Society Foundations’ grantee the Lawyers Collective on behalf of Sankalp Rehabilitation Trust, a Mumbai organization that works with drug dependent patients. In this case, IPAB ruled to revoke the patent held by the pharmaceutical company Roche for its hepatitis C drug, Pegasys, on the grounds that the process used to develop the medicine was not novel or innovative enough to warrant a patent. Since patented Pegasys costs between US$10,000-15,000 per treatment, this ruling is an important first step toward making hepatitis C medicines more accessible by allowing for future production of more affordable generics.
IPAB’s decision was made possible because of India’s stringent patent law which includes safeguards to address public health needs. For example, the law prevents companies from obtaining patents on medicines that don’t involve an ‘inventive step’—i.e. the process to make the medicine cannot be obvious to those skilled in the art. This was the main argument used in the Pegasys case. Another critical safeguard prevents patents from being granted on medicines that show no significant therapeutic benefit beyond existing drugs. These safeguards, and India’s ability to make quality medicines in its own factories, has kept generic drug production high while keeping prices low. In fact, India has been dubbed the pharmacy of the developing world, most notably for HIV/AIDS medicines. The IPAB decision may mean that India will become the supplier of affordable generic treatment for hepatitis C, a disease affecting roughly 180 million people worldwide but for which treatment—as also highlighted in previous blogs—remains unaffordable.
Drug companies consistently argue that patents are needed to stimulate innovation and to cover the costs of developing new medicines. The truth however, is that real innovation is rare. Most medicines brought to market in the last two decades are so-called ‘me-too drugs’—medicines that present no therapeutic benefit beyond existing drugs. And as one of the most profitable industries in the world—fourth only after mining, crude oil production, and commercial banking—profits for multinational drug companies are astronomical. Take Pegasys for example. In 2012 alone the drug generated nearly US$970 million in sales, and has been on the market for years. Suffice it to say, Roche has already recouped its research and development costs. The time is ripe for affordable generic alternatives and substantial price reduction of this medicine.
As a victory for civil society organizations involved in increasing access to medicines, IPAB’s decision sets the important precedent that NGOs represent the public interest—despite Roche’s claims that NGOs and patient organizations like Sankalp are not legitimate third parties with the authority to challenge patents. While the court sided with the patients in this case, trade negotiators from the US and EU are pressuring the country to take away the right to challenge patents—even if experience shows that frivolous patents abound. Through so called “free trade agreements,” including with India, Western governments are pushing for stronger intellectual property protections on pharmaceuticals all over the world, and asking poorer countries to deny NGOs the ability to challenge patents.
As the Don’t Trade Our Lives Away Listserv highlights in countless examples, the battle for affordable medicines is taking place all over the world. The Pegasys case is one victory, but many more are needed to ensure that the millions of people who cannot afford expensive drugs have access to lifesaving medicines.