The Fight Against Big Pharma and Patent Protection on Drugs
The Fight on Drug Patent Protections
When a drug company patents a drug, they retain sole manufacturing rights for 20 years. This enables pharmaceutical companies to charge whatever they feel appropriate for the drug as there is no rival product to bring down the price. Some argue that this practice is immoral because it puts business before humanitarian needs, allowing companies to put life-saving medications beyond the reach of poorer patients. Others argue that the companies deserve these patents, because companies fund the lengthy and costly development of these drugs.
In October 2015, the Trans-Pacific Partnership (TTP) between the United States and 11 other countries added eight years of patent protection. The agreement also lowered the requirements necessary to register a new patent for an existing drug because of formulation improvements. These so-called ‘evergreen drugs’ are another way of pharmaceutical companies protect their income.
Long Patents Limit Access to Drugs
The TPP agreement ignited further controversy among groups who argue that the protection of intellectual property, in regards to drugs, is already too strong. The humanitarian organization Doctors Without Borders (MSF) argues the exorbitant price of medications makes them inaccessible to people in the developing world and this new extension worsens the already dire problem.
MSF cites the cost of HIV medication as an example. Around 34 million people worldwide live with HIV, but their ability to receive treatment depends on their ability to pay. With strict patents that allow companies sole control of drug prices, there is little hope of improving this situation for poor patients in the near future.
High Costs of Production
Pharmaceutical companies justify high prices by quoting the costs of drug development, testing, and FDA approvals. The Tufts Center for the Study of Drug Development which cites costs of around $2.6 billion to bring a drug to market. In 2012, U.S. pharmaceutical and medicinal companies collectively spent $42.6 billion on research and development.
However, many opponents regard these figures—especially from Tufts—with skepticism. Larger pharmaceutical companies have been known to buy up smaller companies to acquire drugs (and their patents). See Turing Pharmaceuticals’ 2015 acquisition of Daraprim, and the company’s move to raise the price from $13.50 to $750 per pill overnight, much to the dismay of patients who have to take the drug daily.
Patent Skirmishes in United Kingdom and India
In the United Kingdom, activists are encouraging parliament to override patents and directly compensate the companies for development—a process known as compulsory licensing. This proposal was first suggested when the National Health Service (NHS) turned down a life-extending breast cancer drug because of its £90,000 price tag per annual treatment. Although it could extend the life of many breast cancer patients, the NHS deemed the drug too expensive to justify its use, even after negotiations with the company lowered the drug’s price.
Meanwhile in India, patents issued in the United States and Europe are not always recognized. Indian law has strict limits on what qualifies for a patent—their courts have continued to narrowly define what is “patent worthy.” In 2013, the Indian Supreme Court rejected a patent appeal from Novartis over the drug Gilvec, because the active ingredient had been previously known. In January of 2015, the Indian patent office rejected Gilead Sciences’ patent request for a hepatitis C treatment, saying that, while novel, the treatment was similar to a previously known compound. Though this may be frustrating for many companies, it prevents bad actors from tweaking a drug formulation with the sole intention of extending the patent protection.
The fight between activists, governments, and pharmaceutical companies over strict or lax patent protections will be a long one, if it’s even resolved. For now, though, everyone involved should carefully consider the morals and the economics of drug development and pricing.