Countries especially developing and under-developed ones are struggling hard to provide basic health facilities to the citizens. Affordability to drugs and medical care is the first condition to get access to health care. But pharma companies are using the tactics like patent evergreening to maintain their monopoly in the drug market and hindering the entry of generic medicine which are more cost effective and accessible to all.
What is patent evergreening?
Patent is a way to grant innovators the exclusive right over the developed products or technology and earn exclusive profits for a certain period of time. After the expiration of that stipulated time, anyone can have access to the technology or the product and innovators lose the exclusive right of profit.
Drug companies make wide use of these exclusive rights known as IPR (Intellectual Properties Rights) to protect their medical inventions and earn huge profits from the market. Hence, patents are crucial for drug companies to maintain barriers from the competition in the market and earn billions of dollars in profit.
Consequently, “patent evergreening” becomes prevalent. It is malpractice whereby drug companies try to extend a patent on medicine by adding little reformulation, trivial modification to the delivery system or the dosage level and necessarily without any enhancement of the therapeutic properties of the drug. Almost 74 percent of drugs associated with new patents are not based on increased efficacy of drugs but are the existing drugs.
Companies are using an evergreening process to undermine the Drug Price Competition and Patent Term Restoration Act of 1984 that introduced the generic drug industry for the benefit of common man with drug affordability.
Pharma companies perform evergreening to maintain their domination in the market and get higher prices over the patented drug. This has become an issue for those poor patients who are struggling to get patented drugs with rising prices. While inventors want to keep their monopoly and invention to themselves. Companies trying hard to maintain the value of their creation.
Why do pharma companies manipulate patent laws?
“Competition is the backbone of the U.S. economy. But it’s not what we’re seeing in the drug industry”. –Professor Robin Feldman (Director of the UC Hastings Centre for Innovation).
Big pharma companies often use the drug evergreening strategy to delay the entry of competition. They target especially the restriction of generic medicines for the widely prescribed medicines like for heartburn, opioids, and chronic pain.
The Evergreen Drug Patent Search, is a comprehensive database released by the Center for Innovation at the University of California Hastings College of Law that provides the details about the patent protection by the companies. It demonstrates how the big pharma companies are extending their patents through an evergreening process and inhibiting the entry of generic drugs at a low cost.
Novartis case is one such famous case of India for its anti-leukemia drug Glivec. Patent office of India rejected the extension of patent for Glivec on the basis that it does not enhance any therapeutic advantage to the patients. Novartis approached the Supreme Court of India and said that it is contrary to the TRIPS agreement. But the court rejected the plea on a very genuine basis. It said that the rejection of patent to Glivec holds the value of providing easy and affordable access to life saving drugs to the citizens, discharging obligations to maintain basic healthcare for all citizens and preventing the ever-greening of drugs. The court judgement was not in contrast to the TRIPS agreement as it was based on public interest.
How does patent evergreening causes harm to patients?
Almost one-third of the population of the world could not get access to basic health care due to rising drug prices. These poor people mostly reside in African and Asian countries. Public welfare is equally important while protecting new inventions and innovations. Patent evergreening clearly impacts public health and welfare. Due to low income, patients often could not afford the essential life-saving drugs. They might resort to taking loans or selling their properties to get access to these costly drugs. Sometimes even delayed the care.
WHO members also recognise the need to protect the public interest and provide affordable drugs to the poor. Hence, after six years of the TRIPS agreement, WHO released the DOHA Declaration for public welfare. But even after this declaration, medicine companies failed to reduce prices especially of those critical health issues like HIV and cancer. This shows that drug companies are not concerned with the health issues of poor people mainly in underdeveloped and developing countries adequately. As a result, health policies of governments worldwide that promise to provide affordable medicines and care are becoming ineffective.
Possible Steps to Curb the Unhealthy Practice
Definitely, we need the protection of innovations and inventions to encourage research and development by individuals and companies. But at the same time, we also need to protect basic health rights of all individuals at all costs.
Thus, undoubtedly we need to strike a balance between the patients and the patents.
USA, Australia, India and many other countries have adopted the legal and constitutional acts to stop the harmful patent evergreening and maintain affordability of drug prices. USA has adopted Hatch-Waxman Act, India introduced Compulsory Licensing provision while Australia has a Limited term extension for the drug patents in its Patents Act, 1990.
But, the positive benefits of such protections can be eroded with the manipulations of the drug regulatory systems. Companies whose billions of dollars are at stake by losing patent rights can resort to exploiting legal ways to manipulate the regulatory systems.
So the governments can protect the rights of patients by adopting the following measures:
- Restrictions on the number of patents that a company can apply for a drug.
- Stop the secondary patent to the drug that does not improve the efficacy or safety of the existing drug.
- Make provision for the generic medicines for the poor sections of the society if the drug prices are unreasonably higher and restrict the drug affordability of the general public in poor countries.
Pharma companies should focus more on research and development for developing more enhanced drugs for the betterment of people and then expect a reward for them. But instead, companies are focusing more on legal and marketing strategies and tactics to make profits from the existing drugs and prohibit poor people from getting access to affordable medicine. Inventions should not become a tool of exploitation for the vulnerable. Research, development and findings should be focused more on making the life of people convenient and easy.
Patents should be provided only to those drugs that meaningfully provide benefits to the lives of people, improving their health conditions. Patents should not become a money making game for the companies.