Patenting and Malpractice of Evergreening of Patents
What is a Patent:
A patent is an exclusive right regarding a invention or process granted by a sovereign authority for a specified period of time. It is a incorporeal right and it is mostly valid for 20 years of time.
A patent may be obtained by anybody who creates or discovers a novel and useful machine, method, manufacturing, composition of matter, or novel and useful improvement thereof, according to the terms and regulations of the relevant legislation.[1]
Types of Patent:
There are majorly three types of patents mainly used which are Utility Patents, Design Patents and Pharmaceutical Patents. Each of these patents differ from durations and specifications.
- Utility Patents: Those who develop a novel and practical method, a manufactured good, a piece of equipment, or a composition of matter are entitled to legal protection through utility patents, sometimes known as patents for innovation. Over 90% of all patents granted by the US government fall under the category of utility patents, which are the most prevalent kind of patents. This patent lasts for 20 years from filing date on payment of maintenance fees.
- Design Patents: Patents on unique, novel, and ornamental designs for manufactured goods are known as design patents. Design patents safeguard an object’s appearance or design. They demand that the design originates from a unique and practical invention. For applications submitted after May 13, 2015, design patents are valid for 15 years. Patents for applications submitted prior to May 13, 2015, expire after 14 years. Design patents are not subject to maintenance costs.[2]
- Pharmaceutical Patents: It’s a highly knowledge-driven industry where the billion-dollar process of developing new drugs is one of the most expensive. It is crucial that innovators withdraw their capital from the economy as a result. Development and innovation will be impeded otherwise. In this sense, by giving inventors exclusive control over the advantages of their inventions, patents are essential for preserving innovation. Different kinds of patents are available for medical inventors or businesses to safeguard and profit from their invention(s).
Evergreening of Patents:
Ever-greening, as the name suggests, is a corporate, legal, business, and technical strategy for prolonging an issued patent’s term in a country where it is set to expire in order to maintain income streams through the acquisition of new patents. In this process, patent holders strengthen their diligent possession powers through legislative and regulatory measures. Evergreen patents allow you to take advantage of their benefits for an extended length of time.
To put it simply, patent evergreening is the process of continuously extending patent rights. It also describes the procedure of getting multiple patents for the same product. These patents cover numerous facets of a single product by accumulating patents on improved versions of already-existing products. Pharmaceutical patents typically have evergreening patents. The most significant strategy employed by multinational pharmaceutical corporations is drug patent evergreening.
The global pharmaceutical industry is estimated to be worth more than $1 trillion based on reports from 2014. US companies have been using it since 1983, and Canadian provinces have been using it since 1993. The long-term financial security that comes with high sales volume is known as the “evergreening” of patents.
India’s law and stand on Evergreening of patent:
A drug doesn’t just pop on the countertops they all have a long history behind them, the first step that pharmaceutical corporations take on discovering an entirely new drug is to secure intellectual property rights for it in the form of a patent. A primary patent, covering a new molecular/chemical entity, rewards innovation with a free reign over the marketplace for a period of 20 years, which is the term of the patent. However, this also sets the clock ticking since innovators need to reap the fruits of their inventive labour and maximize revenue within this period. Once this time ends the pharmaceutical companies resort to innovative ways to reclaim the patent.[3]
But Indian Patent Act of 1970 which deals with the patents in India has a protection against evergreening in section 3 which defines what are not an invention and sub clause (d) in that states that[4]“The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”
Section 3 (d) in itself is an innovative clause as it specifically deals with minor modifications done for the sake of evergreening of patents. This section lays down the standards for the follow up of the patents with clarity. This standard was tested and upheld by the Supreme Court in a landmark decision in 2013 involving a patent application for Novartis’ anti-cancer drug Glivec. This was heralded by many as an example of India leading the charge on curbing evergreening, thereby safeguarding its access to public health.
After seeing that India already has a law which bars evergreening one must be thinking that there will be less or no evergreening or secondary patents happening in India, but to their surprise from 2009 to 2016 there were 2300 patents for drugs granted. And out of these 2300 patents around 72% were secondary patents. This signifies the incompetency of government when it comes to the execution of the law.
Conclusion:
The patent system is a complicated and crucial subject that impacts both inventors and patients. On the one hand, patents encourage innovation by granting inventors exclusive rights to their creations. This could lead to the creation of novel and potentially life-saving medications. Patents, on the other hand, might limit access to medications, particularly in low- and middle- income nations. This has major implications for public health.
There is no simple solution to the problem of balancing the interests of innovators and patients. However, it is evident that a strategy to create a balance between these two crucial goals is required. One method is to create a system of compulsory licensing that allows governments to develop generic versions of proprietary medications under specified conditions. This can aid in making drugs more affordable and accessible to those in need.
Finally, the patent system is a vital instrument for encouraging innovation. However, it is critical to ensure that the patent system does not impose undue restrictions on access to medicines. Compulsory licensing and public health research and development are two approaches to balancing the interests of inventors and patients. We can assist ensure that everyone has access to the medicines they need to live healthy lives by finding a method to strike a balance between these two critical aims.
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Written by- Sushant Kumar Sharma
[1] United Nations Conference on Trade and Development. (2015). The relationship between intellectual property rights and public health: Towards a balanced approach. Geneva: United Nations Conference on Trade and Development.
[2] Supra
[3] Rajagopal, Feroz Ali, Sudarsan. ‘Rampant Evergreening in Indian Pharma Industry’. Mint, 26 Apr. 2018, https://www.livemint.com/Opinion/aIqAgfMWLyel1uPEfEcEtI/Rampant-evergreening-in-Indian-pharma- industry.html.
[4] Patents Act, 1970 (Act 39 of 1970)
