Pharmaceutical industry has provisions to ban anti-evergreening during secondary patenting of drugs.
Indian Patent Office (IPO) abstains from following such provisions and has been granting more secondary patents.
What is Evergreening in intellectual property?
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.
Once this expires, generics enter the fray with cheaper versions and compete in this lucrative marketplace to drive prices down.
This entails the pharma companies to go through an entire cycle of discovery, clinical trials, marketing and distribution, replete with the risk of failure at every step.
To resolve such issues Innovators seek to reset the 20-year time frame by subsequently filing patents that are minor variants of the parent compound, called secondary patents.
This practice, known as evergreening which allows a prolonged monopoly that unfairly denies the public access to medicines at equitable prices.
What is Patent Act in India?
The present Patents Act, 1970 came into force in the year 1972, amending and consolidating the existing law relating to Patents in India.
India has been at the forefront of developing an alternative model of patent law which many developing countries have since emulated.
The IPO incorporated following anti-evergreening provisions into the Patents Act
Section 3(d) - Covers combinations and other derivatives of known substance.
Section 3(e) - Covers substance obtained by a mere admixture resulting only in the aggregation of the properties of the components or a process for producing such substance.
Section 3(i) - Excludes methods of treatments from the purview of patent protection.
These provisions were introduced to restrict patentability of a host of secondary patents, which were basically alternative forms of already existing patented drugs aimed to further extend their term of protection.
In case of objections in these provisions, the law requires the patent applicants to submit efficacy data for the former drug and demonstrate synergism for the later.
What are the existing concerns in patenting of drugs?
In recent times, the IPO has been focussing on granting patents expeditiously and reducing the backlog of pending applications.
Despite high standards for granting patents, the IPO has been granting patents for merely tweaks in drugs.
Due to this the IPO is also operating at an error rate of more than 70% corresponding to all secondary patents granted.
Stringent rules are being bypassed by the patent applicants which allows the IPO to grant patents only for new form of substances and not combination of known substances.
Thus the application of law with regard to anti-evergreening, by IPO has been far from satisfactory.
