What is evergreening in the context of product patents? Discuss the effectiveness of the Indian patent laws in safeguarding against this practice.

Approach:

* Introduce with product patents
* Explain the practice of evergreening, with special reference to pharma industry
* Briefly note the important provisions of Indian patent law
* Examine the successes and failures of the laws in preventing evergreening
* Conclude appropriately

Model Answer :
A patent is an exclusive right granted for an invention, which is a product or a process that provides a new way of doing something, or offers a new technical solution to a problem. In the case of product patent, it gives an exclusive right given to the original inventor of a product for fixed years (usually 20 years).

Evergreening:
When brand-name companies patent “new inventions” that are really just slight modifications of old products, it’s called evergreening. It is mostly used in the context of pharmaceuticals, as the practice is rampant in the industry. This is because once the patent protection expires after 20 years, generic cheaper versions of the drugs compete in the marketplace. Original drug manufacturers seek to restart the 20-year cycle of exclusivity by subsequently filing patents that are minor variants of the parent compound, called secondary patents. This practice is known as evergreening, and seeks to extend monopolistic production of the drug.

India's patent regime:
In India, The Patents Act, 1970, later updated with 2005 amendment, is the legislation covering patents.
Patents are granted for a maximum term of 20 years.
India's patent law has provisions to guard against unethical practices such as evergreening. Significant provisions include:
Section 3(d) of the Patent Act, 1970, which was introduced in 2005. It does not allow mere discovery of a new form of a known substance, or new property/use for a known substance or etc. to be accorded a patent.
Section 2(1)(ja) of the Patents Act requires that the product in question must feature a technical advance over what came before that’s not obvious to a skilled person.

Impact of Indian patent regime on evergreening:
Success:
The Indian patent law, especially through the application of section 3(d), makes evergreening of patents difficult in India (in contrast to many other developed countries). Secondary patents for several blockbuster medicines have been rejected by the Indian Patent Office, dramatically lowering prices and expanding access to medicines for important health problems such as cancer, AIDS, asthma and cardiovascular diseases. More than 1700 such patent applications were rejected in the last decade.
India's success in preventing evergreening can also be seen in, and has aided, the growth of India generic drug manufacturing industry.

Failures:
High error rate: Studies have found that evergreening practices may be rampant in India despite the law and the watch. Some studies note that almost 72% of those who got secondary patents between 2009 and 2016 could have been avoided.
Loopholes in the law: While Section 3(d) sets the bar high for secondary patents with the mandated requirement for clinical evidence, others such as Section 3(e) set less well-defined thresholds. Demonstrating requirements under Section 3(e) is relatively easier and companies take this route to avoid section 3 (d).  In order for blockbuster medicines to be accessible, there can be no surer way than to enact strong standards that reject bad patents. Hence, it is important for to plug any loopholes in the laws or the award of patents to maintain the integrity of Indian patent regime.