What is Section 3 (d)?
Any patent related statute in any country has the intention of fostering innovation in that country. A patent can be considered to be a recognition of one person’s effort towards building something innovative in nature. Innovators are motivated to work on and try to come up with new solutions like a new machine or a new tool or appliance that helps all of humankind in countering a hurdle prevalent before the invention.
This is where section 3(d) of the Indian Patent Act (1970) has come under scrutiny. This section is a tool to understand the parameters that a patent application needs to qualify before being considered eligible for a patent. The section essentially conveys that changing the form in which a substance occurs naturally or even changing the way it is presented or administered won’t qualify it for a new patent until and unless it increases the efficacy of the substance. Efficacy here meaning an increase in the desired resultant effect expected.
The Madras High Court has observed in it’s judgment Fresenius Kabi Oncology Limited v. Glaxo Group Limited that
“going by the meaning for the word “efficacy” and “therapeutic” … …, what the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease/ having a good effect on the body? In other words, the patent applicant is definitely aware as to what is the “therapeutic effect” of the drug for which he had already got a patent and what is the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for.”
The Question of Efficacy
One of the major contentions for corporations which are trying to get patents or renewals is the definition of efficacy. A major industry which is interested in the workings of section 3(d) is the pharmaceutical industry. The pharma industry is axis around which the world operates today, from ensuring basic vaccinations to making sure that a person can access therapeutics to recover from an ailment. The industry relies primarily on research through which they can find better solutions and introduce it to the market. With tough competition amongst a number of players in the Indian market, companies try their best to maintain exclusivity on medicines they came up with first.
The landmark case of Novartis AG v. Union of India is a great case study to understand the situation of Section 3(d) in our country. The petitioners claimed that they had invented a new form of methanesulfonic acid. While the company claimed that their product was revolutionary, the court differed and stated that although the product was chemically different the end result (efficacy) wasn’t improved perceptibly. Novartis still stayed firm on its claim of increasing the efficacy of the product upon use.
However, one cannot overlook that neither the Indian statute nor TRIPS have actually defined efficacy or the parameters which can determine a new products efficacy.
The Road Ahead
The road thus far has left us at a standstill with regards to the existing law. It certainly cannot be argued that the intention of the lawmaker was maleficent in any way. However, the ambiguity left with regards to the definition of certain terms leaves a gap which can be misused.
Section 3(d) of the Patents Act (1970) also very conspicuously based around a political and financial decision concerning Indian Pharma’s future. While our patent law can be viewed as something that upholds the interest of the population, the ambiguous nature of the law might stall the research of not only local inventors who might not get the recognition but also the larger foreign corporations who might view the operations in the country rather costly.
This seems like a two way street wherein the lawmakers can ponder on potential changes to make the statute more equitable to all involved parties.
Author: Apurva Kumar Das, Legal Intern at PA Legal.
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