This has led to the promotion of real innovation and protection of the consumers, with lowest financial burden.
What is Section 3(d)?
In 2005, India made some remarkable amendments to the Indian Patents Act of 1970, to promote genuine innovation.
It includes, Section 3(d), which is responsible for over 65% of all pharmaceutical patent rejections.
This section provides for rejecting applications that are mere variants of known compounds and lack a demonstrable increase in therapeutic value.
Basic patentability criteria are that the invention should be new, involve a significant inventive step, and should be capable of industrial application.
Not meeting one of these was the most frequently used grounds for rejection.
The section 3(d) was challenged in the Madras High Court and the Supreme Court on separate occasions, both of which decisively upheld its validity.
How did it make Indian patents structure strong?
This means weeding out non-serious patent applications.
In all, 1,723 pharmaceutical applications were rejected by the nodal agency, Indian Patent Office (IPO) between 2009 and 2016.
Yet it still was in perfect compliance with the WTO norms.
Such strong standards for patents resulted in effectively keeping medicines lowly priced and affordable in the country.
This created significant opposition from global pharmaceutical majors and the countries of the developed world.
e.g Novartis Case - patent for its anti-cancer drug Gleevec, rejected by invoking Section 3(d).
Significantly, these countries continue to have weaker patent standards due to massive corporate lobbying.
Hence they reject far lesser bad patents than India.
How section 3(d) reduces financial burden?
In the last 10 years, Indian Patents Office (IPO) had rejected about 95% of all pharmaceutical related rejections on its own.
Only 5% of the rejections were through the intervention of a third party, such as a pre-grant opponent.
This is mainly because of Section 3(d), which provides the advantage of questioning an application at the IPO itself.
Without the provision, the expensive and time consuming litigation will be the only alternate.
In such cases, disputes are often settled before reaching a conclusion, in pay-for-delay settlements negotiated by patent owners.
Patent claimers usually pay off generic manufacturers to stay off the market, which effectively increases the cost of medicines.
Hence, without Section 3(d), Indian public would have to either bear the burden of invalidating a bad patent through litigation or the cost of expensive medicines.
It would hence be wise for other countries to incorporate similar provisions in their patent laws to reduce the medical bills of its citizens and prevent undue profiteering by pharma companies.
