A new template for pharma research

The Supreme Court’s Novartis judgment (striking down the patent for blood cancer drug Glivec) has given rise to polarised reactions. Patient groups, generic industry, public health activists and the government have hailed the decision as ‘landmark’ and ‘historic’.

However, global Big Pharma has minced no words in warning that the judgment puts pharmaceutical innovation in great danger, especially in India.

Critics of the judgment feel there is an element of perceived bias in Indian patent law in its treatment of pharmaceutical inventions.

It is easy to align oneself with either of these two positions. It is more difficult, however, to analyse the issue rationally.

‘Evergreening’ on the rise

The fact is that pharmaceutical inventions in the form of new compounds are in gradual decline.

Drug regulatory approval figures and studies have pointed out that between 1990 and 2010, pharmaceutical inventions constituting new chemical compounds have almost halved.

There are myriad reasons for this decline in ‘breakthrough’ inventions. Prohibitive input costs and the ‘risk’ factor (cost of failed R&D) are the most important.

At the same time, it is important to note that patents are proliferating: a decline in new chemical entities (NCEs) has not resulted in a proportional decline in global pharma patenting behaviour.

The research-based global industry is leveraging its monopoly by patenting new forms of known substances without demonstrating their enhanced therapeutic benefits. New properties and new uses of known pharmaceutical substances are being patented, often by diluting patentability standards. In legalese, this practice is usually referred to as ‘ever-greening’.

Many countries have succumbed to industry pressures and have opened up to patents for such incremental inventions, some of which are merely a routine experimentation for persons skilled in pharmaceutical experimentation.

The EU Competition Commission notes that: “Filing numerous patent applications for the same medicine (forming so called “patent clusters” or “patent thickets”) is a common practice. Documents gathered in the course of the inquiry confirm that an important objective of this approach is to delay or block the market entry of generic medicines”.

Unworthy patents increase the social cost of legal monopolies.

Early generic entry paves the way for increased competition in the market, and hence improves accessibility and affordability of drugs to the general populace.

The exclusion in 3(d)

The question is: should such ‘repetitive’ patenting behaviour that extends the life of a patented drug and blocks early entry of low-cost generic medicines be considered as ‘genuine’ inventions entitled to a 20-year monopoly? Section 3(d) of the Indian Patent law aims precisely to restrict such patents by requiring a heightened standard of ‘efficacy’.

There is a perception (not backed by any empirical claim) that Section 3(d) kills pharmaceutical innovation by excluding certain subject matter from the protection of patent law. However, the important question is, what should be the measure of ‘invention’ in patent law?

Section 3(d) is only a narrow subject-matter exclusion that helps us understand the legal construct of the term ‘invention’ in its totality, along with other patent law thresholds of novelty, inventive step and utility.

Most pharmaceutical products that possess novelty, inventive step and utility are patentable without question. Section 3(d), as a qualification, applies only when “known substances” form the subject matter of an application.

Meaning of ‘invention’

All innovations are not inventions within the meaning of patent law. In fact, there is no standard methodology to construe the term ‘invention’ in its totality in both its avatars — that is, by positively defining what an invention is, or by negatively defining what it is not.

Different countries have formulated the legal concept of invention in the light of “purpose of the patent system”, “history and philosophy of science and technology” and a “close conceptual analysis” based on the “nature and field of technology”.

As Judge Prescott QC of the UK Patents Court has noted: “What is an ‘invention’…….. is a topic bedevilled by verbal formulae – and by the sweeping of problems under the carpet. ….whoever controls the meaning of ‘invention’ controls what can be patented and hence an important aspect of industrial policy.

“The hard truth is this: concepts of that sort (invention, technology and art) have no existence, and words of that sort have no meaning, except by human convention; but human beings are hopelessly in disagreement at the margin. And it is, precisely, at the margin of uncertainty that cases come up for decision”.

Exclusions under section 3(d) present the hard cases that lie at the margins of the patent system due to the eternally unsettled nature of the definition of an ‘invention’.

It is difficult to readily assume that known substances in pharmaceutical art that do not show “enhanced therapeutic efficacy” are inherently patentable as an invention.

Any advance in “known efficacy” without any enhancement in known therapeutic benefits does not cater to the utility/purpose that the patent system ideally strives to achieve.

The showing of pure ‘vendibility’ as ‘efficacy’ cannot be the sole test to determine the inherent patentability of an invention.

Therapeutic efficiency

It can be argued that the Supreme Court’s decision is geared towards changing the direction and the pattern of pharmaceutical research in India.

Patent incentives will now be aligned towards not merely inventing a new form of a known compound with some random benefits, but by showing that new forms of the known substance contribute to some curative benefits as well.

In terms of policy, the right bargain has been struck on patents. Genuine innovators have all reasons to cherish that their ‘useful’ contributions will still be respected by patent law.

(The author is Assistant Professor and coordinator of Ministry of HRD Chair on IPR, National Law University, Jodhpur.)

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