In medicine, every little innovation matters

In the past few months, India’s Ambassador to the US, Nirupama Rao made some declarations aimed at allaying concerns over the country’s stringent patent regime.

Her statements notwithstanding, India seems to have failed to create an environment to nurture and protect innovation, as recent court decisions indicate.

The much debated Section 3(d) of the Indian Patent Act forbids patenting new forms of existing drugs, unless they markedly improve efficacy and generate therapeutic benefits. Consequently, much of the incremental innovation done on existing treatments will no longer be patentable in India. This is disastrous for medical progress and for patients.

Variety matters Let’s examine why. First, from a public health perspective, incremental innovation ensures that an array of drugs is offered within a therapeutic class, and that helps doctors treat individual needs of diverse patients. Innovative improvements can increase the number of available dosing options, reveal new physiological interactions of existing medicines, allow for reformulations to encourage children’s compliance, increase the shelf-life or heat-stability of a given drug to secure effectiveness in diverse environments, minimise or eliminate treatment-limiting reactions or side effects, and improve patient compliance.

In a 2001 paper ( Too many drugs? The clinical and economic value of incremental innovations ), Albert Wertheimer, Richard Levy, Thomas O'Connor note that drugs within a single therapeutic class differ in their therapeutic profile, metabolism, adverse effects, dosing schedules, delivery systems, and other features.

Further, a variety of therapies ensures an uninterrupted supply and increased availability of vital medications if the initial drug fails at the development stage in the market or suffers from manufacturing interruptions.

BETTER RESULTS Second, such innovation generates follow-on medicines and develops new uses for existing therapies. Given that first-in-class drugs (that use a unique mechanism to treat a disease) are rarely optimal, incremental innovations may become best-in-class and first-line therapies.

A 2008 study by Cohen, J., and K. Kaitin published in the American Journal of Therapeutics found that 63 per cent of the drugs on the World Health Organisation’s Essential Drug Lists are follow-on drugs. Moreover, follow-on drugs are becoming more important over time as this share has increased more than 25 per cent over the previous two decades.

Further, incremental innovation is critical to the developing world. They provide for more convenient, extended-release dosing and formulations that do not need refrigeration or are less temperature sensitive-- valuable characteristics in developing countries. .

In the treatment of HIV/AIDS, Atripla was the first-ever single-pill regimen combining three drugs into one pill, which simplified the dosing to increase patient compliance. Again, in the battle against malaria, incremental innovation led to the development of two anti-malarial drugs — artesunate and amodiaquine, reducing the dose required from eight tablets a day to two.

Finally, clinical trials are underway to explore effects of the antifungal medicine, ravuconazole, against the pathogen that causes Chagas disease, a neglected tropical disease that hits nearly 10 million people.

On that cue, incremental innovations are valuable improvements and in no way exploit existing protections for intellectual property. As such, two widely-propagated fallacies must be countered: patents protecting improvement innovations are not legitimate patents and incremental innovations delay generic competition.

Legally, as in the case of all innovation, incremental innovations are required to meet all patentability standards. Specifically, all patents require advances that are novel, useful and non-obvious — characteristics that may clearly describe both incremental innovations as well as groundbreaking advances. In addition, the patents granted for innovative improvements do not delay or prevent generic competition.

The patent system provides for the production of generic copies of the initial innovation, even while improved innovation is protected. Importantly, incremental innovations are usually launched at a discount and the resulting competition across drugs in a therapeutic class results in lower prices. Incremental innovation does not stymie competition; instead, it has the potential to enhance it. .

That said, recent Indian court rulings are eroding the incentives for incremental innovation. Recognising that first-in-class treatments are rarely optimal, incremental innovation plays a fundamental role in improving health outcomes, frequently becoming best-in-class and first-line therapies.

Couched in the pejorative language of ‘evergreening’, Indian decisions to weaken intellectual property protections fail to recognise that all innovation is valuable — both breakthrough discoveries as well as improvements to existing therapies.

(The author is Assistant Professor of Economics at Colorado College in Colorado Springs)

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