Let’s unlock the value of Incremental Innovation – Health Files by Ranjit Shahani | ET HealthWorld

Innovation, it is said, is a change that unlocks new value.

The pharmaceutical arena is no different. The very purpose of the industry is to save lives, shorten duration of disease and improve drug efficiency. Developing a new prescription medicine that gains marketing approval is estimated to cost drug makers $2.6 billionaccording to a recent studyby Tufts Center for the Study of Drug Development and published in theJournal of Health Economics. These rapidly increasingly R&D costs impact the pace of innovation in drug research. Moreover, in the case of pharmaceuticals, spectacular breakthroughs (so-called “first-in-class products” or new active substances originating from pioneering approaches) are extremely rare – it takes more than a decade to develop one new medicine from the time it is discovered to when it is available for treating patients and involves many failures starting with 10,000 drug candidates and ending up with just one new, approved medicine.

Thus the need to understand and respect the value of incremental innovation.

According to the George Washington University Law School, India: Innovation at the Crossroads, Prof. Trevor M Jones, CBE, Incremental innovation is the major means through which significant benefit to the health of patients worldwide has been, and can continue to be improved.

It is important to understand the critical role that incremental innovation essays in public health. With the underlying objective of better health outcomes, pharmaceutical advances have increased longevity and productivity and helped provide tailored treatments to patients through product alternatives. New medicines coming as a result of incremental innovation can bring benefits in many different forms. A new medicine may be more effective in improving a medical condition. It can improve patient compliance through better dosage and forms of administration. It can have fewer side effects or reduced toxicity. Extending the indications of an existing medicine can also represent a significant innovation.

Further, having multiple options within the same therapeutic class allows differing patient responses to similar medicines to be taken into account. Product alternatives permit treatments to be better tailored to individual patient needs, since not every patient responds to every drug in the same manner. Moreover, new, incremental innovations are often less expensive than existing agents in a same therapeutic category.

One of the significant examples of the benefits of incremental innovation relates to the treatment of diabetes. New oral agents and insulin analogs developed in the mid-1990s have contributed substantially to our ability to improve glycaemic control. These new agents provide more options for achieving tight glycaemic control and allow individualized treatment. Premixed preparations of insulins with different onset and duration times offer added convenience, improved compliance, greater dosage accuracy, and reduced risk of hypoglycaemia. These are especially useful for patients who have difficulty preparing their injections. Finally, sulfonylurea agents for treating Type II diabetes have similar molecular structures but differ widely in potency, duration of action, dose range, metabolism, side effects, convenience, and potential for interaction with other drugs

One of the biggest advantages of incremental innovation remains tracking new diseases. Evolutionary progress in pharmaceuticals can take several forms. E.g. Introduction of a new medicine in an existing class; New dosing or delivery forms and New uses for existing medicines. E.g. Treatment of deep vein thrombosis with low-molecular weight heparins. The Low-molecular weight heparins expands their indication from prophylaxis of deep vein thrombosis to treatment of deep vein thrombosis. Expanded marketing approval of Adalimumab, from the European Commission, for the treatment of severe Crohn’s disease: the drug is also approved in both the US and Europe to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Thus, results of incremental innovation in terms of efficiency, patient responsiveness, reduced side effects, add up to one outcome: better value for money.

In India, Section 3 (d) of the Indian Patent Act 1970, as amended in April 2005, represents a unique requirement to be fulfilled for patentability of certain types of pharmaceutical inventions. According to Section 3(d), in order for a new form of a known substance to be patentable it must show an enhanced efficacy with respect to the known efficacy of the known substance.

To explain further, Section 3(d) of the Indian Patents Act adds an additional hurdle to pharmaceutical patents, beyond the requirements of novelty, inventive step and capability of industrial application by adding a fourth substantive criteria of “enhanced efficacy”. Under this provision, salts, esters, ethers, polymorphs, and other unspecified ‘derivatives’ of known substances are presumed to be the same substance as the original chemical and thus are not patentable, unless it can be shown that they differ significantly in properties with regard to efficacy.

Patent law all over the world protects each phase of the research done irrespective of who does it. In India, because of the higher and additional criteria of patentability under Section 3(d), a patent may not be granted for a derivative unless enhanced therapeutic efficacy is established.

The dramatic improvement in saving lives and health came about through both radical and incremental innovation. Research-based pharmaceutical companies generate innovation in health needs by inventing new treatments for previously untreated health problems (radical innovation) and also developing new or improved uses for existing therapeutics (incremental innovation). The latter is crucial because the process of pharmaceutical innovation, just like any other innovative process, is built on constant improvements. This applies not only in biological sciences but also in physics, mathematics, engineering and about every human endeavour.

Policies aiming to curb the granting of patents for incremental innovations will ultimately lead to a reduction in the overall quality of medicines in existing classes of drugs, and may ultimately hinder the creation of genuinely novel drugs. Provisions like Section 3(d) undermines protection to such inventions. In fact, in the present stage of research & development particularly in the life sciences sector, India is most capable of such innovations and this must be incentivized through adequate protections under the Patent Law.

Incremental innovation generally results in better health outcomes. So, as we approach World IP Day on April 26, let us look at unlocking the value of incremental innovation.

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