Incremental innovation is the term used for subsequent improvements made to a “first-in-class” medicine, but it is often incorrectly associated with prolonging the patent term for an existing medicine which is not the case. Indeed, once the patent exclusivity period of the existing “first-in-class” patent has expired, any firm, regardless of patenting related to improvements or incremental innovation, may begin to produce and market that medicine. A new publication by IFPMA explains that incremental innovation of medicines is an important stage in the process of expanding a medicine’s use for patients, so that it can be applied to more therapeutic classes, as well as increasing the number of available dosing options, discovering new physiological interactions – and improving other properties – of existing medicines. Such innovations are developed under the same R&D and clinical trial requirements as “first-in-class” medicines.

Andrew Jenner’s blog – placed on PhRMA and Global Health Matters

Incremental Innovation: Adapting to Patient Needs

There have been many discussions lately on incremental innovation and global health. In order to contribute to this debate, we at IFPMA recently launched a new brochure: “Incremental Innovation: Adapting to Patient Needs”. This report highlights how incremental innovation improves medicines, explaining its scientific rationale, its medical value, and the economic incentives needed for its development.

Incremental innovation increases treatment options available to healthcare providers and adapts medicines better to patients’ needs. This process is marked by expanding the number of medicines within a therapeutic class, increasing the number of available dosing options, discovering new physiological interactions, and improving other properties of existing medicines. Such innovations often require as much research and development (R&D) and clinical trial investments as first-in-class medicines.

Evidence-based discussions are key to advancing global health. This publication illustrates how biopharmaceutical innovation benefits patients by providing facts and examples of improved medicines and their impact on health. In this manner, this brochure helps provide context to the various commitments throughout medicines’ R&D and dispels the misperception that incremental innovation is trivial. There are countless examples of the significant public health impact of incremental innovation. R&D efforts based on existing medicines have led to wide-ranging therapeutic improvements, such as a new use for an antifungal medicine’s metabolite to treat Chagas disease, a neglected tropical disease affecting nearly 10 million people. Improved health outcomes have also been achieved by reducing the antimalarial dosing of ASAQTM from eight to two tablets daily. A

case study cited in the report highlights an improved treatment of hepatitis C, which has boosted cure rates from 38% to 54%.

Medical innovation has brought dramatic improvements in healthcare during the last several decades, but innovation, especially when related to health, is a step-by-step process. If we are going to effectively address non-communicable diseases like cancer, heart disease and diabetes, research must continually build on these lessons.

Author

• Andrew Jenner