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International Federation of Pharmaceutical Manufacturers & Associations



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  • Incremental innovation adapts to patient needs by expanding the number of medicines in therapeutic classes, increasing the number of available dosing options, discovering new physiological interactions of known medicines, and improving other properties of existing medicines.
  • Incremental innovation advances medicines by improving the safety, efficacy, and quality of medicines.
  • Incrementally improved medicines increase the number of treatment and methods of treating options available to healthcare providers, thereby facilitating patient compliance.
  • Incremental innovation involves many of the same research and development (R&D) and clinical trial commitments as first-in-class medicines.

Background

Incremental innovation widens 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.

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. Cure rates can be drastically improved through medicines based on incremental innovation. For example, an improved treatment of hepatitis C has boosted cure rates from 38% to 54%.

In addition, patent rights associated with a medicine based on incremental innovation do not affect the patent term for the existing medicine. In other words, patents relating to a subsequent improvement of an existing medicine will not prolong the patent term of that existing medicine because the two patents are independent of one another. Once the patent exclusivity period of the existing medicine expires, any firm, regardless of the patenting activity related to a subsequent improvement, may begin to produce and market that medicine so long as appropriate regulatory requirements are met. Thereafter, only patient needs will determine whether there is a demand for the subsequent improved medicine.

Incremental innovation is marked by improvements in therapeutic quality, safety, and efficacy over existing medicines. In practice, such improvements inherently expand the number of treatment and dosing options available, thereby allowing healthcare providers to better treat diverse patient groups.

Pharmaceutical companies often conduct incremental or adaptive innovation in order to improve the efficacy and safety of an existing medicine. This innovation is by no means “frivolous” and has positive impact in the improvement of patients’ health.