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Key Messages

• Adaptive or incremental innovation is an important aspect of Pharmaceutical R&D. It allows the development of safer and more efficient medicines.
• A product cannot be “double-patented.” A new patent covering an improvement to an existing product protects only the new improved version.

Background

It is sometimes claimed that the main output of the big R&D pharmaceutical companies is “me-too” drugs: minor variations of highly profitable pharmaceuticals already on the market. Such criticism of incremental innovation is prompted by a narrow vision of the R&D pharmaceutical industry as both imitative and anti-competitive: that any patent obtained beyond the patent on the original compound itself is “frivolous” because it is motivated solely by commercial reasons, rather than a commitment to innovation to benefit patients.

In fact, the patent system provides an essential guarantee that inventors will be rewarded for the risks they take during the R&D process , which averages more than a decade and consumes enormous financial resources. But in return, they must transform “proof of concept” into a safe and effective medicine. Patent law requires that patent holders prove that their inventions are both novel and “non-obvious.” In practical terms, this means that applicants must prove that the invention they seek to patent has new, improved or unexpected therapeutic effects or properties compared to what is known.

In addition, multiple patents  relating to a single product sometimes occur over time because significant hurdles were encountered in the product’s development that, if not overcome, would have prevented its manufacture or its safe and effective use. Even the most innovative new compound will fail the test of the market if its pharmacokinetic properties prove unstable, if the medicinal content degrades in the human system or cannot be safely stored on the shelf, or if it cannot be manufactured in standardized acceptable quantities, at reasonable cost. These and other “inventive steps” that drive the long journey from laboratory to patient are critical to ensuring that a medicine is approved for the intended indication, with minimal risk to the patient, population, and which is cost effective. An invention can range from manufacturing improvements or modifications to changes in inert or active ingredients. None of these are “trivial” if the end result is a product approved by governments and appreciated by patients.

A product cannot be “double-patented.” A new patent covering an improvement to an existing product protects only the new improved version, such as the once-a- day dosing formulation cited in the example above. Both versions can be on the market; competition is then between the off-patent original product and the patented new formulation. In fact, any new product must demonstrate distinct value to the patient and payer communities or it will not be accepted. Physicians, payers or patients do not respond to a new product simply on the basis of its patent status; the level of engagement is far more complex, with assessment of therapeutic benefit driving acceptance by patients.