Me-Too Drugs: Good or Bad?
The subject of so-called "me-too" drugs (sometimes called "follow-on" or incrementally modified drugs (IMDs)) has been raised with the Commission numerous times by the research-based industry, the generic industry and NGOs.
The substance of the argument on this subject is the contention that the current incentive structure (which is determined not only by the patent regime) may result in the diversion of R&D efforts to areas where private returns exceed social returns in terms of enhanced therapeutic value or, conversely, away from areas where private returns are much lower than social returns. In simpler terms, do current incentives mean that too many R&D resources are devoted to developing drugs, which are similar in composition or mode of action, for mainly chronic diseases prevalent in the developed world? And, taking account of the agenda of the Commission, do they mean that too few resources are devoted to developing drugs for mainly infectious diseases which predominantly affect developing countries? The latter question is also often asked more generally in relation to vaccines and antibiotics.
The practice of so-called "evergreening" has also been brought to the attention of the Commission, principally by the generic industry and NGOs. "Evergreening" is the practice of applying for patents on aspects of an existing drug (e.g. the form or colour of the tablet) or minor modifications to it, which may have the effect of delaying the entry of generic competitors beyond the expiry of the initial patent (or patents) on the drug.
Critics claim that brand-name manufacturers utilise the patent system (and the links between the patent system and marketing approval, where these exist) to delay generic entry as long as possible beyond the expiry of the initial patents. They regard this as misusing the patent system to deter competition rather than to stimulate genuine innovation.
For the research-based companies, such practices are regarded as a normal and legitimate use of the patent system in pursuit of their commercial objectives and shareholders' interests and that, as in the case of "me-toos", these incremental modifications benefit patients e.g. through better dosage forms, or bioavailability.
To initiate this discussion, we have asked Professor Ken Kaitin of Tufts University, and Professor Aidan Hollis of the University of Calgary to start the ball rolling.
Secretariat for the Commission on
Intellectual Property Rights,
Innovation and Public Health (CIPIH)