Medicines – In Support of Follow-On Innovation

25 Sep 2018
In a recent article Professor Christopher Holman (University of Missouri – Kansas City School of Law) again comes out in support of patent protection for the embodiment of follow-on innovation in medicines (Christopher M. Holman, “Inside views: Why Follow-On Pharmaceutical Innovations Should Be Eligible For Patent Protection”, Intellectual Property Watch, 21 September 2018). Follow-on pharmaceutical innovation seeks to improve upon existing medicines by a range of alternatives such as offering a safer and more effective variation than the original product or creating a more patient- and treatment-friendly formulation.

Despite its frequent benefits to public health and medical progress, follow-on medication has repeatedly been criticised for its supposedly inhibiting effect on the sales of generic rivals of the original medicinal product whose active substance is no longer patent-protected. According to this criticism, the pharmaceutical industry does nothing more than artificially extending, or “evergreening”, the patent protection of an existing medicine (see, for example, European Commission, Pharmaceutical Sector Inquiry, Final Report, §§ 993 et seq., 8 July 2009).

In his article, Professor Holman counters this long-standing position and cites numerous practical examples of genuine follow-on innovation. He also stresses that awarding patent protection to a “secondary” patent that improves upon the technology underlying the original medication is not tantamount to extending the original patent but is simply limited to protecting the improvement. This is why he argues in favour of applying the traditional concepts of patent protection to these improvements, rather than creating more exacting standards of protection. In other words, the requirements of patentability, including novelty, inventive step and industrial application, should apply to “secondary” inventions in just the same manner as they do to their primary counterparts.

Professor Holmes thus firmly rejects the approach embraced by the United Nations Development Programme which, back in 2015, recommended that courts and patent offices around the world should apply more stringent patentability standards to follow-on pharmaceutical innovation (Carlos M. Correa, “Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective”). Professor Holmes adds that in the rare cases of patent misuse which result in restricted access to unprotected medicines, that misuse should be addressed directly on the basis of existing rules designed to tackle abuse such as the competition laws and narrow statutory exceptions to patent protection.

Peter L’Ecluse | Catherine Longeval  | Koen T’Syen

Click here for Follow-On Innovation Article