In Defense of Secondary Pharmaceutical Patents: A Response to the UN’s Guidelines for Pharmaceutical Patent Examination

Christopher M. Holman
Professor of Law, University of Missouri-Kansas City School of Law

In 2015, the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of twelve types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms of pharmaceutical innovation are inherently routine, and absent some sort of exceptional circumstance should be treated as obvious/non-inventive, and hence unpatentable. In my experience, however, the Guidelines’ assumption that many types of pharmaceutical inventions are inherently obvious and undeserving of patent protection is incorrect and based on an oversimplified view of how these inventions come about. This Article provides an evidence-based response to the Guidelines that refutes, or at least qualifies, some of the significant conclusions and recommendations set forth by its author. [View Full Article]