Healthcare innovation and patent law’s ‘pharmaceutical privilege’: is there a pharmaceutical privilege? And if so, should we remove it?

Abstract

This article reviews current trends in patent claims regarding personalised, stratified and precision medicine. These trends are not particularly well understood by policymakers, even less by the public, and are quite recent. Consequently, their implications for the public interest have hardly been thought out. Some see personalised and other secondary drug patent claims as promoting better targeted treatment. Others are inclined to see them as manifestations of 'evergreening' whereby companies are, in some cases quite cynically, trying to extend market monopolies in old products or creating new monopolies based on supposedly improved versions of such earlier drugs. The article claims that the relaxation of 'novelty' is a privilege unavailable to inventions in other fields and that on balance the patent system does privilege this industry and that no adequate case has yet been made thus far to prove the public benefits overall.

Research on the Adjustment of Patent Protection Standards under Emergencies: Based on the TRIPs Agreement

“…Because of this benefit, it would seem that extending patent protection in the face of the current Covid-19 epidemic would provide an incentive for pharmaceutical companies to engage in research and development, thereby alleviating the shortage of vaccines. However, this is not the case, as pharmaceutical companies have often obtained exclusive marketing periods of well over 20 years through what has been described as an 'evergreening' strategy, and further increases in patent protection are unnecessary and may even introduce a greater risk of market failure [25].…”

Pharmaceutical Patents in Europe: Radical Reforms Rather Than Getting Rid?

“…Unsurprisingly, the current regulatory framework on pharmaceutical IP exclusivity has often been criticized [ 2 , 21 ], with arguments about whether it remains fit for public purposes. Drastic proposals to ‘de-link’ R&D investments from financial returns have been raised to make regulations more responsive to the health needs of patients and society [ 17 , 22 ].…”

Regulatory theory: commercially sustainable markets rely upon satisfying the public interest in obtaining credible goods

“…The European Commission’s Pharmaceutical Sector Inquiry Report and the subsequent 4th Report on the Monitoring of Patent Settlements identify a commitment to increasing competition law scrutiny in the pharmaceutical industry and regulating practices falling short of the rules. But monitoring and enforcement are intended to be a co-operative endeavour between the industry, ‘market participants’ and regulators (European Commission, 2009, 2012).…”