Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-25T10:07:03.455Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  18 April 2017

Graham Dutfield
Graham Dutfield*
Affiliation:
School of Law, University of Leeds, UK
*
*Correspondence to: Graham Dutfield, School of Law, University of Leeds LS2 9JT, UK. Email: [email protected]
Get access Rights & Permissions [Opens in a new window]

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.

Type
Articles
Information
Health Economics, Policy and Law , Volume 12 , Special Issue 4: SPECIAL ISSUE: Healthcare and Health Innovation in Europe: Regulating for public benefit or for commercial profit? , October 2017 , pp. 453 - 470
Check for updates
Copyright
© Cambridge University Press 2017 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Allison, M. (2008), ‘Is personalized medicine finally arriving?’, Nature Biotechnology, 26(5): 509–517.Google Scholar
Amin, T. and Kesselheim, A. S. (2012), ‘Secondary patenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades’, Health Affairs, 31(10): 2286–2294.CrossRefGoogle ScholarPubMed
Angell, M. (2004), The Truth About the Drug Companies: How They Deceive Us and What to Do About It, New York: Random House.Google Scholar
Bostyn, S. J. R. (2016a), ‘Personalised medicine, medical indication patents and patent infringement: Emergency treatment required’, Intellectual Property Quarterly, 2: 151–200.Google Scholar
Bostyn, S. J. R. (2016b), ‘Medical treatment methods, medical indication claims and patentability: A quest into the rationale of the exclusion and patentability in the context of the future of personalised medicine’, Intellectual Property Quarterly, 3: 203–230.Google Scholar
Cragg, G. M., Grothaus, P. G. and Newman, D. J. (2014), ‘New horizons for old drugs and drug leads’, Journal of Natural Products, 77(3): 703–723.Google Scholar
Edwards, A. M., Isserlin, R., Bader, G. D., Frye, S. V., Willson, T. M. and Yu, F. H. (2011), ‘Too many roads not taken’, Nature, 470: 163–165.CrossRefGoogle Scholar
Elenco, E., Underwood, L. and Zohar, D. (2015), ‘Defining digital medicine’, Nature Biotechnology, 33(5): 460–461.Google Scholar
Gupta, H., Kumar, S., Roy, S. K. and Gaud, R. S. (2010), ‘Patent protection strategies’, Journal of Pharmacy and BioAllied Sciences, 2(1): 2–7.Google Scholar
Joyner, M. J. and Paneth, N. (2015), ‘Seven questions for personalized medicine’, Journal of the American Medical Association, 314(10): 999–1000.CrossRefGoogle ScholarPubMed
Kapczynski, A., Park, C. and Sampat, B. (2012), ‘Polymorphs and prodrugs and salts (oh my!): An empirical analysis of “secondary” pharmaceutical patents’, PLoS One, 7(12): e49470.Google Scholar
Manners, S. (2006), Super Pills: The Prescription Drugs We Love to Take, Vancouver, BC: Raincoast Books.Google Scholar
Moir, H. V. J. (2016), ‘Exploring evergreening: Insights from two medicines’, The Australian Economic Review, 49(4): 413–431.CrossRefGoogle Scholar
Mullard, A. (2012), ‘Drug repurposing programmes get lift off’, Nature Reviews Drug Discovery, 11: 1–2.Google Scholar
Parker, S. and Hall, B. (2014), ‘Patenting personalized medicines in the UK, Europe and USA’, Pharmaceutical Patent Analyst, 3(2): 163–169.Google Scholar
Peck, R.W. (2016), ‘The right dose for every patient’, Nature Reviews Drug Discovery, 15: 145–146.CrossRefGoogle ScholarPubMed
Schork, N. (2015), ‘Personalized medicine: time for one-person trials’, Nature, 520: 609–611.CrossRefGoogle ScholarPubMed
Sterckx, S. and Cockbain, J. (2012), Exclusions From Patentability: How Far has the European Patent Office Eroded Boundaries? Cambridge: Cambridge University Press.CrossRefGoogle Scholar
Vernaz, N., Haller, G., Girardin, F., Huttner, B., Combescure, C., Dayer, P., Muscionico, D., Salomon, J.L., Bonnabry, P. (2013), ‘Patented drug extension strategies on healthcare spending: A cost-evaluation analysis’, PLoS Medicine, 10(6): e1001460.CrossRefGoogle ScholarPubMed
Warren-Jones, A. (2016), ‘Regulatory theory: Commercially sustainable markets rely upon satisfying the public interest in obtaining credible goods’, Health Economics, Policy and Law (this issue).Google Scholar