Photo of person with gloved hand holding flask at lab bench.

Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?

By Laura Karas

Are manufacturing method patents — patents not on a pharmaceutical drug itself, but on a method of production of a drug — warranted intellectual property protections, or groundless obstacles to competition?

Patents protect and reward innovation by permitting the patent-holder the exclusive right to make, use, and sell the invention for a twenty-year period. Pharmaceutical companies have attracted scrutiny, criticism, and legal challenges for amassing large numbers of patents on pharmaceutical drugs, especially high-priced and high revenue-earning drugs.

Here I explore the topic of pharmaceutical patents on methods of production and translate into layman’s terms some thought-provoking recent scholarship by innovation scholars W. Nicholson Price and Arti Rai.

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“Measuring the Un-measurable”

By Scott Burris

A couple weeks ago, I was in a conference room at a global health organization, all ready to give my talk on monitoring and evaluating legal health interventions. The chief of the organization’s formidable M&E operation was my host, and after briefly going through my bio he wound up his introduction by describing me as “the guy who will be telling us how to measure the un-measurable.”


In that one flourish, he captured the biggest barrier to more and better research on the impact of laws and legal practices on health: the cultural belief that law is different from other forms of individual and institutionalized human behavior and belief, so that it, alone, must perforce remain an evidence-free zone.  This is certainly a tragedy of low expectations if ever there was one.  Uncertainty is part of any hard decision, but if people in the organization I was visiting were talking about defining the optimum treatment regimen for a particular disease, they would take for granted that the deliberations of the decision-makers would be guided by a substantial evidence base. Yet when the question is what package of laws and legal practices create the best environment for preventing the same disease, or encouraging people to seek treatment, they see nothing strange about proceeding entirely on intuition and experience.

As Evan Anderson and I have recently written, the importance of law to health, and the overall success in properly evaluating its impact, belie this continued cultural prejudice. Law can be hard to evaluate, but so are most other influences on our behavior and environment.  In a number of areas of legal intervention, researchers have found ways to measure the hard-to-measure and produce credible findings that have shaped policy.  They have done so in ways that respect the prosaic realities of practical science work:  developing reliable measures and data and deploying them within robust designs is not the work of individuals, it’s not cheap, and it is not quick.  Where legal evaluation has thrived, it has done so because enough money was available for long enough to support multiple lines of inquiry by multiple teams of researchers. Careers, or stands of careers, could be built, and competition and disagreement could drive rigor and relevance.

This week, PHLR is celebrating one very tangible result of investment in the field: the publication of Public Health Law Research: Theory and Methods, which was conceived by the PHLR Methods Core and edited by Alex Wagenaar and me.  The book, which was written both as a methods class text book and a general reference work, is an important piece of field-building, in that it tries to define the basic good practices of PHLR.  But I think it does more: Alex, whose work on crash law exemplifies all that legal monitoring and evaluation can be, has led the production of a book that we can drop on the desk of every person in every funding and health services organization who thinks that measuring law is measuring the un-measurable.