[Ip-health] PLoS piece on secondary patents in pharma

Thirukumaran Balasubramaniam thiru at keionline.org
Wed Jan 30 08:27:29 PST 2013

I am posting this on behalf of Amy Kapczynski.



From: Amy Kapczynski <amy.kapczynski at yale.edu>
To: Ip-health <ip-health-bounces at lists.keionline.org>
Cc: Bhaven Sampat <bhaven at gmail.com>, Chan Park <cpark at medicinespatentpool.org>
Subject: PLoS piece on secondary patents in pharma 

Hi all -

Chan Park, Bhaven Sampat and I recently published in PLoS, perhaps of interest to folks here.  We provide data about the ubiquity and significance of so-called "secondary" patents in pharma (e.g. salt patents, polymorph patents, dosage and method of treatment patents, etc).  

Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents. PLoS ONE 7(12): e49470. doi:10.1371/journal.pone.0049470

We coded all of the patents in the Orange Book, and provide evidence find that secondary claims are common, and add substantial additional patent life.  Particularly relevant for this list, we note: 

"Our data also reveal the stakes of the decision that developing countries must make about the permissible scope of patents. Although the World Trade Organization's Trade-Related Aspects of Intellectual Property Agreement does require member countries to adopt patent protection for medicines, its requirements are general, and do not clearly require countries to permit secondary patents. We can quantify the stakes of such decisions: If the future looks like the past (and the patent landscape in other countries like that in the U.S.) a conservative estimate is that eliminating secondary patents could free up 36% of new medicines for generic production, since only 64% of drugs in our sample had patents with chemical compound claims. Additionally, for those drugs that still come under patent because a chemical compound claim exists, exclusions on secondary patents could limit the duration of patent protection by 4–5 years. The converse is that this study reveals the very substantial implications of new trade agreements. Negotiations are now underway for a new “Trans-Pacific Partnership” treaty, and the U.S. has apparently proposed barring exactly the kind of limits on secondary patents adopted by India, and under consideration by other countries."

Amy Kapczynski
Associate Professor of Law
Yale Law School
Office M15
Tel: 203-432-8005


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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