[Ip-health] Do Pharmaceutical Firms Invest More Heavily in Countries with Data Exclusivity?"

Baker, Brook b.baker at neu.edu
Thu May 9 07:54:08 PDT 2013

It might well be true that data exclusivity on pharmaceuticals biologics
in the US and EU affects only 14% and !3% of medicines, but that is
significantly because of patent term extensions.  Is it not a problem that
insurers, governments, and patients pay higher prices for a longer time on
one out of seven medicines?

However, the article authored by Mike Palmedo also addresses non-US/EU
markets.  Even if Mr. Rader thinks those markets are irrelevant, I'm sure
patients there don't.  Moreover, pharmaceutical companies often do not
file, prosecute or maintain patents in many low- and middle-income
countries and therefore look to data exclusivity as a means of achieving
exclusive marketing rights and supra-competitive pricing in those markets.
 The advantage of data exclusivity (and patent/registration linkage) from
Pharma's perspective is that the company knows the product is a salable
product and they get exclusive rights exactly when they want them.

Professor Brook K. Baker

Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker at neu.edu

On 5/8/13 3:05 PM, "Biotech. Info. Inst." <biotech at biopharma.com> wrote:

>Regarding data exclusivity, I've recently evaluated the patent, market
>and data exclusivities in the U.S. and EU for 119, essentially all,
>currently-approved potential reference biologics/biopharmaceuticals
>(ignoring vaccines and blood products; >90% recombinant
>proteins/antibodies), and calculated biosimilar and biobetter
>launchability in these major markets.  [See www.biosimilars.com, left
>side; with patent and exclusivities data already included in the
>BIOPHARMA database (www.biopharma.com)].  I found that patent expiration
>exceeds the regulatory-granted exclusivities with 87% of products in the
>U.S. and 86% in the EU.  The average length for patent protection after
>initial approval was 15.3 years in the U.S.  Patent coverage exceeds
>market (orphan) exclusivity, 7 years in U.S. and 10 in EU, with 96% of
>products in both the U.S. and EU.
>Bottom Line:  Patents are what really matters in terms of follow-on
>biopharmaceutical marketability in the U.S. and EU.  Regulatory-granted
>market and data exclusivities are essentially totally irrelevant.
>Shortening U.S. data exclusivity for biologics, with proposals for this
>recurring periodically, would be useless in terms of getting follow-on
>biologics on the market  sooner.
>Does anyone still believe that shortening data exclusivity for U.S.
>biologics will have any affect on U.S. biosimilars marketability?  Are
>there any studies, either pre-BPCIA that have withstood peer review or
>more recent, showing that shortening U.S data exclusivity would
>accelerate access to biosimilars?
>For those interested in the biosimilars development pipeline and likely
>evolution of the U.S. market, watch for an article on these topics I
>authored to be published in the June issue of BioProcess International
>(journal and articles free online).  Most members of this list will
>likely be encouraged by my asserting that the U.S. biosimilars market
>will be more like that of generic drugs, with lots of competition, likely
>>10-12 biosimilars for most current major (blockbuster) products, with
>>prices significantly lower than the wimpy 20%-30% at best currently
>>projected for U.S. biosimilars.
>Thank you.
>Ronald A. Rader
>President / Author & Publisher of BIOPHARMA:  Biopharmaceutical Products
>in the U.S. and European Markets
>Biotechnology Information Institute
>1700 Rockville Pike, Suite 400
>Rockville, MD 20852
>Phone:  301-424-0255
>E-mail:  biotech at biopharma.com
>Web sites:  www.biopharma.com; www.bioinfo.com;
>    www.biosimilars.com; www.biopharmacopeia.com
>On May 8, 2013, at 10:45 AM, Michael Palmedo wrote:
>> Hello all. 
>> I wanted to share my paper "Do Pharmaceutical Firms Invest More Heavily
>> in Countries with Data Exclusivity?" which will be coming out in
>> Currents International Trade Law Journal this summer.
>> Abstract:     Countries may choose various methods of data protection in
>> order to comply with the TRIPS Agreement. Policymakers should consider
>> the effects of data exclusivity on prices and investment relative to
>> other types of data protection. The data presented here suggest there is
>> no relationship between whether or not a country has data exclusivity,
>> and the amount of investment in the country by the pharmaceutical
>> industry. On the other hand, empirical evidence in previous papers has
>> shown that data exclusivity does drive prices higher.
>> Full paper: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2259797
>> Mike
>> --
>> Mike Palmedo
>> Program on Information Justice and Intellectual Property
>> American University Washington College of Law
>> 4801 Massachusetts Ave., NW, Washington, D.C. 20016
>> W: 202-274-4442 | M: 571-289-3683
>> wcl.ameican.edu | infojustice.org | pijip-impact.org
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