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

Michael Palmedo mpalmedo at wcl.american.edu
Thu May 9 07:42:28 PDT 2013

Thanks for your comment.


The paper wasn't really written about whether or not biologics in the
U.S. should have 12 or 7 or X years of data exclusivity.  It says that
Member countries of the WTO have a range of options for data protection;
data exclusivity has been shown to raise prices (see Oxfam
<http://www.oxfam.org/en/policy/bp102_jordan_us_fta>  and Shaffer and
Brenner <http://content.healthaffairs.org/content/28/5/w957> ); and the
relationship between whether or not a country has data exclusivity and
the level pharmaceutical investment is uncertain at best.  


That said, the Obama Administration certainly thinks that less data
exclusivity for biologics will lead to greater access to generics/FOBs.
As you know, the 2013 budget proposal
budget.pdf>  predicts that reducing the term of exclusivity will "will
result in $4 billion in savings over 10 years to Federal health programs
including Medicare and Medicaid."  A footnote would have been nice...
any idea where the number comes from?  





From: Biotech. Info. Inst. [mailto:biotech at biopharma.com] 
Sent: Wednesday, May 08, 2013 3:05 PM
To: Michael Palmedo
Cc: Ronald A. Rader; ip-health
Subject: Re: [Ip-health] Do Pharmaceutical Firms Invest More Heavily in
Countries with Data Exclusivity?"


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 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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