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

Biotech. Info. Inst. biotech at biopharma.com
Wed May 8 12:05:00 PDT 2013


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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