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

Biotech. Info. Inst. biotech at biopharma.com
Sun May 19 09:03:24 PDT 2013


Professor Outterson:  Regarding your request to see "the start of this email string," below are my original message that started this side discussion regarding U.S. biologics data exclusivity and a follow-up message with more details.  Otherwise, I'll announce to the list a link to the related article when it comes out next month.

Thank you.

Ronald A. Rader
President 
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
E-mail:  biotech at biopharma.com


>>>> 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 10, 2013, at 10:11 AM, Biotech. Info. Inst. wrote:
> I don't have much time now, but to hit some major points:
> 
> My analysis only concerns comparing patent vs. regulatory approval-conferred exclusivity expirations for U.S. marketed biologics/biopharmaceutical products.  I evaluated relevant patents (identified using my BIOPHARMA database at www.biopharma.com), often did some updating or confirmatory patent searching, calculated related patent expirations, and then calculated potential orphan (7 years from approval) and granted data exclusivity (12 years from approval), and compared the dates.  This was done for 119 currently-approved biologics (excluding vaccines and blood products), with ≥90% of these being recombinant proteins/antibodies, obviously including those products with any significant markets.  In fact, all or nearly all of these 119 products have one or more biosimilar/biobetter versions reported as in development (derived from the most extensive biosimilars/biobetters pipeline database, which I will be launching soon; see www.biosimilars.com, left side).  For comparison, there are ≥140 recombinant proteins currently approved in the U.S.  The core data are shown in the following figure:
> 
> Table 1:  Percent of Reference Products with Patents Expiring After Market and Data Exclusivities Expirations
> Patents Expire After
> 
> U.S.
> 
> EU
> 
> Data exclusivity
> 
> 87% (12 yr.)
> 
> 86% (10 yr.)
> 
> Orphan exclusivity
> 
> 96% (7 yr.)
> 
> 96% (10 yr.)
> 
> 
> Regarding how many products evaluated have ≤10 years U.S. patent protection post-approval, it looks to be 15 out of 119 or 12.6%.  Also, the above chart shows that European patents expire after 10 years EU orphan and data exclusivities with 96% of products evaluated. 
> 
> Yes, from my analyses, all the effort put in, by both industry and activists, concerning biologics data exclusivity in the context of BPCIA legislation was a waste.  I welcome receiving information about any U.S. biopharmaceutical products where relevant patents expire before approvals-conferred exclusivities.  
> 
> A major reason why I may be reporting longer patent protection than others is that I believe my patent analysis has been done in more depth than other published studies.  Besides starting out with more extensive patent information (from BIOPHARMA), similar studies have mostly simplistically concentrated on just the composition-of-matter (sequence)-type patents and ignored:  other types of patents (use/indications, formulation, bioprocessing, reference standards, etc.); exclusively licensed patents (just as important as company-assigned patents); and patent extensions.  
> 
> I hope to provide more information this weekend.
> 
> Thank you for your interest.
> 
> 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 18, 2013, at 5:10 PM, Outterson, Kevin wrote:

> I missed the start of this email string - can you provide the data or the article on DE?
> 
> Kevin Outterson
> ----------------------------------
> Professor, BU Law & SPH
> Editor in Chief, Journal of Law, Medicine & Ethics
> Faculty Associate, Harvard Center for Communicable Disease Dynamics
> Blogging health law at The Incidental Economist
> Research papers at SSRN 
> mko at bu.edu
> 617 935 6517 c
> Twitter @koutterson
> 
> 




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