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

Jamie Love james.love at keionline.org
Fri May 10 04:23:08 PDT 2013


I agree with Brook's comments about the importance of test data
exclusivity as regards developing countries with different patent
landscapes, and thank Michael for addressing an important policy issue
of particular relevance to developing countries.

It is also true that BIO and PhRMA have gone to the wall in the US
legislative battles to get 12 rather than 7 years of test data
protection for biologic drugs. Were the companies spending their
political capital for an issue that was unimportant in practice?

These are a few additional comments and questions.

It is more difficult to understand the patent terms for biologic
drugs, because we don't yet have a good biosimilar pathway, and we
also don't have Orange Book patent disclosures.

The first drug that I worked on was Taxol, the cancer drug, which had
zero patent protection when first registered, and test data was the
only barrier for generic competition.  It is true that for small
molecule drugs, with only a bioequivalence standard for generic entry,
few NMEs have term terms less than 5 years of patent protection, but
it does happen, on drugs that are expense because of the test data
barrier to entry.  I imagine it happens more frequently the longer the
term of the test data protection.

For Ronald Rader, you say that the mean period of patent protection
for drugs is 15.3 years. That number seems roughly consistent with
some earlier work that Michael Palemdo and I did looking at the period
of time before a drug has one or more competitor.   Can you tell us
more about your sample?  Is this all NMEs?  All small molecule drugs?
Does it include or exclude NDAs that involve fixed dose combinations
or new formulations of drugs?   Also, can you tell us how many drugs
have less than 10 years of patent protection (as opposed to 7)?
Between 7 years and 12 years, there are probably more cases where the
test data would become relevant.


On Thu, May 9, 2013 at 12:49 PM, Biotech. Info. Inst.
<biotech at biopharma.com> wrote:
> Yes, the 2013 administration budget proposal cites $4 billion in savings over 10 years for federal pharmaceutical expenditures from shortening U.S. data exclusivity from 12 to 10 years.  $.4 billion/year is not all that much considering over 100 current products with a current U.S. market about $60 billion, including >40 current blockbusters (>$1 billion/year worldwide revenue), will be coming off-patent with biosimilars entering the U.S. market by the end of the decade.  If  $400 million/year savings is spread out over just 20 products affected by this data exclusivity change, that's a an average savings of $20 million/year/product.  In this context, the $4 billion/decade savings could even be low.
>
> But my data shows that patents almost always determine U.S. biosimilar marketability.  So where does this study come up with any savings from shortening the U.S. data exclusivity period?  It would be interesting to know what products data exclusivity shortening promoters and lobbyists presume would get into the market sooner, if U.S. data exclusivity were shortened, and how patent expirations were calculated.  As with nearly all biosimilar-related patent expiration studies, did the one used simplistically just look at composition-of-matter (sequence) patents, and as I've reported concerning nearly all such published data, ignore:  patent extensions; licensed patents, particularly exclusively exclusively licensed patents; and other types of patents, including key use/indications, bioprocessing, formulation, reference standards, etc. patents (as my analysis included)?  I suspect so, since essentially all published data have ignored these aspects.
>
> To address the question posed by the subject of this thread:  At least in the U.S. and with biopharmaceuticals, I expect data exclusivity to not have any significant impact.  In fact, it is rather irrelevant.  I realize that this is not welcome news for most members of this list, and I welcome learning of conflicting studies.
>
> Thank you.
>
> Ronald A. Rader
> President
> Biotechnology Information Institute this
> 1700 Rockville Pike, Suite 400
> Rockville, MD 20852
> Phone:  301-424-0255
> E-mail:  biotech at biopharma.com
>
>
> On May 9, 2013, at 10:42 AM, Michael Palmedo wrote:
>
>> 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 and Shaffer and Brenner); 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 proposalpredicts 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?
>>
>> Mike
>>
>>
>> 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
>>
>>
>>
>> --
>>
>> 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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-- 
James Love.  Knowledge Ecology International
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