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

Ruth Lopert ruth.lopert at gmail.com
Fri May 10 06:10:59 PDT 2013


For the record biologics in the US have FOUR years of data exclusivity but
(and more egregiously ) TWELVE years of market exclusivity. If they had
twelve years of DE they'd effectively have 14 years of ME.

People really should stop using the terms interchangeably - there is a
world of difference

On Fri, May 10, 2013 at 9:23 PM, Jamie Love <james.love at keionline.org>wrote:

> 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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> >>
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> >>
> >
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>
> --
> James Love.  Knowledge Ecology International
> http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
> Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
> twitter.com/jamie_love
>
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