[Ip-health] Important neglected & tropical disease / patent extensions on antibiotic legislation signed by Bush

[Outterson, Michael Kevin]

I=92ve been meaning to send this since Friday, but was busy at the excellen=
t UAEM conference this weekend at Harvard (www.essentialmedicine.org).  It'=
s a long post, but worth reading.

Last week, Bush signed PL 110-85 (HR 3580), which reauthorized the FDA user=
 fee system, among other things.  2 provisions are clearly relevant to IP h=
ealth readers.

I.  Section 1102 of PL 110-85 establishes new sec. 524 of the FDCA, and cre=
ates a priority voucher system for tropical disease innovation.  The vouche=
r is fully transferable, which means that a small biotech or non-profit can=
 sell it to the highest bidder (this provision was apparently added after t=
he early drafts).  The voucher system appears to be an implementation of Dr=
. Mary Moran=92s paper from LSE on fast-track options: https://www.who.int/=
entity/intellectualproperty/submissions/Mary.Moran2.pdf

The list of qualifying tropical diseases is long, and includes TB, malaria =
and cholera, in addition to many other traditional tropical diseases.  HHS/=
FDA can add =93any other infectious disease for which there is no significa=
nt market in developing nations and that
disproportionately affects poor and marginalized populations=94 through a d=
esignation process.

The standard for being awarded a voucher is quite high (cmp Bioshield II). =
 First, a human drug application must be filed and designated for priority =
review by FDA (ie, an innovative drug); it must then be FDA approved for =
=93use in the prevention, detection, or treatment of a tropical disease=94 =
(ie, no off-label vouchers or vouchers for drugs not yet approved); and fin=
ally, the human drug must be new =96 and esters or salts don=92t count (cmp=
 omeprazole).

The holder of the priority review voucher gets the opportunity to pay for e=
xpedited 6 month review at the FDA for another drug.


II.  The second provision (sec. 1111-1114 of PL 110-85) adds a new drug cat=
egory:  =93Orphan Antibiotic Drugs=94 with $150 million over 5 years in orp=
han antibiotic drug grants and contracts.  The FDA will convene a public me=
eting to discuss further incentives for AB development.

Much more controversially, section 1113 of PL 110-85 gives drug companies a=
 very carefully worded option to grant marketing exclusivity for what is ap=
parently evergreening with little innovation.  See the article by Peter Man=
sfield, David Henry and A Tonkin on the racemic / non-racemic single enanti=
omer patent extension (evergreening) process: http://www.ncbi.nlm.nih.gov/s=
ites/entrez?cmd=3DRetrieve&db=3Dpubmed&dopt=3DAbstractPlus&list_uids=3D1508=
0762

The result will be 10 years of marketing exclusivity with a potentially mis=
leading label (10 years of =91super DE=92!) and delayed generic entry for s=
ome drugs.  The GAO is instructed to prepare a report by Jan. 1, 2012 on wh=
ether this provision has:  =93(1) encouraged the development of new antibio=
tics and other drugs; and (2) prevented or delayed timely generic drug entr=
y into the market.=94  It's not entirely clear whether it's limited to anti=
biotics, or whether this single enantiomer process applies to all drugs (th=
e Mansfield article suggests broader application).

In general, these antibiotic provisions follow from the IDSA=92s report, Ba=
d Bugs, No Drugs:
http://www.idsociety.org/badbugsnodrugs.html and various lobbying efforts b=
y drug companies over the past few years.  The idea of encouraging antimicr=
obial innovation through patent extensions is quite controversial (or shoul=
d be).  See my recent article in the Lancet Infectious Diseases, Aug 2007: =
 http://www.thelancet.com/journals/laninf/article/PIIS1473309907701883/abst=
ract
and an earlier but longer treatment in the University of Pittsburgh Law Rev=
iew:
Outterson, Kevin, "The Vanishing Public Domain: Antibiotic Resistance, Phar=
maceutical Innovation and Global Public Health" . University of Pittsburgh =
Law Review, Vol. 67, pp. 67-123, 2005 Available at SSRN: http://ssrn.com/ab=
stract=3D873401

In both articles I argue that patent extensions are an inefficient and pote=
ntially counterproductive mechanism to stimulate better antimicrobials, and=
 that significant attention should be paid to conservation as well as innov=
ation in this area.

Kevin Outterson