[Ip-health] Compulsory licensing of Pharmaceutical patents

Jamie Love james.love at keionline.org
Fri Aug 22 15:29:14 PDT 2014

I would agree with Al Engelberg on the challenges of registering a generic,
and the importance of the US test data exclusivity, as a general matter.
 That said, there is some flexibility if the executive branch wanted to
speed things up (a big if, but relevant and logical if they were willing to
use 28 usc 1498).  Note, for example, the Obama Executive order for
registration of generic Doxil,
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm, or
the FDA actions on the vaccine use at Princeton, or the measures taken
during the Fabry shortage.  None of these cases were exactly on point, but
they show some ability to make things happen when they want.

For the new HCV drugs from Gilead and BMS (or others), the period of time
for trials to support registration might be pretty short, and trials
combining Sofosbuvir and other non-Gilead drugs might be done anyway by
third parties.  If the government really wanted marginal cost pricing of
HCV drugs to pursue more widespread use of the drugs, including for
patients with less severe medical problems, via a patent buyout of some
type, and was willing to pay for the trials for registration, they could
make things happen sooner.  And, of course, movements in this direction
would certainly change bargaining positions over prices.


On Fri, Aug 22, 2014 at 11:54 AM, Alfred Engelberg <aengelberg at nglbrg.com>

> The Hatch-Waxman Act prohibits the FDA from accepting  an Abbreviated New
> Drug Application for 5 years (4 years in the case of a paragraph IV Patent
> Certification of non-infringement) following the approval of a
> pharmaceutical product containing a new chemical entity (NCE). Given
> current FDA backlogs, it would probably take at least 6 years for a generic
> version of a new drug to reach the market even if  the US, which clearly
> possesses sovereign immunity under 28 USC 1498, exercised that right by
> authorizing a generic company to produce product for sale to the United
> States.  In the case of biologic drugs the non-patent exclusivity period is
> 12 years before a biosimilar application can be approved.
> In short, a compulsory patent license will not produce generic competition
> for a new drug in the near term. The situation is not like CIPRO where the
> competitive generic products actually had tentative FDA approval at the
> time the US undertook its price negotiations with Bayer.
> Alfred Engelberg
> aengelberg at nglbrg.com
> _______________________________________________
> Ip-health mailing list
> Ip-health at lists.keionline.org
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James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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