E-DRUG: Patented new uses for old drugs (10)
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Interesting discussion on new uses for old drugs and keeping patent
protection. This is a variation on the theme of keeping exclusivity
through "evergreening" patents, adding patents to the patent register
to get additional protection, and compounding patent infringement
challenges against generics who attempt to enter the market before
patent expiration. These have been limited by the Medicare
Modernization Act in the USA.
Note that actually it is brand name companies that are the target of
off label use marketing restrictions; it is considered
anticompetitive and a false claim for promoting such use [the
neurontin case against parke-davis, now pfizer, is a good example,
although it has pretty egregious facts]. Brand name pharmaceutical
marketing guidelines are in place now, which put distinct borders
around these activities [as well as encourage competitor
whistleblowing for violations].
Generics, as a rule do not market off label, and gain most of their
sales during the first 6 months if they have marketing exclusivity
under US law if they are first to challenge a patent successfully.
More commonly now, generic firms are getting income by being
somewhat/very co-opted by brand name firms which either introduce
their own generic if there is the potential for generic entry, or
license the product to a generic firm, which then does not have to
expend litigation costs to fight off the brand name lawsuit for
patent infringement. the other strategy is to simply pay off the
generic to stay off the market to settle the patent infringement
suit; this is currently being litigated/reviewed as to its
anticompetitive nature.
Off label use by individual doctors is legal, and can help in
discovering new advances. Examples of off label use that have
resulted in new advances include beta-blockers applied now to
congestive heart failure, angiotensin-converting enzyme inhibitors
for heart attack/myocardial infarction patients, etc.
The FDA certainly does not prohibit medical off label use, which does lead to
additional applications, often through initial case reports which
then fuel studies.
Note that there are ethical considerations for off label use, which
should be followed if used for study purposes or because there is a
paucity of safety data. it's pretty standard now that patients are
well informed about the drug that is to be used and what evidence
there is about it, at least in the USA.
--
Bryan A. Liang, MD, PhD, JD
Executive Director and Professor
Institute of Health Law Studies
California Western School of Law
Co-Director and Adjunct Associate Professor of Anesthesiology
San Diego Center for Patient Safety
University of California San Diego School of Medicine
Contact information:
350 Cedar Street
San Diego, CA 92101
phone: 619.515.1568
fax: 619.515.1599
email: baliang@alum.mit.edu
url: http://www.ihls.org