Written by Mark Terry
The unfortunate death of Michael Jackson and the trial of Dr. Conrad Murray has made a little-known drug, propofol (marketed as Diprivan by AstraZeneca), into a household name. What is fundamentally important about drugs like propofol may not only be what they’re used for but their impact on the economy.
Propofol
was originally developed in the UK by Imperial Chemical Industries (see U.S.
Patent No. 4056635). Though clinical trials followed in 1977, due to negative
reactions, the formulation was withdrawn from the market and subsequently
reformulated as an emulsion of a soya oil/propofol mixture in water. The
emulsified formulation, which is not a complex formula, was relaunched in 1986
by ICI (now AstraZeneca) under the brand name Diprivan. Propofol emulsion is a
highly opaque, white fluid due to the scattering of light from the tiny oil
droplets that it contains. There are 4 patents (5714520, 5731355, 5731356,
5908869) for Diprivan that are set are to expire in 2015.
The relatively simple formula for
Diprivan, which generates annual sales of $400 – $500 Million for AstraZeneca,
may make it easy for generics to enter the propofol market. True generics are
not expected until 2015, but generics with different formulas are expected to
come to market before 2015. It has been reported that propofol is a low
profit-margin product. Thus, once generic-like products and generics hit the
market, the margins will likely fall further. This brings up fundamental
questions about the patent system. Should patent protection be extended in
order to protect a patent owner’s investment in a drug? Inventors and investors
must justify the return on investment (ROI) on millions and billions of dollars
spent on developing new drug products, otherwise, they simply won’t do it
anymore. Is 20 years enough time to obtain an adequate return on those large
R&D; expenditures? For instance why has Pfizer drastically cut its research
and development spending and why has Amgen decided to buy back $5 billion of
its stock? Are those indications that they don’t have the incentive to invest
in new products?
Creating an incentive to invent, via
recovery of R&D; expenditure and production of profits, is the premise of
the U.S. patent system. We would be wise to review the current system to make
sure this is still the case.
Mark Terry is a Board
Certified Intellectual Property attorney in Miami, FL who specializes in
helping companies and individuals protect their ideas and creations using
patents, trademarks and copyrights.