[Ip-health] British scientists find patent loophole

[Tim Hubbard]

Nature Medicine - 13, 112 (2007)

31 January 2007

British scientists find patent loophole

Brandon Keim

New York

Recreating a molecule with some variations could evade patents.
Two British researchers say they have found a way
to produce low-cost versions of expensive
pharmaceuticals without breaking patent laws.

Sunil Shaunak and Steve Brocchini call their
products "ethical pharmaceuticals."

Their first target is a naturally occurring
molecule called interferon, which is used to
treat hepatitis C. Commercial interferon has a
coat of sugar molecules that reduces side effects
and helps it last longer in the body. It is safe
and effective, but also expensive.

In the UK, a full course of treatment costs
around =A37,000, well beyond the means of most
people in the developing world. Hepatitis C
affects 200 million people and kills about half a
million people each year.

The researchers attached sugar molecules to a
different part of interferon, creating a
configuration that may be novel enough to evade
existing patents.

If it passes regulatory hurdles-and legal
challenges-the compound would then be made
affordable in the developing world. Patents on
the process, along with the resulting interferon
formulation, are held by PolyTherics Ltd., a
company founded in 2001 by the researchers.
Shantha Biotech, based in Hyderabad, India, has
agreed to produce the drug, and the Indian
government is set to conduct clinical trials.

Shaunak says other researchers should follow this
example by reformulating other drugs. They have
also partnered with the Drugs for Neglected
Diseases Initiative to alter a leishmaniasis
treatment. Drugs created by this method will need
to be approved by regulatory agencies.

Pharmaceutical companies Roche and
Schering-Plough, which hold patents on
sugar-coated interferon, declined to comment. But
Frederick Abbott, a Florida State University law
professor and intellectual property expert, says
the patents are sure to be contested.

"Are scientists morally and ethically justified
in trying to develop workarounds to the patent
system to provide treatment to more people?
Absolutely," says Abbott. "But one shouldn't
assume that industry is just going to accept
that."


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Dr Tim Hubbard                      email: th@sanger.ac.uk
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