In the
United States, the drug company Allergan has found an ingenious solution to the
patent expiry issue. It involves an unlikely alliance with a native American
tribe.
How?
To defend
its dry eye treatment Restasis (ciclosporin) against generic competition, Allergan
has transferred the patent to the St Regis Mohawks, who have 'sovereign immunity'
under US law. The result is a win-win outcome, as the Mohawks gain over $13m a
year in royalties, while Allergan protects its annual sales of the drug, which
was worth $1.5 billion last year. The only losers are the generics companies.
This is a
rare case of indians winning against cowboys, if that is how you view generic manufacturers.
In America,
tribal reservations are often dispiriting places, with high levels of
unemployment, and health problems including alcoholism and drug addiction. Many
reservations take advantage of US tax laws to set up gambling casinos as a revenue
stream for otherwise impoverished tribes.
The idea of
using sovereign immunity was broached to the Mohawks by a Dallas law firm with
the wonderful name of Shore Chan DePumpo. The ruling is powerful medicine for
native Americans who have faced years of exploitation and underprivilege. So
even if you regard generics companies as champions of affordable healthcare,
it's hard to argue against the poetic justice of the decision.
The Restasis
case is not so much an example of 'evergreening' - extending the patent life of
a compound by devising slightly different formulations - as a 'patent relay',
passing the baton to keep it beyond the reach of competitors.
The case
may open up lots of creative ways for innovative pharmaceutical companies to
protect their intellectual property. What is to stop them transferring patents
to other deserving entities? Why not assign copyright to threatened animal
species such as elephants or rhinos (or the charities that look after them),
which could benefit from the income but are protected against legal claims?
You can
expect lawyers working for generics manufacturers to vigorously challenge the Allergan
strategy. At the same time, imaginative patent lawyers will be racking their
brains to exploit new opportunities.
In the
meantime, the St Regis Mohawks can safely say: you may steal our land and our
buffalo, but you won't steal our ciclosporin ophthalmic emulsion. And there are
500 more tribes who could benefit from similar arrangements.
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