September 27, 2017 | Patent, Pharma law, patent challenge
An unlikely treaty between global pharma and native Americans
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.
© 2017 Life Healthcare Communications
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