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12:00 AM
Oct 11, 2010
 |  BioCentury  |  Strategy

Beat The Clock

Medicines Co. turns focus from patent disputes to new indications for Angiomax

After years of uncertainty surrounding the patent life for its Angiomax bivalirudin, The Medicines Co. now is pivoting to focus its attention and resources on developing the anticoagulant for additional indications, rather than paying lawyers and lobbyists to persuade lawmakers and agencies to extend the drug's patent life.

The company believes it now will have freedom to operate after the U.S. government chose not to contest a federal court ruling backing Medicine Co.'s argument that the biotech had not missed its deadline to file for a patent term extension for Angiomax.

But the company will have to act fast. Any new indication it chooses to pursue will require new Phase III trials, and the extension is expected to buy just 4.5 more years on the primary patent covering Angiomax's composition of matter.

Medicines Co. sued the U.S. Patent and Trademark Office in January after the agency denied the patent extension and rejected two requests for reconsideration after because the application was filed 62 calendar days after Angiomax received FDA approval.

This was two days later than the deadline according to the PTO's interpretation of the Hatch-Waxman Act. The law, which created the generics pathway in the U.S., allows patent holders to...

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