Generic drugmakers have complained to the European Patent Office over the agency’s surprise restoration of a patent for Merck’s blockbuster drug Fosamax, The Financial Times reports. The generic groups are asking for a review about whether Merck “misled” Europe’s patent-granting authority or whether public interest was best served with the patent restoration of Fosamax.

The generic drugmakers are complaining that new intellectual property protection for Fosamax was an “abuse of the European patent system.” The situation was triggered by Merck’s stunning victory in March with the unusual reinstatement of a critical European patent for Fosamax. The decision could be worth hundreds of millions of dollars in new sales.

Generic companies are concerned that the system gives them little recourse to fight Merck’s new patent, with any appeal likely to last five years over an issue they believed was decided when the drugmaker saw another Fosamax patent invalidated three years ago.

Complaints by the generic industry could complicate Merck’s already delicate challenge of persuading government health authorities to pay for a branded version of Fosamax, as they file lawsuits to keep generics off the market.

A letter to the European Patent Office says the new patent “is causing significant prejudice to millions of patients around Europe as a result of the unjustified stifling of fair competition,” and asks for an urgent “internal enquiry” of the reinstatement of the Fosamax patent to see whether Merck misled the examining division or whether there was a mistake by patent authorities.

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