Biosimilars: Twisting and turning

27-10-2015

Biosimilars: Twisting and turning

In July the US Court of Appeals for the Federal Circuit sought to clarify the rules on the ‘patent dance’, but with confusion reigning there are likely to be more twists and turns to come, as LSIPR finds out.

“I’ve given up predicting what the court is going to do,” says one lawyer commenting on the latest ‘patent dance’ ruling.

Although not often associated with high-stakes litigation, the term ‘dance’ has recently become widely used in the US biopharmaceutical industry. In July one of the biggest disputes surrounding the patent dance was resolved when the US Court of Appeals for the Federal Circuit ruled in Amgen v Sandoz.

But several months later, there seems to be plenty of confusion around key aspects of the ruling.


Biosimilar, Barnes & Thornburg, BPCIA, patent dance, FDA, Amgen, en banc review, US Court of Appeals for the Federal Circuit, Sandoz

LSIPR