www-billionphotos-com-shutterstock-com-4
www.BillionPhotos.com / Shutterstock.com
10 June 2015Americas

Shire v Watson Lialda dispute heads back to district court

The US Court of Appeals for the Federal Circuit has sent a patent dispute between drugs companies Shire and Watson Pharmaceuticals back to a district court, ruling again that the lower court erroneously construed claims related to Lialda (mesalamine).

It was the second time the federal circuit ruled on the case after the US Supreme Court requested in January that it re-hear the dispute.

The dispute concerns Shire’s patent 6,773,720, which covers a controlled-release drug taken orally to treat inflammatory bowel disease. The patent protects its branded drug Lialda.

In 2013, Shire accused Actavis-owned Watson of infringing the patent in its submitting of an Abbreviated New Drug Application (ANDA) to market a biosimilar version of the drug.

The US District Court for the Southern District of Florida ruled that Watson’s ANDA application infringed the ‘720 patent and that Shire was “entitled to injunctive relief”.

But the federal circuit reversed that decision a year later, stating that the district court’s construction of claims in the ‘720 patent “impermissibly broaden the ordinary meaning of the terms”.

Shire appealed against the decision and petitioned the US Supreme Court, which asked the federal circuit to review its ruling again.

This was following the Supreme Court’s decision in the Teva v Sandoz case, where the court ruled that the federal circuit must give deference to the lower court in relation to conclusions about facts, including conclusions of facts in the context of claim interpretation.

However, the federal circuit stated on remand that based on the intrinsic evidence of the case (including claims, specification and prosecution history), which is entitled to de novo review, the district court reached an incorrect interpretation.

The case will now head back to the district court, which has to change its claim interpretation and reconsider the infringement issue based on the federal circuit’s required claim interpretation.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
30 March 2016   Biopharmaceutical company Shire has had a patent for Lialda upheld in its trial against Watson Pharmaceuticals.

More on this story

Americas
30 March 2016   Biopharmaceutical company Shire has had a patent for Lialda upheld in its trial against Watson Pharmaceuticals.

More on this story

Americas
30 March 2016   Biopharmaceutical company Shire has had a patent for Lialda upheld in its trial against Watson Pharmaceuticals.