Allergan Wins Patent Infringement Lawsuit Against Generic-Drug Manufacturers

January 30, 2013, by Mandour & Associates, APC

San Diego – The Federal Circuit ruled in favor of multi-specialty health care company Allergan, Inc., upholding the district court’s ruling that two generic-drug manufacturers would infringe the Irvine-based pharmaceutical company’s patent if the companies produced a generic form of the drug Lumigan.

The Third Circuit agreed with the trial court that after Barr Laboratories, Inc. and Sandoz, Inc.’s expert testimony was discredited during the trial, the companies failed to prove their claims that Allergan’s patent should not be valid due to obviousness and the fact that it was based on prior art.

Judge Evan Wallach wrote in the opinion released Monday, “the district court did not err in finding that common sense and logic were not sufficiently illuminating in this case to carry Barr and Sandoz’s burden of proving the obviousness.”

Monday’s decision is another win for Allergan against Israel-based Barr Laboratories and Germany-based Sandoz in their ongoing patent disputes and upholds the September 2011 ruling from U.S. District Judge Sue L. Robinson that stated the two generics makers would infringe Allergan’s patents if they began making the generic version of Lumigan.

Judge Robinson claimed that the two generics makers failed to prove that Allergan’s patents were invalid and went on to say that the defendants’ expert witness Dr. Ashim K. Mitra “was eviscerated on cross-examination.”

Allergan filed the lawsuit in May 2009 against Barr Laboratories, which was acquired by Teva Pharmaceuticals USA Inc. in 2008, after the company filed an abbreviated new drug application with the U.S. Food and Drug Administration for a generic form of Lumigan.  Allergan filed a similar suit against Novartis International AG subsidiary Sandoz shortly after.  The two cases were combined in April 2010.

Due to the ruling, Sandoz and Barr will have to wait until the Lumigan patent expires in August 2014 before the companies can submit their abbreviated new drug application to the U.S. Food and Drug Administration to get approval to sell a generic form of Lumigan in the United States.

The patent-in-suit is U.S. Patent Number 5,688,819.  Lumigan is used to treat pressure that develops inside the eye in glaucoma patients and brings in more than $400 million in annual sales.