TWi Pharmaceuticals, Inc. Receives Favorable Decision from the U.S. Court of Appeals for the Federal Circuit Regarding TWi's Generic Version of MEGACE ES(R) 625mg/5ml

Dec 15, 2015, 23:48 ET from TWi Pharmaceuticals, Inc.

TAIPEI, Taiwan, Dec. 15, 2015 /PRNewswire/ -- TWi Pharmaceuticals, Inc. ("TWi") (Stock Ticker: 4180.TT) today announced that it has received a favorable decision from the U.S. Court of Appeals for the Federal Circuit regarding TWi's generic version of Par Pharmaceutical's MEGACE ES® (megestrol acetate oral suspension) 625mg/5ml.  The United State Court of Appeals for the Federal Circuit affirmed all aspects of the judgment by the United States District Court for the District of Maryland that the asserted claims of United States Patent No. 7,101,576 (the '576 Patent) are invalid.   

On February 24, 2014 the district court found the asserted claims of the '576 patent invalid.  TWi received final approval for its generic megestrol product on August 28, 2014, but was enjoined by the district court from launching its product while Par appealed the ruling.  As required by Federal Rule of Civil Procedure 65(c), Par posted Preliminary Injunction Bonds in the total amount of $16 million as security against any losses TWi may have suffered from wrongfully being excluded from the market after receiving its final approval.  On December 3, 2014, the appellate court remanded the case for further findings of fact from the district court.  On July 28, 2015, the district court made additional findings of fact and conclusions of law reaffirming that the asserted claims of the '576 patent are invalid.

On July 29, 2015, the district court lifted its injunction and TWi began selling its product.  Par again appealed and the appellate court affirmed all aspects of the district court's judgment without issuing an opinion on December 15, 2015.  TWi may now seek to recover from the posted bond any damages it incurred as a result of the injunction.

Megace ES® is indicated for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients. It is a reformulation of megestrol acetate oral suspension and is prescribed for patients to help improve appetite and gain weight. 

SOURCE TWi Pharmaceuticals, Inc.