TYLER, Texas, Jan. 15, 2014 /PRNewswire/ -- Fish & Richardson announced today that it won an important Hatch-Waxman litigation for client Allergan, Inc. (NYSE: AGN) in a patent infringement suit against Sandoz Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., Hi-Tech Pharmacal Co., Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., and Watson Pharma, Inc. On January 14, 2014, the U.S. District Court for the Eastern District of Texas ruled that the defendants could not sell their generic versions of Allergan's popular LUMIGAN® (bimatoprost ophthalmic solution) 0.01% until Allergan's last patent expires in 2027.
LUMIGAN® 0.01 is a leading treatment for elevated eye pressure in people with glaucoma or ocular hypertension. LUMIGAN® 0.01% was first approved by the FDA in 2010.
Under Hatch-Waxman, drug companies may file a so-called abbreviated new drug application (ANDA) with the FDA to seek approval for generic versions of already-approved drugs by submitting bioequivalence studies instead of clinical studies, which is a much cheaper method than the normal FDA process. Branded companies that own the patents and believe the generic will infringe must then sue to enforce their patent rights to attempt to prevent the approval of the infringing generic.
As part of the ruling, the court permanently enjoined the defendants from the commercial manufacture, use, offer to sell and/or sale of their proposed generic products in, as well as the import of those products into, the U.S. or its territories.
"We are very pleased for our client Allergan and to have had the privilege of representing them in this case," said Jonathan Singer, head of the Life Sciences Litigation practice at Fish & Richardson who, along with Juanita Brooks and Douglas McCann, led the litigation and trial effort for Allergan. "This is a victory for all companies that put their R&D dollars into developing new and important products that address the unmet medical needs of patients around the world."
Fish & Richardson is a global law firm providing strategic counseling and litigation services to innovative clients who seek to protect and maximize the value of their intellectual property (IP). The firm has over 400 attorneys and technology specialists practicing IP strategy and counseling, IP litigation, and commercial litigation. Fish has been named the top U.S. patent litigation firm for 10 consecutive years. Visit www.fr.com and http://fishlitigationblog.com, and follow @fishrichardson.
SOURCE Fish & Richardson