San Diego – The United States Supreme Court denied Barr Laboratories writ of certiorari on October 31, 2011 in Barr Laboratories v. Cancer Research Technology, Ltd. The action arose out of Barr Laboratories’ filing of an Abbreviated New Drug Application (ANDA), or application for approval to produce a generic version of the drug Temodar. Barr Laboratories, a division of Teva Pharmaceutical Industries, Ltd., filed an ANDA to manufacture a generic version of the brain cancer drug Temodar which is currently covered under a patent owned by Cancer Research Technology and licensed to Merck & Co.
The ANDA filing led to an action in a U.S. District Court in Delaware filed by Cancer Research Technology, a British licensor of the Temodar patent to New Jersey based Merck and Co, to enforce the Temodar patent. The Delaware District Court found for Barr Laboratories, holding that the Temodar patent was unenforceable due to incomplete information in the application and that the patent applicant had engaged in delay tactics before the USPTO. The USPTO did not issue the Temodar patent for nine years after receiving the application.
However, that ruling was later overturned by the United States Court of Appeals for the Federal Circuit which found that Barr Laboratories was not harmed by the USPTO’s delay in issuing the patent. The result of the Federal Circuit ruling prevented Barr Laboratories from producing the generic version of Temodar pending further appeal before the U.S. Supreme Court. However the Supreme Court refused to grant certiorari and hear Barr’s appeal. The Supreme Court, which has vast discretion over the cases it hears, refused to grant the appeal without comment.
Barr Laboratories and parent company Teva agreed to withhold its plans to produce a generic version of the brain cancer drug pending the appeals. In exchange for agreeing to withhold production pending the outcome of the case, Barr Laboratories may begin production of a generic version of Temodarin August of 2013. Temodar experienced sales of over one billion dollars in 2010.