The company said this was action for patent infringement arising under the patent laws of the US. The action relates to an Abbreviated New Drug Application (ANDA) filed by DRL with the United States Food and Drug Administration (USFDA) for approval to market generic versions of Novartis Gleevec 100 mg Imatinib Mesylate capsules. Gleevec is used in the treatment of myeloid leukemia.
Earlier, Novartis had filed a similar suit against Dr Reddy's in February for infringing an US patent No. 6,894,051. This patent was legally issued on May 17, 2005 to inventors Jrg Zimmerman, et al. Later, the 2005 patent was assigned to Novartis AG and Novartis Pharmaceuticals Corporation is an exclusive licensee. However, on March 26, Novartis again filed an infringement of US patent No. RE43,932, a crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use, which was issued January 15, 2013.
Novartis holds approved NDA for Gleevec tablets containing 100 mg and 400 mg imatinib mesylate, which was approved by the FDA on April 18, 2003. In its action, DRL stated it will not assert lack of personal service or lack of personal jurisdiction as a defense, a court order said.
DRL notified Novartis that it had submitted ANDA to the FDA of the Federal Food, Drug and Cosmetic Act seeking approval to engage in the commercial manufacture, use and sale of oral capsules containing 100 mg of imatinib mesylate oral capsules, 100 mg base. In its notice letter, DRL notified Novartis that its ANDA contained a paragraph IV certification and that in DRLs opinion, the RE932 patent is invalid, unenforceable or will not be infringed by the manufacture, use, sale, or offer to sell of DRLs Imatinib Mesylate ANDA capsules.
The court order said that DRLs filing of its ANDA to obtain approval to engage in the commercial manufacture, use, offer to sell or sale of its Imatinib Mesylate ANDA capsules, prior to the expiration of the RE932 patent, constitutes infringement of one or more of the claims of that patent.
As per available reports, sales of Gleevec totalled more than $1.8 billion in 2013, but the patent protecting the active principle will expire on January 4, 2015 while the patent protecting the beta crystal form of the active principal ingredient will expire on May 23, 2019.
Incidentally, Novartis has never been granted an original patent for Gleevec in India. In fact, in April 2013, the Supreme Court denied an appeal challenging the rejection of a patent for Gleevec, a life-saving medicine for certain forms of cancer, patented in nearly 40 countries, including China, Russia, and Taiwan. Novartis filed a special leave petition with the Supreme Court in 2009 challenging the denial of the Gleevec beta crystal form patent on two grounds, based on of the Indian patent law.