Federal Circuit Upholds Two District Court Decisions Concerning Patent Term Extensions: Ortho-McNeil Pharmaceuticals v. Lupin Pharmaceuticals and Photocure ASA v. Kappos

Ortho-McNeil Pharma v. Lupin Pharma and Photocure ASA v. Kappos Two recent cases decided before the U.S. Court of Appeals for the Federal Circuit (CAFC) on May 10, 2010 upheld two Patent Term Extensions (PTE) under 35 U.S.C. § 156. In the first case, Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., Lupin challenged the USPTO’s granting an extension to US Patent No. 5,053,407 that claims Levofloxacin, an enantiomer of a racemic compound ofloxacin that had previously been approved by the Food and Drug Administration (FDA), but to no avail. In the other case, Photocure ASA v. Kappos, Photocure challenged the USPTO’s... Read More

Bayer Vs Cipla

BAYER Vs CIPLA & UNION OF INDIA Does a combined reading of the Drug Control Act and the Patents Act lead to an inference that no marketing approvals can be granted to a third party for a drug/formulation for which a patent exists? This was a primary question before the Delhi High Court in a recent case involving, inter alia, Bayer & Cipla as the opposing parties. There has been a long standing controversy on linking patent status with the drug regulatory/marketing approval process. As it happens, the drug regulatory/marketing body is separate from the patent granting body and there... Read More