Judiciary Watch

Patent Applicant May Introduce New Evidence in Suit Challenging PTO’s Denial of Patent Claims

In a suit to challenge the denial of patent claims, there are there are no limitations on a patent applicant’s ability to introduce new evidence beyond those provided in the Federal Rules of Evidence and the Federal Rules of Civil Procedure, the U.S. Supreme Court has ruled (Kappos v. Hyatt, April 18, 2012, Thomas, C.). If new evidence is presented on a disputed question of fact, the federal district court must make de novo factual findings that take account of both the new evidence and the administrative record before the Patent and Trademark Office, the Court also held.

 

Supreme Court ruling favors generic drug maker

The U.S. Supreme Court ruled that generic drug makers can sue their brand-name rivals for overstating the reach of their patents.  Caraco Pharmaceutical Laboratories Inc., a generic-drug company sought permission from the Food and Drug Administration to market a generic version of Novo Nordisk AS’s Prandin diabetes drug. In a unanimous decision, the court ruled that Caraco could, in a patent infringement action brought against it by the manufacturers of the brand-name version of the drug (“Novo”), assert a counterclaim seeking an order requiring Novo to correct the drug’s FDA Orange Book “use code” because the drug’s method-of-use patent did not claim two of the three approved uses for the drug asserted in the use code. (Caraco Pharamaceutical Laboratories Ltd. v. Novo Nordisk A/S, April 17, 2012, Kagan, E.).