Summary Judgment of No Infringement Granted in MIRTAZAPINE Patent Litigation

Organon, Inc. and Akzo Nobel, N.V. listed U.S. Patent 5,977,099 (the "'099 patent") in the Orange Book under Remeron® (mirtazapine). The '099 patent covers the use of a combination of mirtazapine and an SSRI to treat depression. Mylan Pharmaceuticals filed an ANDA requesting FDA approval for Mylan to manufacture a generic mirtazapine product. The ANDA contained a paragraph IV certification with respect to the '099 patent. The patent on mirtazapine and its use to treat depression has expired. Organon, Inc. and Akzo Nobel N.V. sued Mylan for infringement of the '099 patent pursuant to the Hatch-Waxman Act. Organon did not allege that Mylan directly infringed the '099 patent. Rather, it alleged that Mylan's sale of a generic mirtazapine would induce doctors and pharmacists to infringe the patent. Mylan filed a motion for summary judgment of no infringement. On December 18, 2002, the Honorable Faith S. Hochberg granted Mylan's motion for summary judgment of no infringement. The court found that the filing of an ANDA, the sale of a generic as "AB rated" and the offer of a generic product at a lower price than brand do not constitute active steps to induce infringement. Several class action plaintiffs have filed antitrust actions against Organon.