Akzo Nobel’s human healthcare business, Organon, has entered into a non-binding letter of intent with Cincinnati’s Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., to settle the pending patent litigation concerning a generic version of Organon’s Mircette® oral contraceptive.

Under the proposed transaction, Barr would pay Organon $142 million to settle the patent litigation and to acquire all rights relating to Mircette, including the U.S. marketing approval. Barr would also pay $13.75 million to Saviant Pharmaceuticals, Inc., owner of the patent covering Mircette. Organon is the exclusive licensee under the patent for Mircette (U.S. Patent No. 4,921,843, the “original patent”, and U.S. Patent No. RE 35724, the “reissue patent”).

Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol) provides an oral contraceptive regimen of tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol).

The patent litigation is currently before the U.S. District Court for the District of New Jersey. The court has agreed to stay any further proceedings to allow all parties involved to negotiate definitive settlement agreements.

Barr and Organon filed the non-binding letter of intent on the settlement with the Federal Trade Commission (FTC) this year, pursuant to the Hart-Scott-Rodino Antitrust Improvements Act. The closing of the deal is subject to FTC approval, which is currently at a second request stage.

The Hart-Scott-Rodino Antitrust Improvements Act of 1976, Pub. L. 94-435 (known commonly as the HSR Act), is a set of amendments to the antitrust laws, principally the Clayton Antitrust Act. The context in which the HSR Act is usually cited is 15 U.S.C. § 18a, title II of the original law, which provides that a company seeking to acquire or merge with another company (or engage in certain other transactions) must file advance notice of its intentions with the Federal Trade Commission and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice at least thirty days prior to consummation of such a transaction.

Title III of the Act allows states to sue companies in Federal court for monetary damages under antitrust laws on behalf of their citizens; previously, only the persons harmed by anticompetitive activity had a right to sue for damages.

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