Orange Book Blog

As Patently-O reported early this morning, the Solicitor General has filed an amicus brief in FTC v. Schering.  The Supreme Court, while considering whether to grant certiorari in the case, had asked for the views of the Solicitor General last fall.  The Solicitor General’s brief advises the Court not to grant the FTC’s cert petition.

If the Court denies certiorari, that would leave standing the 11th Circuit’s decision that a settlement of a patent infringement lawsuit between Schering-Plough and Upsher-Smith did not violate the antitrust laws.  The patent infringement suit concerned Upsher’s generic version of Schering’s K-Dur 20 drug product, a treatment for high blood pressure and heart disease.  The settlement agreement between Schering and Upsher included a cash payment from Schering to Upsher in exchange for Upsher’s promise not to launch its generic version of K-Dur 20 for six more years—close to the end of Schering’s patent term.

The FTC’s petition for certiorari presents the following questions for review:

1. Whether the antitrust laws prohibit a brand name drug patent holder and a prospective generic competitor from settling patent infringement litigation by agreeing that the generic manufacturer will not enter the market before a future date within the term of the patent and that the patent holder will make a substantial payment to the generic manufacturer.
2. Whether the court of appeals erred in concluding that "substantial evidence" did not support the Federal Trade Commission’s factual finding that a payment from a patent holder to an allegedly infringing generic manufacturer was consideration for the generic manufacturer’s delayed entry into the market rather than a separate royalty for a license concerning a different product.

The following briefs have been filed:

• FTC’s cert petition
• Schering’s brief in opposition to certiorari
• FTC’s reply brief in support of its cert petition
• AARP’s amicus brief in support of FTC
• Bayer Corp.’s amicus brief in opposition to certiorari
• PUBPAT’s amicus brief in support of FTC
• Nat. Assoc. of Chain Drugstores’ amicus brief in support of FTC
• Rep. Henry A. Waxman’s amicus brief in support of FTC
• Solicitor General’s amicus brief in opposition to certiorari
• States’ amicus brief in support of FTC

Thanks to Dennis Crouch for sending me copies of the briefs!

RELATED READING:

• 08 June 06 New York Times editorial