Antitrust Law Blog

Under the Hatch-Waxman Act, a drug manufacturer must file a New Drug Application ("NDA") in order to obtain FDA approval of a new drug. Along with the NDA, the drug company must inform the FDA of any patents that cover the drug so the FDA can list the patents in a publication known as the "Orange Book." If such patents are listed in the Orange Book, a generic manufacturer, must make a certification with respect to the listed patents in its Abbreviated New Drug Application ("ANDA"). One certification is that the listed patents are either unenforceable or not infringed by the generic drug ("Paragraph IV certification"). The generic must give notice of the Paragraph IV filing to the NDA company, which has 45 days to file an infringement suit. If no suit is filed, the ANDA may be approved immediately. If suit is filed, that delays approval for 30 months. Either way, any subsequent generic making a similar Paragraph IV certification may not receive approval until 180 days after the earlier of either (1) the first ANDA applicant that submitted a Paragraph IV certification begins commercial marketing, or (2) a court decision holding that the relevant patent is invalid or not infringed.

On May 16, 2005, the United States Supreme Court struck down state laws in Michigan and New York, barring out of state wineries from selling directly to instate consumers, while allowing such sales by instate wineries. The laws were an unconstitutional discrimination against interstate commerce, in violation of the Commerce Clause of the Constitution. Granholm v. Heald, No. 03-1116 (May 16, 2005).¹

The DOJ has been conducting an aggressive enforcement campaign against international cartels since 1996. In the past, the DOJ could indict suspects located in the UK, but the requirement under previous extradition arrangements for the offence to be a crime in both requesting and receiving states (i.e. dual criminality) prevented their extradition since price-fixing was not a criminal offence on the UK. Most notably, in the auction house commissions scandal, the former Chairman of Christie's, Sir Anthony Tennant, could not be extradited under the dual criminality principle, and refused to go to New York to stand trial.