Merck v. Integra: Supreme Court Hears Drug Development Patent Case

On April 20, 2005, the Supreme Court heard oral arguments in the case of Merck KGaA v. Integra (Statutory safe harbor for drug development activity).  However, the oral arguments do not appear to have raised any new issues that will impact the case. 

The High Court was critical of the Federal Circuit prose:

• “not a crystal clear opinion by any means” (J. Ginsburg).
• “pretty foggy” (J. Breyer).

These remarks did not extend to the substance of the opinion.  Book-makers expect that the CAFC’s decision will be at least partially reversed — the real question is the eventual breadth of the statute.

In January 2005, Tom Mauro of the Legal Times reported that Justices Sandra Day O’Connor and Stephen Breyer did not participate in the decision to grant cert.  Interestingly, both Justices took part in the oral arguments.

A decision is expected this summer.

Links:

• Patently-O: Information on the case
• AP Article by Hope Yen [2nd copy]