Supreme Court’s Copaxone Ruling Already Influencing Other Drug Patent Cases

The Supreme Court wasted no time in acting on the precedent it set in its recent Copaxone ruling, sending several patent cases, including one Hatch-Waxman dispute, back to the appellate level.

The high court cited the Copaxone (glatiramer acetate) decision last week when it vacated an appellate court ruling invalidating a Shire patent protecting the company’s anti-inflammatory drug Lialda (mesalamine), remanding the case back to the U.S. Court of Appeals for the Federal Circuit.

In the Copaxone ruling, the Supreme Court found that the appellate court should not have done its own fact-finding when assessing the validity of the multiple sclerosis drug’s patent.

Appellate courts are only supposed to do their own fact-finding beyond the lower district court rulings when there is a clear error in what the district court found, the justices said in a 7-2 decision. Otherwise, appellate courts are expected to restrict their ruling to issues of law rather than issues of fact, which should have been settled at the district level.

Shire’s Hatch-Waxman infringement case against Actavis subsidiary Watson was sent back to the lower level precisely because the appellate court did its own fact-finding, just as it did in the Copaxone case, says D’vorah Graeser, CEO of Graeser Associates International, an IP strategy firm.

In this case, Shire is once again protected from any planned generic versions of Lialda, Graeser said. The federal circuit appellate court reversed an earlier district court decision in March 2014 that found Watson’s ANDA infringed on the drug’s ‘720 patent, according to court documents.

Shire said that it was pleased with the ruling. Actavis did not respond to a request for comment by press time. — Bryan Koenig