Mylan's win against Celgene drug-patent claims OK'd by Fed Circ.

(Reuters) - Mylan Pharmaceuticals Inc can shake off patent claims in New Jersey over its proposed generic of a breakthrough blood-cancer drug because it didn't have a significant connection to the state, a federal appeals court said Friday.

Mylan applied for U.S. Food and Drug Administration approval for its generic version of Celgene Corp's Pomalyst outside of New Jersey, and its few employees in New Jersey didn't justify hearing the case there, the U.S. Court of Appeals for the Federal Circuit said.

The opinion clarifies where a drugmaker can file patent infringement claims under the Hatch-Waxman Act, the federal framework for generic drug approval.

Celgene, now part of Bristol-Myers Squibb Co, sued Mylan Pharmaceuticals and its parent companies in New Jersey federal court after it filed an Abbreviated New Drug Application for FDA approval of the generic. An ANDA asserts that the relevant drug patents are invalid or that the generic wouldn't infringe them, and opens the applicant to infringement claims from the patent owner.

BMS sold more than $3 billion worth of Pomalyst worldwide last fiscal year, according to U.S. Securities & Exchange Commission filings.

Mylan, which has since become part of Viatris Inc, was based in West Virginia, and its parents were based in Pennsylvania and the Netherlands when it filed for approval.

U.S. Magistrate Judge Michael Hammer dismissed the New Jersey case last year for improper venue. Celgene appealed, arguing that Mylan Pharmaceuticals' alleged infringement happened in New Jersey and the companies have employees in the state.

The Federal Circuit rejected Celgene's argument Friday, in an opinion written by U.S. Circuit Judge Sharon Prost.

"For the purposes of the Hatch-Waxman Act, it is the submission of the ANDA, and only the submission, that constitutes an act of infringement," Prost said. The court said the ANDA only justifies infringement claims where it was filed, not where Celgene received Mylan's notice letter or where the generic would be sold.

Mylan also didn't have a regular place of business in New Jersey, Prost said. A "handful of homes" there belonging to Mylan employees didn't prove otherwise, nor did the fact that Mylan had another subsidiary with an office in New Jersey.

BMS declined to comment. Celgene's attorneys Ellyde Thompson of Quinn Emanuel Urquhart & Sullivan and Matthew Hertko of Jones Day didn't immediately respond to a request for comment, nor did Viatris or Mylan's attorney Tung-On Kong of Wilson Sonsini Goodrich & Rosati.

The case is Celgene Corp v. Mylan Pharmaceuticals Inc, U.S. Court of Appeals for the Federal Circuit, No. 2021-1154.

For Celgene: Ellyde Thompson of Quinn Emanuel Urquhart & Sullivan; and Matthew Hertko of Jones Day

For Mylan: Tung-On Kong of Wilson Sonsini Goodrich & Rosati