Federal Circuit finds Millennium’s cancer drug to be novel

The US Court of Appeals for the Federal Circuit has reversed and remanded a decision from a district court which ruled that a patented Millennium Pharmaceuticals cancer drug was invalid.

In the  decision, handed down yesterday, July 17, the Federal Circuit found that Velcade (bortezomib) is novel.

The case arose after generic companies filed Abbreviated New Drug Applications (ANDAs), admitting infringement of Millennium’s patent and seeking to invalidate it.

The patent involved is US number 6,713,446, titled “Formulation of boronic acid compounds”.

Some of the generic companies that filed ANDAs were Sandoz, Mylan, Dr Reddy’s, Teva and Apotex.

After the generic companies each filed an ANDA seeking Food and Drug Administration approval, Millennium filed patent infringement suits alleging that the products infringed the ‘446 patent.

The US District Court for the District of Delaware held that the patent was obvious because it was the “inherent result of an allegedly obvious process”.

Millennium appealed.

The Federal Circuit said: “On review of the record and the applicable law, we conclude that the district court erred in the Sandoz litigation and that invalidity was not established.”

It added: “We reverse and enter judgment in favour of Millennium in the Sandoz litigation.”

Dr Reddy’s and Mylan were part of the Sandoz litigation.

“We also vacate the district court’s judgment in the action between Millennium, Teva, and Apotex based on our decision in the Sandoz litigation and remand that action for further proceedings.”

According to the Federal Circuit ruling, Apotex, Teva, and Millennium have agreed that because the Sandoz case has been reversed, the litigation between them should be vacated and remanded.

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