US court invalidates Velcade patent after Sandoz challenge

Sandoz, Allergan and Accord Healthcare have demonstrated “clear and convincing” evidence that a patent owned by Millennium Pharmaceuticals and used in its Velcade (bortezomib) cancer treatment drug is invalid, according to a US court ruling.

On Thursday, August 20, the US District Court for the District of Delaware invalidated US patent number 6,713,446 on the grounds that it was obvious.

Velcade is used to treat people suffering from multiple myeloma, a type of cancer that starts in the bone marrow.

Takeda Pharmaceutical Company acquired Millennium Pharmaceuticals for around $8 billion in 2008.

The ‘446 patent is called “Formulation of Boronic Acid Compounds” and was issued to Millennium Pharmaceuticals in 2004.

In 2012, Sandoz, Allergan and Accord all submitted Abbreviated New Drug Applications (ANDA) to the US Food and Drug Administration seeking permission to market a generic version of the drug.

Later that year, Millennium Pharmaceuticals sued all three companies in separate cases at the Delaware court claiming that the ANDAs infringed the ‘446 patent. The district court consolidated the cases in 2013.

The defendants challenged the validity of the patent on the grounds that it was obvious and the district court agreed.

Judge Gregory Sleet, presiding over the case, said: “The defendants have presented a prima facie case by clear and convincing evidence that the asserted claims of the patents-in-suit are invalid as obvious.”

James Hurst, partner at law firm Kirkland & Ellis and representing Sandoz, said: "The trial was watched closely, including by investors who sat through the trial and issued daily blow-by-blow reports."