Spectrum Pharms., Inc. v. Sandoz Inc.

Case Name: Spectrum Pharms., Inc. v. Sandoz Inc., 12-cv-111-GMN-NJK, 2015 U.S. Dist. LEXIS 22112 (D. Nev. Feb. 20, 2015) (Navarro, J.)

Drug Product and Patent-in-Suit: Fusilev® (levoleucovorin); U.S. Pat. No. 5,800,829 (“the ’829 patent”)

Nature of the Case and Issue(s) Presented: Leucovorin has been used in association with cancer treatment since the 1950s. Only the (6S) isomer of leucovorin, known as levoleucovorin, provides the desired biological activities in a human being. The ’829 patent relates to a method of preparing substantially pure levoleucovorin solutions in order to isolate the useful isomer.

Sandoz submitted an ANDA for approval to market generic levoleucovorin. In response, Spectrum initiated this lawsuit, alleging infringement of the ’829 patent. Sandoz responded, alleging that the ’829 patent was obvious in light of the prior art. After trial, the court found that the ’829 patent was invalid as obvious.

Why Sandoz Prevailed: The court first performed an analysis of the prior art relating to leucovorin and specifically levoleucovorin. A person of ordinary skill in the art was aware that leucovorin was useful in treating a number of ailments relating to cancer. It was used to treat folate deficiencies, used in methotrexate rescue, and, in larger dosages, used in 5-FU combination therapy. The skilled artisan also knew that the levoleucovorin isomer provided the therapeutic benefit in treating humans. In addition, the prior art contained teaching relating to purifying the levoleucovorin isomer. Thus, the levoleucovorin isomer had previously been isolated prior to the critical date of the ’829 patent, and the patent was prima facie obvious.

Spectrum failed to prove evidence of secondary considerations in order to rebut the court’s prima facie finding of obviousness. Spectrum argued that the secondary considerations of long-felt need and commercial licensing suggested the ’829 patent was not obvious. First, Spectrum failed to provide a nexus between the claimed invention and the secondary-consideration evidence.  Second, the court considered the facts supporting these arguments as weak at best and declined to reconsider its obviousness decision. Although two companies licensed the ’829 patent, they did so for extremely low amounts of money. Further, many drug companies declined to license the patent. Simply expressing an initial interest in a patent is not sufficient to suggest a long-felt need or commercial success. Accordingly, the court held that the patent was invalid, and entered judgment in favor of Sandoz.