VALEANT PHARMACEUTICALS INTL. v. MYLAN PHARMACEUTICALS INC.
Before Lourie, Reyna, and Hughes. Appeal from the United States District Court for the District of New Jersey.
Summary: Prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range can establish a prima facie case of obviousness.
Mylan filed an Abbreviated New Drug Application (‘ANDA’) and Valeant responded by bringing suit against Mylan in district court. The claim at issue was directed to a formulation with a pH of 3.0 – 4.0. Valeant moved for summary judgment that the claim at issue was not obvious. The court rejected Mylan’s expert testimony and cited references as insufficient, because although the references taught the pH range of interest, they did not teach formulations of the claimed compound but instead formulations of different, albeit related, compounds. Mylan’s second argument was based on an obvious-to-try theory. The district court rejected this argument, asserting there are an infinite number of possible pH values between two finite numbers. Ultimately, the district court granted summary judgment, finding the claim at issue not invalid. Mylan appealed.
The Federal Circuit reversed and remanded. With regards to Mylan’s first argument, the Federal Circuit held that a person of skill in the art can expect that compounds with common properties are likely to share other related properties. The district court erred by rejecting this inference as a matter of law at the summary judgment stage. The Federal Circuit further held that because the prior art molecules bear significant structural and functional similarity, and because the prior art teaches pH ranges that overlap the pH range recited in the claim at issue, Mylan succeeded to at least raise a prima facie case of obviousness sufficient to survive summary judgment. With regards to Mylan’s second argument, the Federal Circuit held that there is no requirement that, for a variable to be obvious to try, it must be the first variable a person of skill would alter. Additionally, the Federal Circuit clarified that a range of parameters, like a range of pH values, does not present an infinite number of possibilities. Limitations in measuring equipment, and the practical importance of adding significant figures to a measured value render the possibilities finite. The Federal Circuit found the District Court’s grant of summary judgment on Mylan’s obvious-to-try theory was in error.
Editor: Paul Stewart
Written by: Benjamin L. Van Adrichem & Karen Cassidy