Naproxen & Esomeprazole - USA

On Nov 19, 2018, New Jersey court found claims covering Vimovo® invalid as indefinite in summary judgment proceeding.

Defendants Dr. Reddy’s & Mylan moved for summary judgement of invalidity of U.S. Patent Nos. 9,220,698 and 9,393,208 on the ground of indefiniteness.

Claim 1 of the ‘698 patent is representative:

A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis comprising orally administering to a patient in need thereof an AM unit dose form and, 10 hours (+/-20%) later, a PM unit dose form, wherein:

the AM and PM unit dose forms each comprises: naproxen, or a pharmaceutically acceptable salt thereof, in an amount to provide 500 mg of naproxen, and esomeprazole, or a pharmaceutically acceptable salt thereof, in an amount to provide 20 mg of esomeprazole; said esomeprazole, or pharmaceutically acceptable salt thereof, is released from said AM and PM unit dose forms at a pH of 0 or greater, the AM and PM unit dose forms target: i) a pharmacokinetic (pk) profile for naproxen where: a) for the AM dose of naproxen, the mean C.sub.max is 86.2 .mu.g/mL (.+-.20%) and the median T.sub.max is 3.0 hours (.+-.20%); and b) for the PM dose of naproxen, the mean C.sub.max is 76.8 .mu.g/mL (.+-.20%) and the median T.sub.max is 10 hours (.+-.20%); and ii) a pharmacokinetic (pk) profile for esomeprazole where: a) for the AM dose of esomeprazole, the mean area under the plasma concentration-time curve from when the AM dose is administered to 10 hours (.+-.20%) after the AM dose is administered (AUC.sub.0-10,am) is 1216 hr*.mu.g/mL (.+-.20%), b) for the PM dose of esomeprazole, the mean area under the plasma concentration-time curve from when the PM dose is administered to 14 hours (.+-.20%) after the PM dose is administered (AUC.sub.0-14,pm) is 919 hr*.mu.g/mL (.+-.20%), and c) the total mean area under the plasma concentration-time curve for esomeprazole from when the AM dose is administered to 24 hours (.+-.20%) after the AM dose is administered (AUC.sub.0-24) is 2000 hr*.mu.g/mL (.+-.20%);

and the AM and PM unit dose forms further target a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state that is at least about 60%.

Defendants moved for summary judgment of invalidity of the ‘698 and ‘208 patents on the ground that the claims are indefinite due to the target clauses. In short, Defendants argued that, given the Court’s construction of “target” as “set as a goal,” the “patents provide no guidance regarding how often, if ever, the recited ranges must be met or how close one must come to those ranges to infringe the asserted claims.”

Since the court construed “target” to mean, “set as a goal,” this requires that the PK and PD profiles stated in the target clauses define the goals to be set. The fact that a goal is clearly defined does not mean that the act of targeting that goal is clearly defined, and this is the crux of the definiteness problem here. The fundamental difficulty is that both key phrases here are incomprehensible: “the AM and PM unit dose forms target:” and “the AM and PM unit dose forms further target.” It is not possible to comprehend what these phrases mean, because pills cannot be said to set goals. In ordinary usage, one understand a goal to be something that people, or perhaps living creatures, set; inanimate objects set no goals.

Therefore claim 1 & claims dependent thereupon of ‘698 and ‘208 patents are invalid as indefinite.