Naproxen & Esomeprazole

Naproxen & Esomeprazole

On Jan. 06, 2021, Federal Circuit affirmed New Jersey District Court decision of invalidity based on indefiniteness of a specific term.

 

Horizon pharma (Plaintiff) appealed the decision of New Jersey Court regarding summary judgment of invalidity of U.S. Patent Nos. 9,220,698 and 9,393,208. The issue was with respect to claim term, “target” as mentioned in claim 1 of US’698 patent, which is representative:

 

1. 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 Cmax is 86.2 µg/mL (±20%) and the median Tmax is 3.0 hours (±20%); and
b) for the PM dose of naproxen, the mean Cmax is 76.8 µg/mL (±20%) and the median Tmax 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 (AUC0–10,am) is 1216 hr*ng/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 (AUC0–14,pm) is 919 hr*ng/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 (AUC0–24) is 2000 hr*ng/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%.

 

During claim construction, Defendant argued that the term, “target” is indefinite or alternatively it has its ordinary meaning, which is “with the goal of obtaining.” Plaintiff on the other hand argued that the term “target” has its ordinary meaning, which is “produce.” District court declined to find “target” indefinite at claim construction, but agreed with Defendants’ proposed construction, slightly adjusted for grammatical fit. The district court found that construing “target” to mean “set as a goal” fit with the court’s understanding of what “target” ordinarily means, with several dictionary definitions, and with claim 1 and the patent as a whole. Defendants then moved for summary judgment of invalidity on the ground of indefiniteness. The court then held that the patent claims were indefinite because, while the goal itself was clearly defined, the “act of targeting that goal” was not. The court found that “pills cannot be said to set goals.” Plaintiff appealed.

 

Federal Circuit on appeal sided with District court & said that the claim term “target” is a commonly understood word, and nothing Plaintiff point to in the specification or the prosecution history suggests that it should be given anything other than its ordinary meaning. The use of both the terms “target” and “produce” at different points in
the specification does not mean that these words have the same meaning. If anything, this suggests that the patent
applicants were aware of their separate meanings and chose to use “target” in the patent claims instead of “produce.” Reading the claim literally, a dose form, which is an inanimate object, cannot set a goal. That the proper construction of the claims is nonsensical does not warrant judicial redrafting of the claims. Thus, Federal Circuit affirmed invalidity of both patents based on indefiniteness.

 

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