Claim Term ‘Target’ Held Indefinite Because Inanimate Object Cannot Set a Goal

Intellectual Property Law

In Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc.,1 the Federal Circuit held that the claim language “the AM and PM unit dose forms further target a mean % time” as indefinite because the phrase was incomprehensible. The court held that a dose form, which is an inanimate object, cannot set a goal and that the correct interpretation, even though nonsensical, did not justify the judicial redrafting of the claims.

Horizon Medicines LLC appealed the district court’s award of summary judgment that U.S. Patent Nos. 9,220,698 (the ’698 patent) and 9,393,208 (the ’208 patent) were invalid for indefiniteness.2

The ’698 patent and the ’208 patent related to methods of administering a pharmaceutical composition comprising the non-steroidal anti-inflammatory drug naproxen and the proton pump inhibitor esomeprazole to a patient to inhibit stomach acid secretion that might cause gastrointestinal complications.3

Claim 1 of the ’698 patent was representative of both the ’698 patent and the ’208 patent and recited the following:

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%.4

Horizon asserted that the claim term “target” has its ordinary meaning, which was “produce.” Dr. Reddy’s argued that “target” was indefinite, but otherwise, it had its ordinary meaning of “with the goal of obtaining.”5

The district court interpreted “target” to mean “set as a goal.” It determined that the specification’s employment of both “target” and “produce” meant that the words were not synonymous. With respect to Horizon’s expert testimony further backing its proposed interpretation, the court determined it was conclusory and unsupported. The district court then held that the claims of the ’698 patent and the ’208 patent were indefinite because pills could not set goals.6

On appeal, the Federal Circuit affirmed. The court observed that “words of a claim are generally given their ordinary and customary meaning.”7 “[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.”8

The court explained that the claim term “target” was “a commonly understood word, and nothing . . . in the specification or the prosecution history suggests that it should be given anything other than its ordinary meaning.”9 The court also determined Horizon’s expert testimony was not persuasive because the expert only provided conclusory statements. According to the court:

While it is true that “the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess,” . . . the specification here does not. We therefore construe the claim term “target” to mean “set as a goal” as the district court did.10

After interpreting “target” to mean to “set a goal,” the Federal Circuit then proceeded to determine whether the claims of the ’698 patent and the ’208 patent were definite. The court reasoned that claims are indefinite if they do not “inform those skilled in the art about the scope of the invention with reasonable certainty.”11

One circumstance in which claims are indefinite is where the claims, as properly construed, are nonsensical. . . . We agree with the district court that the “target” clauses of claim 1 render the claim indefinite because “[t]he 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.” . . . As the district court explained, both clauses are incomprehensible. . . . 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.12

Accordingly, the Federal Circuit affirmed the district court’s interpretation of “target” to mean “set as a goal” and its conclusion that the claims of the ’698 patent and the ’208 patent were invalid for indefiniteness.

Takeaways:

In this case, defendant Dr. Reddy’s prevailed during litigation based on its asserted claim interpretation, which was based on the plain and ordinary meaning of “target.” The Federal Circuit rejected, in part, Horizon’s asserted claim construction based on conclusory statements provided by its expert. Patent litigants, whether in district court or at the Patent Office, need to provide adequate support based on objective evidence as understood by one of ordinary skill in the art at the time of the invention if their interpretation is to get serious consideration. As confirmed in Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc., claim interpretation is often the focal point in a litigation or Patent Office contested proceeding and can be, and oftentimes is, dispositive.


Irah Donner is a partner in Manatt’s intellectual property practice and is the author of Patent Prosecution: Law, Practice, and Procedure, Eleventh Edition, and Constructing and Deconstructing Patents, Second Edition, both published by Bloomberg Law.


1 Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc., Civ. App. 2019-1607, ---- Fed.Appx. ----, 2021 USPQ2d 24, 2021 WL 48428 (Fed. Cir. Jan. 6, 2021) (unpublished).

2 Id., slip op. at 2–3.

3 Id., slip op. at 3.

4 Id., slip op. at 3–5 (quoting U.S. Patent No. 9,220,698, col. 52 ll. 26-67) (emphasis added by court).

5 Id., slip op. at 5.

6 Id., slip op. at 5–6.

7 Id., slip op. at 7 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1312, 75 USPQ2d 1321, 1326 (Fed. Cir. 2005)) (internal quotation marks and citations omitted).

8 Id., slip op. at 7 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326 (Fed. Cir. 2005)).

9 Id., slip op. at 8.

10 Id., slip op. at 8 (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)).

11 Id., slip op. at 8–9 (quoting Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910, 110 USPQ2d 1688, 1693 (2014)).

12 Id., slip op. at 9 (quoting Summary Judgment Opinion at *4 and citing Becton Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 799 n.6, 17 USPQ2d 1097, 1102 n.6 (Fed. Cir. 1990); see also Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374, 69 USPQ2d 1857, 1860 (Fed. Cir. 2004) (“Even a nonsensical result does not require the court to redraft the claims of the [patent].”) (internal quotation marks omitted)).

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