Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc.

The word “target,” appearing twice in each of the independent asserted claims is indefinite, thereby rendering the patents-in-suit invalid on summary judgment.

November 19, 2018

GENERICally Speaking

Case Name: Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., C.A. No. 15-3324 (SRC), -3326, -3327, 16-4918, -4920, -4921, -9035, 2018 U.S. Dist. LEXIS 196702 (D.N.J. Nov. 19, 2018) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen/esomeprazole tablets); U.S. Patents Nos. 9,220,698 (“the ’698 patent”) and 9,393,208 (“the ’208 patent”)

Nature of Case and Issue(s) Presented: The patents-in-suit disclosed methods of treatment using pharmaceuticals containing naproxen and esomeprazole, and each included one independent claim. The word “target” appears twice in each claim. The first clause stated, “the AM and PM unit dose forms target: …,” and the second clause stated, “and the AM and PM unit dose forms further target a mean % time ….” Defendants contended that the claim language involving “target” was indefinite and moved for summary judgment of invalidity.

In its Markman Opinion, the court construed “target” to mean “set as a goal,” but reserved decision on the issue of whether the target clauses would operate as claim limitations. Defendants argued that the target clauses did not limit the claims; plaintiffs argued to the contrary. Regardless, the parties agreed that if the court were to find that the target clauses were not claim limitations, the summary-judgment motion would be moot. The court decided that the “target” clauses were claim limitations, and that the “target” clauses were invalid as indefinite.

Why Defendants Prevailed: The court first found that the “target” clauses were claim limitations. The prosecution history showed that the applicants relied on the “target” clauses to distinguish the claimed invention from the prior art. To overcome an obviousness rejection, the applicants argued that the prior art did not teach or suggest the features contained in the “target” clauses. The court reasoned that this demonstrated that the applicants used the “target” phrases to define, in part, the claimed invention. Thus, the “target” phrases limited the claims. The specification further supported this position.

Having resolved the issue of whether the “target” clauses were limiting, the court found the summary judgment motion ripe for consideration. Because the court construed “target” to mean, “set as a goal,” this required that the PK and PD profiles stated in the target clauses defined the goals to be set. Plaintiffs argue that the PK and PD profile definitions were quite clearly delineated. But the fact that a goal was clearly defined does not mean that the act of targeting that goal was clearly defined. “The fundamental difficulty is that both key phrases here are incomprehensible.” The court found that it was not possible to comprehend what those phrases meant, because pills cannot be said to set goals. “In ordinary usage, we understand a goal to be something that people, or perhaps living creatures, set; inanimate objects set no goals.”

The court found that the “target” clauses failed to draw clear boundaries. “Suppose you are a physician who has obtained pills that provide 500 mg of naproxen and 20 mg of esomeprazole, and you want to treat a patient suffering from osteoarthritis, but you want to avoid infringing the ’698 patent. How do you determine the boundary for what you may legally do and what you may not? If we understand these target clauses to mean that the pills cannot set particular goals, you can relax about infringing, because your pills will never set any goals. If we understand these target clauses to mean that you, the treating physician, cannot yourself set treatment goals for PK and PD outcomes that fall within the claimed values, do you now know, with reasonable certainty, what you may permissibly do and what you may not? This Court sees no way that defining the goals for a method can, without more, inform the public of how to act to avoid infringement.”

The court rejected plaintiffs’ position for two primary reasons: (i) plaintiffs gave only lip service to the court’s claim-construction decision that “target” means “set as a goal”; and (ii) plaintiffs repeatedly focused on the larger part of the target clauses which they contended was definite, and not on the smaller portion which the court found indefinite.

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