Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2021)

By Kevin E. Noonan --

Indefiniteness under U.S. patent law is a failure to satisfy the statutory requirements of 35 U.S.C. § 112(b), which reads:  "The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention" (emphasis added).  The meaning of the statute was most recently explicated by the Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014), which established the standard that the inherent imprecision of language cannot create "ambiguity . . . so great that it creates a 'zone of uncertainty' around the patent claims."  In practice, this led the Court to require "reasonable certainty" in claim language, a standard the patent claims at issue failed to satisfy in the Federal Circuit's recent decision in Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc.

The case arose in litigation of over a combination therapy of a non-steroidal anti-inflammatory (NSAID) medication and a proton-pump inhibitor (PPI) that minimized the gastrointestinal complications of NSAID administration.  The asserted patents, U.S. Patent Nos. 9,220,698 and 9,393,208, claimed methods of treating certain diseases with such combination formulations; claim 1 of the '698 patent was deemed representative by the Federal Circuit panel:

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 C_max is 86.2 µg/mL (±20%) and the median T_max is 3.0 hours (±20%); and
        b) for the PM dose of naproxen, the mean C_max is 76.8 µg/mL (±20%) and the median T_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_0–10,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 (AUC_0–14,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 (AUC_0–24) 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%.

The District Court granted summary judgment in favor of defendants that this claim (and the remaining asserted claims) in the '968 and '208 patents were invalid for indefiniteness.  Among all the terms, technical and otherwise, in this claim the basis for the District Court's decision is the term "target," which the District Court construed to have its ordinary meaning of "set as a goal."  In so construing this claim term, the District Court rejected patentee Horizon's alternative construction, to "produce," because the specification used the words "produce" and "target" in ways that the term were not necessarily interchangeable.  Under this construction, the District Court held that "while the goal itself was clearly defined, the 'act of targeting that goal' was not."  Specifically, the District Court said that "'pills cannot be said to set goals,' and even if the claims were understood to say that it is a treating physician who sets the goals, the claims would require a treating physician to 'avoid having a subjective intent to achieve the defined outcomes.'"  Finally, the District Court found that the differing views of plaintiff's and defendant's experts as to the meaning of the term did not raise issues of material facts because the dispute involved opinion not fact.  This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Hughes, joined by Judges Moore and O'Malley.  The panel found the term in this case to be readily construed according to its plain meaning, saying that "the claim term 'target' is a commonly understood word, and nothing Appellants point to in the specification or the prosecution history suggests that it should be given anything other than its ordinary meaning," which was the meaning used by the District Court, i.e., "set as a goal."  (Somewhat parenthetically, the opinion rejected patentee's argument that case law favors a construction that preserves validity, because this principle applies only where "the court concludes, after applying all the available tools of claim construction, that the claim is . . . ambiguous," citing LiebelFlarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004), and that was not the case here in the Court's opinion).

While relying expressly on the Supreme Court's Nautilus opinion, the Federal Circuit also opined that "[o]ne circumstance in which claims are indefinite is where the claims, as properly construed, are nonsensical," citing Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1366–67 (Fed. Cir. 2016).  In upholding the District Court's construction, and finding of indefiniteness, the panel asserted 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.'"  Simply put (as the District Court had) "a dose form, which is an inanimate object, cannot set a goal."

After agreeing with the District Court that a dispute between experts does not raise a genuine issue of material fact that would preclude summary judgment, the panel affirmed the construction and the District Court's decision that the claims were indefinite and consequently invalid.

Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2021)
Panel: Circuit Judges Moore, O'Malley, and Hughes
Opinion by Circuit Judge Hughes

Comments

[hardreaders]

I'm not usually sympathetic to patentees in general, or dosing claims in particular, but in this one it does seem like the patentee got something of a raw deal.

For indefiniteness, just like for any other basis of invalidity, I thought it should still be the challenger's burden by clear and convincing evidence, but here CAFC seemed like it was going out of its way to be unsympathetic to the patentee. Conversely, it seemingly didn't require much of the challenger to carry it's burden.

Just as a matter of common vernacular, I don't think it's so implausible to say that a drug can "target" a particular physiological profile in the sense of being designed to produce that profile when administered. After all, don't we often say that drugs target a specific pathogen and/or area of the body, without that sounding absurd? If so, I think you can say a drug targets a profile too. Presumably one of skill would view it the same way, but this isn't my particular field.