Takeda v. Hikma: a tour of Hatch-Waxman, or a misunderstanding of Hatch-Waxman?
The affliction in question is gout and the relevant drug is colchicine, which has been known to treat gout for centuries. One item that is not mentioned in the decision is the following, taken from
As a drug predating the FDA, colchicine was sold in the United States for many years without having been reviewed by the FDA for safety and efficacy. In 2009, the FDA reviewed a New Drug Application submitted by URL Pharma. They approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity, prohibiting generic sales, and increasing the price of the drug from $0.09 to $4.85 per tablet.242526
Knowledge of that FDA action is helpful in understanding what is going on in the case.
The majority opinion alludes to alternative gout treatments, such as with the NSAID indomethacin, which tend to diminish the practical significance of the case.
Judge Newman in dissent brings out the legal significance of the case. There is some interesting text
about what Hatch-Waxman is about.
Judge Newman wrote:
The panel majority today adopts a rule that inducement
cannot be found, whatever the facts of the particular
medicament and use. That is seriously flawed, for the
variety of medicinal situations is unlimited. In turn, the
public interest in new uses, new methods, and new combination
treatments is disserved by a rule that is a disincentive
to the development of new uses of unpatented
Thus I dissent from the court’s ruling that the provider
of a known drug product, with knowledge that it is
likely to be used in direct infringement, can never be
liable for induced infringement. These are fact-specific
circumstances, and are not amenable to final disposition
at a preliminary injunction hearing. The question requires
trial on the facts of this case.
Judge Newman's discussion begins:
The panel majority presents an incomplete picture of
the facts and the law and ignores the public interest in
the development of improved methods of treatment.
Although colchicine is a known gout treatment,
Takeda, through its predecessor Mutual, developed new
treatment protocols for acute gout flares, conducted
clinical trials, including treatment for patients concomitantly
taking other drugs, and secured FDA approval for
safety and efficacy of specified dosages and combinations
and schedule of administration. This information is
included on the FDA-approved Takeda label, and omitted
from the Hikma label.
Judge Newman mentions Grokster:
The panel majority goes too far, and states a general
rule that provides easy avoidance of patents on new uses
and improvements. The Hatch-Waxman Act is intended
to encourage drug research and development, not to
provide a disincentive by negating enforcement of improvement
patents by the simple expedient of omitting
the improvement from the label. With the removal of the
patent incentive for improvements, the loser is the afflicted
The panel majority is incorrect in stating that “in the
Hatch-Waxman Act context . . . . [t]he label must encourage,
recommend, or promote infringement.” Maj. Op. at
11 (citing Metro-Goldwyn-Mayer Studios Inc. v. Grokster,
Ltd., 545 U.S. 913, 936 (2005). The FDA label is not a
vehicle of promotion of any use; it is a record of approved
safety and efficacy of the product as used in accordance
with the label. Nor does the FDA “aid and abet” infringement
by including approved uses on the label.
Grokster is a copyright case, and although there is common
law commonality in the word “inducement,” questions
of intent and scienter are as fact-specific in the
copyright field as in connection with patents. An oversimplified
analogy between copyright and patent causes
does not aid understanding of these complex issues.
Judge Newman asserts:
The panel majority also appears to misunderstand the
Hatch-Waxman Act. The majority says “the statute was
designed to enable the sale of drugs for non-patented uses
even though this would result in some off-label infringing
uses,” Maj. Op. at 11, citing purported authority in Caraco
Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct.
1670, 1681-82 (2012); Warner-Lambert, 316 F.3d at 1359.
That is a misreading of statute and precedent. The
Hatch-Waxman Act is not designed to enable off-label
uses, whether or not they are infringing.
The cited cases do not hold otherwise. To the contrary,
Warner-Lambert states that “‘[I]f there are indications
which are claimed by any use patent and for which the
[ANDA] applicant is not seeking approval, then an ANDA
must state that the applicant is not seeking approval for
those indications which are claimed by such use patent.’”
316 F.3d at 1359 (quoting House Report No. 98-857).
TAKEDA PHARMACEUTICALS vs. HIKMA