Thursday, March 28, 2019

CAFC explicates Mayo, Vanda in Endo v. Teva

The outcome was reversal:

Endo Pharmaceuticals Inc. appeals the district court’s
decision holding the claims of U.S. Patent No. 8,808,737
ineligible under 35 U.S.C. § 101. See Endo Pharms. Inc. v.
Actavis Inc., No. 14-cv-1381-RGA, 2015 WL 7253674
(D. Del. Nov. 17, 2015) (“District Court Op.”), adopting report and
recommendation, 2015 WL 5580488 (D. Del.
Sept. 23, 2015) (“Magistrate Op.”). Because the district
court incorrectly concluded that the claims at issue are directed to a natural law, we reverse

As to 12(b)(6)

“We apply regional circuit law to the review of motions
to dismiss for failure to state a claim under Rule 12(b)(6),”
In re TLI Commc’ns Patent Litig., 823 F.3d 607, 610
(Fed. Cir. 2016), here, the Third Circuit. The Third Circuit
“review[s] de novo a district court’s grant of a motion to dismiss
for failure to state a claim under Federal Rule of Civil
Procedure 12(b)(6).” Ballentine v. United States, 486 F.3d
806, 808 (3d Cir. 2007). To survive a motion to dismiss for
failure to state a claim, a complaint must allege “enough
facts to state a claim to relief that is plausible on its face.”
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “We
review issues unique to patent law, including patent eligibility under § 101,
consistent with our circuit’s precedent.”
Smart Sys. Innovations, LLC v. Chi. Transit Auth.,
873 F.3d 1364, 1367 (Fed. Cir. 2017)

As to 101:

Applying this law, we conclude that the asserted claims
are not directed to patent-ineligible subject matter.3 On
the contrary, the claims are directed to a patent-eligible
method of using oxymorphone or a pharmaceutically acceptable salt
thereof to treat pain in a renally impaired patient.4 Our conclusion is supported by the claim language
itself and confirmed by the specification. The claims recite
“[a] method of treating pain in a renally impaired patient.”
’737 patent col. 48 ll. 7–9. Claim 1 also requires specific
steps: (a) providing a pharmaceutical (5–80 mg of oral controlled-release
oxymorphone or one of its pharmaceutically
acceptable salts), (b) testing the patient for a disease state
(reduced kidney function based on creatinine clearance
rate), and then (c) administering the pharmaceutical (a
lower dose of oxymorphone) based on the creatinine clearance rate to achieve
an average AUC of oxymorphone over
a 12-hour period of less than 21 ng·hr/mL. Consistent with
the claims, the abstract, patent title, and summary of the
invention all describe the invention as a “method of treating pain” in patients
with renal impairment. Id. at Abstract, col. 1 ll. 1–5; see id. at col. 2 ll. 35–43. The
specification predominantly describes the invention as a
method that treats renally impaired pain patients with less
oxymorphone while still treating their pain. Indeed, the
specification explains that the method “avoid[s] possible issues in dosing” and allows for treatment with “the lowest
available dose” for patients with renal impairment. Id.
at col. 10 ll. 26–27, 40–41.

We held similar claims patent-eligible in Vanda Pharmaceuticals Inc. v.
West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018).
The patent at
issue in Vanda related to a method of treating schizophrenia patients with a drug (iloperidone),
where the administered dose is adjusted based on whether or not the patient
is a “CYP2D6 poor metabolizer.” 887 F.3d at 1121.


The claims at issue here are legally indistinguishable
from the representative claim in Vanda. Both claims recite
a method for treating a patient. The Vanda patent claims
recite the steps of carrying out a dosage regimen based on
the results of genetic testing. Id. at 1135. Here, the claims
similarly recite the steps of carrying out a dosage regimen,
though the steps are based on the results of kidney function
testing. Additionally, the claims in both cases require specific treatment steps.


Also like the claims in Vanda, the claims here differ
from those in Mayo in material respects. Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed
to the application of a drug to treat a particular disease.
See Mayo, 566 U.S. at 74, 87; Vanda, 887 F.3d at 1134.
Furthermore, the administering step in Mayo is distinguishable from the administering step in the ’737 patent
because the administering step in Mayo is the first step in
the method that simply describes giving the drug to a patient with a certain disorder. By contrast, the administering step in the ’737 patent is the step that describes giving
a specific dose of the drug based on the results of kidney
function testing. The Supreme Court in Mayo underscored
the distinction between such method of treatment claims
and those in Mayo, noting that “[u]nlike, say, a typical patent on a new drug or a new way of using an existing drug,
the patent claims do not confine their reach to particular
applications of those laws.” Mayo, 566 U.S. at 87; Vanda,
887 F.3d at 1135. In Vanda, the inventors recognized the
relationship between iloperidone dosage and the patient’s
CYP2D6 poor metabolizer genotype, but that was not what
they claimed.


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