CAFC affirms SD Ind in Lilly v. Teva in pemetrexed case Teva loses;
The overview of the action:
Eli Lilly & Co. (“Eli Lilly”) is the owner of U.S. Patent
No. 7,772,209 (“’209 patent”). It filed this consolidated
Hatch-Waxman suit against Teva Parenteral Medicines,
Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.;
Teva Pharmaceuticals USA, Inc.; and Barr Laboratories,
Inc. (collectively, “Defendants”) to prevent Defendants
from launching a generic version of a chemotherapy drug
with accompanying product literature that would allegedly
infringe methods of treatment claimed by the ’209
patent. The United States District Court for the Southern
District of Indiana held two bench trials, one on infringement
and one on invalidity. The district court found that
no single actor performs all steps of the asserted claims
because the actions of both physicians and patients are
required. Nonetheless, under Akamai Technologies, Inc.
v. Limelight Networks, Inc. (Akamai V), 797 F.3d 1020,
1022 (Fed. Cir. 2015) (en banc) (per curiam), cert. denied,
136 S. Ct. 1661 (2016), the court found direct infringement
attributable to physicians and held Defendants
liable for inducing that infringement. The court also
determined that the asserted claims were not invalid for,
inter alia, indefiniteness, obviousness, or obviousnesstype
For the reasons below, we affirm
The Akamai issues
The parties agree for purposes of this appeal that no
single actor performs all steps of the asserted claims;
rather, the steps are divided between physicians and
patients. Though physicians administer vitamin B12 and
pemetrexed, patients self-administer folic acid with
guidance from physicians. Eli Lilly’s theory of infringement
therefore requires establishing liability for divided
infringement—an area of law that this court was actively
reconsidering during the pendency of this case.
In June 2013, Defendants conditionally conceded induced
infringement under then-current law set forth in
Akamai Technologies, Inc. v. Limelight Networks, Inc.
(Akamai II), 692 F.3d 1301 (Fed. Cir. 2012) (en banc) (per
curiam), rev’d, 134 S. Ct. 2111 (2014).1 At the time, the
Akamai II decision was the subject of a petition to the
Supreme Court for a writ of certiorari. The parties’
stipulation included a provision reserving Defendants’
right to litigate infringement if the Supreme Court reversed
or vacated Akamai II.
Of Akamai V:
Here, the district court decided that “the factual circumstances
[we]re sufficiently analogous to those in
Akamai [V] to support a finding of direct infringement by
physicians.” Eli Lilly & Co. v. Teva Parenteral Meds., Inc.
(Eli Lilly III), 126 F. Supp. 3d 1037, 1041 (S.D. Ind. 2015).
The court observed initially that taking folic acid in the
manner recited by the asserted claims is a “critical” and
“necessary” step to “reduc[e] . . . potentially lifethreatening
toxicities caused by pemetrexed,” i.e., to
“receive the benefit of the patented method.” Id. at 1042.
Regarding the first Akamai V prong, the court found,
based on the product labeling, that “taking folic acid in
the manner specified is a condition of the patient’s participation
in pemetrexed treatment.” Id. Regarding the
second prong, the court found that physicians would
“prescrib[e] an exact dose of folic acid and direct that it
be ingested daily.” Id. at 1043. The court therefore held
that, under Akamai V, the performance of all steps of the
asserted claims would be attributable to physicians.
Meeting the two prongs of Akamai is not sufficient to
prove induced infringement:
Although we conclude that the two-prong Akamai V
test is met here, this does not end our inquiry. “The mere
existence of direct infringement by physicians, while
necessary to find liability for induced infringement, is not
sufficient for inducement.” Takeda Pharm. USA, Inc. v.
West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir.
2015). To show inducement, Eli Lilly carries the burden
of further proving “specific intent and action to induce
infringement.” Takeda, 785 F.3d at 631. Mere
“knowledge of the acts alleged to constitute infringement”
is not sufficient. DSU Med., 471 F.3d at 1305.
We make two observations at the outset. First, to be
clear, the intent for inducement must be with respect to
the actions of the underlying direct infringer, here physicians.
Second, we have not required evidence regarding
the general prevalence of the induced activity. When the
alleged inducement relies on a drug label’s instructions,
“[t]he question is not just whether [those] instructions
describ[e] the infringing mode, . . . but whether the instructions
teach an infringing use such that we are willing
to infer from those instructions an affirmative intent to
infringe the patent.” Takeda, 785 F.3d at 631 (internal
quotation marks omitted). “The label must encourage,
recommend, or promote infringement.” Id. For purposes
of inducement, “it is irrelevant that some users may
ignore the warnings in the proposed label.” AstraZeneca
LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010).