In Eli Lilly
& Co. v. Teva Parenteral Medicines, Inc., Appeal No. 2015-2067 (Fed.
Cir. Jan. 12, 2017), the Federal Circuit held that the generic pharmaceutical companies
induced infringement despite some of the steps of the patented method claim being
performed by a physician and some by a patient.
Eli Lilly & Co. (“Eli Lilly”) is the owner of
U.S. Patent No. 7,772,209 (“’209 patent”). It filed suit to prevent several pharma
companies from launching a generic version of a chemotherapy drug ALIMTA. The asserted claims stated a method for
administering pemetrexed disodium with three different steps, two of which were
performed by a physician and one of which was performed by a patient:
12. An improved method
for administering pemetrexed disodium to a patient in need of chemotherapeutic
treatment, wherein the improvement comprises: a) administration of between
about 350 μg and about 1000 μg of folic acid prior to the first administration
of pemetrexed disodium; b) administration of about 500 μg to about 1500 μg of
vitamin B12, prior to the first administration of pemetrexed disodium; and c)
administration of pemetrexed disodium.
The parties all agreed that no single actor performed all steps of the asserted claims; rather, the steps were 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 required first establishing direct infringement based on
actions of two different actors.
Where no single actor performs all steps of a method
claim, direct infringement only occurs if “the acts of one are attributable to
the other such that a single entity is responsible for the infringement.” The
performance of method steps is attributable to a single entity in two types of
circumstances: when that entity “directs or controls” others’ performance, or
when the actors “form a joint enterprise.” Akamai Techs., Inc. v. Limelight Networks,
Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc) (Akamai V). Eli Lilly did not pursue a joint enterprise
theory, so the question of direct infringement was whether physicians direct or
control their patients’ administration of folic acid.
In Akamai V, The Federal Circuit held that directing
or controlling others’ performance includes circumstances in which an actor:
(1) “conditions participation in an activity or receipt of a benefit” upon
others’ performance of one or more steps of a patented method, and (2) “establishes the manner or
timing of that performance.”
The district court had relied in part on Defendants’
proposed product labeling as evidence of infringement: The Physician Prescribing Information
provides, among other things:
Instruct patients to
initiate folic acid 400 μg to 1000 μg orally once daily beginning 7 days
before the first dose of pemetrexed . . . . Instruct patients
on the need for folic acid and vitamin B12 supplementation to reduce treatment-related
hematologic and gastrointestinal toxicity . . . .
The Patient Information included similar
information:
To lower your chances
of side effects of pemetrexed, you must also take folic acid . . . prior to
and during your treatment with pemetrexed. It is very important to take folic acid and vitamin B12 during your treatment
with pemetrexed to lower your chances of harmful side effects. You must start
taking 400–1000 micrograms of folic acid every day for at least 5 days out of
the 7 days before your first dose of pemetrexed. . . .
With respect to the first prong— conditions participation
in an activity upon others’ performance —the Federal Circuit held that the
district court’s finding that physicians “condition” pemetrexed treatment on the
administration of folic acid was supported by the record evidence. The
Physician Prescribing Information, which is “directed to the physician,” explains
that folic acid is a “requirement for premedication” in order “to reduce the
severity of hematologic and gastrointestinal toxicity of pemetrexed.” Consistent
with the importance of folic acid pretreatment, the product labeling repeatedly
states that physicians should “instruct patients” to take folic acid and
includes information about folic acid dosage ranges and schedules
.
With respect to the second prong—establishing the
manner or timing of performance—the Federal Circuit again relied in the product
labeling, stating that the Physician Prescription Information instructs
physicians not only to tell patients to take folic acid orally, but also to
take “400 μg to 1000 μg of folic acid once daily beginning 7 days before the
first dose of pemetrexed,” accompanied with warnings about the consequences of
non-compliance. In addition, Eli Lilly’s
expert testified that “it’s the doctor” who “decides how much folic acid the
patient will take and when the patient takes it.”
After finding direct infringement by the physician, the
Federal Circuit analyzed whether the pharma companies induced the physician’s direct
infringement. The intent for inducement
must be with respect to the actions of the underlying direct infringer, here
physicians. When the alleged inducement
relies on a drug label’s instructions, “the question is not just whether those
instructions describe 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.” “The label must
encourage, recommend, or promote infringement.” For purposes of inducement, “it
is irrelevant that some users may ignore the warnings in the proposed label.” The
Federal Circuit held that the product labeling includes repeated instructions
and warnings regarding the importance of and reasons for folic acid treatment,
and there is testimony that the Physician Prescribing Information, as the name
indicates, is directed at physicians. The instructions are unambiguous on their
face and encourage or recommend infringement.
The case can be accessed here: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-2067.Opinion.1-10-2017.1.PDF
