United States District Court, S.D. Indiana, Indianapolis Division
ELI LILLY AND COMPANY, Plaintiff: Adam L. Perlman, Bruce
Roger Genderson, PRO HAC VICE, WILLIAMS & CONNOLLY LLP,
Washington, DC; Andrew V. Trask, PRO HAC VICE, WILLIAMS &
CONNOLLY, Washington, DC; Anne N. DePrez, Jan M. Carroll,
BARNES & THORNBURG LLP, Indianapolis, IN; David M. Krinsky,
Dov P. Grossman, Ellen E. Oberwetter, Megan A. Hughes, PRO
HAC VICEs, WILLIAMS & CONNOLLY, LLP, Washington, DC.
TEVA PARENTERAL MEDICINES, INC., APP PHARMACEUTICALS, LLC,
PLIVA HRVATSKA D.O.O., TEVA PHARMACEUTICALS USA INC., BARR
LABORATORIES, INC., Defendants: Brian J. Prew, Daryl L.
Wiesen, Elaine Herrmann Blais, Emily L. Rapalino, Michael B.
Cottler, PRO HAC VICEs, GOODWIN PROCTER, LLP, New York, NY;
Briana Lynn Clark, David O. Tittle, E. Ashley Paynter, Kandi
Kilkelly Hidde, BINGHAM GREENEBAUM DOLL LLP, Indianapolis,
IN; Natasha E. Daughtrey, GOODWIN PROCTER LLP, New York, NY.
LILLY AND COMPANY, 1:11-cv-00942-TWP-TAB, Consol Plaintiff:
Andrew V. Trask, PRO HAC VICE, WILLIAMS & CONNOLLY,
Washington, DC; Anne N. DePrez, Jan M. Carroll, BARNES &
THORNBURG LLP, Indianapolis, IN; Megan A. Hughes, WILLIAMS &
CONNOLLY, LLP, Washington, DC.
PHARMACEUTICALS, LLC, 1:11-cv-00942-TWP-TAB, Consol
Defendant: Brian J. Prew, Elaine Herrmann Blais, PRO HAC
VICEs, GOODWIN PROCTER, LLP, New York, NY; Kandi Kilkelly
Hidde, BINGHAM GREENEBAUM DOLL LLP, Indianapolis, IN; Natasha
E. Daughtrey, GOODWIN PROCTER LLP, New York, NY.
OF FACT AND CONCLUSIONS OF LAW FOLLOWING SECOND BENCH TRIAL
HELD MAY 28, 2015
WALTON PRATT, JUDGE, United States District Court, Southern
District Of Indiana.
a Hatch-Waxman patent infringement action brought by Eli
Lilly and Company (" Lilly" ), the owner of U.S.
Patent No. 7,772,209 (the " '209 patent" ),
against Defendants Teva Parenteral Medicines, Inc. ("
Teva Parenteral" ), Teva Pharmaceuticals USA, Inc.
(" Teva Pharmaceuticals" ) (collectively with Teva
Parenteral, " Teva" ), APP Pharmaceuticals, LLC
(" APP" ), Barr Laboratories, Inc. ("
Barr" ), and Pliva Hrvatska D.O.O. (" Pliva" )
(collectively, " Defendants" ) arising out of
Defendants' filing of Abbreviated New Drug Applications
(" ANDAs" ) with the FDA seeking approval to market
the pemetrexed disodium products identified in Teva's
ANDAs Nos. 90-352 and 90-674, APP's ANDA No. 90-384, and
Barr's and Pliva's ANDA No. 91-111 (collectively, the
" ANDA Products" ) and covered under the '209
patent. The '209 patent describes a method of
administering a chemotherapy drug, pemetrexed disodium
(" pemetrexed" ), with vitamins, which is marketed
by Lilly under the trade name ALITMA® .
matter was before the Court for a second bench trial on May
28, 2015, on the issue of infringement of claims 9, 10, 12,
14, 15, 18, 19 and 21 (the " Asserted Claims" ) of
the '209 patent" . During the first trial, the
parties jointly stipulated to induced infringement and
proceeded to trial only on the issue of validity. As part of
their stipulation, however, defendants reserved the right to
litigate infringement if the Supreme Court granted the
then-pending petition for writ of certiorari in
Lime-light Networks, Inc. v. Akamai Technologies,
Inc., 134 S.Ct. 2111, 189 L.Ed.2d 52 (2014) and reversed
or vacated the Federal Circuits decision. Following the
United States Supreme Court's decision in
Akamai, the parties jointly moved to remand their
pending appeal so that they could litigate the issue of
Court has set forth the facts of this case in its ruling from
the first bench trial on the issue of validity, including the
history of the development of antifolate chemotherapy and
specifically ALITMA® , and thus the facts are not
repeated in detail here. ( See Filing No. 336.) The
following constitutes the basic facts giving rise to this
infringement action, and the relevant factual findings as it
relates to the second bench trial on the issue of indirect
patent-in-suit is U.S. Patent No. 7,772,209, which was issued
to Lilly on August 10, 2010, and Lilly is the current owner
of the '209 patent. The '209 patent covers the method
of administration of ALIMTA® , requiring that physicians
co-administer the drug with folic acid and vitamin B12 to
reduce the incidence of patient toxicity caused by
pemetrexed. Lilly sells pemetrexed in the United States under
the trademark ALIMTA® for treatment of specific types of
lung cancer and mesothelioma. The Defendants in this case
seek FDA approval to market generic forms of pemetrexed, and
further seek to sell their pemetrexed products with
prescribing information (TX 3018) and patient information (TX
3017) that provides instructions to both doctors and patients
that is identical to the methods described in the '209
is asserting claims 9, 10, 12, 15, 18, 19, and 21 of the
'209 patent with respect to the ANDA Products. TX 1 at
cols. 11-12. Each claim requires pretreatment with a
specified amount of folic acid, up to 1000 ¼ g, and
with vitamin B12 in the amount of 55-1,500 ¼ g in
claims 12, 14 and 21, and 1000 ¼ g in claims 15, 18,
and 19, prior to administering pemetrexed. Claims 19, 21, and
22 further require a specific schedule for those
pretreatments, and claims 15, 18 and 19 require
administration of vitamin B12 by intramuscular injection. The
Defendants' product labeling for their proposed generic
versions of ALITMA® instructs doctors to follow exactly
the claimed regimen, as the ANDA Products will be required to
be distributed with materially identical labeling as that for
ALITMA® . See 21 U.S.C. § 355(j)(2)(A)(v).
primary focus of the infringement trial is on whether the
steps of the claimed methods may be attributed to a single
actor, thus supporting a finding that Defendants would induce
infringement of the Asserted Claims. Specifically, the
parties dispute whether physicians will directly infringe the
patent by directing or controlling the administration of
folic acid to patients. Claim 12 of the '209 patent
describes an improved method for administering pemetrexed
disodium, comprising " a) administration of between 3500
¼ g and about 1000 ¼ g of folic acid prior to
the first administration of pemetrexed disodium; b)
administration of about 500 ¼ g to about 1500 ¼
g of vitamin B12, prior to the first administration of
pemetrexed disodium; and c) administration of pemetrexed
disodium." TX. 1 at col. 11-12. The prescribing
information for ALITMA® states that physicians
administering the treatment should " instruct patients
to initiate folic acid 400 mcg to 1000 mcg orally once daily
beginning 7 days before the first dose of ALITMA® ."
TX 3018 at 2. The instructions also state that physicians
should " [a]dminister vitamin B12 1 mg intramuscularly 1
week prior to the first dose of ALITMA and every 3 cycles
thereafter" and that physicians should "
[a]dminister dexamethasone 4 mg by mouth twice daily the day
before, the day of, and the day after ALITMA
administration." Id. Both Lilly's and the
Defendants' experts, Dr. Bruce A. Chabner, M.D. and Dr.
Thomas K. Schulz, M.D., agreed that, following these labels,
the doctor or other medical professional will administer the
vitamin B12 by injection, and pemetrexed by infusion. Tr.
138, 139, 141, 189. However, it is the patient, at the
instruction of the physician, who must obtain and take the