Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.

• Decision Date: 12 January 2017
• Docket Number: 2015-2067
• Citation: 121 U.S.P.Q.2d 1277,845 F.3d 1357
• Parties: ELI LILLY AND COMPANY, Plaintiff-Appellee v. TEVA PARENTERAL MEDICINES, INC., APP Pharmaceuticals LLC, Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., Barr Laboratories, Inc., Defendants-Appellants
• Court: U.S. Court of Appeals — Federal Circuit

845 F.3d 1357

121 U.S.P.Q.2d 1277

ELI LILLY AND COMPANY, Plaintiff-Appellee

v.TEVA PARENTERAL MEDICINES, INC., APP Pharmaceuticals LLC, Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., Barr Laboratories, Inc., Defendants-Appellants

2015-2067

United States Court of Appeals, Federal Circuit.

Decided: January 12, 2017

Adam Lawrence Perlman , Williams & Connolly LLP, Washington, DC, argued for plaintiff-appellee. Also represented by Dov Philip Grossman , Bruce Genderson , David M. Krinsky , Allison Jones Rushing , Ellen E. Oberwetter .

William M. Jay , Goodwin Procter LLP, Washington, DC, argued for defendants-appellants. Also represented by Daryl L. Wiesen , Elaine Blais , Emily L. Rapalino , Henry C. Dinger , Boston, MA; Brian Joseph Prew , Michael B. Cottler , Natasha Elise Daughtrey , New York, NY.

Christina Jordan McCullough , Perkins Coie, LLP, Seattle, WA, for amicus curiae Generic Pharmaceutical Association. Also represented by Shannon Bloodworth , Washington, DC.

Kevin Scott Prussia , Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by Sameer Ahmed ; Jamie Wisz , Washington, DC.

David S. Forman , Osha Liang LLP, Alexandria, VA, for amicus curiae Biotechnology Innovation Organization. Also represented by Hansjorg Sauer , Biotechnology Innovation Organization, Washington, DC.

Before Prost, Chief Judge, Newman and Dyk, Circuit Judges.

Prost, Chief Judge.

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 , ––– U.S. ––––, 136 S.Ct. 1661, 194 L.Ed.2d 767 (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 obviousness-type double patenting.

For the reasons below, we affirm.

BACKGROUND

The '209 patent, which issued in 2010, relates to methods of administering the chemotherapy drug pemetrexed

disodium ("pemetrexed") after pretreatment with two common vitamins—folic acid and vitamin B12. Pemetrexed is an antifolate that kills cancer cells by inhibiting the function of folates, a class of nutrients necessary for cell reproduction. The purpose of the dual vitamin pretreatments is to reduce the toxicity of pemetrexed

in patients. Eli Lilly markets pemetrexed under the brand name ALIMTA ®, and the drug is used to treat certain types of lung cancer and mesothelioma.

Around 2008–2009, Defendants notified Eli Lilly that they had submitted Abbreviated New Drug Applications ("ANDAs") seeking approval by the Food and Drug Administration ("FDA") to market generic versions of ALIMTA®. After the '209 patent issued, Defendants sent Eli Lilly additional notices regarding their ANDAs, including notices that they had filed Paragraph IV certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), declaring that the '209 patent was invalid, unenforceable, or would not be infringed. Eli Lilly subsequently brought this consolidated action against Defendants for infringement under 35 U.S.C. § 271(e)(2). Specifically, Eli Lilly alleged that Defendants' generic drugs would be administered with folic acid

and vitamin B12 pretreatments and, thus, result in infringement of the '209 patent. Defendants raised noninfringement and invalidity defenses.

Eli Lilly asserted claims 9, 10, 12, 14, 15, 18, 19, and 21 of the '209 patent at trial. Importantly, all of the asserted claims require patient pretreatment by "administering" or "administration of" folic acid

. Claims 9 and 10 depend from claim 1, which recites:

1. A method of administering pemetrexed

disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein

the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

'209 patent col. 10 ll. 55–65 (emphasis added). The additional limitations of claims 9 and 10 restrict the dose of folic acid

to particular ranges. Id. at col. 11 ll. 19–22.

Asserted claim 12 is independent and recites:

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.

Id. at col. 11 l. 25–col. 12 l. 4 (emphasis added). Asserted claims 14, 15, 18, 19, and 21 depend from claim 12 and further limit the dose, schedule, or route of folic acid

or vitamin B12 administration. Id. at col. 12 ll. 7–11, col. 12 ll. 16–20, col. 12 ll. 24–27.

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 , ––– U.S. ––––, 134 S.Ct. 2111, 189 L.Ed.2d 52 (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 .

Eli Lilly and Defendants proceeded with a bench trial on invalidity, after which the district court held that the asserted claims were not invalid for, inter alia, obviousness or obviousness-type double patenting. The court had also previously rejected Defendants' contention that the asserted claims were invalid for indefiniteness of the term "vitamin B12." Defendants filed an appeal on invalidity, which was docketed in this court as Case No. 14-1455. While that appeal was pending, the Supreme Court reversed Akamai II , holding that liability for inducement cannot be found without direct infringement, and remanding for this court to possibly reconsider the standards for direct infringement. Limelight Networks, Inc. v. Akamai Techs., Inc. (Akamai III ), ––– U.S. ––––, 134 S.Ct. 2111, 189 L.Ed.2d 52 (2014). In view of that development, the parties in this case filed a joint motion to remand the matter to the district court for the limited purpose of litigating infringement. We granted the motion.

The district court held a second bench trial in May 2015 and concluded in a decision issued on August 25, 2015 that Defendants would induce infringement of the '209 patent. As explained in further detail below, the court applied our intervening Akamai V decision, which had broadened the circumstances in which others' acts may be attributed to a single actor to support direct-infringement liability in cases of divided infringement.² See Akamai V , 797 F.3d at 1022. The court accordingly entered final judgment against Defendants, barring them from launching their generic products before the expiration of the '209 patent.

Defendants timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

DISCUSSION

Defendants appeal the district court's finding of induced infringement, as well as the court's decision that the asserted claims are not invalid for indefiniteness, obviousness, or obviousness-type double patenting. We will address each of these issues in turn.

I

Pursuant to 35 U.S.C. § 271(b), "[w]hoever actively induces infringement of a patent shall be liable as an infringer."³ Importantly, liability for induced infringement under § 271(b)"must be predicated on direct infringement." Akamai III , 134 S.Ct. at 2117. The patentee must also show that the alleged infringer possessed the requisite intent to induce infringement, which we have held requires that the alleged infringer "knew or should have known his actions would induce actual infringements." DSU Med. Corp. v. JMS Co. , 471 F.3d 1293, 1304 (Fed. Cir. 2006) (en banc in relevant part) (internal quotation marks omitted). A patentee seeking relief under § 271(e)(2) bears the burden of proving infringement by a preponderance of the evidence. Warner – Lambert Co. v. Apotex Corp. , 316 F.3d 1348, 1366 (Fed. Cir. 2003).

"Infringement is a question of fact that, after a bench trial, we review for clear error." Alza Corp. v. Mylan Labs, Inc. , 464 F.3d 1286, 1289 (Fed....