GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.

• Decision Date: 02 October 2020
• Docket Number: 2018-1976, 2018-2023
• Citation: 976 F.3d 1347
• Parties: GLAXOSMITHKLINE LLC, SmithKline Beecham (Cork) Limited, Plaintiffs-Appellants v. TEVA PHARMACEUTICALS USA, INC., Defendant-Cross-Appellant
• Court: U.S. Court of Appeals — Federal Circuit

976 F.3d 1347

GLAXOSMITHKLINE LLC, SmithKline Beecham (Cork) Limited, Plaintiffs-Appellants

v.TEVA PHARMACEUTICALS USA, INC., Defendant-Cross-Appellant

2018-1976, 2018-2023

United States Court of Appeals, Federal Circuit.

Decided: October 2, 2020

Juanita Rose Brooks, Fish & Richardson, PC, San Diego, CA, argued for plaintiffs-appellants. Also represented by Michael Ari Amon, Craig E. Countryman, Jonathan Elliot Singer ; Elizabeth M. Flanagan, Michael J. Kane, William Woodford, Minneapolis, MN; Douglas E. McCann, Wilmington, DE.

William M. Jay, Goodwin Procter LLP, Washington, DC, argued for defendant-cross-appellant. Also represented by Jaime Ann Santos ; Elaine Blais, J. Anthony Downs, Robert Frederickson, III, Christopher T. Holding, Alexandra Lu, Lana S. Shiferman, Daryl L. Wiesen, Boston, MA; Ira J. Levy, New York, NY.

Hansjorg Sauer, Biotechnology Innovation Organization, Washington, DC, for amicus curiae Biotechnology Innovation Organization. Also represented by Melissa A. Brand ; Brian Paul Barrett, Eli Lilly and Company, Indianapolis, IN.

Michael N. Kennedy, Covington & Burling LLP, Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by Steven John Winkelman ; David Evan Korn, Pharmaceutical Research and Manufacturers Association of America, Washington, DC.

Andrew Curtis Nichols, Winston & Strawn LLP, Washington, DC, for amicus curiae Association for Accessible Medicines. Also represented by George C. Lombardi, Kurt A. Mathas, Chicago, IL; Jeffrey Francer, The Association for Accessible Medicines, Washington, DC.

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

Dissenting opinion filed by Chief Judge Prost.

Newman, Circuit Judge

GlaxoSmithKline LLC and SmithKline Beecham (Cork) Ltd. (collectively, "GSK") charged Teva Pharmaceuticals USA, Inc. with infringement of GSK's Reissue Patent No. RE40,000 ("the ’000 patent"). Trial was held in the United States District Court for the District of Delaware; the jury found the patent valid and infringed, and assessed damages. The jury also found that the infringement was willful. The district court then granted Teva's motion for judgment of non-infringement as a matter of law.¹ GSK appeals the JMOL, and Teva conditionally cross-appeals the damages verdict. No appeal is taken from the verdict of patent validity.

On appellate review, we reverse the grant of JMOL and reinstate the jury verdicts, for the verdicts are supported by substantial evidence. We remand to the district court for appropriate further proceedings.

BACKGROUND

The GSK patents

This litigation concerns the medicinal product having the common name "carvedilol." United States Patent No. 4,503,067 ("the ’067 patent") was issued in 1985 for carvedilol and related compounds; this patent expired on March 5, 2007.

The FDA initially approved carvedilol

for treatment of hypertension and the product was marketed with the brand name Coreg ®. Scientists continued to study carvedilol, and discovered its efficacy in treating congestive heart failure. In May 1997, the FDA approved carvedilol for the additional treatment of congestive heart failure. The method was patented in United States Patent No. 5,760,069 ("the ’069 patent") entitled "Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure." The ’069 patent was issued on June 2, 1998, and describes and claims treatment with a combination of carvedilol and one or more of an angiotensin-converting enzyme ("ACE") inhibitor, a diuretic, and digoxin.² The ’069 patent was listed in the FDA's Orange Book with use code U-233, "decreasing mortality caused by congestive heart failure." J.A. 6868. The FDA in 2003 approved this Coreg ® combination for use by patients suffering from left ventricular dysfunction following a myocardial infarction.

Teva's generic carvedilol, and reissue of the ’069 patent

In March 2002, Teva applied for FDA approval of its generic carvedilol, certifying in the Abbreviated New Drug Application ("ANDA") under Paragraph III of the Hatch-Waxman Act that its product would not be launched until the ’067 patent expired in March 2007. Teva also made a Paragraph IV certification that the ’069 patent was "invalid, unenforceable, or not infringed," and, on May 24, 2002, Teva sent GSK a Paragraph IV notice stating that the claims of the ’069 patent are invalid for anticipation or obviousness. Teva received FDA "tentative approval" for this ANDA in 2004, "for treatment of heart failure

and hypertension," to become effective on expiration of the ’067 patent. Teva, on June 9, 2004, issued a press release to this effect. Press Release, Teva Pharm. Ind. Ltd. Teva Announces Tentative Approval of Carvedilol Tablets , Business Wire (June 9, 2003).

GSK on November 25, 2003 filed an application to reissue the ’069 patent, as provided in 35 U.S.C. § 251. The ’000 patent was issued on January 8, 2008; the italicized text in claim 1 illustrates the limitations added by reissue:

1. A method of decreasing mortality caused by congestive heart failure

in a patient in need thereof which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of an angiotensin converting enzyme inhibitor (ACE), a diuretic, and digoxin,

wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months. ‘000 patent, col. 8, ll. 30–40 (emphasis added). On expiration of the ’067 patent in 2007, Teva launched its generic carvedilol. Teva's label dated "8/2007" states:

1 INDICATIONS AND USAGE

1.1 Left Ventricular Dysfunction

following Myocardial Infarction ...

1.2 Hypertension ...

The label stated that "Carvedilol

is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of = 40% (with or without symptomatic heart failure )." J.A. 5508. Teva's press releases and marketing materials state that its carvedilol is "an AB Rated generic of Coreg ® Tablets."³

In 2011 the FDA required Teva to amend its carvedilol

label to be "identical in content to the approved [GSK Coreg ®] labeling (including the package insert and any patient package insert and/or Medication Guide that may be required)." Dist. Ct. Op. at 587. Teva amended its label to include the indication for treatment of heart failure, as required by the FDA. Dist. Ct. Op. at 587.

GSK's suit for infringement

On July 3, 2014, GSK filed suit for induced infringement of the ’000 patent. As defendants, GSK named Teva and Glenmark Pharmaceuticals USA, the two largest providers of generic carvedilol

. The action against Glenmark was severed and stayed.

Trial was to a jury. Teva presented the defenses of patent invalidity and non-infringement. Teva argued that since it had omitted ("carved out") from its initial (2007) label the indication and prescribing information for treatment of congestive heart failure

, citing the carve-out authorization in 21 U.S.C. § 355(j)(2)(A)(viii), then Teva could not be found to induce prescribing physicians to infringe the ’000 patent, at least not before Teva amended its label to include all of the information that the FDA had approved for Coreg ®.

Teva also argued that to establish liability for induced infringement, GSK is required to prove that Teva directly communicated with the direct infringers and "caused" them to directly infringe the method in the ’000 patent. The district court instructed the jury that:

Teva cannot be liable for induced infringement where GSK does not show that Teva successfully communicated with and induced a third-party direct infringer and that the communication was the cause of the direct infringement by the third-party infringer.

Jury instruction 4.2.4. The jury was instructed that proof of induced infringement may be based on circumstantial evidence:

GSK is not required to present hard proof of any direct infringer physician stating, for example, that she read Teva's labels or other Teva materials and that these labels or other Teva materials caused her to prescribe Teva's generic carvedilol

in an infringing manner. GSK must prove that Teva's actions led physicians to directly infringe a claim of the ’000 patent, but GSK may do so with circumstantial – as opposed to direct – evidence.

Jury instruction 4.2.4.

Both sides presented witnesses, documents, and argument. The jury found that Teva induced infringement of claims 1–3 during the period starting January 8, 2008 (the date of the ’000 patent ’s issuance) to April 30, 2011 (the last day before Teva amended its label); and that Teva induced infringement of claims 1–3 and 6–9 during the amended label period starting May 1, 2011 and ending June 7, 2015 (the date of expiration of the ’000 patent ). The jury assessed damages based on a combination of lost profits and royalty, and found that the infringement was willful.

Grant of judgment as a matter of law

The district court granted Teva's motion for JMOL, stating that the verdict of induced infringement was not supported by substantial evidence because "GSK failed to prove by a preponderance of the evidence that ‘Teva's alleged inducement, as opposed to other factors, actually caused the physicians [i.e., as a class or even at least one of them] to directly infringe,’ by prescribing generic carvedilol

and to do so for the treatment of mild to severe CHF." Dist. Ct. Op. at 591 (emphases and bracketed text in original). The district court explained that: "Without proof of causation, which is an essential element of GSK's action, a finding of inducement cannot stand." Id.

The district court referred to the many sources of information available to prescribing physicians, such as the American Heart...