GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.

• Decision Date: 05 August 2021
• Docket Number: 2018-1976, 2018-2023
• 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

7 F.4th 1320

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: August 5, 2021

Juanita Rose Brooks, Fish & Richardson P.C., 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; Nitika Gupta Fiorella, Douglas E. McCann, Wilmington, DE.

William M. Jay, Goodwin Procter LLP, Washington, DC, argued for defendant-cross-appellant. Also represented by Jaime 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.

Andrew M. Alul, Taft, Stettinius & Hollister, LLP, Chicago, IL, for amicus curiae Apotex Inc.

Matthew S. Hellman, Jenner & Block LLP, Washington, DC, for amicus curiae Association for Accessible Medicines. Also represented by Noah Bokatlindell; Jeffrey Francer, Association for Accessible Medicines, Washington, DC.

Michael Carrier, Rutgers Law School, Camden, NJ, for amici curiae Margo Bagley, Ann Bartow, Jeremy Bock, Irene Calboli, Michael Carrier, Bernard Chao, Thomas Cheng, Andrew Chin, Jorge L. Contreras, Joshua Davis, Stacey L. Dogan, Stacie B. Dusetzina, Samuel F. Ernst, Harry First, Michal Gal, William Gallagher, Shubha Ghosh, Yaniv Heled, Tim Holbrook, Erik Hovenkamp, Eileen M. Kane, Ariel Katz, Aaron S. Kesselheim, John B. Kirkwood, Mark A. Lemley, Christopher R. Leslie, Yvette Joy Liebesman, Lee Ann Wheelis Lockridge, Phillip R. Malone, Duncan Matthews, Stephen M. Maurer, Stephen McJohn, Michael J. Meurer, Roger Noll, Tyler T. Ochoa, Jennifer D. Oliva, Barack Orbach, Luigi Palombi, Jordan Paradise, Srividhya Ragavan, Zia Rahman, Arti K. Rai, Ana Santos Rutschman, Rachel E. Sachs, William M. Sage, Christopher L. Sagers, Catherine Sandoval, Joshua David Sarnoff, Ameet Sarpatwari, Kurt M. Saunders, Steven Semeraro, David A. Simon, Michael Sinha, Jennifer Sturiale, H.H.B. Vedder, Liza Vertinsky, Melissa Feeney Wasserman. Also represented by Matthew James Dowd, Robert James Scheffel, Dowd Scheffel PLLC, Washington, DC.

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.

Kathryn Ardizzone, Knowledge Ecology International, Washington, DC, for amici curiae Knowledge Ecology International, James Packard Love.

Steffen Nathanael Johnson, Wilson Sonsini Goodrich & Rosati, Washington, DC, for amicus curiae Mylan Pharmaceuticals Inc. Also represented by Adam William Burrowbridge, John Bernard Kenney ; Wendy L. Devine, Tung On Kong, San Francisco, CA; George E. Powell, III, Palo Alto, CA.

Jane M. Love, Gibson, Dunn & Crutcher LLP, New York, NY, for amicus curiae Novartis Pharmaceuticals Corporation. Also represented by Robert Trenchard.

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

Mason Andrew Kortz, Cyberlaw Clinic, Harvard Law School, Cambridge, MA, for amicus curiae The R Street Institute.

Dan L. Bagatell, Perkins Coie LLP, Hanover, NH, for amicus curiae Sandoz, Inc. Also represented by Andrew Dufresne, Madison, WI.

William Barnett Schultz, Zuckerman Spaeder LLP, Washington, DC, for amicus curiae Henry A. Waxman. Also represented by Margaret Dotzel, Cassandra Trombleyshapir Jonas.

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

Dissenting opinion filed by Circuit Judge Prost.

Per Curiam.

GlaxoSmithKline LLC and SmithKline Beecham (Cork) Ltd. (collectively, GSK) sued Teva Pharmaceuticals USA, Inc. in the United States District Court for the District of Delaware for infringement of claims of GSK's Reissue Patent No. RE40,000. After the jury's verdict of infringement and its award of damages, the district court granted Teva's renewed motion for judgment as a matter of law of noninfringement. GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. , 313 F. Supp. 3d 582 (D. Del. 2018) ( Dist. Ct. Op. ). GSK appeals the JMOL, and Teva conditionally cross-appeals the jury's damages award. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

For the reasons below, we vacate the grant of JMOL, reinstate the jury's verdict and damages award, and remand for appropriate further proceedings.

BACKGROUND

GSK markets and sells the medicinal product carvedilol, a beta-blocker, under the brand name Coreg ®. The Food and Drug Administration (FDA) has approved carvedilol for three indications of use. By 1997, the FDA had approved carvedilol for treatment of hypertension and congestive heart failure (CHF). Then, in 2003, the FDA approved carvedilol for a third use: to reduce cardiovascular mortality in patients suffering from left ventricular dysfunction following a myocardial infarction, i.e., the "post-MI LVD" indication.

When GSK began investigating carvedilol's use for treating CHF, beta-blockers were contraindicated for that use. This was because beta-blockers slow the heart rate and reduce the heart's ability to pump blood, a potentially deadly combination for patients with heart failure. Very few doctors or companies, therefore, saw the potential for investigating beta-blockers for treating CHF. Despite this skepticism, GSK spent years investigating, and conducting trials of, carvedilol for the treatment of heart failure. And at the time, the only known treatment for improving mortality rates in CHF patients was with angiotensin-converting enzyme (ACE) inhibitors. Still, even with ACE inhibitors, patients continued to die from heart failure at high rates. It was not until the FDA approved GSK's Coreg ® that using a beta-blocker to treat CHF became the standard of care for reducing mortality in heart failure patients.

The carvedilol compound was patented in 1985. See U.S. Patent No. 4,503,067, expiration date March 5, 2007. In 1998, U.S. Patent No. 5,760,069 issued, which claimed a method of administering a combination of carvedilol and one or more of an ACE inhibitor, a diuretic, and digoxin to decrease mortality caused by CHF in a patient.

In March 2002, Teva filed an Abbreviated New Drug Application (ANDA) for FDA approval of its generic carvedilol for all three indications. It certified, under Paragraph III of the Hatch-Waxman Act,¹ that it would not launch its product until the ’067 patent on the carvedilol compound expired in March 2007. See 21 U.S.C. § 355(j)(2)(A)(vii)(III). Teva also certified, under Paragraph IV, that the ’069 patent was "invalid, unenforceable, or not infringed."

See 21 U.S.C. § 355(j)(2)(A)(vii)(IV). On May 24, 2002, Teva sent GSK a Paragraph IV notice stating that the claims of the ’069 patent are anticipated or would have been obvious. GSK did not sue Teva upon receipt of the notice, and on November 25, 2003, GSK applied for reissue of the ’069 patent under 35 U.S.C. § 251. Teva received FDA "tentative approval" for its ANDA in 2004, "for treatment of heart failure and hypertension." J.A. 7437. The approval was to become effective when the ’067 patent expired in 2007.

On January 8, 2008, the PTO issued Reissue Patent No. RE40,000, and GSK notified the FDA on February 6, 2008. See J.A. 6880–82. The ’000 patent, asserted in this case, claims a method of decreasing mortality caused by CHF by administering carvedilol with at least one other therapeutic agent. See, e.g. , ’000 patent, col. 1, ll. 17–25. Claim 1 recites:

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.

(emphasis in original). The ’000 patent is listed in the FDA's publication "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the Orange Book, as a patent claiming a method of using Coreg ®.

Just before Teva launched its generic carvedilol in 2007, it certified to the FDA that its label "will not include the indication defined in use code U-233" until the expiration of the ’069 patent. J.A. 6176; see 21 U.S.C. § 355(j)(2)(A)(viii) (section viii). Patent use code U-233 corresponded to "decreasing mortality caused by congestive heart failure." J.A. 7833. Teva's label dated "8/2007" thus included only two indications: the post-MI LVD indication and the hypertension indication. J.A. 5506, 5508. Teva's press releases and marketing materials, however, touted its generic carvedilol as "indicated for treatment of heart failure and hypertension," as the "Generic version of [GSK's] cardiovascular agent Coreg ®," and as an "AB-rated generic equivalent of [GSK's] Coreg ® Tablets."² J.A. 6347, 6353.

In 2011, following GSK's delisting of certain patents from the Orange Book, including the ’069 patent and U.S. Patent No. 5,902,821, the FDA instructed Teva to "revise [its] labeling to include the information associated with patent ’821 (delisted) and the associated Use Code (U-313)." J.A. 5557. It told Teva to submit labeling "that is 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)." J.A. 5557. The FDA also requested Teva "provide information regarding [its] position...