Case: 18-1976   Document: 111    Page: 1    Filed: 10/02/2020




    United States Court of Appeals
        for the Federal Circuit
                 ______________________

       GLAXOSMITHKLINE LLC, SMITHKLINE
           BEECHAM (CORK) LIMITED,
               Plaintiffs-Appellants

                            v.

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

                  2018-1976, 2018-2023
                 ______________________

     Appeals from the United States District Court for the
 District of Delaware in No. 1:14-cv-00878-LPS-CJB, Chief
 Judge Leonard P. Stark.
                  ______________________

                 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.
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 2    GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.




 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.
     Opinion for the court filed by Circuit Judge NEWMAN.
          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
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 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.       3



 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



     1 GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.,
 313 F. Supp.3d 582 (D. Del. 2018) (“Dist. Ct. Op.”).
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 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).




     2  A 65% reduction in mortality was observed in the
 clinical trial, whereby the FDA terminated the clinical trial
 so that the patients on placebo could receive the treatment.
 Milton Packer, M.D. et al., The Effect of Carvedilol on
 Morbidity and Mortality in Patients with Chronic Heart
 Failure, 334 NEW ENG. J. MED. 1349, 1349 (1996)
 (reporting 65% reduction in risk of death in clinical trials).
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     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
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 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®.



     3   The “AB rating” is an FDA coding system “to allow
 users to determine quickly whether the Agency has
 evaluated a particular approved product as therapeutically
 equivalent to other pharmaceutically equivalent products
 first letter) and to provide additional information on the
 basis of FDA’s evaluations (second letter).” U.S. Food &
 Drug Admin., Approved Drug Products with Therapeutic
 Evaluations (FDA Orange Book, preface).
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     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.
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 8   GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.




     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.”

referred to the many sources of
 information available to prescribing physicians, such as
 the American Heart Association, the American College of
 Cardiology, and various publications. The court stated
 that GSK’s Coreg® label and promotion of carvedilol had
 already informed physicians about the uses of Coreg®.
 Dist. Ct. Op. at 594. Cardiologists testified that they knew
 of the various uses of carvedilol before the FDA required
 Teva to amend its label. The court stated that “even in
 September 2007, when generic companies (including Teva)
 began selling carvedilol, doctors relied on guidelines and
 research, as well as their own experience, in addition to
 GSK marketing.”

concluded that: “A reasonable
 factfinder could only have found that these alternative,
 non-Teva factors were what caused the doctors to prescribe
 generic carvedilol for an infringing use.”

The
 court ruled: “In sum, substantial evidence does not support
 the jury’s finding on causation, and therefore does not
 support its verdict that Teva is liable for induced
 infringement, during both the skinny and full label
 periods.”

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     GSK appeals, arguing that the district court erred in
 law and in fact, and that the jury’s finding of induced
 infringement was supported by substantial evidence, and
 should be sustained.
                         DISCUSSION
     Standards of review
     For procedures not unique to patent law, the district
 court is subject to the standards of the regional circuit and
 is reviewed on that basis. The Third Circuit holds that
 when trial is to a jury, the district court should grant JMOL
 “sparingly” and “only if, viewing the evidence in the light
 most favorable to the nonmovant and giving it the
 advantage of every fair and reasonable inference, there is
 insufficient evidence from which a jury reasonably could
 find liability.” Marra v. Phila. Hous. Auth., 

,
 300 (3d Cir. 2007); see also Moyer v. United Dominion
 Indus., 

, 545 n.8 (3d Cir. 2007) (same).
     The Third Circuit provides that a “court may grant a
 judgment as a matter of law contrary to the verdict only if
 ‘the record is critically deficient of the minimum quantum
 of evidence’ to sustain the verdict.” Acumed LLC v.
 Advanced Surgical Servs., Inc., 

, 211 (3d Cir.
 2009). The Federal Circuit has well recognized such a
 requirement for jury trials, stating, for example: “To
 prevail on a renewed motion for JMOL following a jury
 trial, a party must show that the jury’s findings, presumed
 or express, are not supported by substantial evidence or, if
 they were, that the legal conclusion(s) implied by the jury’s
 verdict cannot in law be supported by those findings.”
 Power Integrations, Inc. v. Fairchild Semiconductor Int’l,
 Inc., 

, 1326 (Fed. Cir. 2016). See also, e.g.,
 Lucent Techs., Inc. v. Gateway, Inc., 

, 1309
 (Fed. Cir. 2009) (infringement is a question of fact, and a
 jury verdict thereon is reviewed for support by substantial
 evidence); Ericsson, Inc. v. D-Link Sys., Inc., 

,
 1225 (Fed. Cir. 2014) (“A jury verdict will be set aside only
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  10 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  if the jury instructions were legally erroneous and the
  errors had prejudicial effect.” (internal quotations
  omitted)).
      We review the district court’s grant of JMOL on this
  basis.
                               A
                   INDUCED INFRINGEMENT
     The patent infringement statute includes 35 U.S.C. §
  271(b):
      Whoever actively induces infringement of a patent
      shall be liable as an infringer.
  GSK argues that the district court erred in law and fact.
  GSK states that Teva’s marketing of carvedilol with
  knowledge and intent of its infringing use, and promotion
  of its generic product as the same as Coreg®, meet the legal
  requirements of active inducement of infringement. GSK
  states that there was substantial evidence whereby a
  reasonable jury could so find.
      Teva responds that the district court correctly ruled
  that Teva could not be liable for inducing infringement,
  because cardiologists already knew of carvedilol and its
  uses, and Teva did not directly “cause” them to infringe.
       GSK states that the district court erred in law, as
  shown in long-established and clear precedent that induced
  infringement may be shown by evidence that the accused
  inducer promoted the infringing use with knowledge that
  such use directly infringes the patent claims. GSK cites,
  e.g., Toshiba Corp. v. Imation Corp., 

, 1365
  (Fed. Cir. 2012) (“[W]here an alleged infringer designs a
  product for use in an infringing way and instructs users to
  use the product in an infringing way, there is sufficient
  evidence for a jury to find direct infringement.”); 

(“Microsoft not only designed the accused
  products to practice the claimed invention, but also
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  instructed its customers to use the accused products in an
  infringing way.”): 

, 1222 (finding
  induced infringement where alleged inducer advertised
  compliance with an infringing standard).
      In Global-Tech Appliances, Inc. v. SEB S.A., 

(2011), the Supreme Court explained that copying of a
  patented product is evidence of inducing infringement.

The Court had applied the principles of induced
  infringement to copyright issues in MGM Studios Inc. v.
  Grokster, Ltd., 

(2005), stating that “active
  steps . . . taken to encourage direct infringement, such as
  advertising an infringing use or instructing how to engage
  in an infringing use, show an affirmative intent that the
  product be used to infringe.” MGM at 936 (citations
  omitted, ellipsis in original).     The Court held that
  inducement to infringe is not negated when the direct
  infringers already knew of the infringing subject matter.

established that “[a] plaintiff may .
  . . prove the intent element [of induced infringement]
  through circumstantial evidence, just as with direct
  infringement.” Warsaw Orthopedic, Inc. v. NuVasive, Inc.,
  

, 1347 (Fed. Cir. 2016) (ellipsis in original).
  See also Power 

(“Indeed, we
  have affirmed induced infringement verdicts based on
  circumstantial      evidence    of    inducement       (e.g.,
  advertisements, user manuals) directed to a class of direct
  infringers (e. g., customers, end users) without requiring
  hard proof that any individual third-party direct infringer
  was actually persuaded to infringe by that material.”);
  Moleculon Research Corp. v. CBS, Inc., 

, 1272
  (Fed. Cir. 1986) (“Circumstantial evidence is not only
  sufficient, but may also be more certain, satisfying and
  persuasive than direct evidence”).
      These principles have been applied to the
  circumstances of FDA-regulated products; see, e.g., Eli
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  Lilly & Co. v. Teva Parenteral Meds., Inc., 

,
  1369 (Fed. Cir. 2017) (“[E]vidence that the product labeling
  that Defendants seek would inevitably lead some
  physicians to infringe establishes the requisite intent for
  inducement.”); Sanofi v. Watson Labs. Inc., 

,
  645 (Fed. Cir. 2017) (finding induced infringement where
  the label “directs medical providers to information
  identifying the desired benefit for only patients with the
  patent-claimed risk factors” and “[t]here was considerable
  testimony that this label encourages . . . administration of
  the drug to those patients”); AstraZeneca LP v. Apotex, Inc.,
  

, 1060 (Fed. Cir. 2010) (finding induced
  infringement where “despite being aware of the
  infringement problem presented by the proposed label,
  Apotex nonetheless proceeded with its plans to distribute
  its generic drug product”); Mentor H/S, Inc. v. Med. Device
  All., Inc., 

, 1379 (Fed. Cir. 2001) (finding
  induced infringement where the defendant “sold the
  [accused] device with the intention that doctors would use
  it to perform the patented method”).
      The jury received evidence that Teva’s promotional
  materials referred to Teva’s carvedilol tablets as AB rated
  equivalents of the Coreg® tablets. See, e.g., Teva June 9,
  2004 press release (J.A. 6347) (describing Teva’s carvedilol
  as the “AB-rated generic equivalent of GlaxoSmithKline’s
  Coreg® tablets.”) See also Teva Spring 2008 Product
  Catalog (J.A. 6221); Teva’s 2011 Generic Product Reference
  Guide (J.A. 6072) stating “AB Rated and bioequivalent to
  Coreg® Tablets”. There was evidence that Teva’s 2007
  press release remained on Teva’s website, and trial exhibit
  PTX 1301.0002 is a screenshot bearing the date
  “4/14/2015,” with the caption “Sept. 06, 2007 1:55 PM ‘Teva
  Announces Approval and Shipment of Generic Coreg®
  Tablets.’” (J.A. 6353). The record shows a screenshot dated
  4/22/2015 captioned “Carvedilol Tablets [-] Generic of
  Coreg® Tablets” (PTX 860) (J.A. 4245–4246). In evidence
  were Teva’s Monthly Prescribing Reference, 2012 and 2013
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  editions, which state that they provide “high-quality
  educational tools to serve as convenient, authoritative
  references in daily use” and are designed to be “a trusted
  tool in [the clinician’s] clinical armamentarium.” J.A.
  6203. Also in evidence was the 2012 edition of Teva’s
  Health Systems Pharmacy Drug Reference (J.A. 6192, et
  seq.).
      Witnesses for both sides testified that cardiologists
  knew of carvedilol and the uses established for Coreg®.
  GSK’s witness, Dr. McCullough, testified that doctors are
  “completely reliant” on information provided by the generic
  producers, and that doctors receive Teva’s product
  catalogs, visit its website, and read its product guides.
  Trial Tr. June 19, 2017, at 1662. Dr. McCullough testified
  that he saw the 2004 press release, in which “Teva is telling
  doctors that they had received tentative approval for
  generic carvedilol, and that its final approval is anticipated
  in 2007.”

He testified that Teva was telling
  him, as a physician, that Teva was “expecting to have a
  generic version of GlaxoSmithKline Coreg that is AB rated,
  and that it is indicated for the treatment of heart failure.”

      Dr. McCullough discussed Teva’s September 6, 2007
  press release announcing that the FDA “has granted final
  approval for the company’s Abbreviated New Drug
  Application (ANDA) to market its generic version of
  GlaxoSmithKline’s       cardiovascular    agent     Coreg®
  (Carvedilol) Tablets.” Dr. McCullough told the jury that
  this release “indicates that we should be able to prescribe
  generic carvedilol for heart failure.” Trial Tr., June 19,
  2017, at 1659. He testified that “we’re completely reliant
  on what [the generics] provide to us.”

      Dr. McCullough testified that Teva’s Spring 2008
  catalog lists Teva’s carvedilol tablets next to Coreg®
  tablets and uses the phrase “AB rating,” and that this
  would lead a doctor to believe that “they’re therapeutically
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  interchangeable.” Trial Tr., June 14, 2017, at 634–635. He
  stated that as to Teva’s carvedilol “we had lots of
  information . . . that indicated that . . . it was a complete
  replacement. That in fact the two, the drug was the same,
  and all the information regarding it was the same.” Trial
  Tr., June 19, 2017, at 1663. Dr. McCullough testified that
  if he just wrote Coreg on a prescription, the patient would
  get the generic unless he explicitly wrote “dispense as
  written” or “DAW.”

      Teva argued that it could not be liable for induced
  infringement because it had deliberately omitted, or
  “carved out” from its 2007 label, reference to congestive
  heart failure. Teva’s Rule 30(b)(6) witness, Director of New
  Products Jennifer King, explained:
      Question: So is the expectation of Teva that when
      you carve out a particular indication, that Teva will
      still get sales of that drug for that indication once
      it’s launched its product?
      Answer: It’s a legal strategy, not a commercial
      strategy.
                              ***
      Question: And so to make it specific to the issues
      here, if Teva has carved out congestive heart
      failure, but not hypertension and not post MILVD,
      Teva still expects to get sales where the doctor
      prescribed carvedilol for congestive heart failure,
      correct?
      Answer: Yes, unless the doctor feels strongly.
      Question: Writes brand only?
      Answer: Yes.
  Trial Tr., June 13, 2017, at 488.
     In response to the question whether “[b]ased on what
  Teva said in 2004 and 2007, any time after that . . . , did
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  you ever come to believe that Teva’s generic carvedilol had
  not been approved for the treatment of heart failure?” Dr.
  McCullough answered: “No, I never knew it.” Trial Tr.,
  June 19, 2017, at 1661.
      GSK also presented an expert witness on the
  regulatory process, Professor Erika Lietzan, who explained
  the drug approval process, and explained that the AB-
  rating means that “if the generic drug is used in accordance
  with its label, you would expect it to have the same clinical
  effect” as the brand drug. Trial Tr., June 13, 2017 at 534,
  542. She introduced Teva’s product catalogs that “list the
  AB ratings and they compare Teva’s carvedilol with Coreg
  on that table with carvedilol on the left and Coreg on the
  right,”

(J.A. 10582–83). She stated that the
  FDA’s “general position is that if you compare one product
  to another by name, you are implying the use of the
  product.”

      Teva argued that the 2004 and 2007 press releases
  should not be considered as evidence of inducement
  because the ’000 patent was not issued until January 8,
  2008. Teva Br. 40, citing Nat’l Presto Indus., Inc. v. West
  Bend Co., 

, 1196 (Fed. Cir. 1996) (Ҥ271(b) does
  not reach actions taken before issuance of the adverse
  patent”). However, the evidence before the jury was that
  the 2007 press release remained on Teva’s website
  throughout the life of the ’000 patent with the caption
  “Sept. 06, 2007 1:55 PM ‘Teva Announces Approval and
  Shipment of Generic Coreg® Tablets.’” Trial exhibit PTX
  1301.0002 bearing the date “4/14/2015,”
      The jury was correctly instructed that it could find
  inducement if Teva “continued to take an action that began
  before the ’000 patent issued, after the ’000 patent was
  issued on January 8, 2008, intending to cause the
  physicians to directly infringe by administering Teva’s
  carvedilol product.” Jury instructions 4.2. The jury
  properly could consider Teva’s continued affirmative
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  promotion of its carvedilol tablet as the AB generic
  equivalent of Coreg® which could be used as a
  cardiovascular agent, well after the issuance of the ’000
  patent. This evidence included the press release on Teva’s
  website after issuance of the ’000 patent, and the
  promotional catalogs circulated by Teva between 2008 and
  expiration of the ’000 patent in 2015. The record includes
  Dr. McCullough’s expert testimony that doctors are
  “completely reliant” on this type of promotional material
  from the generic producer. The jury found Teva liable for
  induced infringement during the period of the ’000 patent.
      The district court granted Teva’s motion for JMOL,
  stating that “there is not legally sufficient evidence to
  support a finding that Teva, by listing its carvedilol as AB
  rated to Coreg® in product catalogs and reference guides,
  encouraged infringement.” Dist. Ct. Op. at 594. The court’s
  reason was that “physicians already knew how to use
  carvedilol for treating CHF” and thus infringement was not
  “caused” by Teva.

applied an
  incorrect legal standard, for precedent makes clear that
  when the provider of an identical product knows of and
  markets the same product for intended direct infringing
  activity, the criteria of induced infringement are met.
  There was ample record evidence of promotional materials,
  press releases, product catalogs, the FDA labels, and
  testimony of witnesses from both sides, to support the jury
  verdict of inducement to infringe the designated claims for
  the period of the ’000 reissue patent.
      Precedent has recognized that the content of the
  product label is evidence of inducement to infringe; see
  Vanda Pharm. v. West-Ward Pharm. Int’l Ltd., 

, 1129 (Fed. Cir. 2018) (holding that “[t]he contents of
  the label itself may permit the inference of specific intent
  to encourage, recommend, or promote infringement”);
  

(“The content of the label in this
  case permits the inference of specific intent to encourage
  the infringing use.”).     These rulings comport with
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.     17



  precedent on causation in tort liability, as in, e.g., Tinnus
  Enter., LLC v. Telebrands Corp., 

, 1204 (Fed.
  Cir. 2017) (approving “the use of instruction manuals to
  demonstrate direct infringement by customers in the
  context of induced infringement”); Golden Blount, Inc. v.
  Robert H. Peterson Co., 

, 1363 (Fed. Cir.
  2006) (“[T]he instructions packaged with each device teach
  the infringing configuration.”).
      Applying the standards of law and precedent, there
  was substantial evidence to support the jury’s verdict of
  inducement to infringe the ’000 patent. We remark that
  our colleague in dissent applies an incorrect standard of
  review, for this court on appeal of a jury verdict does not
  find facts afresh, contrary to the substantial evidence
  standard. For example, the dissent finds that neither
  “Teva’s press releases [nor] its product catalogs encourage
  doctors to practice the patented method,” Diss. Op. at 22,
  although Dr. McCullough testified that doctors do read
  press releases and product catalogs, and even Teva’s
  expert, Dr. Zusman, conceded that “it’s possible” that
  doctors read these materials. Trial Tr., June 16, 2017 at
  1238–1241.
      Nor is this appeal a policy debate about whether GSK
  made enough money from carvedilol in past years, and
  therefore should not be permitted to enforce its patent on
  its discovery of this novel method of prolonging life for
  persons with congestive heart failure. The implications of
  the dissent’s position are vast, and if enforcement of
  patents on new discoveries varies with the extent to which
  the patentee has profited from past discoveries, this is a
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  18 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  policy matter for Congress, not a factor in judicial review
  of jury verdicts. 4
      We conclude that there was substantial evidence to
  support the jury’s findings of induced infringement,
  throughout the term of the ’000 patent, on the entirety of
  the documentary and testimonial record concerning
  liability before and after Teva amended its label. The grant
  of JMOL is reversed; we remand for entry of judgment on
  the verdict.
                               B
                           DAMAGES
      The jury received the calculation of GSK’s damages
  expert that 17.1% of generic carvedilol sales during the
  period of infringement were for the method claimed in the
  ’000 patent. Teva does not dispute this calculation. The
  jury assessed damages of $234,110,000 based on lost
  profits, plus royalty payments of $1,400,000. The verdict
  amount is about half of that presented by GSK’s damages
  expert. Teva does not challenge quantum, but argues that,
  on correct instructions, Teva would have incurred no
  damages, or at most only a reasonable royalty.
      Teva argues that the jury should have been instructed
  that GSK must prove that, for every infringing sale made
  by Teva, the direct infringer would have purchased the
  prescribed carvedilol as GSK’s Coreg® branded product,
  and not from another generic producer. The district court
  had declined to present that instruction, explaining:



      4  The dissent’s proposed restriction on enforcement of
  patents on new uses of known products is a matter of public
  interest, for, as observed by amicus curiae Biotechnology
  Innovation Organization: “Developing innovative new uses
  of known substances has great societal value, but often
  requires significant time and expense.” BIO Br. 1.
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.      19



      The undisputed evidence is that [Teva’s] generic
      carvedilol is interchangeable with the generic
      carvedilol of the non-party manufacturers;
      therefore, the generic carvedilol of these non-party
      manufacturers is an infringing alternative – and
      not a non-infringing alternative. These non-
      parties’ products, thus, would not exist in the but-
      for world, which must be constructed to include
      “likely outcomes with infringement factored out
      of the economic picture.” Grain Processing
      Corp. v. Am. Maize-Prods. Co., 

, 1350
      (Fed. Cir. 1999) (emphasis added).
  Memorandum Order (June 9, 2017) (emphasis in original).
  The district court recognized: “It is undisputed that, at all
  times relevant to the lost profits analysis, there were
  generic carvedilol tablets available from at least eight
  different generic manufacturers that were approved by the
  [FDA],”

that “[i]t doesn’t matter whether
  the sales by other generic suppliers would be non-
  infringing, because the ultimate use of those products by
  doctors would be infringing and thus not a permissible
  consideration.”

      Teva argues that it was incorrect to require the jury to
  ignore the reality of the marketplace, in which there were
  other producers of generic carvedilol who had not been
  sued for infringement. Teva states that the district court
  incorrectly instructed that: “The use of the acceptable
  substitutes also must not infringe the patent because they
  did not include all the features required by the patent. For
  example, the use of generic carvedilol supplied by
  companies other than Teva was not an acceptable non-
  infringing substitute.” Jury instruction 6.3.3.
       Teva also argues that the “prerequisite for lost profits”
  is “but-for causation,” and not the Panduit factors on which
  the jury was instructed. Teva Reply Br. 4. Teva points out
  that pharmacies are allowed or required to substitute
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  20 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  generic products unless explicitly ordered otherwise, and
  that this would deprive GSK of all profits on its higher
  priced Coreg®.
      GSK responds that the district court correctly held that
  generic carvedilol is not a non-infringing alternative, and
  that the court correctly stated that “the law is clear that a
  lost profits analysis must be based on a world in which
  infringement of the asserted patent does not exist, and
  therefore it does not allow for infringing alternatives to be
  available in the hypothetical ‘but for’ world.”
  Memorandum Order (June 9, 2017), citing Grain
  

). See generally Micro Motion,
  Inc. v. Kane Steel Co., 

, 1322 (Fed. Cir. 1990)
  (“There is precedent for finding causation despite an
  alternative source of supply if that source is an infringer or
  puts out a noninfringing product that is an unacceptable
  alternative, or has insignificant sales.”). The district court
  correctly instructed the jury that the availability of
  carvedilol from other generic producers is not a “non-
  infringing substitute.”)
      We have considered all of Teva’s arguments, and
  conclude that the jury instructions are in conformity to law.
  The damages verdict is not otherwise challenged, and is
  sustained.
                          CONCLUSION
      We vacate the district court’s grant of JMOL and
  reinstate the jury verdicts of infringement and damages.
  We remand for appropriate further proceedings, including
  consideration of GSK’s post-trial motion based on the
  verdict of willful infringement.
                VACATED AND REMANDED
      Each party shall bear its own costs.
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    United States Court of Appeals
        for the Federal Circuit
                    ______________________

        GLAXOSMITHKLINE LLC, SMITHKLINE
            BEECHAM (CORK) LIMITED,
                Plaintiffs-Appellants

                               v.

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

                     2018-1976, 2018-2023
                    ______________________

      Appeals from the United States District Court for the
  District of Delaware in No. 1:14-cv-00878-LPS-CJB, Chief
  Judge Leonard P. Stark.
                   ______________________

  PROST, Chief Judge, dissenting.
       Through the decades, many, including my colleagues,
  have spoken on the importance of patents in incentivizing
  innovation. The calls for robust patent protection have
  been particularly passionate in the pharmaceutical space.
  The critical balance of those patent rights, however, is pub-
  lic access to the innovation once patents have expired. In-
  deed, Congress designed the generic approval system with
  the express purpose of speeding the introduction of generic
  drugs to the market as soon as patents allow. Today, the
  Majority’s decision undermines this balance by allowing a
  drug marketed for unpatented uses to give rise to liability
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  2   GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.




  for inducement and by permitting an award of patent dam-
  ages where causation has not been shown.
      This case is about whether Teva induced infringement
  of GSK’s reissue patent, RE40,000, by marketing its ge-
  neric carvedilol of for unpatented uses through a “skinny
  label.” The clear answer: Teva did not.
      Congress provided for skinny labels for exactly these
  circumstances, see 21 U.S.C. § 355(j)(2)(A)(viii), such that
  the lone method covered in the ’000 patent would not fore-
  close access to more affordable carvedilol. And Teva acted
  exactly as Congress intended. Teva waited until GSK’s pa-
  tent covering the carvedilol compound expired to launch its
  product covering two unpatented indications—hyperten-
  sion and post-MI LVD. So, when GSK’s ’000 reissue patent
  later issued—reciting a narrow method of treating a third
  indication, CHF—Teva’s skinny label did not even suggest
  using its product according to the patented method.
      At the FDA’s direction, Teva amended its label years
  later to include the patented method, but there was still no
  inducement via the full label. Nothing changed in the mar-
  ket, and doctors’ prescribing decisions were not affected.
  By that time, GSK could not rely on Teva’s ANDA as an
  artificial act of infringement. Thus, to prove induced in-
  fringement, GSK had to show that Teva actually caused
  doctors to directly infringe the ’000 patent. It failed to do
  so.
      The jury returned a verdict in favor of GSK, finding
  that Teva had induced infringement of the ’000 patent by
  marketing both its skinny and full labels. The district
  court thereafter applied the law to the evidence presented
  at trial. In a thoughtful and thorough opinion, the court
  concluded that there was not legally sufficient evidence to
  show that Teva infringed the ’000 patent and granted
  JMOL for Teva. The Majority, with little explanation, re-
  verses that decision by misapplying the law and miscon-
  struing the facts.
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.      3



      The district court got it right: no evidence established
  that Teva actually caused the doctors’ infringement for ei-
  ther label. No communication from Teva encouraged doc-
  tors to use generic carvedilol to practice the patented
  method. And no evidence showed that doctors relied on
  Teva’s label. Indeed, GSK’s own expert admitted that he
  had not read Teva’s label before prescribing generic carve-
  dilol. Rather than suggest inducement, the record estab-
  lished that doctors relied on other sources of information,
  not Teva, in making their decision to prescribe carvedilol.
  And in any case, the record showed that the switch from
  Coreg® to generic carvedilol occurred “automatically,” often
  without doctors’ knowledge at all.
      The Majority nonetheless reinstates the jury’s verdict
  of inducement based on its conclusion that the district
  court applied the incorrect legal standard. Respectfully,
  the Majority is wrong. According to the Majority, the “con-
  tent” of Teva’s skinny label alone is sufficient to prove in-
  duced infringement—even though Teva’s skinny label did
  not encourage, promote, recommend, or even suggest the
  patented method. Maj. 16. This holding is no small matter:
  it nullifies Congress’s statutory provision for skinny la-
  bels—creating liability for inducement where there should
  be none. Contrary to Congress’s intent, the Majority
  thereby allows one patented method to discourage generics
  from marketing skinny labels—thus, slowing, rather than
  speeding, the introduction of low-cost generics.
       The legal insufficiency of GSK’s evidence should not be
  shielded by the jury’s verdict. While juries must be af-
  forded deference, it is central to our judicial system that
  their verdicts conform to the limits of the law. Where, as
  here, a verdict is not supported by legally sufficient evi-
  dence, judges are given the authority—indeed, the respon-
  sibility—to enter judgment as a matter of law. The role of
  judges as gatekeepers preserves the integrity of our juries’
  verdicts; it does not diminish them. In this case, the dis-
  trict court’s judgment of noninfringement justly upheld the
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  4   GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.




  law, because GSK’s evidence of inducement was legally in-
  sufficient to support the jury’s verdict.
      Because I believe the Majority’s holding is counter to
  Congress’s intent and incorrectly concludes that the jury’s
  verdict was supported by substantial evidence, I respect-
  fully dissent.
                                ***
       There is a lot to be said about the law and about this
  case. I try to do so here. Section I briefly describes Con-
  gress’s complex statutory scheme governing pharmaceuti-
  cal approval, including Congress’s design for skinny labels.
  Section II reviews the facts and procedural background of
  this case. Section III rejects the Majority’s nullification of
  Congress’s provision for skinny labels. Finally, Section IV
  discusses the evidence in this case and how that evidence
  fails to provide substantial evidence for the jury’s verdict.
                I.      THE STATUTORY BACKGROUND
      Congress contemplated the very circumstances this
  case presents, and plainly intended for the opposite out-
  come. It facilitated generic drug approval as soon as pa-
  tents     would       allow      and,    through      21 U.S.C.
  § 355(j)(2)(A)(viii), specifically provided generics a pathway
  to approval that avoids any infringement of a brand’s pa-
  tents.
      When Congress passed the Hatch-Waxman Act in
  1984, it designed a complex statutory scheme to regulate
  drug approval. See Drug Price Competition and Patent
  Term Restoration Act of 1984, Pub. L. No. 98-417,
  98 Stat. 1585. One essential purpose was to “speed the in-
  troduction of low-cost generic drugs to the market.” Caraco
  Pharm. Labs., Ltd. v. Novo Nordisk, 

, 405
  (2012); see also H.R. Rep. No. 98–857, pt. 1, at 14–15
  (1984), as reprinted in 1984 U.S.C.C.A.N. 2647, 2647–48
  (“The purpose . . . is to make available more low cost
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.        5



  generic drugs by establishing a generic drug approval pro-
  cedure . . . .”).
      According to Congress’s scheme, the FDA regulates the
  manufacture, sale, and labeling of prescription drugs. The
  process begins when a brand manufacturer submits a new
  drug application (“NDA”). The NDA must include, among
  other things, proposed labeling describing the use, or
  uses—often called “indications”—for which the drug may
  be marketed. See 21 U.S.C. § 355(b)(1).
      Once the FDA has approved the brand manufacturer’s
  drug, a generic company may seek permission to market its
  version of the drug by filing an abbreviated new drug ap-
  plication (“ANDA”). The ANDA substantially relies on the
  information in the brand’s NDA. The scheme is designed
  to minimize the barriers to entry for generic drugs. Even
  the generic’s proposed labeling essentially copies the brand
  label. See 21 U.S.C. § 355(j)(2)(A)(i), (v). The generic is not
  required to provide information about clinical trials and in-
  vestigations, but it must demonstrate that its generic ver-
  sion is bioequivalent to the branded drug. See 21 U.S.C.
  § 355(j)(2)(A)(iv).
      Related to the approval process, the FDA publishes the
  Orange Book, 1 which identifies drug products that have
  been approved as safe and effective. The Orange Book is
  updated to identify generic versions once an ANDA has
  been finally approved. It reports a therapeutic equivalence
  rating that signals whether the generic drug can be ex-
  pected to have the same clinical effect and safety profile
  when administered as labeled. Orange Book Preface, at



      1   Formally, “Approved Drug Products with Thera-
  peutic Equivalence Evaluations.” See U.S. Food & Drug
  Admin., Preface to Approved Drug Products with Thera-
  peutic Equivalence Evaluations (40th ed. 2020) (“Orange
  Book Preface”).
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  6   GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.




  § 1.2. Relevant to this case, for example, a therapeutic
  equivalence rating of “AB” means that the generic version
  of the brand drug meets necessary bioequivalence require-
  ments. Orange Book Preface, at § 1.7.
      The FDA cannot approve a generic drug that would in-
  fringe a patent. To determine whether an ANDA would
  infringe, the FDA relies on the brand manufacturer to file
  with its NDA information for any patents that cover a com-
  pound or method of use described in the brand label. The
  FDA does not attempt to verify the accuracy of the submit-
  ted patent information but publishes it in the Orange Book
  and applies it in approval decisions.
      Congress, however, provided the generic manufacturer
  two pathways to show that its proposed label will not in-
  fringe an Orange-Book-listed patent. The first and most-
  commonly used pathway is to file one of four certifications
  explaining that the generic label will not infringe the Or-
  ange-Book-listed patent. See 21 U.S.C. § 355(j)(2)(A)(vii)(I)
  –(IV). For example, a “paragraph III certification” states
  that the generic label will not infringe because the generic
  will not launch its product until the Orange-Book-listed pa-
  tent expires.

a “paragraph
  IV certification” states that a generic label will not infringe
  because the Orange-Book-listed patent “is invalid or will
  not be infringed by the manufacture, use, or sale of the [ge-
  neric] drug.”

though the FDA may approve a label for which a
  generic has certified that it will not infringe, Congress
  made it an artificial act of infringement to file an ANDA
  covering an Orange-Book patented drug or method. See
  35 U.S.C. § 271(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc.,
  

, 670–71, 676 (1990); cf. 35 U.S.C. § 271(a) (im-
  posing patent-infringement liability generally only when
  an infringer makes, uses, offers for sale, sells, or imports
  an invention).     The brand may therefore bring an
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.       7



  infringement action based solely on the generic’s ANDA
  and proposed label.
      The second pathway, available in circumstances where
  at least one indication on the brand label is no longer pa-
  tent protected, allows the generic to “carve out” other still-
  patented indications from its label.         See 21 U.S.C.
  § 355(j)(2)(A)(viii)   (“section     viii”);   21     C.F.R.
  § 314.94(a)(8)(iv). The resulting label is commonly called a
  “skinny label.” When the ANDA is finally approved, the
  generic will be limited to the indications included on its
  skinny label but will nonetheless be able to launch its prod-
  uct without infringing the remaining method patent.
      Congress therefore specifically designed the statutory
  scheme governing drug approval such that one patented
  use would not foreclose a generic from marketing a drug for
  other unpatented uses. Caraco 

;
  see also Warner-Lambert Co. v. Apotex Corp., 

, 1359–60 (Fed. Cir. 2003) (quoting the legislative his-
  tory and concluding that “Congress recognized that a single
  drug could have more than one indication and yet that the
  ANDA applicant could seek approval for less than all of
  those indications”). As I address in more detail below, the
  Majority’s holding in this case directly undermines Con-
  gress’s design. See infra § III.
       II.      THE FACTUAL AND PROCEDURAL BACKGROUND
     A. Carvedilol: An unpatented compound useful for un-
                  patented methods of treatment
      Carvedilol—the drug at the center of this suit—is well
  studied and well understood. By 2007, the compound itself
  was not patent protected, nor were multiple uses of it.
      Carvedilol is a beta-blocker, which is a class of drugs
  that have been used since the 1960s to treat certain heart
  conditions. Carvedilol in particular was developed in the
  1980s and was covered by U.S. Patent No. 4,503,067, which
  issued in 1985 and expired in 2007. The ’067 patent
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  8   GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.




  claimed the carvedilol compound and a method of using
  carvedilol to treat hypertension and angina pectoris. See
  ’067 patent claims 1–18.
       By the early 1990s, research revealed that beta-block-
  ers could also be useful for treating a different condition
  called congestive heart failure (“CHF”), which prevents the
  heart from being able to deliver enough oxygenated blood
  to the body. GSK filed an NDA that included indications
  for both hypertension and CHF. GSK’s NDA was approved
  in 1997 under the brand name Coreg®. Later, in 2003, a
  third indication, often called “post-MI LVD,” was approved
  and added to Coreg®’s label, covering patients that had re-
  cently suffered heart damage from a heart attack.
       After the initial approval of its NDA, GSK was issued
  two method patents, U.S. Patent Nos. 5,760,069 and
  5,902,821, related to using carvedilol to treat CHF. GSK
  listed the ’069 and ’821 patents, along with the ’067 patent,
  in the FDA’s Orange Book. Once the ’067 patent expired in
  March 2007, no Orange-Book-listed patent covered the hy-
  pertension or post-MI LVD indications.
       B. Generic carvedilol: Teva launches its low-cost ge-
          neric for unpatented uses based on a skinny label
      The record shows that Teva did everything right—pro-
  ceeding precisely as Congress contemplated.            Teva
  launched its low-cost generic carvedilol for unpatented
  uses using a skinny label. And Teva did not encourage doc-
  tors to use generic carvedilol to practice the one still-pa-
  tented use.
      When Teva initially filed its ANDA, it sought approval
  for all three approved indications—CHF, hypertension,
  and post-MI LVD. At the same time, Teva filed certifica-
  tions explaining that it would not infringe any of GSK’s
  three Orange-Book-listed patents. With respect to the
  ’067 patent, Teva filed a paragraph III certification, notify-
  ing GSK that it would not market its generic carvedilol
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.      9



  until the ’067 patent expired. And with respect to the ’069
  and ’821 patents, Teva filed a paragraph IV certification,
  notifying GSK that it would not infringe the method-of-use
  patents because they were invalid and unenforceable.
  Upon receiving the certifications, unlike the typical Hatch-
  Waxman case, GSK did not sue Teva based on any of the
  Orange-Book-listed patents. Instead, seemingly acknowl-
  edging the deficiencies in its patent, GSK filed a reissue
  application for the ’069 patent.
      Meanwhile, in 2004, the FDA granted tentative ap-
  proval for Teva’s ANDA application. Teva issued a press
  release, announcing the “tentative approval . . . for Carve-
  dilol Tablets” and stating that “Carvedilol Tablets are the
  AB-rated generic equivalent of GlaxoSmithKline’s Coreg®
  Tablets and are indicated for treatment of heart failure and
  hypertension.” J.A. 6347. Though Teva was surely encour-
  aged by the FDA’s tentative approval, neither it nor any
  other generic could yet enter the market; therefore, GSK
  remained the only manufacturer of carvedilol for several
  more years.
      Before Teva’s carvedilol product was finally approved,
  Teva amended its ANDA and proposed label to carve out
  the     CHF      indication   according    to    21 U.S.C.
  § 355(j)(2)(A)(viii). Thus, in September 2007, when the
  FDA finally approved Teva’s ANDA as an AB-rated version
  of GSK’s Coreg®, Teva’s skinny label was only indicated for
  hypertension and post-MI LVD—neither of which was cov-
  ered by any patent.
      Both Teva and the FDA announced the approval of ge-
  neric carvedilol with a press release. Teva’s short press re-
  lease stated that it had been granted “final approval for the
  company’s [ANDA] to market its Generic version of Glax-
  oSmithKline’s cardiovascular agent Coreg® (Carvedilol)
  Tablets.” J.A. 6342. Teva also announced that it would
  immediately begin shipping its product but did not suggest
  that its product should be used to treat CHF. See

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  10 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



      The FDA’s press release, which was published a day
  earlier, went further than Teva’s. It named fourteen ge-
  neric manufacturers, including Teva, and announced that
  it had approved “the first generic versions of Coreg (carve-
  dilol).” J.A. 7116. All fourteen AB-rated generics were ap-
  proved based on skinny labels indicated only for
  hypertension and post-MI LVD. The FDA’s release stated
  that “Coreg is a widely used medication that is FDA-
  approved to treat high blood pressure, mild to severe
  chronic heart failure and left ventricular dysfunction fol-
  lowing a heart attack.”

stated that “[t]he
  labeling of the generic products may differ from that of
  Coreg because parts of the Coreg labeling are protected by
  patents and/or exclusivity.”

the FDA, not
  Teva, that informed the public that the approved generic
  carvedilol products could be used for treating CHF.
       Upon approval, Teva and seven other AB-rated gener-
  ics began selling carvedilol. By that time, GSK had already
  profited from a monopoly in the carvedilol market for a dec-
  ade, earning it $7.1 billion. Without competition, GSK was
  selling Coreg® for roughly $1.50 per pill. Generic carve-
  dilol, in contrast, entered the market at a dramatically
  lower cost—only 3.5 cents per pill.
      In marketing its generic carvedilol, Teva never stated
  that it was approved, or could be used, to treat CHF. In
  fact, the record suggests Teva hardly marketed its generic
  at all. Teva publicly acknowledged that it sold generic car-
  vedilol in product catalogs, which were produced for phar-
  macists and described basic identifying information for all
  Teva products. In these catalogs, Teva listed carvedilol
  tablets with the appropriate identifying information and
  reported that the therapeutic equivalence rating was “AB”
  and the “Brand” was Coreg® Tablets. J.A. 6214, 6221 (2008
  Product Catalog); J.A. 6054, 6056, 6072 (2011 Product
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.     11



  Catalog). 2 Teva’s product catalogs explained that thera-
  peutic equivalence ratings are codes that “are published in
  the FDA’s Orange Book” for “[d]rug products the FDA con-
  siders therapeutically equivalent to other pharmaceuti-
  cally equivalent products.” J.A. 6256. With respect to an
  “AB” rating, in particular, the catalog stated that an “AB”
  code identifies “[p]roducts meeting necessary bioequiva-
  lence requirements.”

prescribing
  references that were distributed to doctors and included
  the same basic information. See J.A. 6192, 6200. Notably,
  from the time the generic product was approved, the FDA
  likewise reported the equivalence rating for Teva’s carve-
  dilol product in the Orange Book. J.A. 6865–67.
      In 2008, after Teva and the other generics had already
  launched their products, the reissue proceedings of the
  ’069 patent finally resulted in the ’000 patent. The ’000 pa-
  tent recited a narrowed method of treating CHF using car-
  vedilol, now additionally requiring treatment in
  combination with another therapeutic agent in daily
  maintenance dosages for a period greater than six months
  to decrease a risk of mortality. Claim 1 of the ’000 patent
  recites:
      1. A method of decreasing mortality caused by con-
      gestive 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 an-
      giotensin converting enzyme inhibitor (ACE), a di-
      uretic, and digoxin,




      2    The 2011 product catalog does not include a date of
  publication but includes a 2010 copyright. See J.A. 10545
  at ll. 18–21.
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  12 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



      wherein the administering comprises administer-
      ing to said patient daily maintenance dosages for a
      maintenance period to decrease a risk of mortality
      caused by congestive heart failure, and said mainte-
      nance period is greater than six months.
  J.A. 45 at col. 8 ll. 30–40 (italics reflects claim narrowing
  during reissue).
        After the ’000 patent’s issuance in 2008, GSK quickly
  removed both of its original patents from the Orange Book
  and listed the ’000 patent. GSK, however, did not assert
  the ’000 patent against any generic based on their ongoing
  sales of generic carvedilol under the approved skinny la-
  bels. Thus, the carvedilol market continued relatively un-
  changed, with GSK selling Coreg® under its label with
  three indications at an increased price of $2.33 per pill, and
  the generics offering carvedilol labeled for only hyperten-
  sion and post-MI LVD at a decreased price of 2.5 cents per
  pill.
       Years later, in 2011, the FDA directed Teva to revise
  its label to include the CHF indication. Teva complied.
  Teva did not issue a press release or otherwise notify doc-
  tors of the change to its label. Indeed, Teva did not change
  anything about how it marketed its generic carvedilol; it
  continued to sell its product in the same manner that it had
  done since approved. See J.A. 6054. GSK still did not al-
  lege that Teva’s sales of its generic product infringed the
  ’000 patent.
      C. The trial: GSK fails to prove that Teva actually in-
           duced doctors to infringe the patented method
      GSK finally sued Teva in the U.S. District Court for the
  District of Delaware in 2014, more than six years after the
  FDA’s approval of Teva’s ANDA and less than one year be-
  fore the expiration of the ’000 patent. GSK did not (and
  could not) bring an ordinary Hatch-Waxman case relying
  on Teva’s ANDA as an artificial act of infringement, but
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  instead alleged for the first time that Teva had induced in-
  fringement of the ’000 patent by selling its generic carve-
  dilol under both its skinny and full labels. GSK sought
  nearly $750 million dollars in damages from Teva. 3
      GSK’s lawsuit ultimately led to a seven-day jury trial
  in 2018. GSK had to show that Teva’s inducement actually
  caused doctors’ direct infringement of the patented
  method. GSK failed to do so for either Teva’s skinny or full
  label. GSK was given multiple opportunities, but still
  could not show that any affirmative act by Teva had caused
  doctors to prescribe generic carvedilol according to the pa-
  tented method.
      Specifically, at trial, GSK failed to produce testimony
  purporting to show that Teva’s label induced infringement
  of the claimed method by even a single doctor. The parties
  agreed that when Teva launched, its skinny label did not
  instruct doctors to prescribe generic carvedilol to treat
  CHF. See J.A. 10584 at ll. 4–6; see also J.A. 10542 at ll. 19–
  23. There was no dispute that the only two uses included
  on Teva’s label were hypertension and post-MI LVD—uses
  that were not patented. See J.A. 10545 at ll. 9–14 (GSK’s
  expert, Dr. Lietzan, testifying that in 2008, Teva’s carve-
  dilol tablets and Coreg® “were approved for different uses,”
  and “[m]ore precisely, the Teva product was not approved
  for one of the uses that the Coreg product was approved
  for”).
       With respect to both Teva’s skinny and full labels, GSK
  failed to present evidence showing that doctors relied on



      3    Between September 2007, when Teva launched its
  product, and June 2015, when the ’000 patent expired,
  Teva sold only $74.5 million of generic carvedilol total (i.e.,
  for any use). Given Teva’s costs, however, Teva sold ge-
  neric carvedilol at a net loss of $13 million. J.A. 10875 at
  l. 22 to 10876 at l. 12.
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  14 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  the label in making prescribing decisions. To the contrary,
  GSK’s expert, Dr. McCullough, testified that he had not
  read the labels of other generic carvedilol products, and
  that he read Teva’s label only “in [the] context of [his] work
  on this case.” J.A. 10671 at ll. 3–9. He repeatedly stated
  that when generic carvedilol launched, he “didn’t actively
  switch” patients from Coreg® to the generic product, but
  that he “continued to prescribe [Coreg®]” and it was “auto-
  matically switched” by pharmacists, often without his
  knowledge. J.A. 10674 at l. 25 to 10675 at l. 9; see also
  J.A. 11662 at ll. 13–20; J.A. 10678 at l. 1 to 10679 at l. 7.
      While Teva’s label did not seem to influence doctors’
  prescribing decisions, numerous other industry materials
  did. Dr. McCullough testified that in prescribing carvedilol
  to treat CHF, he was informed by prescribing guidelines
  established by the American Heart Association and the
  American College of Cardiology, medical research studying
  carvedilol, and even GSK’s own Coreg® label and the pro-
  motional materials advertising it. J.A. 10676 at l. 2 to
  10677 at l. 25.
       No one reviewing the record should ignore what hap-
  pened on the fourth day of trial.             Following Dr.
  McCullough’s testimony, Teva moved for JMOL that GSK
  had not demonstrated induced infringement of the ’000 pa-
  tent. GSK’s counsel argued in response that it had shown
  inducement through Teva’s label. GSK stated unequivo-
  cally, “[n]o label, no inducement.” J.A. 10962 at l. 7; see
  also J.A. 10962 at ll. 8–10 (“[Teva’s label is] the only way
  the doctors know how to prescribe it or why they would pre-
  scribe it for congestive heart failure.”). But when the dis-
  trict court asked GSK whether Dr. McCullough or any
  other doctor had testified that they had even read Teva’s
  carvedilol label, GSK agreed they had not. J.A. 10959 at
  ll. 9–14.
     GSK asked for the opportunity to put Dr. McCullough
  back on the stand, representing that “he would absolutely
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  give” the relevant testimony. J.A. 10959 at ll. 15–20. He
  didn’t. Instead, when the district court let him back on the
  stand, Dr. McCullough testified that he had not read Teva’s
  label before he started prescribing generic carvedilol.
  J.A. 11662 at l. 25 to 11663 at l. 3. Dr. McCullough reas-
  serted his testimony that substitution of Coreg® for generic
  carvedilol was automatic. J.A. 11662 at ll. 13–24.
             D. JMOL: The district court gets it right
       At the conclusion of trial, the jury was instructed that
  to prove inducement, GSK had to show by a preponderance
  of the evidence that, among other elements, Teva took some
  affirmative act that actually caused doctors’ subsequent di-
  rect infringement. J.A. 11798 at ll. 1–3; see also J.A. 11802
  at ll. 9–16. The jury was asked to determine whether Teva
  induced infringement of the ’000 patent based on its skinny
  and full labels separately. It found that Teva induced in-
  fringement of the ’000 patent based on both labels. The
  jury also found that GSK was entitled to $234.1 million in
  lost profits and $1.4 million in reasonable royalty damages.
  Following the verdict, however, amid other post-trial mo-
  tions, Teva filed a renewed motion for JMOL, again argu-
  ing that GSK had not presented legally sufficient evidence
  to support a finding of inducement. The district court
  agreed and granted Teva’s motion. See GlaxoSmithKline
  LLC v. Teva Pharm. USA, Inc., 

(D. Del.
  2018).
       The district court granted JMOL in favor of Teva be-
  cause “neither sufficient nor substantial evidence supports
  the jury’s finding of inducement.”

In reaching
  its decision, the district court carefully considered the evi-
  dence that GSK had presented at trial. And it concluded
  that this evidence failed to show that even a single doctor,
  much less a class of doctors, was induced to infringe the
  ’000 patent based on Teva’s actions.

It was
  not disputed that Teva’s label, at launch, did not include
  treating CHF or the method claimed in the ’000 patent.
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  16 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  The record also showed that Dr. McCullough had not even
  read Teva’s label and that his prescribing behavior, like
  other doctors, had not changed when generic carvedilol en-
  tered the market.

–95.
      The court also recognized that Teva had reported the
  FDA’s AB rating for Teva’s generic carvedilol, communi-
  cating that it was therapeutically equivalent to GSK’s
  branded carvedilol.

But it rejected GSK’s
  view that communicating therapeutic equivalence with
  Coreg® caused any infringement of GSK’s ’000 patent.

The district court stated:
      As both parties showed at trial, being AB rated sig-
      nifies that a generic drug is therapeutically equiv-
      alent to a branded drug. The undisputed evidence
      demonstrates that a generic drug cannot be listed
      as “AB rated” generally, as “AB rated” is a relative
      term; it necessarily requires a comparison between
      the generic drug and some branded reference drug.

The district court also cited
  testimony from GSK’s expert, Dr. Lietzan, confirming that
  AB rating reports therapeutic equivalence only “if the ge-
  neric drug is used in accordance with the label.”

original). Thus, the district court concluded that
  “there is not legally sufficient evidence to support a finding
  that Teva, by listing its carvedilol as AB rated to Coreg®,”
  encouraged infringement.

(emphasis added).
      Even though no direct evidence was presented at trial
  that Teva induced infringement of the ’000 patent, see
  J.A. 10960 at ll. 6–9, the district court correctly considered
  whether circumstantial evidence supported the jury’s ver-
  dict. GlaxoSmithKline 

. The
  district court concluded it did not. It stated:
      [G]iven the dearth of evidence that doctors read
      and understand and are affected by labels, and
      given the vast amount of evidence that doctors’
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.      17



      decisions to prescribe carvedilol during the rele-
      vant periods were influenced by multiple non-Teva
      factors[, an inference that Teva induced infringe-
      ment] was an unreasonable one for the jury to have
      drawn.

therefore granted JMOL that Teva
  had not infringed the ’000 patent during either the skinny
  or full label periods.

GSK appealed.
     III.   THE MAJORITY NULLIFIES CONGRESS’S PROVISION
                        FOR SKINNY LABELS

      The Majority’s holding that the content of Teva’s
  skinny label can itself establish inducement nullifies Con-
  gress’s provision for skinny labels. The Majority is wrong
  as a matter of law.
       The Majority states that “precedent makes clear that
  when the provider of an identical product knows of and
  markets the same product for intended direct infringing ac-
  tivity, the criteria of induced infringement are met.”
  Maj. 16. Then, citing Vanda Pharmaceuticals, Inc. v. West-
  Ward Pharmaceuticals International Ltd., 

,
  1129 (Fed. Cir. 2018), and Sanofi v. Watson Laboratories
  Inc., 

, 646 (Fed. Cir. 2017), the Majority ex-
  plains that the content of an FDA-approved label can es-
  tablish inducement to infringe. Maj. 16. The Majority,
  however, does not distinguish between Teva’s skinny and
  full labels. As applied to Teva’s skinny label, the Majority’s
  holding therefore has the effect of nullifying Congress’s
  provision for skinny labels.
      Contrary to the Majority’s suggestion that Teva pro-
  vided and marketed an “identical product,” see Maj. 16,
  Teva did not launch its product with a label that was
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  18 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  identical to GSK’s. 4 This case is therefore not analogous to
  either Vanda or Sanofi, where a brand manufacturer al-
  leged patent infringement based on the generic’s ANDA
  that included a virtually identical label. Unlike those
  cases, here, Teva’s skinny label is insufficient to prove in-
  fringement.
       When Teva launched its product, Teva’s carvedilol la-
  bel did not suggest that it was approved to treat CHF at
  all, much less the ’000 patent’s narrow method of treating
  CHF by administering “daily maintenance dosages” for at
  least “six months” in conjunction with another therapeutic
  agent. J.A. 10584 at ll. 4–6; see also J.A. 10542 at ll. 19–
  23; J.A. 10695 at l. 21 to 10696 at l. 1. And there is no dis-
  pute that the only two uses included on Teva’s label, i.e.,
  hypertension and post-MI LVD, were not patented.
  J.A. 10545 at ll. 9–14. Teva’s skinny label therefore did not
  infringe.
       To hold otherwise, as the Majority does, undermines
  Congress’s provision for skinny labels by substantially nul-
  lifying section viii. According to the Majority, a generic
  company that carves out from its label a patented method
  of use can nonetheless be found to infringe that patented
  method based on the content of the FDA-approved label.
  See Maj. 16. By finding inducement based on Teva’s skinny
  label, which was not indicated for—and did not otherwise
  describe—the patented method, the Majority invites a


      4    It is worth repeating—Teva’s generic product in-
  cluded the same drug compound, carvedilol, but that drug
  compound was no longer patent protected. Nor were two
  approved indications of carvedilol patent protected. Teva
  did not infringe any patent by marketing a generic product
  for those uses. Teva’s product that was approved and mar-
  keted through its skinny label was not identical to Coreg®
  because, unlike Coreg®, Teva’s product was not approved
  to treat CHF patients according to the patented method.
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.     19



  claim of inducement for almost any generic that legally en-
  ters the market with a skinny label. That is directly con-
  trary to Congress’s intent. See, e.g., Caraco 

–06, 415; 

–71, 676.
       The Majority’s holding is also contrary to our caselaw.
  In Warner-Lambert v. Apotex Corp., we considered whether
  an ANDA applicant infringed a patented method by seek-
  ing approval for a label that did not include an indication
  for that method. 

. In that case, the patented
  use was not an approved use in the brand label. We ex-
  plained that “Congress recognized that a single drug could
  have more than one indication and yet that the ANDA ap-
  plicant could seek approval for less than all of those indi-
  cations.”

We held that the generic label was
  neither an artificial act of infringement under
  § 271(e)(2)(A) nor an act of inducement under § 271(b).

With respect to inducement, we explained, “the
  request to make and sell a drug labeled with a permissible
  (non-infringing) use cannot reasonably be interpreted as
  an act of infringement (induced or otherwise) with respect
  to a patent on an unapproved use, as the ANDA does not
  induce anyone to perform the unapproved acts required to
  infringe.”

      The same is true in yet another one of our cases. In
  Takeda Pharmaceuticals U.S.A. v. West-Ward Pharmaceu-
  tical Corp., we considered whether a drug’s label induced
  infringement of a patented method for which it was not in-
  dicated. 

(Fed. Cir. 2015). Takeda argued that
  the label induced infringement of the patented method of
  treating acute gout flares by instructing that “[i]f you have
  a gout flare while taking [the drug], tell your healthcare
  provider.”

(first alteration in original). Takeda
  argued that this instruction would “inevitably” lead physi-
  cians to use the drug for the treatment of acute gout flares.

it did not induce infringement. We
  explained that “vague label language cannot be combined
  with speculation about how physicians may act to find
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  20 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  inducement,” and held that to induce infringement of a pa-
  tented method, a “label must encourage, recommend, or
  promote infringement.”

      Like the labels in Warner-Lambert and Takeda, Teva’s
  label is not itself a basis for infringement. Teva’s skinny
  label did not “encourage, recommend, or promote infringe-
  ment” of the ’000 patent. In fact, Teva’s skinny label did
  not even suggest the patented method; it said absolutely
  nothing about CHF. It is legal error for the Majority to hold
  otherwise.
       Contrary to the Majority’s suggestion, it does not mat-
  ter that Teva “deliberately,” or intentionally, carved the
  CHF indication from its label. See Maj. 14. Far from abus-
  ing the system, Teva was acting in accordance with Con-
  gress’s goals for it. The Supreme Court has explained that
  skinny labels provide a “mechanism for a generic company
  to identify [unpatented uses], so that a product with a label
  matching them can quickly come to market.” Caraco
  

. It is not gamesmanship for Teva
  to exercise this mechanism. Nor is it infringement.
       Finally, to the extent the Majority finds liability for in-
  duced infringement based on Teva’s expectation that “off-
  label” sales of generic carvedilol would occur, see Maj. 13–
  15, we have repeatedly rejected the argument that
  knowledge of off-label infringing uses establishes induce-
  ment. See 

(“The requirement of
  inducing acts is particularly important in the Hatch-Wax-
  man Act context because the statute was designed to ena-
  ble the sale of drugs for non-patented uses even though this
  would result in some off-label infringing uses.”); Warner-
  

(“[M]ere knowledge of possible
  infringement by others does not amount to inducement;
  specific intent and action to induce infringement must be
  proven.”); see also Dynacore Holdings Corp. v. U.S. Philips
  Corp., 

, 1276 n.6 (Fed. Cir. 2004).
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.       21



            IV.    THE MAJORITY MISAPPLIES THE LAW AND
                        MISCONSTRUES THE FACTS
      To prove inducement under 35 U.S.C. § 271(b), GSK
  was required to show causation. That is, GSK had to show
  that doctors relied on Teva’s inducing communications in
  directly infringing the claimed method. See Power Integra-
  tions, Inc. v. Fairchild Semiconductor Int’l, Inc., 

, 1330–32 (Fed. Cir. 2016); 

–
  32; Ericsson, Inc. v. D-Link Sys., Inc., 

, 1219
  (Fed. Cir. 2014). It failed to do so.
       GSK failed to prove causation based on either Teva’s
  skinny or full label. I address the skinny and full label pe-
  riods below. 5 I also discuss uncontroverted evidence that
  showed that other sources, not Teva, influenced doctors’ de-
  cisions to prescribe generic carvedilol according to the pa-
  tented method during both periods.
          A. The Skinny Label Period: GSK fails to show that
           Teva actually caused doctors to directly infringe the
                            patented method
      The Majority’s conclusion that substantial evidence
  supports the jury’s verdict of inducement during the skinny
  label period is contradicted by the record. Simply put, GSK
  cannot show that Teva’s skinny label alone induced in-
  fringement of the ’000 patent, and GSK failed to show that
  any other communication from Teva to doctors actually
  caused doctors to directly infringe the patent method.
      During the skinny label period, GSK primarily relied
  on Teva’s label as the basis for its claim that Teva induced



      5  Teva’s skinny label period runs from January 8,
  2008, when the ’000 patent issued, until April 30, 2011.
  The full label period runs from May 1, 2011, when Teva
  amended its label at the FDA’s direction, until June 7,
  2015, when the ’000 patent expired.
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  22 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  doctors to practice the claimed method. E.g., J.A. 10692 at
  ll. 7–10. Critically, as just discussed, Teva’s skinny label
  did not teach the patented method and could not induce in-
  fringement of the ’000 patent. 

§ III.
       Moreover, regardless of what Teva’s skinny label en-
  couraged, GSK failed to show that doctors actually relied
  on Teva’s label in deciding to prescribe generic carvedilol.
  GSK’s expert Dr. McCullough expressly testified that he
  had not read Teva’s label before prescribing generic carve-
  dilol, J.A. 11662 at l. 25 to 11663 at l. 3, and also that he
  had not read any other generic carvedilol label, J.A. 10671
  at ll. 3–9. Dr. McCullough was also unequivocal that his
  prescribing behavior did not change once generic carvedilol
  was launched, e.g., J.A. 10674 at l. 25 to 10675 at l. 9.
       The Majority nonetheless summarily concludes that
  there is substantial evidence to support the jury’s verdict.
  Because even GSK’s counsel admitted there is no direct ev-
  idence of inducement in the record, see J.A. 10960 at ll. 6–
  9, the Majority’s conclusion is necessarily based only on cir-
  cumstantial evidence. During the skinny label period, the
  Majority generally cites product catalogs and press re-
  leases published by Teva. See Maj. 12–16 (citing J.A. 6221,
  6072 (product catalogs) and 6347, 6353 (press releases)).
       Teva’s documents fail to provide substantial evidence
  of inducement. First, Teva’s press releases are not affirm-
  ative acts of inducement that occurred after the ’000 patent
  issued. Second, no reasonable juror could conclude that
  Teva’s press releases or its product catalogs encourage doc-
  tors to practice the patented method. Third, GSK failed to
  produce any evidence establishing that doctors relied on
  these materials in making their prescribing decisions. In-
  deed, in contrast to GSK’s legally insufficient evidence,
  other uncontroverted evidence showed that other sources,
  not Teva, influenced doctors’ decisions to prescribe generic
  carvedilol according to the patented method.
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  GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.      23



      1. Teva’s press releases fail to provide substantial evi-
          dence of inducement because they were published
                     before the ’000 patent issued
      Teva published two releases before the ’000 patent is-
  sued. The first was published in 2004 and announced the
  tentative approval of Teva’s generic product. J.A. 6347.
  The second was published in 2007 and announced that
  Teva’s generic product had been approved and that Teva
  would immediately begin shipping its product. J.A. 6353.
  Importantly, both of these press releases were published
  before the ’000 patent issued in 2008 and therefore cannot
  alone be acts of infringement. Nat’l Presto Indus., Inc. v.
  W. Bend Co., 

, 1196 (Fed. Cir. 1996) (“[W]hen
  no patent has issued at the time of the inducement there
  can not be a violation of § 271(b).”).
       The Majority nonetheless exhumes Teva’s press re-
  leases to establish infringement because they remained on
  Teva’s website after the ’000 patent’s issuance. Maj. 15–
  16. The continued presence of the press releases, however,
  is not probative evidence of inducement. Our caselaw is
  clear that inducement requires “an affirmative act to en-
  courage infringement.” E.g., 

n.4;
  Microsoft Corp. v. DataTern, Inc., 

, 904 (Fed.
  Cir. 2014); see also Metro-Goldwyn-Mayer Studios Inc. v.
  Grokster, Ltd., 

, 918 (2005); see also J.A. 11797
  at ll. 7–8, 13–18 (jury instructions). In this case, passive
  maintenance of the pre-issuance press releases is not an
  affirmative act of inducement. 6



      6   To the extent the Majority means to argue that the
  press releases are probative evidence of continued induce-
  ment because they were maintained on Teva’s website,
  that argument also fails. Not only is passive maintenance
  not an affirmative act, but further, the “continued infringe-
  ment” argument was not made to the jury. It therefore
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  24 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



      Moreover, with respect to the 2004 press release, I am
  particularly unpersuaded that it could be probative evi-
  dence of inducement given that it reports only “tentative
  approval.” J.A. 6347; see also J.A. 11656 at ll. 22–24
  (Dr. McCullough testifying that the 2004 press release an-
  nounced only “tentative approval” and what was “expected”
  in the future). The FDA does “not include drug products
  with tentative approvals in the Orange Book because a
  drug product that is granted tentative approval is not an
  approved drug product.” Orange Book Preface, at § 1.1 (em-
  phasis added). The suggestion that a practicing physician
  would (or should) rely on an announcement for “tentative
  approval” in making prescribing decisions over three years
  in the future seems unlikely.
     2. Teva’s documents did not encourage doctors to prac-
                    tice the patented method
      Moreover, GSK did not produce any evidence during
  the skinny label period upon which a reasonable juror
  could conclude that Teva encouraged doctors to prescribe
  carvedilol to practice the patented method.
      Teva’s press releases and product catalogs, like its
  skinny label, do not promote treating CHF at all. For ex-
  ample, the 2007 press release said nothing of CHF.
  J.A. 6373; see also J.A. 10671 at ll. 11–14 (GSK’s expert Dr.
  McCullough testifying that the release “said nothing about
  what indications were or weren’t on the label”). The prod-
  uct catalogs likewise said nothing about the product’s indi-
  cations. Instead, the catalogs merely included carvedilol in
  a table that reported basic product information, like



  could not have provided substantial evidence for its verdict.
  At most, the jury saw a copy of the press releases taken
  from Teva’s website with a footer indicating that they had
  been printed from the website in 2015. J.A. 6346–47,
  6352–53.
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  physical description, units of sale, and therapeutic equiva-
  lence. See J.A. 6221. The Majority, purportedly “[a]pply-
  ing the standards of law and precedent,” focuses on
  whether doctors read these materials. Maj. 17. But the
  question is not just whether these materials were read
  (though there is scant evidence even of that, see infra
  § IV.A.3); the question is whether these materials can rea-
  sonably be viewed as having encouraged infringement. And
  they simply cannot.
       Moreover, for Teva to have induced infringement of the
  ’000 patent, Teva must have induced infringement of
  “every single step” of the claimed method, 

—including the steps that GSK added to se-
  cure its reissue patent and thereby extend its carvedilol
  coverage. 7 Thus, even if Teva’s documents suggested using
  its carvedilol products to treat CHF, which they do not,
  such a suggestion would not be enough to induce infringe-
  ment of the ’000 patent. See J.A. 10695 at l. 21 to 10696 at
  l. 1 (Dr. McCullough agreeing that not every CHF patient
  treated with carvedilol infringes the claimed method).
       Without a disclosure of the claimed method, the Major-
  ity seems to rely on references to Teva’s “AB rating” or ther-
  apeutic equivalence as evidence of inducement. See
  Maj. 12–16. These statements, however, cannot be legally
  sufficient to prove inducement. As recognized by the Ma-
  jority, see Maj. 6 n.3, and clarified in Teva’s publications,


      7    As previously noted, the specific method steps of
  the ’000 patent’s very narrow method required administer-
  ing to a CHF patient a therapeutically acceptable amount
  of carvedilol in conjunction with one or more particular
  therapeutic agents, wherein the administering comprises
  daily maintenance dosages for a maintenance period to de-
  crease a risk of mortality caused by CHF, and wherein said
  maintenance period is greater than six months. See J.A. 45
  at col. 8 ll. 30–40.
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  26 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



  see J.A. 6256, therapeutic equivalence is a designation pro-
  vided by the FDA relating to the safety and efficacy of the
  drug compound. 8 See also J.A. 10533 at l. 24 to 10534 at
  l. 1. Indeed, in closing arguments to the jury, GSK’s coun-
  sel acknowledged that “the fact that Teva said they were
  AB rated isn’t enough to prove inducement . . . . [W]e have
  to show you more than just the AB rating.” J.A. 11849 at
  ll. 1–8. The Majority, however, seems quite content with
  the AB rating. Maj. 12 (mentioning the AB rating), 13 (not-
  ing use of the phrase “AB rating”), 15 (recounting GSK’s
  expert’s testimony of what an “AB rating” means, and ob-
  serving that Teva’s product catalogs included that term),
  15–16 (“The jury properly could consider Teva’s continued
  affirmative promotion of its carvedilol tablet as the AB ge-
  neric equivalent of Coreg® . . . .”).
      Further, Orange Book determinations of therapeutic
  equivalence are not made for unapproved indications. See
  

; see also Orange
  Book Preface, at § 1.2; J.A. 10543 at ll. 1–10. GSK’s expert
  Dr. Lietzan testified that AB rating “is an indication that
  the product is therapeutically equivalent when used as la-
  beled” and that “it doesn’t reflect a decision of the thera-
  peutic equivalence with respect to the off-label uses.”
  J.A. 10583 at ll. 1–4; see also J.A. 10542 at ll. 13–14 (“AB



      8   To the extent the Majority believes that Teva had
  an affirmative duty to inform doctors that it was not ap-
  proved for one indication, respectfully, that is not the law.
  We expressly rejected this argument in Takeda. 

n.4 (rejecting Takeda’s argument that Hikma’s
  label needed to contain a “clear statement to show that it
  was avoiding the patented indication”). There, we stated
  that “[the patentee] needs to show that [the alleged in-
  fringer] took affirmative steps to induce, not affirmative
  steps to make sure others avoid infringement.” Id.; see also
  

; 

.
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  rating means that [the drug is] therapeutically equivalent
  as labeled . . . .”). Thus, Teva’s reporting of equivalence in-
  formation cannot be evidence of inducing infringement for
  a method that the generic is not indicated to treat. 9
      3. No evidence suggests that doctors relied on commu-
         nications by Teva in prescribing carvedilol accord-
                     ing to the patented method
      Even if the product catalogs or press releases encour-
  aged doctors to prescribe generic carvedilol according to the
  patented method, which they do not, GSK failed to show
  that doctors would have relied on those materials in mak-
  ing prescribing decisions.
      With respect to Teva’s product catalogs, GSK’s expert
  Dr. McCullough was not even able to say that they would
  have been seen by doctors, much less relied on. See
  J.A. 10686 at ll. 5–7 (“Q: So you are testifying that this
  [2008 Product Catalog] was actually given to doctors or you
  just don’t know? A: I don’t know that. I think it’s possi-
  ble.”). If the doctors never even received Teva’s product
  guides, they cannot be evidence that Teva caused infringe-
  ment. Power 

–31.




      9   To be approved as a generic, Teva’s primary re-
  quirement was to show that its carvedilol product is bioe-
  quivalent, or therapeutically equivalent, to Coreg®. Teva
  was not required to be approved for all of indications.
  Thus, even were it correct that by reporting its “AB rating”
  Teva communicated that its generic carvedilol should be
  used for an indication not approved on its label, it would
  nonetheless stretch the bounds of reason to restrict Teva
  from accurately reporting that equivalence information
  upon approval. In fact, the Orange Book publicly reports
  the very same information, and has done so since Teva’s
  generic was approved. See J.A. 6866–67.
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  28 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



      Similarly, with respect to the press releases, no testi-
  mony suggested that doctors were in the habit of searching
  websites for past-published press releases to influence
  their prescribing behavior. Indeed, no record evidence
  even implies that doctors saw Teva’s press releases when
  they were published, must less after the ’000 patent issued
  in 2008. To the extent pharmaceutical press releases were
  considered at all, the record suggests that doctors only
  checked their email for new announcements to inform them
  “when drugs are going generic.” J.A. 11655 at ll. 20–24.
       Though circumstantial evidence may be sufficient evi-
  dence to prove inducement in some cases, this is not one of
  them. Beyond Teva’s skinny label—which does not encour-
  age doctors to practice the patented method—the only
  other evidence the Majority cites—i.e., press releases and
  product catalogs—are documents that do not describe the
  patented method, and for which little evidence, if any at
  all, even hints they were ever considered by doctors during
  the allegedly infringing period. The inferences required to
  reach a finding of inducement exceed the bounds of reason.
      GSK failed to present evidence demonstrating that
  Teva caused the doctors’ direct infringement of the ’000 pa-
  tent during the skinny label period. Without causation,
  GSK failed to prove inducement.
      4. Uncontroverted evidence in the record establishes
        that other sources, not Teva, induced doctors to pre-
         scribe carvedilol according to the patented method
       In contrast to the absence of evidence suggesting that
  Teva induced infringement, uncontroverted record evi-
  dence establishes that it was other sources, and not Teva’s
  label or other documents, that induced doctors to prescribe
  carvedilol according to the claimed method. See Integra
  Lifesciences I, Ltd. v. Merck KGaA, 

, 1345
  (Fed. Cir. 2007) (“The rule that a jury verdict is reviewed
  for support by ‘substantial evidence’ does not mean that the
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  reviewing court must ignore the evidence that does not
  support the verdict.”).
       In particular, the record confirmed that doctors pre-
  scribed carvedilol according to the claimed method based
  on the prescribing guidelines established by the American
  Heart Association and the American College of Cardiology,
  medical research studying carvedilol, and even GSK’s own
  Coreg® label and GSK’s promotional materials advertising
  it. E.g., J.A. 10676 at l. 2 to 10677 at l. 25; J.A. 11151 at
  l. 3 to 11153 at l. 22; J.A. 11164 at l. 11 to 11172 at l. 12;
  J.A. 11296 at l. 17 to 11297 at l. 3.
      The record additionally showed that the day before
  Teva published its 2007 press release, the FDA had pub-
  lished its own press release, J.A. 7116, which detailed even
  more about using carvedilol to treat CHF than did Teva’s
  (indeed, Teva’s said nothing about it). And the record
  showed that doctors would have actually relied on the
  FDA’s release in making prescribing decisions.           See
  J.A. 10670 at ll. 9–11; see also 

  (finding insufficient evidence of induced infringement in
  part because before the generic’s alleged inducement, the
  FDA had previously informed healthcare providers to pre-
  scribe the drug according to the claimed method).
       Further still, the record showed that substitution of ge-
  neric carvedilol for Coreg® often happened without doctor
  involvement at all. At trial, Dr. McCullough repeatedly
  testified that when the generics launched, he “didn’t ac-
  tively switch” patients from Coreg® to the generic product,
  but that he “continued to prescribe [Coreg®]” and it was
  “automatically switched.” J.A. 10674 at l. 25 to 10675 at
  l. 9; see also J.A. 10675 at ll. 6–9; J.A. 11662 at ll. 13–20;
  J.A. 11176 at ll. 4–13; J.A. 11177 at ll. 10–16 (Teva’s expert
  Dr. Zusman testifying). The switch did not occur because
  doctors relied on Teva’s marketing materials. In fact, the
  switch did not even occur with the doctors’ knowledge. See
  J.A. 10678 at l. 1 to 10679 at l. 7.
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  30 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC.



      In sum, the district court’s JMOL of noninfringement
  during the skinny label period should be affirmed. Teva
  did not induce infringement of the ’000 patent during the
  skinny label period. And the record does not include legally
  sufficient evidence to support the jury’s verdict.
     B. The Full Label Period: GSK fails to show that Teva
        actually caused doctors to directly infringe the pa-
                          tented method
      GSK also failed to prove causation during the full label
  period. No evidence suggests that any affirmative act by
  Teva actually caused doctors to directly infringe the pa-
  tented method. Specifically, no evidence suggests that doc-
  tors relied on Teva’s full label in making their prescribing
  decisions.
       During the full label period, GSK primarily relied on
  Teva’s label as evidence of inducement. Of course, unlike
  the skinny label, Teva’s full label included an indication for
  the treatment of CHF. But because GSK could not rely on
  Teva’s ANDA as an artificial act of infringement, GSK was
  required to show actual inducement, including that doctors
  actually relied on Teva’s full label in making its prescribing
  decisions. See 

. GSK
  failed to do so.
       As previously described, GSK’s evidence showed that
  doctors, including the very doctor it chose to put on the
  stand, did not rely on generic labels in making prescribing
  decisions. See J.A. 10671 at ll. 3–9. Though GSK was
  given multiple opportunities to prove causation, e.g.,
  J.A. 10962 at ll. 7–10; J.A. 10959 at ll. 9–20, GSK’s expert
  Dr. McCullough testified that he did not read Teva’s label
  before prescribing generic carvedilol, J.A. 11662 at l. 25 to
  11663 at l. 3, and he testified that his decision to prescribe
  carvedilol never changed, J.A. 10674 at l. 25 to 10675 at
  l. 9. Indeed, when Dr. McCullough was asked about Teva’s
  amendment from a skinny to a full label, he specifically
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  testified that the change had no effect on his prescribing
  habits:
      Q: You agree that at least in your practice, there’s
      no difference in your prescribing habits from when
      Teva had its skinny label to after Teva amended to
      have its full label; right?
      A: I would agree with that.
  J.A. 10699 at ll. 6–10. If Teva’s full label did not influence
  doctors’ prescribing habits—i.e., if Teva did not induce doc-
  tors to directly infringe the patented method—then Teva
  cannot be liable for inducement.
      The only other evidence that GSK offered from the full
  label period similarly fails to provide a basis for inferring
  causation. GSK introduced evidence of prescribing refer-
  ences that were distributed after Teva amended its label to
  the full label. See Maj. 12–13 (citing J.A. 6192–94). 10 But
  the limited testimony at trial did not establish that doctors
  relied on these references in making prescribing decisions.
  Dr. McCullough was asked whether the prescribing refer-
  ences “encourage[ed] the sales of Teva’s product”—he
  stated “no.” J.A. 10680 at ll. 9–16.
      While the evidence failed to show that doctors relied on
  Teva’s full label (or any other communication by Teva dur-
  ing the full label period), the record was consistent with the
  skinny label period demonstrating other sources, not Teva,
  influenced doctors’ decision to prescribe generic carvedilol
  according to the patented method. 

§ IV(A)(4).



      10  The Majority states that “[a]lso in evidence was the
  2012 edition of Teva’s Health Systems Pharmacy Drug Ref-
  erence.” Maj. 13. Despite the suggestion that this is an
  additional document, it is the same as Teva’s 2012 Monthly
  Prescribing Reference that was mentioned in the immedi-
  ately preceding sentence.
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  Specifically, the record confirmed that information from
  the American Heart Association and American College of
  Cardiology, as well as medical research, and even GSK’s
  own marketing, encouraged doctors to prescribe carvedilol
  according to the ’000 patent. E.g., J.A. 10676 at l. 2 to
  10677 at l. 25; J.A. 11151 at l. 3 to 11153 at l. 22; J.A. 11164
  at l. 11 to 11172 at l. 12; J.A. 11296 at l. 17 to 11297 at l. 3.
      The record also demonstrated that many generic car-
  vedilol sales occurred without the doctors’ knowledge at all.
  

§ IV(A)(4). That is, even after Teva amended its
  label, doctors merely prescribed carvedilol, and it was
  pharmacies that dispensed generic carvedilol.             See
  J.A. 10674 at l. 25 to 10675 at l. l. 9; J.A. 10678 at l. 2 to
  10679 at l. 7.
       In sum, to the extent the doctors prescribed generic
  carvedilol to treat patients according to the claimed
  method, no evidence shows that they did so because of any
  action taken by Teva. The district court’s JMOL of nonin-
  fringement during the full label period should therefore be
  affirmed. Teva did not induce infringement of the ’000 pa-
  tent during the full label period. And the record does not
  include legally sufficient evidence to support the jury’s ver-
  dict.
                         V.     CONCLUSION
      The Supreme Court has explained that one of Con-
  gress’s essential purposes in designing a procedure for ge-
  neric approval was to “speed the introduction of low-cost
  generic drugs to the market.” Caraco 

. The Majority’s holding undermines this purpose by
  creating infringement liability for any generic entering the
  market with a skinny label, and by permitting infringe-
  ment liability for a broader label that itself did not actually
  cause any direct infringement. Congress did not intend ei-
  ther of these consequences.
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      Indeed, far from “speed[ing] the introduction of low cost
  generic drugs,” this result discourages generics from enter-
  ing the market in the first instance. Teva did everything
  right—using a skinny label, taking care not to encourage
  infringing uses—and yet, given today’s result, it was ulti-
  mately more costly for Teva to sell an unpatented drug for
  unpatented uses than it would have been to stay out of the
  market altogether: Teva only sold $74 million worth of car-
  vedilol during the allegedly infringing period (mostly for
  unpatented uses) but now owes $234 million in damages
  for sales made for a single indication. This irony reflects
  the fact that Teva’s product was dramatically less expen-
  sive—costing less than 4 cents per pill as compared with
  Coreg®’s price of at least $1.50 per pill.
      Simply put, allowing such an outcome undermines
  Congress’s design for efficient generic drug approval. Teva
  entered the market according to this design and refrained
  from encouraging doctors to practice the ’000 patent’s
  method. Teva should not be liable for inducement.
      For these reasons, I respectfully dissent.