Opinion ID: 4572416
Heading Depth: 1
Heading Rank: 4

Heading: the majority misapplies the law and

Text: 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 Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 843 F.3d 1315, 1330–32 (Fed. Cir. 2016); Takeda, 785 F.3d at 631– 32; Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 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 periods below. 5 I also discuss uncontroverted evidence that showed that other sources, not Teva, influenced doctors’ decisions to prescribe generic carvedilol according to the patented method during both periods.
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 infringement 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. Case: 18-1976 Document: 111 Page: 42 Filed: 10/02/2020 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 infringement of the ’000 patent. See supra § III. Moreover, regardless of what Teva’s skinny label encouraged, 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 carvedilol, 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 evidence of inducement in the record, see J.A. 10960 at ll. 6– 9, the Majority’s conclusion is necessarily based only on circumstantial evidence. During the skinny label period, the Majority generally cites product catalogs and press releases 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 affirmative 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 doctors to practice the patented method. Third, GSK failed to produce any evidence establishing that doctors relied on these materials in making their prescribing decisions. Indeed, 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. Case: 18-1976 Document: 111 Page: 43 Filed: 10/02/2020 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 23 1. Teva’s press releases fail to provide substantial evidence of inducement because they were published before the ’000 patent issued Teva published two releases before the ’000 patent issued. 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., 76 F.3d 1185, 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 releases 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 encourage infringement.” E.g., Takeda, 785 F.3d at 632 n.4; Microsoft Corp. v. DataTern, Inc., 755 F.3d 899, 904 (Fed. Cir. 2014); see also Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 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 inducement 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 infringement” argument was not made to the jury. It therefore Case: 18-1976 Document: 111 Page: 44 Filed: 10/02/2020 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 evidence 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 announced 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 (emphasis 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 practice 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 example, 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 product catalogs likewise said nothing about the product’s indications. 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. Case: 18-1976 Document: 111 Page: 45 Filed: 10/02/2020 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 25 physical description, units of sale, and therapeutic equivalence. See J.A. 6221. The Majority, purportedly “[a]pplying 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 reasonably 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, Ericsson, 773 F.3d at 1219—including the steps that GSK added to secure 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 infringement 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 Majority seems to rely on references to Teva’s “AB rating” or therapeutic equivalence as evidence of inducement. See Maj. 12–16. These statements, however, cannot be legally sufficient to prove inducement. As recognized by the Majority, 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 administering 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 decrease 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. Case: 18-1976 Document: 111 Page: 46 Filed: 10/02/2020 26 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. see J.A. 6256, therapeutic equivalence is a designation provided 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 counsel 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 (noting use of the phrase “AB rating”), 15 (recounting GSK’s expert’s testimony of what an “AB rating” means, and observing 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 generic equivalent of Coreg® . . . .”). Further, Orange Book determinations of therapeutic equivalence are not made for unapproved indications. See GlaxoSmithKline, 313 F. Supp. 3d at 593; 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 labeled” and that “it doesn’t reflect a decision of the therapeutic 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 approved for one indication, respectfully, that is not the law. We expressly rejected this argument in Takeda. See 785 F.3d at 632 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 infringer] took affirmative steps to induce, not affirmative steps to make sure others avoid infringement.” Id.; see also Grokster, 545 U.S. at 918; Microsoft, 755 F.3d at 904. Case: 18-1976 Document: 111 Page: 47 Filed: 10/02/2020 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 27 rating means that [the drug is] therapeutically equivalent as labeled . . . .”). Thus, Teva’s reporting of equivalence information 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 according to the patented method Even if the product catalogs or press releases encouraged 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 making 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 possible.”). If the doctors never even received Teva’s product guides, they cannot be evidence that Teva caused infringement. Power Integrations, 843 F.3d at 1330–31. 9 To be approved as a generic, Teva’s primary re- quirement was to show that its carvedilol product is bioequivalent, 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. Case: 18-1976 Document: 111 Page: 48 Filed: 10/02/2020 28 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. Similarly, with respect to the press releases, no testimony 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 evidence to prove inducement in some cases, this is not one of them. Beyond Teva’s skinny label—which does not encourage 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 patent 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 evidence 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, 496 F.3d 1334, 1345 (Fed. Cir. 2007) (“The rule that a jury verdict is reviewed for support by ‘substantial evidence’ does not mean that the Case: 18-1976 Document: 111 Page: 49 Filed: 10/02/2020 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 29 reviewing court must ignore the evidence that does not support the verdict.”). In particular, the record confirmed that doctors prescribed 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 published 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 Takeda, 785 F.3d at 631 (finding insufficient evidence of induced infringement in part because before the generic’s alleged inducement, the FDA had previously informed healthcare providers to prescribe the drug according to the claimed method). Further still, the record showed that substitution of generic carvedilol for Coreg® often happened without doctor involvement at all. At trial, Dr. McCullough repeatedly testified that when the generics launched, he “didn’t actively 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. Case: 18-1976 Document: 111 Page: 50 Filed: 10/02/2020 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 patented 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 patented method. Specifically, no evidence suggests that doctors 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 Warner-Lambert, 316 F.3d at 1363. 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 Case: 18-1976 Document: 111 Page: 51 Filed: 10/02/2020 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 31 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 doctors 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 references 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 references “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 during 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. See supra § IV(A)(4). 10 The Majority states that “[a]lso in evidence was the 2012 edition of Teva’s Health Systems Pharmacy Drug Reference.” 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 immediately preceding sentence. Case: 18-1976 Document: 111 Page: 52 Filed: 10/02/2020 32 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. 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 carvedilol sales occurred without the doctors’ knowledge at all. See supra § 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 noninfringement during the full label period should therefore be affirmed. Teva did not induce infringement of the ’000 patent during the full label period. And the record does not include legally sufficient evidence to support the jury’s verdict.