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Exploring the Latest in Intellectual Property Law
Inducement
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Is Pleading “Generic” Enough to Plead Inducement?

by | Jul 11, 2024 |

The US Court of Appeals for the Federal Circuit held that a branded pharmaceutical manufacturer properly pled a theory of inducement by alleging that the generic competitor promoted its product as “generic” to the branded product and referred to the branded product’s sales for patented uses. Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., Case No. 23-1169 (Fed. Cir. June 25, 2024) (Moore, Lourie, Albright, JJ.)

Amarin Pharmaceuticals sells the drug Vascepa, which the US Food and Drug Administration (FDA) approved for two uses:

  1. To treat severe hypertriglyceridemia.
  2. As an adjunct therapy to reduce certain cardiovascular risks.

In 2016, Hikma submitted an abbreviated new drug application (ANDA) to market a generic version of Vascepa, which at the time was only approved for treatment of severe hypertriglyceridemia. Hikma and Amarin then litigated patents covering Vascepa under the Hatch-Waxman Act, with Hikma invalidating the patent claims covering the severe hypertriglyceridemia indication. After Amarin obtained approval for its second indication, Hikma submitted to the FDA a “section viii carve out” (i.e., prescribing information that purposedly did not include the second indication). The FDA approved Hikma’s product, which was sold with a “skinny label.” After Hikma’s ANDA was approved, Hikma issued a series of press releases that referred to its product as a “generic” version of Vascepa, even though the product was not approved for the cardiovascular risk indication. The press releases also referred to Vascepa’s annual sales as approximately $1.1 billion – the amount of Vascepa scales for all uses – as well as its usage information.

Amarin sued Hikma again for patent infringement, this time claiming that Hikma induced infringement of patents covering the cardiovascular risk indication. The district court overruled the magistrate judge’s recommendation and concluded that Amarin’s complaint did not plead a plausible case of induced infringement. Amarin appealed.

The Federal Circuit reversed. First, it explained its view that the case was a “run-of-the-mill” inducement infringement case, rather than one governed by the Hatch-Waxman Act framework. Emphasizing the deferential plausibility standard applicable at the pleadings stage, the Court held that, combined with allegations that Hikma’s label included warnings that would promote infringement, Amarin’s averments about Hikma’s press releases were sufficient at this stage to plausibly claim that Hikma induced infringement of the cardiovascular risk limitation by its references to the branded product.

The Federal Circuit also rejected Hikma’s claim that a ruling in Amarin’s favor would “effectively eviscerate section viii carve-outs.” The Court explained that its ruling was an ordinary application of induced infringement that promotes scrutiny of generic companies’ communications for clarity and consistency.

Practice Note: This case continues the trend of inducement cases that has received renewed interest after GlaxoSmithKline v. Teva Pharmaceuticals. Branded pharmaceutical manufacturers may be emboldened to sue after launch based on theories of inducement where section viii carveouts were employed.



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Terms of Degree Not Always Indefinite

by | Apr 21, 2022 |

The US Court of Appeals for the Federal Circuit overturned a district court determination that the claim terms “resilient” and “pliable” were indefinite. The Federal Circuit found that the claims, while broad, were sufficiently definite in view of both intrinsic and extrinsic evidence. The Federal Circuit also upheld the district court’s findings of no induced infringement, finding zero evidence of predicate direct infringement of the properly construed method claims. Niazi Licensing Corp. v. St. Jude Medical S.C., Inc., Case No. 21-1864 (Fed. Cir. Apr. 11, 2022) (Taranto, Bryson, Stoll, JJ.) The Federal Circuit also affirmed entry of sanctions excluding portions of the plaintiff’s technical and damages expert reports for failing to disclose predicate facts during discovery and also affirmed exclusion of portions of plaintiff’s damages expert report as unreliable for being conclusory and legally insufficient.

In reaching its decision on indefiniteness, the Federal Circuit focused on the terms “resilient” and “pliable” as used in a claim directed to a double catheter structure. Citing the 2014 Supreme Court decision in Nautilus v. Biosig Instruments, the Federal Circuit explained that language has “inherent limitations,” and stated that a “delicate balance” must be struck to provide “clear notice of what is claimed” and avoid the “zone of uncertainty” relating to infringement. The Court noted that under Nautilus, claims must provide “objective boundaries,” but the Court distinguished the present case from those in which “subjective boundaries” created uncertainty and rendered the claim indefinite. The Court pointed to its 2005 decision in Datamize v. Plumtree Software as a “classic example” of subjectivity where the term “aesthetically pleasing” was deemed indefinite because the patent provided no way to provide “some standard for measuring the scope of the phrase.” The Court also noted that a patent’s claims, written description and prosecution history—along with any relevant extrinsic evidence—can provide or help identify the necessary objective boundaries for claim scope

The Federal Circuit concluded that there was sufficient support in the intrinsic evidence, both in the claims themselves and the written description, to allow a skilled artisan to determine the scope of the claims with reasonable certainty. The Court explained that the claim at issue recited “an outer, resilient catheter having shape memory” that “itself provides guidance on what this term means—the outer catheter must have ‘shape memory,’ and ‘sufficient stiffness.’” The Court also cited to “[n]umerous dependent claims [that] further inform the meaning of this term by providing exemplary resilient materials of which the outer catheter could be made. . . . The written description provides similar guidance . . . . Thus, a person of ordinary skill reading the claims and written description would know of exemplary materials that can be used to make a resilient outer catheter, i.e., one that has shape memory and stiffness such that it can return to its original shape.”

The Federal Circuit distinguished this case from Datamize, where the claim scope depended on the eye of each observer, finding it more akin to its 2017 decision in Sonix Technologies. In that [...]

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The Skinny Label That Wasn’t—Federal Circuit Reinstates Induced Infringement Verdict

by | Aug 12, 2021 |

The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by an attempted “skinny label” that nonetheless encouraged doctors to engage in a patented use. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Case Nos. 18-1876, -2023 (Fed. Cir. Aug. 5, 2021) (Moore, C.J.) (Prost, J., dissenting).

GlaxoSmithKline LLC (GSK) sells a drug called carvedilol (brand name Coreg®), which is approved for three indications: Hypertension, congestive heart failure (CHF) and left ventricular dysfunction following a myocardial infarction (post-MI LVD). In 2002, Teva filed an abbreviated new drug application (ANDA) for US Food and Drug Administration (FDA) approval of its generic carvedilol for all three indications. At that time, GSK’s patent on the carvedilol compound was still in force; Teva certified that it would not launch its product until the patent expired in 2007. GSK also had a second patent on a method of treating CHF using carvedilol and a second agent. In 2002, Teva sent GSK a Paragraph IV notice contending that the claims of that patent were invalid over prior art. Rather than sue Teva, GSK applied for reissue of the patent. In 2004, Teva received FDA “tentative approval” for its ANDA “for the treatment of heart failure and hypertension,” which was to become effective at the expiry of the compound patent in 2007.

In January 2008, the method-of-use patent reissued with claims directed to a method of decreasing mortality caused by CHF by administering carvedilol with at least one other therapeutic agent. Just before its launch in 2007, Teva certified to the FDA that its label would not include the indication listed in the Orange Book as covered by the original method-of-use patent (i.e., “decreasing mortality caused by congestive heart failure”), and thus included only the hypertension and post-MI LVD indications. Teva’s press releases stated that its generic carvedilol was “indicated for treatment of heart failure and hypertension.” In 2011, the FDA asked Teva to revise its labeling to be identical with GSK’s. Teva obliged (listing again the CHF indication) and took the position that it did not need to provide certification for the reissued patent because it received final approval of its ANDA before the patent reissued. GSK sued.

GSK won a jury verdict that the challenged patents had not been shown to be invalid and that Teva was liable for induced infringement. At trial, GSK contended—and the jury heard evidence—that post-MI LVD is a form (and fell within the Court’s construction) of CHF such that Teva’s attempted skinny label nonetheless encouraged doctors to engage in a patented use. After trial, however, the district court granted JMOL of non-infringement because the CHF and post-MI LVD indications were different. On appeal, the Federal Circuit found that substantial evidence supported the implied jury, finding that post-MI LVD is a form of CHF such that the label with the post-MI LVD indication induced infringement of the reissued [...]

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The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

by | Feb 25, 2021 |

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., Case no.18-1876 (Fed. Cir. Feb. 9, 2021) PER CURIAM. The case concerns communications regarding generic approvals and “skinny labels,” which permit companies to sell pharmaceutical products that omit certain patented uses.

On Oct. 2, 2020, a panel of the Federal Circuit (PROST, C.J ., NEWMAN and MOORE, JJ.) issued an opinion finding that Teva induced infringement of a patent covering GlaxoSmithKline’s (GSK’s) drug Coreg® (carvedilol). In a per curiam Order, the Court has now vacated that opinion and set a new round of oral arguments that was held on February 23.

Teva had requested an en banc rehearing the case, which was denied in the Order vacating the Oct. 2, 2020 opinion while ordering panel rehearing limited to the following issue:

Whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011.

Background

GSK’s patent covers a method of using carvedilol, the active ingredient in Coreg®, for the treatment of congestive heart failure. In 2007, the FDA approved Teva’s application to market generic carvedilol tablets. To obtain that approval prior to the expiration of the patent (or prevailing on noninfringement, invalidity, or unenforceability of the patent in litigation), Teva had “carved out” certain patent-protected left ventricular dysfunction uses and only included claims to treat hypertension, i.e., claims not covered by the GSK patent. That original patent expired in 2007, but it was reissued in 2008.

Teva had deliberately omitted congestive heart failure in its label until the FDA made it add that indication in 2011. In accordance with the Order, the February 23 oral argument focued on alleged infringement in the period before the label change, i.e., the period 2008 and 2011. The outcome is expected to turn on associated activities and statements made by Teva that went beyond the approval of the generic drug with skinny labeling, where Teva did not explicitly claim that their product was for the patent-protected uses.



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Too Good to Be True? Federal Circuit Demands Evidence of Reliance on Favorable Ruling, Stipulation

by | Nov 4, 2020 |

The US Court of Appeals for the Federal Circuit held that notwithstanding a stipulation on claim construction, a party may still induce infringement absent proof that it actually relied on the stipulation, and that mere inaction, absent an affirmative act to encourage infringement, cannot be the basis for a claim of inducement. The Federal Circuit also affirmed the district court’s reduction of the jury’s damages award to $0 despite a finding of direct infringement because the plaintiff failed to prove damages. TecSec, Inc. v. Adobe Inc., Case Nos. 19-2192, -2258 (Fed. Cir. Oct. 23, 2020) (Taranto, J.).

TecSec owns several patents on systems and methods for multi-level security for network-distributed files. TecSec sued Adobe (among other defendants) in this now-10-year-old-case, which the Federal Circuit has considered several times. As relevant here, the district court entered a claim construction in 2011 that led to a stipulation of non-infringement, and the Federal Circuit reversed that claim construction in 2013. On remand, the district court barred TecSec from introducing evidence of inducement in the 2011–2013 period on the grounds that it was reasonable for Adobe to have relied on the district court’s ruling and the stipulation. On the new claim construction, Adobe stipulated to one act of direct infringement. Adobe also moved for summary judgment of patent ineligibility, which the district court denied, stating that its rationale supported judgment for TecSec that the patents claimed eligible subject matter. At trial, the jury found that the claims were valid and that Adobe directly infringed but did not induce infringement. The jury awarded TecSec $1.75 million in damages. On Adobe’s post-trial motion, the district court reduced the damages award to $0 because TecSec had not proved inducement and had proved no damages associated with the single act of direct infringement. Both parties appealed.

Inducement

The Federal Circuit reversed the district court’s decision on Adobe’s motion in limine barring inducement evidence for the 2011–2013 period. The district court’s primary rationale for granting the motion had been the reasonableness of Adobe’s reliance on the claim construction order and stipulation of non-infringement. However, the Federal Circuit reasoned that the intent prong of inducement is a subjective inquiry, and that inducement could still be found upon a showing that Adobe subjectively believed that the claim construction order was wrong and would subsequently be reversed.

Jury Instructions

The Federal Circuit next addressed two challenges by TecSec to jury instructions. The first instruction was predicated on three facts: (i) that Adobe had admitted that a certain sequence of steps constituted direct infringement, (ii) that Adobe had performed the steps on at least one occasion, and (iii) that “the parties agree that the one time for which Adobe had admitted infringement . . . occurred before TecSec filed its lawsuit.” The Court found that this instruction was factually accurate and therefore not erroneous. The second instruction explained that inducement required “an affirmative act to encourage infringement,” and that “[e]vidence of mere inaction, or a failure to stop or prevent infringement, does not [...]

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Federal Circuit Restores Induced Infringement Verdict Against Teva

by | Oct 15, 2020 |

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of Appeals for the Federal Circuit held that circumstantial evidence of inducement was sufficient. The Court relied on evidence that defendant stated its drug was a “complete replacement” for plaintiff’s drug covered by the asserted patent. GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Newman, J.) (Prost, C.J., dissenting). The Court reinstated a jury verdict against Teva Pharmaceuticals, ordering it to pay GlaxoSmithKline (GSK) $235 million.

GSK brought suit against Teva in 2014 in response to Teva’s attempt to market a generic form of carvedilol, developed and marketed by GSK under the brand name Coreg®. Coreg® was US Food and Drug Administration (FDA) approved for three separate indications: hypertension, congestive heart failure (CHF), and left ventricular dysfunction following a myocardial infarction (post-MI LVD). After March 2007, however, no GSK Orange-Book-listed patent covered the hypertension or post-MI LVD indications. A reissue patent that issued in January 2008 remained in force for CHF.

In 2002, Teva filed an abbreviated new drug application (ANDA) with the FDA. Before Teva’s carvedilol product was finally approved in September 2007, Teva amended its ANDA and proposed label to “carve out” the CHF indication according to 21 USC § 355(j)(2)(A)(viii)—often referred to as a “section viii carve-out.” Thus, Teva’s carvedilol “skinny label” was only indicated for hypertension and post-MI LVD, neither of which was, at that time, covered by any GSK patent.

After a trial, the jury found that Teva had willfully induced infringement of GSK’s patent and awarded GSK $235 million in damages. The district court then granted Teva’s motion for judgment as a matter of law, concluding that the inducement verdict was not supported by substantial evidence. GSK, the district court reasoned, had failed to prove by a preponderance of the evidence that Teva’s alleged inducement (as opposed to other factors) had actually caused even at least one physician to prescribe generic carvedilol for CHF. GSK appealed.

On appeal, the Federal Circuit overturned the grant of judgment as a matter of law, reasoning that the “intent element” of inducement may be proven through circumstantial evidence. The Court noted that the jury had received evidence of, e.g., “Teva’s promotional materials [referring] to Teva’s carvedilol tablets as AB rated equivalents of the Coreg® tablets,” press releases identifying Teva’s product as “Generic Coreg® Tablets,” Teva’s Monthly Prescribing References, and testimony from GSK’s cardiologist witness that physicians are “completely reliant” on information provided by the generic companies. The majority concluded that this was “ample record evidence . . . to support the jury verdict of inducement.”

Chief Circuit Judge Prost authored a lengthy dissent warning of the broad implications of the majority’s ruling, including contravening the congressional design and intent of the generic approval system, and potentially stifling innovation by giving rise to [...]

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