Split Federal Circuit Panel Reinstates Jury Verdict of Induced Infringement in Coreg (carvedilol) Case

GlaxoSmithKline v. Teva, No. 18-1976 (Fed. Cir. 2020)

     by Alex Menchaca

In our last post, we reported that Chief Judge Stark of the District of Delaware granted Judgment as a Matter of Law of no induced infringement in a case concerning Coreg® (carvedilol) tablets, wiping away a $200 million jury verdict in favor of GSK and against Teva.

In a precedential decision on October 2nd, a split Federal Circuit panel reversed that judgment, finding that the jury verdict was supported by substantial evidence. Judge Newman, joined by Judge Moore, wrote the majority opinion. Chief Judge Prost dissented.

This note addresses primarily the Federal Circuit's treatment of Teva's "skinny label" as evidence of inducement. Teva sold with a skinny label from September 2007 until April 2011 and with a full label after April 2011. At the end of this note (in case you want to skip the juicy details), we state our hopes for the next steps in this case.

A skinny label alone cannot support a determination of induced infringement. Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364-65 (Fed. Cir. 2003) ("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 question then is what was the additional evidence, as evaluated by the Federal Circuit, that justified a jury verdict of induced infringement. That additional evidence had to show "an affirmative act to encourage infringement with the knowledge that the induced acts constitute patent infringement." Power Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc., 843 F.3d 1315, 1332 (Fed. Cir. 2016)).

The claim at issue included detailed instructions for administering the drug:

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.

According to the claim, there must be daily administering for a period greater than six months. If there is no daily administering, there is no infringement. If there is no six months of administering, there is no infringement. And, if Teva did not undertake an affirmative act to induce those administering claim limitations, there is no induced infringement. Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011) ("we now hold that induced infringement under § 271(b) requires knowledge that the induced acts constitute patent infringement."); Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1219 (Fed. Cir. 2014) ("In order to prove induced infringement, the patentee must show that the alleged infringer performs, or induces another party to perform, every single step in the method.")

So what evidence did the Federal Circuit identify that the jury relied on as an affirmative act by Teva to induce physicians to undertake daily administering for greater than six months? Spoiler – it's really hard to find.

The evidence introduced at trial and referenced by the Federal Circuit is described below with discussion from both the majority and the dissent. There is a lot of discussion for some of the evidence, so we limited our recitation to the best quotes (unless indicated otherwise the below are direct quotes from the opinion):

A general statement by the majority: "Teva’s promotional materials referred to Teva’s carvedilol tablets as AB rated equivalents of the Coreg® tablets."

Majority

  • [GSK's expert], 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.

Dissent

  • [I]n 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."
  • 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.
  • [E]ven 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. ([GSK's doctor expert]agree[d] that not every CHF patient treated with carvedilol infringes the claimed method). 

Teva June 9, 2004 press release describing Teva’s carvedilol as the "AB-rated generic equivalent of GSK's Coreg® tablets."

Majority

  • [GSK's expert] 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."

Dissent

  • [The 2004 press release was] published before the '000 patent issued in 2008 and therefore cannot alone be an act of infringement.
  • [T]he 2004 press release . . . reports only "tentative approval." . . . 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.
  • GSK's counsel acknowledged that "the fact that Teva said they were AB rated isn't enough to prove inducement."

Teva's 2007 press release remained on Teva's website; screenshot bearing the date "4/14/2015" with the caption . . . “Teva Announces Approval and Shipment of Generic Coreg® Tablets”

Majority

  • [GSK's expert] told the jury that [the 2007 press] release "indicates that we should be able to prescribe generic carvedilol for heart failure."
  • [T]he 2007 press release remained on Teva's website throughout the life of the '000 patent [which the Federal Circuit characterized as] continued affirmative promotion of its carvedilol tablet as the AB generic equivalent of Coreg®.

Dissent

  • Teva's short [2007] press release stated that it had been granted "final approval . . . to market . . . Generic . . . Coreg® (Carvedilol) Tablets."
  • [The 2007 press release was] published before the '000 patent issued in 2008 and therefore cannot alone be an act of infringement.
  • [P]assive maintenance of the pre-issuance press releases [on the Teva website] is not an affirmative act of inducement.
  • Teva's press releases . . . do not promote treating CHF at all.

Teva Spring 2008 Product Catalog [listing the AB rating of Teva's carvedilol]

Majority

  • [GSK's expert] 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 interchangeable."
  • GSK [regulatory expert] . . . 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. 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,"

Dissent

  • The product catalogs likewise said nothing about the product’s indications.
  • GSK's counsel acknowledged that "the fact that Teva said they were AB rated isn’t enough to prove inducement."
  • GSK's [regulatory expert] testified that AB rating "is an indication that the product is therapeutically equivalent when used as labeled" and [not] with respect to the off-label uses."

None of the cited evidence supports a finding of an affirmative act by Teva to induce physicians to undertake the administering steps. As the dissent notes, "the Majority seems to rely on references to Teva's 'AB rating' or therapeutic equivalence as evidence of inducement." But that also cannot support induced infringement by Teva, GSK's counsel acknowledged that.

With respect to the full label period, the only additional evidence was the full label and product reference guides. The reference guides stated nothing more than that Teva's generic was "AB Rated and bioequivalent to Coreg® Tablets." The full label included reference to treatment of CHF, but there was no evidence that any doctor even read the full label. Still, it seems to us, not enough.

We think the dissent has the better position. But the dissent overstates the majority's view when it states that the "Majority [holds] that the content of Teva's skinny label can itself establish inducement." The majority did not really say that, generally stating: "[p]recedent has recognized that the content of the product label is evidence of inducement to infringe" (citing cases).

The real problem in the majority opinion is that it conflates its treatment of the skinny label period with that of the full label period. The majority lumps the documentary evidence for both periods into one paragraph (Slip Op. pp. 12-13) and glosses over the language distinctions of the labels (Slip Op. pp. 16-17). Perhaps that is why the dissent understood the majority opinion to "nullif[y] Congress's statutory provision for skinny labels—creating liability for inducement where there should be none."

What would we like to see happen in this case? We would like to see the panel or the en banc Federal Circuit revisit this opinion and clearly break out the skinny label period from the full label period. Everybody involved in the case understood that each period deserved its own treatment; the dissent emphasized that GSK's counsel argued "[n]o label, no inducement." There simply is no evidence to support a finding of induced infringement during the skinny label period. A clear statement to that effect following Supreme Court and Federal Circuit precedent would undo the damage this opinion could do to the rights of ANDA applicants to pursue approval of skinny labels and file Section viii statements rather than paragraph IV certifications.

Regarding the full label period? Based on the evidence detailed in the opinions, we don’t see inducement. But that is what the jury considered and perhaps the Federal Circuit may simply rely on that jury finding.

Split Federal Circuit Panel Reinstates Jury Verdict of Induced Infringement in Coreg (carvedilol) Case