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Inventorship Hosed Clean: Contribution, Corroboration and Collaboration Prove Joint Invention

The US Court of Appeals for the Federal Circuit affirmed a decision to correct inventorship, finding that the alleged joint inventor’s contribution to a claimed invention was significant and adequately corroborated by evidence. Blue Gentian, LLC v. Tristar Products, Inc., Case Nos. 21-2316; -2317 (Fed. Cir. June 9, 2023) (Prost, Chen, Stark, JJ.)

Blue Gentian owns utility and design patents directed to an expandable hose. Prior to filing the first patent application, Michael Berardi (the sole inventor of the asserted patents and Blue Gentian’s principal) met with non-party Gary Ragner to discuss investing in Ragner’s expandable hose. Berardi had no experience designing hoses at the time of the meeting. Berardi testified that he came up with the idea of his hose after watching a demonstration video of Ragner’s hose but before the meeting. At the meeting, Ragner disclosed a prototype and documents relating to his hose and discussed the inner components of the hose. Berardi built his first prototype a day after the meeting and filed his first patent application three months later. Blue Gentian subsequently filed suit against Tristar for infringement of its expandable hose patents. Tristar counterclaimed to correct inventorship of the patents, alleging that Ragner should have been named a co-inventor.

A court may order a correction of inventorship when it determines that an inventor has been erroneously omitted from a patent. The inventors listed on an issued patent, however, are presumed to be the only true inventors. Thus, a party must prove incorrect inventorship by clear and convincing evidence. An alleged joint inventor’s testimony standing alone is insufficient to establish inventorship by clear and convincing evidence; the testimony must be corroborated by evidence. A joint inventor must contribute significantly to the invention’s conception or reduction to practice, and the contribution must involve some collaboration with the other inventor.

The district court, after an evidentiary hearing, entered judgment on the inventorship counterclaim in Tristar’s favor and ordered correction of the patents under 35 U.S.C. § 256. Blue Gentian appealed.

The Federal Circuit found that Ragner conveyed three key elements of the hose to Berardi at the meeting and that these elements were a significant contribution to the conception of at least one claim of each asserted patent. The Court noted that these were the very elements Blue Gentian used to distinguish the invention from the prior art, establishing the element’s significance. The Court also found that Ragner’s testimony about conveying the three elements to Berardi at the meeting was adequately corroborated by both physical and circumstantial evidence. The evidence showed the similarity between Ragner’s disclosed prototype and Berardi’s first prototype, and documentary evidence showed Ragner’s familiarity with the three elements before the meeting. Finally, the Court found sufficient collaboration between Berardi and Ragner based on the information exchanged at the meeting, including Ragner’s prototype, confidential documents and verbal explanations about alternative hose designs.

The Federal Circuit dismissed Blue Gentian’s argument that claim construction was needed before analyzing Ragner’s contribution because Blue Gentian did not identify a dispute [...]

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The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

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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Fifth Circuit Says No Preliminary Injunction in Boozy Beverage Trademark Fight

The maker of BRIZZY-brand hard seltzer claimed that consumers would confuse a product branded VIZZY hard seltzer with its own. The United States Court of Appeals for the Fifth Circuit disagreed, however, and affirmed the district court’s denial of the preliminary injunction with an explanation as to how the plaintiff failed to demonstrate a substantial likelihood of success on the merits with respect to its trademark infringement claim. Future Proof Brands, L.L.C., v. Molson Coors Beverage Company, et. al., Case No. 20-50323 (5th Cir. December 3, 2020) (Smith, J.).

With a booming market for hard seltzers and ready-to-drink cocktails, it is no surprise that disputes over brand names of the bubbly alcoholic beverages have followed. After the district court denied Proof Brands’ request for a preliminary injunction against Molson Coors’ entry into that market, Proof Brands appealed. The Fifth Circuit issued a reminder that a preliminary injunction is “an extraordinary remedy which should not be granted unless the party seeking it has clearly carried [its] burden of persuasion,” and reviewed the district court’s denial of Future Proof’s request for an abuse of discretion. The Court further noted that under Planned Parenthood Ass’n of Hidalgo Cnty. v. Suehs, Future Proof must demonstrate four factors to obtain a preliminary injunction, namely: (1) a substantial likelihood of success on the merits, (2) a substantial threat of irreparable injury if the injunction is not granted, (3) that the substantial injury outweighs the threatened harm to the party sought to be enjoined and (4) that granting the preliminary injunction would not disserve the public interest. Concluding that Future Proof was unable to demonstrate a substantial likelihood of success on the merits of its trademark infringement claim, the court did not address the remaining three preliminary injunction factors.

Future Proof argued that in the course of determining whether there was a likelihood of confusion between the BRIZZY and VIZZY trademarks, the district court erred in analyzing the various factors, or “digits,” of consumer confusion used by the Fifth Circuit. The Court tackled each of the “digits” assessing the likelihood of consumer confusion, noting that even with “some errors,” the district court correctly concluded that Future Proof failed to show a substantial likelihood of success on its trademark infringement claim.

Starting with the type or strength of the trademark allegedly infringed factor, the Fifth Circuit disagreed somewhat with the district court and found the BRIZZY mark to be suggestive, rather than merely descriptive of “fizzy” beverages. Nevertheless, the Court noted that suggestive marks—like descriptive marks— are “comparatively weak” for purposes of a confusion analysis, and cited a number of third-party carbonated beverage brands sharing the common “-IZZY-” root to affirm its agreement with the district court that BRIZZY is a weak trademark. With a “weak” mark at issue, the Court found the similarity factor to weigh only marginally in favor of the injunction, especially given key differences between the product packaging and labels for the respective BRIZZY and VIZZY beverages.

Moving on to the defendant’s intent factor, [...]

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

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

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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