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A Clear Need: To Allege Misappropriation, Identify Trade Secret

by Jodi Benassi | Oct 29, 2020 | Trade Secrets

The US Court of Appeals for the Ninth Circuit reversed a district court’s grant of summary judgment, finding that the plaintiff had sufficiently pled trade secret misappropriation by identifying its trade secrets and how they were protected with sufficient particularity. InteliClear, LLC v. ETC Global Holdings, Inc., Case No. 19-55862 (9th Cir. Oct. 15, 2020) (Gould, J.).

In 2004, InteliClear began development on a comprehensive electronic system for managing stock brokerage firm accounting, securities clearance and securities settlement services using a Structured Query Language relational database designed to handle millions of trades each business day. It named the program the “InteliClear System.”

In 2008, ETC’s predecessor signed a software license agreement with InteliClear and obtained a license for the InteliClear System. The license agreement acknowledged that all information InteliClear provided was confidential, proprietary and copyrighted, and ETC agreed to maintain that information in confidence “during and after” the terms of the agreement.

In 2017, InteliClear sent ETC a notice terminating the license agreement. ETC committed to remove the InteliClear database from its systems by February 26, 2018. On March 5, 2018, ETC certified that the InteliClear System had been removed from all ETC servers and that all copies had been destroyed. But, before the license agreement ended, ETC had already begun building its own securities clearance software. Around the same time that InteliClear terminated the license agreement, ETC launched its own electronic trading system. InteliClear immediately contacted ETC about its suspicion that ETC had improperly used the InteliClear System to build its own system, and, after months of negotiations, ETC agreed to allow a computer forensics company to compare the two systems and investigate. The forensics company found an abundance of evidence that the elements of each system were identical.

InteliClear sued ETC for trade secret misappropriation under federal and state law and for unfair competition. The district court dismissed the claim for unfair competition, reasoning that it was preempted by the California Uniform Trade Secrets Act. One day into discovery, and before any discovery had been requested or provided, ETC moved for summary judgment, asserting that InteliClear failed to identify its trade secrets with sufficient particularity and that InteliClear did not show that the InteliClear System was a trade secret or that ETC had access to InteliClear’s source code. The district court granted ETC’s motion and denied InteliClear’s motion to defer ruling until after completion of discovery under Rule 56(d). InteliClear appealed.

The Ninth Circuit analyzed the federal and state trade secret misappropriation claims together because the elements were substantially similar. The Court noted that to succeed on a claim for misappropriation, a plaintiff must prove (1) that the plaintiff possessed trade secrets, (2) that the defendant misappropriated the trade secrets, and (3) that the misappropriation caused or threatened damage to the plaintiff. To prove the first element, “a plaintiff must identify the trade secrets and carry the burden of showing they exist.” The Court pointed out that it is important to identify trade secrets with sufficient particularity because [...]

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Cookie Trade Dress Infringement Case Crumbles in Face of Functionality Challenge

by Eleanor B. Atkins | Oct 29, 2020 | Trademarks

The US Court of Appeals for the Third Circuit found that trade dress protection did not extend to the design of a chocolate-dipped, stick-shaped cookie, because the product configuration was useful. Ezaki Glico Kabushiki Kaisha v. Lotte Int’l America Corp., Case No. 19-3010 (3d Cir. Oct. 8, 2020) (Bibas, J.).

Ezaki Glico is a Japanese confectionary company that makes and sells the snack food Pocky, which is a thin, stick-shaped cookie with one side dipped in chocolate (or a flavored cream) and the other uncoated. Pocky cookies have been sold in the United States for more than 40 years, during which time Ezaki Glico obtained two trade dress registrations for the Pocky design and a patent for a “Stick Shaped Snack and Method for Producing the Same.”

In 2015, Ezaki Glico sued its competitor, Lotte, alleging that Lotte’s similarly designed cookie, Pepero, infringed the Pocky trade dress. The district court granted Lotte’s motion for summary judgment, finding the Pocky product configuration functional and therefore not protected by trade dress. Ezaki Glico appealed.

Ezaki Glico argued that the Pocky trade dress is not functional because it is not essential to its design. The Third Circuit disagreed, stating “that test is too narrow.” The Court explained that functionality applies to features that are useful, even if they are not necessarily essential. The Court enumerated four indicators of functionality:

Evidence that the feature or design makes the relevant product work better
Examples of marketing materials touting the usefulness of the feature or design
Existence of a utility patent
Availability of other designs.

The Third Circuit found that most of these factors supported the finding of functionality. First, the design makes the product work better because “[e]very feature of Pocky’s registration relates to the practical functions of holding, eating, sharing, or packing the snack.” Ezaki Glico’s advertisements also promoted the functional features of Pocky’s design: they featured phrases such as “convenient design,” “the no mess handle of the Pocky Stick,” and “easier for multi-tasking without getting chocolate on your hand.” Likewise, the Court was unpersuaded by Ezaki Glico’s evidence of alternative designs, finding that “[e]very aspect of Pocky is useful. The nine other designs do not make it less so.”

The existence of the utility patent, however, was not a supporting factor in the functionality analysis. The Third Circuit explained that “the patent’s innovation is a better method for making the snack’s stick shape. The method is useful for making the shape whether or not the shape itself is useful for anything.” Although the district court improperly considered this factor in its analysis, the Third Circuit noted that the misstep was “immaterial” given that the district court ultimately reached the correct conclusion.

Practice Note: It is not necessary for a design feature to be essential for it to be considered functional. Trade dress may be considered functional—and therefore not protectable via trademark law—if it is merely useful to the design.

PTO Seeks Comments on Proposed Rulemaking for Denying Patent Reviews

by McDermott Will & Emery | Oct 29, 2020 | America Invents Act, Patents

The US Patent and Trademark Office (PTO) requested public comments on considerations for instituting trials under the Leahy-Smith America Invents Act (AIA). Comments are due by November 19, 2020.

Patent practitioners have grown accustomed to reviewing the PTO Patent Trial and Appeal Board (Board) administrative guide, precedential or informative opinions, and other published filings and decisions to discern best practices for filing petitions for and defending against inter partes review, post-grant review, covered business method and derivation proceedings before the Board. For example, the latest Board Consolidated Trial Practice Guide (Nov. 2019) (CTPG) is available here. The PTO is considering codifying or modifying its current policies and practices through formal rulemaking and wishes to gather public comments on its current approach and other approaches suggested by stakeholders.

PTO policies and Board decisions such as General Plastic, Valve Corp. I, Valve Corp. II, NHK Spring and Fintiv set forth factors for analyzing whether to institute an AIA proceeding (and particularly a follow-on or serial petition) or issue a discretionary denial due to the timeline for parallel district court proceedings. Many of these policies and cases are also discussed in the CTPG. The PTO already has received input from stakeholders on these policies that expand on the PTO director’s discretionary authority to institute an AIA trial. Most stakeholder comments suggested that the case-specific analysis outlined in precedential opinions and the CTPG achieves the appropriate balance and reduces gamesmanship—for example, by ensuring that AIA proceedings do not create excessive costs and uncertainty for the patent owner or the system, while allowing meritorious challenges to patents to be heard. However, some stakeholders have proposed that the PTO adopt brightline rules, regardless of the case-specific circumstances, to:

Use its discretion to preclude claims from being subject to more than one AIA proceeding
Permit more than one AIA proceeding only if the follow-on petitioner is unrelated to the prior petitioner
Place no limits on the number of petitions that can be filed or the number of AIA trials that can be instituted against the claims of a patent, so long as the petition complies with statutory timing requirements and the institution threshold of showing that at least one claim of the patent is unpatentable
Preclude institution of an AIA trial against challenged claims if the patent owner opposes institution and a related district court or US International Trade Commission (ITC) action (in which any of the challenged claims are or have been asserted against the petitioner, the petitioner’s real-party-in-interest or a privy of the petitioner) is unlikely to be stayed
Eliminate any consideration of the status of any district court or ITC actions involving the challenged patent, so long as the petition complies with statutory timing requirements and the institution threshold.

These contrasting views prompted the PTO to issue a request for comments on the factors that should be considered as part of a balanced assessment of the relevant circumstances when exercising its discretion to institute an AIA trial. The PTO [...]

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Only Human: Broadest Reasonable Interpretation Standard Applies to Intentionally Expired Patent

by Paul Devinsky | Oct 22, 2020 | Life Sciences, Patents

Affirming an invalidity finding by the Patent and Trial Appeal Board (PTAB), the US Court of Appeals for the Federal Circuit found that the claims of the now-expired patent should be construed under the broadest reasonable interpretation (BRI) standard, and not under the Phillips standard, because the patent owner intentionally gave up the remainder of the patent term only after the appeal was fully briefed. Immunex Corp. v. Sanofi-Aventis U.S. LLC, Case Nos. 19-1749, -1777 (Fed. Cir. Oct. 13, 2020) (Prost, C.J.).

Immunex owns a patent directed to human antibodies that inhabit certain receptors to treat inflammatory diseases such as arthritis. After being sued for infringement, Sanofi and Regeneron (collectively, Sanofi) requested inter partes review (IPR) of the patent, which the PTAB instituted. Based on the IPR filing date and because the patent was unexpired during the pendency of the IPR proceeding, the PTAB used the BRI standard to construe various claim terms. Had the patent been expired, the PTAB would have used the more stringent Phillips standard to construe the claims. Ultimately, the PTAB found all of the challenged claims unpatentable. Immunex appealed.

After appellate briefing was complete, Immunex filed a terminal disclaimer of its patent. The US Patent and Trademark Office accepted the terminal disclaimer, and as a result the patent term expired approximately two months before oral argument. Immunex then filed a citation of supplemental authority informing the Federal Circuit of the terminal disclaimer and asking the Court to change the applicable claim construction standard from BRI to Phillips.

The Federal Circuit found that the application of the BRI standard to Immunex’s patent was appropriate. Although the PTAB currently applies the Phillips claim construction standard in all newly filed IPRs, at the time that Sanofi filed its IPRs, the PTAB applied the Phillips standard only to expired patents. For unexpired patents, it applied the BRI standard. The Court noted that the use of the Phillips standard in cases where the patent expired during the appellate process should not be an absolute, particularly when the patent term expired at an unexpected early date, such as through the filing of a terminal disclaimer.

The Federal Circuit further affirmed the PTAB’s claim construction under the BRI standard and the invalidity finding predicated on that claim construction. The issue on appeal was whether a “human antibody” must be entirely human (as asserted by Immunex) or whether it may also be “partially human,” including “humanized” (as asserted by Sanofi and construed by the PTAB). The Court agreed with the PTAB and found that the patent’s specification supported the conclusion that the BRI of “human antibody” “includes both fully human and partially human antibodies.” The Court also found that “human antibodies” in the context of the patent-in-suit is a broad category that encompasses both partially and completely human antibodies. The Court therefore affirmed the PTAB’s finding.

The Federal Circuit also commented on the PTAB’s departure from an earlier claim construction ruling by a district court in which “human” was construed to mean “fully [...]

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Inventor Uses Abstention to Avoid Getting “Screwed”

by Jodi Benassi | Oct 22, 2020 | Patents

The US Court of Appeals for the Federal Circuit affirmed the dismissal of a declaratory judgment complaint related to patent validity under the federal abstention doctrine because the issue had been decided in state court. Warsaw Orthopedic, Medtronic Inc., et al. v. Rick C. Sasso, M.D., Case No. 19-1583 (Fed. Cir. Oct. 14, 2020) (Newman, J.).

Warsaw Orthopedic and Medtronic (collectively, Medtronic) filed a declaratory judgment complaint against Sasso, a surgeon and inventor. The district court dismissed the complaint, without prejudice, under the doctrine of federal court “abstention” because of a concurrent lawsuit in state court between the same parties and concerning the same dispute. As described by the respective plaintiffs, the state court case is “a contract case for payment of patent rights,” and the federal case is “a patent case in which payment requires valid patents.”

In 1999, Medtronic and Sasso entered into an agreement that provided for quarterly royalty payments based on Medtronic’s sales of medical devices using Sasso’s inventions related to screw delivery systems and methods. The agreement does not terminate until “the last to expire of the patents included in Intellectual Property Rights, or if no patent application(s) issue into a patent having valid claim coverage of the Medical Device, then seven (7) years from the Date of First Sale of the Medical Device.” Two patents issued for the invention at issue, and Medtronic made royalty payments from 2002 to 2018.

In 2014, Sasso filed a lawsuit in Indiana state court for breach of contract and damages because Medtronic was not paying royalties on all relevant devices. Medtronic argued that Sasso was seeking royalties for products not covered by a valid patent claim. The district court granted Sasso’s motion for summary judgment on the term of the agreement and on patent validity as a defense to payment, stating that the monies to be paid under the agreement depend on the issuance of the patents and their expiration—not their validity. At trial, the jury found that Medtronic had breached the agreement and awarded damages. Medtronic filed an appeal to the Indiana Court of Appeals.

Medtronic also filed a declaratory judgment action in Indiana district court. Medtronic alleged that no valid claim of the patents covered the Medtronic products for which Sasso sought royalties. The district court dismissed the action without prejudice, stating that the state court had already entered judgment in favor of Sasso and no order from the district court could undo that judgment—only the Indiana Court of Appeals and the Indiana Supreme Court have authority to review that judgment.

Medtronic appealed to the Federal Circuit, asserting that the district court’s “abstention” was an abuse of discretion. Medtronic argued that because the agreement required valid claim coverage, and patent validity is within exclusive federal jurisdiction, the district court had an obligation to receive and resolve the dispute.

The Federal Circuit found that the district court had reasonably relied on the Supreme Court’s Wilton/Brillhart abstention doctrine (1995), which provides support for district courts to dismiss or [...]

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Define Frustration: Appealing from Decision in Suit Against Co-Owner’s Wholly Owned Subsidiary with Major Issues Still Undecided

by Thomas DaMario | Oct 22, 2020 | Patents

The US Court of Appeals for the Federal Circuit vacated a grant of summary judgment of non-infringement and remanded for resolution of numerous factual issues in a case addressing “extremely frustrating” issues involving the litigant’s failure to differentiate statutory prerequisites for bringing suit under 35 USC §262 and Article III standing, waiver of a co-owner’s right to refuse to join a patent enforcement action, and the existence of an express or implied license. AntennaSys, Inc. v. AQYR Techs., Inc., Case No. 19-2244 (Fed. Cir. Oct. 7, 2020) (O’Malley, J.).

AntennaSys and Windmill International are co-owners of the patent in suit. AntennaSys and Windmill entered into a license agreement pursuant to which Windmill acquired an exclusive license to AntennaSys’s one-half interest in the patent in two separate markets. In exchange, AntennaSys was entitled to a royalty of 3% of gross sales. Windmill was also required to create a wholly owned LLC, GBS Positioner, which would own both the license interest and Windmill’s ownership interest in the patent. In the event that Windmill failed to meet the minimum sales targets, the exclusive license became non-exclusive and either party was granted the right to commence a lawsuit against “third party” infringers.

Windmill did not meet its sales targets. AntennaSys subsequently brought suit against AQYR Technologies, a wholly owned subsidiary of Windmill, for patent infringement and several state-law claims. The suit named Windmill as a co-defendant. Following claim construction, AntennaSys conceded that it could not prevail on its patent infringement claim under the court’s construction of one of the claim terms. In an apparent attempt to moot the affirmative defenses of invalidity and unenforceability, AntennaSys sought summary judgment of non-infringement, which the district court granted. Additionally, after a hearing where AntennaSys admitted that its state law claims were dependent on the success of its patent infringement claim, the court entered judgment in favor of defendants on the state law claims. AntennaSys appealed.

AntennaSys challenged the district court’s claim construction. Windmill and AQYR countered that the Federal Circuit need not reach the merits because AntennaSys “lacks standing” to bring an infringement action in federal court absent joining co-owner Windmill as a co-plaintiff.

The Federal Circuit agreed that the need to join Windmill as a co-plaintiff was a threshold question, but stressed that the issue did not affect AntennaSys’s Article III standing. Instead the issue stemmed from AntennaSys’s ability to satisfy the statutory prerequisites for bringing an infringement action. Under 35 USC § 262, each joint owner of a patent may make, use, offer to sell, or sell the patented invention without the consent of, and without accounting to, the other owners. Furthermore, in order to bring an action for infringement, all co-owners must be joined as plaintiffs. The Court acknowledged two exceptions to this rule: (1) when any patent owner has granted an exclusive license, and (2) when a co-owner waives its right to refuse to join an infringement action.

As the license in this case had morphed into non-exclusive status, the question became whether [...]

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Significant Third-Party Discovery Too Complex for ITC Early Disposition Program

by Jay Reiziss and Paul Devinsky | Oct 22, 2020 | Patents, Technology

The US International Trade Commission (ITC) denied a proposed respondent’s request to use the early disposition program to determine whether a complainant met the domestic industry requirement in a Section 337 investigation. The ITC concluded that the issues proposed for resolution were too complex to be decided within 100 days of institution because significant third-party discovery was likely necessary. Certain Video Processing Devices, Components Thereof, and Digital Smart Televisions Containing Same, Comm’n Order, USITC Inv. No. 337-TA-1222 (Oct. 14, 2020).

The early disposition program aims to limit unnecessary litigation and save time and resources for litigants and the ITC by resolving obvious and fatal deficiencies in a complainant’s case before the parties embark on a full Section 337 investigation. The program provides for an initial determination by the presiding administrative law judge within 100 days of institution on potentially dispositive issues. The administrative law judge may hold expedited hearings and stay discovery of any other issues during the pendency of the 100-day proceeding. The ITC has indicated that appropriate issues for resolution include domestic industry, importation, standing and patent subject matter eligibility.

Complainant DivX, LLC, a video software technology company, relied on its licensee’s assembly of smart TVs in the United States to satisfy the domestic industry requirement. Proposed respondent Realtek Semiconductor Corporation, a chipmaker for consumer electronics, argued that DivX would be unlikely to meet the domestic industry requirement because DivX’s licensee stopped identifying several of its products as “Assembled in the USA” to avoid deceiving consumers in connection with a petition filed before the Federal Trade Commission. Realtek also argued that DivX could not identify smart TVs as the domestic industry product for purposes of the economic prong and a different video processor product for purposes of the technical prong. Realtek sought to resolve these issues through the early disposition program, and DivX opposed. Although neither party raised the issue of third-party discovery, the ITC denied Realtek’s request because such discovery was likely necessary, making adjudication within 100 days impracticable.

Practice Note: The ITC places great emphasis on the expeditious adjudication of Section 337 investigations because of the ITC’s statutory mandate to complete them at the earliest practicable time. The early disposition program builds on that mandate and can provide an even speedier timeframe by streamlining and resolving dispositive issues within 100 days of institution. A proposed respondent should consider requesting early disposition for clear weaknesses in a complainant’s case where the issue to be decided is not complex and does not require significant discovery. While the ITC does not grant use of the early disposition program often, where it has done so, several cases have ended with withdrawal of the complaint or termination before a hearing.

Supreme Court to Consider Whether PTAB Judges Are Unconstitutionally Appointed

by Amol Parikh | Oct 22, 2020 | Cert Alert

The Supreme Court of the United States agreed to consider whether Patent Trial and Appeal Board (PTAB) judges are unconstitutionally appointed. The United States of America v. Arthrex, Inc., Case Nos. 19-1452, -1458, -1459 (Supr. Ct. October 13, 2020) (certiorari granted).

In what quickly turned into a controversial decision, the US Court of Appeals for the Federal Circuit held the appointment of administrative patent judges at the PTAB unconstitutional. Arthrex, Inc. v. Smith & Nephew, Inc. The Federal Circuit found that PTAB judges were appointed as if they were “inferior officers” but vested by the PTAB with authority that is reserved for Senate-confirmed “principal officers.” Smith & Nephew, Arthrex and the United States of America petitioned the Supreme Court for review of the decision.

The questions presented are:

Whether, for purposes of the Appointments Clause, US Const. Art. II, § 2, Cl. 2, administrative patent judges of the US Patent and Trademark Office are principal officers who must be appointed by the president with the Senate’s advice and consent, or “inferior officers” whose appointment Congress has permissibly vested in a department head.
If administrative patent judges are principal officers, whether the court of appeals properly cured any Appointments Clause defect in the current statutory scheme prospectively by severing the application of 5 USC 7513(a) to those judges.

Eye Don’t: No Counterfeiting Without Likelihood of Confusion

by Sarah Bro | Oct 15, 2020 | Trademarks

Referring to the act of counterfeiting as “hard core” or “first degree” trademark infringement, the US Court of Appeals for the Ninth Circuit for the first time confirmed that the Lanham Act requires a likelihood of confusion in order for the trademark holder to prevail on a counterfeiting claim. Arcona, Inc. v. Farmacy Beauty, LLC, et al., Case No. 19-55586 (9th Cir. Oct. 1, 2020) (Lee, J.) In doing so, the Court affirmed a grant of summary judgment in favor of defendant Farmacy Beauty in a counterfeiting action brought by skin care brand Arcona.

Arcona’s counterfeiting claims (which remained in the district court action after Arcona requested dismissal of its trademark infringement and unfair competition claims) stemmed from Farmacy Beauty’s use of the term EYE DEW on its skincare products, which Arcona asserted to be counterfeit versions of its eye cream sold in the United States under the registered EYE DEW trademark. The district court, however, found that dissimilar packaging and branding made it “implausible” that consumers would be tricked into believing that Farmacy’s EYE DEW product was actually one of Arcona’s skin care products, and granted partial summary judgment for Farmacy on the counterfeiting claim. Arcona appealed.

Arcona argued that it was not required to show a likelihood of consumer confusion with respect to the parties’ EYE DEW eye creams in order to pursue its trademark counterfeiting claim. The Ninth Circuit starkly disagreed, finding that the plain language of the Lanham Act, 15 USC § 1114, expressly states that likelihood of confusion is a requirement for a counterfeiting claim.

The Ninth Circuit also rejected Arcona’s alternative argument, that there should be a presumption of likelihood of confusion based on the parties’ use of the identical mark EYE DEW. The Court explained that in a claim of counterfeiting—even with identical trademarks—there is no presumption of consumer confusion if the products themselves are not identical. Here, evidence demonstrated that the parties sold their respective EYE DEW products in very different packages, with Arcona’s eye cream being in a “tall, cylindrical, silver bottle encased in a slim, cardboard outer box,” and Farmacy’s eye cream sold in a “short, wide, white jar, along with a squarish outer box.” In reviewing the parties’ respective products as a whole, including prominent displays of the respective house marks FARMACY and ARCONA, as well as differences in packaging, size, color, shape and “all other attributes,” the Court determined that the parties’ products were not identical and that there was no presumption of consumer confusion.

The Ninth Circuit concluded that summary judgment of no counterfeiting was proper because there was no genuine dispute of material fact about the likelihood of consumer confusion factor. The Court acknowledged that the parties’ eye cream products do compete in the same space and in the same geographic markets, but explained that a claim of counterfeiting nevertheless requires that the parties’ marks be “considered in their entirety and as they appear in the marketplace.” Noting that the available evidence demonstrated significant differences between [...]

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Federal Circuit Restores Induced Infringement Verdict Against Teva

by April E. Weisbruch | Oct 15, 2020 | Patents

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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