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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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Overcoming Heavy Burden Required to Succeed on Venue-Related Writ of Mandamus

Addressing a venue challenge, the US Court of Appeals for the Federal Circuit denied a petition for a writ of mandamus because the challenger did not demonstrate it had no adequate alternative means to obtain desired relief since meaningful review could occur after final judgment was entered. In re. Google, Case No. 20-144 (Fed. Cir. Sept. 18, 2020) (Reyna, J.).

Personalized Media Communications (PMC) sued Google in the Eastern District of Texas for infringement of six patents related to adaptive video streaming. PMC initially asserted venue was proper based on the presence of several Google Global Cache (GGC) servers at facilities owned by internet service providers (ISPs) located within the district. Google moved to dismiss for improper venue. While Google’s motion was pending, the Federal Circuit issued its decision in In re. Google, rejecting a venue argument asserted by a different plaintiff against Google that was also premised on the presence of GGC servers, and finding that a regular and established place of business requires the regular physical presence of an employee or other agent of the defendant conducting the defendant’s business at the alleged place of business.

After the Federal Circuit’s decision, PMC asserted a different venue theory based on Google’s agreements with Communications Test Design (CTDI) to warehouse, refurbish, repair and ship hardware products, such as Google’s cellphones and speakers, from a CTDI facility located in the Eastern District of Texas. The district court agreed with PMC and denied Google’s motion, finding that CTDI was acting as Google’s agent and was conducting Google’s business from its facility. Google filed a petition for a writ of mandamus seeking to vacate the district court’s order.

The Federal Circuit denied Google’s petition. The Court explained that a party seeking a writ bears the heavy burden of demonstrating that it has no adequate alternative means to obtain the desired relief and that the right to issuance of the writ is clear and indisputable. Without providing an explanation, the Court found that although Google raised viable arguments based on the law of agency and the Court’s precedent, it was not satisfied that Google’s right to a writ was clear and indisputable. The Court concluded that Google can obtain meaningful review of the district court’s venue ruling after final judgment in the case.

Practice Note: The Federal Circuit was also concerned that the district court did not move more quickly to resolve Google’s venue challenge. Significant work in the case had already been done, and the trial date is currently set for November 2020. If the venue is later found to be improper, the case will be transferred and a new trial will occur.




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Challenge to PTAB’s Finding of Non-Obviousness Fails to Pay Out

Addressing whether the Patent Trial and Appeal Board (PTAB) ran afoul of the Administrative Procedure Act (APA) in finding that a dependent claim was valid despite the patent owner’s lack of validity arguments beyond those advanced for the corresponding and invalid independent claim, the US Court of Appeals for the Federal Circuit affirmed the PTAB’s ruling and found no APA violation. FanDuel, Inc. v. Interactive Games LLC, Case No. 19-1393 (Fed. Cir. July 29, 2020) (Hughes, J.) (Dyk, J. concurring in part and dissenting in part).

Interactive Games owns a patent directed to a method for allowing users to gamble remotely via a mobile device, according to certain game configurations. Specifically, the independent claim is directed to altering a user’s game outcome based on the gaming configuration associated with the location of a user’s mobile gaming device. A dependent claim adds the additional limitation of “accessing a lookup table which contains an ordered list of locations and associated game configurations.”

FanDuel petitioned for inter partes review (IPR) of the patent as obvious based on three references. The first reference (Carter) disclosed a mobile wagering system capable of determining a gambler’s location and restricting access based on the location. Carter’s system used a database that correlated various locations with applicable access levels. Importantly, the reference generally indicated that the system may employ various components such as “memory elements, processing elements, logic elements, look-up tables, and the like.” The second reference (Walker) disclosed enabling or disabling certain features on a mobile gaming device based on a user’s location. And the third reference (the webpage) included a list of slot payouts by casino, city and state, alphabetically organized by state. FanDuel also submitted an expert declaration that the use of look-up tables was well known in the art and that it would have been an obvious design choice to store Carter’s jurisdictional information in an “ordered list” similar to the webpage.

In its Preliminary Patent Owner Response, Interactive incorporated its validity arguments for the independent claim into its arguments for the dependent claim, but did not otherwise advance any substantive arguments specific to the dependent claim. The PTAB instituted IPR for all challenged claims. Following institution, Interactive submitted a patent owner response, which again did not advance any substantive arguments specific to the dependent claim. While Interactive did submit an expert declaration, the statements made by FanDuel’s expert specific to the dependent claim were uncontested. Ultimately, the PTAB found the independent claim invalid, but found the dependent claim valid. FanDuel appealed.

FanDuel argued that the PTAB’s decision with respect to the dependent claim violated the APA because the PTAB changed its obviousness theory midstream. FanDuel alleged that no further record development was presented regarding the dependent claim after institution, and therefore a finding of validity in light of the PTAB’s decision to institute amounted to a changed position by the PTAB, to which FanDuel was entitled notice and an opportunity to respond.

The Federal Circuit disagreed and affirmed the PTAB’s decision. In finding [...]

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Delicate Balance: Details of Parallel Proceeding Tip Scales for Discretionary Denial

The Patent Trial and Appeal Board (Board) designated two decisions informative as they relate to weighing factors for determining how a parallel district court proceeding may impact the Board’s determination of whether to discretionarily deny institution under § 314(a).

In Apple Inc. v. Fintiv, Inc., Case No. IPR2020-00019, Paper 15 (USPTO May 13, 2020) (Horner, APJ) (designated informative on July 13, 2020), the Board had previously requested supplemental briefing in a pre-institution order in this case (itself now designated by the Board as precedential) regarding six factors for weighing the impact of the parallel district court proceeding on whether to discretionarily deny institution.

As to factor (1), whether the district court action is stayed or evidence exists that a stay may be issued, the Board weighed this factor as neutral because neither party had requested a stay and the district court had given no indication as to whether it would entertain a stay. Absent definitive statements by the district court as to the specific case, the Board declined to infer how a judge might rule if a motion were to be filed.

Under factor (2), the proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision, the Board found this factor weighed slightly in favor of a discretionary denial. Even though the district court’s initial trial date had been pushed back, the new date was still two months earlier than the Board’s one-year deadline for issuing a final written decision. In addition, the new date appeared to be relatively certain, and mere speculation about the further delays being typical was not enough to weigh this factor in favor of a discretionary denial.

As to factor (3), the court’s and parties’ investment in the parallel proceeding, the Board found this weighed somewhat in favor of discretionary denial. Even though expert reports had not been served, the district court had already issued a detailed Markman order construing seven claim terms, and the parties had already served their final invalidity contentions.

Under factor (4), the extent of overlap of the issues raised in the petition compared to those raised in the parallel proceeding, the Board found this factor favored discretionary denial because the Petitioner was pursuing the same prior art on the same claims in district court.

Under factor (5), the parties in the district court action were the same as the IPR, so this factor weighed in favor of discretionary denial.

As to the catch-all factor (6), including considering the merits of the challenge, the Board found that there were key weaknesses in the petition that helped tip the scales toward discretionary denial. In sum, the Board found that the weight of the factors tipped toward exercising its discretion to deny institution.

In Sand Revolution II, LLC v. Continental Intermodal Group–Trucking LLC, Case No. IPR2019-01393, Paper 24 (USPTO June 16, 2020) (Flax, APJ) (designated informative on July 13, 2020), the Board came to slightly different conclusions for some of the factors, ultimately granting the Petitioner’s request [...]

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Third Parties Not Responsible for Defective Motion to Seal

The US Court of Appeals for the Federal Circuit held that a district court did not abuse its discretion in denying reconsideration of a previous order denying a litigant’s defective motion to seal  with regard to the litigant’s own information, but vacated and remanded for further consideration with regard to third-party information. Uniloc 2017 LLC v. Apple, Inc., Case Nos. 19-1922, -1923, -1925, ‑1926 (Fed. Cir. July 9, 2020) (Mayer, J.).

Uniloc sued Apple for patent infringement in the Northern District of California. Apple moved to dismiss. The briefing on the motion included material that Uniloc had designated as highly confidential. Both parties filed motions to seal. Uniloc’s motions to seal covered quotations from published opinions and matters of public record, among other things. Uniloc’s supporting declarations included only boilerplate assertions of harm from disclosure. Non-party Electronic Frontier Foundation asked Uniloc to narrow its redactions, and when Uniloc declined, Electronic Frontier moved to intervene for the purpose of opposing Uniloc’s sealing motions. The district court denied the motions to seal as overbroad under the local rules, which require such motions to be narrowly tailored.

Uniloc sought an extension of time and ultimately filed a motion for leave to seek reconsideration. In that motion, it agreed to make public more than 90% of the material it had originally sought to seal. It also filed a new motion to seal the remainder. In support, it attached a much more specific declaration supporting sealing the more limited set of materials, as well as several declarations of third-party licensees, who stated that disclosure of their confidential information would be harmful to them. The court denied the motion seeking leave as not meeting the local rules’ requirements for reconsideration. The court also denied the narrower motion to seal, reasoning that Uniloc should have filed a proper motion to seal in the first instance. Uniloc appealed.

Uniloc argued that the district court had abused its discretion in denying the narrower motion to seal. In considering Uniloc’s argument, the Federal Circuit distinguished between Uniloc’s information and third-party information. Applying Ninth Circuit law, the Court held that the district court had not abused its discretion by strictly enforcing its local rules with regard to Uniloc’s information. Uniloc had violated the local rules in its motion to seal and subsequent motion for reconsideration. Moreover, the Court explained that notwithstanding the submission of a narrowly tailored motion, the burden is always on the moving party to provide compelling reasons for sealing, which Uniloc had failed to do.

Next, the Federal Circuit explained that third-party information “calls for an analysis not dependent on the overbreadth rationale” because third parties should not be harmed by a litigant’s failure to follow the local rules. Because the district court’s analysis had been based on overbreadth, the Court found that the district court “failed to make findings sufficient to allow us to adequately assess whether it properly balanced the public’s right of access against the interests of the third parties in shielding their . . [...]

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Federal Circuit Extends Arthrex to Ex Parte Re-Examination Proceedings

The US Court of Appeals for the Federal Circuit vacated and remanded a decision issued by the Patent Trial and Appeal Board (PTAB), holding that its decisions in Arthrex and VirnetX also apply to ex parte examinations at the PTAB. In re: Boloro Global Ltd., Case Nos. 19-2349, -2351, -2353 (Fed. Cir. July 7, 2020) (Dyk, J.).

The issue regarding ex parte appeals started to take shape in October 2019—in the context of an inter partes review (IPR) proceeding—when the Federal Circuit held that the appointment of administrative patent judges (APJs) at the PTAB is unconstitutional. Arthrex v. Smith & Nephew (IP Update, Vol. 22, No. 11). APJs are appointed by the secretary of commerce in consultation with the director of the US Patent and Trademark Office (PTO) pursuant to 35 USC § 6(a). In Arthrex, The Federal Circuit determined that APJs are principal officers and are not constitutionally appointed, because as principal officers they must be appointed by the president with the advice and consent of the Senate.

Having concluded that the appointment of APJs violated the Appointments Clause, the Federal Circuit held that “where the final decision was rendered by a panel of APJs who were not constitutionally appointed,” and “where the parties presented an Appointments Clause challenge on appeal,” the decision below “must be vacated and remanded.” The Court further instructed that, on remand, a new panel of APJs must be designated and a new hearing granted. The Court put a bookend on its holding, ruling that where an Appointment Clause challenge was not raised in an opening brief, the challenge was waived. So PTAB decisions that issued before Arthrex, if timely appealed and subject to an Appointment Clause challenge in the opening brief, could be vacated as unconstitutional and remanded for a new panel of APJs.

In May 2020, the Federal Circuit extended its decision in Arthrex to final decisions issued by APJs in inter partes re-examination proceedings (VirnetX v. Cisco Systems). In VirnetX, the Court discerned no differences between the duties of an APJ in an IPR proceeding as compared to an inter partes examination proceeding, because both proceedings involve third-party challenges to an issued patent and in both proceedings APJs exercise significant authority by issuing final decisions that decide the patentability of the challenged claims, and the PTO director does not have an independent way of reviewing those final determinations.

The present case arose in the context of an appeal from an examiner in ex parte prosecution. Boloro argued that APJs in ex parte appeals also exercise significant authority by virtue of the matters on which they are asked to render judgment, and carry out similar functions when they carry out their function of deciding IPRs. Boloro asserted that although ex parte appeals were not specifically addressed in Arthrex, the PTAB also has the power in ex parte appeals to disqualify counsel, to admit people pro hac vice, and to order appellants to additionally brief any matter that the PTAB considers to [...]

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Reliance on Common Sense Permitted in Obviousness Analysis

The US Court of Appeals for the Federal Circuit affirmed a final written decision from the Patent Trial and Appeal Board (PTAB) finding patent claims directed to aircraft lavatories obvious based on prior art because a skilled artisan would have used common sense to incorporate a missing limitation into the prior art. B/E Aerospace, Inc. v. C&D Zodiac, Inc., Case Nos. 19-1935, -1936 (Fed. Cir. June 26, 2020) (Reyna, J.).

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Chalk One Up to the Knock-Off

Addressing issues of design patent infringement, copyright infringement, trade dress infringement and unfair competition, the US Court of Appeals for the Federal Circuit affirmed a district court’s grant of summary judgment on all claims. Lanard Toys Limited v. Dolgencorp LLC, Ja-Ru, Inc., Toys “R” Us-Delaware, Inc., Case No. 2019-1781 (Fed. Cir. May 14, 2020) (Lourie, J.).

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Arthrex Extended to Inter Partes Re-examination

The US Court of Appeals for the Federal Circuit denied a petition for panel rehearing regarding the constitutionality of decisions issued by the United States Patent and Trademark Office (USPTO) Patent Trial and Appeal Board (PTAB), holding that its decision in Arthrex, Inc. v. Smith & Nephew, Inc. (IP Update, Vol. 22, No. 11) also applies to final decisions issued by administrative patent judges (APJs) in inter partes re-examinations. Virnetx v. Cisco Systems, Inc., Case No. 19-1671 (Fed. Cir. May 13, 2020) (O’Malley, J.). The Court also denied (per curiam) a concurrently filed petition for rehearing en banc.

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The “Plotting” Thickens: Claims that Solve Known Problem with Known Methods Are Obvious

The US Court of Appeals for the Federal Circuit applied KSR and its obviousness progeny, finding that patent claims directed to location plotting were obvious under 35 USC § 103. Uber Techs., Inc. v. X One, Inc., Case No. 19-1164 (Fed. Cir. May 5, 2020) (Prost, CJ).

X One sued Uber Technologies asserting a patent directed to exchanging location information between mobile devices, such that a user could add other mobile device users to a “Buddy List,” share her location with listed buddies or temporary “instant buddies,” and see the locations of her buddies on a map. The patent’s purported novelty lay in “two way position information sharing,” creation of location sharing “groups,” and “temporary location sharing” that “automatically expires.”

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