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Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

by Paul Devinsky | Feb 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny labeling rules, and suggested that equitable estoppel was the appropriate vehicle for considering whether the branded drug manufacturer’s representations to the US Food & Drug Administration (FDA) should prevent it from recovering. GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Feb. 11, 2022) (per curiam) (Moore, C.J., concurring) (Prost, J., dissenting) (Dyk, J., dissenting) (Reyna, J., dissenting).

GlaxoSmithKline (GSK) developed a drug called carvedilol, which it markets (with FDA approval) for three indications: hypertension, left ventricular dysfunction following myocardial infarction (post-MI LVD) and congestive heart failure (CHF). GSK indicated to the FDA that only the CHF indication was under patent. Teva developed a generic version of carvedilol. Commensurate with skinny labeling regulations, Teva carved out from its label the language that GSK indicated was related to the protected CHF indication. Nonetheless, GSK alleged that Teva’s label induced infringement of patents covering the CHF indication. After trial, the jury agreed that the remaining language on Teva’s label would encourage physicians to practice the patented method of treating CHF. Notwithstanding the jury’s verdict, the district court granted judgment as a matter of law that Teva did not induce infringement. GSK appealed, and a divided panel reinstated the verdict (GSK v. Teva). Teva sought panel rehearing, which was denied, and then sought en banc review.

Out of the nine judges who considered the petition for en banc review, six voted to deny it and three would have granted it. All nine judges expressed concern that Teva should be held liable for induced infringement notwithstanding its compliance with the skinny labeling regulations and GSK’s representation to the FDA that the carved-out language was the only language in the label that would implicate its patents on the CHF indication. The judges differed, however, as to why Teva should not be held liable.

Chief Judge Moore’s concurrence, in which Judges Newman, O’Malley, Taranto, Chen and Stoll joined, affirmed the panel majority’s opinion and endorsed its approach of considering all the evidence. According to Judge Moore, any concerns that the result was unfair to Teva, which had complied with the skinny labeling requirements, should be addressed in the district court’s resolution of the still-pending equitable estoppel defense. In Judge Moore’s view, the facts fit squarely within the doctrine of equitable estoppel: GSK’s representations to the FDA could be seen as misleading Teva into believing that GSK would not seek to enforce its patents against the skinny label (which would omit the language GSK identified as relating to the infringing use); Teva could be seen as having relied on GSK’s representations in obtaining its skinny label and bringing its generic carvedilol product to market; and Teva could be seen as having been greatly prejudiced by later being found liable for GSK’s lost profits, which were greatly in [...]

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Bargained-Away Rights to File for IPR May Not Be Recovered

by McDermott Will & Schulte | Feb 17, 2022 | Patents

In a precedential opinion, the US Court of Appeals for the Federal Circuit reversed a district court’s denial of a plaintiff’s requested injunction seeking to force a patent challenger to abandon its petitions for inter partes review (IPR). Nippon Shinyaku Co. Ltd. v. Sarepta Therapeutics, Inc., Case No. 2021-2369 (Fed. Cir. Feb. 8, 2022) (Newman, Lourie, Stoll, JJ.)

Nippon Shinyaku and Sarepta Therapeutics executed a mutual confidentiality agreement (MCA) to facilitate discussion of “a potential business relationship relating to therapies for the treatment of Duchenne Muscular Dystrophy.” The MCA established a mutual covenant not to sue for “any legal or equitable cause of action, suit or claim or otherwise initiate any litigation or other form of legal or administrative proceeding against the other Party . . . in any jurisdiction in the United States or Japan of or concerning intellectual property in the field of Duchenne Muscular Dystrophy” during a covenant term. The mutual covenant explicitly “include[d], but [wa]s not limited to, patent infringement litigations, declaratory judgment actions, patent validity challenges before the U.S. Patent and Trademark Office or Japanese Patent Office, and reexamination proceedings before the U.S. Patent and Trademark Office” (emphasis added). The MCA also included a forum selection clause to govern post-term intellectual property disputes between the parties, which stipulated:

that all Potential Actions arising under U.S. law relating to patent infringement or invalidity, and filed within two (2) years of the end of the Covenant Term, shall be filed in the United States District Court for the District of Delaware and that neither Party will contest personal jurisdiction or venue in the District of Delaware and that neither Party will seek to transfer the Potential Actions on the ground of forum non conveniens (emphasis added).

“Potential actions” were defined as:

any patent or other intellectual property disputes between [Nippon Shinyaku] and Sarepta, or their Affiliates, other than the EP Oppositions or JP Actions, filed with a court or administrative agency prior to or after the Effective Date in the United States, Europe, Japan or other countries in connection with the Parties’ development and commercialization of therapies for Duchenne Muscular Dystrophy (emphasis added).

The day the covenant term ended, Sarepta filed seven petitions for IPR at the Patent Trial & Appeal Board (Board). Nippon Shinyaku filed suit in the US District Court for the District of Delaware for breach of contract, declaratory judgment of noninfringement and invalidity and patent infringement. Nippon Shinyaku motioned for a preliminary injunction to enjoin Sarepta from proceeding with the IPR petitions and to force Sarepta to withdraw them. The district court denied Nippon Shinyaku under each of the preliminary injunction factors (likelihood of success on the merits, irreparable harm in the absence of extraordinary preliminary relief, balance of harms in its favor and relief being in the public interest).

The district court explained that any irreparable harm arguments fell within Nippon Shinyaku’s contract interpretation arguments, and that Nippon Shinyaku’s balance of hardships and public interest arguments relied on Sarepta’s ability to file [...]

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Federal Circuit Tosses Shaw: IPR Estoppel Applies to All Grounds That Reasonably Could Have Been Raised

by Paul Devinsky | Feb 17, 2022 | Patents

March 2022 Update: The Federal Circuit has issued an errata to this decision. Read about it here.

Addressing inter partes review (IPR) estoppel after the Supreme Court of the United States’ 2018 decision in SAS Institute, Inc. v. Iancu, the US Court of Appeals for the Federal Circuit overruled its decision in Shaw Industries Group v. Automated Creel Systems, stating that the only plausible reading of 35 U.S.C. § 315(e)(2) estops a party from raising all claims and grounds that reasonably could have been included in the party’s petition for IPR. The Court also rejected the district court’s two-tier damages model as contrary to customary patent damages calculations. California Institute of Technology v. Broadcom Limited, Case Nos. 20-2222; 21-1527 (Fed. Cir. Feb. 4, 2022) (Lourie, Linn, Dyk, JJ.) (Dyk, J., dissenting in part).

Background

California Institute of Technology (Caltech) filed suit against Broadcom and Apple, alleging patent infringement directed to the generation and repetition of information in a wireless data transmission system. Wireless transmission systems generally use data repetition so that the transmitted information may be decoded even when data loss occurs. The patented circuitry discloses a form of irregular data repetition in which portions of the information bits may be repeated a varying number of times.

Apple filed multiple IPR petitions challenging the validity of the claims at issue. The Patent Trial & Appeal Board (Board) concluded in all cases that Apple failed to show that the challenged claims were unpatentable as obvious. At the district court, Apple and Broadcom raised new arguments of obviousness not asserted in the IPR proceedings. The district court granted Caltech’s motion for summary judgment of no invalidity, precluding Apple and Broadcom from raising arguments at trial that they reasonably could have raised in their IPR petitions.

At trial, the district court instructed the jury that “repeat” means “generation of additional bits, where generation can include, for example, duplication or reuse of bits.” Apple and Broadcom argued that the Broadcom chips (which were integrated into Apple devices) did not infringe the asserted claims because they did not repeat information at all. With respect to one of the asserted patents, the district court did not provide a jury instruction relating to its construction that the claim language “information bits appear in a variable number of subsets” requires irregular information bit repetition. The jury found infringement of all asserted claims. Apple and Broadcom filed post-trial motions for judgment as a matter of law (JMOL) and a new trial, both of which the district court denied.

The district court adopted Caltech’s proposed two-tier damages theory, explaining that Broadcom and Apple’s products were different and therefore possessed different values simply because they were “different companies at different levels in the supply chain.” The district court ultimately entered judgment against Broadcom for $288 million and against Apple for $885 million. Broadcom and Apple appealed.

The Appeal

Broadcom and Apple argued that the district court’s construction of “repeat” was inconsistent with the claim language and specification. The Federal Circuit [...]

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Change the Look of the Room: Appeal Transferred to Federal Circuit

by Amol Parikh | Jan 6, 2022 | Copyrights, Trademarks

The US Court of Appeals for the Second Circuit transferred an appeal of a preliminary injunction enjoining alleged copyright and trademark infringement to the US Court of Appeals for the Federal Circuit because the operative complaint included six counts of patent infringement and thus arose under patent law. Hudson Furniture, Inc. et al. v. Lighting Design Wholesalers Inc., Case No. 20-3299 (2d Cir. Dec. 21, 2021) (Livingston, CJ; Kearse, Lee, JJ.) (per curiam).

Hudson filed a complaint against Lighting Design alleging patent, trademark and copyright infringement. The district court granted Hudson’s preliminary injunction and enjoined Lighting Design from alleged infringement of Hudson’s copyrights and trademarks. The district court also denied Lighting Design’s motion to dismiss for lack of personal jurisdiction and its motion for reconsideration permitting alternative service of process. Lighting Design appealed the rulings to the Second Circuit.

Hudson asked the Second Circuit to dismiss the appeal, arguing that the appeal arose from a complaint involving patent law claims and thus fell under the exclusive jurisdiction of the Federal Circuit. Under 28 U.S.C. §§ 1292 and 1295, the Federal Circuit has exclusive jurisdiction over interlocutory appeals involving any action that arises under any act of US Congress relating to patents. An action arises under patent law when a well-pleaded complaint establishes that (1) federal law creates the cause of action or (2) the plaintiff’s right to relief necessarily depends on resolution of a substantial question of federal patent law.

The Second Circuit agreed that exclusive jurisdiction rested with the Federal Circuit, explaining that the operative complaint included six counts of patent infringement, and the appeal concerned the district court’s ruling on a motion for injunctive relief involving patent law and non-patent law claims. The Court rejected Lighting Design’s argument that patent law did not constitute a substantial part of the overall success of the case since Hudson failed to secure preliminary injunctive related to the patent law claims. The Court explained that Lighting Design’s argument focused on only the second basis for Federal Circuit jurisdiction (whether the right to relief depends on a “substantial question” related to patent law). The Court found that even if it accepted Lighting Design’s argument, the fact that federal patent law created the cause of action was sufficient to establish Federal Circuit jurisdiction under the first basis of jurisdiction. While the Second Circuit agreed with Hudson, it declined to dismiss the appeal and instead opted to transfer the appeal to the Federal Circuit because the original appeal was timely filed in good faith and transferring the appeal was in the interest of justice.

No More Bites at the Apple: Imminent and Non-Speculative Standing Still Required

by McDermott Will & Schulte | Nov 18, 2021 | Patents

The US Court of Appeals for the Federal Circuit reiterated that a patent challenger did not have Article III appellate standing to obtain review of a final Patent Trial & Appeal Board (PTAB) ruling because the underlying district court proceedings had been dismissed with prejudice after the parties reached a settlement and license agreement. Apple Inc. v. Qualcomm Inc., Case Nos. 20-1683; -1763; -1764; -1827 (Fed. Cir. Nov. 10, 2021) (Prost, J.) (Newman, J., dissenting).

This is the second dispute between Apple and Qualcomm to reach the Federal Circuit. In the first appeal (Apple I), the Court found that Apple did not have standing to maintain an appeal from the PTAB because the parties had entered into a settlement agreement.

As in the earlier case, here Qualcomm asserted patent infringement in district court, and Apple filed petitions for inter partes review of the patent claims that Qualcomm asserted Apple had infringed. The PTAB instituted on four petitions. While the inter partes review proceedings were pending, the parties settled the district court litigation, whereby Apple received a license in exchange for royalty payments to Qualcomm. The parties filed a joint motion to dismiss Qualcomm’s district court action with prejudice, which the district court granted. Ultimately, the PTAB found that Apple failed to prove that the challenged claims were unpatentable. Apple appealed.

As in Apple I, Qualcomm moved to dismiss the appeal for lack of standing. Apple responded by arguing that “[a]lthough Apple continues to disagree with [Apple I], in light of that decision and the . . . order denying Apple’s petition for rehearing en banc, Apple believes that the present appeal can be resolved on the briefs without the need for oral argument.” The parties filed a joint motion to vacate oral argument, but the Federal Circuit instead held a consolidated oral argument. Apple reiterated its disagreement with the Court’s ruling in Apple I but admitted that the operative facts in this appeal were “the same.” The Court found that other than the specific difference of the patents in issue themselves, the operative facts were the same and the alleged failure of proof as to certain patent claims (regarding whether the petitioner had established them to be unpatentable) were the same. The Court further found that any specific patent differences were irrelevant since the settlement and license agreements in each case covered the patents in issue in that case.

Apple raised a “nuance” not “specifically addressed” in Apple I, namely that Apple I “did not explain why the threat of liability, if Apple ceases the ongoing payment and the agreement is terminated, is not a sufficient injury to support standing.” The Federal Circuit was not convinced that this nuance merited a different treatment because:

The Court would need to sit en banc to change Apple I, and panels of the Court are bound by stare decisis.
Apple acknowledged that this “nuance” was at the core of its denied en banc petition in Apple I.

Accordingly, [...]

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Authentication Claim Under Alice—A Two-Step Process

by Jodi Benassi | Oct 14, 2021 | Patents

The US Court of Appeals for the Federal Circuit found patent claims directed to a method of authenticating the identity of a user performing a transaction at a terminal was patent-eligible under 35 U.S.C. § 101 and reversed the district court’s entry of judgment on the pleadings. CosmoKey Solutions GmbH & Co. KG. v. Duo Security LLC, Case No. 20-2043 (Fed. Cir. Oct. 4, 2021) (Stoll, J.) (Reyna, concurring).

CosmoKey sued Duo for patent infringement and Duo moved for judgment on the pleadings, arguing that all claims of the patent at issue are ineligible under 35 U.S.C. § 101. The district court analyzed the claims under the Alice two-step framework. At step one, the court agreed with Duo, finding that the patent claims were directed to the abstract idea of authentication—the verification of identity to permit access to transactions. Relying on Federal Circuit precedent, the court reasoned that “authentication” is an abstract concept. Moving to step two, the court determined that the patent merely teaches generic computer functionality, reasoning that the patent itself admits that “the detection of an authentication function’s activity and the activation by users of an authentication function within a pre-determined time relation were well-understood and routine, conventional activities previously known in the authentication technology field.” After the court granted Duo’s motion for judgment on the pleadings, CosmoKey appealed.

Applying Third Circuit law, the Federal Circuit reversed the lower court’s decision and provided more insight into the “inventive concept” analysis and “two-step” process framework. The Federal Circuit first acknowledged that while it had previously found claims directed to authentication to be abstract, it also found claims directed to specific verification methods that depart from earlier approaches and improve technology eligible under § 101.

The Federal Circuit disagreed with the district court’s broad characterization of the claims under Alice step one, finding instead that the claims and written description suggest that the claims are directed to a more specific authentication function. Nevertheless, the Court noted that it did not need to answer this question because the patent claims satisfy Alice step two. Under step two, the Court focused on the purported technical advance and found that the invention provides a “specific improvement to authentication that increases security, prevents unauthorized access by a third party, is easily implemented, and can advantageously be carried out with mobile devices of low complexity.” The Court explained that the district court erred in its interpretation of certain sections of the specification. Specifically, the court read the specification to describe prior art that shows the steps were routine or conventional. However, the Court pointed out that the last four steps of claim one of the patent solved a technical problem in the field using steps that were not conventional.

Judge Jimmie V. Reyna concurred with the decision but took issue with the Court’s dismissal of analyzing the claims under Alice step one, finding the approach “extraordinary and contrary to Supreme Court precedent.” He noted that step two does not operate independently of step one, [...]

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Discretion to Authorize Hague Alternative Service on Foreign Defendant—it’s All About Time and Cost

by Paul Devinsky | Sep 23, 2021 | Patents

The US Court of Appeals for the Federal Circuit denied a petition for a writ of mandamus, directing the US District Court for the Western District of Texas to dismiss multiple infringement actions for insufficient service of process and lack of personal jurisdiction where the plaintiff used alternative methods to effect service of process on a foreign defendant instead of the more conventional Hague Convention. Although the Court expressed reservations about the district court’s authorization of alternative service methods solely because of the Hague Convention’s slower and more expensive procedures, it found the decision to be within the district court’s discretion. In re: OnePlus Tech. (Shenzhen) Co., Ltd., Case No. 21-165 (Fed. Cir. Sept. 10, 2021) (non-precedential) (per curiam).

OnePlus is a Chinese consumer electronics manufacturing company. WSOU Investments d/b/a Brazos Licensing and Development is a non-practicing entity headquartered in Texas. Brazos filed five patent infringement actions against OnePlus and alleged that OnePlus had no place of business or employees in the United States. Although the People’s Republic of China is a signatory to the Hague Convention, Brazos decided not to attempt service on OnePlus by invoking the Hague Convention because of the burdens involved. Instead, Brazos requested that the district court grant leave under Fed. R. of Civ. Pro. 4(f)(3) to use alternative methods to effect service. Brazos made no showing that service under the Hague Convention had been tried and failed, would have been unlikely to succeed or was otherwise impracticable. The district court regarded the Hague Convention procedure as slow and expensive and granted the motion. Brazos served the complaint and summons on lawyers who represented OnePlus in the past and on OnePlus’s authorized agent for service in California.

OnePlus made a special appearance to challenge the sufficiency of the service and the district court’s jurisdiction over OnePlus. The district court rejected the challenge on the basis that Rule 4(f)(3) gave it discretion to order service on a foreign defendant by means other than those prescribed by the Hague Convention, and that the service was effective to grant the district court personal jurisdiction over OnePlus. OnePlus sought mandamus.

OnePlus’s mandamus petition requested that the Federal Circuit compel the district court to vacate its order authorizing alternative service and require that Brazos effect service pursuant to Hague Convention procedures. OnePlus argued that:

Brazos’s service was ineffective because it did not satisfy Texas state law.
As a result of the ineffective service, the district court lacked personal jurisdiction over OnePlus.
It was an abuse of discretion for the district court to authorize alternative service absent showing of a need to forego Hague Convention procedures.

OnePlus argued that the district court had jurisdiction over it only if OnePlus was subject to jurisdiction in Texas under the Texas long-arm statute. Because valid service under Texas law required the transmittal of documents abroad and triggered the Hague Convention (which Brazos did not use), OnePlus contended that there was no valid service and the district court therefore lacked personal jurisdiction over [...]

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Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

by Paul Devinsky | Sep 16, 2021 | Patents

The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent, sufficient evidence for a finding of inequitable conduct. Belcher Pharmaceuticals, LLC v. Hospira, Inc., Case No. 20-1799 (Fed. Cir. Sept. 1, 2021) (Reyna, J.)

The patent in issue relates to injectable formulations of l-epinephrine. Epinephrine is a hormone that has been on the market since approximately 1938 and is used for a variety of medical purposes. It is also known that l-epinephrine degrades into a more potent isomer known as d-epinephrine. L-epinephrine also degrades into an impurity known as adrenalone through a process called oxidation.

In 2012, Belcher first submitted a New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based, meaning that Belcher did not perform any clinical or non-clinical studies on its epinephrine formulation to support its application. Among the materials submitted to the FDA was an article by Stepensky et al to support its statement that “racemization of the enantiomerically pure L-Epinephrine isomer in injectable formulations of epinephrine is a well-known process.” It also submitted data from Swiss pharmaceutical company Sintetica SA’s formulation that had a pH range of 3.1 – 3.3 and undetectable levels of adrenalone. Ultimately, Belcher pursued a formulation with a similar pH range of 2.8 – 3.3.

In 2014, Belcher filed a patent application that was ultimately issued as the asserted patent. The patent taught that increasing the in-process pH to 2.8 – 3.3 unexpectedly reduced the racemization of l-epinephrine to d-epinephrine at release by approximately two thirds. The asserted claims covered pharmaceutical epinephrine formulations having a pH between 2.8 – 3.3 and certain concentrations of l-epinephrine, d-epinephrine and adrenalone at the time of release and 12 months later.

The prosecution of the application involved a single office action in which the pending claims were rejected in view of Helenek. The examiner explained that Helenek taught 1 mg/ml of epinephrine injection that, among other things, had a pH range of 2.2 – 5.0. Belcher overcame this rejection by arguing that Helenek did not render obvious the claimed range of 2.8 – 3.3 because the claimed range was unexpectedly found to be critical to reduce racemization of l-epinephrine.

Hospiria also submitted an NDA seeking approval of an injectable l-epinephrine formulation, which included a certification under 21 U.S.C. § 355(b)(2)(A)(iv)(Paragraph IV) that the asserted patent’s claims were invalid, unenforceable and/or not infringed by Hospira’s NDA product. Belcher subsequently sued Hospira for patent infringement.

During trial, Darren Rubin, Belcher’s Chief Science Officer, testified that in his role at Belcher, he was involved in the drafting and development of the NDA and in the prosecution of the asserted patent—including drafting the claims and specification and responding to the examiner’s office action. Darren admitted he knew of Stepensky before the application was filed and that he possessed a label for a 1 mg/mL epinephrine product marked [...]

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Federal Circuit Finds Interlocutory Appeal Untimely

by Paul Devinsky | Aug 19, 2021 | Patents

Addressing the time limits for filing an interlocutory appeal in patent cases, the US Court of Appeals for the Federal Circuit dismissed such an appeal as untimely, finding that the appellant did not file within 30 days of all liability issues except for a determination of damages being resolved. Mondis Technology Ltd. v. LG Electronics Inc., Case No. 20-1812 (Fed. Cir. Aug. 3, 2021) (Hughes, J.)

Mondis Technology sued LG Electronics for infringement of a patent related to display technology. In a consolidated district court case joining other parties to dispute with LG, a jury found that (1) LG infringed certain claims of the patent owned by Mondis, (2) the patent claims were not invalid and (3) LG’s infringement was willful. The jury awarded $45 million in damages. LG filed multiple post-trial motions relating to infringement, invalidity, willfulness and damages. In September 2019, the district court denied LG’s motions regarding infringement, invalidity and willfulness. Then, in April 2020, the district court granted LG’s motion for a new trial on damages.

Within 30 days of the April 2020 order, LG filed a notice of interlocutory appeal with the Federal Circuit, seeking to challenge the denial of its three post-trial motions.

The Federal Circuit first discussed its jurisdiction to hear interlocutory appeals under 28 U.S.C. § 1292(c)(2), which provides the Court with exclusive jurisdiction over “an appeal from a judgment in a civil action for patent infringement which would otherwise be appealable to the . . . Federal Circuit and is final except for an accounting.” The Court explained that appeals under this section are subject to the time limits of § 2107(a), which in this case would give LG 30 days from the date the judgment became “final except for an accounting.” The Court cited to a previous case in which it held that a judgment is “final except for an accounting” under § 1292(c)(2) when all liability issues have been resolved and only a damages determination remains. The Court further supported its position by citing the Supreme Court of the United States’ 1988 decision in Budinich v. Becton Dickinson in which it found that the merits decision was final after the first post-trial order that resolved all issues except for attorneys’ fees. The Court thus found that all such liability issues were resolved as of the district court’s September 2019 order and that the 30-day clock started at that time.

LG also argued that Rule 4 of the Federal Rules of Appellate Procedure tolled the time to file its appeal. Rule 4(a)(4) provides that “the time to file an appeal runs for all parties from the entry of the order disposing of the last such remaining motion.” The Court disagreed with LG’s characterization, citing a Third Circuit opinion which found that a motion only tolls the time to file interlocutory appeals if the motion relates to the interlocutory judgment. The Court found that Rule 4(a)(4) did toll the time to file the interlocutory appeal but only until motions concerning liability [...]

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Employee Agreement of What “Shall Be” is Future Promise, Not Present Assignment

by Paul Devinsky | Aug 12, 2021 | Patents

The US Court of Appeals for the Federal Circuit concluded that university bylaws did not automatically effectuate a present automatic assignment of patent rights and affirmed the district court’s denial of a motion to dismiss for lack of standing by the transferee. Omni MedSci, Inc. v. Apple Inc., Case No. 20-1715 (Fed. Cir. Aug. 20, 2021) (Linn, J.) (Newman, J., dissenting).

Upon joining the faculty of the University of Michigan, Dr. Mohammed Islam executed an employment agreement assenting to abide by the university’s bylaws. The bylaws provide, in relevant part, that patents obtained by university staff that are supported directly or indirectly by university funds “shall be the property of the University.” In 2012, Dr. Islam took an unpaid leave of absence and filed several provisional patent applications. After he returned to the university in 2013, he filed non-provisional patent applications claiming priority to the 2012 provisional applications. Once those applications issued as patents, he assigned the patent rights to the plaintiff, Omni MedSci.

In 2018, Omni initiated a patent infringement action against Apple asserting certain patents, including one in the family of patents that Islam assigned to Omni. Apple moved to dismiss, arguing that Omni lacked standing to assert the patents-in-suit because the university—not Omni—owned the patents-in-suit. Apple argued that the university’s bylaws automatically transferred legal title to Dr. Islam’s patents to the university, leaving Dr. Islam with nothing to assign. Therefore, Omni had no standing to assert the patents.

The US District Court for the Eastern District of Texas denied the motion to dismiss and transferred the action to the Northern District of California. The California court certified the standing question to the Federal Circuit.

In this interlocutory appeal, the Federal Circuit considered whether the university bylaws automatically assigned the patent rights to the university. The Court explained that a patent assignment clause may presently assign a to-be-issued patent automatically—in which case no further acts to effectuate the assignment are necessary—or may merely promise to assign the patent in the future. The issue in the appeal was which type of assignment was intended by the “shall be the property of the University” language in the bylaws—i.e., whether it was “a statement of an intended outcome [or] a present assignment.” Analyzing the university bylaws, the Court agreed with the district court that the bylaws did not automatically assign the patent rights to the university and therefore did not negate Dr. Islam’s assignment of the patent rights to Omni.

The Federal Circuit concluded that the bylaw language “is most naturally read as a statement of intended disposition and a promise of a potential future assignment, not as a present automatic transfer. … It does not purport to effectuate the present transfer of a present or future right.”

In dissent, Judge Pauline Newman noted that at the district court, Dr. Islam only argued that he was not subject the bylaw obligation since the patent applications were filed without university support. However, the district court did not rule on that issue and [...]

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