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Third Circuit Orders Second Look at Delays and Disgorgement of Profits

by Sarah Bro | Aug 26, 2021 | Trademarks

In a long-running trademark dispute between two charitable organizations, the US Court of Appeals for the Third Circuit found that the appellee did not preserve its challenge to the district court’s denial of summary judgment on its trademark cancelation claims, the appellant waived any challenge to the validity of the defendant’s mark and the district court did not abuse its discretion by declining to award enhanced monetary relief or prejudgment interest. Kars 4 Kids Inc. v America Can!, Case Nos. 20-2813; -2900 (3rd Cir., August 10, 2021) (Shwartz, J.) The Court also vacated-in-part and remanded for the district court to reexamine its laches and disgorgement conclusions under applicable law.

As charitable organizations that sell donated vehicles to fund children’s programs, both America Can (as CARS FOR KIDS) and Kars 4 Kids have used similar trademarks since their respective starts in the early- to mid-1990s. In 2003 and 2013, America Can sent cease and desist letters to Kars 4 Kids after seeing its advertisements in the state of Texas. In 2014, Kars 4 Kids sued America Can for federal and state trademark infringement, unfair competition and trademark dilution claims. Less than one year later, America Can filed its own suit—alleging the same claims—plus a petition to cancel a Kars 4 Kids trademark registration and seeking a nationwide injunction and financial compensation.

Both parties appeal from a denial of their respective summary judgment motions as well as (1) the jury finding that Kars 4 Kids willfully infringed America Can’s trademark rights in Texas, (2) the rejection of America Can’s petition for cancellation of a KARS FOR KIDS trademark registration finding that the registration was not knowingly procured by fraudulent means, (3) the conclusion that laches did not apply against America Can’s claims, (4) disgorgement of Kars 4 Kids profits in Texas totaling about $10.6 million, (5) rejection of enhanced monetary relief and (6) an injunction against Kars 4 Kids with respect to use of its trademark in Texas and from using the carsforkids.com domain name. On appeal, Kars 4 Kids also renewed its motion for judgment as a matter of law, including an argument that America Can’s trademark is invalid.

The Third Circuit rejected Kars 4 Kids’ effort to overturn the jury’s liability verdict, concluding that Kars 4 Kids failed to preserve its challenge to the validity of the CARS FOR KIDS trademark when it left that issue out of its Rule 50(a) motion. Instead, evidence of America Can’s continuous use of the CARS FOR KIDS mark well prior to 2003 predated Kars 4 Kids’ first use of its trademark in Texas in 2003 and established America Can’s ownership of the CARS FOR KIDS trademark in Texas.

However, after examining the laches claim, the Third Circuit explained that it considered (1) the plaintiff’s inexcusable delay in bringing suit and (2) prejudice to the defendant as a result of the delay. With no statute of limitations under the Lanham Act, the parties agreed that their claims are properly analogized to New Jersey’s six-year [...]

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When it Comes to Method of Use Claims, Preamble Language Regarding Intended Use is Limiting

by Paul Devinsky | Aug 26, 2021 | Patents

The US Court of Appeals for the Federal Circuit issued three separate but related rulings (two precedential, one non-precedential) affirming decisions by the Patent Trial & Appeal Board (Board) regarding the validity of nine US patents and addressing the limitations of preamble language and motivation to combine. Eli Lilly Co. v. Teva Pharmaceuticals, Case Nos. 20-1876, -1877, -1878 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1747, -1748, -1750 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1749, -1751, -1752 (Fed. Cir. August 16, 2021) (Lourie, J.). These decisions come as the latest events in a dispute between Teva and Eli Lilly Company over competing products for the treatment of migraine headaches.

Teva owns nine patents directed to humanized antagonist antibodies that target calcitonin gene-related peptide. In 2018, the Food and Drug Administration (FDA) first approved Teva’s version of the biologic fremanezumab (Ajovy®) and then approved Lilly’s biologics license application for galcanezumab (Emgality®) eight days later. Both drugs are part of a new class of migraine therapeutic agents called calcitonin gene-related peptide antagonists.

Lilly challenged the validity of Teva’s nine patents covering Ajovy® in a series of inter partes review (IPR) petitions, arguing that the claims were obvious. The Board instituted IPR for all nine Teva patents. The similarity of subject matter and arguments led to three separate written opinions, each addressing three of the patents. In these decisions, the Board upheld the validity of three of the patents at issue (which covered methods of treating migraines with the antibodies) but found the claims of the six other patents directed to the antibodies themselves invalid.

Lilly appealed the first Board ruling covering methods of treating migraines to the Court. Lilly argued that the Board erred by (1) “reading a result into the constructions of the preambles and the term ‘effective amount,’” which led the Board to erroneously require Lilly to prove that a skilled artisan would have had “a reasonable expectation of achieving a result that was not claimed,” and (2) applying a too-high standard when weighing evidence to determine whether a skilled artisan would have a reasonable expectation of success. Lilly contended that a claim preamble containing only a statement of purpose cannot be a claim limitation and that no weight should have been given to the preambles. Teva argued that Lilly was basing its analysis on a false dichotomy between “limiting preambles” and preambles that are mere statements of purpose.

The Federal Circuit found the claim preambles to be limiting, reasoning that claims directed to methods of using compositions “are not directed to what the method ‘is’” but rather to “what the method ‘does,’” which usually is recited in the preamble. The preambles provided the only metric by which one practicing the claim could determine whether the amount administered is an “effective amount” and provided the antecedent basis for at least one later claim term in the independent claims.

After finding the preambles to [...]

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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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Without More, Mere Automation is Abstract—Not Construing Interchangeable Terms Doesn’t Give Them the Cold Shoulder

by McDermott Will & Emery | Aug 19, 2021 | Patents

In the latest development relating to patent eligibility of content-based identifier patents, the US Court of Appeals for the Federal Circuit affirmed decisions finding patent claims ineligible under 35 U.S.C. § 101. PersonalWeb Techs. LLC v. Google LLC, YouTube, LLC, Case No. 20-1543 (Fed. Cir. Aug. 12, 2021) (Prost, J.) (consolidating PersonalWeb Techs. LLC v. Facebook, Inc., Case No. 20-1553, and PersonalWeb Techs. LLC, Level 3 Commc’ns. LLC v. EMC Corp., VMWare, Inc., Case No. 20-1554).

PersonalWeb sued technology companies in the Eastern District of Texas in 2011 over three of its patents. The patents were directed to data-processing systems that assign each data item a substantially unique content-based identifier, generated by hash algorithm, which changes when the content changes and is used to perform data-management functions. Several defendants successfully motioned for transfer to the Northern District of California, where their companies were headquartered and/or their employees responsible for the development of the accused products were based. After claim construction in Texas, the cases were transferred and stayed pending several inter partes reviews before the US Patent Trial & Appeal Board (Board). Previous decisions before the Federal Circuit affirmed the Board’s findings that using hash-based identifiers for data management was disclosed in the prior art, that content-based identifiers in performing file-management functions, such as backing up files, were also known and other independently unpatentable aspects were recited in the claims. After the stay was lifted, the California court granted the defendants’ motion for judgment on the pleadings that the remaining asserted claims were patent ineligible under 35 U.S.C. § 101. PersonalWeb appealed.

To assess patent eligibility, the Federal Circuit applied the two-step Mayo/Alice framework. Under step one (determining whether the claims at issue are directed to a patent-ineligible concept, such as an abstract idea), the Court considered the focus of the claimed advance over the prior art and found that the claims were directed to an abstract idea. PersonalWeb contended that its claims were directed to “a substantially unique, algorithm-derived, content-based identifier for all data items in a networked computer, which allows a computer within a network containing diverse computing and storage systems to locate and distribute data without knowing either the file system of any device within the network or the conventional name of any data item.” However, the Court adopted the district court’s view, which was that the patents were directed to “(1) using a content-based identifier generated from a ‘hash or message digest function,’ (2) comparing that content-based identifier against something else, [that is,] another content-based identifier or a request for data; and (3) providing access to, denying access to, or deleting data.” Given the focus in Mayo/Alice step one of “whether the claims of the asserted patents fall within the excluded category of abstract ideas,” and citing to parallel examples from precedent cases, the Court concluded that the claims were directed to the use of an algorithm-generated content-based identifier to perform the claimed data-management functions, which include controlling access to data items, retrieving and delivering copies [...]

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If Intrinsic Evidence Provides a Clear Meaning, Just Stop

by Paul Devinsky | Aug 19, 2021 | Patents

The US Court of Appeals for the Federal Circuit vacated a final written decision of the Patent Trial & Appeal Board (Board) based on its finding that the Board erred in its ultimate claim construction by relying on extrinsic evidence that was inconsistent with the intrinsic evidence. Seabed Geosolutions (US) Inc. v. Magseis FF LLC, Case No. 20-1237 (Fed. Cir. Aug. 11, 2021) (Moore, C.J.)

In April 2018, Seabed Geosolutions petitioned for inter partes review of a patent owned by Magseis directed to “seismometers for use in seismic exploration.” Every claim recited a “geophone internally fixed within” either a “housing” or an “internal compartment” of a seismometer. The Board construed this limitation to require a non-gimbaled geophone based entirely on extrinsic evidence. The Board found that the term “fixed” had a special meaning of “non-gimbaled” at the time of the invention. Based on this finding, the Board determined that Seabed had failed to prove that the challenged claims were unpatentable because the cited prior art did not disclose a non-gimbaled geophone. Seabed appealed.

The Federal Circuit reversed the Board’s claim construction of the term “fixed” because it relied on extrinsic evidence that was inconsistent with the intrinsic evidence and unnecessary to consider given the clarity of the intrinsic evidence. The Court reminded the Board that it “resort[s] to extrinsic evidence to construe claims only if it is consistent with the intrinsic evidence,” and that “[i]f the meaning of a claim term is clear from the intrinsic evidence, there is no reason to resort to extrinsic evidence,” citing prior Federal Circuit decisions.

Contrary to the special meaning found by the Board, the Federal Circuit determined that the term “fixed” carried its ordinary meaning (i.e., attached or fastened). The Court found that the term “specifies the geophone’s relationship with the housing, not the type of geophone.” As an initial matter, the specification was silent as to whether the geophone was gimbaled or not. “That silence does not support reading the claims to exclude gimbaled geophones,” in part because the specification used the term gimbaled when describing other aspects of the invention. Had the applicant intended to limit the claimed geophone, it would have done so.

Furthermore, the specification described the internal mounting of the geophone as a key feature to overcome issues with the then-conventional method of separating the geophone from the seismometer’s other components. The specification reiterated that by internally mounting the geophone, the invention was “self-contained.” The prosecution history also revealed that both the applicant and examiner understood the term to carry its plain and ordinary meaning, equating “internally fixed within” with “disposed, and electrically connected, within.” That equivalence indicates that the term was intended to describe the relationship of the geophone with the seismometer, rather than to limit the type of geophone as contemplated by the Board. Accordingly, the Court found that the intrinsic record was clear, and that the Board’s reliance on extrinsic evidence—much less extrinsic evidence that was inconsistent with the specification itself—was improper and remanded for [...]

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Publisher’s Co-Authorship Claim Arises Under Copyright Act, Invoking Exclusive Federal Jurisdiction

by Paul Devinsky | Aug 19, 2021 | Copyrights

The US Court of Appeals for the Fifth Circuit reversed a district court’s dismissal of a copyright authorship dispute, finding that the district court had exclusive jurisdiction over the case because a book publisher’s claim of co-authorship arose under the federal Copyright Act, not state contract law. Di Angelo Publ’ns, Inc. v. Kelley, Case No. 20-20523 (5th Cir. Aug. 12, 2021) (Higginbotham, J.)

Makeup artist Jentry Kelley and Di Angelo Publications entered into a publishing contract for Kelley’s cosmetics book. Kelley provided Di Angelo with an initial three-page manuscript, which Di Angelo claimed it then transformed into a book while communicating and collaborating with Kelley. The book listed Kelley only as the holder of the book’s copyright. After an initial 1,000-copy print run, Kelley asked Di Angelo to prepare an updated or revised version of the book for sale. Di Angelo claimed it had prepared the updated work when it discovered that Kelley was attempting to work directly with Di Angelo’s printer to reduce the costs she would incur selling the revised edition, which violated the parties’ contract.

After unsuccessful overtures to the printer, Kelley filed a complaint in Harris County, Texas, asking for rescission of the parties’ contract because Di Angelo intentionally misled her regarding publishing costs and overcharged her for publishing services. Kelley alleged that she was the sole copyright owner and that Di Angelo did not develop or have any intellectual property rights in connection with the book. Di Angelo counterclaimed for breach of contract, among other claims, and sought a declaratory judgment that Kelley failed to substantially perform under the contract. Di Angelo alleged that Kelley had prevented it from selling the updated edition of the book.

Following partial summary judgment in favor of Kelley, including on the declaratory judgment claim, Di Angelo filed suit in the Southern District of Texas. Di Angelo disputed Kelley’s claim to exclusive copyright ownership and asserted a single claim for relief: A declaration that Di Angelo owned the copyright in the two editions of the book, as well as any derivative works, and had rights in their printing and distribution. Additionally,Di Angelo alleged that it acquired copyrights in the books by “writing, editing, planning and taking all photographs and making all illustrations, and planning, designing, and arranging the layout” of the book. Kelley moved to dismiss Di Angelo’s declaratory relief claim, characterizing the suit as an end-run around the Harris County rulings against Di Angelo and arguing that there was no federal jurisdiction because Di Angelo’s claim was premised solely on Kelley’s alleged breach of the contract, which was governed by Texas law. Di Angelo responded that resolution of the authorship dispute required the district court to interpret federal copyright law, including definitional and ownership provisions, which the state court lacked jurisdiction to address. The district court agreed with Kelley on the jurisdictional question and granted the motion to dismiss. Noting that the parties’ contract referred to Kelley as the “author,” the district court found that that Di Angelo’s claim [...]

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Patents and Trade Secrets Aren’t Mutually Exclusive: The Nuanced Nature of Trade Secret Protection

by Paul Devinsky | Aug 19, 2021 | Trade Secrets

Addressing the nuanced nature of trade secret protection of patented products, the US Court of Appeals for the Seventh Circuit affirmed a district court’s trade secret protection determination, finding that the asserted trade secrets were not publicly disclosed and had been adequately protected. Life Spine, Inc. v. Aegis Spine, Inc., Case No. 21-1649 (7th Cir. Aug. 9, 2021) (St. Eve, J.)

The underlying conflict in this case has its roots in a short-lived business relationship between two companies specializing in selling spinal implant devices. Life Spine makes and sells a device called the ProLift Expandable Spacer System. Aegis Spine contracted with Life to distribute Life’s ProLift system to hospitals and surgeons for scheduled surgeries. Under the distribution agreement, Aegis was obligated to protect Life’s confidential information, act as a fiduciary for Life’s property and refrain from reverse engineering the ProLift system. Aegis did not abide by its contractual promises. It gave information about Life’s ProLift system to L&K Biomed, Aegis’s parent company and Life’s direct competitor. L&K used Life’s confidential information to develop a competing spinal implant device. Shortly after L&K’s device appeared on the market, Life sued Aegis for trade secret misappropriation and breach of the distribution agreement. The district court ruled in favor of Life, granting its motion for preliminary injunction against Aegis and its business partners, all of whom could no longer market the competing product. Aegis appealed.

Aegis argued that the injunction rested on the flawed legal conclusion that a company can have trade secret protection on a device that it publicly discloses through patents, displays and sales. The Seventh Circuit disagreed.

While the Court reaffirmed that there can be no trade secret protection in information available in the public domain, it found that such was not the nature of the information sought to be protected in this matter. Rather, the Seventh Circuit agreed with the district court that Life did not publicly disclose the specific information it sought to protect via patenting, displaying and selling its ProLift system.

The ProLift expandable spinal implant consists of the implant (or cage) component and an installer. The cage comprises an upper and lower endplate, a nose and base ramp and an expansion screw. The installer is used to insert the cage into a patient’s spine and expand the affected spinal disc height. Life considers “the precise dimension and measurements of the ProLift components and subcomponents and their interconnectivity” to be confidential trade secrets. The district court found that third parties are unable to access that precise dimensional information without first signing confidentiality agreements, and the information is not available in any of Life’s marketing materials (which include only dimensional approximations) or patents. Life’s ProLift system cannot be purchased by the general public or even handled at industry convention displays without Life’s close supervision. Instead, Life’s distributors sell ProLift directly to hospitals and surgeons for scheduled surgeries only.

The Seventh Circuit noted that “a limited disclosure” does not destroy all trade secret protection on a product, allowing a company [...]

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Injunctive Relief Available Even Where Laches Bars Trademark Infringement, Unfair Competition Damage Claims

by Paul Devinsky | Aug 12, 2021 | Trademarks

The US Court of Appeals for the 11th Circuit affirmed a district court’s conclusion that laches barred an advertising and marketing company’s claims for monetary damages for trademark infringement and unfair competition, but remanded the case for assessment of injunctive relief to protect the public’s interest in avoiding confusion between two similarly named companies operating in the advertising sector. Pinnacle Advertising and Marketing Group, Inc. v. Pinnacle Advertising and Marketing Group, LLC, Case No. 19-15167 (11th Cir. Aug. 2, 2021) (Branch, J.)

Pinnacle Advertising and Marketing Group (Pinnacle Illinois) is an Illinois-based company and owner of two registered trademarks including the name “Pinnacle.” Pinnacle Illinois learned of a Florida-based company operating under almost the same name that was also in the advertising and marketing space—Pinnacle Advertising and Marketing Group (Pinnacle Florida) —through potential clients and a magazine’s accidental conflation of the two unrelated companies. Several years later, Pinnacle Illinois sued Pinnacle Florida for trademark infringement, unfair competition and cybersquatting. Pinnacle Florida filed a counterclaim seeking to cancel Pinnacle Illinois’s trademark registrations and also alleged that Pinnacle Illinois’s claims were barred by the doctrine of laches.

Following a jury trial, the district court granted Pinnacle Florida’s motion for judgment as a matter of law on Pinnacle Illinois’s cybersquatting claim. The jury returned a verdict in favor of Pinnacle Illinois on its claims for trademark infringement and unfair competition, awarding Pinnacle Illinois $550,000 in damages. The district court then granted Pinnacle Florida’s motion for judgment as a matter of law on its laches defense, concluding that Pinnacle Illinois’s trademark infringement and unfair competition claims were barred by laches because it waited more than four years to bring suit after it should have known that it had a potential infringement claim against Pinnacle Florida. The district court also cancelled Pinnacle Illinois’s registrations because it concluded that Pinnacle Illinois’s marks were merely descriptive and lacked secondary meaning. Pinnacle Illinois appealed.

Pinnacle Illinois argued that the district court abused its discretion in finding that Pinnacle Illinois’s claims were barred by laches, and that even if laches did bar Pinnacle Illinois’s claims for money damages, the district court should have considered whether injunctive relief was proper to protect the public’s interest in avoiding confusion between the two companies. Pinnacle Illinois also argued that the district court erred when it cancelled its registrations without regard to the jury’s findings of distinctiveness and protectability or the presumption of distinctiveness afforded to its registered marks.

The 11th Circuit found that the district court did not abuse its discretion in determining that laches barred Pinnacle Illinois from bringing its trademark infringement and unfair competition claims for monetary damages. Pinnacle Illinois sued after the Florida four-year statute of limitations had passed, and the Court found that the company was not excused for its delay because it did not communicate with Pinnacle Florida about the infringement until it filed suit. Pinnacle Florida also suffered economic prejudice because it invested significant time and money, including around $2 million, in developing its business under [...]

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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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The Skinny Label That Wasn’t—Federal Circuit Reinstates Induced Infringement Verdict

by Paul Devinsky | Aug 12, 2021 | Patents

The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by an attempted “skinny label” that nonetheless encouraged doctors to engage in a patented use. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Case Nos. 18-1876, -2023 (Fed. Cir. Aug. 5, 2021) (Moore, C.J.) (Prost, J., dissenting).

GlaxoSmithKline LLC (GSK) sells a drug called carvedilol (brand name Coreg®), which is approved for three indications: Hypertension, congestive heart failure (CHF) and left ventricular dysfunction following a myocardial infarction (post-MI LVD). In 2002, Teva filed an abbreviated new drug application (ANDA) for US Food and Drug Administration (FDA) approval of its generic carvedilol for all three indications. At that time, GSK’s patent on the carvedilol compound was still in force; Teva certified that it would not launch its product until the patent expired in 2007. GSK also had a second patent on a method of treating CHF using carvedilol and a second agent. In 2002, Teva sent GSK a Paragraph IV notice contending that the claims of that patent were invalid over prior art. Rather than sue Teva, GSK applied for reissue of the patent. In 2004, Teva received FDA “tentative approval” for its ANDA “for the treatment of heart failure and hypertension,” which was to become effective at the expiry of the compound patent in 2007.

In January 2008, the method-of-use patent reissued with claims directed to a method of decreasing mortality caused by CHF by administering carvedilol with at least one other therapeutic agent. Just before its launch in 2007, Teva certified to the FDA that its label would not include the indication listed in the Orange Book as covered by the original method-of-use patent (i.e., “decreasing mortality caused by congestive heart failure”), and thus included only the hypertension and post-MI LVD indications. Teva’s press releases stated that its generic carvedilol was “indicated for treatment of heart failure and hypertension.” In 2011, the FDA asked Teva to revise its labeling to be identical with GSK’s. Teva obliged (listing again the CHF indication) and took the position that it did not need to provide certification for the reissued patent because it received final approval of its ANDA before the patent reissued. GSK sued.

GSK won a jury verdict that the challenged patents had not been shown to be invalid and that Teva was liable for induced infringement. At trial, GSK contended—and the jury heard evidence—that post-MI LVD is a form (and fell within the Court’s construction) of CHF such that Teva’s attempted skinny label nonetheless encouraged doctors to engage in a patented use. After trial, however, the district court granted JMOL of non-infringement because the CHF and post-MI LVD indications were different. On appeal, the Federal Circuit found that substantial evidence supported the implied jury, finding that post-MI LVD is a form of CHF such that the label with the post-MI LVD indication induced infringement of the reissued [...]

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