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PTO Rules Not Subject to the Paperwork Reduction Act

The US Court of Appeals for the Ninth Circuit concluded that certain challenged rules of the US Patent and Trademark Office (PTO) that relate to the patent application process do not violate the Paperwork Reduction Act (PRA) because each called for a response to an individualized communication; a category which is expressly exempted from the PRA. Hyatt v. Office of Management and Budget, Case No. 20-15590 (9th Cir. May 20, 2021) (Nguyen, J.).

Inventor Gilbert Hyatt and the American Association for Equitable Treatment (AAET) contended that patent applicants should not have to comply with certain PTO rules, alleging that the rules violated the PRA, which Congress passed to reduce the burden imposed on the public when responding to federal agencies’ requests for information from private individuals. The PRA requires federal agencies engaged in “collections of information” to first submit them to the Office of Management and Budget (OMB) for approval and an assignment of a control number. Collections of things other than “information” do not need to receive OMB approval, and the PRA applies only to “collections” seeking information through identical questions or requirements imposed on 10 or more people. Thus, the PRA and its regulations expressly exclude individualized communications from PRA applicability.

Hyatt asked OMB to review PTO rules 111, 115 and 116, arguing that those rules imposed “collections of information” under the PRA. Hyatt suggested that because the rules had not received OMB approval and control numbers, he was not required to maintain, provide or disclose the information these rules referenced. OMB responded that it had already determined that “these collections are not subject to the PRA because what is collected is not considered ‘information,’ pursuant to [three] exemptions in OMB’s PRA implementing regulation”:

  • Exemption 1: “[a]ffidavits, oaths, affirmations, certifications . . . provided that they entail no burden other than that necessary to identify the respondent, the date, the respondent’s address, and the nature of the instrument. . .”
  • Exemption 6: “request[s] for facts or opinions addressed to a single person”
  • Exemption 9: “[f]acts or opinions obtained or solicited through nonstandardized follow-up questions designed to clarify responses to approved collections of information.”

5 C.F.R. §§ 1320.3(h)(1), (6), (9).

AAET made similar arguments in submitting three requests to OMB on PTO rules 105, 130, 131 and 132 and MPEP § 2173.05(n). In its response to AAET, OMB only stated that “the requests under Rule 1.105 are not subject to the PRA because the responses to questions submitted under Rule 1.105 are not ‘information,’ but instead are exempt under” Exemption 9. AAET submitted three more requests to OMB on the same rules with similar arguments. OMB responded that Rules 105, 130, 131 and 132 and MPEP § 2173.05(n) were exempt under Exemptions 6 and 9; and Rules 130, 131 and 132 were additionally exempt under Exemption 1.

Hyatt and AAET sued OMB in district court, alleging that OMB’s denial of their petitions was arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law in [...]

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Arthrex Argument May Be Available in Round Two

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Arthrex Argument May Be Available in Round Two

The US Court of Appeals for the Federal Circuit found that a party did not waive the Patent Trial & Appeal Board’s (Board) constitutionality argument by raising it for the first time in its opening brief because the Court’s decision in Arthrex, Inc. v. Smith & Nephew, Inc. was issued after the party sought rehearing. New Vision Gaming v. SG Gaming, Inc., Case Nos. 20-1399, -1400 (Fed. Cir. May 13, 2021) (Moore, J.) (Newman, J. concurring in part, dissenting in part)

New Vision appealed two covered-business method (CBM) review final written decisions in which the Board found that all claims of the patents, as well as its proposed substitute claims, were directed to patent ineligible subject matter under 35 U.S.C. § 101. In its opening brief before the Federal Circuit, New Vision requested the Court vacate and remand the Board’s decisions in light of Arthrex. SG Gaming argued New Vision had waived its right to a challenge under Arthrex since it raised it for the first time on an appeal. The Court disagreed, finding that New Vision had not waived its ability to challenge the Board’s decision under Arthrex since Arthrex was issued after the Board’s final written decisions and after New Vision sought Board rehearing. The Court vacated the Board’s final written decisions in the CBMs and remanded for further proceedings consistent with Arthrex without reaching the merits or any other issues.

In her partial dissent, Judge Pauline Newman agreed that Arthrex applied and vacating the Board’s final written decisions was appropriate. She also argued that another threshold issue (venue) should have been resolved, rendering the remand under Arthrex unnecessary and unwarranted. Additionally, Judge Newman agreed with New Vision that since the parties agreed to a different forum for dispute resolution in their license agreement, compliance with the parties’ patent license agreement would be appropriate. Under that agreement, if “any dispute” arose, jurisdiction would be “exclusive” in the appropriate federal or state court in the state of Nevada. New Vision filed suit in the federal district court in Nevada before SG filed CBM petitions before the Board. The Board stated it “[does] not discern, nor has Patent Owner pointed to, any portions of chapter 32 or § 18 of the AIA, or authority otherwise, that explicitly provide for a contractual estoppel defense,” in its decision and proceeded to a final decision despite the forum selection agreement.

Both parties briefed the forum selection question, with New Vision citing the Federal Circuit 2019 decision in Dodocase VR v. MerchSource in which a case was removed from the Board based on an agreed choice of forum. SG countered that the Board’s rejection of choice of forum is an unreviewable “institution” decision under Thryv vs. Click-to-Call. Andrei Iancu, the Director of the US Patent and Trademark Office (USPTO), intervened in the appeal, arguing that the Board’s decision is “final and nonappealable” under 35 U.S.C. § 324(e). As to the Board’s “conduct” in declining to [...]

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Full Scope of Claimed Invention Must Be Enabled

In a case relating to nucleic acid sequencing, the US Court of Appeals for the Federal Circuit upheld a jury verdict of non-enablement because a skilled artisan would have only known how to successfully practice a narrow range of the full scope of the nucleic acids covered by the asserted claim at the time of the invention. Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Case No. 21-2155, -2156 (Fed. Cir. May 11, 2021) (Taranto, J.)

PacBio sued Oxford for infringement of two patents related to methods for sequencing nucleic acids (such as DNA) using nanopore technology. The methods involve drawing nucleic acids through a nanometer-sized hole formed in a substrate. A voltage is applied to the substrate, and as the nucleic acids pass through the hole, the identity of each nucleic acid is identified based on changes in electric current passing through the substrate.

At trial, Oxford’s lawyer made opening remarks that included references to the potential applications of Oxford’s accused products to the then-emerging global COVID-19 crisis. PacBio immediately objected, and the district court gave exactly the curative instruction that PacBio requested. The district court also required that going forward, the parties give advance notice if they intended to make any reference to COVID-19. Ultimately, the jury found all asserted claims infringed, but also determined that the claims were invalid for lack of enablement under 35 USC § 112. In post-trial motions, the district court denied PacBio’s request that the court grant a new trial because of Oxford’s remark during opening statements regarding the accused products’ potential application to the then-emerging COVID-19 crisis. PacBio appealed.

On appeal, PacBio argued that the jury’s finding of lack of enablement was unsupported by the evidence, citing to testimony from its expert that a person skilled in the art at the priority date would have been able to successfully perform the methods of the asserted claims. The Federal Circuit disagreed, noting that the expert only demonstrated successful practice of the asserted claims for a narrow subset of nucleic acids covered by the claims—namely DNA hairpin molecules. The Court cited evidence where PacBio admitted through a stipulation that it had never performed the nanopore sequencing methods of the asserted claims, meaning its reduction to practice was purely constructive. The Court also noted that Oxford produced evidence that it was not until 2011 (two years after the priority date) that anyone in the field was able to use nanopore sequencing to sequence biological DNA—a different type of nucleic acid within the scope of the asserted claims. Thus, the Court found that PacBio had only demonstrated that a person of skill in the art would have been able to successfully practice a narrow range of the full scope of the nucleic acids covered by the asserted claim. The Court explained that it is not enough for enablement that the relevant artisans knew how to perform some nanopore sequencing before the priority date. Instead, what matters is the scope of the asserted claims, which relate [...]

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Use is ACTUALLY Measured by Benefit

Addressing whether a service mark owner had established a protectable interest in his marks through actual or analogous use, the US Court of Appeals for the 10th Circuit reversed in part the district court’s grant of summary judgment for the alleged infringer, explaining that by focusing on sales, the district court applied the wrong legal standard for analyzing actual use. Underwood v. Bank of Am. Corp., Case Nos. 19-1349, 20-1087 (10th Cir. Apr. 30, 2021) (Matheson, J.)

In 2010, Erik Underwood and My24HourNews.com (collectively, Underwood) applied for, and were granted, registration of a service mark in Georgia for a computer-animated woman named Erica who verbally reports the news through cell phones and computer programs. In 2012, Underwood registered the domain name for a website, my24erica.com. On the website, E.R.I.C.A. could answer questions and offer recommendations regarding movies and television shows. In 2016, Bank of America filed an intent to use application with the US Patent and Trademark Office for ERICA, a mark for goods and services including voice-controlled information, personal assistant banking and finance services. Underwood sued Bank of America, alleging common law service mark infringement of two marks, E.R.I.C.A. and my24erica.com.

The district court granted summary judgment for Bank of America, concluding that Underwood had not established a protectable interest in either of the marks through actual or analogous use. Underwood appealed.

The 10th Circuit concluded that the district court applied the wrong legal standard and committed two legal errors in its analysis of the issue of actual use of the E.R.I.C.A. mark. First, the district court erred by assuming that in order to establish actual use, Underwood’s customers must have purchased the services offered or Underwood must have generated revenue, because actual use is measured by benefit—not sales to third parties. Second, the district court erred by limiting the services at issue to those listed on the Georgia registration (i.e., newscasting). Instead, the district court should have considered all services identified by the mark, including those on the my24erica.com website (i.e., search engine and personal assistant services). The Court remanded the issue of actual use to permit the district court to address the factual issues under the correct legal standard.

Analogous use of a mark is use in commerce that is non-transactional, e.g., promotional efforts for the goods or services, such as advertising brochures, catalogs, newspaper ads, and articles in newspapers and trade publications. Although actual use need not have a substantial impact on the purchasing public, analogous use must be “of such a nature and extent as to create public identification of the target term with the [user’s] product or service.” To qualify as analogous use, the use must be open and notorious, i.e., “of such a nature and extent that the mark has become popularized in the public mind so that the relevant segment of the public identifies the marked goods with the mark’s adopter.” Because the analogous use in terms of the E.R.I.C.A. mark had large gaps in time; consisted only of PowerPoint presentations at [...]

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Tax Court Allows Partial Deduction, Requires Partial Capitalization of Generic Drug Approval Legal Expenses

The US Tax Court determined that a pharmaceutical manufacturer’s legal expenses incurred to defend against a patent infringement suit were eligible for an immediate deduction as ordinary and necessary business expenses, while legal expenses incurred as part of an abbreviated new drug application (ANDA) were not eligible for an immediate deduction and thus had to be capitalized and then amortized over 15 years. Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (Apr. 27, 2021) (Urda, J.)

The ANDA process allows for faster approval of a generic drug if the manufacturer can show that the generic drug is sufficiently similar to an approved brand name drug. As part of the ANDA process, the generic manufacturer must file statements certifying that the generic drug does not infringe any brand drug patents, or that such patents are invalid. The generic manufacturer also must send a notification to the holder of any patents covered by the certification statements.

Mylan filed several ANDAs for generic versions of brand name drugs, including Celebrex, Lunesta and Nexium, during the tax years at issue in the case. Considerable legal expenses were incurred as part of filing the ANDAs and making the required certifications and notifications. As a result of those certifications and notifications, patent holders brought approximately 120 patent infringement suits against Mylan. Mylan defended itself against the infringement suits, incurring litigation expenses.

In general, taxpayers may take an immediate deduction for ordinary and necessary business expenses. However, taxpayers must capitalize expenditures that create or enhance a distinct asset or otherwise generate benefits for taxpayers beyond a single tax year. Special rules apply to determine whether expenses related to an intangible asset should be capitalized. The income tax regulations provide that a “taxpayer must capitalize amounts paid to a governmental agency to obtain, renew, renegotiate, or upgrade its rights under a trademark, trade name, copyright, license, permit, franchise, or other similar right granted by that governmental agency.” Taxpayers must also capitalize an amount paid to facilitate an acquisition or creation of an intangible.

Litigation expenses for patent suits may be deducted or must be capitalized depending on the nature of the litigation. Defense of title claims are treated as the acquisition or disposition of a capital asset and must be capitalized. In contrast, patent infringement claims arise in tort and can be deducted in the year the expense is incurred.

Applying these rules to Mylan’s legal expenses, the Tax Court held that expenses related to the preparation of the ANDA, including the certifications and notices, were capital expenses to acquire or create an intangible asset and had to be recovered incrementally over 15 years. However, the Tax Court held that the costs of defending against patent infringement suits is an ordinary and necessary business expense for a generic drug manufacturer and permitted Mylan to deduct its litigation expenses in the year the expense was incurred.




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Employment Agreement Assignment Provisions Don’t Reach Post-Employment Inventions

The US Court of Appeals for the Federal Circuit rejected a biotechnology company’s argument that assignment provisions in its employment agreements granted ownership rights in post-employment inventions. Bio-Rad Laboratories, Inc. v. Int’l Trade Comm’n, Case No. 20-1785 (Fed. Cir. Apr. 29, 2021) (Taranto, J.)

10X filed an International Trade Commission (ITC) complaint against Bio-Rad, alleging that Bio-Rad’s microfluidic systems infringed 10X’s gene sequencing patents. Bio-Rad raised an affirmative defense alleging that it co-owned the asserted patents because two of the named inventors, formerly employed by Bio-Rad and its predecessor QuantaLife before forming 10X, conceived the ideas embodied in the patents while they were still employed by Bio-Rad. The two inventors had executed employment agreements, including provisions requiring disclosure and assignment of intellectual property created during their employment with Bio-Rad. The two inventors left Bio-Rad and formed 10X several months before the earliest conception date of the asserted patents.

The ITC administrative law judge rejected Bio-Rad’s co-ownership defense, concluding that Bio-Rad had not shown the inventive concept of the asserted patents was conceived before the inventors left Bio-Rad. The administrative law judge also found that Bio-Rad infringed 10X’s patents and that 10X satisfied the technical domestic industry requirement by practicing the asserted patents. The ITC affirmed the administrative law judge’s determinations and also found that the asserted claims were not invalid for indefiniteness. Bio-Rad appealed.

Bio-Rad argued, among other things, that the ITC erred in not finding co-ownership of the asserted patents based on the assignment provisions. Bio-Rad also contended that during their employment at Bio-Rad, the two inventors had conceived the ideas that contributed to the inventions reflected in the 10X patents, and the invention assignment provisions of their employment agreement required assignment of their interest to Bio-Rad.

The Federal Circuit affirmed the ITC. On the co-inventorship issue, the Court adopted the ITC’s conclusion and found that Bio-Rad had no ownership interest in the asserted patents, explaining that the assignment provisions did not apply to ideas developed during employment solely because the ideas ended up contributing to a post-employment patentable invention. The Court found that the language was limited to a grant of actual intellectual property, i.e., subject matter protectable as a patent created during the term of employment with Bio-Rad. The Court reasoned that a person’s work that contributes, even significantly, to a later patentable invention does not create protectable intellectual property until a patentable invention is made, and that therefore, the assignment provisions did not reach the ideas that Bio-Rad alleged were conceived during the inventors’ Bio-Rad employment.

The Court also noted policy reasons for limiting the reach of the assignment provisions, including the difficult compliance issues raised by requiring assignment of rights in post-employment inventions. The Court explained that such provisions might deter a former employee from pursuing work related to their prior work, or deter a potential future employer from hiring that individual to work in an area similar to that in which they had prior experience. The Court also agreed with the ITC’s conclusion that [...]

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If You Can’t Build it, They Won’t Come: No Obviousness Based on Fanciful Engine Design

Reaffirming that a person of ordinary skill in the art must have been able to actually create a disclosure at the time of invention in order for it to serve as an obviousness reference, the US Court of Appeals for the Federal Circuit reversed a decision by the Patent Trial & Appeal Board (the Board) in an inter partes review (IPR), concluding that a patent covering certain turbofan engine technology was not rendered obvious by a prior art publication that could not be realized into practice. Raytheon Techs. Corp. v. General Electric Co., Case No. 20-1755 (Fed. Cir. Apr. 16, 2021) (Chen, J.)

The issue on appeal was relatively straightforward. In an IPR, GE challenged as obvious a Raytheon patent that covered a specific design of geared gas turbine engine that provided for a “power density” higher than previously invented turbine engines. The patent defined “power density” as a “sea-level-takeoff thrust” divided by the engine turbine volume. During the IPR, GE relied on a 1987 NASA technical memorandum as art and argued that the reference, which envisioned superior performance characteristics based on an advanced engine that was made entirely of composite materials, rendered the challenged claims obvious. The parties did not dispute that this engine was unattainable in 1987, and may still be impossible today, because the envisioned composite materials do not yet (and may never) exist. The memorandum disclosed several performance factors, but not power density, sea-level-takeoff thrust or turbine volume. Nonetheless, GE argued, and the Board agreed, that the memorandum disclosed performance parameters that would have permitted an ordinarily skilled artisan to derive power densities that would have fallen within the range claimed in Raytheon’s patent.

On appeal, the Federal Circuit agreed with Raytheon, concluding that the imaginary engine of the NASA memorandum could not serve as an invalidating reference. In reversing the Board, the Federal Circuit reiterated two bedrock principles of obviousness law:

  • An obviousness reference must be enabled by the knowledge of an ordinarily skilled artisan at the time of the invention (but need not be self-enabling).
  • An invention cannot be rendered obvious by a non-self-enabling reference if no other prior art evidence or reference enables the non-self-enabling reference.

In addition, when a reference’s enablement is challenged, the party offering the reference bears a burden to establish that the reference, itself or in combination with other contemporaneous knowledge, was enabled.

Applying these principles here, the Federal Circuit determined that GE had not met its burden to show that the memorandum was indeed enabled. The Board, wrongly in the Court’s view, focused solely on whether an ordinarily skilled artisan was taught the parameters to ascertain a power density, rather than whether the prior art disclosed a turbofan engine possessing the requisite power density. Finding no evidence in the record to conclude that “a skilled artisan could have made the claimed turbofan engine with the recited power density,” the Court reversed.

Practice Note: Although this case does not break new obviousness ground, it reinforces the general [...]

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You Want Some “Metchup” with That?

The US Court of Appeals for the Fifth Circuit found no infringement by a large, well-known company that used the registered mark of an individual whose own use was local and generated only a few sales and minimal profits. The Court vacated and remanded the case to determine whether plaintiff had abandoned the mark. Dennis Perry v. H.J. Heinz Co. Brands, L.L.C., Case No. 20-30418 (5th Cir. Apr. 12, 2021) (Graves, J.)

In 2010, Dennis Perry created a condiment concoction in his home kitchen that he named “Metchup,” constituting a blend of private label mustard and ketchup, and a blend of mayonnaise and ketchup. Perry sold the concoction in the lobby of his small motel in Louisiana. The US Patent & Trademark Office granted registration for his trademark “Metchup” and after five years declared his mark “incontestable.” Perry had slow sales, however, only selling about 60 bottles with $50 total profit over the years. Perry had a Facebook page for his product, but did not advertise or sell the product in stores or online.

Meanwhile, Heinz produced a condiment called “Mayochup,” a blend of mayonnaise and ketchup, that it began selling in the United States in 2018. Heinz held an online naming contest to promote its product, and when one participant suggested the name “Metchup,” Heinz posted a mock-up picture with the “Metchup” name, along with other proposals. Heinz’s counsel saw Perry’s trademark registration, but because Heinz was not actually selling a product named “Metchup” and there were so few indications that Perry’s product was actually being sold, Heinz concluded that Perry’s mark was not in use and could be used in its promotion. When Perry saw Heinz’s posting, he sued for trademark infringement.

The district court found that while Perry may have once had a valid trademark registration for “Metchup,” there was no likelihood of confusion with the Heinz product and the mark had been abandoned as a consequence of de minimis use. Perry appealed.

The Fifth Circuit analyzed the dispute based on the eight-factor likelihood of confusion test. The Court found three factors weighed in Perry’s favor:

  • Product similarity: Both products were mixed condiments.
  • Potential purchaser care: Consumers would exercise less care for a low-priced condiment.
  • Mark similarity: Both products used the same word “Metchup,” although the Court noted that the packaging design looked very different.

The Court also found five factors weighed in Heinz’s favor:

  • The type of mark on the spectrum (i.e., whether the name is related to what the product is): Here, the mark was “suggestive” because it was a mash-up of names related to the sauces used.
  • Outlet and purchaser identity: The parties targeted different markets because Perry had limited sales in one motel, while Heinz targeted online and at almost all grocery stores.
  • Advertising identity: Perry did not advertise besides his one Facebook page without online sales, while Heinz had large-scale advertising and sales.
  • Defendant’s intent: Heinz did not intend to infringe because it assumed Perry’s mark was no longer [...]

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Inventions Not Made Under Employment Agreement

Applying a “middle ground” standard of review, the US Court of Appeals for the First Circuit affirmed a district court’s decision denying a company’s request for a declaratory judgment asking a former employee to assign patent rights to the company under the employment and separation agreements, because there were inconsistencies in the jury verdict. Covidien LP; Covidien Holding Inc. v. Brady Esch, Case No. 20-1515 (1st Cir. Apr. 8, 2021) (Gelpi, CDJ.)

During his employment with Covidien, Esch signed employment and separation agreements, which required a duty of confidentiality, an obligation to disclose any invention created during his employment with Covidien or within one year after leaving Covidien, and assignment of such inventions to Covidien. After his termination, Esch founded his own company (Venclose) and filed patent applications that were assigned to Venclose. Covidien sued Esch for breach of confidentiality and breach of obligation to disclose inventions.

At trial, the jury found that Esch breached his duty of confidentiality by publication of the patent applications, but did not breach his obligation to disclose inventions to Covidien under the agreements (question 3 on verdict form). The verdict form also included questions 6-8 concerning whether inventions were made under the agreements, but the jury was not required to answer these questions if the answer to question 3 was negative. After trial, Covidien moved for a declaratory judgment requesting that Esch assign patent rights to Covidien pursuant to the assignment provision of the agreements. The district court denied the motion, finding that the jury verdict questions were “internally inconsistent” and that “the jury’s ‘decisive’ negative answer to Question 3 could only be read as a factual finding that no ‘Inventions’ were made that are encompassed under the Employment Agreement.” Covidien appealed.

The First Circuit agreed with the district court, applying a “middle ground” standard, which is more rigorous than abuse of discretion but less open-ended than de novo review. This standard of review “requires attentively digest[ing] the facts and the district court’s stated reasons.” The Court found that the district court sufficiently addressed the agreements under applicable Massachusetts law and specifically explained the definition of “inventions” and the assignment requirement to the jury. The Court found that Covidien’s request that the jury should answer questions 6-8 regardless of the answer to question 3 was neither “substantively correct” nor “essential to an important issue,” and was an instruction “substantially covered in the charge.” Further, the Court found that the “internally inconsistent” jury verdict, namely that Esch met his disclosure obligation by violating his confidentiality duty via publication of the patent applications, could only be read as a factual finding that there were no inventions encompassed by the agreement. Accordingly, the First Circuit concluded that the district court did not abuse its discretion in denying Covidien’s post-trial declaratory judgment request.




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