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Navigating the Interplay Between the ITC, PTAB and District Courts

by McDermott Will & Schulte | Jun 3, 2021 | Patents

Recent changes in intellectual property law in the US International Trade Commission (ITC), the Patent Trial and Appeal Board (PTAB) and federal US District Courts have had major impacts on litigation strategy and business operations. Within these venues, key changes often run parallel to each other, and understanding and maximizing the interplay between them is critical to formulizing an IP strategy. A panel of McDermott attorneys, including Charlie McMahon, Amol Parikh, Jay Reiziss and Jiaxiao Zhang, recently hosted a webinar exploring these issues in collaboration with IAM and Lexology. Click here to watch their discussion of the complexities of these related developments as well as innovative and practical insights to help you navigate them.

KEY TAKEAWAYS

The rate at which the PTAB institutes petitions for Inter Partes Review (IPR) has been steadily declining, with a newer low expected this year. The falling institution rate over the last several years is attributable in part to discretionary denial under § 314(a).
Until 2020, there was still uncertainty behind the contours of how the PTAB’s discretionary denial would be applied when there was a co-pending district court or ITC proceeding. Last year, the PTAB designated as precedential its decision in Apple v. Fintiv, setting forth factors intended to guide the discretionary decision to institute when there are parallel proceedings.
Post-Fintiv, it looks less likely that litigants will be able to simultaneously pursue district court litigation and a PTAB proceeding. One of the benefits of the PTAB is the lower burden of proof to demonstrate that a patent is unpatentable. Removing this tool from the litigation toolbox could have a profound impact on defensive strategy.
It is still unclear how the PTAB’s Finitiv decision will apply to ITC investigations. Fitness technology companies, among others, have since asked the PTAB’s Precedential Opinion Panel (POP) to determine whether Fintiv should apply to parallel ITC investigations.
There have also been additional developments at the ITC related to the use of licensing to satisfy the domestic industry requirement. The pending Advancing America’s Interests Act (AAIA) would significantly change how complainants can rely upon licensing activities to establish a domestic industry.

It’s Highlighted and Verified: Reversal of PTAB Non-Obviousness Decision

by Cecilia Choy, Ph.D. | Jun 3, 2021 | Patents

In a relatively unusual outcome, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board (Board) decision finding non-obviousness in an inter partes review (IPR). Becton, Dickinson, and Co. v. Baxter Corp. Englewood, Case No. 20-1937 (Fed. Cir. May 28, 2021) (Dyk, J.)

Becton petitioned the Board for IPR of Baxter’s pre-America Invents Act (AIA) patent, directed to a system for preparing patient-specific doses and a method for telepharmacy. The Board decided that the patent claims were not shown to be invalid as obvious, but also found that Baxter’s secondary considerations evidence was “weak.” Becton appealed based on two contested limitations: a verification limitation and a highlighting limitation. The Federal Circuit reversed the Board, concluding that the challenged claims were obvious and explained that weak evidence of secondary considerations could not overcome the strong showing of obviousness.

First, the Federal Circuit decided that the Board erred in finding that a prior art reference that taught a remote pharmacist may verify a dose preparation did not render obvious a claimed method where a remote pharmacist must verify. The reference made clear that a non-pharmacist could not further process work without the verification step. Baxter’s own expert witness conceded that, in accordance with the teachings of the prior art, a non-pharmacist would be disciplined for continuing to process dose preparation without authorization. The Court concluded there was no significant difference between the teaching in the prior art reference and Baxter’s verification requirement.

Second, the Federal Circuit decided that the Board erred in finding that the “highlighting” limitation as it relates to a set of drug preparation steps on a computer was non-obvious. In what it characterized as a “close case,” the Board decided that a prior art reference’s teachings highlighting patient characteristics when dispensing repackaged medication did not make obvious highlighting, in a drug formulation context, prompts for additional information. Citing KSR v. Teleflex, the Court explained that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” The reference taught highlighting in terms of various inputs and information delivered. Becton’s expert testified that one of ordinary skill would understand from the reference that other information, such as prescription order information, could be displayed on the user interface. Baxter’s expert did not contradict Becton’s expert. Because “a person of ordinary skill is also a person of ordinary creativity, not an automaton,” the Board erred in using that one reference as the only source for what one of ordinary skill would consider.

Lastly, Baxter unsuccessfully argued that under pre-AIA 35 U.S.C. § 102(e)(2), one of the patent references was ineligible as prior art. Sec. 102(e)(2) provides that a prior art reference may be a “patent granted” on another’s application filed in the United States before the invention by the applicant. Baxter argued that since the claims of the reference were cancelled after a 2018 IPR, the reference no longer qualified as a “patent granted” [...]

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PTO Rules Not Subject to the Paperwork Reduction Act

by McDermott Will & Schulte | May 27, 2021 | Patents

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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by McDermott Will & Schulte | May 27, 2021 |

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Arthrex Argument May Be Available in Round Two

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Arthrex Argument May Be Available in Round Two

by McDermott Will & Schulte | May 20, 2021 | Patents

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

by Paul Devinsky | May 20, 2021 | Patents

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

by Paul Devinsky | May 13, 2021 | Trademarks

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

by Brian Moore | May 13, 2021 | Patents

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.

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

by Paul Devinsky | May 6, 2021 | Patents

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

by Christopher M. Bruno | Apr 29, 2021 | Patents

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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