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Intellectual Property US Patent and Trademark Office (USPTO) The USPTO is the agency that issues all patents in the United States and administers post-grant review proceedings; therefore, it is an important agency for any life sciences company looking to protect its intellectual property. Under a prior ruling in the Federal Circuit, it was established that the USPTO’s interpretations of substantive patent law were not subject to deference because the agency was never granted substantive rulemaking authority by Congress. Instead, USPTO interpretations of substantive patent law have been reviewed de novo on appeal. Therefore, Loper Bright will not impact how substantive patent law is interpreted at the USPTO. Nor will the decision affect cases where the Federal Circuit holds that there is no statutory ambiguity, which has frequently been the case. However, Loper Bright will likely impact how the Federal Circuit treats the USPTO’s interpretations of its own ambiguous procedural statutes, as the USPTO previously enjoyed deference in those instances. There may, accordingly, be an increase in challenges at the Federal Circuit with respect to how the USPTO implements its procedural requirements, including while administering inter partes review.

The Court’s decision in Loper Bright will likely have a significant impact on all regulated industries, including the highly regulated life sciences industry. The decision may provide opportunities to raise new or enhanced arguments at various stages of proceedings to support or oppose an agency’s interpretation, as well as new proactive challenges to existing agency rules or standards. This is especially true with respect to disputes pending in the federal courts, including rulemaking challenges or agency decision appeals. The exact impact of Loper Bright on the life sciences industry will likely only be truly known with the passage of time. What is clear, however, is that the Loper Bright decision will affect the application and interpretation of a significant number of the statutes under which the life sciences industry operates. This will impact a multitude of areas, including regulation by the Food and Drug Administration (FDA), healthcare and product reimbursement, white collar enforcement and investigations, intellectual property, Federal Trade Commission and antitrust enforcement, international trade and national security regulation, public company disclosures, environmental regulation, government contracting, business transactions, and litigation, which we discuss below.

The Law of Unintended Consequences In evaluating the potential dismantling of the Chevron doctrine, it’s instructive to consider the principle known as “the law of unintended consequences” and the metaphor of Chesterton’s Fence. The latter, from the writings of G.K. Chesterton, suggests that one should not remove a fence without first understanding why it was erected in the first place. This wisdom underscores the importance of considering the original purpose and the potential ramifications of altering long-standing legal and regulatory structures, such as Chevron deference. The principle of Chesterton’s Fence—urging caution before removing established structures without understanding their purpose—is illustrated in the passage of the America Invents Act (AIA) of 2011. Enacted with the intention of streamlining the patent process and reducing litigation, the AIA marked the most significant overhaul of the U.S. patent system in decades. Among its reforms, the shift from a “first-to-invent” to a “first-inventor-to-file” system was aimed at simplifying the application process and aligning U.S. patent law with international standards. However, the AIA’s well-intentioned changes brought about unintended consequences that underscore the complexity of reforming existing laws—including intellectual property laws. Some smaller inventors and startups, which the patent system seeks to protect and encourage, found themselves at a disadvantage to larger counterparts, struggling with the increased pace and cost of filing patents in what has become more of a “race to the patent office” environment. This real-world example underscores not just the potential for unintended consequences within patent law, but also serves as a cautionary tale for broader regulatory environments. As the AIA’s reforms have shown, changes intended to simplify and improve one area of the law can lead to increased challenges for those it aims to benefit, particularly small entities and startups. This experience mirrors the concerns surrounding the potential overhaul of the Chevron doctrine. The doctrine, much like a proverbial fence, was established to address specific needs within the regulatory and judicial landscape, balancing agency expertise and judicial oversight. It has, over the decades, facilitated a certain predictability and efficiency in how federal statutes are interpreted and enforced, particularly in complex areas intersecting with intellectual property law. Intellectual property, by its nature, thrives on a delicate balance between protecting innovators’ rights and fostering a competitive, dynamic environment conducive to further innovation. As we await the Supreme Court’s ruling regarding the fate of the Chevron doctrine, it’s important to ponder the “fence” that Chevron represents—not just as a barrier but as a boundary that delineates roles and responsibilities within the federal regulatory framework. Removing this boundary without fully appreciating its function could introduce a series of unintended consequences, particularly for the realm of intellectual property. These consequences might manifest as increased litigation, higher barriers to entry for startups, and a chilling effect on the very innovation that intellectual property laws are designed to promote.

The impending decision on the Chevron doctrine not only raises questions about the direction of the United States Patent and Trademark Office (USPTO), but also signals potential shifts across a spectrum of regulatory environments intersecting with intellectual property (IP). The USPTO, which relies on Chevron deference for interpreting complex statutes in patent law, exemplifies the immediate challenges of a post-Chevron landscape. Should this deference be curtailed, the agency’s decisions and regulations might face heightened scrutiny and uncertainty, complicating the patent examination process and affecting applicants’ strategies. This scenario at the USPTO serves as a microcosm for the broader regulatory ecosystem. Similar challenges could ripple through antitrust enforcement, where the FTC and DOJ navigate IP rights within competitive markets; biotechnology, where the FDA’s expedited approval processes for new medical innovations could slow; environmental law, with the EPA’s facilitation of green technologies potentially facing roadblocks; and telecommunications, as the FCC’s management of spectrum rights and net neutrality principles might encounter increased litigation. Each of these domains relies on a nuanced interpretation of laws that govern the balance between innovation, public interest, and market competition. Accordingly, a shift in Chevron deference, therefore, could potentially introduce a layer of unpredictability and legal complexity, affecting not just the USPTO but also the broader landscape of regulatory action that is intertwined with intellectual property. This interconnectedness underscores the need for careful consideration of the potential consequences that such a legal shift might entail for innovation and regulatory clarity across industries.

Since their inception in 2013, inter partes review proceedings have steadily gained in popularity, killing patents at an astounding rate. It is no wonder that defendants flee to the PTAB when staring down costly patent infringement suits in federal court. But an IPR institution is not a right––it is at the sole discretion of the USPTO Director. And despite increased petitions for IPR over the past few years, institution rates have declined. The reason for fewer institutions seemingly lies with the PTAB’s decision to employ certain factors in determining whether public policy weighs against IPR institution. This precedential doctrine—known as the NHK-Fintiv Rule—was created by the PTAB without any formal procedure. Following the Federal Circuit’s rulings that decisions relating to IPR institution are not subject to judicial review, the Rule has resulted in a frenzy of litigation and related pleas to the Supreme Court. While IPR institution denials continue to accumulate, accused infringers are engaged in a game of Whack-a-Mole with the Rule. Instead of continuing to attack the Rule as arbitrary and capricious, litigants should explore other avenues offered by the Administrative Procedure Act and the Constitution—these attacks on procedure may be the key in whacking the Rule for good. Further, the ramifications of the Rule on patent-specific forum shopping and litigation by nonpracticing entities are profound. For these reasons, the Supreme Court should heed the call by technology companies to clarify when judicial review is permissible for acts associated with discretionary agency action.

Several challenges have been made recently to the Patent Trial and Appeal Board’s (“PTAB’s or Board’s”) controversial practice of denying inter partes review (IPR) petitions based on the status of parallel infringement litigation involving the same claim. The so-called NHK-Fintiv rule, resulting from Board-designated precedential cases in 2018 and 2020, allows the PTAB to decline review of a patent based on several discretionary factors, including whether the patent is being asserted in ongoing parallel district court litigation, presumably to prevent the inefficient use of the Board’s resources. The challenges to the NHK-Fintiv rule have been unsuccessful to date, with appellate courts holding that they lack jurisdiction to review institution decisions, and the Supreme Court in January 2022 denying certiorari with respect to two of those challenges. We examine below the current status of the various challenges, and the uncertain fate of the NHK-Fintiv rule. NHK-FINTIV FRAMEWORK: Established under former USPTO director Iancu, the NHK-Fintiv rule resulted from the Board’s precedential opinions in NHK Spring Co. v. Intri-Plex Techs.1 and Apple Inc. v. Fintiv,2 which set forth the circumstances under which the Board may exercise its discretion to deny institution of IPRs. The PTAB considers the following six factors for discretionary denials under 35 U.S.C. § 314(a): (1) whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; (2) proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; (3) investment in the parallel proceeding by the court and the parties; (4) overlap between issues raised in the petition and in the parallel proceeding; (5) whether the petitioner and the defendant in the parallel proceeding are the same party; and (6) other circumstances that impact the Board’s exercise of discretion, including the merits.3 NHK-FINTIV CHALLENGES: The NHK-Finitiv rule has been the subject of numerous challenges from technology and pharmaceutical companies. On August 31, 2020, Apple, Cisco, Google and Intel (“plaintiffs”) filed a lawsuit in the Northern District of California, arguing that the NHK-Fintiv rule violated the Leahy-Smith America Invents Act (“AIA”), which created the IPR regime, and the Administrative Procedure Act (“APA”), which governs the process by which federal agencies develop and issue regulations.4 Plaintiffs argued that by applying the NHK-Fintiv rule, the Director exceeded his statutory authority and thus violated the AIA, since nothing in the AIA authorizes the Director to deny IPR petitions based on perceived overlap with pending infringement litigation involving the same patent claims.5 According to the plaintiff, the fact that AIA requires IPR petitions to be filed within a year of a company being sued reflects that Congress carefully calibrated the one-year limit to ensure that IPR is not used for purposes of delay, while also giving infringement defendants an adequate opportunity to investigate the claims asserted against them in litigation.6 Plaintiff also argued that the NHK-Fintiv rule should be overruled because it is arbitrary, capricious, and violates the AIA with inconsistent outcomes in different cases that make it hard to know how the factors will be applied.7 Finally, Plaintiffs argued that the NHK-Fintiv rule should be held unlawful and set aside because it is a final, binding rule that substantially alters the rights and interests of IPR petitioners without any notice-and-comment rulemaking.8 USPTO (“defendant”) argued that the plaintiffs’ claims are not justiciable under the APA. The California Court granted defendant’s motion to dismiss, finding that the case is precluded by an AIA provision stating that decisions on whether to institute IPR are “final and nonappealable.” 9 The court reasoned that the Supreme Court in Cuozzo determined that issues closely related to the Director’s decision to institute an IPR petition are non-appealable under 35 U.S.C. § 314(d), and that a court will lack jurisdiction to review such cases.10 The court also relied on the Supreme Court’s decision in Thryv, which held that the USPTO’s decision to implement the time bar provision of the IPR regime under 35 U.S.C. § 315(b), so as to refuse institution of an IPR, was also not reviewable since the “time limitation is integral to, indeed a condition on, institution,” and a lawsuit challenging the time bar was merely “an ‘ordinary dispute about the application of’ an institution-related statute.”11 Relying on Cuozzo and Thryv, the court found that the NHK-Fintiv rule establishes factors that are “closely related to [the Director’s decision] whether to institute [IPR],”12 and that it “cannot deduce a principled reason why preclusion of judicial review under § 314(d) would not extend to the Director’s determination that parallel litigation is a factor in denying IPR” under § 314(a).13 The court did note that the Supreme Court in Cuozzo stated that § 314(d) may be reviewable if it implicated “constitutional questions . . . of interpretation that reach, in terms of scope and impact, well beyond [§ 314(d)],”14 and that institution decisions that implicate due process concerns or jurisdictional violations are not “categorically precluded” from judicial review under § 314(d).15 Nevertheless, the court found that plaintiffs’ challenges did not rise to the level of a constitutional violation warranting review. An appeal is currently pending before the Federal Circuit. While the case was still pending, the USPTO requested comments on discretion to institute trials in IPR and post grant review (PGR) proceedings, and specifically solicited comments on whether rulemaking was necessary and the type of rules it should adopt. The USPTO did not itself propose any rules.16 The USPTO received over 800 submissions, and published a summary in January 2021.17 On July 28, 2021, Apple Inc. petitioned the Supreme Court for relief after the Federal Circuit refused to review the Board’s discretionary denial of an IPR.18 Apple had argued that it should be able to appeal the denial of institution based on the Fintiv factors, and that, in the alternative, the Federal Circuit should grant mandamus to review the denials. Apple also contended that the language of § 314(d) is not an absolute bar that prevents arguments that the PTAB’s denial of an IPR petition rested on grounds that exceed the agency’s statutory authority, are arbitrary and capricious, or fail to comply with basic procedural requirements of the APA.19 The government had argued that Apple cannot establish the “clear and indisputable right” to a different outcome that the mandamus standard requires. The Federal Circuit held that it lacks jurisdiction to hear the case.20 On August 9, 2021, Mylan Laboratories urged the Supreme Court to strike down the NHK-Fintiv rule and argued, amongst other things, that the rule is unlawful and renders Congress’s one-year period for seeking IPR illusory.21 Mylan’s IPR had been denied by the USPTO based on the status of pending litigation against a different Hatch-Waxman litigant, not Mylan. In its petition, Mylan also took issue with Federal Circuit’s position that PTAB institution decisions are not subject to appellate review, which it said “effectively handed the director and the board carte blanche to deny IPR petitions for any random (and potentially unlawful) reason they can dream up.”22 Mylan also highlighted that the rule has encouraged patent owners to file suits in districts that promise a fast time to trial, such as Waco in the Western District of Texas, partly to avoid PTAB review of the patents.23 The Supreme Court denied both Mylan’s and Apple’s petitions on January 18, 2022. On, November 29, 2021, US Inventor Incorporated, a non-profit, filed an appeal with the Fifth Circuit arguing that the district court wrongly concluded that the group does not have standing to bring an action challenging the lack of agency rulemaking, seeking formalizing of NHK-Finitiv rule through notice and comment rulemaking.24 The district court had ruled that US Inventor did not face any injury and was generally complaining about the system which Congress had established.25 On December 15, 2021, Intel filed a petition at the Supreme Court arguing that the NHK-Fintiv rule is arbitrary and capricious and requires the Board to deny IPR petitions after speculating when the infringement trial will conclude, the calculation of which is mostly incorrect considering trials are often rescheduled.26 In its appeal, Intel states that “by treating such decisions as if they are immune from judicial review, the Federal Circuit’s position endangers a tool that Congress determined to be essential to the integrity of the patent system.”27 Unified Patents, the Alliance for Automotive Innovation and Cable Television Laboratories have filed an amicus brief supporting Intel’s petition. The petition is currently pending FATE OF NHK-FINTIV RULE: While the Supreme Court has thus far not taken up any of the challenges to the rule, there has been proposed legislation from senators that would nullify the NHK-Fintiv rule altogether. Last year, Senators Patrick Leahy and Republican Senator John Cornyn introduced a new bill, the Restoring the America Invents Act, arguing against the use of discretionary denials at the PTAB. The new nominee to lead the U.S. Patent and Trademark Office, Kathi Vidal, has promised to look into the PTAB’s practice of discretionary denials and engage with stakeholders. In her written response to Senate Judiciary Committee members, Ms. Vidal stated “PTAB decisions are not themselves rules within the meaning of the APA and the decision to deem a PTAB decision as precedential is not a rule within the meaning of the APA, so notice-and-comment rulemaking is not required to make the precedential designation.”28 Recently, a group of legal executives from companies like Intel, Fresenius Kabi, Hyundai Motors, Netflix and several others collectively wrote to the Secretary of Commerce, Ms. Raimondo, urging her to immediately repeal the NHK-Finitiv rule because it unfairly denies access to IPR proceedings and effectively wrote out vital protections out of the law without any public notice or comment.29

The first step Director Vidal must take is to fully repeal the NHK-Fintiv rule, which was unlawfully implemented by her predecessor. This rule makes it more difficult for innovators targeted by patent trolls to have expert judges at the USPTO determine whether the patent being asserted against them is valid. Those expert judges exist to give businesses and innovators targeted by patent trolls a cheaper, more reliable alternative to litigation; limiting their use is a step backwards. In 2011, Congress recognized that our patent system needed a significant overhaul and a large bipartisan majority in the House and Senate passed the Leahy-Smith America Invents Act (AIA). The AIA made a number of changes, shifting the U.S. from a first-to-invent to a first-to-file patent system and creating the review process at the Patent Trial and Appeal Board (PTAB), which allowed expert judges to review patents of questionable validity. The AIA had a large positive impact on U.S. economic growth and after 2011 patent troll litigation began to decline. But this progress was interrupted by the previous USPTO director, Andrei Iancu, who unilaterally made the Fintiv rule precedential in 2020. Under Fintiv, petitions for PTAB review are denied based on factors unrelated to a petition’s merits. Primary among them, PTAB review is denied if there is parallel litigation already in progress involving the patents in question. For example, a startup gets notified that an LLC that they have never heard of, and that they can’t find much information about, is suing them for patent infringement. If this litigation is expected to begin ahead of a potential PTAB review, then review is declined because litigation is already in process. This is especially troubling because PTAB incorrectly evaluates future trial dates in more than 90% of cases. When Congress passed the AIA, we intended for review to be in place as a protection for businesses and innovators who were in this exact position, actively facing infringement claims. For review to be denied due to parallel litigation, it is removed as an option in the instances where it is most valuable. Fintiv was supposedly instituted in the name of efficiency, with the PTAB not getting involved in disputes that the courts were already handling. But, particularly in highly technical matters, PTAB judges are far better equipped to handle disputes than the courts are and needing to proceed with litigation opens up defendants to a massive financial burden and increased risk. In essence, Fintiv has forced more companies, including everyone from small startups to large manufacturers, to spend more of their time and resources defending themselves in expensive litigation with the possibility of disastrous outcomes, despite having done nothing wrong. Repealing Fintiv would give innovators currently under siege a fairer, less expensive, more efficient option for resolving infringement disputes. It would allow them to spend less of their money hiring lawyers and invest more of it creating jobs, lifting wages, and developing more of the cutting-edge products that catalyze our economy and improve our quality of life.

Finally, the City’s policy objections cannot override Title VII’s text. In the City’s view, a significant-injury requirement is needed to prevent transferred employees from “swamp[ing] courts and employers” with insubstantial lawsuits requiring “burdensome discovery and trials.” Brief for City 45, 49 (capitalization and boldface omitted). But there is reason to doubt that the floodgates will open in the way feared. As we have explained, the anti-discrimination provision at issue requires that the employee show some injury. See supra, at 5–6. It requires that the injury asserted concern the terms or conditions of her employment. See ibid. Perhaps most notably, it requires that the employer have acted for discriminatory reasons—“because of ” sex or 10 MULDROW v. ST. LOUIS Opinion of the Court race or other protected trait. §2000e–2(a)(1). And in addressing that issue, a court may consider whether a less harmful act is, in a given context, less suggestive of intentional discrimination. So courts retain multiple ways to dispose of meritless Title VII claims challenging transfer decisions. But even supposing the City’s worst predictions come true, that would be the result of the statute Congress drafted. As we noted in another Title VII decision, we will not “add words to the law” to achieve what some employers might think “a desirable result.” EEOC v. Abercrombie & Fitch Stores, Inc., 575 U. S. 768, 774 (2015). Had Congress wanted to limit liability for job transfers to those causing a significant disadvantage, it could have done so. By contrast, this Court does not get to make that judgment.

The term "trademark" includes any word, name, symbol, or device, or any combination thereof-

(1) used by a person, or

No trademark by which the goods of the applicant may be distinguished from the goods of others shall be refused registration on the principal register on account of its nature unless it—

(a) Consists of or comprises immoral, deceptive, or scandalous matter; or matter which may disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs, or national symbols, or bring them into contempt, or disrepute; or a geographical indication which, when used on or in connection with wines or spirits, identifies a place other than the origin of the goods and is first used on or in connection with wines or spirits by the applicant on or after one year after the date on which the WTO Agreement (as defined in section 3501(9) of title 19) enters into force with respect to the United States.

A trademark is any word, name, symbol or device (or any combination thereof) that identifies and distinguishes the source of the goods of one party from those of others. Similarly, a service mark is any word, name, symbol or device (or any combination thereof) that identifies and distinguishes the services of one party from those of others. Service marks are often referred to as trademarks for convenience or because certain jurisdictions may not recognize the term service mark. A trademark or service mark can be a word, logo, slogan, package design or other source indicator (or a combination thereof), or any other cognizable thing that serves to indicate a particular source, good or service.

Copyright is a type of intellectual property that protects original works of authorship as soon as an author fixes the work in a tangible form of expression. In copyright law, there are a lot of different types of works, including paintings, photographs, illustrations, musical compositions, sound recordings, computer programs, books, poems, blog posts, movies, architectural works, plays, and so much more!

Copyright is a form of protection provided by the laws of the United States to the authors of “original works of authorship” that are fixed in a tangible form of expression. An original work of authorship is a work that is independently created by a human author and possesses at least some minimal degree of creativity. A work is “fixed” when it is captured (either by or under the authority of an author) in a sufficiently permanent medium such that the work can be perceived, reproduced, or communicated for more than a short time. Copyright protection in the United States exists automatically from the moment the original work of authorship is fixed.1

The conjunctions and and or are two of the elemental words in the English language. Under the conjunctive/disjunctive canon, and combines items while or creates alternatives. Competent users of the language rarely hesitate over their meaning. But a close look at the authoritative language of legal instruments—as well as the litigation that has arisen over them—shows that these little words can cause subtle interpretive problems. Although these conjunctions can appear in countless constructions, we have identified six types of sentences in which they most frequently appear in legal instruments.

#1: The Basic Requirement

Section 5 (a) requires the physician to observe the prescribed standard of care if he determines "that the fetus is viable or if there is sufficient reason to believe that the fetus may be viable" (emphasis supplied). The syntax clearly implies that there are two distinct conditions under which the physician must conform to the standard of care. Appellants' argument that "may be viable" is synonymous with "viable" would make either the first or the second condition redundant or largely superfluous, in violation of the elementary canon of construction that a statute should be interpreted so as not to render one part inoperative. See United States v. Menasche, 348 U.S. 528, 538 -539 (1955).

"IPR" shall mean any intellectual property right conferred by statute law including applications therefor other than trademarks. For the avoidance of doubt rights relating to get-up, confidential information, trade secrets or the like are excluded from the definition of IPR.

The Copyright Office serves as the main administrator of copyrights in the United States; organized as a department of the Library of Congress. Individuals who create a work eligible for a copyright can automatically be legally protected from infringement, but to bring a legal action for infringement, the person must register the work with the Copyright Office. Individuals also have to send two copies of their work to the Copyright Office for many types of works or face a fine. The Copyright Office manages the copyright catalog that documents all the major details for every registered copyrighted work, allowing individuals, businesses, and the government to search for existing copyrights. 

Besides administering the registration of copyrighted works, the Copyright Office also plays a fundamental role in the policymaking process for copyrights. Congress allocates authority to the Copyright Office for creating regulations for much of U.S. copyright law. Also, the executive, legislative and judicial branches of government look to the Copyright Office for guidance when dealing with copyright issues or changing the current copyright law. 

The United States Patent and Trademark Office (USPTO) is the federal agency responsible for granting U.S. patents and registering U.S. trademarks. The USPTO is the sole entity capable of granting patents and trademarks legally recognized in the United States.

The USPTO is an agency within the U.S. Department of Commerce in the executive branch of the U.S. government. Congress established the USPTO by exercising its Article 1, Section 8, Clause 8 and commerce clause authority to pass 35 U.S.C. § 1. The USPTO operates pursuant to statutes passed by Congress and rules governing USPTO proceedings established by the USPTO that are consistent with law.

Intellectual property (IP) pertains to any original creation of the human intellect such as artistic, literary, technical, or scientific creation. Intellectual property rights (IPR) refers to the legal rights given to the inventor or creator to protect his [their] invention or creation for a certain period of time.[1] These legal rights confer an exclusive right to the inventor/creator or his assignee to fully utilize his [their] invention/creation for a given period of time. It is very well settled that IP play a vital role in the modern economy. It has also been conclusively established that the intellectual labor associated with the innovation should be given due importance so that public good emanates from it. There has been a quantum jump in research and development (R&D) costs with an associated jump in investments required for putting a new technology in the market place.[2] The stakes of the developers of technology have become very high, and hence, the need to protect the knowledge from unlawful use has become expedient, at least for a period, that would ensure recovery of the R&D and other associated costs and adequate profits for continuous investments in R&D.[3] IPR is a strong tool, to protect investments, time, money, effort invested by the inventor/creator of an IP, since it grants the inventor/creator an exclusive right for a certain period of time for use of his [their] invention/creation. Thus IPR, in this way aids the economic development of a country by promoting healthy competition and encouraging industrial development and economic growth. Present review furnishes a brief overview of IPR with special emphasis on pharmaceuticals.

: of, relating to, or originating within a country and especially one's own country