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Patent litigation is an important component of a strong appropriability regime, critical for ensuring that firms can effectively protect their patented inventions. An issue that has mostly gone unnoticed in the innovation literature is the role of the rules and procedures of patent litigation in helping to create unintended knowledge spillovers. Using an inductive approach, we examine where, what, and how spillovers occur in the litigation process. Our findings demonstrate that knowledge spillovers can happen throughout the litigation process, and benefit not only the defendant but also the plaintiff. Furthermore, we show that the knowledge spilled over is often about proprietary methods and procedures utilized by a litigant to bring about an innovation, above and beyond the knowledge already in the patent. Based on these findings, we develop a framework for how knowledge spillovers happen during litigation, offering a more nuanced perspective on how strong appropriability regimes work. Finally, we suggest a number of directions for future policy development in this arena. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) has become an important driver of economic growth and innovation. With rapid advances in AI, firms have a strategic opportunity to re-envision the cognitive reapportionment of tasks between humans, AI, and non-AI technologies. In doing so, firms can transform and dramatically elevate value creation through their business models, processes, and market offerings. We focus on a key risk, patent infringement litigation (PIL), that can adversely impact a firm's value creation with AI. We posit and demonstrate that firms facing AI-PILs would have more negative short term abnormal returns compared to firms facing non-AI PILs. We further suggest that the abnormal returns are moderated by the types of plaintiffs and AI patents in which the abnormal returns are more negative when the plaintiffs are non-practicing entities (versus practicing entities) and when the AI patents at suit concern expertise-driven (versus data-driven) AI. Exploring the moderators jointly, we find evidence that for data-driven AI patents, the negative abnormal returns are stronger when the plaintiffs are practicing entities, but for expertise-driven AI patents, the negative abnormal returns are stronger when the plaintiffs are non-practicing entities. [ABSTRACT FROM AUTHOR]

I study the effect of patent-infringement claims by patent trolls on acquisitions of small firms. Exploiting staggered adoption of state anti-patent troll laws, I find that the laws have two effects. First, the number of acquisitions of small firms declines after these laws are adopted. Second, the anti-troll laws increase the acquisition price for acquirers. The market reflects the increased cost of acquisition as measured by lower acquisition announcement returns. Large firms increase R&D after the adoption of state laws, replacing external innovation. Using a sample of acquisitions that are plausibly unaffected by the laws, I disentangle alternative explanations. [ABSTRACT FROM AUTHOR]

This Article uses a massive collection of data to document, for the first time, the interplay between the substantive subject areas, the intensity, and the procedural complexity of federal civil litigation. The results indicate that like substance, intensity and complexity are pivotal features of litigation. These findings suggest that what might be termed "our uniformity"--the de jure uniform applicability of the Federal Rules of Civil Procedure and other procedural law--should be understood as a broader phenomenon than the traditional focus on transsubstantivity. The Article documents extensive variation in measures of intensity and complexity among cases sharing the same broad substantive legal subject matter, such that intensity and complexity may vary more importantly within than across substantive areas. For example, it is true that patent cases have comparatively high average intensity as measured by their numbers of docket entries, but there are also plenty of patent cases that terminate without having enormous docket activity. It is also true that patent cases are much more likely than, say, contract cases to be extremely intense, but because there are so many more contract than patent cases, my data have nearly twice as many highly intense contract cases as highly intense patent cases. The Article's twin key conclusions are, thus: (1) even for cases in areas thought to be especially intense or complex, there are cases with both high and low intensity and complexity, and (2) intensity and complexity are transsubstantive--e.g., there are highly intense and highly complex cases in most substantive areas of litigation, not just the usual suspects such as patents, antitrust, or securities. The Article closes by treading gingerly into normative waters. One unavoidable consequence of our uniformity with respect to formal procedural rules is that judges exercise enormous case-level discretion. Further, in part due to legislative forays in the securities and patent arenas, we have some degree of substance-specificity in our procedure. The Article suggests considering formal procedural tracking as an alternative to each of these approaches. That approach, which has been suggested in the past and is used in some states and other countries, might allow us to break out of some of our ossified debates about matters such as the rancor set off by the pleading revolution the Supreme Court effected a decade and a half ago in Twombly and Iqbal. If the plausibility standard is here to stay because of its role in limiting intense and complex litigation, perhaps it could be revisited in simpler cases that don't pose the challenges the Supreme Court first flagged in Twombly. Whether this is possible depends on our capacity to identify cases' likely intensity and/or complexity early in the litigation life cycle, which is a topic beyond the scope of this Article. Still, we ought to consider the possibility of a certification process for intense, complex cases, like the one we have for class actions, so that procedure might be adjusted where doing so makes sense. The Article's contributions include its use of docket-level data on more than 500,000 cases whose dockets could be followed for at least seven years. In addition, the Article offers a novel approach to measuring procedural complexity by showing how links between entries in docket reports may be viewed as mathematical networks. [ABSTRACT FROM AUTHOR]

The article delves into the process of determining SEP license fees and infringement compensation in China, particularly focusing on negotiations between patent holders and implementers. The recent ruling by the Supreme People’s Court in the case between ACT and OPPO established a Chinese model for resolving SEP disputes, emphasizing factors like negotiation behaviors, market value considerations, and good faith negotiations. The court's guidelines address issues such as the application of different approaches in determining compensation, the obligation of implementers to provide sales data, and the importance of a favorable judicial environment for all parties involved in the SEP industry. The ongoing resolution of SEP disputes is viewed as a step towards developing a comprehensive adjudicative system in China. [Extracted from the article]

Research Summary: Non‐practicing entities (NPEs) are firms that accumulate and acquire patents but do not further develop or implement the patented inventions (known as patent trolling). NPEs seek to receive royalties or profits through out‐of‐court settlements in patent infringement cases. We examine how firms targeted by NPEs in NPE‐initiated litigations (i.e., target firms) shift their innovation strategies and trajectories in response to heightened litigation risks. We theorize and show that after the initial lawsuit, target firms draw more upon their in‐house technologies to reduce the legal ground for further lawsuits. Furthermore, nontarget firms in related technology areas shift their innovation activities away from those of target firms under high NPE litigation risks. These effects are more pronounced with higher innovation costs and under more competitive product markets. Managerial Summary: Non‐practicing entities (NPEs) are known as patent trolls that accumulate and acquire patents but do not further develop or implement these patented inventions. These patent trolls aim to obtain royalties or profits through out‐of‐court settlements in patent infringement cases. We investigate how firms targeted by patent trolls in litigations (i.e., target firms) change their innovation strategies and trajectories to deal with increased NPE litigation risks. After the initial lawsuit, we find that these target firms use their in‐house technologies more to reduce the legal ground for future lawsuits. Moreover, nontarget firms in related technology areas move their innovation activities away from those of target firms under high litigation risks. These effects are stronger when innovation costs are higher and under more competitive product markets. View Video S1 [ABSTRACT FROM AUTHOR]

This article explores the impact of the America Invents Act (AIA) on patent laws, specifically focusing on the grace period exceptions and prior user rights defense. It discusses the uncertainty surrounding the definitions of certain terms within the act, particularly in relation to the grace period exceptions. The article recommends redefining key terms and implementing additional reforms to clarify the AIA's policy goals. It also highlights the potential consequences of the uncertainty in patent law, such as inventors inadvertently invalidating their patent rights and discouraging investment in inventions. The article emphasizes the need for certainty and proactive reforms in the patent system. [Extracted from the article]

Starting from 2020, the Chinese courts have actively participated in the jurisdictional battles for the standard essential patent (SEP) disputes, a pivotal development marked by the Supreme People's Court's inaugural SEP-related anti-suit injunction (ASI) in Huawei v Conversant. Subsequently, lower courts in China have emulated this approach by issuing ASIs targeting SEPs in the domain of information and communication technology. The present study highlights the features of the Chinese 'act preservation measures' by comparing them with the typical ASIs originally developed in the common law jurisdictions. This comparison reveals significant divergence in the factors considered by Chinese courts issuing ASIs, particularly in the context of cross-border patent litigation. The study aims at elucidating potential defenses that the respondents in SEP litigation may employ to contest the issuance of ASIs in Chinese judicial proceedings, with particular attention accorded to the principles of comity and public interest. The article concludes that the invocation of international comity and public interest in SEP litigation will encounter a formalistic assessment by the Chinese judiciary due to potential conflicts with statutory provisions and the lack of a more context-specific analysis. As a result, in the absence of supra-national mechanisms that would address the problem of parallel litigation, there appears to be little room for judicial self-restraint. [ABSTRACT FROM AUTHOR]

In design patent law, we have created a monster—a chimera, a hybrid that sometimes looks and acts like a patent regime and then, unexpectedly, doesn’t. Courts in design patent cases sometimes apply the rules as they would in utility patent cases, sometimes modify those rules for the design context, and sometimes ignore the utility patent rules altogether. The consequences of that incomplete adoption of utility patent rules are grossly underappreciated. Among other things, it has wreaked havoc on the law of novelty and nonobviouness—doctrines that are supposed to ensure that we grant design patent protection only to new and meaningfully different designs. And it has too often resulted in rules that ignore how designers actually work. In this Article, we suggest that the problem stems from trying to fit design into a framework that was intended for the very different context of inventions. There are good reasons not to use the utility patent infringement rules for design, even if we are skeptical of the particular design patent infringement rule the Federal Circuit has settled on. And there are good reasons not to allow a design patent to have a different scope when it comes to infringement than for validity; doing so allows patent owners (and infringers) to game the system in litigation. The Federal Circuit has recognized some—but not all—of these necessary differences. But if there are good reasons to depart from utility patent rules in some cases, why insist on symmetry with utility patent in other respects? We think design patent law’s strange hybridity is largely a historical accident. In 1842, when design patents were first created, the utility patent system looked fundamentally different than it does today—and a lot more like an ideal design patent system would. Most significant, it used central rather than peripheral claiming. But as utility patent law changed, design patent law tagged along to its detriment. Courts (and ultimately Congress) should recognize the fundamental divergence between utility and design patents. Perhaps we should get rid of design patents altogether and adopt a sui generis regime for design, as virtually every other country has done. But if we are stuck with design patents, courts should apply design patent law with sensitivity to the differences between design and invention. [ABSTRACT FROM AUTHOR]

Despite the recent complex intertwining of firms in fierce intellectual property disputes, the formation mechanisms of patent infringement litigation relationships between firms have been little studied from a network science perspective. We construct an inter-firm patent litigation network using longitudinal data on patent infringement litigation and the firms involved in the US, and examine its structural characteristics and the mechanisms of tie formation through network motif analysis, linking it to existing knowledge on negative ties. The results reveal the significant influence of mechanisms such as homophily, popularity, and activity on network formation, with reciprocity emerging as a pivotal factor. The absence of triadic closure is also observed. This distinct structural pattern is consistent across different technological fields and throughout the 20-year period. Furthermore, our analysis delves into the rapid countersuit strategies common within this network and provides valuable insights into patent litigation strategies between firms. [ABSTRACT FROM AUTHOR]

Female patent attorneys face multiple layers of bias and discrimination. This article uses qualitative and quantitative data to analyse the experiences of female patent attorneys in Australia and New Zealand and their movements around the profession. Through interviews with 53 patent attorneys and an analysis of over 5 years of data on registered patent attorneys, we examine the experiences of women and how this can affect their decision to move to in-house roles, set up their own entities or move to smaller firms. While noting that women appear to face bias regardless of where they practice, the article concludes that the particular issues mothers face represent a key factor in why women are disproportionately over-represented in in-house roles. The issues also constitute a motivation for many women to set up their own entities and to move firms (though not necessarily from a larger to a smaller firm). [ABSTRACT FROM AUTHOR]

As a class of weight-loss medication known as GLP-1 drugs have skyrocketed in popularity, pharmaceutical companies are rushing to develop generic versions, triggering patent litigation with original brand-name manufacturers under the patent linkage system. This article explores the patent validity challenge aspect of this array of litigation, parsing three PTAB IPR institution decisions in challenges against leading manufacturer Novo Nordisk's GLP-1 drug patents. These decisions reveal the technological focus of the company's GLP-1 drug patent protection, allow for extracting general rules potentially applicable in future bio/pharma IPR cases, and further invite reflection on the patenting and litigation landscape in the pharmaceutical industry. [ABSTRACT FROM AUTHOR]

This multipart article examines the relationship between arbitration and intellectual property, specifically patent disputes. This article adopts a comparative analysis approach and compares the approach taken by civil law and common law systems toward the arbitration of patent disputes. The primary focus is on the United States, Switzerland, and Australia. This article adopts a doctrinal legal research methodology. The process of obtaining a patent will be analyzed. The legislation and case law regarding the arbitrability of patent disputes will be discussed. A clear distinction between patent and standard essential patent disputes will be demonstrated. The difference between erga omnes and inter partes patent arbitral awards effects will be illustrated. The enforcement and recognition of arbitral patent awards will be critiqued, which demonstrates that arbitrating patent disputes faces various recognition and enforcement hurdles. This article will assert that multiple factors need to be considered before determining whether arbitration is the right forum for resolving patent disputes, and that those factors should be determined on a case-by-case basis. This article will conclude that the outlook for arbitrating some patent disputes is unclear, but that arbitration should be the preferred forum for standard essential patent disputes to keep royalty rates confidential. [ABSTRACT FROM AUTHOR]

This document presents a study on the impact of skinny-label generic competition on Medicare Part D spending from 2015 to 2021. Skinny-label generics are generic drugs that are approved for a subset of the indications of the brand-name drug. The study found that skinny-label generic competition saved Medicare approximately $14.6 billion during this period. The savings were highest for drugs such as Crestor, Lyrica, and Gleevec. The study suggests that skinny-label generics can improve patient access to lower-cost medications and recommends reinforcing the skinny-label pathway to encourage timely generic competition. [Extracted from the article]

Propose: The regulatory regulations of different nations globally differ from one another. As a result, it is difficult for the corporations to create a single medication that can be concurrently filed for approval in every country. The various requirements for registration for generic medicine in the US were presented by the present research. In the United States, approved under the abbreviated new drug application are generic medications. Exclusivity rights, which prevent generic businesses from launching a product right away after patent expiration, are used to prolong a product's patent duration after it has expired. The United States (US) generic marketplace was the study's main objective. Aim: Infringement of patents lawsuits are necessary for the approval of generic drugs prior to patent expiration since brand businesses employ strong Life Cycle Management (LCM) techniques. Method: The study focused on three key areas: patents and exclusivities, paragraph IV of the certificates, and emerging therapeutic areas--all of which provide significant challenges for generic businesses. We conducted a case study using statistical analysis on 12 drug firms in India between 2010 and 2020 which produced 2633 US-approved generic medicines. Results: We discovered that the majority of patent litigations involving secondary patents and new clinical indications exclusivity are filed by Indian corporations. The percentage of Indian companies in certificates increased to 18% in Paragraph IV. In contrast to pharmaceuticals for the cardiac and central nervous system, more cancer therapies were produced, according to a parallel investigation on changes in these generic medicines' therapeutic regions over the previous ten years. Conclusion: The present research, which examined the knowledge gaps among generic and branded firms that must be filled for a successful promotion of generic pharmaceuticals, will aid in resolving the aforementioned problems. [ABSTRACT FROM AUTHOR]

In 2023, several noteworthy decisions relating to the enforcement of intellectual property rights (IPRs) were handed down, including in relation to anti-counterfeiting, parallel trade, litigation aspects and restrictions on the enforcement of IPRs. The decisions of the Court of Justice of the European Union and Supreme Courts and Courts of Appeals of the European Union Member States that the authors consider important are summarized in this contribution. The judgments were rendered between 1 January 2023 and 31 December 2023. As in previous editions, the authors have adopted a practical approach aimed at readers seeking an overview of the key IPR enforcement decisions of 2023. [ABSTRACT FROM AUTHOR]

The US Supreme Court and lower court provided further guidance on fair use defense. The US Copyright Office provided guidance on AI as an author. The Court of Appeals provided guidance on substantial similiarty, server test, abstraction-filtration-comparison, and discovery rule. [ABSTRACT FROM AUTHOR]

We contribute a unique empirical account of Freedom to Operate (FTO) analysis in respect to patent claims of others to avoid infringement liability. Over a century ago, the Selden automobile patent owners asserted that its scope encompassed early US automobiles. FTO analyses of the Selden patent claims demonstrated their narrow scope and hence their non-infringement. The legal opinion by patent attorney Parker on the Selden patent gave Ford Motor Company the confidence to publicly indemnify its customers from infringement liability and to publicly challenge the broad claim interpretation of the Selden patent. The asserted broad interpretation of Selden's patent claims is sometimes alleged today to have retarded US automobile industry development but a review of commercial evidence of the development does not support this conjecture. That developers were undeterred is consistent with the FTO analyses conducted by Ford and others, and the patentee's avoidance of a court challenge to the validity of the Selden patent on the merits. The Selden case should be known as the classic empirical example of how firms conduct FTO analysis to assess patent scope and validity to enable continued development. The prevalence of FTO practice today should be considered as a reason why such conjectured economic harms from 'over-broad' patents may not be realized today. Yet, we found a dearth of publicly available FTO analyses and lack of rigorous empirical studies demonstrating the actual extent of FTO analyses. Given continuing concerns over the harms from 'over-broad' patents, there is a need for research into the economics and behavioural influence of FTO analysis. [ABSTRACT FROM AUTHOR]

This article examines the statute of limitations applicable to patent infringement actions in China, highlighting open questions that will require legislative and judicial clarification over the coming years. In 2020, the fourth amendment to the Chinese Patent Law introduced a 3-year limitation period, resolving the pre-existing discrepancy with the Civil Code. However, several issues remain open to interpretation and in need of further clarification. These include the commencement of the limitation period, proof of actual or constructive knowledge of the infringement and of the identity of the infringer(s) and the applicable statute of limitations for acts of infringement occurred before the 2020 amendment. [ABSTRACT FROM AUTHOR]

While patent litigation is an important appropriability mechanism for protecting firms' proprietary knowledge, through the litigation process, valuable knowledge may unintentionally spill over from firms defending their patents to those they accuse of patent infringement. We examine whether such spillover subsequently enhances the innovation of accused firms by analyzing over 3,000 patent litigation cases from 1998 through 2015 in the U.S. pharmaceutical industry. We find that firms accused of infringement have higher levels of innovation following litigation relative to other similar firms. Furthermore, litigation of patents that build on recent and heterogeneous knowledge and are characterized by greater scope more strongly enhance the accused firms' subsequent innovation. These findings support the argument that patent litigation can facilitate knowledge spillovers. [ABSTRACT FROM AUTHOR]

The article focuses on the importance of protecting intellectual property (IP) in joint ventures and collaborations within industries where scientific innovation drives value. It explores the risks associated with sharing confidential knowledge and trade secrets in collaborative endeavors and provides guidance on how companies can mitigate these risks through strategic planning and clear contractual agreements.

Patent monetisation is an important source of revenues worldwide. This activity is increasingly carried out by patent assertion entities (PAE), which are at the origin of about 40% of infringement actions filed in the United States. This paper uses an original database of US patents reporting PAE patent acquisitions. We document two key empirical facts about the presence of PAEs in the market for patents. First, PAEs build large patent portfolios and contribute significantly to patent transfers in the US. Second, their impact on follow-on innovation is, on average, negative. With a series of dynamic diff-in-diffs analyses, we estimate a significant post-transfer drop in forward citations received by patents acquired by PAEs. This drop is not immediate but takes some years to materialise. Heterogeneity tests show that our results are driven by acquisitions of old and highly cited patents, as well as by patent acquisitions by large patent aggregators. [ABSTRACT FROM AUTHOR]

This article provides information on the process of challenging a patent through a scope confirmation trial in Korea. It explains that materials published between the filing of the patent application and the infringement can be considered when determining the convenience of composition change. The scope confirmation trial is an expedited civil action aimed at quickly confirming whether the invention subject to confirmation falls within the objective scope of the patent right. The article also discusses the concept of equivalent infringement and the purpose of a scope confirmation trial. It concludes that the lower court made a reasonable judgment in a specific case and dismisses the appeal. [Extracted from the article]

This article presents a legal case involving the termination of an unresolved PCT application in China. The liquidation team members of a company were found to have violated the principle of good faith by mishandling the application without consulting the actual right holder. As a result, the application was terminated, and the right holder was awarded compensation for damages. The judgment ruled that the PCT application belonged to Cankun Company and that two members of the liquidation team, Biwen Gu and Zhirong Zhou, were responsible for its invalidation and ordered them to compensate Cankun Company. The appeal made by Gu and Zhou was dismissed, and the original judgment was upheld. [Extracted from the article]

Reproductive rights have been repeatedly challenged before the same judge in the Northern District of Texas’ Amarillo Division. In the Western District of Texas, patent litigation boomed in one judge’s Waco courtroom. And several cases involving former President Trump were assigned to the same judge in the Southern District of Florida. When a party steers a case toward a particular judge, the outcome in that case may seem predetermined and therefore unfair. Assigning cases at random is one way to ensure at least the appearance of fairness. Yet there is no right to random case assignment in federal court. This Article offers three unique contributions to understanding federal case assignment. First, it contends that whether a party is entitled to a certain form of case assignment is a question of power, not fairness. The statutes, rules, and orders that determine how federal cases are assigned are creatures of federal procedure. The Constitution assigns the power to create that procedure to Congress, which Congress can delegate to the courts. Second, the Article identifies the procedure that controls case assignment in the federal district courts. A first-of-its-kind review of hundreds of local rules and general orders highlights how often cases are not assigned at random. Third, the Article evaluates the validity of case assignment practices that have impacted reproductive rights and patent litigation in Texas, and cases involving the former President in Florida. If the local rules and general orders that govern case assignment are invalid exercises of the rulemaking power Congress delegated to the courts, then the case assignments they create may be unconstitutional. [ABSTRACT FROM AUTHOR]

We study all of the nearly 4.5 million patents, filed on or after May 29, 2000, that were issued by the United States Patent and Trademark Office since 2005. We find that most patents (63.6%) get at least some “patent term adjustment” (PTA)—an additional patent term to compensate for delays in patent prosecution. The patents that get PTA get more than a year on average (411 days, a median of 290 days), and more than 25% of all patents have more than a year of extra term. Some get as much as ten years of extra term. Despite its imperfections, the PTA system works pretty well at achieving the goal of compensating patentees for patent prosecution delay. But we would be better off with a world in which delay wasn’t nearly as common as it is, because adding a year at the end of a patent’s life is not the same as having an extra year at the beginning. And the PTA system ends up disproportionately being used by patent trolls in litigation, a result that seems socially unproductive. We offer some suggestions for how to reduce delay and describe the more efficient PTA that could potentially result. [ABSTRACT FROM AUTHOR]

Jurists and scholars have long debated (and often decried) the practice of forum shopping. Critics note, for example, that forum shopping both yields procedural gamesmanship and undermines the courts’ legitimacy, while supporters contend that competition for cases increases access to the courts and improves litigants’ experiences. Such debates have overlooked the effects of forum shopping on an important constituency: litigants who have little choice over forum. When forum shopping causes a sudden influx of cases—when, that is, it crowds a forum—what happens to other cases that have nowhere else to go? Are busy judges—made busy by forum shopping—more prone to error? In this Article, we conduct a novel analysis of the effects of such forum crowding. In particular, we draw on ongoing pathologies in patent litigation, which has been subject to extreme forum shopping for over a decade, to empirically examine the effects of these practices on other cases, including criminal and civil rights cases, which are subject to more stringent forum rules. We find that, in some crowded courts, these cases may get short shrift. And so we conclude by offering procedural reforms aimed at protecting these cases from being crowded out. [ABSTRACT FROM AUTHOR]

Standard-essential patent royalty disputes have typically been litigated in U.S. federal district courts, but patent owners have recently started to file suit in courts across the globe, leading to issues of comity, anti-suit injunctions, and increased litigation costs. International arbitration provides a unique forum for parties to litigate these royalty disputes and avoid, or at least lessen the burden, of these issues. This Article explores the advantages and disadvantages of using international arbitration to resolve standard-essential patent royalty disputes. [ABSTRACT FROM AUTHOR]

Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. We reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases. We find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays. Our results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility. • Although it has been claimed that manufacturing patents filed after the originator is approved are a key driver of biosimilar market launch delay, we lack a detailed empirical understanding of the association between the number and types of patents asserted in litigation by originator owners in the United States and how that affects litigation outcome and length of biosimilar commercial market entry delay. • It was found, unexpectedly, that manufacturing patents were having less of an impact on market launch delays than other types of patents, which is contrary to current thinking. • These findings support greater efforts at exploring and addressing biosimilar market launch delays caused not just by manufacturing patents, but also active pharmaceutical ingredient, composition, and treatment patents and the broader implications for patent policy. [ABSTRACT FROM AUTHOR]

The article discusses the use of march-in rights to lower drug prices in the United States. March-in rights, which were established by the Bayh-Dole Act in 1980, allow the government to license patents to others if the recipient of federal funding fails to make reasonable efforts to use the patented technology. The Biden administration has proposed a framework for considering the exercise of march-in rights in situations where drug prices are deemed unreasonable. The draft guidance does not specify what prices are considered reasonable, but it provides a hypothetical scenario to illustrate the considerations involved. The article acknowledges the challenges of balancing access to affordable treatments with the promotion of innovation in the pharmaceutical industry. The proposed framework has received criticism, and the debate on this issue is ongoing. [Extracted from the article]

Within the debate on the role of competition law in standard essential patents (SEPs) litigation, German case law has taken centre stage because of the number of decisions handed down and its traditional patent-owner-friendly approach. As the framework handed down by the European Court of Justice (CJEU) in Huawei is usually interpreted as being opposed to the approach adopted by the German Federal Court in the Orange Book Standard decision, it is worth investigating how German courts have tackled the competition law defence in the post-Huawei scenario. The article maintains that the Federal Court’s rulings in Einwand have aligned German case law with the Huawei framework and that the attention devoted in German case law to the implementer’s obligations is consistent with the principles set out by the CJEU. Nonetheless, recent lower courts’ decisions confirm that the case-by-case detection of the licensee’s willingness is still a challenging issue. [ABSTRACT FROM AUTHOR]

The article focuses on proposing a heuristic approach to solving complex litigation problems, advocating for critical thinking over linear thinking in legal problem-solving. Topics discussed include the limitations of linear thinking, the critical thinking approach rooted in scientific methodology, and methodologies for solving complex problems, such as heuristic methods like means-ends analysis.

Purpose: The purpose of this study is to investigate whether repeated alliances between two members of a patent pool boost enterprise innovation. Furthermore, this paper intends to determine whether the innovation performance becomes higher or lower based on the partnership characteristics. Design/methodology/approach: In this empirical study, hierarchical regression is used to analyze the longitudinal data obtained from 12 patent pools managed by MPEG LA during a time period ranging from 2006 to 2018. The members of patent pools comprise research institutions, firms and universities. Research analyses are performed based on a sample of 68,400 member pairs who had established repeated alliances. The information regarding such pairs is gathered from public databases. Findings: Repeated alliances positively correlate with enterprise innovation performance in patent pools; this performance is higher when the two enterprises have exploratory collaborations. Conversely, the performance is lower when the partners have a similar technology base and are engaged in a technological competition (competitive learning and patent litigation). Moreover, the performance is lower when one partner demonstrates higher network centrality and richer structural holes than the other partner. Originality/value: Patent pools play an instrumental role in eliminating patent-licensing barriers, thereby allowing mutual acquisition of complementary technologies, and cooperatively strengthening technology development. From the perspective of theories of coopetition, knowledge management and social network, this study explores the impact of patent pools on enterprise innovation performance and ascertains the moderating roles of technology coopetition, technology similarity and network position, thereby expanding the scope of innovation effect in the context of patent pools. [ABSTRACT FROM AUTHOR]

This article explores the jurisdictional dispute over Walker Process appeals between the Federal Circuit and regional circuit courts. The Walker Process Doctrine allows alleged infringers in patent infringement cases to argue that the lawsuit violates antitrust laws. The Supreme Court's decision in Gunn v. Minton has further complicated the jurisdictional issue, leading to disagreements between the Federal Circuit and regional circuit courts. Two recent cases, Xitronix Corp. v. KLA-Tencor Corp. and Chandler v. Phoenix Services LLC, highlight the ongoing dispute. The article suggests that clearer guidelines and potential legislative amendments are needed to resolve the jurisdictional question. [Extracted from the article]

The article offers information on the concept of prescriptive comity and its evolution within U.S. law, particularly highlighted by Judge Weis's ruling in flooring company "Mannington Mills" case against Congoleum Corp. Topics include the legal implications of competing patents and antitrust claims; the distinction between rules and standards in prescriptive jurisdiction; and the ongoing influence of international comity principles in federal courts.

Previous studies have examined the determinants of stock price crash risk. However, extant literature overlooks the relationship between patent infringement litigation and stock price crash risk. Based on a dataset of Chinese firm‐year observations for the period 2007–2021, we fill the gap by examining how patent infringement litigation affects stock price crash risk and the underlying channels through which this effect occurs. We provide robust evidence that corporate patent infringement litigation increases its risk of one‐year‐ahead stock crash. This unfavourable effect is more pronounced in firms that were involved with invention patent infringement lawsuits, lost a patent litigation case, suffered from larger litigation costs and are defendant firms. The channel analysis confirms that increased information risks and exacerbated financial constraints are two plausible channels explaining how patent infringement litigation leads to stock price crash risk. Finally, we find that effective corporate governance and risk‐taking level are conducive to mitigate the unfavourable effect of patent infringement litigation on stock crash risk. This study enriches the literature on stock price crash risk from the perspective of patent infringement litigation. [ABSTRACT FROM AUTHOR]

Though the Patent Act broadly defines the types of inventions eligible for patenting—processes, machines, manufactures, or compositions of matter— judicially created exceptions exclude certain fundamental categories. No inventor may patent a natural law, mathematical formula, or an abstract idea. But what separates an abstract idea from a concrete implementation that integrates the abstract idea into a patentable invention? In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court required inventors to add significantly more to the underlying principle, formula, or abstract idea to receive a patent. And in Alice Corp. v. CLS Bank, the Court held that adding generic computer technology does not suffice. Subject matter eligibility of patents in the wake of Mayo and Alice has become a major obstacle to many inventions, and patentability has been difficult to predict. Asking whether a patent claim includes an inventive concept that adds significantly more to an ineligible idea is straightforward; answering consistently has proven elusive for both the courts and the patent office. This Comment proposes borrowing a principle from copyright law—the merger doctrine—to bear on patent eligibility. Under the merger doctrine, if there are only very few ways of expressing an uncopyrightable idea, then each of those expressions is uncopyrightable because they are merged with the idea. The merger doctrine aim of separating the protectable from the unprotectable parallels the eligibility question in patents, and it offers more intuitive application and framing than what is currently used in the patent sphere. [ABSTRACT FROM AUTHOR]

The subject matter eligibility doctrine initially existed as a means of limiting the scope of an inventor's patent claim. Over the past decade, the Supreme Court has broadened the scope of the doctrine to invalidate patents that effectively recite a claim for processes or products that exist in nature. These recent decisions have led to confusion over what inventions qualify as patent eligible under 35 U.S.C. § 101. The Federal Circuit and commentators have implored the legislature to weigh in on the issue and establish clearer guidance for what constitutes patentable subject matter. Two proposed bills introduced in the House and Senate seek to clarify the doctrine by allowing for patents to be granted more broadly to inventions that incorporate biological materials and other routine scientific practices. This Note argues that neither proposed law adequately addresses the underlying policy concerns left unaddressed by the Supreme Court in their recent decisions regarding the patentability of biological materials and processes. Rather than adopt either proposed law, Congress should draft an exclusionary rule for patent eligibility that precludes inventors from claiming a genetic sequence that exists in nature within their patent claim. Such a rule would impose a necessary limit to the scope of patent claims that reinforces the original goals of the subject matter eligibility doctrine. [ABSTRACT FROM AUTHOR]

This Article provides the results of an empirical study assessing the impact of panel composition in patent cases at the Federal Circuit. The dataset includes 2675 three-judge panel-level final written decisions and Rule 36 summary affirmances issued by the Federal Circuit between January 1, 2014 and May 31, 2021. The study informs the longstanding debate concerning whether the Federal Circuit is succeeding as a court with nationwide jurisdiction in patent cases and provides insight into judicial decisionmaking more broadly. And several results show that many of the worst fears that commentators have about the Federal Circuit appear overstated or untrue. For example, the results show that, in the aggregate, patent-related ideology plays a role in voting and decisionmaking at the Federal Circuit--that is, some judges are more likely to vote in a pro-patentee direction than others. This patent ideology is not explained by political affiliation, nor is it significantly explained by the judges' prior patent-related experience. The former observation undercuts the assumption made by scholars that if political affiliation does not predict voting in an area of law, then that area of law must either be clear and binding, or there must be a near-consensus about the appropriate principles. The results also indicate that decisionmaking at the Federal Circuit is influenced by panel effects, which refer to changes in judges' voting patterns based on the preferences of the other judges on the panel. The study exemplifies how prevalent panel effects can be in an area of law, considering they persist in patent cases at the Federal Circuit despite several reasons to believe panel effects may not exist. This study also compares decisionmaking in precedential, nonprecedential, and summarily affirmed cases and finds that voting and decisionmaking is most influenced by patent ideology in precedential cases. Prior studies of judicial decisionmaking in other circuits typically focus exclusively on precedential cases, and thus must be interpreted in view of that limitation. Furthermore, according to the results, judges do not appear to use summary affirmances as a tool to systematically bury cases opposing their patent ideology. To the contrary, decisionmaking in summarily affirmed cases is largely, if not entirely, independent of patent ideology. And judges are not more likely to summarily affirm cases coming out against their patent ideology, when considered as a fraction of the total number of opportunities to issue a summary affirmance. The results also show that judges tend to write a disproportionate share of opinions favoring their patent ideology. As a result, there is greater risk than previously recognized that the law will develop to reflect the idiosyncratic preferences of a few judges and that opinions will be written ideologically. [ABSTRACT FROM AUTHOR]

The article explores the issue of drug affordability and the impact of patents and monopolies on access to medication. It discusses the differences between innovator and generic pharmaceutical companies and the problem of delayed generic access. The article proposes the use of incentive programs, such as wildcard exclusivity vouchers, to encourage innovator companies to lower prices and increase generic competition. It also discusses the advantages and potential benefits of these incentive programs for patients and the healthcare system. The article further examines strategies used by pharmaceutical companies to delay generic competition and maintain monopolies, such as reverse payment settlements and evergreening. It concludes by discussing the potential effectiveness of FDA priority review vouchers and wildcard exclusivity vouchers in improving drug affordability and access. [Extracted from the article]

This Article describes how the original understanding of properly granted patents, from Renaissance Italy to the Patent Act of 1836, generally required tangible proof of the thing to be patented's immediate commercializability and its benefits to society at large, along with ready access to courts or other means to challenge improperly-granted patents (under ordinary standards of proof), as such improperly-granted patents were understood to constitute unjust monopolies that deterred, rather than facilitated, desired innovation. That original understanding is then contrasted throughout to the patent litigation system as it exists in America today in which challengers of improperlygranted patents are effectively denied access to court, while "patent trolls" can come to own vaguely-worded or overly-broad patents that should never have been granted and, without ever producing anything themselves, assert those patents in court under a "presumption of validity" to extort resources from productive enterprises that, unlike the trolls, are making products people want. The situation now--in which the original understanding of the purpose of the patent laws is so diametrically opposed to patent law's operation today--invites reform by supporters of the patent law's original design. [ABSTRACT FROM AUTHOR]

This case study provides an inside view regarding a highly successful B2B rebranding initiative in the clothing and textiles space. Enova — a B2B brand launched in 2008 as an eco-friendly unused-cotton reclamation process — was rebranded and relaunched in late 2022 as 'precycled' 'ecotton', with a view to greater solution descriptiveness and brand-essence clarity. Problems addressed in the present ecotton case include the following: (1) overcoming greenwashing scepticism; (2) renaming and repositioning the brand as a premier eco-friendly ingredient brand; (3) developing phase one of a celebrity-endorsement programme for the new brand; (4) identifying, connecting with and pitching consumer-facing clothing brands; and (5) simplifying the articulation of a complex technical solution. Important trends identified include the finding that greenwashing lawsuits by environmental advocacy groups as well as stricter governmental regulations are on the rise across the West, and, thus, brands must be able to authenticate eco-friendly claims, not simply be 'certified' as eco-friendly sans a concomitant ability to prove such claims. Notable success factors identified for ecotton — and that may also serve as takeaways for other authentically eco-friendly and social-impact-friendly B2B ingredient brands — include the following: (1) a portfolio of factory-proven interlocking patents allowing would-be waste materials to be transmuted into a high-value authentic (and authenticatable) green commodity; (2) a deep network of trusting connections at highly respected consumer-facing brands; (3) world-class branding and marketing skills; and (4) recognition that the recent emergence of greenwashing-related litigation and pending eco-regulations has created a forcing function and concomitant huge window of opportunity for authentic-and-authenticatable green inputs such as precycled ecotton. [ABSTRACT FROM AUTHOR]

This article explores the issue of "no-challenge clauses" in Standard Essential Patent (SEP) licensing agreements and whether they are an abuse of a dominant position. It argues that adding such clauses is indeed an abuse and that licensees should have the right to question the validity of the patent. The article also addresses the argument that these clauses can reduce global litigation, stating that this argument alone is insufficient. It provides a summary of a court decision in Turkey where a company was fined for violating competition law by failing to comply with fair, reasonable, and non-discriminatory (FRAND) licensing terms and inserting a non-assertion of invalidity clause. The article discusses the importance of FRAND commitments in ensuring access to standardized technologies and highlights decisions made by the European Commission and the Court of Justice of the European Union regarding invalidity clauses in patent agreements. It concludes that including a right-to-terminate clause in a contract can be seen as an abuse of a dominant position. [Extracted from the article]