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The inter partes review (IPR) is an administrative procedure conducted by the Patent Trial and Appeal Board (PTAB), an adjudicative body within the U.S. Patent and Trademark Office (USPTO). IPR provides an opportunity for third parties to challenge a patent's validity after it has already been granted. A petitioner can file a petition with the PTAB to "institute" IPR. If the review is instituted, the PTAB considers the evidence presented and issues a final written decision, either holding the patent valid or striking it down as invalid. Although IPR was introduced as an alternative to litigation, it is often used alongside litigation. In response to this dual track, the PTAB has introduced a practice of exercising discretion in determining whether to institute or deny institution of an IPR. The PTAB's discretionary-denial practice uses the NHK-Fintiv factors, established in two precedential PTAB decisions, that allow the PTAB to consider the progress of a parallel court proceeding in its decision whether to institute. The PTAB's use of these factors has created controversy and uncertainty for stakeholders, who have found it difficult to predict whether the PTAB will exercise its discretion, and whether their valuable patents may be deemed invalid as a result. This Note argues that the PTAB has exceeded its statutory authority in its practice of discretionary denial, and that the U.S. Supreme Court should bar this practice. Furthermore, this Note argues for legislative reform that would not only allow the PTAB to consider evidence of the resources already expended in a parallel litigation, but would also prohibit the consideration of circumstances such as scheduled trial dates, which are often subject to change. The proposed action would restore stability and confidence in the PTAB's IPR procedure. [ABSTRACT FROM AUTHOR]

We analyze the extent to which private defensive litigation insurance deters patent assertion by non-practicing entities (NPEs). We study the effect that a patent-specific defensive insurance product, offered by a leading litigation insurer, had on the litigation behavior of insured patents' owners, all of which are NPEs. We first model the impact of defensive litigation insurance on the behavior of patent enforcers and accused infringers. We show that the availability of defensive litigation insurance can have an effect on how often patent enforcers will assert their patents. We confirm this result empirically showing that the insurance policy had a large, negative effect on the likelihood that a patent included in the policy was subsequently asserted relative to other patents held by the same NPEs and relative to patents held by other NPEs with portfolios that were entirely excluded from the insurance product. Our findings suggest that market-based mechanisms can deter so-called "patent trolling." (JEL: G22, K41, O34) [ABSTRACT FROM AUTHOR]

After receiving FDA approval, a generic drug manufacturer can launch ‘at risk’ before any patent infringement litigation concludes, but it risks paying damages if it ultimately loses the litigation. A generic can eliminate the risk by waiting to launch until after the appeals process is complete but waiting has downsides too. We examine FDA approvals of generic drug applications with ‘first-filer’ status (which precludes other generics from entering beforehand) to examine empirical patterns of at-risk entry. In our data, litigants usually settled prior to a legal decision. For the remainder, drugs that received FDA approval prior to a favorable district court decision were always launched at risk. Generics without FDA approval before a favorable district court decision launched upon approval unless the approval was close in time to the appeal decision, or it had forfeited the first-filer exclusivity (indicating a low cost of waiting). [ABSTRACT FROM AUTHOR]

Patent thickets, a phenomenon of fragmented ownership of overlapping patent rights, hamper firms' commercialization of patents and thus deliver asset pricing implications. We show that firms with deeper patent thickets are involved in more patent litigations, launch fewer new products, and become less profitable in the future. These firms are also associated with lower subsequent stock returns, which can be explained by a conditional Capital Asset Pricing Model (CAPM) based on a general equilibrium model that features heterogeneous market betas conditional on time-varying aggregate productivity. This explanation is supported by further evidence from factor regressions and stochastic discount factor tests. This paper was accepted by Karl Diether, finance. Funding: This work was supported by the National Natural Science Foundation of China [Grant 72003206], the E.SUNAcademic Award, fromtheMinistry of Education in Taiwan [MOE110J0321Q2], and the Ministry of Science and Technology in Taiwan [MOST109-2628-E-004-001-MY3 and MOST109-2628-H-007-001-MY4]. Supplemental Material: The data files and online appendix are available at https://doi.org/10.1287/mnsc.2021.4229. [ABSTRACT FROM AUTHOR]

The article focuses on the doctrine of assignor estoppel in patent litigation, particularly its application in both district court proceedings and inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB). It discusses the implications of the Minerva Surgical, Inc. v. Hologic, Inc. decision and argues for the consistent application of assignor estoppel across both types of proceedings to promote fairness and consistency in patent law.

Picking up a smartphone to contact someone across the globe is facilitated by technical standards like 5G. These standards allow for technological compatibility worldwide. For instance, a 5G capable device can connect to 5G networks anywhere in the world because the same 5G standard is used globally. Standards, particularly those integral to the telecommunications industry, are also highly complex and contain many patents that are necessarily infringed when the standard is implemented. To avoid rampant patent infringement, owners of these standard-essential patents ("SEPs") are required to license them to standard implementers at fair, reasonable, and nondiscriminatory ("FRAND") rates when their patents are incorporated into a standard. Apart from that, standard setting organizations ("SSOs") provide minimal guidance about what rates are FRAND. As a result, SEP litigation over whether a rate is FRAND has spiked. Courts hearing FRAND cases can set global rates, but patent rights are territorial. In response to the threat of foreign courts setting rates on patents granted in their jurisdiction, some courts have issued anti-suit injunctions to prevent parties from litigating a FRAND dispute elsewhere. This rise in antisuit injunctions has resulted in some courts turning to anti-anti-suit injunctions as a response or preemptive measure. Parties have even petitioned courts for anti-anti-anti-suit injunctions. This spiral poses a threat to international comity because these injunctions, although directed at the litigants, interfere with a foreign court's ability to decide what to do with a matter before it. Within the FRAND context, an added danger is the potential breakdown of future technological interoperability if some parts of the world adopt different standards than others. For example, this might make some smartphones incompatible with some cellular data networks. In place of litigation, international commercial arbitration has been used with some success in FRAND disputes, but there are downsides to using arbitration alone. This Note recommends federal courts grant anti-suit injunctions in SEP litigation only under a restrictive test, rather than maintaining the current variation by circuit. Injunctions that up the "anti" should face greater scrutiny under a stricter test with international comity guiding the decision through concrete factors outlined in the sections on nonrecognition of foreign judgments in the Restatement (Fourth) of Foreign Relations Law of the United States. The Note further suggests that Congress should codify this test, but in the event of an injunction spiral that might preclude litigation altogether, SSOs should require the parties arbitrate the dispute before experts at the World Intellectual Property Organization ("WIPO"). Together, litigation and arbitration can help preserve the interconnected and technologically compatible system currently in place around the world. [ABSTRACT FROM AUTHOR]

We examine the impact of legal representation in an administrative setting. Focusing on adversarial proceedings within the United States Patent and Trademark Office and employing new data on patent litigation, we investigate patent rights—a legal area dominated by specialized, upper‐hemisphere litigation teams that generally represent parties with ample resources. Even in an environment with substantial parity in representational capability, we find that litigation team quality matters. Perceived firm quality and litigation team size both enhance the likelihood of victory; these findings are robust under a number of different approaches used to account for the ability of attorneys to select their clients. [ABSTRACT FROM AUTHOR]

Furthermore, in connection with the expectation of success, the complainant bases its criticism on the premise that the lower court should have defined the objective technical problem as an improvement and not merely as an alternative. The complainant complains that the lower court incorrectly and incompletely interpreted the general technical knowledge available in the state of the art and thus violated the prohibition of arbitrariness (Art. Thus, the complainant also does not show a violation of federal law in that the lower court, based on Ogura et al. affirmed a reasonable expectation of success of the expert. The complainant is not convincing when it counters the lower court's assessment of the content of Ogura et al. with its own interpretation, which is disputed by the respondent. [Extracted from the article]

The generic pharmaceutical sector in India transformed over the last few decades. However, certain recent judicial developments may impact the flexibility that generic companies have for development of future generics. This article looks at some of these developments. The developments covered are: a) interpretation and application of the Bolar flexibilities and b) hurdles in claiming use under S.107 A. [ABSTRACT FROM AUTHOR]

Research summary: We claim that, because patent citations influence examiner selection, firms disclose citations strategically to influence which examiner is assigned to their application ("examiner‐shopping"). Specifically, firms are more likely to cite patents reviewed by "lenient" examiners in their original information disclosure statement (IDS) (sent before the examiner has been selected), and delay citations to patents reviewed by "tough" examiners to subsequent IDS (sent once the examiner has been selected). We propose this strategy will be implemented by those firms who benefit the most (firms that face patent thickets and are developing high strategic‐stakes technologies) but only when the costs are low (when firms face a low probability of patent litigation). We find support to our theory in a sample of 9,763 United States patent and trademark office (USPTO) patent applications during 2000 to 2006. Managerial summary: We find that firms facing patent thickets and developing high strategic stakes technologies try to get more "lenient" examiners to increase the probability of patent approval. The cost of this strategy is that "lenient" examiners usually grant weaker patents that are more likely to be litigated and invalidated. Firms overcome this by using "examiner‐shopping" mainly in fields where litigation is relatively infrequent. This behavior has relevant implications: fields where property rights are rarely challenged tend to become "denser" and populated by weaker patents. Our study's discussion of the limitations within the United States patent and trademark office (USPTO) that seem to provide the opportunity to implement "examiner‐shopping" strategies provides a path to address this from a policy standpoint. [ABSTRACT FROM AUTHOR]

Patent systems are only becoming more critical with the onset of greater mechanisation and robotics, which stands at the precipice of overturning conventional production methods, thus equating patent ownership to the ownership of capital. While this argument would explain away the allegation that the patent system delayed the Industrial Revolution, it is unclear whether we can use this to issue a blanket statement over whether patent systems never delay industrial progress. Khan then balances other incentive systems and problems they faced and how many of them evolved into the modern patent system as we know it today - eventually arguing how patent systems are at the very least the system with the smallest number of issues. [Extracted from the article]

This Article presents an empirical study of gender diversity--or, more accurately, the lack thereof--among the lawyers who handle patent cases in the federal courts, focusing on appellate litigation at the Federal Circuit and the Supreme Court. Drawing on two original datasets, the Article finds that, over the past decade, 87.4% of oral arguments in patent appeals at the Federal Circuit have been presented by men. The numbers are similar at the Supreme Court: over the past thirty years, more than 90% of arguments in patent cases have been delivered by male attorneys. The typical explanation for these sorts of gender gaps is that men are disproportionality represented in the science and technology fields that underlie patent practice. But a closer look at the numbers shows that gender parity exists in specific areas of patent litigation. Until a recent retirement, half of the Federal Circuit's twelve active judges were women, and the women on the court tend to have more pre-appointment experience in patent law than their male counterparts. In addition, the data collected for this study demonstrate that, when the government becomes involved in patent litigation (usually because a case involves the Patent and Trademark Office), women present oral argument at the Federal Circuit 48.5% of the time--more than five times as frequently as the rate for private-sector litigants. The story this Article tells--of women being largely absent from high-level patent litigation--is actually a story about gender inequality among the lawyers hired by large corporations, particularly the Federal Circuit's most frequent litigants, including Apple, Amazon, Google, and Samsung, all of which have been represented by women in less than 15% of their arguments over the past decade. Figuring out why women rarely litigate patent appeals for private-sector clients is challenging, but the disparity between law firms and the government parallels inequalities in law practice more generally. To that end, this Article suggests both small steps that would increase gender balance among the lawyers arguing patent cases as well as broader structural reforms that would improve diversity across the bar. [ABSTRACT FROM AUTHOR]

"Seed Activism: Patent Politics and Litigation in the Global South" by Karine E. Peschard is a critical analysis of the role of courts in intellectual property imposition, farmers' rights, and the public good, with a focus on Brazil and India. The book examines three legal disputes related to seed patents, highlighting the complex issues faced by farmers and their organizations. It explores the power dynamics at play in seed patenting and the interplay between public law and private contracts. While the book provides valuable insights, it is limited in accessibility, structural cohesion, and actionable recommendations. [Extracted from the article]

121 Secondly, we do not accept the premise of the proposition, accepted by the primary judge and apparently influential in his reasoning, that if DABUS is not accepted to be an inventor, no invention devised by an artificial intelligence system is capable of being granted a patent. First, that the primary judge misconstrued Sec. 15 of the Patents Act and reg 3.2C(2)(aa) of the Regulations and, secondly, that the primary judge erred by making factual findings beyond the evidence before the Court. 3 The application entered the national phase of processing on 9 September 2020, and, shortly after that date, IP Australia wrote to Dr Thaler's patent attorneys stating that the application did not comply with reg 3.2C of the Regulations because it failed to identify a natural person as the inventor. [Extracted from the article]

Research summary: Patent assertion entities (PAEs) are intermediaries that acquire patents from inventors and license them to firms that use the intellectual property to develop products. We consider how PAE intermediation influences inventor behavior by reducing the costs to monetize their inventions. Using a proprietary dataset that tracks PAE lawsuits, we find that, as PAE intermediation for a given class of technologies increases, larger numbers of focused inventors (i.e., small firms, universities, and labs) that typically lack commercializing capabilities begin to produce inventions in this class. Further, we find that, compared to their larger counterparts, focused inventors are particularly responsive to increasing PAE intermediation by producing greater numbers of inventions, albeit inventions that likely advance the state of the art only incrementally. Managerial summary: Patent assertion entities (PAEs) serve as brokers of intellectual property by purchasing patents from inventors and licensing these patents to firms that develop products based on them. We investigate how PAE brokerage activities influence inventors. We find that as PAEs become more active in a particular class of patents, inventors who lack commercialization capabilities (e.g., small firms, universities, and research labs) are particularly prone to both begin patenting and increase their rate of producing patented inventions in this patent class. We also find, however, that as PAEs become more active in a given patent class, patented inventions produced by inventors lacking commercialization capabilities are increasingly incremental in nature as compared to patented inventions produced by larger firms that commercialize products. [ABSTRACT FROM AUTHOR]

The article discusses legal issues on patents in the U.S., particularly on how the ruling in the case Mayo Collaborative Services v. Prometheus Laboratories, Inc. could affect the problem with patent eligibility. Also cited is whether the provision of the Constitution on intellectual property (IP) is being upheld by the courts and how the courts test the subject matter eligibility requirement in patent lawsuits.

The article explores the need for modifications to the factors consolidated by the cases, NHK Spring Co. v. Intri-Plex Technologies Inc. and Apple Inc. v. Fintiv Inc., that guide the U.S. Patent Trial and Appeal Board's institution decisions where there is a corresponding civil case. Topics discussed include the use of inter partes review (IPR) in challenging patent validity, and the history of post-grant proceedings prior to the American Invents Act.

An amendment to the Japanese Patent Act introduces a system for the filing of amicus briefs specifically in patent infringement suits. The change in business and industry models brought by emerging ICTs such as AI and IoT necessitates this change. By broadening the stakeholders and calling for more expertise, ICTs require an expansion of input by outsiders to advise legal decision-making. This paper examines the issues discussed during the process of amendment, especially with respect to the conditions set on the filing of amicus briefs, and considers insights on these issues offered by the experience of third-party submissions and amicus curiae submissions under the WTO dispute settlement mechanism. The conclusion raises broader implications for adapting legal frameworks to accommodate the complex and rapidly changing society brought by the development of ICTs. [ABSTRACT FROM AUTHOR]

The article scrutinises patent prosecution practices in the ICT sector under Arts. 101 and 102 TFEU in light of the CJEU case law and economic arguments pointing to their anti- and pro-competitive effects. Although the data on European ICT patent prosecution reveals a 'bad dream' of entry barrier features prone to anti-competitive practices, the article acknowledges the limited scope under the existing jurisprudence for EU competition law intervention to awaken from it. Indeed, the data on the European ICT patent landscape hint at substantial patent prosecution cost and timing, rising patent applications and granted patents owned by a few large ICT undertakings, and rare administrative oppositions, especially between symmetric firms. Despite the competition policy appeal of collusive cross-licensing agreements coordinating the parties' ICT patent prosecution strategies to the detriment of technology competition, their investigation under Art. 101 TFEU is yet to be seen. However, the offered evidence suggesting restrictions of competition in ICT technology markets coupled with the anti-competitive findings of the recent Consumer IoT Sector inquiry might justify a follow-on inquiry limited to ICT cross-licensing agreements. Regarding Art. 102 TFEU, the article concludes that the AstraZeneca jurisprudence on abusive patent prosecution is of a limited application for anti-competitive ICT patenting practices that essentially concern blocking patents. Absent fundamental patent law reforms, EU competition law remains not only a second-best solution to address the depicted bad dream of the ICT patent landscape, but also a very remote one. [ABSTRACT FROM AUTHOR]

Critics claim that patent screening is ineffective, granting low-quality patents that impose unnecessary social costs. We develop an integrated framework, involving patent office examination, fees, and endogenous validity challenges in the courts, to study patent screening both theoretically and quantitatively. In our model, some inventions require the patent incentive while others do not, and asymmetric information creates a need for screening. We show that the endogeneity of challenges implies that courts, even if perfect, cannot solve the screening problem. Simulations of the model, calibrated on U.S. data, indicate that screening is highly imperfect, with almost half of all patents issued on inventions that do not require the patent incentive. While we find that the current patent system generates positive social value, intensifying examination would yield large welfare gains. The social value of the patent system would also be larger if complemented by antitrust limits on licensing. [ABSTRACT FROM AUTHOR]

Keywords: written description; invalidity; 35 U.S.C. § 112; numerical ranges; priority; pharmaceutical compositions EN written description invalidity 35 U.S.C. § 112 numerical ranges priority pharmaceutical compositions 126 129 4 06/07/22 20220601 NES 220601 I A US intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: i I Inter partes i Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing This section is intended to be a synopsis of recent developments and is not intended to be exhaustive. Dr. Reddy's asserted that certain claims of the '454 patent are not supported by the earlier application, and that the intervening publication of the earlier application therefore anticipated those claims of the '454 patent. Generic drug maker Doctor Reddy's Laboratories challenged the patent in the USPTO Patent Trial and Appeal Board ("PTAB") by a procedure known as I inter partes i review. [Extracted from the article]

Patent settlements between rivals restrain competition in many different ways. Antitrust requires that their anticompetitive effects are reasonably commensurate with the firms' expectations about (counterfactual) patent litigation. Because these expectations are private and non‐verifiable, this standard is hard to administer; to date, it has been successfully applied only within a very narrow class of agreements. We show that it can be applied universally by policing the economic structure of the firms' contract. This approach determines whether settlement outcomes will be antitrust‐compliant for any private beliefs the firms might have, thus avoiding the need to speculate about such beliefs. [ABSTRACT FROM AUTHOR]

The Patent Holder wishing to enforce her patent has several ways of doing so. In the world of patent litigation, however, one of the most important remedies is the preliminary injunction (PI), whereby an allegedly infringing competitor is forced to stop selling the goods in the market in the interim period before the court reaches its final decision on the merits. In spite of this, the economic literature has afforded little attention to PIs. This article uses a simple economic model to investigate how a Patent Holder and an Alleged Infringer will behave with and without the PI instrument. We show that party behavior depends on the probability that the Patent Holder does indeed have a valid patent and will prevail in a final court decision and on the extent to which courts can determine damages correctly. We find that while patent rights benefit the Patent Holder, the PI instrument to a large extent benefits the Alleged Infringer. It does so by insuring him against large damages payments and allowing him to receive compensation for actions not taken, i.e. for not being on the market in the interim period before the final court decision. Finally, we discuss different decision rules a court could use to decide whether to grant a PI, and propose a decision rule whereby courts can take into account the social benefits or losses of an erroneous PI decision. [ABSTRACT FROM AUTHOR]

The article examines Patent Trial and Appeal Board (PTAB) proceedings across various technologies and industries in the U.S. Topics discussed include the treatment of Non-practicing Entities and Patent Assertion Entities by PTAB, the treatment of serial inter partes review petitions and concurrent litigation by PTAB, an overview of the U.S. patent system and purpose of the PTAB and the American Invents Act.