Patent Cases Research Articles

The False Marking Gold Rush: A Case Study of the Private Enforcement of Public Laws

Abstract Federal law prohibits deceiving the public by falsely marking an item as patented. The “false marking” prohibition has been enforced primarily by private lawsuits on behalf of the United States, with the party plaintiff and the government splitting the penalty. When a court decision dramatically increased the potential recovery for false marking claims, lawyers pounced immediately, filing more cases per week than had previously been filed in years. Indeed, many lawyers who did not previously work on patent cases joined the fray. Within two years, Congress eliminated this type of false marking suit and terminated all pending cases. Using empirical data, interviews with lawyers, legislative history, litigation documents, and news sources, this article tells the instructive history of false marking litigation. This history shows that the supply of private enforcement—lawsuits by private parties to enforce laws in the public interest—is sensitive to market forces. It also shows that, even when concentrated interests encourage Congress to cut back on private enforcement, Congress does not move as quickly as the bar. This matters because once Congress authorizes private enforcement, the maintenance of that system depends on judges and lawyers interpreting private enforcement statutes.

INDEX OF PATENT CASES

INDEX OF PATENT CASES

INDEX OF PATENT CASES

INDEX OF PATENT CASES

Escaping the patent trolls: The impact of non‐practicing entity litigation on firm innovation strategies

AbstractResearch SummaryNon‐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 SummaryNon‐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.

Characteristics and outcomes of the drug patent linkage system in China

BackgroundOn July 4, 2021, China officially introduced the drug patent linkage system, which has made more localized adjustments than have similar systems in the US and South Korea. This study describes the characteristics and outcomes of China’s patent linkage system.MethodsFor this study, we used the database of China’s patent information registration platform for marketed drugs to capture all listed patents and patent certifications from June 25, 2021, to June 30, 2023. We used descriptive statistics for the above data to assess the impact of patent linkage on branded drug manufacturers, generic drug manufacturers, and the public’s access to medicines.ResultsDuring the study period, the patents of 632 branded drugs were listed, and 5058 ANDAs submitted patent certifications to the Registration Platform. Of these 632 branded drugs, 462 (73.1%) drugs were approved before the year of patent registration, and the average number of listed patents per drug was 1.8, with a standard deviation of 1.4. However, of these 5058 ANDAs, P1 certifications accounted for 85.1%, and P3 and P4 certifications accounted for 16% combined. In addition, according to the detailed statistics of P2 certifications, we found that the proportion of patent invalidation cases was 46.4%. The remaining validity of the patents corresponding to P3 certifications was longer, with a median value of 17 months, and the IQR was 10-30.75, ranging from − 2 to 204 months.ConclusionsChina’s patent linkage aims to promote the balance of multiple interests —innovation, imitation and public health—and has its own system characteristics. Patent listing and patent certification are the key indicators reflecting the implementation effect of the system. From the perspective of system outcomes, ANDAs have been connected to the patent linkage system in an orderly manner, but the growth of patent challenges is not obvious. Moreover, manufacturers of foreign branded drugs that have not yet entered the Chinese market need to pay more attention to the role of patent listing.

Epistemic competition in global governance: The case of pharmaceutical patents

AbstractExpert consensus helps policymakers solve complex problems by identifying and legitimizing policy solutions. Yet, persistent hesitation remains among policymakers regarding the technically adequate policy solution despite the existence and mobilization of epistemic communities. This paper contends that more attention should be given to studying the epistemic competition that may arise when multiple epistemic communities grapple with the same problem but have divergent understandings of its technical nature and its adequate policy solutions. Building on Science and Technology Studies and on the literature on polarization, this paper suggests that two social dynamics, namely the mobilization of resources and increased polarization, may complexify the technical disagreement among experts. In turn, these dynamics may lead to a deadlock in the debates, negatively impacting the institutional context where they take place. To illustrate this, this paper analyzes the case of the pharmaceutical innovation system, which has been prone to tensions between experts arguing for strong patent protection and experts arguing for greater flexibility to meet public health needs. This paper builds on a mixed method combining a social network analysis of experts invited to provide their expertise in the WHO‐WTO‐WIPO Trilateral Cooperation events and on semi‐structured interviews with 24 of these experts.

INDEX OF PATENT CASES

INDEX OF PATENT CASES

Freedom to Operate analysis as competitive necessity—the Selden automobile patent case revisited

Abstract 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.

No Transfer? No Problem!: The Federal Circuit's Excessive Use of the Most Potent Weapon in the Judicial Arsenal for §1404(a) Transfer Appeals

Like all federal plaintiffs, patent owners who feel their patent has been infringed have the right to file suit in any federal court, so long as venue is proper. Patent plaintiffs often select plaintiff-friendly venues, like the Eastern and Western Districts of Texas. Usually, plaintiffs may select these venues because many of the alleged infringers are large companies with a national presence, which makes them susceptible to suit in many federal courts around the country. Defendants in patent cases often file a motion under 28 U.S.C. § 1404(a) to transfer a case to a more defendant-friendly venue, on the basis that the destination venue is more convenient. If the district court denies the motion to transfer, that almost always ends the matter. The exception is that the defendant can petition the proper appellate court—the Federal Circuit in patent cases—for a writ of mandamus: an “extraordinary remedy” that directs the district court to transfer the case. The Supreme Court has mandated that this remedy is reserved for extreme circumstances and may not be used as an appeal. Despite this clear mandate, the Federal Circuit appears to treat such petitions as full-fledged appeals. This Comment seeks to address the ever-growing number of mandamus petitions being granted by the Federal Circuit. Specifically, this Comment focuses on patent cases filed in Texas federal courts. While patent cases in Texas federal courts, like all other patent cases, are appealed to the Federal Circuit, the Federal Circuit remains bound by Fifth Circuit law on motions to transfer under § 1404(a). The Supreme Court and Fifth Circuit have held that a mandamus petition should only be granted upon a clear abuse of discretion by the district court, but the Federal Circuit seems to misapply Fifth Circuit law. The Federal Circuit’s proclivities in determining the propriety of a petition for a writ of mandamus have caused confusion among Texas plaintiffs and uncertainty in the law. This Comment calls attention to the Federal Circuit’s tendency to: (1) misapply Fifth Circuit transfer law; (2) impermissibly add its own nuances to transfer law; and (3) substitute the district court’s judgment for its own, effectively giving defendants a de novo review; or in other words, a second bite at the apple in attempting to transfer a case. Finally, this Comment proposes solutions including: (1) an expansion of Fifth Circuit § 1404(a) jurisprudence; (2) the Supreme Court granting certiorari to provide clarity on the issue; or (3) a change in the Federal Circuit’s choice of law rule.

Investigating Patent Value and Litigation Probability of Global Technology Standards

Standard-essential patent (SEP) is a patent that claims an invention that must be used to comply with a technical standard. The issues of patent infringement are often at the forefront of the strategy and planning in patent litigation. Determining an appropriate methodology for valuing a patented invention is a complex and nuanced undertaking. This is particularly true for patent cases where the accused product or service includes many overlapping features and technologies. Patent information can be used in important issues of global technological standardization in order to evaluate the competitive potential of the SEP. This article makes two major contributions: First, it compares the patent value of SEPs with that of non-SEPs. According to the results, SEPs do have higher value, which indicates the effectiveness of the SEP system supported by standard setting organizations. Second, based on comprehensive observations of litigated SEPs, a model for predicting the probability of litigation is established and the litigation probability distribution of SEPs is plotted.

Top Ten Biotechnology Patent Cases of 2023: Antibodies Unenabled, Extrinsic Evidence Excluded, and Double Patenting Prohibited

Top Ten Biotechnology Patent Cases of 2023: Antibodies Unenabled, Extrinsic Evidence Excluded, and Double Patenting Prohibited

Freedom to Operate Analysis as Competitive Necessity - The Selden Patent Case Revisited

A current policy concern is that the alleged uncertainty over the enforceability of “overly-broad” patents of “dubious validity” may retard innovation. We take the Selden patent on the automobile as a classic of this type of patent. We review the evidence of commercial development during its term and show that there is no evidence that innovation was retarded. To better understand this result we follow Henry Ford’s investigation of the Selden patent’s scope during 1903, the year when the Ford Motor Co. was most vulnerable to “uncertainty” over the enforceability of the asserted broad construction of the Selden patent claims. We use new primary sources to show how Henry Ford and others engaged in what today is called “Freedom to Operate” patent analysis when it most mattered commercially. We show that Ford correctly anticipated that a future court adjudication of the Selden patent claims would not support the broad construction of those claims. Ford’s and the Ford Motor Co.’s confidence in their understanding was powerfully illustrated by their Company’s public offer to indemnify purchasers of Ford automobiles against the threatened suits for infringement under the Selden patent. This and other public actions effectively induced the Selden patent owners to bring suit against the Ford Motor Company. Finally, we show that the Ford Motor Company litigation costs in its first year of operation were trivial yet litigation brought valuable market publicity. We find that Henry Ford’s investigative actions provide an exemplary model for what innovators unremarkably do today when faced with “uncertainty” over the breadth or validity of patent claims.

A Critic on Legal, Ethical, and Regulatory Issues of Off-Label Medicines Shepardizing Intellectual Property Law towards Pharmacoeconomics: A Discussion of Pfizer’s Norvasc Patent Case

Purpose: Pharmacoeconomics is a pharmacy discipline designed to tackle issues on clinical, ethical, and safety factors leading to advocacy of healthcare corporate governance in fulfillment of the pillars of sustainable development. Thus, it is necessary to discuss illegal diversions of Intellectual Property of drug patents as these legal problems serve as impediments to Pharmacoeconomics. This paper aims to elucidate the advantages of Off-label medicines in favor of clinical, ethical, and safety aspects of Pharmacoeconomics towards patient safety and treatment for welfare.
 Methodologies: Quantitative measurement is crucial for validation of drug quality products. It is used for comparison of both legal and illegal diversions of healthcare corporate governance. Patent Law and its policy options are tools to measure the violations of the perpetrator under Intellectual Property Law. Meanwhile, the British National Formulary follows the Human Medicines of 2012 and communicate with FDA for the implementation of off-label medicines as policy for clinical practice under legal removal of patent protection for medical research and practice. This study follows a diagnostic design as a research method based on ethical, regulatory, and legal presentations to characterize problems involved in drug management system towards efficiency of evidence-based medicine practice utilizing theories, models, and frameworks towards financial intelligence. 
 Findings: The elucidation of Kano Model Framework exhibits the aberration and compliance of patent drugs towards compliance of healthcare corporate governance. Based on exhibition of intellectual property law, it can be extended to fulfill the goals of sustainable development of monetary success and hence, the human society can be reflected as their success to their financial intelligence as their inventorship is declared as non-obviousness to public welfare and safety. Moreover, the moral standard of ethical decision-making illustrated the importance of opting to off-label medicines emphasizing cost-efficiency goals of Pharmacoeconomics in drug therapy. Hence, the Shariah Jurisprudence Method for Pharmacoeconomics is the modelling of Clinical Pharmacy Practice towards Healthcare Corporate Governance in fulfillment of business ethics as public welfare and safety of human society.
 Recommendation: Kano Model Framework is an integrated tool of measuring the success of healthcare corporate governance. With the elucidation aids of modelling the importance of Pharmacoeconomics, it is recommended to develop ways of making artificial intelligence as a sole success, profit, benefit, and contribution to clinical pharmacy practice, starting from its drug development up to its intended purpose of human drug treatment in healthcare setting, in relation to its accompanied FDA regulating bodies, as British National Formulary team compliance of maintaining the crucial functions of observing and monitoring document for patient safety.

Legal Protection of Intellectual Property Rights Intellectual Property Rights in the Field of Patents According to Law Number 13 of 2016

This study analyzes the Indonesian patent legal system and the comparison of legal protection against simple patents. Descriptive normative juridical research method that uses a statutory approach supported by a theoretical approach. In this case, Law No. 13/2016 on Patents is studied using legal theory to study the comparison of legal protection available for simple patents in the Indonesian patent legal system. The results show that several mechanisms and principles of legal protection are seen in the regulatory standards that still adhere to the principles of the WTO/TRIPs Agreement. Indicators of infringement that are important in the settlement of simple patent disputes are related to (1) the introduction of the invention in the claim supported by the description of the simple patent, (2) identifying competitors' inventions before the date of acceptance; and (3) anticipating prior art against inventions that are considered not new for each claim unit of the patent to be invalidated, so that at least it can provide an overview of the settlement of patent cases in the future.

Motivations for the restructuring of China’s patent court system

Is the evolution of China’s patent litigation courts from a scattered expansion to a shrinking concentration spontaneous or is it a rational construction? Understanding the motivation for the adjustment of China’s patent court system is important for judging whether the system change is appropriate and for choosing the optimal patent litigation system. After addressing the endogeneity between the number of patents and the adjustment of the patent court system using patent incentives as an instrumental variable for the number of patents, responding to the need to protect the growing number of patents appears to be the underlying reason for the expansion of the number of patent courts in China until 2014. The number of patents directly contributed to the growth of the number of patent courts as patent cases proliferated. The downsizing of the patent court after 2014 was, in contrast, a targeted reform initiative in response to the decline in the quality of cases heard due to the increase in the number of patent courts. The adjustment of China’s patent court system thus appears to be the result of rational constructions in response to a changing reality.

Third-Party Patent Litigation Financing in the United States: Do You Know Who is Sitting in Your Courtroom?

The goal of this paper is to present the current landscape of third-party litigation financing in the United States—namely, patent disputes, as well as a brief insight into the litigation funding business. In the last ten years, patent litigation brought by patent trolls has increased, creating a significant problem. First, this paper explains the basic rules of federal civil procedure that relate to deciding which court will hear a patent case. Next, this paper discusses the Nimitz case before the United States District Court for the District of Delaware, which gained publicity due to the non-disclosure of certain facts by Nimitz’s counsel to the court. Finally, the author recognizes problems raised after the Nimitz case in connection to third-party litigation financing.

Welcome to Waco! The impact of judge shopping on litigation

Abstract We analyze the effect of judge shopping in patent litigation following the appointment of a former patent litigator as the sole district judge assigned to the Waco Division of the US District Court for the Western District of Texas (WDTX). We find that patent enforcers’ ability to select, with certainty, a judge widely regarded as patentee-friendly increased the number of cases filed, especially by non-practicing entities. We show that the increase in litigation was driven by both an influx of cases that would not have been filed but for the judge’s appointment and a geographic reallocation of cases that would have been filed regardless. Overall, judge shopping in the WDTX induced over a 33-month period an increase of around 460 patent cases that otherwise would not have been filed. (JEL: K41, O34).

Effects of uncomplicated malaria parasitaemia on selected haematological parameters and phagocytes of children living in Port Harcourt, Southern Nigeria

This cross-sectional and case control study evaluated the effects of malaria parasites on selected haematological parameters of children living in Port Harcourt, Nigeria. A total of 352 participants were randomly recruited and their blood samples collected. Malaria diagnosis and estimation of haematological parameters were determined using standard parasitological and haematological methods respectively. Sociodemographics of participants showed that 109 (31%) of female children and 106 (30%) of male children were infected with malaria parasites. Overall prevalence of Plasmodium falciparum found was 215(61%). The study found a statistically significant difference in the mean values of packed cell volume (PCV), haemoglobin concentration (Hb), and white blood cell count (WBC) of Plasmodium parasitized children compared with their matched controls: PCV(34.83±2.76% versus 36.06±1.41%; P=0.001); Hb(11.58±0.92g/dL versus 11.98±0.46g/dL; P=0.001); WBC (8.96±4.56(x109/L) versus 7.33±1.39(x109/L); P=0.001).While the mean values of lymphocyte counts were relatively reduced in malaria infected children than their control participants (41.66±13.57(x109/L) versus 42.95±8.36(x109/L); P=0.27). A weak relationship was found to exist between density of parasitaemia and ages of children infected with malaria parasites (R2=0.0093; P=0.1584). Though more children had low parasitaemia (1-999 parasites/μL), followed with high parasitaemia (>10,000 parasites/μL), while few had moderate parasitaemia (1000-9999 parasites/μL). There was no case of complication with respect to WHO standard which described complicated or severe anaemia in malaria as haemoglobin (Hb) of < 5g/dl or packed cell volume (PCV) of < 15% with parasitemia of > 250,000 parasites/μL. Malaria parasites affect outcomes of some haematological parameters. We recommend that all febrile children in our study area should be tested for malaria parasites in conjunction with estimation of their full blood count for effective malaria diagnosis and treatment particularly in sub patent cases.

Do Standard-Essential Patent Owners Behave Opportunistically? Evidence From U.S. District Court Dockets

Abstract To what extent and with what effect do owners of standard-essential patents (SEPs) “hold-up” companies that produce standard-compliant products? To explore this question, we construct measures of opportunistic patent licensing behaviors using detailed information collected from the dockets of U.S. patent cases filed (2010–2019) to enforce SEPs and a matched sample of non-SEPs. Overall, we find evidence of at least one opportunistic behavior by the patent enforcer in approximately 77% of SEP and 65% of non-SEP assertions in court. However, these figures mask important heterogeneity across types of conduct. There is significantly more opportunistic conduct that tends to increase a potential licensee’s loss if the patent enforcer prevails in court: 35% of SEP assertions versus 10% of non-SEP assertions. In contrast, conduct that tends to increase a potential licensee’s litigation costs is less common, and the difference between SEP assertions (8%) and non-SEP assertions (6%) is small. We also show that opportunistic behavior is associated with case settlement, with the direction and strength of the correlation depending on the type of opportunistic behavior. Behavior that increases a potential licensee’s litigation costs is associated with an increase in the probability of settlement, while behavior that increases a potential licensee’s loss if the patent enforcer prevails in court is negatively associated with settlement.

Does patent infringement litigation affect stock price crash risk? Evidence from China

AbstractPrevious 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.