European Union Plant Variety Protection

This book explains how the Community plant variety rights system works and provides guidance regarding the field of law relating to the Basic Regulation and other implementing regulations. It gives an idea of how the grant system works, the advantages of Community plant variety rights, and the aspects to be considered in exploiting and defending. It also explains the mechanisms in the Basic Regulation on how infringements of Community plant variety rights should be dealt with, including certain enforcement systems of the EU Member States. This book analyses major aspects that are considered of practical relevance in infringement proceedings under the applicable national law. It elaborates how the case law is limited in comparison with patent infringement proceedings throughout the EU Member States.

Impact of Patent Infringement Compensation Rules on Patent Quality Problems

Compensation rules for patent infringement greatly affect patent quality, which is closely related to R & D investments. In this study, A duopoly game model was developed to analyze innovative factories’ R&D investment and patent licensing behavior, as well as the strategic choices of potential infringers under different compensation rules for patent infringement. Furthermore, a comparative analysis was conducted to analyze the patent quality under different scenarios, ultimately finalizing an optimal sequence rule for patent infringement compensation. The results show that patent quality is influenced by the invention height of patent and R&D efficiency, while the amount of patent infringement compensation has a great effect on potential infringement behavior. Patent quality can be effectively improved if the court adopts a proper sequence rule for patent infringement compensation according to the market circumstances.

Validity in patent infringement proceedings – a new approach to transnational jurisdiction

Validity is frequently raised as an issue in patent infringement proceedings, either as a defence or as a preliminary question. Where a court may hear a dispute in relation to infringement of foreign patents, whether the court could and should adjudicate their validity is controversial. This article examines five approaches to this matter. It concludes that none of these approaches is perfect and that there is a lack of evidence-based assessment as to their efficiency. It then moves on to discuss the similar jurisdictional segregation which occurs between validity and infringement at the domestic level in those countries which have adopted a bifurcation system of patents. It suggests that measures adopted domestically may shed light on the international conflict, and that courts should consider factors exceeding those ordinarily considered by international lawyers. A jurisdiction ‘matrix’ is proposed, aimed at providing a pragmatic solution. It grants the court on infringement the initial power to screen the likelihood of success of the infringement claim and then the validity defence, taking into account the accuracy of decision, expertise, chances of success, sound management of justice and deterrence of torpedo defences, before making a decision on validity jurisdiction.

Liability Insurance: Equilibrium Contracts under Monopoly and Competition

In liability lawsuits (e.g., patent infringement), a plaintiff demands compensation from a defendant, and the parties often negotiate a settlement to avoid a costly trial. Liability insurance creates bargaining leverage for the defendant in this settlement negotiation. We study the characteristics of monopoly and equilibrium contracts in settings where this leverage effect is a substantial source of value for insurance. Our results show that under adverse selection, a monopolist offers at most two contracts, which underinsure low-risk types and may inefficiently induce high-risk types to litigate. In a competitive market, only a pooling equilibrium with underinsurance may exist. (JEL D41, D42, D82, D86, G22, K13, K41)

Is Biopharma Ready for the Standard Wars?

This symposium contribution sheds new light on Momenta v. Amphastar, a case in which issues relating to standardization and patent disclosure that have previously been observed in the semiconductor, computing, and telecommunications sectors found their way into a dispute between two biosimilar manufacturers. One such manufacturer, Momenta, participated in the development of a standard for testing the purity of generic enoxaparin under the auspices of the United States Pharmacopeial Convention but failed to disclose that it had applied for a patent on the testing method. When Momenta later sued Amphastar for patent infringement by using the method in accordance with the FDA’s approval of its own generic version of enoxaparin, Amphastar raised waiver and equitable estoppel as defenses, then brought antitrust claims against Momenta and its distribution partner Sandoz. Amphastar prevailed at the district court, obtaining a ruling that Momenta’s patent was unenforceable. This case demonstrates that issues surrounding the acquisition and disclosure of patents on standardized technologies have more salience in the biopharma sector than commonly believed. As such, standards organizations operating in this sector should ensure that their policies and procedures are robust enough to delineate clearly the obligations of participants with respect to patents covering standardized technologies, and organizations that participate in biopharma standards-development should heed the valuable lessons offered by more than three decades of litigation and policy making in the technology sector.