Patent Term Research Articles

SPC squatting

Abstract Supplementary protection certificates (SPCs) for pharmaceutical products are an important complement to patent protection which is often inadequate in commercial terms. SPCs are designed to ensure that originators can amortize their high investments in research and clinical trials. But unlike in the USA, for example, the European SPC is not simply a patent term extension. Rather, it is a unique form of intellectual property right whose subject matter is not the overall patented invention, but the active ingredient or combination of active ingredients of a patented and authorized pharmaceutical product. This link between the basic patent and market authorization has led to many questions of interpretation and Court of Justice of the European Union (CJEU) rulings since the SPC Regulation was adopted. An issue that has not yet been decided by the CJEU concerns the discrepancy between the ownership of the patent and the marketing authorisation under pharmaceutical law. This scenario, in which a patent proprietor relies on the marketing authorisation of a third party (possibly even a competitor) in said patent proprietor’s application for an SPC, is also referred to as “SPC squatting”. The following article discusses the admissibility of such a practice de lege lata, which also becomes relevant in light of current reform efforts by the legislator.

Why Patents on Climate Technologies Must Be Cut Short

Abstract This contribution questions the term of protection for patents under circumstances of climate change. Patents typically last for 20 years but, for climate-related technologies, this is arguably too long. Under the 1.5°C scenario of the Paris Agreement, we need to make significant headway before 2030. Luckily, the technologies that need to be implemented broadly to reach the 2030 threshold have been developed already. To save civilisation from the worst impacts of climate change, the roll-out of existing technologies (static efficiency) is more important than the development of new ones (dynamic efficiency). However, patent terms take neither static efficiency nor the climate timeframe into account. Technologies developed today will come off patent only in the 2040s, limiting their free availability when their wide roll-out should be the main concern. Conversely, the climate technologies that come off patent today were developed in the early 2000s, long before climate change acquired its current urgency and investment in climate technologies was ramped up. These developments show that innovation systems for climate change have worked well, but they also show how terms of protection may now curtail the usefulness of past innovations. The contribution will analyse patent terms from a domestic and an international political economy perspective. The contribution will argue that, on balance, the situation requires a change of the TRIPS Agreement to shorten the term of patents on mature climate technologies. The TRIPS-waiver for patents on COVID-19 vaccines provides a partial precedent.

Study on the Improvement of China's Pharmaceutical Patent Term Compensation System

The implementation of the pharmaceutical patent term compensation system can greatly stimulate the research and development enthusiasm of pharmaceutical enterprises, enhance the accessibility of medicines and promote the national health level. However, the system is still in the preliminary stage of implementation, and there are still a lot of inconsistencies with the real contradictions and the national situation. Through the study, it is found that the following problems exist in the implementation of China's pharmaceutical patent term compensation system: the details of the legislative provisions have not yet been perfected, the approval process cannot exclude the malicious opposition, the interests of creation and imitation are not yet balanced, and the opposition procedure is difficult to implement. Based on this, a systematic study of the legal framework and practice of pharmaceutical patent term compensation system in other countries is conducted, and corresponding solutions to the problems are proposed, i.e., improving the legislative framework and specific provisions, optimizing the examination and approval process and regulatory mechanism, balancing the incentives for innovation and the public interest, and establishing an opposition procedure to prevent abuse of rights, with a view to contributing to the improvement of the system.

Use of patent term extensions to restore regulatory time for medical devices in the United States

ABSTRACT Background Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear. Research Design and Methods We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office. Results Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average. Conclusions The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.

Commentary on the Latest Revisions to the Detailed Rules for the Implementation of the Chinese Patent Law

Abstract To implement its patent law amended in 2020, China revised the Detailed Rules for the Implementation of the Chinese Patent Law on 11 December 2023. Since the revisions concern many important and controversial topics in the patent field, it is necessary to evaluate how they will impact the interests of patentees and related parties domestically and worldwide, and how China can improve its patent system to not only meet the expectations from Chinese society but also accelerate the innovation process in the world community. To achieve that goal, this report discusses the benefits of the changes, the controversies behind them, the factors and opinions that affected the revisions, as well as the unaddressed issues and problems. Specifically, it highlights the important revisions in the principle of good faith, the request for the delayed examination, the priority system, patent term compensation, international design application, service inventions, and the open licensing system. It then briefly discusses the minor changes in the ex officio examination conducted by the patent administrative department, the patent right evaluation report, information disclosure of generic resources, and the responsibility of the patent administrative department. Meanwhile, this report points out the unsolved issues and problems in the definition of new drugs, the compensation rules for the delays caused by the marketing review of new drugs, the legislative basis of the ex officio examination conducted by the patent administrative department in the patent invalidation procedure, and the reform of the re-examination and invalidation procedures.

Data exclusivity and patent monopoly extension: A view from Australia

AbstractData exclusivity and patents are important to the pharmaceutical industry, and both these regimes coexist in the pharmaceutical landscape. Both data exclusivity and patents provide market exclusivity through monopoly periods. Because data exclusivity and patents can protect the same pharmaceutical, beginning at different times in the pharmaceutical lifecycle and having different durations, these terms may not coincide, and each can extend the effective market exclusivity period of the other. For example, when data exclusivity persists beyond patent expiry for a pharmaceutical, subsequent entrant access to the market is restricted and the period during which originators can charge high prices is extended. This article seeks to eliminate the situation where patent monopolies have expired, but data exclusivity remains in force by proposing a method to ensure that data exclusivity and patent terms expire simultaneously. Further, the proposal maintains the protection to innovators afforded by both data exclusivity and patents, recognising that these regimes protect different things in pharmaceutical development.

Promoting innovation in mental health treatment: Exploring intellectual property laws in innovative and affordable technologies

The paper explored promoting innovation in mental health treatment through exploring intellectual property laws in innovative and affordable technologies. The current intellectual property landscape presents challenges that demand strategic adjustments to strike a balance between incentivizing innovation and ensuring widespread accessibility to groundbreaking mental health technologies. Proposed recommendations encompass among others; advocating for shorter and more flexible patent terms, introducing legislative clarity on patent infringement, and promoting collaboration through legal measures. Additionally, the recommendations prioritize incentivizing information sharing, discouraging knowledge fragmentation, and embedding provisions that prioritize the accessibility and affordability of mental health technologies. This comprehensive strategy aims to create a legal environment that not only safeguards intellectual property but also propels the mental health technology sector toward heightened innovation, collaboration, and accessibility. The urgency for these reforms is underscored by the identified challenges within the intellectual property framework, emphasizing the need for nuanced adjustments. Ultimately, the recommended reforms offer a holistic approach to foster an environment that protects intellectual property rights while advancing mental health innovation to benefit a diverse range of individuals and communities.

AI-driven molecular generation of not-patented pharmaceutical compounds using world open patent data

Developing compounds with novel structures is important for the production of new drugs. From an intellectual perspective, confirming the patent status of newly developed compounds is essential, particularly for pharmaceutical companies. The generation of a large number of compounds has been made possible because of the recent advances in artificial intelligence (AI). However, confirming the patent status of these generated molecules has been a challenge because there are no free and easy-to-use tools that can be used to determine the novelty of the generated compounds in terms of patents in a timely manner; additionally, there are no appropriate reference databases for pharmaceutical patents in the world. In this study, two public databases, SureChEMBL and Google Patents Public Datasets, were used to create a reference database of drug-related patented compounds using international patent classification. An exact structure search system was constructed using InChIKey and a relational database system to rapidly search for compounds in the reference database. Because drug-related patented compounds are a good source for generative AI to learn useful chemical structures, they were used as the training data. Furthermore, molecule generation was successfully directed by increasing and decreasing the number of generated patented compounds through incorporation of patent status (i.e., patented or not) into learning. The use of patent status enabled generation of novel molecules with high drug-likeness. The generation using generative AI with patent information would help efficiently propose novel compounds in terms of pharmaceutical patents. Scientific contribution: In this study, a new molecule-generation method that takes into account the patent status of molecules, which has rarely been considered but is an important feature in drug discovery, was developed. The method enables the generation of novel molecules based on pharmaceutical patents with high drug-likeness and will help in the efficient development of effective drug compounds.

Classification of Terms in Patent Law

The paper attempts to explore the complex of patent legal terms as a separate group of terms in civil law through the prism of the elements that make up this set. The classification was carried out in two stages. At the first stage, taking into account the approaches developed in the science of civil law, seven bases of division and the features of their application to patent legal terms are considered. At the second stage, five additional grounds for dividing patent legal terms into groups are proposed. The analysis of the elements identified as a result of the classification made it possible to formulate conclusions about the features of urgent regulation of patent-legal relations: a high degree of certainty and at the same time flexibility of temporary regulation; about the absence of certain deadlines and the presence of specific groups of deadlines in connection with the peculiarities of the subject of regulation of patent law and the focus of patent legislation on the creation of favorable conditions for scientific, scientific-technical and other types of creative activities.

Patent Term Extension in the Pharmaceutical Sector and the Recent Development in the Judicial Practice in Taiwan

Patent Term Extension in the Pharmaceutical Sector and the Recent Development in the Judicial Practice in Taiwan

The prevalence of drug patent term extensions in the United States, 2000–2018

The prevalence of drug patent term extensions in the United States, 2000–2018

Patent term extension and test data protection obligations: identifying the gap in policy, research, and practice of implementing free trade agreements.

Much of the academic literature criticizes the inclusion of patent term extensions (PTE) and test data protection into the pharmaceutical provisions and/or intellectual property (IP) chapters of free trade agreements (FTAs), with many arguing that such provisions will increase the cost of pharmaceuticals for the implementing government. Such arguments are often backed by studies conducted prior to the conclusion of the relevant FTA. This is problematic for several reasons, most notably that the studies make assumptions that subsequently turn out not to be false and that the claims are not revisited and supported with empirical data following implementation. This article reviews the experience of two jurisdictions - Canada and Australia - in order to provide an analysis of legislative and judicial practices with a focus on implications and the cost of FTAs. The article examines how Canada and Australia have implemented their FTA obligations domestically and on the hereto ignored but important role of courts. One key finding is how courts in both countries are vigilant in narrowing the scope of obligations under FTAs to accommodate the need of the domestic market. The article ultimately concludes by calling on governments to conduct a detailed analysis of PTE and test data protection so as to better inform and prepare policymakers and, ultimately, improved FTA provisions and health outcomes.

최적의 특허 존속기간에 관한 연구

Theoretically, the ideal term of a patent is to set up to expire when the social costs outweigh the benefits. However, given the decline in returns from patents over time and the discount rate of the annual patent value, a period of 20 years is actually quite a long time for the average inventor. In particular, considering that the product cycle in the high-tech industry is very short, it is doubtful whether the current long and uniform duration adequately reflects society's expectations, or whether the costs for access or transaction are excessively imposed. Many studies on finding the optimal patent term have discussed it as an economic point of view. Some have proposed an optimal patent policy through a combination of patent length and scope, while others have suggested adjusting the strength of patent protection through a single adjustment of the length. This paper attempts to approach this problem based on the latter. And when setting the optimal patent term, classification by industry(or by technical characteristics) should be premised. This is because, in fact, the cost of developing an invention and its benefits in terms of social welfare vary from field to field. This paper emphasizes the need to shorten the term of patents and grant differentiated terms for each category of patents, and proposes to realize these policies.

A Review on Immediate Release Drug Delivery System

Among the dosage forms, tablets are the most popular dosage form today due to their convenience, compactness and ease of preparation; Immediate effect is required in many cases compared conventional therapy. So much so that to overcome these drawbacks, the immediate release ganic form has positioned itself as an alternative to the oral ganic form immediate-release dosage forms disintegrate rapidly after administration with an increased dissolution rate. The basic method used in tablet development is the use of super dissolves such as cross-linked polyvinylpyrrolidonecrospovidone (Polyplasdone),sodium starch glycolate (Primogel, Explotab), carboxymethyl cellulose (Croscarmellose), etc.These super disintegrators allow the tablet to disintegrate immediately after administration in the stomach. In this area, immediate-release liquid dosage forms of and parenteral dosage forms have also been introduced to treat patients. In liquid dosage form, can be a suspension with typical dispersants such as hydroxypropyl methylcellulose,AOT (dioctylsulfosuccinate), etc. cardiovascular drugs, analgesics, antihistamines and other drugs can be considered as candidates for this dosage form. When a pharmaceutical entity is nearing the end of its patent term, it is common for pharmaceutical manufacturers to develop a certain pharmaceutical entity in a new and improved dosage form. The new dosage form allows the manufacturer to exclusively expand the market of the, while providing its patients with a more convenient dosage form or regimen.

Hacking or Hatching the Skinny Label: How the Federal Circuit’s Decision in GSK v. Teva Threatens Generics and Induced Infringement

This Note focuses on the recent precedential decision handed down by the Federal Circuit in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., which impacts “one of the greatest public health inventions of the 21st century”: generic drugs. An invention that rose to prominence when former President Ronald Reagan signed into law the Hatch-Waxman Act (“the Act”), formally known as the Drug Price Competition and Patent Term Restoration Act of 1984. The Act aimed to increase competition between brand-name and generic manufacturers while balancing two seemingly opposing interests: (1) encourage and reward innovation by pioneer drug companies and (2) increase access to low-cost alternatives. This in-depth analysis will evaluate how the Federal Circuit’s decision has jeopardized the Act’s purpose and conflicts with present U.S. policy under the Biden administration. Additionally, it will offer a critical analysis of Katherine Eban’s book, Bottle of Lies, which chronicles the generic drug boom that transpired after the Act’s passage. Eban’s often one-sided account fails to provide depth and context to an industry vital to public health.

Patent term extensions and commercialization lags in the pharmaceutical industry: A growth-theoretic analysis

Due to the lags in commercialization, the effective life of a patent is generally less than its statutory term. We introduce commercialization lags into the Schumpeterian growth model and explore the effects of patent term extensions on pharmaceutical R&D and social welfare. Our results show that extending patent terms stimulates the consumption of homogeneous goods but generates an ambiguous effect on the consumption of pharmaceuticals. When patent extensions have an inverted-U effect on social welfare, the optimal patent extension increases with the length of commercialization lags but decreases with the input intensity of commercialization lags. Finally, we calibrate the model and find that increasing patent breadth reduces the optimal patent extension.

Patent Challenges And Litigation On Inhalers For Asthma And COPD.

Between 1986 and 2020 the Food and Drug Administration (FDA) approved fifty-three brand-name inhalers for asthma and chronic obstructive pulmonary disease (COPD), but by the end of 2022 only three of those inhalers faced independent generic competition. Manufacturers of brand-name inhalers have created long periods of market exclusivity by obtaining multiple patents, many on the delivery devices rather than the active ingredients, and by introducing new devices that contain old active ingredients. Limited generic competition for inhalers has raised questions about whether the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, for challenging patents is adequately facilitating the entry of complex generic drug-device combinations. For the fifty-three brand-name inhalers approved during the period 1986-2020, generic manufacturers filed challenges authorized by the Hatch-Waxman Act, which are known as paragraph IV certifications, on only seven products (13percent). The median time from FDA approval to first paragraph IV certification was fourteen years. Paragraph IV certifications resulted in approved generics for only two products, each of which experienced fifteen years of market exclusivity before generic approval. Reform of the generic drug approval system is critical to ensuring the timely availability of competitive markets for generic drug-device combinations such as inhalers.

Continuing patent applications at the USPTO

Despite their growing importance for firm innovation strategy and frequent appearance in U.S. patent policy debates, how continuing patent applications are used remains unclear. Turn-of-the-century reforms strongly limited opportunities to extend patent term and surprise competitors, but continuing applications have steadily risen since. We argue that they retain a subtle use, as applicants can file continuations to keep prosecution open and change patent scope after locking in gains with the initial patent. We document a sharp drop in parent abandonment and rise in continuations per original patent after the reforms. Continuing applications are more privately valuable than original patents, are filed in more uncertain contexts, for higher value technologies, by more strategic applicants, and react strongly to the notice of allowance. The evidence supports a current strategic use of continuing applications to craft claims over time.

Analyzing the impact of stock options on talent retention and knowledge product generativity at knowledge intensive firms

PurposeSince the subject matters of human resources activities on knowledge intensive firms have been changed by coronavirus disease 2019 (COVID-19) pandemic, this study aims to analyze the impact of stock options on talent retention (knowledge worker retention) and knowledge productivity (innovation) in terms of patents, which directly affect the financial performance of knowledge intensive firms.Design/methodology/approachDrawing on agency and contingency theory to design the causality model, this study analyzes the data obtained from 227 publicly traded knowledge intensive firms in information technology (IT) and healthcare sectors. Panel data analysis is used to determine the long run causal relationship between firm innovation, knowledge worker retention and financial performance, in addition to ANOVA for evaluating firm size as a lurking variable on the effect of stock options.FindingsThe results of this study demonstrate that, when firm size is taken into account, (1) stock options significantly affect knowledge worker retention and firms' financial performance, and this impact is stronger in a during-pandemic situation than in a pre-pandemic situation (2) firm innovation significantly affects firms' financial performance and this impact is stronger in a during-pandemic situation than in a pre-pandemic situation; (3) knowledge worker retention doesn't have a significant impact on firm innovation and firms' financial performance. Moreover, random effect regression analysis for long-term relationships also depicts the same results: knowledge worker retention has non-significant impact on firm innovation and financial performance, but firm innovation significantly affects financial performance.Originality/valueTo the best of the authors' knowledge, the authors are the first to compare the effects of stock options, knowledge worker retention and firm innovation in both pre- and during-pandemic scenarios where firm size is taken into consideration.

Biotechnology Patent Law Top Ten of 2022: Inducement, Clear Error, and Interferences Galore

Five-year anniversaries are symbolized by a product of natural biotechnology: wood. This article marks the wood anniversary of the “Top Ten Biotechnology Patent Cases” series that began in 2018. Imagining the world in 2018 is challenging, in part because it was, indeed, a different world. There had not been a major pandemic in one hundred years. Inflation was low. The economy hummed along. No individual war appeared to threaten more than regional stability. O tempora, o mores! The year 2022 was quite different. SARS-CoV-2 continued to stalk the land, having had a monumentally mortiferous effect for several years. High inflation was rampant. The economy was still recovering from one of the deepest declines in history, with imbalances across many sectors. Moreover, eastern Europe had let slip the dogs of war, threatening peace worldwide. Biotechnology also has seen changes of significant magnitude. Venture capital investment in biotechnology was small compared to what it is now. Efficient genome editing was restricted to first-generation CRISPR-Cas9 systems, while now it may be accomplished using more powerful and accurate methods, like base editing and prime editing (the latter offering hope for treatment in almost 90% of genetic diseases). Courts had declared that diagnostic methods did not constitute patentable subject matter, which remains the case today, although clever draftswomen continue their efforts to obtain claims protecting such methods to some extent. Over the course of 2022, courts decided a generous selection of cases covering a wide variety of biotechnology patent law issues. These cases ran the gamut, from patent doctrines concerning satisfaction of the written description requirement for antibody claims to mechanisms for augmenting patent terms using either Patent Term Extension, or Patent Term Adjustment, or both. This article has chosen ten of the most important, though, as is the case every year, our choice of only ten was difficult, and, by necessity, left worthy cases on the cutting room floor.