Patent Term Research Articles

Inter-lingual correspondence between the conceptual systems of patent law in Russia and the United States

Due to its deep connection with international law and the requirement to register patents in every country where protection of an invention is sought, patent law requires an immense number of translations every year. Nevertheless, considerable diversity in national patent legislations around the world hinders translation of patent documentation because of significant terminology differences. This paper studies patent law terminology equivalence in Russian and U.S. patent law. The main objective is to identify concept correlation between the main patent law terms in the U.S. and Russian legal systems and to classify the identified term-pairs according to their degree of equivalency, pointing out problematic cases and suggesting ways of their resolution for better translation of documents in this field. This objective is reached through comparative definitional analysis of the key patent law terminological units extracted from legislation texts, monolingual term glossaries, and bilingual term dictionaries. Notwithstanding the predominance of full equivalents, the research shows that national patent law systems preserve their characteristic features which result in a significant number of partially equivalent and non-equivalent terms, many of which are related to the very basic patent law concepts such as patentability. However, no currently existing bilingual English-Russian or Russian-English dictionary provides up-to-date and accurate information about Russian and American patent law terms with all necessary remarks concerning possible differences between the concepts. The research results can serve as the basis for compilation of a specialised bilingual glossary of Russian and American patent terms which can be used as a reference during translation of patent documentation.

Study on Protection of the Right to Health, Access to Medicines and the Construction of the Rule of Law for Medicine Patents

The Access to Medicines is related to the basic rights of people's rights to life and health. It has been widely recognized by international conventions and has become a basic duty of the state to ensure and improve the level of citizens' access to medicines. At the same time, in the face of increasingly widespread uncertainties in modern society, building a fair and efficient legal system for medicines access is a necessary measure to promote citizens' trust in the government and maintain the legitimacy of power. In the conditions of 1.3 billion population and an unbalanced and inadequate economic development, China strives to ensure that its citizens’ medicines are economically affordable through continuous improvement of the legal system and arrangements, and to encourage local pharmaceutical companies to develop and manufacture better-quality medicines. On the premise of respecting the status of market players and property rights of pharmaceutical companies, China comprehensively uses diversified tools such as information, standards, market access, and competition law enforcement to establish a legal system for medicines accessibility from two channels: supply guarantee and price control. Particular attention is paid to the adjustment of the medical and social insurance and essential medicines systems. In recent years, China has focused on improving the pharmaceutical patent system, promoting the balanced development of local original research medicines and generic medicines, as well as the overall optimization and upgrading of the pharmaceutical industry through the protection of patent rights and appropriate restrictions. Driven by the economic and trade agreement reached between China and the United States in 2020, China's Patent Law will introduce a drug patent term extension system and a drug patent linkage system, and further improve the legal mechanism to encourage innovative activities of pharmaceutical companies.

Pharmaceutical patent term extension and patent prosecution in Brazil (1997-2018).

In Brazil, if patent prosecution takes more than 10 years, this extra period is added to the regular 20-year term. This paper analyses all pharmaceutical patents granted by the Brazilian National Institute of Industrial Property (INPI) with term extension and later discusses some intellectual property and health policy implications. On average, pharmaceutical patent applications wait seven years after substantive examination is requested before being examined, which takes only three and a half years. Furthermore, the role of the Brazilian Health Regulatory Agency (Anvisa) in providing prior consent has a marginal effect in prolonging the prosecution. Therefore, the extension of pharmaceutical patents' term is caused by the number of pending applications per examiner, which halts the prosecution for double the time it takes to examine the applications. Thus, proper solutions should focus on reducing the backlog per examiner at the INPI, which has caused the extension of 92% of the pharmaceutical patents in three and a half years, on average. We concluded that the Brazilian pharmaceutical patenting policy is biased towards the patentee. This imbalance will only be effectively corrected when the INPI is financially and administratively autonomous to reduce the ratio between the pharmaceutical patent application backlog and the number of examiners.

Analysis of Historical Patenting Behavior and Patent Characteristics of Computer Architecture Companies—Part II: Prosecution Time and Effective Patent Term Length

Presents an analysis of historical patenting behavior and patent characteristics of computer architecture companies.

Automatic Patent Term Extensions Ruled Unconstitutional in Brazil: Better Late Than Never?

Automatic Patent Term Extensions Ruled Unconstitutional in Brazil: Better Late Than Never?

A Proposal to Amend the Patent Right Direct Infringement Jurisprudence in the Republic of Korea

Current direct infringement jurisprudence in patent law of the Republic of Korea has the following problems: (1) there exists no provision which defines direct infringement; (2) the majority opinion demands “as business” requirement; and (3) with regard to relationship with indirect infringement, dependent theory, independent theory, etc. co-exist. To solve such problems, this paper has examined direct infringement jurisprudences of the U.S.A., Germany, England, China, Taiwan and Japan. The comparative examination has revealed that majority countries (1) have provisions, which define direct infringement, (2) do not demand “as business” requirement and (3) have taken dependent theory. Under such comparative examination, this paper proclaims that (1) a provision which prescribes direct infringement shall be newly inserted in section 127(1) and (2) the provision must not demand “as business” requirement. Furthermore, section 127(2) must clarify that for indirect infringement to be established there exist direct infringement first. The specific provision, section 127(1) could be as the following: “A person who exploits a patented invention, during patent term, within the Republic of Korea, without authority, is liable for direct infringement of a patent right or exclusive licensee right. To exempt a private and non-commercial activity from infringement, Section 96(1) could be amended to newly insert a provision which exempt such an activity from effect of a patent right. Further study on indirect infringement of a patent right should be followed to make a perfect infringement jurisprudence as a whole.

Progress on familial hypercholesterolemia.

Familial hypercholesterolemia (FH) is an autosomal inherited disease characterized by a significant increase in low density lipoprotein cholesterol (LDL-C), tendon xanthoma and premature coronary artery disease (PCAD). In this paper, we analyze the current research status of FH, summarize the reported mutation gene loci in Chinese FH patients and treatment for them, and elaborate the current status of patents and drug researches. The results show that scientific outcomes of FH are increasing with a good developmental trend and the most popular topics of FH study are pathogenesis, treatment of FH, and research on juvenile FH patients. In terms of patents, large pharmaceutical companies, such as Regeneron Pharmaceuticals Inc, AstraZeneca Plc, Merck & Co Inc, are actively engaged in FH detection, diagnosis and treatment. In addition, 12 drugs have been launched in the United States, Japan, Europe and other countries or regions, bringing hope to FH patients.

Generics and Biosimilars: Barriers and Opportunities

Generics and Biosimilars: Barriers and Opportunities

Perception of rural and urban population on generic and branded drugs

Generic medicines are identical/ clone to an innovator or product brand name. After expiration of patent terms of the innovator product, other pharmaceutical companies usually apply to the drug regulatory bodies for approval to market the generic versions of the innovator's drugs. Generic drugs in the market were sold under the non-proprietary name or brand name. Drugs and medicines form a significant portion of out of pocket (OOP) expenses in Indian households. In order to resolve this issue, Government of India launched Jan Aushadhi Scheme (JAS) to provide inexpensive generic drugs to the patients. A separate interview was conducted for the illiterate people and Google forms were forwarded through whatsapp for literates, both contain the same questions to exclude the bias. The collected data was analysed and converted to graphs/ pie charts and the collected data was documented. Our study concludes that by using the questionnaire, the total patients (n= 500) were interviewed, different ages of people were included(15 to above 50).15-30 age group 29.2%, 31-49 age group 39.8%, above 50 age group 31% were involved. Male 60.4%, Female 39.4%, literate 47.4%, illiterate 52.6%, rural 49%, urban 51% were involved. A standard survey form/data collection sheet for both rural and urban population was used. Both literates and illiterates in rural and urban population almost 49% preferred branded drugs due to brand trust, quality, efficacy, and nearly 38% purchase medications based on the availability and remaining 13% preferred generic due to various reasons like cost effectiveness, same as branded quality and effectiveness.

Dynamic Sales Price Control Model for Exclusive Exquisite Products within a Time Interval

When information regarding the effective evaluation of the value of exquisite products is lacking, the market demand function for such products at a given time point is affected by the diffusion of historical transaction price information before the time point. This is because historical transaction prices play an active role in influencing the internal reference price (IRP) of customers, and the continuous diffusion of historical transaction price information leads to the continuous correction, adjustment, and updating of customers’ IRPs. Given the varying rates of such information diffusion, the speed at which customers adjust their IRPs also varies across individuals and contexts. By considering the exponential distribution of potential customers’ IRPs as an example to establish the dynamic demand function that considers the effect of historical transaction prices, this paper discusses the effect of different information diffusion rates on the demand function at a time point. On the basis of this demand function, a sales price control model that maximizes the discounted profitability for businesses in the patent term of an exquisite product is then constructed to provide businesses with an operation method to cultivate prices and increase profits.

Hidden Champions as a Determinant of Regional Development: An Analysis of German Districts

Abstract Hidden Champions (HCs) are defined as market leaders in niche markets. They represent the success of the German Mittelstand like no other group of firms. However, little is known on how HCs contribute to regional development. Given their export strength, regional embeddedness, and strong vertical integration we expect HCs to have a profound effect on regional development. Using a German dataset of 1,645 HCs located in 401 German districts, we analyze the effect of HCs on a variety of regional development dimensions. Our results show that HCs are not equally distributed across regions and influence regional development. Regions with a higher number of HCs show strong regional economic performance in terms of median income. Moreover, HC intensity affects regional unemployment and trainee rates as well as regional innovation in terms of patents. Surprisingly, we did not find an effect of regional HC intensity on regional R&D levels and GDP. We can further conclude that the effect of HCs is not limited to the particular region in which they are located but that sizable spillover effects exist. Besides its contribution to the regional development literature, our study adds to a better understanding of the HC-phenomenon. Implications for regional policy makers are discussed.

Combining topic modeling and SAO semantic analysis to identify technological opportunities of emerging technologies

With the advancement of science and the emergence of new technologies, technology opportunities analysis has attracted increasing attention from both society and academia. This study proposes a hybrid approach to integrate topic modeling, semantic SAO analysis, machine learning, and expert judgment, identifying technological topics and potential development opportunities. The systematical methodology is applied to analyze a set of 9,883 Derwent Innovation Index (DII) patents related to the dye-sensitized solar cell to present its potential contribution of technical intelligence for R&D management. Also, how the approach is validated and optimized is illustrated. The main contributions of this paper are two-fold. First, an optimized topic extraction model with high accuracy is constructed, considering both the patent classification codes and term location. Second, we integrate the topic modeling, SAO technique, and machine learning to explore semantic relationships among technological topics represented as a suite of terms. The methodology overcomes some drawbacks of the current studies. It can be used as a powerful tool for technological opportunities analysis.

Do Patents Alleged to be “Overly-broad” and of “Dubious Validity” Retard Innovation?

A current refrain in patent policy discourse is that “overly-broad” patents of “dubious validity” retard innovation. We briefly review expressions of the thesis to show that they reduce to the allegation that disagreements over enforceable patent scope and/or validity harm innovation. The Selden automobile patent is alleged to have been such a patent. We review the evidence of commercial development during the Selden patent term and show that although there was disagreement as to the scope and validity of Selden’s patent claims, there is no evidence that innovation was retarded. We show that Henry Ford and others relied on “freedom to operate” analyses of the Selden patent claims that unambiguously demonstrated their narrow scope. We reexamine archival evidence and cite new primary sources, in particular the legal Opinion given to Ford on the Selden patent to provide a more accurate account than hitherto published of how Ford made his analysis. It was this analysis embodied in the legal Opinion that gave the Ford Motor Company the confidence to publicly indemnify all its customers from infringement liability. Suit for infringement of the Selden patent was brought against the Company, and Ford ultimately prevailed. The Selden patent was licensed, not to create a patent pool, cross-licensing agreement or cartel, but a “patent enforcement collective”; the Selden case should be known as the exemplary instance of how freedom-to-operate analysis can provide the confidence to invest and develop business.

The anatomy of CUSMA’s patent: Does it still reflect an equipoise?

The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics). Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.

Overview of Canada's energy storage related research activities: A perspective

Overview of Canada's energy storage related research activities: A perspective

Changing paradigm of supplementary protection of inventions in the national legislation of Ukraine

Key words: patent term extension, supplementary protection, supplementary protectioncertificate, drug patents, patent legislation reform
 The article is mainly aimed at distinguishingtwo mechanism: patent term extension which used to be applied inUkraine before the patent reform, and supplementary protection certificates whichwere introduced to national legislation in 2020.Patent term extension in the way it was provided in the Ukrainian Patent Law is arather simple mechanism that didn’t require much regulations. It used to provide additionalperiod of patent monopolies which was equal to the period which elapsed betweenthe date on which the patent application was filed and the date of the marketingauthorisation, not more than 5 years. Since there were no limitation on the type ofpatent (basic patent) or requirement of the first marketing authorization, this regimeprovided an opportunity to extend not only basic patent term, but also all secondarypatents related to one drug. This created a situation when duration of patent monopolyfor one drug exceeded 35 years.Provided that national pharmaceutical industry is oriented on manufacturing ofgeneric drugs, supplementary protection certificates are more appropriate forUkraine. Firstly, this is due to the limitation of effective patent life to 15 years whichis more feasible considering the national context. Another positive thing about SPCsis some uncertainty in relation to definition of the subject matter and scope of SPCprotection. That means that the country can have some freedom in determining theways of its interpretation. However, it should be noted that such indeterminacy is agrey zone. Thus, it is necessary to consider how the country can benefit from the supplementaryprotection regimen. Since the pharmaceutical sphere is very sensitive,the SPC issues have direct effect on public health and access to treatment. So, the articlejustifies the general idea that implementation of new legislation provisions shallbe aligned with both ensuring pharmaceutical innovations and guaranteeing that thepublic health needs are still a priority. Therefore, considering the long-term negativeeffect of the patent term extension regimen, the new SPC approach should be as balancedas possible.

A Comparative Study of Pharmaceutical Incentives to Patents in India, USA and Europe

Background: Protection of Intellectual Property Rights is a clear incentive to innovations; yet, several countries have provided further incentives to patents in pharmaceuticals because the full patent term of 20 years is largely exhausted, before marketing authorization. Objective: The purpose of this article is to describe the various incentives to patents in the form of financial support, data exclusivity and most importantly, extended market exclusivities and comparison of various incentives to patents in the United States of America, European Union and India. Methods: The detail of incentives is collected from various articles, latest topics, books, and newspapers. Result: These incentives create a positive environment to encourage the drug development process, strengthen economic growth and improve a balance between new pharmaceuticals in the market and access of that medicine to the general public at a reasonable price. Conclusion: European Union and the United States of America are leading in the field of incentives to patenting in pharmaceuticals as compared to India. Indian Patent Act, 1970, needs to be relooked in terms of data exclusivity and patent term extensions.

Lipid Nanoparticles as Carriers for Bioactive Delivery.

Nanotechnology has made a great impact on the pharmaceutical, biotechnology, food, and cosmetics industries. More than 40% of the approved drugs are lipophilic and have poor solubility. This is the major rate-limiting step that influences the release profile and bioavailability of drugs. Several approaches have been reported to administer lipophilic drugs with improved solubility and bioavailability. Nanotechnology plays a crucial role in the targeted delivery of poorly soluble drugs. Nanotechnology-based drug delivery systems can be classified as solid lipid nanoparticulate drug delivery systems, emulsion-based nanodrug delivery systems, vesicular drug delivery systems, etc. Nanotechnology presents a new frontier in research and development to conquer the limitations coupled with the conventional drug delivery systems through the formation of specific functionalized particles. This review presents a bird's eye view on various aspects of lipid nanoparticles as carriers of bioactive molecules that is, synthesis, characterization, advantage, disadvantage, toxicity, and application in the medical field. Update on recent development in terms of patents and clinical trials of solid lipid nanoparticles (SLNs) and nanostructure lipid carriers (NLCs) have also been discussed in this article.

Brazilian Supreme Court considers ruling on patent case for the first time this century

The Brazilian Supreme Court (STF) is going to analyse patent term provisions for the first time in this century. The case filed by an association representing generic pharmaceutical companies alleges unconstitutionality of the provision establishing a minimum patent protection for patent owners. The issue before the Court is whether patent owners can enjoy a minimum patent term of 10 years from grant. The challenged provision is found in the Brazilian Industrial Property Law (LPI, Article 40, sole paragraph): Article 40. A utility patent will have a term of 20 (twenty) years and a utility model patent term of 15 (fifteen) years, counted from the filing date. Sole ¶ The term will not be less than 10 (ten) years for utility patents and 7 (seven) years for utility model patents, counted from grant, except when the BRPTO is barred from proceeding with the substantive examination of the application, due to proven pending judicial decision or for reasons of “force majeure”.

Amend Patent Legislation to Expand Access to Pharmaceuticals during National Emergencies

As of February 2021, the COVID-19 pandemic has led to almost 109 million cases worldwide and over 486,000 American deaths (Johns Hopkins University 2021). With the federal government pouring more than $9 billion in taxpayer money to develop vaccines and treatments for COVID-19, accessibility to these taxpayer-funded products is a public concern (Witters 2020). Under current U.S. law, private entities of any size are allowed to keep patents funded by taxpayer dollars (Stevens 2004). Although government use of taxpayer funded patents exist in limited circumstances, there is little incentive beyond public and political pressure for pharmaceutical companies to forgo patent enforcement for public good. We recommend that Congress amend Title 35 of United States Code to allow patent term extensions when a patent holder agrees to forgo patent enforcement in times of presidentially declared public health national emergencies under the National Emergency Act.