Pharmaceutical Patents Research Articles

OUTLOOK OF ARBITRARY MEASURES OF FAIR AND EQUITABLE TREATMENT UNDER HEALTH URGENCY: THE WAIVER OF PHARMACEUTICAL PATENT

Patent has long been recognized as an important subject of investment particularly for Pharmaceutical Companies. In its development, patents have become one of the most prominent tools in international health investment for its economic benefit sourced from its exclusive right. Most of the Multilateral and Bilateral Investment Treaties recognized intellectual property rights as protected investments, which allows patent holders to benefit from the substantive and procedural safeguards granted by the applicable treaty for foreign investments. In the situation of health urgency, many patents rights are being waived by the government to make the innovation more affordable and accessible to citizens. In this situation, tension in the governance of pharmaceutical patents between patent holders and state authorities is an example of a broader recurring dynamic in international law: the tension between foreign investors' private interests and the host state's regulatory autonom. This research paper will discuss whether the patent waiver enacted by the government is considered as an arbitrary action under the Fair and Equitable Treatment standard as it causes harm to the foreign investor by analyzing several precedent jurisprudences through juridical normative methods

When Cyclodextrins Met Data Science: Unveiling Their Pharmaceutical Applications through Network Science and Text-Mining.

We present a data-driven approach to unveil the pharmaceutical technologies of cyclodextrins (CDs) by analyzing a dataset of CD pharmaceutical patents. First, we implemented network science techniques to represent CD patents as a single structure and provide a framework for unsupervised detection of keywords in the patent dataset. Guided by those keywords, we further mined the dataset to examine the patenting trends according to CD-based dosage forms. CD patents formed complex networks, evidencing the supremacy of CDs for solubility enhancement and how this has triggered cutting-edge applications based on or beyond the solubility improvement. The networks exposed the significance of CDs to formulate aqueous solutions, tablets, and powders. Additionally, they highlighted the role of CDs in formulations of anti-inflammatory drugs, cancer therapies, and antiviral strategies. Text-mining showed that the trends in CDs for aqueous solutions, tablets, and powders are going upward. Gels seem to be promising, while patches and fibers are emerging. Cyclodextrins’ potential in suspensions and emulsions is yet to be recognized and can become an opportunity area. This is the first unsupervised/supervised data-mining approach aimed at depicting a landscape of CDs to identify trending and emerging technologies and uncover opportunity areas in CD pharmaceutical research.

Intellectual Property Rights Issues in Indian Pharmaceutical Industry

Historically, India has neglected, and even made a farce of, pharmaceutical patents. In fact, it was not until 2005 that India offered patent protections for pharmaceutical companies at all. This has led to abuses of the compulsory licensing agreement with the World Trade Organisation, and has led to major criticisms of other global pharmaceutical companies like Pfizer, Roche, and Bayer. According to these companies, India’s generic drug manufacturing industry is destroying R&D funding and future innovation. This is because the companies which invented the brand name drugs are not receiving royalties; and therefore, losing out on profit, a lot of which would have been put back into R&D. While the World Trade Organisation under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement (Doha Declaration) has provided for the use of compulsory licenses (temporary patent rights for life-saving pharmaceuticals), recently India has been more lenient in its use of this stipulation. In fact, the first use was in 2012 for Nexavar. Since then India has used the compulsory licensing provision at least five times. The total numbers of Indian Pharmaceutical Companies those who are having Research and Development facilities and also having Intellectual Property Rights for the past five years consecutively are take for this study.

The Contrasting Perceptions and the Cause Regarding Patenting Technologies Between Academic Medical Researchers and Pharmaceutical Companies Based in Japan.

BackgroundThe recent trend of pharmaceutical companies commercializing new objects as new drugs based on the findings of academic medical researchers, commonly categorizing them as “academic drug discovery” is increasingly gaining popularity in the pharmaceutical industry. Studies state that academic researchers based in universities have lower motivation to apply for patents. However, none of the studies evaluated the existence and extent of the “motivation for patent” in academic researchers, being lower than that of pharmaceutical companies. This study assesses two hypotheses; H1: academic medical researchers are less likely to believe that the patent system is necessary for pharmaceuticals, and thus have diminished interest in the commercialization of their research findings when compared to those in the pharmaceutical industry, H2: apprehension of the raison d’être of the patent system affects positive impressions on patents among academic medical researchers.MethodsFrom February to March 2020, an anonymous survey was conducted among academic medical researchers, pharmaceutical industry professionals, and IP researchers based in Japan. Overall response rate was 27.4% (192/700). We conducted an analysis of variance for H1 and used the PLS-SEM model for H2 in order to verify the hypotheses.ResultsThe results confirmed that the mean calculated from the responses of the academic medical researchers was significantly lower than the mean of pharmaceutical company personnel when responses to patenting an emerging technology or drug for the advancement of medicine were analyzed. In addition, we found that a causal relationship between academic medical researchers’ understanding of patents and their positive impressions on patents, depending on the degree to which they consider that the patent system is to encourage and promote new inventions.ConclusionWe conclude that a contrasting perception of patents not only exists between academic medical researchers and pharmaceutical company personnel but also it is caused by their apprehension of patents. More efforts to promote the raison d’être of the patent system among academic medical researchers will enable them to view pharmaceutical patents in a more positive light. Through this study, the pertinence to promote academic drug discoveries has been uncovered.

Pledging Patent Rights for Fighting Against the COVID-19: From the Ethical and Efficiency Perspective.

In response to the great crises of the COVID-19 coronavirus, virtually all new technologies protected by patent rights have been used in practice from diagnostics, therapeutic, medical equipment, and vaccine to prevention, tracking, and containment of COVID-19. However, the moral justification of patent rights is questioned when pharmaceutical patents conflict with public health. This paper proposes a revised approach of deciding on how to address the conflicts between business ethics and patent protections and then compares the different mechanisms of clearing patent thickets. Our findings highlight that patent pledges may not only contribute to achieving the maximized substantive justice of the public but also help patent pledgors fulfill procedural justice. The advantages of patent pledges have attracted many patent holders to make public statements during the COVID-19 pandemic. In contrast, the disadvantages of a free license may make patent pledges not sustainable for a long time without the related supporting measures. Our findings will be helpful for policymakers or company managers to make an appropriate decision on rationally utilizing patent portfolios for fighting against public health crises.

Brexit – The Consequences for Pharmaceutical Patents and Supplementary Protection Certificates

Now that the UK has left the EU, and the transition period following this departure is over, we have a clearer view on the implications of Brexit on intellectual property rights and the consequences for UK based pharmaceutical companies.  Although little has changed for UK applicants wishing to obtain a European patent via the European Patent Office, the UK’s withdrawal from the Unified Patent Court and Unitary Patent is a huge blow to the realisation of the long awaited Unitary Patent system.  Meanwhile, breaking away from the EU has also had effects on how UK pharmaceutical companies can apply for supplementary protection certificates (SPCs), with further intricacies due to the Northern Ireland Protocol.  The introduction of a new manufacturing waiver for medicinal products protected by SPCs in the UK and EU will allow pharmaceutical companies more leeway with regards to stockpiling and export provisions. Perhaps most interesting of all is how UK and EU laws will diverge over the following years, now that the UK is no longer under the jurisdiction of the Court of Justice of the European Union.

Perverse Results from Pharmaceutical Patents in the United States.

In the United States, pharmaceutical patents have had a number of perverse and anticompetitive effects on the development and marketing of prescription drugs. Although some of these effects are unique to the United States, others have implications for patent policy across the world. Among the negative effects of drug patents are: (1) examples of misguided, anti-social, and anticompetitive promotion of patented drugs; (2) misguided incentives that push drug firms toward too much or too little research and development in critical areas: and (3) cartel-facilitating conduct linked to patent licenses or settlements of litigation involving drug patents. Some of these issues can be addressed directly through reforms in patent and competition law policy. There is, however, a need for a broader study of the role of patents in promoting drug research. That study should consider alternatives to the patent system, such as a prize system structured to supplement or partially replace patent rewards for pharmaceutical R&D.

Pharmaceutical Product Liability, Litigation Regimes, and the Propensity to Patent: An Empirical Firm-Level Investigation

Do different pharmaceutical product liability regimes in different countries induce propensity to patent? We exploit the variation in pharmaceutical liability and litigation rules across firms in the pharmaceutical industry and countries to explain the firm-level propensity to patent. Drawing on a large dataset from European Patent Office (EPO) covering over 9,950 pharmaceutical patents from 63 countries over the period 1991–2015, we compute the conditional probabilities of individual pharmaceutical firms to acquire a valid-based patent on the validation outcomes and examine whether different liability regimes encourage or deter firm-level propensity to patent. Our empirical strategy addresses firm-level idiosyncrasies, country-level unobserved effects, and common technology shocks that potentially invoke omitted variable bias in the effects of liability regimes on the propensity to patent. Our investigation reveals that liability regimes combined with damage caps, broad statutory excuses, and reversed burden of proof have a strong positive effect on the firm-level patent stock and a negative effect upon EPO patent validation rate. The evidence suggests that not all liability rules and related litigation procedures are created equal. Firms are systematically more likely to hold (firm-level patent stock) valid patents at the EPO when the liability and litigation rules are not complex and when the damage cap, broad statutory excuses, and reversed burden of proof are introduced.

Assessing the content of a package of SGT-151 sold online

Introduction Synthetic cannabinoids (SCs) are novel psychoactive substances that mimic the effects of cannabis [1–3]. These products were sold via online shops and consisted of herbal mixtures sprayed with SCs [3]. Since then, a deluge of chemical variations of SCs has been occurring worldwide due to their synthesis in clandestine laboratories, often based on pharmaceutical research and patents, posing a growing challenge for authorities regarding regulation of these substances [1,3]. More recently, several highly potent compounds have emerged on the drug market, synthesised as stated in the patent application of Bowden and Williamson (“SGT-compounds”). These drugs are characterised by a cumyl substituent, which is attached to an indole, indazole or azaindole structure. One of the first cumyl-derivatives, CUMYL-PEGACLONE, was found in 2016 on the German drug market, being sold under the street name SGT-151 [1,2]. The present study aims to understand what is inside of a SGT-151 package sold in the internet as a ‘research chemical’. Materials and methods The cannabinoid identification was based on its mass spectra using the Cayman database (Chemical C. Cayman Spectral Library, vol. v08302018). GC/MS was the technique used to analyse the compound using a MEGA–5 MS capillary column (0.25 µm, 0.32 mm, 30m). Chromatographic analysis was carried out under the following conditions: injection volume 1 µL and splitless injection at 280 °c. The initial oven temperature was 100 °C for 3 min, ramped to 310 °C at a rate of 30 °C/min and held at 310 °C for 10 min. The MS conditions were as follows: ionisation energy was set at 70 eV; acquisition was carried out in a scan mode range of m/z 30–450. Helium was used as the carrier gas. For purification, a HPLC/DAD, operated by Clarity software, was used with a reversed-phase column. The mobile phase was a solvent gradient system consisting of (A) 5% 10 mM ammonia format and (B) 95% acetonitrile, optimised to achieve the best resolution. The results were recorded at λ = 252 nm. Results Figure 1(A) shows the GC/MS chromatogram of SGT-151. It is clear the presence of a peak corresponding to SGT-151 and several other peaks from other compounds. It was not possible to identify the remaining peaks. Figure 1(B) shows a GC/MS chromatogram after purification of the package content. Discussion and conclusions: The data gathered in this study shows that SGT-151 contains a significant amount of impurities. This working progress data is the initial step of a bigger project aiming to understand whether there are differences in the toxicity of pure and non-pure SGT-151 on human cell lines, once it is important to understand if the impurities may have any influence on the cytotoxicity, compared to substances in their pure form, since most of the times the substances that are sold on the streets are not 100% pure. Figure 1. GC/MS analysis: chromatogram before (A) and after (B) purification by HPLC/DAD and mass spectrum (C).

Reflections of the transnational capitalist class on the global health: The case of India

Abstract Objectives This study aims to explore the transformations in the relation of global health and capitalism during the last three decades and its reflections on the nature of power relations between the state, local and transnational capital in the Indian pharmaceutical industry. Methods In this study, the effects of the developments in the international political economy after TRIPS (Trade-Related Aspects of Intellectual Property Rights) in the global pharmaceutical sector and in the Indian local sector are examined within the framework of the International Relations discipline. In this sense, a historical review of the Global Patent Regime has been made and a literature review has been conducted on the global pharmaceutical industry, drug patents and post-TRIPS agreements. Qualitative research method is used in the study in which the literature review is evaluated in an empirical and theoretical framework. Key findings The Global Patent Regime has been constructed for the interests of the transnational capitalist hegemon and in this sense has increased inequality in the global health. However, when the changes created by the global economy in the pharmaceutical sector, cooperation between the Southern countries and state policies are analysed, it is seen that a struggle area has been formed. This struggle adds value to global health in terms of access to medicine. Conclusions In transnational capitalism, the emergence of the state in strategic sectors such as the pharmaceutical sector in India indicates a new political and economic power.

The Compulsory Licensing for Exploiting Patented COVID-19 Pharmaceutical Treatment: Legal Approaches of Some Arab Countries

This article deals with exploitation of a pharmaceutical patent to treat the novel coronavirus. The laws of several Arab nations, which regulate industrial property rights in regard to the use of c...

Analysing the interplay between the right to health and pharmaceutical patent rights in the introduction of a COVID-19 vaccine into the Philippines

PurposeThe COVID-19 pandemic has devastated economies and public health systems across the globe, increasing the anticipation for the creation of an effective vaccine. With this comes the reinforcement of debates between the right to health and pharmaceutical patent rights. The purpose of this study is to illustrate how the Philippines could attempt to balance the right to health with pharmaceutical patent rights in the introduction of a potential COVID-19 vaccine into the country.Design/methodology/approachThis will be accomplished through an examination of the flexibilities allowed by international agreements and domestic patent laws.FindingsWith the economic and health challenges brought about by the COVID-19 pandemic, the Philippine Government will have a strong justification to pursue parallel importation and compulsory licencing under the Agreement on Trade-Related Aspects of Intellectual Property Rights. This is exacerbated by the bold leadership of President Duterte, whose administration has so far shown a propensity to decide in favor of the right to health at the expense of other rights in dealing with the pandemic.Originality/valueWhile this paper focuses on the Philippines, it has a potential application in the least developed and developing countries which aim to gain access to a prospective COVID-19 vaccine. Moreover, while this study discusses the harmonization of laws on the right to health and patent laws as a solution to the COVID-19 pandemic and the lack of access to vaccines, it also calls for solutions that go beyond the application of the law.

Принудительное лицензирование в фармации: текущее регулирование и перспективы

The problem of compulsory licensing (CL) in the pharmaceutical industry is being discussed worldwide. The aim of this paper was to analyze the effects of using CL for pharmaceutical drugs (PD) as part of competitive policies aimed at safeguarding the life and health of the population. Using PEST-analysis, we identify the main political, economic, social and technological problems associated with using CL in the pharmaceutical industry. We demonstrate the potential of CL as a tool for countering the threats to public health caused by the abuse of market dominance by pharmaceutical patent holders. At present, both developers of pharmaceutical innovations (patent-holders) and other entities involved in drug circulation are protected by law. There is ongoing debate about the efficacy of CL as a tool ensuring the implementation of competitive policies aimed at safeguarding the rights to life and health. However, in Russia CL is applied only under exceptional circumstances. An economic balance should be sought between the incentives for innovation, long-term profits from selling PDs and PD accessibility.

Proposed Title of the Project: Should China Implement Compulsory Drug Patent Licenses? - From the Perspective of COVID-19

<p>Although China has already issued laws and regulations on compulsory licensing of pharmaceutical patents, it has not yet implemented specific practices. After the outbreak of “COVID-19”, realistic needs have made it urgent for China to implement compulsory drug patent licensing. Therefore, this study will be based on China’s national conditions, combined with China’s laws and regulations on the compulsory licensing of pharmaceutical patents, and compare specific practices in other countries. Through qualitative analysis, it’s clear that China implements compulsory pharmaceutical patent licensing in three aspects: domestic system, international level, and government responsibility. To analyze the feasibility of China’s drug patent compulsory licensing system and provide suggestions.</p>

Prescribing originality: investigating the impact of original knowledge on patent quality in the pharmaceutical sector

PurposeThis paper examines the relationship between the originality of a pharmaceutical innovation and its patent quality. Greater patent quality has been shown in the extant literature to enhance market value, which better enables firms to recoup research and development (R&D) expenditures incurred during the innovation process. Understanding how originality improves patent quality can assist policymakers, when determining the optimal length of pharmaceutical patent protection and/or market exclusivity.Design/methodology/approachThe relationship between originality and patent quality is empirically investigated using a tobit, as well as a zero-inflated negative binomial, estimation approach to account for prevalence of patents receiving zero forward citations. Moderating effects of joint innovation, innovation by a university researcher and innovation by an established innovator on originality are also considered.FindingsThere is a robust and positive relationship between patent originality and quality in the pharmaceutical sector. This relationship is positively moderated by joint patent ownership with a university. As such, innovators that target originality in new drug development (especially those collaborating with universities) should, according to extant literature, see greater increases in their market value.Originality/valuePolicymakers can use information on the originality of a new drug to discern the optimal length of market exclusivity needed to enable the innovator to recoup expenditures related to R&D. Better predictions of the timing for which firms can recoup R&D expenditures will equip policymakers with knowledge about the appropriate timing to introduce competition into the market, which is critical to reducing the price of pharmaceuticals to consumers.

Modalities, Challenges, and Possibilities

On October 25, 2019, the Texas A&M Journal of Property Law and the Center for Law and Intellectual Property at Texas A&M University School of Law jointly organized the “Pharmaceutical Innovation, Patent Protection, and Regulatory Exclusivities” Symposium. Although none of the organizers and participants could predict what was to come in the next few months, there was a wide consensus that the rapid changes in the pharmaceutical landscape and our continuous struggle to strike a proper balance between proprietary protection and public access in the public health arena deserves scholarly, policy, and regulatory attention. To help contextualize the articles included in this special issue and to inform readers about the inspirations and motivations behind the Symposium, Part II of this Introductory Article explores the different modalities of protection—in particular the role of patents and regulatory exclusivities in providing the needed incentives to pharmaceutical developers. Part III identifies three sets of challenges that affect the future of pharmaceutical innovation at both the domestic and international levels. Part IV utilizes a very recent event—the COVID-19 pandemic—to illustrate the wide array of policy options and possibilities both within and outside the intellectual property system. This Part makes salient the nexus between the domestic and international debates on pharmaceutical innovation.

On Conflicts between Pharmaceutical Patent Protection and the Right to Life and Health Based on a Stackelberg Game.

To solve the conflict between pharmaceutical patent protection and the right to life, health and increased patient satisfaction, drug prices can be regulated by levying an excess profit tax. An optimal tax strategy was formulated that not only could lower drug prices and improve public health and welfare, but also considers companies’ earnings. The strategy was based on the Stackelberg game theory as a bi-level mathematical model. In the model, the government is the leader, with patient satisfaction as the main goal, and pharmaceutical companies are the followers, with maximum drug revenue as the goal. The results show that under the premise of ensuring sufficient incentives for patent holders, the optimized tax on excess profit can effectively compensate for the shortcomings of pharmaceutical patent protection, alleviate the failure of market regulation of drug prices, improve patient satisfaction, and increase total social welfare.

Pharmaceutical Patent Term Compensation System in China—Centered on Article 42(3) of the Amendment to the Patent Law of the People's Republic of China

Pharmaceutical Patent Term Compensation System in China—Centered on Article 42(3) of the Amendment to the Patent Law of the People's Republic of China

What Litigators Can Teach the Patent Office About Pharmaceutical Patents

Pharmaceutical patents listed in the FDA’s “Orange Book” are some of the most valuable patents in the world. Accordingly, for this valuable subset of patents, it is paramount that the Patent & Trademark Office (PTO) correctly issue valid patents and preclude invalid patents from issuing. In this paper, we study what happens to those patents in litigation, reporting the results for every Orange Book patent case that resulted in a merits decision. We find that about 25% of active Orange Book patents were invalidated in court. Since these invalid patents could wrongly increase the costs of prescription drugs, we investigate what happens during prosecution of these patents at the PTO. Our study is the first to link the prosecution of Orange Book patents directly to litigation outcomes. Our goal is to determine if there are ways to identify and prevent the issuance of these later invalidated Orange Book patents. We find that litigated Orange Book patents have unique characteristics that distinguish them from other pharmaceutical patents. They are issued by a relatively small number of examiners. Most litigated patents (90%) are “secondary” patents – patents on smaller tweaks to an existing drug rather than a patent on a new chemical. The owners of these later-litigated patent applications treat them very differently than they do other patents in the same field. They are part of large patent families, suggesting that the applicants are trying to build a patent fence around a known product. They frequently employ a procedural device known as “Track One” to obtain quicker patent prosecution. They are more likely to be subject to rejections based on double-patenting. When initially rejected by the patent examiner, owners of these applications are more likely to fight back rather than amend their claims. All of this suggests that applicants enter prosecution with these patents knowing that they are important and likely destined for litigation, and that they are deliberately creating patent “thickets” to make it harder for generics to enter the market. Remarkably, we find that while patent examiners already have more time to spend on Orange Book patents than on other patents, the prosecution history of many of these invalidated patents are identical. That is, many of these invalidated patents have the same assignee, the same examiner and the same prosecuting attorney cut and paste rejections as well as responses, thus creating identical or very similar prosecution histories. We also find that while the patents that end up being litigated are clearly distinguishable from other pharmaceutical patents during patent prosecution, there is little difference in the PTO between the patents that end up surviving a court challenge and the ones that are invalidated. Our data offer important guidance for reforming the process of prosecuting Orange Book patents. We can and should take advantage of advance knowledge about the importance of these patents to give them a more thorough examination early on. At the same time, the experience with cut-and-paste rejections suggests that we cannot simply give examiners more time and hope that they will do a more thorough job. That not only helps inform the policy suggestions we offer, but it sheds light on a long-standing academic debate about how much time and money we should spend examining patents. Further, our data highlight the importance of secondary patents and patent thickets in Orange Book litigation. We offer a number of suggestions to simplify and streamline patent prosecution and litigation to make it harder to exclude generic entry with a thicket of bad patents.

Drug Prices, Patents and Access to Life-Saving Medicines: Changes Are Urgently Needed in the COVID-19 Era

When patented life-saving drugs are inaccessible to patients due to high prices it is evident that the system does not perform its intended function and urgently requires reforming. The paper discusses the evidence recently revealed by the US House Committee on Oversight and Reform that directly contradicts pharmaceutical companies’ traditional argument justifying strong patent protection as a vehicle for recouping their R&D investments. It further suggests that structural and comprehensive changes are necessary, including a rigorous investigation into pharmaceutical pricing and patenting practices, ensuring adequate access to the drugs developed with public funds, and assuming the responsibility for public health by governments.