Patentability Criteria Research Articles

UTILITY MODEL PROTECTION - TRENDS IN THE EUROPEAN UNION AND CHALLENGES FOR UKRAINE

The issue of utility model (UM) protection in Ukraine in1993–2020 and the practice of the EU Member–States is considered. It is noted theproblem of UM trolling and exceeding the number of applications in Ukraine for UM in comparison with inventions. It is associated with the expansion in 2003 of the UM object in addition to the device also to a process, substance, microorganism strain, plant or animal cells culture and limiting the criterion of patentability only to the requirementnovelty and industrial applicability.It is concluded that the adoption of the Law of 21.07.2020 № 816-IX is an important step to limit patent trolling. The Law provides for exclusion from the protection of the substance and the introduction of post grant opposition in the Appellate Chamber.However the Law does not solve the problem of patent trolling at the customs border and did not exclude process from the protection. Also there will still be the problem at the courts as well Appellate Chamber to declare a utility model invalid if the UM is a new but obvious technical solution due to the lack of inventive step requirement or lower requirements for inventive step.The peculiarities of the protection of the utility model in the 15 old EU member states and the United Kingdom are analyzed. It is shown the tendency to increase level of protection of UM in the EU. In 6 EU countries there is no UM protection. In 5 there is an inventive step requirement. In 2 countries protection is possible only for three-dimensional objects (Italy, Greece). In 2 countries (Finland, Spain) - lower requirements for the inventive step.The directions of change of UM legislation in Ukraine are substantiated, including: Option 1: cancellation of protection of UM taking into account experience of Luxembourg, Sweden, Great Britain, Belgium, the Netherlands.Option 2: introduction of protection only for three-dimensional UM (protection is not provided to the method, substances, biotechnological inventions). Establishment of the criterion of inventive step the same as for inventions. Determination of mandatory examination of compliancewith the criteria of patentability (novelty, inventive step, industrial applicability) before the enforcement of UM in the courts, customs, Antimonopoly Committee.Option 3. Definition of protection of utility model as a form of protection of the invention with similar requirements as in option 2.

Significance of Utility Patents in the Economic Development of India

Utility Patents protects the incremental inventions on existing inventions, which do not fulfill the stern patentability criteria. But in India, we still do not have any laws on Utility Patent. Hence, there is an imminent necessity for legislation on protection of Utility Patent rights in India. The effective diffusion of innovation has always contributed to the economic growth of the country. If laws on protection of Utility Protection Rights are legislated in India, like any other country in the world, our country will also progress in the ranking of the international IPR index, and the Global Innovation Index, which in turn will contribute and enhance the economic development of India.

What Cannot be Patented in the Jurisdiction of India?

The exceptions to patentable inventions are reviewed and analyzed. These are Sections 3, 4 and 5 of The Patents Act, 1970. They are accompanied with examples that demonstrate that it is not sufficient for the inventions to satisfy just the three criteria of patentability. The working of an invention should also promote and address public order, social harmony, rights of farmers and public health concerns. Patentable inventions that concern us most are related to agriculture and human health. The Patent Laws while supporting inventors must also provide for equitable distribution of the benefits of the invention across all sections of the society. In the broader scheme of things, the laws governing what inventions can be patented and what cannot be patented should be in harmony with the provisions of the TRIPS Agreement administered by WTO.

Patentability of mathematical modelling and simulation methods

"Patentability" refers to conditions laid down by law to what can be patented and what cannot. In this study, changes in the patentability of simulation methods are compared with the rapid development of computational science since 1970s. Although technological progress has caused computational simulation and modelling methods to grow to an everyday tool of technology, these methods have traditionally been excluded from patentability as "non-technical subject matter" or "abstract ideas". We describe the changes in patentability criteria in Europe and in the USA, and illustrate the development of patenting activity in this field during the last decade. Practisers should be aware of these changes, and investigate the possibilities they might offer.

SOFOSBUVIR: TREATMENT OF CHRONIC HEPATITIS C AND THE MAIN TRENDS IN PATENT PROTECTION

The purpose of the study was to analyze and systematize the literature data on the benefit/risk ratio of sofosbuvir administration in the treatment of patients with chronic hepatitis C and the main trends in its patent protection. Studies were conducted using databases on the Internet: Ukrainian patent office, the European patent office, the US patent office, the Food and drug administration, European Medicines Agency (EMEA), State enterprise “The State Expert Center” of the Ministry of Health of Ukraine. It has used retrospective, logical, systematic and analytical methods. Data from clinical studies abroad and meta-analyses indicate that sofosbuvir is one of the most promising drugs for the treatment of chronic HCV infection. Its indisputable advantages are that this drug can be used with different genotypes of the virus, decompensated liver function, it is well tolerated. Sofosbuvir has an improved safety profile and a low probability of viral resistance. The high cost of sofosbuvir is due to the powerful patent protection. As mechanisms for working with patent barriers, it is recommended to use the flexible mechanisms of the TRIPS Agreement: the grant of compulsory licenses, the implementation of parallel imports, the tightening of the criteria for patentability (prohibition of patenting new forms that do not improve therapeutic efficacy).

Patente de invención, procedimientos para inscribir una patente en Costa Rica

Este artículo tiene como objetivo principal ser un instrumento de referencia para las personas interesadas en conocer los requisitos y procedimientos, establecidos en la legislación mundial y costarricense, para la inscripción de una patente de invención. Se dan a conocer las definiciones más importantes, así como las leyes que delimitan los criterios de patentabilidad y documentos técnicos que deben presentados. Una conclusión relevante del estudio es que en Costa Rica existe toda la normativa jurídica necesaria para poder inscribir con éxito una patente. Además, se recomienda el asesoramiento por medio de expertos para que el proceso culmine con un resolución positiva, de manera tal que la Oficina de Patentes del Registro Nacional elabore la resolución de inscripción concediendo un número de patente, se emita un aviso de inscripción y se confeccione un certificado.

Writing successful patents and overcoming patent barriers

Inventions related to pre-harvest and post-harvest technologies have revolutionized agriculture. There is a significant growth of intellectual property rights (IPR) in agriculture across the globe. The predominant forms of IP relevant to agriculture sector are patents and designs. Patents are given to inventions that qualify patent eligibility, patentability criteria and disclosure norms. In the area of agriculture, patents provide a great opportunity for improving agricultural processes and products. Understanding the requirements of an invention under the Indian Patents Act, 1970 is necessary to know what can be patentable in India. The criteria of novelty, non-obviousness and industrial application and disclosure norms are applicable to all inventions irrespective of the technology areas. Examination guidelines for each technology area indicate to the elaborateness of the practice in relation to patents. While preparing patent specifications for agriculture inventions, it is important to ensure that the subject matter claimed should not be a method of agriculture (under Section 3h) or plants or plant parts (under Section 3j of the Act). Identification of relevant prior art and its anticipatory value is very important for the assessment of novelty of inventions. Agriculture inventions which can lower the cost, be obtained by reduced number of steps and are environment friendly can be considered under ‘economic significance’ by the Indian patent office (under the purview of Section 2(1) ja). Adhering to the disclosure norms (as mandated under Section 10 of the Act) are also important. Inventors/applicants need to also consider the deposit requirements. The present work examines the relevance of IPR and expansion of the patentability criteria, disclosure norms and additional requirements in relation to agriculture. It will highlight the need for patent search as an integral requirement for research, the process of preparation of invention disclosures to enhance the innovative ability of academic institutions as well as researchers.

Patenting Bioinformatic Inventions: Global Perspective

Patenting bioinformatic inventions has become a ride on the rail to the scientists and inventors. Specifically in bioinformatics, drafting an invention in bounds of patentability criteria is one the most critical task for an inventor to protect his invention. As bioinformatics is a budding field of science, patentable subject matter in bioinformatics was not specifically defined by most of the patent offices in the world. In this regard, we have tried to explain patentable subject matter in bioinformatics by classifying bioinformatics into different subject fields. Additionally, we have tried to trace out patentable subject matter for bioinformatic inventions based on country-specific patentability standards and granted bioinformatic patents of US, Europe, India, Canada and Australia.

The choice of examiner patent citations for refusals: evidence from the trilateral offices

Utilizing a novel methodology based on international family-to-family patent citation data, this paper directly compares X/Y patent citations (i.e., those cited as grounds for rejections, equivalent to “blocking patents” in the US) between major patent offices. Remarkable discrepancies between the offices were revealed, despite the common patentability criteria of novelty and inventive step to generate citations. This paper then introduces a simple cosine similarity measurement between a family of X/Y patent citations and all citations added globally to the same original application. How the discrepancies of X/Y patent citations at the European Patent Office (EPO) and the US Patent and Trademark Office (USPTO) relate to the characteristics of applications and longitudinal aspects of office actions were also examined. X/Y patent citations from both the EPO and USPTO commonly show that the range of patent application classes is positively correlated with divergent reasons for refusal, suggesting that costly examinations lead to diversified X/Y patent citations. One novel methodological feature of this paper is that examiner citations across jurisdictions are comparable if we employ family-to-family citations and common criteria for the X/Y citation category. Furthermore, unlike the normal citation-generating process where a citing document adds citations to prior art only once, this paper represents the first attempt to analyze a citation network with multiple citing opportunities from separate parties. We find that the variance of citation linkages has a negative relationship with the ease in which different citers evaluate prior art in the same way, thereby providing a new perspective on the notion of breadth in citation impact.

Patentability Standards for Follow-On Pharmaceutical Innovation

Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays an important, but at times underappreciated, role in providing innovative solutions to compelling medical needs. Examples of follow-on innovation include new forms of a drug with improved safety-efficacy profiles, new formulations and dosages providing improved patient outcomes, and new methods of using an established drug more safely or to treat new indications. Patents play a critical role in incentivizing the research, development, testing, and ultimately commercialization of follow-on pharmaceutical innovation, and in doing so provide substantial benefits for public health and patients' quality of life. There is, however, a body of literature characterizing patents directed towards follow-on innovations as “secondary pharmaceutical patents.” Some have even gone so far as to propose that the criteria for patentability should be enforced more stringently with respect to follow-on pharmaceutical inventions as compared to other inventions. The underlying assumption of such proposals is that follow-on pharmaceutical innovations are somehow secondary to other pharmaceutical innovation, and thus less deserving of patent protection. In this article, we refute the notion that follow-on pharmaceutical innovation should be categorically singled out for unfavorable treatment under the patent laws, and provide numerous examples of the value that follow-on innovation brings to medicine, and ultimately to patients. We also propose, in view of the international treaty obligations set out in, inter alia, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), standards and best practices for assessing the patentability of inventions arising out of follow-on pharmaceutical innovation. These are essentially the same stringent standards applicable to “primary” pharmaceutical innovation, and inventions in general. This article provides numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.

Controversies over the moral justification for patent protection in biotechnology

This paper discusses the controversies over the moral justification for patent protection in biotechnology. Special emphasis has been put on the controversy over the moral justification for patent protection of stem cells. By referring to arguments for (1) human dignity and (2) patentability criteria, the moral justifiability of patent protection of stem cells is in serious doubt. A whole section of the paper is devoted to the moral issues linked to patent protection in biotechnology and their political and economic significance. An attempt is made to solve some of the discussed problems, i.e., the introduction of decision criteria based on the system of values shared by the members of a given society.

Positivity creation and its effect on idea patentability: a case of a new faucet invention

Among criteria of patentability, concern of novelty is taking priority in comparing to non-obviousness and industrial applicability. However, novelty is difficult to be demonstrated before conducting a thorough research of the prior art after a proposal is been designed, which is time-consuming. Under such circumstance, 1) Positive creativity is applied in this research to enhance idea patentability by positively building it during a design process. 2) Start with elaborating idea of positive creativity, its conceptual tool is applied in this research to design a new faucet, and do actual patent application. 3) The result of patents obtained in several countries, including invention (Taiwan) and design patents (Taiwan, U.S., China), indicates that positive creativity is capable of producing patentable ideas. 4) Faucet manufacturing is a traditional industry within which theoretically more difficult to get invention patents. This further indicates that positive creativity (through positivity creation) should have similar effect in providing patentable ideas in highly-innovative industries.

Inventions Related to Gamification Can Be Patented in Brazilian Patent Office

Gamification is a solution applied in the main companies of the world. The objective was to discuss the patentability of gamification in the Brazilian Patent Office (INPI). This article reviewed the scientific literature, patent office guidelines and related websites. The documents consulted have shown that patentability criteria are similar among patent offices worldwide; American and European offices have patents related to gamification; the justifications presented by these offices for patenting the inventions related to Gamification are in line with the criteria presented in the guidelines of the Brazilian Patent Office (INPI). Therefore, the present article concluded that inventions related to Gamification meet the patentability criteria of the INPI.

Kontrowersje związane z moralnym uzasadnieniem ochrony patentowej w biotechnologii

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Patents in Nanobiotechnology: A Cross Jurisdictional Approach.

Bionanomaterials create new opportunities for advancing medical sciences and diseases treatment in relation to human health care. Innovations in the use of such nanomaterials and nanodevices can lead to significant improvements in the use of drugs/devices. The present study attempts to analyse patenting trends in different areas and compare the patentability criteria and the disclosure norms for nanobiotechnology inventions in countries such as US, EU and India in the field of diagnostics and therapeutics. Nanobiotechnology patents were identified based on the search using IPC/CPC as well as keywords conducted on Relecura (a web-based patent and portfolio analysis platform). Growth of filing/ grants and by area was analysed. Comparative analysis of the patentability criteria was done to identify challenges in prosecution of nanobiotechnology applications. US, China, followed by Europe are top patent filing countries in nanobiotechnology. Topic maps indicate medicinal preparations to be the major area of patenting. There is an increase in patenting in BRIC since 2000. The assessment of novelty, inventive step and specific disclosure norms in different jurisdictions related to nanobiotechnology inventions reveal challenges in patent prosecution. 79% of the overall nanobiotechnology patents are from the medicinal preparation area followed by a significant number in case of diagnostic and surgical applications. The upward trend in patenting indicates to the potential of inventions in the field of diagnostics. The development of objective and subjective criteria with respect to patentability indicates to elaborate patent office practice and prosecution in this area.

Clinical significance of the Scheuer histological staging system for primary biliary cholangitis in Japanese patients.

Inadequate response to ursodeoxycholic acid (UDCA) is associated with unfavorable outcomes in patients with primary biliary cholangitis (PBC). We aimed to identify surrogate markers for predicting long-term prognosis and biochemical response to UDCA in patients with PBC. In this single-center, retrospective study, 99 patients with PBC were classified into responders (n=53) and nonresponders (n=46) based on reductions in the γ-glutamyl transpeptidase levels at 1 year after initiating UDCA therapy (Nara criteria). We assessed whether the criteria for patentability by different countries are useful in predicting the prognosis of PBC. The accuracy of Scheuer and Nakanuma staging systems in predicting prognosis and treatment response was compared. Nara definition had comparable utility to the Paris-II definition for selecting patients in whom UDCA monotherapy can be safely continued. Patients at Scheuer stage 1 had a significantly better prognosis than those at Scheuer stages 3 or 4 (P<0.05 and 0.0001, respectively). Patients at Nakanuma stage 4 had decreased survival compared with those at stage 1 (P<0.05). The proportion of responders to nonresponders was significantly higher in stages 1-3 PBC than in stage 4 PBC, according to both staging systems (P<0.05 for both). All patients with Scheuer stage 4 PBC were nonresponders, whereas only 28.6% (2/7) of those with Nakanuma stage 4 PBC were responders. The Scheuer staging system had greater utility in predicting long-term prognosis and UDCA response than the Nakanuma staging system.

Antiretroviral Drugs: Analysis of Ukrainian pharmaceutical market and Intellectual Property

The aim of this study was to analyze Ukrainian pharmaceutical market and patent protection of antiretroviral drugs in Ukraine and abroad. It has established that in Ukraine most of medicines are foreign antiretroviral drugs under patent protection. Take into account the prevalence of HIV in Ukraine the introduction into clinical practice domestic generic antiretroviral drugs which included in clinical guidelines for the management of HIV and AIDS in adults and adoloscents and have obvious economic benefits is prospect and economically reasonable. It has found out that the most negative risks of commercialization antiretroviral drugs which influence on their access for patients with HIV are next risks: high cost of foreign antiretroviral drugs; lack of original domestic antiretroviral drugs; sharp rise in antiretroviral drug prices as a result of switch to second- and third line therapy; patent protection and monopolization of antiretroviral drugs; exclusivity data of clinical trials. It has proved that the use of the flexible mechanisms of the TRIPS Agreement in Ukraine, namely involving the grant of compulsory licenses, the implementation of parallel imports, the tightening of the criteria for patentability is necessary for increase of antiretroviral drugs access for patients with HIV infection.

Should we manage the process of inventing? Designing for patentability

The IP design is often neglected by the management literature, whereas the issue of the strategic IP management begins with IP creation. This paper intends to deal with IP as an asset to be designed and focuses on IP design by ensuring novelty and inventive step of the inventions and not their quantity. By building on the most recent design theories like Conceot Knowledge design theory, this research introduces a general framework of patent design that allows controlling for patentability criteria, describe a patent in a unique way using actions, effects and associated knowledge and consider reasoning of person skilled in the art. Using the introduced model, the existing patent design methods are compared and their performance characterized using an introduced patent design model. The results show that patent proposal quality depends on the capacity to extend the existing knowledge combinations; to overcome the initial design reasoning of person skilled in the art and ensure sufficient inventive step and novelty. Finally, the patent design model actually demonstrates that there is an unexplored property of design theories-non-substitution-showing that the order in design is irreversible and influences the quality of results.

Alice and 'something more': the drift towards European patent jurisprudence.

On the face of it the doctrinal lines of disagreement around subject matter eligibility in US law and the invention requirement, as it is known in Europe, could not be further apart. The US statute is silent as to what does not constitute patentable subject matter, while the European Patent Convention takes a much more formal approach. Unpatentable subject matter is listed, categorized either as things not to be regarded as inventions under Article 52(2) ; or as exceptions to patentability under a small number of umbrella contexts. Professor Burk’s incisive analysis of the two-pronged test of subject matter eligibility in Alice and its place within recent decisions by the SC is monitory in three particular aspects of direct relevance to the many decisions of the European Patent Office (EPO) on the ‘invention’ requirement. First, the use and development of a common denominator across excluded categories. Second, the seeping of patentability criteria into eligibility. Third, the nascent focus on the language of the claims which so far the US Supreme Court has declaimed. I will address each of these points in turn, comparing the direction of legal ideas around patent eligibility in both systems of law, before drawing conclusions.

Ever-greening of Patents in the Context of Trans – Pacific Partnership Agreement: Implications for South Asian Countries

Patents are monopolies granted by state to inventors for a limited period of time. Disclosure of invention and technology transfer are the raison d etre for patents. The Intellectual property balancing is well in place in the multilateral WTO TRIPS regime through patentability criteria’s, flexibilities, limitations and exceptions. But the recent mega Regional Trans Pacific Partnership Agreement establishing Gold standards for Intellectual property generates great IP imbalance between private and public interest. The Pharmaceutical patents is one of the controversial area even within the multi lateral trade agreement is further becomes murkier beyond the imagination of TPPA Negotiators, activists, even WTO. The most controversial issues in pharmaceutical patents are patent linkages should be allowed in chemicals, pharmaceutical products. Data exclusivity should be given for minimum 10 years and biologics for 8 years, Ever greening should be allowed for new process, use, indication, and improvement of known product. Patent term adjustments and patent term extensions for administrative reasons and through ever greening will be very common. Compulsory licensing provisions of chapter 9 and chapter 18 limiting government use and the incorporation of ISDS dispute mechanism will have adverse effects taking each ground individually and collectively. The present concern is to analyze the patent ever greening or incremental innovation as dealt in article 18.37 (2) of Chapter 18 of TPPA which categorically states that ever greening should be allowed under three criteria’s new use of known product, new methods of using a known product, or new processes of known product provided the parties can limit the last criteria with process patent and exclude product patents. The author argues that ever greening provisions is never leading to innovations rather extending undue monopolies when issued without improved efficacy. The author further argues that ever greening is bad for generics as the period of patent goes uncertain and it delays the entry of generics and will impact market power. Ever greening is bad for patients as it raises affordability issues. The Indian supreme court in Novartis II (2013) also states that there needs to be 3(d) because to curb undue monopolies and this does not in any way intended to stop incremental innovations.