Pharmaceutical Patent Applications Research Articles

Herbal pharmaceutical patent protection: Illustrative evidence on prosecution stages and section 3 [d] implication of Indian Patent Act

Abstract Background: Pharmaceutical industries are increasingly vigilant on filing patent protection in the field of herbal medicine due to increase in annual growth rate/demand of natural products. These industries dependant on medicinal system(s) primarily on AYUSH system of Medicine apart from traditional knowledge practices. Since 2005, India had complied with Trade Related Aspects of Intellectual Property Rights [TRIPS] obligations by evolving suitable patent protection system. Indian patent system had advanced by various amendment(s) including Section 3 (d) of the Act (Patent Act 1970). Aim: The study is aimed essential to provide evidence in protection of desirable patent and to understand implications of Section 3 (d) in terms of protecting creativity, appreciating variations in development of pharmaceutical products. Material and methods: The study had examined 41 herbal pharmaceutical patent grants from grassroots innovations during 2021 to 2022 incubated by National Innovation Foundation-India. The implications of pharmaceutical grants with respect to Section 3 (d) were elaborated. Results: It was encouraging to note that 24 percent of these applications were accorded with herbal pharmaceutical product patent grants. The study observed that on an average these applications received grant by seven years with a prosecution period of 19 months. Conclusion: These features reflect evolving nature of IP regime in dealing with herbal pharmaceutical patent applications as India is recognized as an innovation economy. The contribution of green grassroots innovation in public health care is illustrated.

Patenting trends in the pharmaceutical field of Mexican universities.

Aim: pharmaceutical patenting activity in developing countries, including Mexico, is unknown. Objective: determine the activity of pharmaceutical patents by Mexican universities. Method: using 'university' as keyword and A61K, A61P and C07 as International Patent Classification codes, was searched to generate a perspective of pharmaceutical patent applications by Mexican universities. Results: 227 patents (186 granted patents + 41 not-granted patents) were claimed in the period 2000-2018. The leading university was the National Autonomous University of Mexico, followed by the Instituto Politecnico Nacional, Universidad Autonoma de Nuevo León, and Universidad Autonoma de Puebla. The pharmaceutical concerns addressed were led by the fields of infectious, cancer and diabetes. Conclusion: in Mexican universities, the licensing of pharmaceutical patents is still in its early stages.

Trends in herbal pharmaceutical patent protection for Dairy industry: Perspectivefrom Grassroots innovations

The national patent regime had amended Patent Acton innovation as per requirement for protecting pharmaceutical product patents among member states of World Trade Organisation. In this respect, the study was conducted to understand patentability nature and prosecution timelines forpatent protected indigenous dairy technologies. Investigators had examined 28 herbal pharmaceutical patent grant(s) from grassroots innovators/outstanding knowledge holders. Patent applications were filed between 2007-2014, prosecution were held and accorded patent grant during 2019-2022. The study noted that Section 3 (d), (e) and (p) were principal factors involved while defending veterinary pharmaceutical patent applications. About 46 percent did not have Section 3 (d) objections inferring these medicinal practices followed by dairy farmers were unique. It was observed that majority of patent grants were in productcategory illustrating transformation of national patent regime from process patent to product-patent grant system. Overall time taken for availing grant was about ten years with an average prosecution period of 2.6 years. Therapeutic efficacy, synergisticaction and suitable claim amendments are pertinent features in responding to prosecution stages. These pharmaceutical product patents from social innovation are of interest to dairy industry. These experimental wisdom provide cost effective sustainable technologies for dairy health system and repurpose existing knowledge of local communities. It is paramount to nurture this bottom-up approach for improvising sustainable dairy health service delivery system.

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.

Technological diversity of patent applications and decision pendency

This study focuses on the duration of the patent examination process to develop a theoretical framework that explains how the effect of an important characteristic, technological diversity of patent applications, influences the duration of patent examination. Drawing on an information-processing perspective, we propose a U-shaped relationship between the level of technology diversity of a patent application and the pendency time for patent office decisions, including both grants and refusals. We run Cox proportional hazard models on a sample of all pharmaceutical patent applications filed between 1985 and 2017 at China's State Intellectual Property Office. Our results support the hypothesized U-shaped relationship between technology diversity and decision pendency. We also theorize and find partial support for the moderating effects of patent agency and inventor team size. The implications of these findings are discussed.

Public health insurance and pharmaceutical innovation: Evidence from China

Developing countries are characterized by low levels of pharmaceutical innovation. A likely reason is their small market size, which is not because of the population size but because of low levels of income and lack of health insurance coverage. This study exploits a natural experiment from the implementation of a public health insurance program for rural residents in China (New Cooperative Medical Scheme [NCMS]) to examine whether the pharmaceutical industry increases innovation regarding diseases covered by the NCMS that are prevalent in rural areas. We examine the 1993–2009 patent data to gauge pharmaceutical innovation in China. Diseases with a 10% higher rural patient share saw a 12.4% increase in relevant domestic pharmaceutical patent applications and a modest increase in patent quality after the NCMS implementation. By providing public health insurance to low-income individuals in developing countries, governments can create incentives for pharmaceutical firms to develop new medical technologies.

Pharmaceutical patent examination outcomes in the Dominican Republic

In the Dominican Republic, the legal provisions requiring the substantive examination of patent applications were enacted 20 years ago, along with the implementation of the TRIPS agreement. Prior to this, the country had a registration system in which all applications that were filed ended up being registered. This offers an opportunity to explore the outcomes of applications in a country that embarked on substantive patent examinations relatively recently. and which has drawn comparatively less attention in academic research related to the rigorousness of patentability criteria. Based on a novel dataset of pharmaceutical patent applications filed in the Dominican Republic between 2000 and 2015, I find that only 16% of them were granted. This seems surprisingly low. However, I also find that grant rates may be influenced by several factors, including some that are not strictly related to patent examination. In particular, some applications may have been disposed of without a grant because their applicants acquired additional knowledge, indicating that the underlying inventions lacked commercial value. This calls for more attention towards other policies – such as legal provisions and institutional arrangements designed to accelerate the speed of patent examination – which could also be determinants of grant rates.

Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination

The debate surrounding escalating prescription drug prices has increasingly focused on the legitimacy of the practice of brand-name manufacturers receiving patent protection on peripheral features of the drug such as the route of administration, as opposed to just the active-ingredient itself. The key question is whether these later-obtained, secondary patents protect novel features and represent true innovation or, instead, provide little to no innovative benefit and improperly delay generic entry. In this paper, we explore how the Patent Office may improve the quality of the secondary patents issued—thereby reducing the degree of unnecessary and harmful delays of generic entry—by giving examiners more time to review patent applications. Our findings suggest that current examiner time allocations are causing patent examiners to issue low quality secondary patents on the margin. We further set forth evidence suggesting that the costs to investing in greater ex ante scrutiny of secondary pharmaceutical patent applications by the Patent Office are greatly outweighed by the benefits, which include the avoidance of downstream litigation expenses and gains to consumer and total surplus from reduced drug prices.

Expedited pharma patenting in Brazil.

This article has the purpose of bringing an updated landscape on expedited protection of pharmaceutical patent applications in Brazil. The serious backlog of examination of patent applications in Brazil is a fact well known worldwide for a long time. In 2017, said backlog related to pharmaceutical patent applications achieved a mean time of about 11-13years. On the other hand, there are alternatives to attempt to surpass such huge delay, based on official regulations for expediting examination, which have shown to be quite effective. Actual examples of pharmaceutical patents beneficiated from such fast track rules have received grant decisions within about 0.5-3.5years counted from request for accelerated examination.

Reaching a milestone in pharmaceutical patenting in Brazil.

Reaching a milestone in pharmaceutical patenting in Brazil.

Patentability of polymorphs: the interpretation of novelty and inventive step in Brazil

... In January 1995, Brazil became a member of the World Trade Organization (WTO) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). As a result, Brazil was required to have a minimal patent protection, and more specifically to provide patent protection to pharmaceutical products and process.1 Brazil had to implement Article 27 of the TRIPS agreement which granted protection to any inventions, whether products or processes, in any field of technology, provided that they are new, involve an inventive step and are capable of industrial application.2 On 14 May 1996, the current Industrial Property Law—Lei da Propriedade Industrial 9.279/96 (LPI)—was passed.3 Historically, Brazil adopted a protectionist position towards its industries. In December 1999, a provisional measure was issued,4 providing that the granting of pharmaceutical patents needed a prior consent from the National Sanitary Regulatory Agency (ANVISA). This was based upon the allegation that the joint work of National Institute of Industrial Property (INPI) and ANVISA would ensure the best technical standards in deciding pharmaceutical patents.5 In practice, it acted as a duplicate review of pharmaceutical patent applications.6

Pharmaceutical patent protection: the United States and Japan in comparative perspective.

Pharmaceutical Patent AnalystVol. 6, No. 1 Special ReportPharmaceutical patent protection: the United States and Japan in comparative perspectiveShinya Kimura & Carlyn A BurtonShinya Kimura*Author for correspondence: E-mail Address: kimura@oshaliang.com Osha Liang Consulting K.K., Level 28, Shinagawa Intercity Tower A, 2-15-1 Konan, Minato-ku, Tokyo, JapanSearch for more papers by this author & Carlyn A Burton Osha Liang LLP, Two Houston Center, 909 Fannin, Suite 3500, Houston, TX, USASearch for more papers by this authorPublished Online:3 Feb 2017https://doi.org/10.4155/ppa-2016-0039AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: intellectual propertypharmaceutical patentthe USA and JapanReferences1 Pallin v. Singer, 36 USPQ 2d 1050 (D. Vt. 1995).Google Scholar2 35 U.S.C. § 287(c)(2)(C).Google Scholar3 35 U.S.C. § 271 (b) and (c).Google Scholar4 Examination Guidelines for Patent and Utility Model in Japan, Part III, Chapter 1 Eligibility for Patent and Industrial Applicability (Main Paragraph of Article 29(1) of the Patent Act).Google Scholar5 Tokyo High Court, Hei 12 (Gyoke) No. 65 (2002).Google Scholar6 M.P.E.P. § 2111.02.Google Scholar7 Examination Guidelines for Patent and Utility Model in Japan, Part III Chapter 2 Section 4 Claims Including Specific Expressions.Google Scholar8 Examination Handbook for Patent and Utility Model in Japan, Annex B, Chapter 3 Medicinal Inventions.Google Scholar9 Tokyo District Court, Hei 2 (Wa) No. 12094 (1992).Google Scholar10 Tokyo High Court, Hei 10 (Gyoke) No. 308 (2000).Google Scholar11 Tokyo High Court, Hei 10 (Gyoke) No. 401 (2001).Google Scholar12 In re Thorpe, 777 F.2d 695 (Fed. Cir. 1985).Google Scholar13 M.P.E.P. § 2113.Google Scholar14 Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009).Google Scholar15 Supreme Court of Japan, Hei 24 (Ju) No. 1204 (2015).Google Scholar16 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013).Google Scholar17 Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __ (2012).Google Scholar18 Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. __ (2014).Google Scholar19 2014 Interim Guidance on Patent Subject Matter Eligibility.Google Scholar20 M.P.E.P. § 2111.Google Scholar21 Examination Handbook for Patent and Utility Model in Japan, Annex B, Chapter 2 Biological Inventions.Google Scholar22 Altman D, Sweeney C, Yasui T. Preparing effective experimental data for pharmaceutical patent applications from US and Japanese perspectives. Pharm. Pat. Anal. 3(5), 469–473 (2014).Link, CAS, Google Scholar23 M.P.E.P. § 2164.03.Google Scholar24 United States v. Telectronics, Inc., 857 F.2d 778 (Fed. Cir. 1988).Google Scholar25 Allergan, Inc., v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015).Google Scholar26 M.P.E.P. § 2163.Google Scholar27 Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006).Google Scholar28 Examination Guidelines for Patent and Utility Model in Japan, Part III Chapter 2 Section 2 Inventive Step.Google Scholar29 Tokyo High Court, Hei 8 (Gyoke) No. 201 (1998).Google Scholar30 Tokyo High Court, Hei 15 (Gyoke) No. 104 (2003).Google Scholar31 Intellectual Property High Court, Hei 17 (Gyoke) No. 10042 (2005).Google Scholar32 35 U.S.C. § 287(c)(2)(A).Google Scholar33 Intellectual Property High Court, Hei 17 (Ne) No. 10125 (2006).Google ScholarFiguresReferencesRelatedDetailsCited ByBiological deposits for patenting purposes under the Budapest TreatyMicrobiology Australia, Vol. 40, No. 3 Vol. 6, No. 1 Follow us on social media for the latest updates Metrics Downloaded 77 times History Published online 3 February 2017 Published in print January 2017 Information© Future Science LtdKeywordsintellectual propertypharmaceutical patentthe USA and JapanFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

Pharmaceutical patent applications in freeze-drying.

Injectable products are often the formulation of choice for new therapeutics; however, formulation in liquids often enhances degradation through hydrolysis. Thus, freeze-drying (lyophilization) is regularly used in pharmaceutical manufacture to reduce water activity. Here we examine its contribution to 'state of the art' and look at its future potential uses. A comprehensive search of patent databases was conducted to characterize the international patent landscape and trends in the use of freeze-drying. A total of 914 disclosures related to freeze-drying, lyophilization or drying of solid systems in pressures and temperatures equivalent to those of freeze-drying were considered over the period of 1992-2014. Current applications of sublimation technology were contrasted across two periods those with patents due to expire (1992-1993) and those currently filed. The number of freeze-drying technology patents has stabilized after initial activity across the biotechnology sector in 2011 and 2012. Alongside an increasing trend for patent submissions, freeze-drying submissions have slowed since 2002 and is indicative of a level of maturity.

TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India

This article compares national approaches towards secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures and policies countries have enacted to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyse the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries, the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches towards secondary patents need to be understood in the context of their broader approaches towards Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s.

Propriedade intelectual e saúde pública: o papel da Agência Nacional de Vigilância Sanitária no patenteamento farmacêutico no Brasil

This article aims to present results of a study on the examination of pharmaceutical patent applications held by the National Health Surveillance Agency (Anvisa), known as prior informed consent. The implementation of patent examination within the Anvisa - health regulatory agency in the country - is an example of using adapting devices of the TRIPS Agreements of the World Trade Organization (WTO) and instrument of promotion of the right to health. With adherence to the TRIPS Agreement, Brazil was taken to recognize patents for pharmaceutical products and processes, which resulted in the enactment of the Industrial Property law (Law 9,279 of 1996). The temporary monopoly created by patentability interferes with access to medicines and health policies, in particular in the pharmaceutical area. To reduce this interference, Brazil implemented, starting in 1999 (with the creation of prior informed consent), a specific procedure for the examination of pharmaceutical patents, done in two steps: in the Industrial Property National Institute (INPI) and the Coordination of Intellectual Property of Anvisa (Coopi-Anvisa). The practice resulting from this measure is permeated today by numerous conflicts and tensions involving different sectors of Brazilian society. The study of this experience was based on specialized literature, on press material examination, patent applications, laws and decrees relating to medicines and intellectual property and in interviews with those responsible for the operation of the prior informed consent.

The Political Contradictions of Incremental Innovation: Lessons from Pharmaceutical Patent Examination in Brazil

Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applications. Though widely celebrated as a health-oriented policy, the Brazilian experience has become fraught with tensions and subject to decreasing levels of both stability and enforcement. I show how one pillar of the neodevelopmental regime, the array of initiatives to encourage incremental innovations, has fostered the acquisition of innovative capabilities in the Brazilian pharmaceutical sector, and how these new capabilities have altered actors’ policy preferences and thus contributed to the erosion of the coalition in support of the other pillar of the neodevelopmental regime, the health-oriented approach to examining pharmaceutical patents. The analysis of capability-derived preference formation points to an endogenous process of coalitional change.

Problem pharmaceutical patents

These days, the number of pharmaceutical patent applications which do not specify the principal active ingredient in the form of a chemical name or structure is increasing. These patents are difficult to retrieve in retrospective on-line searches using chemical structures or keywords. Furthermore, even if you could find them, the situation with regard to patentability is obscure and this causes considerable problems for the experts in charge of the patent search. If you are a searcher for a large pharmaceutical company, you might already be apprehensive of infringing such patents. We, the JFA, ∗ ∗ The JFA is the abbreviation of the Japan Farmdoc Association. The JFA was organised in 1968 by patent information specialists of 14 Japanese pharmaceutical corporations to explore mutual interests of Farmdoc in Japan. Today membership is restricted to full subscribers to the B-section of the Derwent CPI and embraces 40 corporations. The JFA holds meetings twice a year and branch meetings several times in a year in order to explore mutual interests about various patent information matters. gathered these patents together and studied the differences between their patentability in Japan, the US and the EPO.

Company Profile: Merck KGaA: Analysis of patenting 1993 – 1996

Merck KGaA are shown in this profile to be filing pharmaceutical patent applications steadily, concentrating on cardiovascular and blood clotting therapies. A large teampreviously producing angiotensin II antagonists is now tuming its attention to Na+/H+ exchange inhibitors; another is exploring cellular adhesion inhibitors. Few of these patenting initiatives have yet shown up in the company's development portfolio. Unlike many companies, Merck KGaA does not routinely use the PCT mechanism to protect major inventions.

Company Profile Sanofi: Analysis of patenting 1992–1995

Due to the recent acquisition of Sterling Winthrop, Sanofi is now the highest ranked French company in terms of its R&D portfolio and occupies tenth place overall. The new company publishes around fifty pharmaceutical patent applications per year, over a quarter of which fall into the neurological and cardiovascular categories. Musculoskeletal, alimentary and anticancer research are of secondary importance with around two or three applications per year. This article serves to analyse the patenting trends for the company during the period 1992 - 1995 and indicates the classes of compounds currently under investigation by the merged company.