An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile

We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between “primary” (active ingredient) and “secondary” patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate “older” therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents.     

An assessment of emerging molecular farming activities based on patent analysis (2002∼2006)

The products of Plant Molecular Farming are recombinant proteins or their metabolic products. In this study, patent data was employed to assess industrial trend in the research and innovation process of Plant Molecular Farming within national and international context. The US Patent and Trade Organization (USPTO), the European Patent Office (EPO) issued a total of 585 patents covering Plant Molecular Farming from 2002 through 2006. By nationality, US inventors predominated as recipients of PMF patents, followed by Germany, Denmark, and Japan. The PMF patents were catagorized in five major areas of research namely pharmaceutical and nutraceuticals with 170 patents (31%) and plant expression tools and methods for alternative production systems with 169 patents (29%) were the dominating patent applications, followed by 102 patent claims associated with antibodies (17%), 71 patents of industrial molecules (12%), 48 patents of vaccines (8%), and finally 18 patents related to post-translational protein glycosylation (3%). The greatest proportion of patentees was of US origin (52%), and PMF associated patenting activities at the USPTO and EPO were dominated with 67% by private organizations. Disclaimer: The views expressed in this study do not necessarily reflect those of the European Commission.     

Strategic mining of cyanobacterial patents from the USPTO patent database and analysis of their scope and implications

Patent analysis with the help of the strategic mining of patents from databases is important and useful within the framework of application-oriented research and its commercialization. In the analysis reported here, we have mined cyanobacterial patents from the patent database of the United States Patent and Trademark Office (USPTO). In order to make an assessment of the commercial potentials of cyanobacteria, we conducted the patent search (from 1976 to April 2006) using certain generic terms and the 84 genera of cyanobacteria as keywords. The search was performed in two major ways – searching the abstracts and claims of the patents cumulatively and searching the entire patent documents by the mode of ‘all fields’ in USPTO. In the abstract- and claims-based search, 234 patents were obtained after the removal of overlapping patents among the keywords. An additional 31 patents were added following the ‘all fields’ search; these patents were not covered in the search that was based on abstracts and claims. The entire package of 265 patents, of which 244 were related to cyanobacteria, was then analyzed. Information derived from these patents identified five major areas of cyanobacterial utilization. Cyanobacteria have been patented as a source of a wide spectrum of products, for medical, agriculture and environmental applications, for gene-based products, for methods of cultivation and for methods of control. The chronological development in granting cyanobacterial patents was also traced. This study demonstrates that such strategic mining and analysis of patent data can be used as an index for future development.     

Patenting genome research tools and the law

Patenting genes encoding therapeutic proteins was relatively uncontroversial in the early days of biotechnology. Controversy arose in the era of high-throughput DNA sequencing, when gene patents started to look less like patents on drugs and more like patents on scientific information. Evolving scientific and business strategies for exploiting genomic information raised concerns that patents might slow subsequent research. The trend towards stricter enforcement of the utility and disclosure requirements by the patent offices should help clarify the current confusion.     

Gene patents: socially acceptable monopolies or an unnecessary hindrance to research?

Why should patents be granted on genes? This question is a provocative and troubling issue currently facing society. Looking at the commercial realities of gene patents, I conclude that on balance their effect is to retard, rather than to stimulate, both scientific and economic progress. The monopolies awarded by patents on genes as novel chemicals are not therefore in the public interest. Society would benefit from immediate change in the policy of patent offices to limit the allowance of patents on genes to specified uses with only narrow claims.     

国际生物技术专利计量分析

目的:通过对近10年全球生物技术专利的文献计量分析,了解其年度分布、国家/地区分布、机构分布和技术热点分布等,结合产业现状,讨论我国在生物技术专利方面的实力和在全球的位置,以期为我国生物技术的研发和产业发展提供参考。方法:在Derwent Innovation Index数据库中检索2001～2010年的生物技术专利,用TDA软件进行数据分析。结果:国际生物技术专利的数量从1996～2002年呈快速增长趋势,2002年后缓慢下降;生物技术专利中的80%分布在美国、日本和中国,集中程度高;申请数排名前20位的专利权人主要分布在美国、日本和中国;专利的技术热点有方法研究、生物医药和治疗研究、生物大分子研究等。美国、日本、欧洲研究机构的专利基础性较中国强,且更加注重产品开发。结论:我国的生物技术专利数量排名靠前值得欣喜,然而在专利的基础性及专利应用于产品转化方面,与美、日、欧等发达国家/地区仍有差距,我国生物技术研发应更加重视基础性研究,同时不断推动生物技术专利的转化。     

Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents

Background

While there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.

Methodology/Principal Findings

We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.

Conclusions/Significance

Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry.     

Phycobiliproteins as a commodity: trends in applied research,patents and commercialization

Phycobiliproteins are a group of colored proteins commonly present in cyanobacteria and red algae possessing a spectrum of applications. They are extensively commercialized for fluorescent applications in clinical and immunological analysis. They are also used as a colorant, and their therapeutic value has also been categorically demonstrated. However, a comprehensive knowledge and technological base for augmenting their commercial utilities is lacking. Hence, this work is focused towards this objective by means of analyzing global patents and commercial activities with application oriented research. Strategic mining of patents was performed from global patent databases resulting in the identification of 297 patents on phycobiliproteins. The majority of the patents are from USA, Japan and Europe. Patents are grouped into fluorescent applications, general applications and production aspects of phycobiliproteins and the features of each group are discussed. Commercial and applied research activities are compared in parallel. It revealed that US patents are mostly related to fluorescent applications while Japanese are on the production, purification and application for therapeutic and diagnostic purposes. Fluorescent applications are well represented in research, patents and commercial sectors. Biomedical properties documented in research and patents are not ventured commercially. Several novel applications are reported only in patents. The paper further pinpoints the plethora of techniques used for cell breakage and for extraction and purification of phycobiliproteins. The analysis identifies the lacuna and suggests means for improvements in the application and production of phycobiliproteins.     

microRNA相关专利分析

目的:分析microRNA(miRNA)相关专利,为我国miRNA科学研究和决策提供一定的参考。方法:运用专利文献计量学方法,使用TDA软件和Excel程序,对DII数据库中收录的miRNA相关专利的年份、国别、专利家族分布、专利权人、发明人和Derwent手工码进行分析。结果:发现了miRNA相关专利的年份分布、主要国家或组织的专利家族分布、前十位专利权人分布、前十位发明人分布及所涉及的Derwent手工代码分布情况。结论:我国在相关专利数量上虽然处于相对领先地位,但与美国等国相比仍存在很大差距,同时miRNA相关专利的专利家族多局限于本国,未曾形成一种广泛的多国高度分布的专利家族形势,缺乏对专利主动运用以获取专利信息和竞争优势的意识。     

Evaluation of brazilian biotechnology patent activity from 1975 to 2010

The analysis of patent activity is one methodology used for technological monitoring. In this paper, the activity of biotechnology-related patents in Brazil were analyzed through 30 International Patent Classification (IPC) codes published by the Organization for Economic Cooperation and Development (OECD). We developed a program to analyse the dynamics of the major patent applicants, countries and IPC codes extracted from the Brazilian Patent Office (INPI) database. We also identified Brazilian patent applicants who tried to expand protection abroad via the Patent Cooperation Treaty (PCT). We had access to all patents published online at the INPI from 1975 to July 2010, including 9,791 biotechnology patent applications in Brazil, and 163 PCTs published online at World Intellectual Property Organization (WIPO) from 1997 to December 2010. To our knowledge, there are no other online reports of biotechnology patents previous to the years analyzed here. Most of the biotechnology patents filed in the INPI (10.9%) concerned measuring or testing processes involving nucleic acids. The second and third places belonged to patents involving agro-technologies (recombinant DNA technology for plant cells and new flowering plants, i.e. angiosperms, or processes for obtaining them, and reproduction of flowering plants by tissue culture techniques). The majority of patents (87.2%) were filed by nonresidents, with USA being responsible for 51.7% of all biotechnology patents deposited in Brazil. Analyzing the resident applicants per region, we found a hub in the southeast region of Brazil. Among the resident applicants for biotechnology patents filed in the INPI, 43.5% were from S?o Paulo, 18.3% were from Rio de Janeiro, and 9.7% were from Minas Gerais. Pfizer, Novartis, and Sanofi were the largest applicants in Brazil, with 339, 288, and 245 biotechnology patents filed, respectively. For residents, the largest applicant was the governmental institution FIOCRUZ (Oswaldo Cruz Foundation), which filed 69 biotechnology patents within the period analyzed. The first biotechnology patent applications via PCT were submitted by Brazilians in 1997, with 3 from UFMG (university), 2 from individuals, and 1 from EMBRAPA (research institute).     

Patent searches as a complement to literature searches in the life sciences--a 'how-to' tutorial

This communication provides an easy-to-follow protocol for using the free Internet-accessible scientific search engine, Scirus, to search for and subsequently retrieve published patents from several patent offices in portable document format (PDF). Hints on how to 'read' patents and how to extract relevant information, as well as how to export bibliographic data from Scirus and how to cite patents, are also given. The reason for providing such a protocol is that a vast amount of information, also of potential interest to life scientists, is largely hidden for those not knowing how to access these data. Several examples are provided that highlight the reasons to include patent searches into the workflow of life scientists. These include early access to data before publication, patents as a source of data that never appear in the literature and patents as a source of critical information otherwise hard to get from commercial suppliers. Finally, alternative free patent search services are briefly discussed, and their differences are highlighted.     

Whole-genome patenting

Gene patenting is now a familiar commercial practice, but there is little awareness that several patents claim ownership of the complete genome sequence of a prokaryote or virus. When these patents are analysed and compared to those for other biological entities, it becomes clear that genome patents seek to exploit the genome as an information base and are part of a broader shift towards intangible intellectual property in genomics.     

Quarterly U.S. patent review: first quarter, 1999.

The following are among the U.S. patents, issued in the first quarter of 1999, directed to combinatorial chemistry and related technologies. Patent issuances in the field are growing in number. Additionally, patents claiming libraries themselves, as opposed to synthetic methodologies, are becoming more common. It is impossible to be comprehensive. The author would be pleased to recognize additional patents and invites the use of his e-mail address for this purpose.     

Power Law Distributions of Patents as Indicators of Innovation

The total number of patents produced by a country (or the number of patents produced per capita) is often used as an indicator for innovation. Here we present evidence that the distribution of patents amongst applicants within many countries is well-described by power laws with exponents that vary between 1.66 (Japan) and 2.37 (Poland). We suggest that this exponent is a useful new metric for studying innovation. Using simulations based on simple preferential attachment-type rules that generate power laws, we find we can explain some of the variation in exponents between countries, with countries that have larger numbers of patents per applicant generally exhibiting smaller exponents in both the simulated and actual data. Similarly we find that the exponents for most countries are inversely correlated with other indicators of innovation, such as research and development intensity or the ubiquity of export baskets. This suggests that in more advanced economies, which tend to have smaller values of the exponent, a greater proportion of the total number of patents are filed by large companies than in less advanced countries.     

Patents Associated with High-Cost Drugs in Australia

Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by “evergreening” blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug''s originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.     

Patent Funded Access to Medicines

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.     

Patent border wars: defining the boundary between scientific discoveries and patentable inventions

Drawing an appropriate boundary between unpatentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle. Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headline-grabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that Congress and/or the courts will address the issue, and perhaps substantially shift the boundary.     

全球虾青素研究专利计量分析

由于虾青素具有极高的应用价值,近几十年来,虾青素的应用研究取得了很大的进展。本文以Derwent Innovations Index(DII)数据库为统计分析源,检索并分析了数据库中关于虾青素的所有专利产出,利用Thomson Data Analyzer(TDA)分析工具和Thomson Inovation分析平台进行数据挖掘。通过对专利申请趋势、高产机构、核心技术、专利布局、热点技术领域等方面的计量分析,揭示了全球虾青素技术的发展现状,探索我国发展虾青素技术面临的机遇与挑战。虾青素的应用集中在鱼类饲料的添加剂和疾病治疗两个领域。日本、美国和中国为排名前三的优先权受理国,日本公司的申请数量占主导地位,从专利布局看,杜邦和东曹公司几乎全部集中在发酵或使用酶的方法合成目标化合物或组合物或从外消旋混合物中分离旋光异构体和微生物或酶其组合物这两个领域,而排名靠前的日本公司的研究领域主要集中在医用、牙科用或梳妆用的配制品、食品、食料或非酒精饮料制备或加工处理以及化合物或药物制剂的特定治疗活性三个领域。     

Quantitative Determination of Technological Improvement from Patent Data

The results in this paper establish that information contained in patents in a technological domain is strongly correlated with the rate of technological progress in that domain. The importance of patents in a domain, the recency of patents in a domain and the immediacy of patents in a domain are all strongly correlated with increases in the rate of performance improvement in the domain of interest. A patent metric that combines both importance and immediacy is not only highly correlated (r = 0.76, p = 2.6*10^-6) with the performance improvement rate but the correlation is also very robust to domain selection and appears to have good predictive power for more than ten years into the future. Linear regressions with all three causal concepts indicate realistic value in practical use to estimate the important performance improvement rate of a technological domain.     

Recent advances and novel applications in microbial diversity estimation based on DNA analysis methods

This review focuses on recent patents on the exploration and quantification of microbial diversity. Only the patents based on DNA analysis are considered. In general terms, the analysis of environmental samples can be investigated by using three main approaches: microarrays based technologies, genomes/metagenomes comparison and amplification and detection of operative taxonomic units. All patents can relate to the estimation of the microbial diversity, however, many of them were initially designed to detect important medical or agronomic microorganisms. Here, we briefly review recent technological achievements for DNA analysis that offer great potentials for the identification of species.