The Cabilly patents

This article discusses the status quo of the Cabilly patents, their scope of protection and the role these patents play for the therapeutic antibody industry in Europe and the US.     

基于专利的冠状病毒技术发展分析

新型冠状病毒(SARS-CoV-2)是目前已知的第7种可以感染人的冠状病毒,尚无用于预防和治疗的药物。本文以全球人类冠状病毒的技术专利为研究对象,采用专利分析和文本挖掘的方法,分析了专利的技术发展趋势和技术分布特点,梳理了关键技术的最新发展动向,以期为SARS-CoV-2检测技术、药物筛选、疫苗及抗体研发提供参考。     

Intellectual property protection: Strategies for future antibody inventions

In the last decade, therapeutic antibodies have become one of the most commercially successful classes of biopharmaceutic drugs. Major drug manufacturers who have successfully managed to occupy this new market, as well as biotechnology firms, some of which have experienced a quick growth and are now on par with the former, owe part of their success to suitable intellectual property (IP) strategies. This article provides an overview of the current thinking on antibody-related patents, and discusses strategies for protecting the antibody products of the future.Key words: antibody, mimetics, patent, inventive, intellectual property     

International intellectual property strategies for therapeutic antibodies

Therapeutic antibodies need international patent protection as their markets expand to include industrialized and emerging countries. Because international intellectual property strategies are frequently complex and costly, applicants require sound information as a basis for decisions regarding the countries in which to pursue patents. While the most important factor is the size of a given market, other factors should also be considered.Key words: antibody, patent, international, PCT, filing strategy     

Patenting antibodies in Europe

As a complement to the series of articles beginning in this issue on obtaining, maintaining and enforcing antibody patents in the United States, this article provides a comparison of the requirements for patenting antibodies in the United States and Europe and provides examples illustrating the application of European patent law to antibodies.     

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.     

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.     

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.     

Anti-IL-1β therapies

IL-1β is one of the major cytokines implicated in the pathogenesis of many inflammatory-associated diseases. Recent studies demonstrate that IL-1β is activated through inflammasomes, which are formed upon recognition of danger signals by the immune system. IL-1β is, therefore, becoming a focus for the development of new anti-inflammatory drug products. Current issued patents mainly covered the methods and the use of four types of IL-1β blockade compounds, namely anti-IL-1β antibody, IL-1 receptor antagonists such as sIL-1Ra and icIL-1Ra and IL1 trap. Two agents, Rilonacept and canakinumab were approved by the US FDA and others are in trial, in which beneficial results have been reported. One can expect that upcoming patents in the field of inflammasome research will facilitate the development of new therapeutic interventions.     

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.     

Patents – a practical perspective

Patent Update is a regular column dedicated to the complex issues that affect patents in the genomics and proteomics field. In each issue, there are two sections compiled by patent attorneys. The first section, Patents – a Practical Perspective, is a commentary on current issues, landmark patents, useful patent resources and how to search them, and legislative changes that impact the pharma and biotech industries. The second section, Patent News, provides brief synopses of recently issued patents and other patent events, and their significance to drug discovery R&D.     

The Academic Advantage: Gender Disparities in Patenting

We analyzed gender disparities in patenting by country, technological area, and type of assignee using the 4.6 million utility patents issued between 1976 and 2013 by the United States Patent and Trade Office (USPTO). Our analyses of fractionalized inventorships demonstrate that women’s rate of patenting has increased from 2.7% of total patenting activity to 10.8% over the nearly 40-year period. Our results show that, in every technological area, female patenting is proportionally more likely to occur in academic institutions than in corporate or government environments. However, women’s patents have a lower technological impact than that of men, and that gap is wider in the case of academic patents. We also provide evidence that patents to which women—and in particular academic women—contributed are associated with a higher number of International Patent Classification (IPC) codes and co-inventors than men. The policy implications of these disparities and academic setting advantages are discussed.     

Patent perspective

Patent Update is a regular column dedicated to the complex issues that affect patents in the genomics and proteomics field. In each issue, there are two sections compiled by patent attorneys. The first section, Patents – a Practical Perspective, is a commentary on current issues, landmark patents, useful patent resources and how to search them, and legislative changes that impact the pharma and biotech industries. The second section, Patent News, provides brief synopses of recently issued patents and other patent events, and their significance to drug discovery R&D.     

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.     

Effects of research tool patents on biotechnology innovation in a developing country: A case study of South Korea

Background  

Concerns have recently been raised about the negative effects of patents on innovation. In this study, the effects of patents on innovations in the Korean biotech SMEs (small and medium-sized entrepreneurs) were examined using survey data and statistical analysis.     

Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

Background

Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market.

Materials and Methods

We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents.

Results

Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years).

Conclusion

Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic improvements in the standard of care, which is highly debatable.     

Patentes fúngicas: de Pasteur a nuestros días

At the end of the 19^th century, the American Patent Office granted the patent known as “Pasteur's application”, claiming the protection of a yeast strain. Since that date, the debate around biotechnology patents, especially for those that affect living organisms or part of them, has grown exponentially.In the present article, the Patent Law is reviewed, pointing out the particular problems about fungi or parts of them. Also, some of the fungus patents are discussed from the perspective of the ethical, economical, social and environmental aspects of these kind of patents.     

以PD-1 为靶点的抗肿瘤药物专利现状分析

PD-1(程序性死亡受体1)是一种重要的免疫抑制分子,其与癌症的治疗密切相关。目前FDA(美国食品药品监督管理局)已经批准了PD-1抑制剂抗体作为癌症治疗药,因此,PD-1具有极高的研究和应用价值。目前在专利领域,全球各大药企均已经开始专利布局,而在中国申请的专利也是日趋增多,对于我国企业来说,把握时机提前布局专利申请,有利于识别竞争对手,抢占市场。本文通过分析以PD-1为靶点的药物专利现状,特别是研究的重点领域,专利申请的国内重点布局等方面,为国内的申请人未来的研发方向和专利布局提供适当的指引。     

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. © 1999 John Wiley & Sons, Inc. Biotechnol Bioeng (Comb Chem) 61:189–190, 1998/1999.