Gene Patents Research Articles

The more you spend, the more you get? The effects of R&D and capital expenditures on the patenting activities of biotechnology firms

This paper provides evidence on the mechanisms influencing the patent output of a sample of small and large, entrepreneurial and established biotechnology firms from the input of indirect knowledge acquired from capital expenditures and direct knowledge from in-house R&D. Statistical models of counts are used to analyse the relationship between patent applications and R&D investment and capital expenditures. It focuses on biotechnology in the period 2002---2007 and is based on a unique data set drawn from various sources including the EU Industrial R&D Investment Scoreboard, the European Patent Office (EPO), the US Patent and Trademark Office, and the World Intellectual Property Organisation. The statistical models employed in the paper are Poisson distribution generalisations with the actual distribution of patent counts fitting the negative binomial distribution and gamma distribution very well. Findings support the idea that capital expenditures--taken as equivalent to technical change embodied in new machinery and capital equipment--may also play a crucial role in the development of new patentable items from scientific companies. For EPO patents, this role appears even more important than that played by R&D investment. The overall picture emerging from our analysis of the determinants of patenting in biotechnology is that the innovation process involves a well balanced combination of inputs from both R&D and new machinery and capital equipment.

Gene patents in Australia: where do we stand?

The provision of a patent system that protects innovators and researchers while ensuring reasonable access to emerging technologies and medical treatments are the key objectives of the Australian government's response to three important reports concerning Australia's patent system and gene patents.

New Biotechnology Patents: News from Amgen, OHR, MorphoSys, Sernova

New Biotechnology Patents: News from Amgen, OHR, MorphoSys, Sernova

Climate change and gene patents

Climate change is imposing significant stresses upon agriculture at a time when more food is required for an increasing world population. Genetic engineering is mooted as a technological response to these difficulties. The modification of the DNA of major crop groups produces plants which are more resistant to drought, salinity and to pests. The patenting of climate-useful DNA provides an opportunity to protect the investment in the exploitation of this DNA. The international IPR regime based upon the WTO TRIPS Agreement enables the patenting of this DNA across the globe. As a matter of practice, this patenting is confined to a relatively small group of life-sciences companies. This market concentration has important agricultural policy implications, particularly for developing countries. This article analyses these issues, concluding that the impact of patenting upon food security is becoming as significant as the impact of patenting upon access to medicines.

Personalized medicine: renewing the social science research agenda.

Since the launch of the Human Genome Project, there has been a significant investment in research to examine the ethical, legal and social issues (ELSI) of what some have called the molecularization of the life sciences and clinical practice [1]. Myriad issues have been addressed in these ELSI research programs across the world, involving sociologists, economists, anthropologists, political scientists and others. Studies have focused on: gene patents, genetic discrimination, geneticization, the governance of biobanks, the familial implications of genetic testing and the regulation of genetic testing, to name just some of the themes. There is not the space here for a thorough review of the literature on even a single one of these topics, and that is not our intent. Instead, the purpose of this commentary is to highlight some of the key areas where we feel there are still gaps in our knowledge, where new questions should be asked or where novel approaches might bring a fresh perspective. To draw an analogy with genomic science: just as researchers have followed the initial findings from the genome-wide association studies of recent years by pursuing the missing heritability of common disease so the ELSI research program has left social scientists with their own mysterious dark matter to explore. There is widespread expectation that the genomic revolution in biomedical science will usher in an age of personalized (or stratified) medicine. A new molecular taxonomy of disease will emerge in tandem with new diagnostic tools for risk stratification, early detection of disease, prognosis and personalized therapies. The rapid decline in the cost of sequencing, coupled with the postgenomic shift towards proteomics and metabolomics, has increased the pace and volume of biomarker discovery. However, the

Debunking the myth that whole-genome sequencing infringes thousands of gene patents

The fear that human gene patents pose a threat to whole-genome sequencing is based largely on widely held misconceptions.

Gene patent case reaches US Supreme Court

Gene patent case reaches US Supreme Court

Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single Policy Perspective article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as covering human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.

Patenting in Biotechnology - An Overview

One of the significant developments in the Patent Laws has been in the Biotechnology sector. With the advent of technology to modify life forms itself, it is becoming extremely difficult for law to join hands with protecting the intangible property vested in biotechnology patents. These patents have inherent tendencies to stir up debates related to ethical and moral issues. Also, many stand up to question the patent system in itself for allowing patents in life forms. The Biotechnology patents are subject to so much debate that many countries consider that these patents create problems such as restricted access and the position of the patenting of life forms is not clear to an extent as to whether it will fall into the category of an invention or discovery. These issues still continue to haunt the Biotechnology Patent Law and this paper gives an overview of the laws in the European Union, India, China, Australia, USA and the TRIPs regime itself. Also, dealt herewith are specific issues relating to patentability of life forms which need to address in context of the world scenario.

The Logistics and Business Behind Gene Patenting

The Logistics and Business Behind Gene Patenting

Gene patents in the US - focusing on what really matters

Gene patents in the US - focusing on what really matters

Gene patents in the US - focusing on what really matters

Gene patents in the US - focusing on what really matters

Die Idee des geistigen Eigentums zwischen Schöpferprinzip und Investitionsschutz

The idea of intellectual property can look back on a long tradition both in countries of European and Anglo-American law. However, for some years now the protection of intangible goods leads to controversial discussions across all social and political groups. Examples are the discussions around gene patents and pharma patents as well as the controversy surrounding Google Books. In the following article the idea of intellectual property as a model for legitimizing intangible effort is looked at from its legal philosophical roots and motives. Building on that, the requirements for a positive protection of those intangible efforts at question, which requirements are interdisciplinary and independent from a legal culture, are to be elaborated.

Patenting of agriculture biotechnology and food security: options and challenges

When corporations develop new agricultural biotechnology products or processes or new crop varieties, they often seek legal rights over the intellectual property these innovations represent. However, intellectual property protection in agriculture is considered controversial because it directly confronts pre-existing systems of agriculture management that were mostly based on free exchange and on public sector involvement. There are five main issues with respect to agriculture and intellectual property. Firstly, question of patenting of life forms whose expansion constitute one of the main vehicle for the increasing role of patents in agriculture. Secondly, it has to take into consideration plant breeder‘s rights and farmers‘ rights, the two agriculture specific framework that have progressively proposed as alternatives to a system based on the free sharing of knowledge and germplasm. Thirdly, rights of sovereign nations from where biological resources are being collected by developing and developed countries for bio prospecting. Fourthly, whether genetically modified food is safe for health, and does it take into consideration environmental safety or not. Lastly, can we use agriculture biotechnology as option for food security?

Empirical Study on the Distribution and Growth Trend of Biotechnology Patents in China

Since 1980s, China has made great performance at economic growth, and greatly improved its innovation level. As one of the most important aspect of emerging technology industry, biotechnology industry has also gotten great development. And, as the most important representation index of innovation activity, number and growth of biotechnology patents are also significant. Using OECD’s standard of biotechnology patents as the method to collect the data of biotechnology patents, this paper got detailed data of biotechnology patents in China, including spatial distribution data across 31 province, autonomous region, municipality directly under the central government, and time series data from 1985 to 2010. And further, this paper constructed quintic overdetermined equation of one variable to simulate the trend of patent number varying with the time from 1985 to 2010, made use of Matlab Software and took the solution of simulation model. After F-test, it is believed that the simulation model is reliable. Based on this model, scientific estimation about the distribution of biotechnology patents in China from 2011 to 2015 is presented.

Scope of Protection of Gene Patents in Europe

After the arrival of the Biotech Directive in 1998, although it was generally welcomed that the Directive clarified that the human body cannot constitute patentable inventions, the exact scope of protection for patentable inventions were unknown until 2010. It took 12 years before the CJEU interpreted the provisions of the Directive regarding the scope of protection. In C-428/08, the CJEU decided for the first time that a gene that does not perform its function cannot be protected by the patent. Once the living organism that hosts the patented gene is dead, the patent protection ceases. The framework of the CJEU ruling remains unchanged under individual countries' laws. Moreover, the CJEU decided that a gene patent holder, whose patent was issued prior to the adoption of the Biotech Directive, cannot enjoy absolute product protection for the patented product under a European national legislation. The ruling further holds that the interpretation of Article 9 of the Directive is not affected by the normal exploitation of a gene patent within the meaning of Article 30 TRIPS. Notably, the ECJ's judgement on the meaning of Article 9 of the Biotech Directive requires a number of Member States to amend their patent laws. Here, I provide an analysis of the mentioned case and its implications. Striking similarities between the logical structure of the Biotech Directive and that revealed in computer Software-related EPO cases, leads us to curious thoughts regarding the future of Gene patents in general.

Mining information across multiple domains: A case study of application to patent laws and regulations in biotechnology

Abstract In this paper, we present a framework that can process a user query for retrieval of information from documents of different properties across multiple domains, with specific application to patent laws and regulations. The framework has three basic components. The first component is ontology mapping and generation. What happens is that the keywords entered by users are mapped into a subset of relevant keywords. This step is performed by looking up those words in an ontology database. The second component is the joint and cross search in various document domains; in our case, they are patents and scientific publications. The last component is to modify the search results by applying user feedback statistics. The results of feedback will be saved as metadata for future uses. A case example is given to demonstrate how results from multiple domain searches can be combined using ontology and cross referencing. We use an example of well-known biotechnology patents on erythropoietin (EPO) and give detailed analysis on each document domain with this keyword. Relationships between each domain are demonstrated. A user feedback mechanism is also discussed in this paper. The ability to take user feedback into the framework is important. There is no doubt that domain knowledge from expert or experienced users could be a very good compliment to the proposed system. Both direct and indirect user feedbacks are discussed.

Gene Patents Related to Common Diseases of the Eye

Visual impairment and blindness impose substantial morbidity and premature mortality on the population. The direct costs for vision disorders have been shown to be more than the cost of coronary heart disease, stroke, arthritis or depression and were estimated to be $9.85 billion in 2004 in Australia. Hence it is important to identify the causes of common eye diseases and understand their aetiology which in turn would allow determination of better management strategies and treatment options. Age related Macular Degeneration, Cataract, Diabetic Retinopathy, Glaucoma and uncorrected refractive errors represent the majority of the visual impairment and blindness in Australia and various parts of the world. This article reviews the gene patents available for these eye conditions and highlights the important discoveries that have so far contributed to our understanding of these diseases and provides valuable information as to where research will be heading in the future.

An Analysis of Federal Circuit Discrimination: The Evolution of the Written Description Requirement Vis-a-Vis DNA and Biotechnological Inventions Concerns for Synthetic Biology

The Federal Circuit uses particular patent doctrines as policy levers to control the nature of the nation's patent output. To this end, the Court will actively discriminate in it's application of the Patent Act, depending on the nature of the technology before it. One example of such a lever is the written description doctrine. Most recently, the court has looked to this doctrine in an effort to limit the scope of biotechnology patents in general and DNA patents in particular. This paper provides a cursory review of this law regarding the enigmatic written description requirement, examining particularly its history and purposes. It then examines some of the recent cases that allude to the Federal Circuit's particular efforts in the biotechnology industry. Finally, it presents a potentially problematic technology for future implementation of discriminatory practices by the court.

Gene patent pool set to launch

Gene patent pool set to launch