Between Knowledge And Technology: Patenting Methods,Rethinking Materiality

How does the law construe certain things and activities as knowledge that can become the object of intellectual property? When we look at the quantitative trends in recent patenting activities—more people patenting many more things—we tend to view that, in part, as an effect of the law's ability to construe new kinds of innovation (software, genetic sequences, etc.) in ways that conform to established legal concepts of patentable invention. The assumption is that what changes is not the shape of the box called invention, but the objects that are made to fit that box. But in fact while new technologies produce new innovations, the very concept of invention has not just expanded but undergone substantial qualitative change. The wave of inventive activity associated with the industrial revolution led to an unprecedented reliance on patenting, but as the law articulated ways to protect those inventions, it also took their emblematic form—the machine—as the template for the legal concept of invention. Analogously, the recent reinterpretations of patent law to enable the protection of living organism and biological entities have challenged and modified the traditional machine-inspired concept of invention, initiating a trend toward a more developmental one. The information-based inventions discussed here may elicit a reconceptualization of invention in yet another way.     

Patently not obvious

Patenting a technology is an increasingly important issue for biometrics companies around the world. On the surface, the reason for obtaining a patent seems obvious: to register a unique invention and in doing so, to stop others from copying a design which may have taken years of dedicated work and investment to complete. In actual fact, patenting is a complex issue, which requires time, money and a clear idea of what the patent may achieve.     

Inventing a new diagnostic test for vaginal infection.

Bacterial vaginosis, which is underdiagnosed in clinical practice, has a characteristic fishy smell because of production of diamines. This smell is the basis of a visual rapid diagnostic test that is technically simple to perform. The test has been patented in Europe and America, and a licence agreement has been negotiated. This paper describes the process from idea to invention to patenting and licensing. The combined costs of research and patenting were met by a multinational company in return for rights to exploit the patent invention. The process has taken nine years and has needed clinical, scientific, legal, and commercial input to get the test to the marketplace.     

Patentable invention in biotechnology

Biotechnology is a rapidly advancing field of technology which offers many benefits to society. It is perceived that an important part of maintaining the momentum, and stimulating further advances, is to protect inventions in biotechnology, where appropriate, with a patent. Here, from the perspective of invention in biotechnology, we examine in brief, the critical elements of proper subject-matter, novelty, utility, non-obviousness and sufficiency of disclosure, as requirements of patentable invention for both the United States and Canada. Topical issues which have arisen in respect of these elements are also canvassed briefly. As will be seen, Canadian Patent Law, while still unresolved with respect to the patenting of higher life forms, is in other respects in step with the pro-patent model of the United States.     

Intellectual property in natural sciences

The way from scientific finding through invention to production line and finally to the consument is long and expensive and patent should be taken into account. This is evident because the investment connected with the new application needs clear definition of intellectual property rights. Independently what we personally think about patenting in nature sciences--this is a common practice around the world. The positive and negative parameters of patenting are focus on biotechnology. The development of biotechnology is a cumulative effect of co-operation of several disciplines: biology, biochemistry, chemistry, engineering, genetics, medicines and pharmacy and many more. Between not cited here is law and consequently the needs of cooperation between researchers and lawyers. There are several barriers in this co-operation, for example: nomenclature as well as the way of thinking. These borders could be pass only with intercommunication and cross-understanding. The dialog and transfer of knowledge is a must for understanding the nomenclature, terminology of nature by lawyers and by researchers in case of law. Polish legislation concerning intellectually rights is regulated by the law "Prawo w?asno?ci przemys?owej" (30 June, 2000; Dz. U. 2003, Nr 119, pos. 1117, with later amendments). This legislation is related to European Union directives and Munich Convention. Accordingly patenting of product and process is possible in Poland. However, the procedure is time and money consuming, particularly in the case of patent submission in several countries. Amendment of the Polish law to biotechnology made possible patenting of living organism and their parts. It is worth to stress that patented inventions can be used free of charge for research and teaching.     

Patenting in biotechnology: a review of the 20th Symposium of ECB8

The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms.     

Identification of gene-related Korean patents and construction of a database server for Korean patent sequences

With the advent of high-throughput techniques, the number of patent applications containing biological sequences has been increasing rapidly in Korea. However, there is little information on gene relatedness of the Korean patent sequences. The primary aims of this study are two-fold. First, we associated Korean patent applications with genes. Second, we have constructed a database server, named Patome@Korea, to provide the gene-patent map and the Korean patent data containing biological sequences. To associate the sequences with genes, we have received patent sequence data from the Korean Intellectual Property Office (KIPO) and annotated them with RefSeq and Entrez Gene. Through the association analysis, we found that nearly 14.7% of human genes were related to Korean patenting, compared to 25% of human genes in the US patent. We have consolidated the association results and the patent sequence data to a relational database and implemented a web-based user interface to provide search service. The database can be queried using application number, applicant, titles, gene ID/name, and RefSeq number. We also provide web-based BLAST facility to allow users to compare their sequences against patent sequences. Equal contribution.     

Patenting nonassociated polymeric structures (NAPS): implications for structural genomic data release

The intellectual property laws that govern patent rights should provide a reasonable balance between the competing concerns of open access and exclusivity. Open access can facilitate knowledge dissemination and collaboration in furthering science. On the other hand, exclusivity can ensure interest and financial investment in scientific research and development.In recent days, the appropriate balance between open access and exclusivity has been a focus of public debate, particularly with regard to genomic inventions and their applications. In seeking to reconcile the timing of structural genomic data release with certain efforts to secure intellectual property rights, the International Structural Genomics Organisation joins others confronting this controversy.This paper seeks to inform the discussion with an overview of the U.S. standards for patenting nonassociated polymeric structures (NAPS), which include polynucleotides or polypeptides of unknown biological significance, and their corresponding structural data. In the United States, the present ability to obtain patent rights to these discoveries appears problematic given the requirement of specific, substantial and credible utility, among other things. Without demonstrable utility, NAPS and NAPS-related data likely will not be entitled to patent protection, whether the U.S. Patent & Trademark Office rejects NAPS claims as unpatentable in the first instance, or the U.S. federal courts invalidate NAPS claims in later patent litigation. As such, the improbability of obtaining enforceable patent rights to NAPS might undermine the rationale for delaying structural genomic data release to allow for the filing of patent applications in this regard.Abbreviations: ESTs, expressed sequence tags; ISGO, International Structural Genomics Organisation; NAPS, nonassociated polymeric structures; SNPs, single nucleotide polymorphisms; USPTO, U.S. Patent & Trademark Office     

Patenting of hybridomas and genetically engineered microorganisms

Summary Many new technologies arrived at through basic research have practical applications. Two recent breakthroughs in microbiology, recombinant DNA techniques and hybridoma techniques, will permit designing cells for specific practical purposes resulting in new products or functions of commercial significance. The unique cell or its usefulness, or both, may satisfy the requirements of a patentable invention, i.e. an inventive act having utility and novelty. Ownership of such patents permits recovery of expenses incurred in the invention process and investment for all concerned in additional research. An integral part of the patenting process is submission of the new cell to an official repository, an outstanding example of which is The American Type Culture Collection.     

Transposon tools: worldwide landscape of intellectual property and technological developments

DNA transposons are considered to be good candidates for developing tools for genome engineering, insertional mutagenesis and gene delivery for therapeutic purposes, as illustrated by the recent first clinical trial of a transposon. In this article we set out to highlight the interest of patent information, and to develop a strategy for the technological development of transposon tools, similar to what has been done in many other fields. We propose a patent landscape for transposon tools, including the changes in international patent applications, and review the leading inventors and applicants. We also provide an overview of the potential patent portfolio for the prokaryotic and eukaryotic transposons that are exploited by spin-off companies. Finally, we discuss the difficulties involved in tracing relevant state-of-the-art of articles and patent documents, based on the example of one of the most promising transposon systems, including all the impacts on the technological development of transposon tools.     

Patenting of university and non-university public research organisations in Germany: evidence from patent applications for medical research results

Background

Patents are one of the most important forms of intellectual property. They grant a time-limited exclusivity on the use of an invention allowing the recuperation of research costs. The use of patents is fiercely debated for medical innovation and especially controversial for publicly funded research, where the patent holder is an institution accountable to public interest. Despite this controversy, for the situation in Germany almost no empirical information exists. The purpose of this study is to examine the amount, types and trends of patent applications for health products submitted by German public research organisations.

Methods/Principal Findings

We conducted a systematic search for patent documents using the publicly accessible database search interface of the German Patent and Trademark Office. We defined keywords and search criteria and developed search patterns for the database request. We retrieved documents with application date between 1988 and 2006 and processed the collected data stepwise to compile the most relevant documents in patent families for further analysis. We developed a rationale and present individual steps of a systematic method to request and process patent data from a publicly accessible database. We retrieved and processed 10194 patent documents. Out of these, we identified 1772 relevant patent families, applied for by 193 different universities and non-university public research organisations. 827 (47%) of these patent families contained granted patents. The number of patent applications submitted by universities and university-affiliated institutions more than tripled since the introduction of legal reforms in 2002, constituting almost half of all patent applications and accounting for most of the post-reform increase. Patenting of most non-university public research organisations remained stable.

Conclusions

We search, process and analyse patent applications from publicly accessible databases. Internationally mounting evidence questions the viability of policies to increase commercial exploitation of publicly funded research results. To evaluate the outcome of research policies a transparent evidence base for public debate is needed in Germany.     

Global unbalance in seaweed production,research effort and biotechnology markets

Exploitation of the world's oceans is rapidly growing as evidenced by a booming patent market of marine products including seaweed, a resource that is easily accessible without sophisticated bioprospecting technology and that has a high level of domestication globally. The investment in research effort on seaweed aquaculture has recently been identified to be the main force for the development of a biotechnology market of seaweed-derived products and is a more important driver than the capacity of seaweed production. Here, we examined seaweed patent registrations between 1980 and 2009 to assess the growth rate of seaweed biotechnology, its geographic distribution and the types of applications patented. We compare this growth with scientific investment in seaweed aquaculture and with the market of seaweed production. We found that both the seaweed patenting market and the rate of scientific publications are rapidly growing (11% and 16.8% per year respectively) since 1990. The patent market is highly geographically skewed (95% of all registrations belonging to ten countries and the top two holding 65% of the total) compared to the distribution of scientific output among countries (60% of all scientific publications belonging to ten countries and the top two countries holding a 21%), but more homogeneously distributed than the production market (with a 99.8% belonging to the top ten countries, and a 71% to the top two). Food industry was the dominant application for both the patent registrations (37.7%) and the scientific publications (21%) followed in both cases by agriculture and aquaculture applications. This result is consistent with the seaweed taxa most represented. Kelp, which was the target taxa for 47% of the patent registrations, is a traditional ingredient in Asian food and Gracilaria and Ulva, which were the focus of 15% and 13% of the scientific publications respectively, that are also used in more sophisticated applications such as cosmetics, chemical industry or bioremediation. Our analyses indicate a recent interest of non-seaweed producing countries to play a part in the seaweed patenting market focusing on more sophisticated products, while developing countries still have a limited share in this booming market. We suggest that this trend could be reverted by promoting partnerships for R and D to connect on-going efforts in aquaculture production with the emerging opportunities for new biotech applications of seaweed products.     

Synthetic biology, patenting, health and global justice

The legal and moral issues that synthetic biology (SB) and its medical applications are likely to raise with regard to intellectual property (IP) and patenting are best approached through the lens of a theoretical framework highlighting the “co-construction” or “co-evolution” of patent law and technology. The current situation is characterized by a major contest between the so-called IP frame and the access-to-knowledge frame. In SB this contest is found in the contrasting approaches of Craig Venter’s chassis school and the BioBricks school. The stakes in this contest are high as issues of global health and global justice are implied. Patents are not simply to be seen as neutral incentives, but must also be judged on their effects for access to essential medicines, a more balanced pattern of innovation and the widest possible social participation in innovative activity. We need moral imagination to design new institutional systems and new ways of practising SB that meet the new demands of global justice.     

Colored de Bruijn graphs and the genome halving problem

Breakpoint graph analysis is a key algorithmic technique in studies of genome rearrangements. However, breakpoint graphs are defined only for genomes without duplicated genes, thus limiting their applications in rearrangement analysis. We discuss a connection between the breakpoint graphs and de Bruijn graphs that leads to a generalization of the notion of breakpoint graph for genomes with duplicated genes. We further use the generalized breakpoint graphs to study the genome halving problem (first introduced and solved by Nadia El-Mabrouk and David Sankoff). The El-Mabrouk-Sankoff algorithm is rather complex, and, in this paper, we present an alternative approach that is based on generalized breakpoint graphs. The generalized breakpoint graphs make the El-Mabrouk-Sankoff result more transparent and promise to be useful in future studies of genome rearrangements     

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.     

Opposition to Myriad Genetics patents and their total or partial revocation in Europe: early conclusions

The proceedings instituted against three European patents held by the US company Myriad Genetics, on the BRCA1 gene and the breast cancer diagnosis gene, resulted in the total or partial revocation of these patents. These decisions put an end to the legal monopoly claimed by Myriad Genetics on the BRCA1 gene and on breast cancer gene tests, and left the field open to European geneticists to develop and implement their test methods within the framework of a clinical not-for-profit organization. The opposition procedure, through which any actor is allowed to challenge European patents, was used by geneticists doctors in Europe to refuse the emergence of an industrial monopoly on a medical service offered in a clinical context. The decision to revoke or strongly limit these patents was based on the European Patent Office's refusal to establish an invention priority on a sequence that had errors at the time the application was filed by the patent holder, in September 1994. The patent holder was granted an invention priority only on 24 March 1995, when it filed an application for a corrected sequence of the gene. But by then the BRCA1 gene sequence had already been divulged in a public data base, Genbank, from October 1994, notably by Myriad. Myriad Genetics' patents were thus victims of the patent race that prompted the firm to file multiple patent applications on insufficiently validated sequences, and of the conflict between diffusion in the public domain and the novelty requirement. Opposition to the patents, undertaken by a coalition of medical institutions, human genetic societies, two States, Holland and Austria, an environmental protection organization (Greenpeace), and the Swiss Labour Party, made it possible to preserve and develop the clinical economy of genetic tests in Europe. It resulted in amendments to intellectual property laws in France and thus extended the possibility of using compulsory licences for public health purposes to in vitro diagnosis.     

Legal Regulation of Plant Genome Editing with the CRISPR/Cas9 Technology as an Example

The product-oriented and the process-oriented legal approaches to the regulation of genome editing technologies, CRISPR/Cas9 in particular, are considered. The relevant legislation of the United States and the European Union and some international treaties are analyzed. The issue of genome editing that is within the scope of GMO legislation and general legislation on risk assessment and regulation is addressed. The issue of patenting of gene editing technologies in the legislation of the United States and the European Union and under international law is considered. “Patent wars” between research teams that developed the CRISPR/Cas9 technology are described. The possibilities of obtaining patent protection for plants produced by genome editing are considered.     

Intellectual property protection of plant biotechnology inventions

The intellectual property protection of biotechnology-related subject matter is undergoing significant change and several countries have revised their legislation and/or patent practice as a result of challenges from industry and members of the public. Plant-related subject matter can be protected using plant variety protection, utility patents or, in the USA, by plant patent. Although easier to obtain than a utility patent, plant variety protection does not provide the same scope of protection. Protecting a plant using a utility patent is permitted only in countries that allow the patenting of higher life forms and requires a higher degree of experimental support than is required for plant variety protection, although the scope of protection is being steadily reduced.