Patent prosecution strategies for stem cell related applications

Stem cell research and the intellectual property derived from it, because of its potential to completely transform health care, demand an especially high level of consideration from business and patent prosecution perspectives. As with other revolutionary technologies, ordinary risks are amplified (e.g., litigation), and ordinarily irrelevant considerations may become important (e.g., heightened level of both domestic and foreign legislative risk). In the first part of this article, general strategies for patent prosecutors such as several prosecution considerations and methods for accelerating patent prosecution process are presented. In the second part, patent prosecution challenges of stem cell-related patents and possible solutions are discussed. In the final part, ethical and public policy issues particular to stem cell-related and other biotechnological inventions are summarized.     

United States patent prior art rules and the neem controversy: a case of subject-matter imperialism?

A recent United States patent covering an improvement to the naturally-occurring pesticide in neem tree seed oil might have been rejected as 'obvious' if United States patent law recognized certain forms of prior inventive activity on a par with similar activity occurring within the United States' borders. But the US only recognizes prior 'knowledge, use or invention' as blocking a claim to a patent when those activities take place within US borders, or are evidenced by publications accessible in the US, or, more commonly, by foreign patents. Neither of these last forms of tangible 'prior art' is likely to be available to block patents on biodiversity inventions – most notably because of the fact that most developing nations do not allow patents on pharmaceutical or agricultural inventions, categories subsuming most biodiversity-related advances. Although the United States patent only has direct force within the United States, it is nonetheless highly significant to this global dispute, since the United States and other developed nations stand to be the major markets for the end-products of neem. This paper argues that the border-drawing distinctions in US patent law are archaic, counter to stated policy directives and are disproportionately influencing the developing world's stance towards GATT and its intellectual property rights provisions.     

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.     

生物技术领域发明专利申请文件撰写中存在的问题

专利申请文件的撰写在一定程度上决定一项专利的命运,针对国内生物技术类专利申请文件撰写中存在的问题,从6个方面提出看法和建议,供国内专利申请人参考,以之保护自己的发明创造成果。     

给药对象特征对医药用途发明权利要求的影响 ——以百时美施贵宝公司与正大天晴公司专利纠纷一案为例

给药对象等给药特征对医药用途发明权利要求是否具备限定作用,在新颖性和创造性评判时是否予以考虑,一直存在不同见解。 通过对百时美施贵宝公司与正大天晴公司专利纠纷一案的缘由、审理过程进行介绍,并对其中所涉及的问题进行分析,探讨给药对象特 征对医药用途发明权利要求的影响。     

Intellectual property protection for plant-related inventions in Europe

The economic and political issues that accompany the commercial growing of genetically modified crops, as well as the risk of transgene spread, are often top of the agenda for debate. But one important aspect is frequently overlooked--the intellectual property protection of plant-related inventions. What protection does European patent law afford to such inventions, how does it compare with the United States law and what are the consequences of the differences between them?     

Patent protection for structural genomics-related inventions

Recently there have been some important developments with respect to the patentability of inventions in the field of structural genomics. The leaders of the European Patent Office (EPO), Japan Patent Office (JPO) and the United States Patent Office (USPTO) came together for a trilateral meeting to conduct a comparative study on protein 3-dimensional (3-D) structure related claims in an effort to come to a mutual understanding about the examination of such inventions. The three patent offices were presented with eight different cases: 1) 3-D structural data of a protein per se; 2) computer-readable storage medium encoded with structural data of a protein; 3) protein defined by its tertiary structure; 4) crystals of known proteins; 5) binding pockets and protein domains; 6) and 7) are both directed to in silico screening methods directed to a specific protein; and 8) pharmacophores. The preliminary conclusions reached at the trilateral meeting provide clarity regarding the types of inventions that may be patentable given a specific set of scientific facts in a patent application. Therefore, the guidance provided by this study will help inventors, attorneys and other patent practitioners who file for patent protection on structural genomics-based inventions both here and abroad comply with the patentability requirements of each office.Abbreviations: (Not Applicable)     

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.     

Enzymes as a subject of invention

A patent-legal situation is analyzed which has arisen in the world in connection with the problem on protection of native enzymes as objects of invention. The objects under study are shown to correspond to the demands of novelty, essential distinctions and positive practical effect which are made by the legislation of the USSR to inventions. Possibility of legal protection of enzymes as substances with unstated structure obtained microbiologically is determined in terms of acting standard statements. A set of characters necessary and sufficient for recognition of enzymes and substantiation of their novelty is suggested for characteristics of enzymes in original papers and patent documents. General approaches to optimization of native enzyme examination for the novelty and essential characteristics are developed.     

Biotechnology--a challenge to the patent system

Biotechnology inventions raise both moral and technical dilemmas. The patent system was developed to protect inventions such as the Spinning Jenny and Stevenson's Rocket. This article looks at how this long-established and slow-moving system is coping with a modern, highly sophisticated and swiftly moving field of science. It looks at specific areas of the technology--research tools and claims that reach to the products produced using those tools, genes, stem cells and bioinformatics. It concludes that the system is having to adapt, but that it will cope.     

Patenting inventions arising from biological research

Patents are the most important way in which researchers can protect the income that might come from ideas or technologies they have developed. This article describes the steps involved and the considerations needed for successful granting of a patent. For instance, inventions must be novel and not obvious, adequately described, and useful, and they should not be disclosed publicly before a patent is applied for.     

Decoding the research exemption

While debate continues as to whether genetic sequences, which many argue represent natural phenomena rather than inventions, should be subject to standard patent protections, issuance of patents that claim DNA sequences remains common practice. In an attempt to insulate researchers from patent claims that could hinder scientific progress, many countries have provided general exemptions for scientific research. However, there is no international consensus about the extent of required protections, and even existing exemptions vary widely in clarity and are limited in practical application. We believe that gene patents raise several unique issues that are inadequately handled by the current research exemptions.     

Invisible genomes: the genomics revolution and patenting practice

In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney's case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a 'genome', and the ways in which it may be different from a 'gene', played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences.     

United States patents and microbes

This article reviews the current state of patent availability in the United States for microbiological inventions and the current controversy as to the patentability of microbes as products. It also sums up the practical value of American patents.     

Freedom‐to‐operate analysis of a transgenic multivitamin corn variety

In this article, we explore the intellectual property (IP) landscape relevant to the production and commercialization of Carolight^?, a transgenic multivitamin corn variety created on humanitarian grounds to address micronutrient deficiencies in low‐and‐middle‐income countries. The successful production of this variety requires IP rights risk management because there is a strong protection on inventions and processes via patent portfolios in both developing and industrialized countries. The IP framework is complex, and specialist patent lawyers are usually employed to perform such analysis, but the costs cannot always be met by small, publicly funded projects. We report an alternative strategy, a do‐it‐yourself patent analysis, to produce a review with limited legal value that can nevertheless lay the foundations for a subsequent more in‐depth professional freedom‐to‐operate opinion.     

Models for facilitating access to patents on genetic inventions

The genetics community is increasingly concerned that patents might lead to restricted access to research and health care. We explore various measures that are designed to render patented genetic inventions accessible to further use in research, and to diagnosis and/or treatment. They include the often-recited research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms. The last two alternatives deserve special attention in the area of human genetics.     

United States patents and fungal cultures

Summary Fungal biotechnology has generated a voluminous amount of technical literature and scientific data. Patents probably contain the most complete and detailed information about the use of fungal cultures in biotechnology. This article contains a brief review of the United States patent system where microorganisms form an integral part of the disclosure and explains the role of the American Type Culture Collection (ATCC) as a patent culture depository. A list based on the application of the ATCC fungal strains which have been cited or used in US patents and the names of the inventors, the titles of the inventions, and their patent numbers are included. This provides resource material particularly for developing countries as they begin to establish their own biotechnology.     

Patents in combi-space: patent challenges in combinatorial chemistry

Patent protection of inventions relating to combinatorial chemistry is attended by special challenges. The "breakthrough" nature of the field together with the always complex and often arcane chemical manipulations, apparatus, and strategies which suffuse this field make it difficult to describe the inventions adequately. It can be a challenge to communicate effectively with official authorities charged with patent examination. Extraordinary effort is called for in clarifying such inventions such that their patentability can be appreciated. The utility of some types of inventions in this field may be open to question; clear statements of at least one acceptable utility-even if only a minor utility-is beneficial. Because a principal product of many aspects of combinatorial chemistry is information, e.g., the identification of a lead compound, offshore "piracy" is a risk. Domestic claim tie-ins may improve the ability to abate such piracy. Copyright 1998 John Wiley & Sons, Inc.     

Patentability of life and ethics

Patent law has relied in part on ethical considerations since its inception in Europe. Such considerations have been introduced more recently in the United States. Whereas the EU Directive on the protection on the occasion of the Human Genome Project of biotechnological inventions was intended to foster economic development in Europe, its implementation is outweighted by controversy about patenting life and commercialization of science. The confusion created must be cleared at the international level through harmonization of patent office policies preventing abusive commercial practices in the absence of inventiveness.     

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.