CAR-T技术中外专利申请分析与比较

基于嵌合抗原受体-T细胞(CAR-T)的免疫疗法已经成为了一种有效治疗恶性肿瘤的全新疗法。通过检索并分析CAR-T领域的专利申请文件,从中获得了国内外专利申请发展趋势、主要专利申请人、专利地区分布情况等信息,并重点综述了获美国FDA批准的首个CAR-T 疗法的所属公司——诺华公司CAR-T技术的研发路线,以及国内主要研究机构的专利申请情况。     

生物技术领域专利申请文件的撰写

介绍生物技术领域专利申请文件的撰写特点和要求,重点介绍DNA重组技术发明专利和微生物发明专利申请文件的写法。     

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。     

“禁止反悔”对药物专利申请文件的撰写和修改的影响

申请人在专利实质审查的过程中,缩小其保护范围使得专利获得了授权,但在主张侵权诉讼中因为禁止反悔原则,却不能将因对权利要求的修改而放弃的技术方案再纳入到专利权的保护范围中。因此,申请人应重视专利授权或者无效宣告程序中权利要求的修改,知晓未公开的针对审查意见通知书的答复也会成为日后侵权判定过程中的一个重要证据,在此,申请人应仔细思考、斟酌每一次权利要求的修改以及每一次审查意见的答复,不能为了在较短的时间内获得授权就同意审查员的观点放弃权利要求中的技术特征,必要时,可以对审查员的观点予以否定。讨论了禁止反悔对药物专利申请文件的撰写和修改的影响。     

我国电疗磁疗领域专利个人申请现状及问题剖析

个人申请在专利申请中占据了一定的比重,而因为对专利法相关知识的缺乏,导致个人申请在专利文件的撰写中会存在一些比较明显的问题。笔者仅从自己的审查经验中,提炼出在电疗、磁疗领域中个人申请经常出现的四类问题,并对相关情况进行分析。     

我国药学类院校的专利分析研究

笔者通过专利检索,分析统计我国具有代表性的药学类院校-沈阳药科大学近十余年来的专利申请、审查和管理情况,并从多个角度综合分析目前我国药学类院校专利申请和保护工作的现状,并提出改进高校专利工作的若干建议。     

埃博拉病毒疫苗研究进展及相关专利浅析

通过非专利数据库的文献检索,总结了埃博拉病毒（EBOV）研究的最新进展,通过专利文献数据库文献检索分析EBOV疫苗的专利申请基本情况、发展趋势和技术点。结果发现专利申请量与疫情的爆发有一定的相关性;专利申请人多为政府主导的机构或非营利性机构;最新的专利申请均关注GP蛋白对病毒侵染的重要性,针对GP蛋白的抗体和疫苗正在开发中,其中Mapp生物制药公司的产品“ZMapp”作为试验性生物药物目前效果最佳。     

药物组合物封闭式权利要求的解读与侵权判定 ——由最高人民法院（2012)民提字第10号判决案例谈起

从最高人民法院的一个典型案例出发，探讨药物组合物封闭式权利要求保护范围的解读及其专利侵权判定标准，比较其他国家 的相关规定和判例，并对药物组合物封闭式权利要求的专利授权、确权审查、侵权判定以及申请文件撰写技巧提出见解，以供借鉴和参考。     

中国生物医药专利的分布及趋势分析

生物医药产业是中国重点发展的战略性新兴产业之一。本文对Derwent数据库中收录,在中国申请的与生物医药领域相关的专利申请数据进行了研究,分别从专利申请量及年度变化、生命周期、专利权人和德温特分类号等角度深入分析了生物医药专利的整体产出情况、重点技术领域和主要申请机构的专利战略布局情况。通过研究发现中国生物医药技术近年来发展迅速,已进入相对成熟阶段。     

基于专利计量分析的抗HIV 药物发展趋势研究

近年来,艾滋病感染人数急剧增加,已成为威胁人类健康的重大疾病。为了对抗HIV药物的研究现状和发展趋势进行深入分析,本文通过在Derwent Innovations Index数据库中检索2006-2012年的抗HIV药物专利。对采集的专利信息用TDA软件进行数据清洗,利用专利计量分析方法,借助可视化的分析工具,从专利申请数量、优先权国、专利技术机构和专利技术领域等方面进行分析。研究发现近几年抗HIV药物专利申请数量较为平稳;专利申请主要集中在美国、加拿大和中国;抗HIV药物的技术领域主要集中在天然产物、发酵工业和杂环化合物等方面。美国在专利申请数量方面远远领先于其他国家,足以见美国在抗HIV药物研发的活跃和强劲的技术实力。我国虽然在专利申请数量方面具有一定优势,但是与国外相比仍有较大差距。     

Bioinformatics -- a patenting view

The use of bioinformatics in the biological sciences has brought about a change in the way that biological inventions can be protected by patent laws. Using approaches developed in the fields of computer science and business, patent applicants now seek to protect certain aspects of their inventions, which include software, methods of doing business and uses of information as well as more traditional biotechnological products and processes. These approaches are useful in resolving some of the difficulties now faced in prosecuting patent applications directed to biological inventions that are claimed in more conventional terms.     

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。     

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)     

The 'real world' utility of miRNA patents: lessons learned from expressed sequence tags

Strategies are needed for drafting miRNA patent applications, in light of the existing patent landscape and genomic patent strategies of the past decades.     

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.     

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?     

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.     

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.     

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.     

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.