说明：本文最初用英语写成，因考虑到大部分读者习惯于中文阅读，所以要简要译成中文。英文版本应该更为完整。 我们常常被告知：知识就是力量，知识就是金钱，似乎知识是完美无缺价值连城的了。结果就是大量的知识通过教育塞进我们的头脑，不管我们是否需要，是否重要。我们常常以在国际奥林匹克竞赛上拿到多少金牌而自豪，可奇怪的是在科学上中国人却乏善可陈。没有人可以否认我们的学生所掌握的知识是世界上最多的，但是这些学生却不能为科技做出很大的贡献，其原因是否与我们对于知识过于重视有关呢？ 毫无疑问，知识具有有益的一面，所以本文的论点既不是知识有害无益，也不是知识弊大于利，本文仅仅指出长期以来被人们所忽视的知识有害的一面，并且希望通过对知识害处的认识，达到尽量减少其弊端的目的。 首先，知识可以减少好奇心。小孩对与外界事物显示出强烈的好奇心，因为他们一无所知。长大了之后，因为知道的东西多了，就会渐渐地丧失好奇心。例如，小孩可能会问：为什么指南针能够指向南北？可是我们有几个会问这样的问题呢？因为我们已经通过教科书知道了，由于地球的磁场作用与指南针，所以指南针指向南北。 但是现有的知识往往仅仅涉及到许多问题的表面。我们以为自己知道了指南针为什么指向南北，便不再关心这个问题。可是，为什么地球电磁场是指向南北，而不是指向东西或其他方向呢？为什么地球会有地磁场呢？其它星球会有吗，例如月亮，太阳？假如带一个指南针去月球，它也会指向南北吗？有多少人会问自己这些问题呢？我估计不到百分之一。 知识往往给出了一些问题的答案，对于大部分人而言，他们很满足这个答案了，其实这个答案仅仅触及到问题的皮毛。如果我们继续追问下去就会发现： 其实我们一无所知。 更糟糕的是，习惯于去学习、接受知识可能会养成一种不良的习惯，就是总是习惯于去记忆却忽视了思考、批判和创造这就是中国应试教育的后果之一。学习知识需要记忆，当思考、批判或创新时，记忆的效率会降低。所以为了提高记忆效率，为了尽快地记住知识，人们选择了放弃思考，放弃创造。 任何事物都是一分为二的，过于强调其中的一点往往会导致忽视另外的一点。对于知识重要性的强调，结果就是忽视了知识的潜在害处。 认识到知识的害处，怎样才能避免呢？首先是要知道我们其实一无所知，我们所有的知识仅仅是触及到问题的表面，在已有问题得到答案之后，不应该满足， 而要继续追问到底，继续提出更深入的问题 唯有如此，我们才能永葆好奇心。第二是在记忆知识的时候，不要为了追求记忆的效率而放弃思考和创新。第三是要有所选择，要选择那些真正重要的知识去学习。人生的目标不应该是成为一个学富五车的饱学之士，这样的人不过是一个活的书橱罢了，更重要的是要利用所学知识去创造社会财富和新的知识。 We are taught to believe that knowledge is one of the most important things in the world, or knowledge is power in short. As a result, large amount of knowledge, from history to geology, from mathematics to chemistry, has been instilled into our mind. We take pride in the prize we have won in the international Olympic contests and the high score in the exams; however, everyone knows that we have attained little significant scientific achievement in China . No one can doubt the fact that Chinese students mastered the most knowledge, but it comes as a surprise that they can not contribute greatly to the scientific research. In my view, it is the result of our neglect of creativity. It is true that knowledge is beneficial, but if too much emphasis has been put on it, we may ignore the disadvantages of it. Knowledge serves as a two-edged sword, but the harmful side is generally ignored. So it is necessary for me to point out the demerits of knowledge and warn people against the negative effect derive from it. To begin with, Knowledge may reduce our curiosity. A little child may manifest great curiosity in everything he sees. He may ask why the sky is blue, why the sun rises in the east, why water evaporates after being heated, why compass can direct to southward. In contrast, as an adult, how many of us will come up with these questions? The reason why we do not ask ourselves these questions is that we know the answer or we have the relevant knowledge. We know that because short wavelength blue ray scattered while penetrating the atmosphere so sky appeared to be blue. We know that because rotation of earth is from west to east, so the sun rises in the east. We are taught that while water is heated, the single molecule has a greater speed hence can escape from the water and this process is termed evaporation. We also know that the reason why compass can direct to southward is that the north magnetic pole of the earth places in Antarctic. Because we have the knowledge, we will not come up with new questions. But our knowledge only skims the surface of the problem. A single example will serve to illustrate my point: It is true that because the north magnetic pole of the earth places in Antarctic so compass direct to southward, but why? Why the north magnetic pole located in Antarctic rather than arctic or other location such as the equator? How does the magnetic pole forms? In other planet or stars, such as the moon or mars, is their magnetic pole also located in their Antarctic region? Or do they have a magnetic field? I am sure 99.9 percent of the people will not come up with these questions. Because they think they have known the answer and they are content with the answer, so their curiosity in this problem declines. Worse yet, people who is ready to learn new knowledge may develop bad habits, namely is always prepared to accept but ignore thinking and questioning. To gain new knowledge means you have to put your mind to memorizing it, but if you are absorbed in memorizing, you may neglect thinking and questioning because your attention is limited so you can not value two matters at the same time. Besides the fact that some existing knowledge is problematic, people who possesses lots of knowledge but can not create new knowledge and come up with questions is no more than a bookshelf. As Plutarch, the ancient Greek biologist and educator put it, the brain of student is not a container that nee to be filled with, but a torch requires to be ignited. Any good thing will become bad if going to its extreme. Since we have attached so much importance to knowledge, there is every chance that we may be blind to the side effect of it, so it is high time that we realize the disadvantages of knowledge, because we will not avoid the side effect until we realize the demerits of it. I must point out that my view is not the demerits of knowledge outweigh its merits. Generally speaking, the advantages we gain from knowledge are greater than the disadvantages. However, as a coin has two sides, knowledge also has some disadvantages but it is widely ignored. So I just want to point the negative effect of knowledge and hope we will avoid it through our realization of it. If you know something, you should keep in your mind that you only skims the surface of it, and never stop coming up with new questions. When you are studying something, never forget thinking and coming up with new ideas while you are absorbed in memorizing.
赵凤光 http://www.dxy.cn/bbs/post/print?bid=204id=909617 再谈专利意识 Copy to clipboard Posted by: windlight Posted on: 2004-04-20 00:02 虽然和ngm、inferno等几位辩论过专利意识问题！ http://www.dxy.cn/bbs/post/view?bid=77id=489388tpg=1ppg=1sty=1age=0#489388 但我一直没有想明白专利意识到底为何物，无知者无畏，跟ngm兄辩论有些强词夺理，有些词实际有公认的含义，但自己想当然的篡改和借用，最近又参加了几个学习班，看了一些文章，现就专利意识这个概念与各位在此重新探讨一下，现汇报我的学习结果。 利用google，以专利意识为关键词搜索到前几页，主要强调为专利保护意识专利申请意识，专利战略。 搜索dxy,也大致如此，下面这个帖子最强调专利意识，也还是专利保护意识。 http://www.dxy.cn/bbs/post/view?bid=93id=775014sty=3keywords=%D7%A8%C0%FB+%D2%E2%CA%B6 专利的概念已经比较公认的有三个含义： 专利权，专利文献，专利产品，而专利意识里还是专利权的概念。 再用google查意识 http://www.med8th.com/readingroom/lhjs/d2z.htm http://asp.7i24.com/mydchina/%E8%AF%BE%E4%BB%B6%E7%BD%91%E7%BB%9C%E7%89%88/%E6%84%8F%E8%AF%86%E7%9A%84%E5%AE%9A%E4%B9%89.htm 1、从意识的起源上看. 意识是物质世界发展到一定阶段的产物. 2、从意识的本质来看. 意识是客观存在在人脑中的反映. 除了以前的意识形态，比较常用的还有安全意识，大众意识等等。 所以目前来看，意识还是强调一定的认识和重视。 那么专利意识我们是不是可以这么说，鉴于专利权的日益重要，专利意识就是要求我们充分认识到专利权的重要，对专利权的取得，保护，侵权，都有全面地认识。 而且就如要培养小孩不能玩火的安全意识，专利意识应该有几个不能违背和触犯的天条和正确的基本认识。 1、产权的产生：知识产权是未来的货币，需要珍惜和兑现，知识产权尤其是专利权不是自发取得，需要主动申请，国家授予，才能形成。 2、新颖性是绝对的天条，一旦公开（包括自己）形成共有技术，就绝没有可能再获得相关保护。 待续 2.Re:再谈专利意识 Copy to clipboard Posted by: 稀糊醋鱼 Posted on: 2004-04-20 01:15 师兄一番具有代表性的发言另人受益非浅. 确实随着专利纠纷的不断出现,不论是企业还是科研结构的专利保护意识不断得到增强,通过申请专利保护自身的发明创造,已经得到了大家的共识. 师兄从理论上概述了专利意识的重要性,如何将已有的意识转化为对实际工作的指导,是我们面对的现实问题. 个人觉得,以下几点是非常关键的: 1. 如何分析现有专利, 2.如何避开专利,或者通过法律手段来否定已有的专利,从而消除专利对自身的威胁. 3.如何通过合理的策略来申请自己的专利. 每一个话题都是值得深入探讨的领域,我想这些都是值得我们继续讨论下去的话题,为了不影响windlight师兄的发贴思路,我就到此打住,希望能听到专业人事的看法. 3.Re:再谈专利意识 Copy to clipboard Posted by: wzuny Posted on: 2004-04-20 09:46 windlight wrote: 那么专利意识我们是不是可以这么说，鉴于专利权的日益重要，专利意识就是要求我们充分认识到专利权的重要，对专利权的取得，保护，侵权，都有全面地认识。 而且就如要培养小孩不能玩火的安全意识，专利意识应该有几个不能触犯的天条和正确的基本认识。 还有，专利意识还应该包括对现有专利的检索全面的检索，才能确定其保护的对象、范围，从而在自己进行相同或相近品种的研发、经销时不至于锓权，或者在别人告自己侵权时能有效地保护自己！ 希望看到 windlight 及醋鱼等高手们后面的精彩发言。。。。。。 y 4.Re:再谈专利意识 Copy to clipboard Posted by: 你好吗 Posted on: 2004-04-20 09:58 近期医药专利纠纷日益增多，我感觉专利知识很是贫乏，很想了解专利方面的知识，请各位同道能在理论上及实践上多多谈谈体会感受 5.Re:再谈专利意识 Copy to clipboard Posted by: 天舒 Posted on: 2004-04-20 14:59 我是近段时间才接触专利的。以前经常看醋鱼兄谈专利，当前着实感兴趣，也受益匪浅，借此帖向醋鱼兄说一声感谢！不知醋鱼兄哪天给我们办个讲座？ 现在专利的确是一个值得研究的话题，自从加入WTO以来，我们的专利保护意识也在不断的增强，专利申请工作也取得了可喜的成绩。但现在我们医药领域的专利工作及我们医药人员的专利意识还不是很到位，与发达国家相比尚有一大段距离需要跨越。 我们的专利意识不强一是体现在立项中忽略了对专利的查询。在新药研发中，由于立项前调研时，忽略了对专利的查询，结果导致整个项目喊停的情况也屡屡出现。如果你有心，你可以在国家药审中心查查雷洛昔芬这个品种，拿到临床批件的研发单位可谓不少，但到现在却迟迟不见有人报生产，原因何在？因这些申报单位都收到了礼莱公司发给的适应症侵权函。这个品种涉及的仅仅是一个适应症专利而已，可以采取一些措施能减少一定的损失，若是涉及化合物专利的品种呢？这样的品种等你拿到了临床批件的时候却收到了侵权函，那你临床前的投入却又如何弥补？ 我们的专利意识不强另体现在专利的申请上。一是盲目申请。申请数量虽然大幅度增长，但申请的质量却参差不齐，出现了盲目申请的情况。比如，有一次我在对一个改剂型的品种进行立项调研时，结果我发现该品种竟然有专利，刚申请公开。经过深入查询可知，该专利是省县镇村一村民申请（不知道是否是搞新药开发的专业人员），分析其权利要求书后我发现这个所谓的公开专利根本不具备专利的申请条件（新颖性根本站不住脚，采用的方法是一般的制剂技术和常规的制剂条件，根本没有什么科技含量；所用辅料也是常规辅料），且仅是个注册分类5的品种，不值得去申报专利。二是轻视申请。实行药品专利保护后，外国制药企业来我国申请专利的数量呈大幅增加势态。而我国制药企业存在着重成果轻专利的状况。本来我国创制新药的能力就不强，而仅有的为数不多的一些创新成果，由于专利意识淡薄，结果自已的专利成了别人的专利。这种极端的做法都对我们的医药开发带来一定的消极影响，都是不可取的做法。 6.Re:再谈专利意识 Copy to clipboard Posted by: 天舒 Posted on: 2004-04-20 15:13 稀糊醋鱼 wrote: 个人觉得,以下几点是非常关键的: 1. 如何分析现有专利, 2.如何避开专利,或者通过法律手段来否定已有的专利,从而消除专利对自身的威胁. 3.如何通过合理的策略来申请自己的专利. 诚如醋鱼兄如上所言，这三个问题的确需要深入的学习，解决了这三个问题，你对专利才能有个实质性的认识。 这三个问题我可以用两个问题来代替，那就是：一是如何撰写专利（包括权利要求书及专利说明），以使自己的专利达到最大保护范围；二是如何分析专利，从而写出无效专利分析。这两个问题其实都是一个写的问题。这儿有一个前题：对专利有个全面的分析。只有分析透了这个专利，你才可以对其或毙或避，游刃有余。 我的观点是要做到不仅会看专利，而且能写专利。看专利要能看出其中的破绽，写专利要能想到所有的可能，尽可能使自己写的专利被别人利用。两者结合起来，才能使自己对专利有全面的把握！ 以上个人拙见，请大家指正。 7.Re:再谈专利意识 Copy to clipboard Posted by: Aldrich Posted on: 2004-04-20 19:33 感兴趣的话不妨接受一些正规的培训和考试，今年就是一个好机会。两年一次的全国专利代理人资格考试将于2004年10月16日、17日举行，目前正在接受报名，虽然考试的通过率不高，但是毕竟是权威的，可以学到许多相关的知识，而且考试资格要求也不高，专科以上两年工作经验即可。详情参见 http://www.sipo.gov.cn/sipo/tz/t20040220_25576.htm 俺下周就准备去报名。 8.Re:再谈专利意识 Copy to clipboard Posted by: 稀糊醋鱼 Posted on: 2004-04-21 00:36 天舒 wrote: 比如，有一次我在对一个改剂型的品种进行立项调研时，结果我发现该品种竟然有专利，刚申请公开。经过深入查询可知，该专利是省县镇村一村民申请（不知道是否是搞新药开发的专业人员），分析其权利要求书后我发现这个所谓的公开专利根本不具备专利的申请条件（新颖性根本站不住脚，采用的方法是一般的制剂技术和常规的制剂条件，根本没有什么科技含量；所用辅料也是常规辅料），且仅是个注册分类5的品种，不值得去申报专利。 呵呵，一个农民都会想到申请药物制剂的专利，足见我们的专利意识在提升，对于上述的情况，师兄说新颖性站不住脚，我有些个人看法，既然这个专利拿来申请了，他应该就有他的闪光点，以为现有的知识，我觉得一般改 剂型的专利，其关键点在于其使用的辅料 ，是否使用了常规辅料在这个特殊的药物品种中就达到了意想不到的效果呢？如果没有，那么其创造性就值得怀疑了。 如果有意开发这个药物制剂，又怕受制于人，那么现阶段是个很好的机会，专利法中规定：在专利公开到授权之前（确切的说应该是专利授权公告日之前），任何人有权对专利提出意见，提供的意见可作为审查员审查专利参考的资料。这时候提交资料是免费的。 当然，如果到了专利授权之后，同样任何人都可以通过启动专利无效申请来对该专利提出质疑（对于此点，我想相关的法规也说的很清楚了，不想在此罗嗦）。 天舒 wrote: 这三个问题我可以用两个问题来代替，那就是：一是如何撰写专利（包括权利要求书及专利说明），以使自己的专利达到最大保护范围；二是如何分析专利，从而写出无效专利分析。这两个问题其实都是一个写的问题。这儿有一个前题：对专利有个全面的分析。只有分析透了这个专利，你才可以对其或毙或避，游刃有余。 以上个人拙见，请大家指正。 谦虚了，这么多的问题，真值得我们一起好好学习了。 关于专利的申请，我就申请的策略，说点自己粗浅的看法吧： 无论专利方面的专家还是审查员，都会有同样的一个理念，专利申请， 核心在于权利要求，其根基在于说明书。 1. 权利要求书： 首先表明请求保护的内容； 采用倒宝塔的形式逐项限制； 采用开放式和封闭式其中之一作为策略。 2. 专利说明书： 几个宗旨： 清楚： 相辅相成的，主题明确，用词准确，附图清楚。 完整： 记载现有的技术背景，对比背景知识，表达所申请专利的创新性。 充分公开： 内容充分，必须由本领域的普通通过普通技术再现所宣称的技术效果为标准。 实施例： 作为权利要求的支持内容，以能否推断出权利要求中所涵盖的内容为目标。 写专利同时还必须具备2种立场， 从 申请者 的角度出发，在充分公开现有技术的同时，尽可能保留住专利技术的核心技术秘密。 在 侵权者 的角度来看，可以重哪些方面规避所写出来的专利，从而再进行补充。我觉得从这点看来，天舒师兄说谈到的专利撰写和专利分析其实是紧密联系的。 以上只是自己对本人现有知识结合相关内容的思路整理，希望能得到大家的补充。 Aldrich wrote: 虽然考试的通过率不高，但是毕竟是权威的。 呵呵，据说是200个取一个，估计今年比例肯定会更小。Aldrich兄可得做好战斗准备。 关于专利代理人相关内容，windlight师兄提到的网站似乎更权威，内容更详尽，希望有所帮助。 http://www.acpaa.cn/c_default.htm 9.Re:再谈专利意识 Copy to clipboard Posted by: 天舒 Posted on: 2004-04-21 08:08 稀糊醋鱼 wrote: 关于专利代理人相关内容，windlight师兄提到的网站似乎更权威，内容更详尽，希望有所帮助。 http://www.acpaa.cn/c_default.htm 听君一席话，胜读十年书！ 关于专利的问题，我基本是个门外汉，而工作中又用到，不得己而学之。还请醋鱼兄不要保留呀！ 10.Re:再谈专利意识 Copy to clipboard Posted by: 稀糊醋鱼 Posted on: 2004-04-22 21:12 专利方面，DXY 中有2位高手是我最佩服的： windlight,inferno 从学习的角度再说说 专利意识 国家知识产权局专利局化学审查一部 张清奎 部长 对专利意识的回答：专利意识是企业通过发明专利的保护，而使企业获得利益的一种认识。 国家知识产权局专利局知识产权发展研究中心 曹津燕 主任 用专利的定义回答了专利意识的概念。 专利： 从字面上理解为专有权利，是通过公开发明技术为贡献，而换取的一定时间的垄断权。其保护的内容是专利权人公开贡献出来的那部分内容。 她认为专利意识的主题还在于维护和尊重知识产权，意识的高低与需求的高低是结合在一起的。 当然也有人提出了这样的观点：专利意识是否指在 合法的条件下找到自己最大的利益 。 有人认为此观点只代表其中的一个方面，但我倒觉得这个理解有2种含义。 1. 从我们自己申请的专利中找到最大利益，即通过合法的途径，通过合理的程序，合理的专利撰写，来获得最大专利权的有效保护。 2. 从人家的专利中找到对我们自身最大的利益，即分析解读公开的专利，在合法的基础上寻求专利的漏洞，规避专利，从而使自己的产品不侵犯现有专利的保护权。 11.Re:再谈专利意识 Copy to clipboard Posted by: junlin Posted on: 2004-04-22 22:17 各位高手，今问一问题：有没有见到过与植物提取有关的专利纠纷？ 12.Re:再谈专利意识 Copy to clipboard Posted by: 稀糊醋鱼 Posted on: 2004-04-22 22:27 junlin师兄可以新开一个植物提取专利纠纷的帖子，windlight 师兄是重要专利方面的高手，我们可以举个实例进行分析学习。 13.Re:再谈专利意识 Copy to clipboard Posted by: junlin Posted on: 2004-04-22 22:36 植提方面好像不太见到，你们可先在此举个实例，谢了先！ 14.Re:再谈专利意识 Copy to clipboard Posted by: jinwsapa Posted on: 2004-04-23 00:12 专利保护和知识产权对生物医药公司的重要性可从下列事实可见一斑: 美国比较有名的仿制药厂 (generic company)每年要花费上千万美元打专利官司, 尤其是与大药厂打, 他们的经验值得借鉴 国外生物技术公司更是不惜代价全力保护自己的专利, 打官司开打起价就是一, 二百万美金, 费时数年, 小公司根本打不起, 耗不起 技术类公司的无形资产在公司市值所占比例可高达80-90%, 重大专利官司一输百输, 公司得关门. 法官的惩罚性条款也非常严厉. Genentech 与 Genetic Institue 的专利官司 (EPO), 后者赔上好几千万美元, 很惨啊, 最后只能卖身给AHP 国外公司上市, 收购兼并, 技术转让, 启动新项目, 都会花很多精力和费用做全面调查, 专利律师非常吃香 待遇极高 (国外中国留学生转行做专利律师的好多是学生命科学的) 在中国也是未来的一门好行当, 不仿试试? 大家已提及的查找专利, 写好专利说明书等 很重要, 但做好做精不易, 需要有很多训练, 很强专业背景和经验, 中国目前非常缺有经验的专利律师. 尤其是双学位 (PH.D. M.D + JD) 我们国家自专利法实施以来, 在具体实施和执行方面虽有改进, 但还有很多问题. 过去实施的强仿战略, 就是鼓励药厂不尊重他人专利成果, 此风不能继续盛行. 中国药厂目前遇到的许多专利纠纷和麻烦, 有许多是低级错误, 除了自我创新太弱外, 不重视专利, 不做仔细调研, 没有专利高人指点是主要原因, 估计还会发生. 但愿未来能有很大改进. 但不要指望专利纠纷从此不再, 只会愈演愈烈, 因为这是企业的核心竞争力和资产所在. 15.Re:再谈专利意识 Copy to clipboard Posted by: jinwsapa Posted on: 2004-04-23 07:51 Biotech Patent Fight By Jennifer Van Brunt From Recombinant Capital (old article) Chief Justice of the Supreme Court Warren Earl Burger set the stage 20 years ago when he ruled that everything under the sun made by man was patentable. This pronouncement kick-started the biotech industry, and ever since companies and their lawyers have been trying to pin down just exactly what that encompasses. They've found one sure way to get some answers -- by carrying a patent-infringement lawsuit to the Court of Appeals for the Federal Circuit, the nation's highest court for such matters. The judicial rulings in these cases have helped to define and refine the circumstances and language necessary to obtain an unassailable patent on a biotech invention. But they've also narrowed the scope of the claims -- and set the direction for what's to come. Patent-infringement lawsuits in biotechnology are so common that the industry has gained itself quite a reputation -- not only among the lawyers, but also in the press. Take the latest high-profile case: Amgen Inc. and Transkaryotic Therapies Inc. (TKT) have locked horns over erythropoietin (EPO) patents in the U.S. District Court in Boston for the last four months. Reports that the two companies have been hurling accusations of greed and dishonesty at each other have, naturally, led the news coverage of this trial. Greed or not, there's no question that the stakes are high. Amgen's version of EPO, Epogen, reaped nearly $1.8 billion in sales in 1999, and had generated $933 million by the end of the second quarter this year. Worldwide sales, including those by Amgen's licensee Johnson Johnson, hit $4 billion in 1999. In counterpoint, patent litigation proceedings are horrifically expensive, win or lose, so many infringement lawsuits that get filed never go the distance. In fact, as often as not, the suing party has no intention of going to court: The lawsuit is, instead, a starting point for negotiation. According to Joshua Lerner, who's made a study out of biotech patent litigation, 103 separate biotech intellectual property litigation cases were filed between 1980 and 1993. Of those, however, a significant number went to trial, or resulted in protracted disputes. Lerner, who is a professor of business administration at Harvard Business School, pointed out that trials bring an extra boon to the winner, above and beyond any financial considerations. The party that prevails not only gets the benefit of winning the lawsuit, but also it builds a reputation for toughness that will facilitate bargaining going forward. But there's more to patent lawsuits than that. Patent protection is critically important in biotechnology. It can establish a product's virtual monopoly in the marketplace, one that lasts long enough for the company to recoup the enormous amounts of cash that it poured into developing the product in the first place. Secondly, patent protection attracts investors, for it at least implies that the company will be able to generate a profit from product sales. And third, patents (issued or pending) are critical bargaining chips in deal-making with pharmaceutical houses (or even other biotech firms). And, in the Amgen/TKT case, an even more fundamental issue is at stake -- the validity and enforceability of early biotech patents, which were broadly written. Do these early patents enable newer technologies? Do they invalidate more recent claims made by others? How succinct must a written description be? Amgen filed its lawsuit against TKT and its pharma partner Hoechst Marion Roussel AG (now Aventis Pharma) in April 1997, claiming that the parties had infringed three of its U.S. patents that claim an EPO product and processes for making it. By September 1999, Amgen had added two more of its U.S. patents to this list. Amgen is seeking to prevent TKT/Aventis from making, importing, using or selling EPO in the U.S. Amgen makes its EPO in cultured Chinese hamster ovary cells via recombinant DNA technology; TKT's technology activates the EPO genes naturally residing in cultured human cells to produce EPO. (In early August, Aventis submitted applications in the U.S. and Europe for marketing approval of this gene-activated drug, known as Dynepo.) TKT argues that its gene-activation technology circumvents genetic engineering and thus does not infringe Amgen's patents. In April, U.S. District Court Judge William Young disagreed, granting Amgen a summary judgment that TKT/Aventis had infringed a single claim on a pharmaceutical composition patent for EPO. The trial then moved to issues surrounding the validity and enforceability of that claim, as well as the infringement, validity and enforceability of the other four patents at issue. TKT has argued that Amgen's patents don't enable the TKT method of producing EPO. But, since Judge Young also indicated in his summary judgement that Amgen's patents may be too broad, the question of whether those claims will still hold remains open. Some analysts predict that if Young rules in Amgen's favor, it will reaffirm the strength of early biotech patents, which are much broader than those issuing today. If so, companies developing so-called generic biotech drugs may be barred from the market for years to come. Other analysts, however, feel that the outcome of this case does not have sweeping implications and is, instead, only of significance to the parties involved. We'll see. But one thing's for sure: The issue is unlikely to be resolved, even when Judge Young emerges from his chambers in a few weeks with his ruling. The loser will most certainly appeal, kicking the case up to the U.S. Court of Appeals for the Federal Circuit. Interestingly, it's the issues surrounding written description and enablement that lie at the core of the landmark biotech patent cases. For 20 years now, we've seen the courts continue to narrow the scope of biotech patents. For, in the end, it's been the Federal Circuit judges -- and even the Supreme Court -- who've decided just how to interpret and apply patent law. According to John Kilyk, Jr., an attorney in Leydig Voit Mayer's Chicago office, The cases that have come before the Federal Circuit Court of Appeals over the last several years have raised the bar for the patent office, which now has a very high burden to deny patents. If you're one of the many who think that the history of patent litigation is as dry as unbuttered toast, or that infringement trials are just another showcase for word-twisting lawyers, then consider this: What's gone before has a very direct bearing on what's to come. This is especially true in the extremely controversial and as yet unresolved arena of EST patents. According to John Wetherell, a principal at the San Diego-based law firm Fish Richardson PC, Biotech is a constantly changing environment. The way we write patent applications today is different than it was even two years ago. Signals interviewed a number of attorneys to get their own picks of the patent litigations that have been the most important in shaping biotech intellectual property today -- and going forward. What follows is a list of their choices, which naturally vary from individual to individual. Some of these will no doubt be obvious to you; others might not. And, some aren't even judgmental rulings per se, but rather stances taken by the Patent and Trademark Office (PTO) that have essentially the same effect as a court's pronouncement. For practical reasons, we have not attempted to present all the facts in any of these cases, but merely the summary judgements as they affect biotech patent law. If you want to read the whole case history, or the ruling, just click on the link. It's widely agreed that without the decision handed down in 1980 by Chief Justice of the Supreme Court Warren Earl Burger, the biotechnology industry might have taken a very different turn. The ruling opened the doors to biotech patents, encouraging companies in the emerging field that they may be able to protect their inventions and turn them into saleable -- even profitable -- drugs. The decision sent a clear message that allowed the establishment of the biotech industry, according to Fish Richardson's Wetherell. It was the first case that allowed the patenting of living things. Before that, it was possible to patent the use of an organism (such as using Streptomyces to make antibiotics) and a method of making the antibiotic (fermentation), but you couldn't patent the organism itself. In fact, he added, this was the first instance in the entire world. And even today, in some foreign countries, you still can't patent living things. John Wetherell In Diamond v. Chakrabarty, the Supreme Court declared that genetically modified microorganisms were patentable matter. Ananda Chakrabarty's patent application, filed in 1972 and assigned to the General Electric Co., consisted of 36 claims to a genetically engineered Pseudomonas bacterium that can break down multiple components of crude oil. This is the bug that was engineered to treat oil spills. The patent examiner allowed two of the claims (the method of producing the bacterium and a method for preparing an inoculum), but balked at the third -- claims to the bacterium itself, because as living things, microbes are not patentable subject matter. The Supreme Court disagreed (although the vote was close). Citing records accompanying the Patent Act of 1952 (when Congress recodified the original Patent Act of 1793, which was authored by Thomas Jefferson) the Court said that Congress intended statutory subject matter to include 'anything under the sun that is made by man'. According to the Court, Judged in this light, microorganism plainly qualifies as patentable subject matter. His discovery is not nature's handiwork, but his own. Many thought that this decision did not apply to plants, for they were already protected under the Plant Protection Act and the Plant Variety Protection Act. However, the PTO was already granting patents on new and unobvious varieties of seed-grown plants. In 1985, the PTO's Board of Patent Appeals and Interferences confirmed this position, stating in its decision In re Hibberd (which concerned a patent on maize that produced elevated levels of tryptophan) that it rejected the argument that the plant-specific acts are the exclusive forms of protection for plant life. And, in 1987, the PTO announced that it considered non-naturally occurring, non-human, multicellular living organisms, including animals, to be patentable subject matter. Thus, anything under the sun meant all forms of life -- except humans. Early U.S. patents on biotech inventions often included seemingly broad, prophetic, claims. Prophetic patents are granted for inventions that have yet to be tested, providing the patent contains a sufficient written description to enable someone skilled in the art to practice the invention (enablement) and use it for its intended purpose (utility). In Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. and Genetics Institute (1991), the U.S. Court of Appeals for the Federal Circuit took its first step toward clarifying just what a written description entails. In short, Amgen had sued Chugai and Genetics Institute for infringing a claim to a DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin. But the Court judged that it's not enough to know how a compound of unknown structure (in this case, the EPO gene) might be isolated in order to claim conception; instead, the inventor must actually isolate that gene. (In patent parlance, an invention is conceived when there is a complete idea for making and using it.) According to the court, It is not sufficient to define solely by its principal biological property, e.g., encoding human erythropoietin When an inventor is unable to envision the detailed construction of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the gene has been isolated. Robert Baechtold Robert Baechtold, a founding partner of New York-based law firm Fitzpatrick, Cella, Harper Scinto, summarized the court's findings thus: Just because you know about the protein, this doesn't constitute conception of the isolated gene. He added that the ruling also prevented getting very broad-based claims on all DNA sequences that code for a protein or analogs of that protein. The Federal Circuit Court addressed this point again in 1993, in Fiers v. Revel and Tiollais v. Sugano, Muramatsu and Taniguchi (generally referred to as Fiers v. Revel). At issue was the resolution of a three-way interference proceeding regarding the priority of invention to the DNA that codes for human fibroblast beta-interferon. All three parties had already filed patent applications in other countries, and each tried to establish U.S. filing priority based on the foreign filings. The PTO's Board of Patent Appeals and Interferences had awarded priority of invention to Sugano et al., basing its conclusions on the disclosure or failure to disclose the complete nucleotide sequence of a DNA coding for beta-interferon. The Court of Appeals agreed, stating that an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself. Moreover, the Court said that Sugano's application satisfies the written description requirement since it sets forth the complete and correct nucleotide sequence of a DNA coding for beta-interferon. According to John Barton, the George E. Osborne Professor of Law at Stanford Law School, this ruling in Fiers v. Revel demonstrated more clearly than in any other case that you can get a patent for a protein once you get a patent for its sequence. You can't claim a protein by demonstrating how to find the sequence. You have to have the sequence. This ruling provided for the definition of a substance other than by its utility, he continued. And, of course, this leads directly to issues surrounding the patenting of the human genome. Is the sequence alone enough to get a patent on, even if you don't know what it does? Barton asked. Several other cases centered on this issue of a written description, including In re Bell (1993) and In re Dueul (Federal Circuit, 1995), but they culminated in The Regents of the University of California v. Eli Lilly and Co.(1997), which concerned insulin. The University of California (UC) claimed that Lilly had infringed its patents in its manufacturing of human insulin. UC's patents, which are considered pioneering and were filed in the early 1970s, relate to recombinant plasmids and microorganisms that produce human insulin. One of these patents, discussed here, is based on the determination of cDNA sequences from rats, but the claims were extended to cover mammalian and human insulin cDNA. The Federal Circuit Court determined, however, that these claims were not sufficient or enabled for human insulin cDNA. Describing a method of preparing cDNA or even describing the protein that the cDNA encodes does not necessarily describe the cDNA itself. No sequence information indicating which nucleotides constitute human cDNA appears in the patent, as appears for rat cDNA Accordingly, the specification does not provide a written description of the invention. The Court went on to state that, In claims to genetic material a generic statement such as 'vertebrate insulin cDNA' or 'mammalian insulin cDNA,' without more, is not an adequate written description of the invention because it does not distinguish the claimed genus from others, except by function is only an indication of what the gene does, rather than what it is. In other words, The sequence of the protein is not a written description of the cDNA that produces the protein, explained Fitzpatrick, Cella, Harper Scinto's Baechtold. It becomes too easy to preempt large fields of research if you can write broad claims based on limited disclosure. And, in fact, he added, this is an ongoing concern. Companies are still trying to write broad claims. Rochelle Seide, a partner in the New York law firm of Baker Botts LLP, believes that UC v. Lilly is the single most important biotech patent ruling, in that the Federal Circuit had a departure on what constitutes a written description of an invention. Seide explained that there are three sections of the patent statute that deal with description. You have to show you're in possession of the invention; you have to enable the invention; and you have to disclose the best mode of practice. In UC v. Lilly, the court decided that UC had not described human cDNA, even though it was enabled, she said. Rochelle Seide This decision came at the end of a line of cases that dealt with description issues, Seide continued. One of the reasons it's had so much impact is that 'written description' has become a hot issue at the PTO. In fact, she added, the Court and the PTO are still grappling with this issue. Patents are moving targets. One of the basic tenets of patent law is that a patent must enable someone skilled in the art to practice the invention, without undue experimentation. Enzo Biochem Inc. and Calgene Inc. learned this as a result of their extended patent battle over antisense technology. Enzo's patents, which it licensed exclusively from the Research Foundation of the State University of New York, claim various fundamental aspects of genetic antisense technology. According to the Court, they teach the application of antisense technology in regulating three genes in the prokaryote E. coli. Calgene's patent, on the other hand, is directed to the use of antisense technology in regulating gene expression in plants (which are eukaryotes). Enzo sued Calgene, claiming that the latter's patented Flavr Savr tomato infringed Enzo's antisense patents. Not so, according to the Court of Appeals. In Enzo Biochem Inc. v. Calgene Inc. (1999), the Court pointed out the fact that despite limited disclosure, inventor Masayori Inouye asserted that the practices of this invention are broadly applicable with respect to any organism containing genetic material which is capable of being expressed. He cited bacteria, yeast, other cellular organisms and even viruses. However, the judges determined that Enzo's patents had not provided enough direction or examples of how to actually practice antisense in those cells. Inouye has provided only the mere germ of the idea for exploiting antisense in eukaryotes The breadth of enablement in the patent specifications is not commensurate in scope with the claims, as the quantity of experimentation required to practice antisense in cells other than E. coli at the filing date would have been undue. If you're going to claim it, you'd better teach it, too. Issues of conception and joint ownership were the focal point of Burroughs Wellcome Co. v. Barr Laboratories Inc. and Novopharma Inc. and Novopharm Ltd. (Federal Circuit, 1994). The patents in question concerned AZT, the first drug approved for treating AIDS. Burroughs Wellcome (later acquired by Glaxo plc ) owned six U.S. patents on various preparations of 3'-azidothymidine and methods for using the drug for treating HIV-infected individuals. Each of the patents named the same five inventors, all of whom were Wellcome employees at the time the inventions were supposedly conceived. But was it these individuals who actually conceived the invention, or did researchers at the NIH share in the conception? For, NIH researcher Samuel Broder and his colleagues, who were developing a cell line to screen compounds for anti-HIV activity, had asked pharmaceutical companies to provide them with samples to test. Burroughs Wellcome did, and one of the compounds was AZT. But that all happened before the company had filed its patent application. To make a long story short, several years after the FDA had approved AZT, Barr Laboratories filed an abbreviated new drug application (ANDA) to manufacture and market a generic version of AZT. Barr claimed it was not infringing Wellcome's patents because Barr had licensed AZT from the government, whose employees (Broder and Hiroaka Mitsuya, who tested the Wellcome compound) should be considered co-inventors. (Later, Novopharma also filed an ANDA on AZT, and was thus included in this lawsuit.) The Federal Circuit judges ruled that the NIH scientists were not co-inventors; in fact, the testing done by the NIH confirmed the operability of the inventions and showed that the Burroughs Wellcome inventors had a definite and permanent idea of the inventions. was part of the reduction of practice The court went on to say that We do not know precisely when the inventors conceived their inventions, but the record shows that they had done so by the time they prepared the draft patent application that thoroughly and particularly set out the inventions as they would later be used The NIH scientists were not joint inventors of these inventions. When the NIH filed the first patent applications on expressed sequence tags (ESTs) in 1991, it sparked a furious debate on whether such partial gene sequences should be patentable. (Three years later, the NIH abandoned those original applications.) ESTs are short sequences of DNA only; they can be (and are) generated automatically by machines; and, though they're extremely useful in locating a full -length gene, and thus predicting the protein that gene makes, by their very nature ESTs cannot disclose the entire protein for which that gene codes, nor can they be used to conclude anything about its function. Are they patentable, then? Do ESTs meet the requirements for utility and enablement? Well, the PTO has been granting patents on gene sequences: In fact, according to the Biotechnology Industry Organization (BIO), by the end of 1999 the PTO had issued 2,330 patents covering gene sequences. And, the U.S. government held the most -- 388 to be exact -- topping all companies, even second-place Incyte Genomics Inc. (which held 356 patents at the time). More than 2,000 patents on gene sequences may seem like a lot, but it's only a drop in the bucket. The PTO has been flooded with gene patent applications, thousands upon thousands of them. To help relieve its burden, the PTO proposed new (revised) utility and written-description guidelines in December 1999. (This is the second time the PTO has published interim guidelines; the first time, in 1998, they were met with such harsh criticism by the research community that the PTO revised them.) Many comments took this opportunity to heavily criticize the patentability of ESTs, grounding their arguments in fairness and policy issues. Many comments also expressed the opinion that ESTs lacked the utility, enablement and written description necessary to satisfy the U.S. code. ESTs are at the root of the written description and utility guideline issues, commented Baker Botts' Seide. These issues may ultimately need some resolution by the court. The revised interim guidelines will be used by PTO examiners in their review of applications for compliance with the written description requirement of patent law. Importantly, however, the PTO has stated that are not the appropriate vehicle to fully address the patentability of ESTs. That will come, apparently, with the PTO's revision of the utility guidelines (including enablement requirements.) The PTO expects to publish the final guidelines this fall. The set of decisions implicit in the utility guidelines represent a very important milestone in biotech patenting, commented Stanford Law's Barton. There's a sticky point in the DNA/gene patent arena, though, and that has to do with the doctrine of equivalence. According to Leydig Voit Mayer's Kilyk, the problem comes up when a client wishes to file a patent application, but first needs to determine whether its claims would potentially infringe on any other patents, issued or pending. Sometimes we find a patent that describes exactly what our client wishes to do, but usually we find patents or applications that are arguably similar. But are they equivalent? For example, he continued, say that one company has a patent on a DNA sequence or protein. Another company wants to work with or market a DNA or protein that differs by one base pair or one amino acid. Are they the same or different? This situation comes up all the time, Kilyk said. And, so far, There haven't been a sufficient number of interpretations by the Federal Circuit in this area to allow an unequivocal answer. According to Stanford Law's Barton, the patent case that could have the biggest impact on biotech in the near future doesn't concern biological molecules at all: It's about algorithms. John Barton In ATT Corp. v. Excel Communications Inc. (1999), the Federal Circuit Court of Appeals reaffirmed the patentability of software. (The case concerned software governing long-distance telephone calls. The patented process aids long-distance carriers in providing differential billing for subscribers, depending on whether they call someone with the same or a different long-distance carrier. ATT's process uses subscribers' primary interexchange carriers as data.) The Supreme Court had already affirmed that even though a mathematical algorithm is not patentable in isolation, a process that applies an equation to a new and useful end is at the very least not barred at the threshold. And the Federal Circuit supported that decision in State Street Bank Trust Co. v. Signature Financial Group Inc. (1998): A mathematical algorithm may be an integral part of patentable subject matter such as a machine or process if the claimed invention as a whole is applied in a useful manner. Importantly, the Court also addressed whether there need be a physical requirement for software to be patentable. The mere fact that a claimed invention involves inputting numbers, calculating numbers, outputting numbers, and storing numbers, in and of itself, would not render it nonstatutory subject matter unless, of course, its operation does not produce a useful, concrete and tangible result. According to Barton, this ruling means that it will be possible to get a patent on an abstract procedure or an algorithm. And it will impact biotechnology. For instance, he continued, We will quickly see patents on computational methods for calculating protein folding. According to Barton, This case is saying that it's a lot harder to draw the line between the discovery of a scientific principle and the development of a patentable invention. Since current biological research (including genomics, proteomics, bioinformatics and systems biology) relies so heavily on computing, and, indeed, already occurs more frequently in silico than in vitro or in vivo, researchers may now have a way to patent these types of inventions -- and an entirely new way to profit from them as well. 16.Re:再谈专利意识 Copy to clipboard Posted by: inferno Posted on: 2004-04-24 12:29 和ngm兄的辩论,其实不用谁说服谁,只是大家看问题的立场和角度不一样.仔细揣摩一下,windlight 和ngm兄讨论的内容,大家一定如有所悟.windlight兄更强调专利的意识,同时技术人员应该参与到专利工作中去.而ngm兄则说明专利申请的细节,技术上的问题应该请专业人员来完成.技术人员应该关注自己的技术同时要有专利意识就可以了.专利的细节问题和(查新,申请等)技术就留给专利专业人员去完成. 非常高兴能和windlight and ngm兄交流探讨,我也能从中学到不少东西 17.Re:再谈专利意识 Copy to clipboard Posted by: windlight Posted on: 2004-04-28 19:04 http://www.blogchina.com/idea/property/ 刚看到这篇文章，正在学习中。 温故而知新，必要的重复绝对是学习所必需的，我将相对系统的给出我对专利意识的认识供大家讨论。 我谈事情喜欢先明确自己的角度和出发点，然后看对方的接受层次和关注范围，也就是一般所说此文适合哪些人阅读。但这篇文章实在是不好写，是给我们这些非专利专业人士的科研工作者，还是老百姓，还是学生，还是专利工作者。后者决定了文章是否有真正的价值。但我思考了这么多天，还是写不出这么多的版本。还是自说自话吧！ 林肯关于专利的名言一定要知道：专利制度是给天才之火浇上利益之油（The patent system has added the fuel of interest to the fire of genius）。 我们生活在这个四维空间里，长、宽、高、时间。这是我们认识事物的基础。我在此文中，分为空间和时间作为出发点来谈。 钱不是万能的，没有钱是万万不能的。财富角度是必不可少的。这也是我的视角和出发点。现在经济学认为财富的来源有四个，土地，资本，劳力，知识技术。 现在我就从专利的三个特点说起：独占性、地域性、时间性 独占性（财产的排他性）：同义的还有垄断性，排他性，禁止他人使用权(处置权），私权而非公权。 这个特点的意义实际就是财产的不可共享，通俗地说，就如我以前的签名，苹果如果给人，自己就要放弃，不可能同时两个人拥有同样的专利（排他性），也不能自己同时拥有两个同样的专利（单一性）。根据法理来说，专利就是通过国家垄断，来把公众的权利（对知识的共享和使用权）牺牲一段时间，集中赋予专利权人来获益，已补偿他的投入和激励更多地发现。实际知识本身是不具有这个排他性的特性，而是通过人为的手段和国家强制力（国家主权）来体现，需要创造者主动申请，主权国家代公众批准授予一定时期。 地域性（空间概念）： 上面实际已经提到了专利权是主权国家授予，这意味着一个主权国家授予的专利，只是在这个国家中有效，别的主权国家没有义务去维护别人的主权。专利申请人如需要在多个国家中获得专利权，必须在多个国家申请。 这是对地域的一般理解。 我在此想强调的是：专利的财产性，还来源于他对财富的贡献，而这个贡献部分是通过对知识空间的圈地行为来获得。也就是在知识空间里的地域性。 你通过圈地来让别人付给你地价或买路钱。 专利中有个上位和下位的概念： 知识和财产都有个累积性（这也是我签名中所提到过的），就是后来者可以依靠前人的积累获得更多。按牛顿的名言就是站在巨人的肩膀上可以看得更远。 知识王国的上位概念一般来说就是抽象的（内涵少，而外延广），而下位就是具体的（内涵多，而外延小）。抽象的一般性更强，如你在知识王国里发现和创造了中国，那么整个中国都是你的圈地范围，任何人使用这个范围里的知识，都需要获得你的许可和付出代价给你。而如果你发现的只是中国广州，那么只有广州范围内的知识，你具有排他性，可以让经过你广州的人留下买路钱，你不能因为别人经过上海，而付给你广州的买路钱。 时间性： 专利的时间性一般的认识就是专利是有期限的，其意义前面也提到了，这就不再重复。一过了期限，专利技术就成为人类的公共财富，任何人都可以无偿使用。 我想强调的时间是指知识王国的圈地也是极其强调时间的(新颖性）。你说你发现了中国（上位概念），而同一时间或之前别人已经发现上海了，那么你是没有新颖性的，你不可能圈住整个中国而获利。你要圈的地（创造性）是前所未有（开发或主人）的，你才能有效的圈住。这也是专利制度意义所在，鼓励创新。 结合以上认识：我们应该对专利的三个特点基本有所认识。 专利的三性：新颖性、创造性也就有所了解。而实用性一般是指该发明或者实用新型能够制造或者使用，并且能够产生积极效果。可以说就是你圈的地不是空中楼阁，是别人能够利用和更上一层楼的。 18.Re:再谈专利意识 Copy to clipboard Posted by: ycxfzf Posted on: 2004-04-28 21:59 专利这个东西，我也是刚接触，导师刚申请了一个药物的化学结构的国际专利，把一系列化学结构全部保护起来了，别的人就再也不能做与这个结构相关的药物研究，刚开始我也不是很懂，现在才慢慢了解了，专利这东西其实对任何人来说都是有利的。保护了一系列的知识产权，以后还要多多学习。 19.Re:再谈专利意识 Copy to clipboard Posted by: wzuny Posted on: 2004-04-29 19:33 精彩！ 看了上面几位高手的讨论，又体会到了不少东东！！！ 关于专利的意识与企业的专利策略，今天刚刚参加了在杭州举办的一个新药开发与知识产权保护学习班，也谈到了这方面的内容，拿出来与大家共享： 根据市场目标，确定理想的专利涵盖范围 对于某一战略需要确定一清楚的目标。这个目标可以是在一非常高的概念水平，或者也可以是针对单一专利申请的。关键是通过获得一项知识产权可以获得哪些市场优势。研究相关的目的应该包括通过研发新的知识产权，将希望达到哪些目标领域。专利是特定的文件，如果一个目标概念上太宽泛，其结果专利战略将是不清楚的和无意义的。 明确竞争优势 确定专利战略的一个关键是了解究竟是什么提供真正的竞争优势，然后努力维持这一优势的产权性质。可以是一个制造一设备的特殊的方法，或可能是用于制造方法中的技术，或是制造方法本身。如果全部竞争优势维系于这一发明，要考虑专利是否将真正保护这一竞争优势，如果不能，也可以将这一发明作为技术秘密保护。通过筛选一个目标，确定将要完成的任务；通过考虑竞争优势，决定这一目标是否将以持续价值方式完成。 关于专利申请的决策 有关是否申请专利的决策是困难的。申请或不申请往往都有很多的理由。所以，最好专人负责处理有关知识产权的困难决定，以及有一特定的程序。做决定的人其自己必须与某一具体的专利申请无关，并且理解这一专利申请如何适合于整个企业的专利战略。许多情况下，发明人与其发明创造关系密切，以致于不能做出独立的判断。一般而言，研究管理者是最合适的决策者，因为他能够理解发明的商业与技术方面的冲击。 根据企业具体情况统筹决定 专利战略中主要原则是就目前所有来分配完成任务的资源。应该从实际角度来考虑：完成该目标是否需要大量人力、钱或设备。 对竞争专利的反映 制定企业战略时，应当考虑竞争对手申请了该技术领域的专利时企业怎样对待。首先，需要检测这些专利，然后分析，最后得出结论需要采取什么措施。至少，应该知道哪些技术领域的竞争专利应该关注。有时，即使仅发现有限的先有技术，也应推翻该领域所有的专利，至少努力限制其权利要求。 跟踪最新专利信息 在战略的发展方法，要考虑技术领域的新信息怎样得到，以及怎样有机地综合。如果专利用一种有效方式综合，最要紧的是：研究者能够得到最新的专利。通过综合技术领域的先有技术，研究者能够节省时间，不做重复性工作，这一综述工作也提供研究者思路、方法及知识。 申请的协调 因为专利是由国家授予的，在申请专利过程中，需要决定向哪些国家申请，怎样申请。而决定向哪些国家申请是最困难的。因为其要考虑企业的全球需要，即在世界上哪些国家拥有专利将有助于市场效益或阻止竞争对手。当企业考虑今后十年或二十年的发展时，预先占领这一时期的市场。 全球公司应该知道企业增长的努力将会集中于世界上哪些地方。而且，因为专利阻止竞争者，要考虑竞争在世界上哪些地方有制造业，可能在哪里建工厂，可能想在哪里发展。第二大问题是要考虑怎样及何时提交申请。如果有几个发明，应该有计划的协调专利申请。大部分国家都是先申请制，在先提交的申请不应影响在后申请的新颖性。 保护商业秘密 这一原则涉及一有机组织或系统保护。为了维护专利权围绕研发需要维系合适程度的保密。但是秘密具有动态的性质，如何避免不必要的公开。通过检索来确定：是申请专利还是公开出版，或保守秘密。是否提交申请取决于一个平衡，即专利申请中公开与专利阻止其他人实施所提出的权利要求的能力。 20.Re:再谈专利意识 Copy to clipboard Posted by: 关耳 Posted on: 2004-05-03 14:11 很好，学习中。 个人认为专利意识还有一点：专利意识除了工作中重视发明创造，写好专利申请资料保护好自己，还要充分利用别人公开的专利信息！ 我们可以利用已经过期的专利；可以在别人专利的基础上创新，申请新的专利，争取交叉许可的机会；可以利用人家的专利漏洞。 另外，专利仅仅是知识产权的一部分，我们在提高专利意识的同时，也应一并提高知识产权的意识。 21.Re:再谈专利意识 Copy to clipboard Posted by: 红领巾 Posted on: 2004-05-03 16:12 对于专利意识,大家各有所见,但我认为,所谓意识仅指其对事件的敏感度,比如,我的学习意识比较强,那是说我很爱学习,重视学习,而不是指我的学习成绩好不好,对于专利来说,我认为专利意识应指其对专利事件的敏感度,即是否重视专利,至于专利知识懂多少,是否会检索专利,是否会分析、规避专利，是否会运用专利战略保护自己的知识产权等等，那应是实际操作人员的事情，是专业知识，而不是意识。 对于中国的企业来说，我认为首先要加强的就是企业领导的专利意识，如果企业领导对专利不重视，不对企业的专利战略做一统计规划，不要求其研究人员在立项、开发过程中监视、规避专利等等，下面的研究人员、执行人员再努力都没用，企业的整体发展都会受到影响的！ 22.Re:再谈专利意识 Copy to clipboard Posted by: xiaopingl100 Posted on: 2004-05-05 18:23 最近我查到原有一个硫普罗宁冻干粉专利取消，在此我想请教各位高手有一些不具备专利的申请条件（新颖性根本站不住脚，采用的方法是一般的制剂技术和常规的制剂条件，根本没有什么科技含量；所用辅料也是常规辅料），怎么使其无效？ 23.Re:再谈专利意识 Copy to clipboard Posted by: 稀糊醋鱼 Posted on: 2004-05-05 20:28 xiaopingl100 wrote: 最近我查到原有一个硫普罗宁冻干粉专利取消，在此我想请教各位高手有一些不具备专利的申请条件（新颖性根本站不住脚，采用的方法是一般的制剂技术和常规的制剂条件，根本没有什么科技含量；所用辅料也是常规辅料），怎么使其无效？ 常规技术加常规辅料并不一定就申请不了专利。 关于专利的申请条件我是这样理解的： 国外判断创造性一般采用的是非显而易见性的原则，而国内则略有区别。 审查员一般会有2个方面： 1. 首先会去考核其非显而易见性（即本领域的普通技术人员不容易想到的方法） 2. 如果采用的是本领域普通人员都容易想到的方法，则会重点考虑是否有显著的效果。如果有的话，还是可以认为具有创造性。 所以关于楼上战友的问题，我觉得还是要具体问题具体分析了，打个比方吧，有一种已知的合成方法A，结合了一种已知的化合物B，但是以前从来没有人将这2种已知技术结合在一起。现在采用了A方法合成了化合物B，并且取得了很好的收率，或者是大大降低了成本，那还是可能会被授予专利的。 说如何无效类似的专利，我想还是应该仔细分析专利所描述的特征，同样一件事情，不同的写法可能会有不同的结果！ 24.Re:再谈专利意识 Copy to clipboard Posted by: windlight Posted on: 2004-05-05 23:05 xiaopingl100 wrote: 最近我查到原有一个硫普罗宁冻干粉专利取消，在此我想请教各位高手有一些不具备专利的申请条件（新颖性根本站不住脚，采用的方法是一般的制剂技术和常规的制剂条件，根本没有什么科技含量；所用辅料也是常规辅料），怎么使其无效？ 新颖性是无效专利所用的主要手段，而创造性在无效时基本不作考虑，因为事后诸葛亮谁都会当。用创造性无效专利，对专利权人一般来说是不公平的。 所以你说新颖性没有，可以无效别人的专利，这是对的，但你后面所说的没有科技含量我理解一般是指创造性，这是你自己的概念没有搞清楚。 新颖性的概念我想也不用在这里重复，还是很好判断的。但创造性的标准实际灵活度还是比较大的，这时就在于审查员掌握的火候怎么样，一般说审查员就是本领域的一般技术人员，但这个本领域实际还是很宽泛的，要是细说起来技术领域可以分到几千几万个吧，而现在国知局整体的审查员大概才在一两千吧，很难覆盖到全部技术领域。 我在sipo的校友说，他们领导说过没有不能授予的专利。只要是专利申请，都是作过了一定的工作，而天下没有绝对一样的专利申请，只要新颖性满足，创造性和实用性一般都没有问题。创造性不高，只是保护的范围很小而已。我这位朋友就是学药学的，他还曾经审过物理化学方面的一个专利申请，他说看申请书就如看天书一般，n多张公式推导，不要说本领域一般人员，就是专家，估计也得十天半个月的才能看懂，何况他一个隔行的人。 想无效别人的专利，就是打官司，而打官司就是打证据，前面提到专利无效就是打别人的新颖性，你就是要找到这样的证据证明他没有新颖性，而不能空手站在法庭上，说他那个创造性不可以，想通过辩论来无效这是没有意义的。 而且如上面醋鱼主任所说，创造性地判断也不是以科技含量来看。 实际这位朋友还是有一些老的发明创造奖励的概念在里面，也就是本贴所说的意识问题。 以前我国实行发明创造奖励，而没有专利制度，这里的发明创造就是要有高度，要成功实现，才可能谈到奖励。你成功实现了，创造了多少效益，才能奖励你。而专利制度里，你已经创造了效益，就说明你已经公用了，就不可能再去申请专利了，并获得知识产权保护。还有就是专利是先申请制，而不是成果报奖制，基本完善的技术方案就可以申请，而不要等十全十美的一个商品生产出来才去申请。你拿一个十全十美的产品去申请专利，往往还存在保护范围太小，失去专利制度的保护意义，别人很容易绕过你或变劣使用而不侵权。 一些大企业如何能一年申请成百上千个专利（如dvd相关专利据说就有几百个），日本的家庭主妇如何能成为日本专利的主要申请者，这些都说明专利申请不是一个产品的申请，dvd的光头移动方式，就是一个专利，在接受sipo老师培训的时候，老师就曾说过，一个技术问题被系统的解决，就可以申请一个专利，而一个产品的成功，实际要解决的技术问题不会是只有一两个那么少。可以说，如果不考虑申请专利的成本问题（时间，精力，金钱）一个产品可以申请n多专利。对一个产品只有一个专利保护，保护力度也往往是不够的。必须要形成专利保护群保护网，才能有效保护。 有些话是我联想的，可能不是这位朋友的本意，但不是批评或责骂的想法，我直言不讳写在这里，与大家共同深入探讨学习。 如何找新颖性证据就不用在这里重复吧！ ps: 醋鱼兄，我谈不上什么专利高手，高手是专业和法律并重的，园子里的高人很多，我能在专利帖子上得点分，只不过是勤快些，早点转了一些别人的文章，另外我是学经济的可能关注专利的经济和法律信息更多一些，角度与大家不是太相同。而且我是偏重抽象，或者说一般思维，和各位搞一些文字游戏，争论争论还可以。 向你所说的剂型专利的常用辅料和新辅料的关系，我就不懂，我知道辅料是剂型专利的主要技术特征，但辅料的新，辅料和药物结合的新，这两者之间的区别到底在那里？ 25.Re:再谈专利意识 Copy to clipboard Posted by: longbow Posted on: 2004-05-12 23:34 关于制剂专利，要看到底是以药物制剂产品作为专利还是药物制剂的制备方法。 对于前者，撇开全新化合物，对于已知活性组分的不同组合或配比作为发明核心的药物制剂，则必须具有出乎意料的协同作用才能认为有创造性；那样的话，其专利申请使用普通制剂条件是不影响的 对于后者，其主要应当令人信服的说明该方法与现有技术的方法相比所具有的优点和效果 26.Re:再谈专利意识 Copy to clipboard Posted by: zhangjie0815 Posted on: 2004-05-14 00:04 谁能谈一下申请药品专利与申请其他专利的异同？谢谢啦。 27.Re:【原创】再谈专利意识 Copy to clipboard Posted by: xuanron0701 Posted on: 2004-05-19 16:53 2004-05-14 00:04 -------------------------------------------------------------------------------- 谁能谈一下申请药品专利与申请其他专利的异同？谢谢啦。 在整个专利申请的程序方法，药品专利申请为发明专利与其它专利申请没有什么区别，都要经过初审、实审过程，只是说药品作用一种商品的特殊性，其专利申请所需的资料来证明其三性，有它独特的地方，所以实质上没有什么区别，建议申请药品专利找具有相关专业背景的代理人代理最佳。 28.Re:【原创】再谈专利意识 Copy to clipboard Posted by: caribbeanpirate Posted on: 2004-05-21 11:42 专利？？？？ 29.Re:【原创】再谈专利意识 Copy to clipboard Posted by: jinwsapa Posted on: 2004-05-21 14:39 制剂方面的专利有很多文章和奥秘, 它是药厂在其药品结构专利到期后的另一道防线. 国外在制剂专利方面有很多保护手段: 如用的原料药晶型, 含结晶水份数, 颗粒密度大小, 剂量范围, 复方与缓释, Cmax, 释放曲线及到达时间, 用药方式. 甚至用药说明书的版权等都可用于保护. 这方面中国的专利律师经验还不足, 国内外专利法也有不同. 但与结构专利比, 制剂专利还是有办法可以绕过.(不然仿制药厂就无法生存了)只是要看条条大道通罗马的结果和成本是否有优势. 国外一个新药有多项甚至10多项专利保护 (patent portfolio),目的是尽可能延长保护期, 增加对手的仿制难度和费用, 以及告倒对方的机会. 但有专利并非就可排他, 专利的重迭性和无效是很普遍存在的, 问题是专利局没有足够的时间精力和经验去排除, 必须要靠相关企业出重金打官司才能见分晓. Patent Lawyer will be a big winner no matter what outcome will be, 通过专利挑战和法庭最终判决, 让原创药厂的制剂和工艺专利无效是仿制药厂争取首先上市其仿制药, 赢得180天专买期的主要手段 30.Re:【原创】再谈专利意识 Copy to clipboard Posted by: windlight Posted on: 2004-08-11 11:08 我们现在很多的决策出问题，看起来是缺乏科学的意识，但根本上是缺乏管理的知识。没有知识，哪里来意识？决策只是凭感觉罢了。丁士昭教授说。 http://finance.sina.com.cn/g/20040811/0825940234.shtml 没有知识，那来意识 精辟！！！ 31.Re:再谈专利意识 Copy to clipboard Posted by: zhengzs Posted on: 2004-11-12 23:37 ycxfzf wrote: 专利这个东西，我也是刚接触，导师刚申请了一个药物的化学结构的国际专利，把一系列化学结构全部保护起来了，别的人就再也不能做与这个结构相关的药物研究，刚开始我也不是很懂，现在才慢慢了解了，专利这东西其实对任何人来说都是有利的。保护了一系列的知识产权，以后还要多多学习。 有几个问题需要澄清: 1 申请国际专利和得到授权是两回事.国际专利要到所指定的国家申请并取得授权才能得到这个国家的保护. 2 国际专利进入国家阶段需要通过代理机构完成.在发达国家代理费很贵.你导师是否准备了足够的钱. 3 从申请到得到授权没有确定的时间.有的专利从公告到授权花了8年时间.在这个期间没有保护,唯一的保护就是阻止别人申请同一内容的专利. 4 得到授权后,别人不经允许不能从事商业用途,作研究完全可以,你不能阻止别人从事研究工作.大部分药物都有专利保护,如果不允许作研究,怎么会有那么多的文献? 32.Re:【原创】再谈专利意识 Copy to clipboard Posted by: hxlleiip Posted on: 2004-11-15 20:50 前面的朋友说到：大家已提及的查找专利, 写好专利说明书等 很重要, 但做好做精不易, 需要有很多训练, 很强专业背景和经验, 中国目前非常缺有经验的专利律师. 尤其是双学位 (PH.D. M.D + JD) 的确如此，专利的专业性很强，学法律的只能泛泛而谈，很空洞，缺少技术支持。所以必须要两者的背景都需要！专利是门实务性的工作，现阶段很多人喊知识产权战略的口号，很宽泛很概括，但具体到某一个技术领域，就非得既动专业又懂法律的实务性人才。所以希望我们都能多学学这方面的知识。另外，有人问道：药物专利与其它领域的专利有什么不同？本人有一个看法，好像以前还没人这样提到过，那就是药物专利一般很少会出现专利群。当然这个观点不一定正确。就一个上市的药品来说，其核心专利一般就是一个具体的化合物，当然也有联合药物的情况。本人这里说的专利群是指相对比如DVD这样的专利来说的，一台DVD需要很多的部件一起构成，每个部件可能就是一项专利。而一个药品，其所包含的专利不可能象DVD那样，含有很多部件。一点浅见，不知当否？ 33.Re:【原创】再谈专利意识 Copy to clipboard Posted by: hxlleiip Posted on: 2004-11-15 21:01 应该说，目前药学科研人员的专利意识确实是越来越强了。政府这几年也在慢慢强化这种观念。比如说，科研立项时，要给出专利申请号才拨付资金。当然这种做法有好的一面也有坏的一面，好的就不多说了可以鼓励大家积极申请专利，单纯在专利申请数量上一片喜人。但实际上，由于我国目前的现状，缺乏懂专利撰写方面的人才，导致这些为了拿个专利申请号匆匆赶上去的申请的撰写很成问题，最后既拿不到专利授权，还被免费公开给社会公众。专利实际上就是利益的竞争，只要当人们真正意识到其价值时（一种就是被人家起诉要侵权费，一种就是卖掉或者实施自己的专利得到利益）才可能真正重视这个东西，才会去学习它。 34.Re:【原创】再谈专利意识 Copy to clipboard Posted by: windlight Posted on: 2004-11-16 10:17 hxlleiip wrote: 前面的朋友说到：大家已提及的查找专利, 写好专利说明书等 很重要, 但做好做精不易, 需要有很多训练, 很强专业背景和经验, 中国目前非常缺有经验的专利律师. 尤其是双学位 (PH.D. M.D + JD) 的确如此，专利的专业性很强，学法律的只能泛泛而谈，很空洞，缺少技术支持。所以必须要两者的背景都需要！专利是门实务性的工作，现阶段很多人喊知识产权战略的口号，很宽泛很概括，但具体到某一个技术领域，就非得既动专业又懂法律的实务性人才。所以希望我们都能多学学这方面的知识。另外，有人问道：药物专利与其它领域的专利有什么不同？本人有一个看法，好像以前还没人这样提到过，那就是药物专利一般很少会出现专利群。当然这个观点不一定正确。就一个上市的药品来说，其核心专利一般就是一个具体的化合物，当然也有联合药物的情况。本人这里说的专利群是指相对比如DVD这样的专利来说的，一台DVD需要很多的部件一起构成，每个部件可能就是一项专利。而一个药品，其所包含的专利不可能象DVD那样，含有很多部件。一点浅见，不知当否？ 同一时间或时间段比较集中的专利群确实很少在药品中出现，就我个人经验，药品专利还有合案申请的倾向，制备，用途，提取物和化合物同时申报，形成一个专利同时拥有三个独立权利要求也是有的。但同族专利和选择发明比较多也是药品专利的特点。 35.Re:【原创】再谈专利意识 Copy to clipboard Posted by: hxlleiip Posted on: 2004-11-18 20:40 windlight wrote: 同一时间或时间段比较集中的专利群确实很少在药品中出现，就我个人经验，药品专利还有合案申请的倾向，制备，用途，提取物和化合物同时申报，形成一个专利同时拥有三个独立权利要求也是有的。但同族专利和选择发明比较多也是药品专利的特点。 仁兄说得在理。其实很多药物申请尤其是新化合物申请都基本上涉及化合物本身、含有该化合物的药物组合物、该化合物的制备方法、该化合物的制药用途几个方面。把我所说的专利群说成专利池应该更恰当。意思就是说一旦药物侵权了，我想出现一群专利权人围着你要侵权费的情况应该比较小，因为一个上市药物不同于一部DVD，前者排出联合用药的情况的话，其专利权实质应该就在该化合物，而该化合物专利权应该是谁的就是谁的。而不像DVD，这个部件有专利权，那个部件也有专利权，这样就形成了专利池。我觉得药物专利应该跟这些不大相同，希望大家继续讨论。
标签: 知识
