Patents and PharmaceuticalsPatentis an intellectual property right (IPR). It is an exclusive monopoly granted by a government to an inventor over the invention for a limited period of time. Patentis a time-limited right to exclude others from making, using or selling a product or process.Key components of a patent:Filing date, Novelty, Inventive stepand Non‐obviousness, Prior art, Claims.药物，专利，为了钱钱钱。ABBA有首歌曲，\"Money, Money, Money\"1Invention is the powerhouse of prosperityWilliam J. Bernstein is an American financial theorist. He is known for his research in the field of modern portfolio theory and for his finance books for individual investors who wish to manage their own equity portfolios. Bernstein holds a PhD in chemistry and an MD; he practiced neurology untilretiring from the field.23456Some key technical points on patentOne of the main criteria of patentability of an invention is itsnovelty. The invention must be new and its information has not been previously revealed in public, either in print or by word of mouth.When a patent is filed or published, it becomes prior art, and thus prevents the allowances of same patents from competitors. Patents are territorial rights. That is, to obtain protection for an invention in a particular country, the inventor must be granted a patent for that invention by the patent office of that country. Patent allows its owner, by enforcement of the patent in court, to prevent others from making the patented items or using or selling the patented method during the life of the patent. 7Continued:Patent infringement is not a criminal offence (while copyright is), and does not come with a police protection. In the case of patent infringement, it is up to the patent owner to enforce the patentright in a court of law (civil law).There is no such thing as an international patent. An international patent application can be filed under the Patent Cooperation Treaty (PCT), to which 122 countries are signatories, but will only produce an International Search Report (ISR), and if desired, an International Preliminary Examination Report (IPER), but no PCT patents are actually granted.The normal length of patent protection is 20 years. But for drugdevelopment, significant proportions of the patent life for a new drug are lost before the drug enters the market. The average effective patent life for medicine is 11.5 years.8There is no such thing as an international patent.WIPO Headquarter in Geneva910Why Patent Protections Are Essential for the Pharmaceutical Industry?Drug development is risky, time consuming and expensive. In order to develop a new drug, the pharmaceutical company has spent enormous amount of time and money to take a concept to a marketed drug. It will need to have the exclusive right to manufacture and sell the new drug for a reasonable period of time with a price which will not only recoup its costs, but will generate sufficient profits for future research and development.For the pharmaceutical industry, 80% of marketed drugs do not recoup their R&D investment. It is very often that the big pharmaceutical companies rely on the blockbuster drugs (those with sales in excess of US 1 billion dollars) for their revenues. 11Fingolimod(Gilenya) is the first oral drug for the treatment of multiple sclerosis (MS, 多发性硬化症)。12WTO and TRIPS The World Trade Organisition(WTO) is the international organisationdealing with rules of trade between nations. WTObecame officially operational in January 1995. In becoming Members of the WTO, countries undertake to abide by its rules.Of the WTOrules, the Agreement on Trade Related Aspects of Intellectual Property Rights(TRIPS) has the greatest impact on the pharmaceutical industry. TRIPSrequires patent protection for all products and processes, with a minimum duration of 20 years from the original date of filing, without any special consideration for pharmaceuticals.China joined the WTO (and TRIPS) in 2002 and enacted regulation to extending all patents to 20 years.13FDA Orange Book14Example: Viagra’s FDA listing, patent protection and litigation151617Please note that this patent covers sildenafilas an antianginalagent. This patent was granted well before the discovery of sildenafilfor the treatment of male erectile dysfunction.18This EP463756 is the counterpart of the US5250534. The same patent is also being listed in many other countries, all with indication as anti-anginalagent.19Please note that this is Pfizer’s medical use patent for Sildenafil(Viagra) for the treatment of male erectile dysfunction 20Please note that claim 24 in this US 6469012 patent has a very broad claim. It actually covers all the PED5 inhibitors. Based on such claim in this patent, Pfizer had launched infringement action in the US against all other companies marketing PDE5 inhibitors.21Claim 24 in U.S. Pat. No. 6469012 was rejected by the USPTOYunnanJ. Traditional Chinese Medicine，1989，10（6），13。22This corresponding EP 702555 patent was revoked in the UK in 2000. The UK High Court ruled that this patent covering the use of PDE5 inhibitors in the treatment of male erectile dysfunction was invalid. EP 702555 had also been declared invalid by the European Patent Office in 2001. 23Pfizer received the US counterpart patent in China in 2001. And in 2004, a review board in the Chinese Patent Office invalidated this patent, but in 2006 a Beijing court sided with Pfizer and upheld Pfizer’s patent.24As to the relationship between the persons whose work led to the invention of Viagra and their company (Pfizer) that owns the patent right and get the benefit:\"Life might seem cruel, but they are paid to work for the company and the company owns their inventions. Literally hundreds of people at Pfizer have been involved in developing the drug. You can't really point to two individuals and say they spawned Viagra.\"Pfizer spokesperson on naming the inventors of Viagra 25Employee Inventor CompensationA Very Rare Case:On 11 February 2009, the UK High Court made the first ever court award of compensation to employee inventors under the Patents Act 1977 (1977 Act) (James Duncan Kelly and Kwok WaiChiu v GE Healthcare Limited [2009] EWHC 181 (Pat)). Although the court characterisedits approach as conservative, the sums awarded were significant: £1 million to one inventor and £500,000 to the other. Dr. Duncan Kelly and Dr. Ray Chiu were formerly scientists employed by AmershamInternational, which was taken over by General Electric in 2004 and renamed GE Healthcare. They were co-inventors of a radiopharmaceutical heart imaging agent called “Myoview”. This has been a huge success for GE Healthcare over the past several years and remains a mainstay of its business, with sales exceeding £1.3 billion. Myoviewhas become a routine tool for investigating heart problems and is now used throughout the world.If you're employed to invent, under the patent act, any invention you make during the course of your employment will belong to the employer.Robert Fitt(An Associate at UK law firm Bristows)26This shows you how commercially important this patent is. This is the key patent for Bayer GSK’smarketing of Levitra.27NH2OON替莫唑胺（Temozolomide），商品名Temodar，是由现在英国诺丁汉大学药学院的Malcolm Stevens教授研发的。Andy Westwell在诺丁汉大学工作的几年中，是跟随Malcolm Stevens工作的。替莫唑胺是用于临床上治疗脑肿瘤，目前由Merck（之前是由Schering-Plough生产的专利药物）生产和销售，是属于重磅型药物。Stevens教授现已基本退休了，替莫唑胺是他在30年前在英国Aston大学药学系工作时开始研发的，经过了许多周折，终于成功，Stevens教授也因此发了大财。据他自己讲，他仅仅是拿了药企利润的一个极其微小的百分数，但这样的话，他也成了百万富翁。替莫唑胺的研发并不顺利，在美国的专利申请也不顺利，在1982年申请美国专利，用了11年时间，拖到1993年才批下来（US 5260291）。这个291专利在2010年初在一个美国地方法院（Delaware District Court）被非专利药生产企业Barr Labs（现是Teva的一部分）挑战而被废除。而在2010年11月初，美国联邦法院（The US Court of Appeals for the Federal Circuit, CAFC）驳回了地方法院的判决，又恢复了291专利的有效性，可见这个药物的商业运作是多么曲折。2829303132“Forget horse racing”, says one patent attorney, “patent litigation is the true sport of kings”The Economist, March 8, 2003333435中国国内专利申请的几个问题我们是社会主义体制，国家的大部分财产属于国家，许多中国专利申请人是国有企业和事业单位，拿着国家的钱来工作，这些人的专利如果有科技创新的话，专利授权是一种垄断，阻碍国内的科技发展。既然是社会主义共同分享资源的话，为什么要自身制造障碍？（论题）我们是社会主义国家，财富归国家和人民所有，企业和高校都是国家的，任何科研成果是给全社会的，我们不需要专利。专利是资本主义的核心部分，但是和社会主义原则背道而驰的。中国的专利实施是最初让美国人逼的，我们国家做妥协让步，开始是中美双边协议，出现了专利前期的行政保护，后来WTO变成了正式的专利体制。我们现在是打肿脸充胖子，宣传专利的重要性。中国和印度加入了WTO（世贸组织），能出口货物到美国和欧洲，不受关税壁垒的折磨，以公平贸易的名义，作为条件，美国和欧洲国家要求中国和印度企业加入知识产权(IP)保护体制，保护国外大企业在中国和印度的知识产权。保护发达国家的知识产权是中国和印度专利法改进和存在的原因，至于保护国内企业和个人发明，只是做戏了，没有任何实质的东西。中国国内专利的急剧膨胀说明了什么？真的多少专利能到生产中使用？有多少专利一直交钱保证有效期？有多少专利是作为申请人的科研成果而凑数？中国需要专利去应付世贸组织的知识产权要求，保护国内人民的利益，减少跨国企业在中国的财富掠夺。但是，中国的体制不需要全国人民都去申请专利，要么是浪费资源，要么是把自己卡死。国内有许多人对于专利的法律含义认识不清楚，最简单的看法是认为专利是不能动的，不能侵犯专利的。但实际上很多专利是垃圾专利，包括国外公司在中国申请和授权的专利，也包括国内企业，个人和科研单位的专利。也许国内鼓励申请专利有个保护国家利益的目的，那就是增加国内企业的专利壁垒，或者作为Defensive目的申请专利，以防止国外企业以专利和知识产权名义敲诈。国内许多申请的专利最后都没有交费用维持，这是算是公开披露了，技术共享，国外公司也不能再申请专利了。也许这是中国的专利壁垒，以后可以阻止国外的产品进口到中国市场，因为以后中国是个很大的市场，国外企业都想进来。中国的企业可以做自己的专利，告国外公司侵权，要么收钱，要么阻止国外企业产品进来。36专利泛滥的例子37Jerome H. Lemelsonand The Submarine Patent (潜水艇专利)A hero among small inventors, Lemelsongarnered more than 550 patents, a number that puts him close behind Thomas Edison. Lemelsonis remembered in America as a generous benefactor to the Massachusetts Institute of Technology, the Smithsonian Institution and others. But many corporations consider him an archvillainwho misused the patent system to obtain claims on things he never invented. Theyclaimed that Lemelson, by applying for additional or expanded claims-and by taking advantage of a procedure that extends the patent application process, would continually delay the issuance of a patent. Theseploys, they say, served to keep the details of a patent secret while allowing him to broaden its scope to encompass technologies invented and commercialized by others. Once a patent finally did surface, in one case almost 40 years after the filing date for claims purported to cover bar-code scanning, Lemelsonsystematically went about seeking licensing fees, and if companies refused, he sued them for infringement.Jerome H. Lemelson(18 July 1923 –1 Oct. 1997)38BiogenUS 75988755 PatentA recent example of submarine patentBiogenUS 75988755 patent was granted in 2009.The patent was filed on May 25, 1995 (just weeks before US patent law adopted the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, in which patents are valid for 20 years from the date of filing and the applications are made publicly available.The ‘755 patent claimed priority to a UK patent application filed byBiogenin 1980.If the ‘755 application had been filed under the terms of TRIPS, the expiry date would have been around 2001.As it stands, the expiry date is estimated to be 2026 (Prior to the adoption of TRIPS, US patents were valid for 17 years from the date of issue and the applications were not published).After the ‘755 patent was granted, Biogenwent to court suing MerckSerono, Pfizer, Bayer and Novartisfor patent infringement.39Patent Trolls有个英文名词patent troll，是个贬义词，中文应该翻译是专利恶魔。这是是近几年兴的名词，形容有专门做这种生意的公司，购买专利（从个人手上的专利和企业不使用的专利，而不是自己做研发和申请专利保护），然后利用购买的专利去法庭诉讼其它公司专利侵权，收取专利使用费。专利维权是正常的情况，但对于patent troll来讲，它们是专门来做生意，做的太过分了，有点像诈骗一样，只是不违法。Patent troll可以是指个人或是一个公司，用自己手中的专利（收购来的，就是为了起诉的目的）去诉讼别的公司专利侵权（manner是unduly aggressive，或者是opportunistic）。有人把Jerome Lemelson看成是最早的patent troll，the grandfather of patent troll（Lemelson’sDemise, Corporate Legal Times, Dec. 2005）。（注：我从所有关于Lemelson的资料看，他和现代的patent troll还不一样，Lemelson的专利都是他自己做的，他并没有很快起诉别人获得钱，他是等了40多年后才有钱的，那时他都70多岁了，而且主要的钱是他去世后，以他名字的基金会得到的）。Patent troll这个名词并没有大家都认同的定义，最初是Intel的Peter Detkin提出的patent extortionist，指有些企业利用专利侵权向Intel要钱。后来人家起诉Intel诽谤罪，损害名誉（for libel），Detkin才把patent extortionist改成了patent troll。实际上，在今天，有些公司指控别人是patent troll，而自己在专利诉讼方面也像patent troll一样去向别人要钱，是双重身份的。Fortune杂志有个2011年的文章，讲了美国最有名的公司Intellectual Ventures（face of patent litigation in the tech spare），就是一个典型的patent troll公司（见：An audience with the king of the patent trolls，CNN，Fortune，15 Sept. 2011）。现在有些大企业一方面指责别人是patent troll，一方面也学会了patent troll的做法，也用这种手段挣钱，向别的企业收取使用费（见：Patent Troll Tactics Spread，Wall StreatJournal，8 July 2012）。Is U.S. innovation experiencing death by patent (WP 27 July 2011)，这篇2011年的文章，提到了Peter Detkin，这个人最早在Intel公司，他提出的Patent Troll的名字。但他今天也加入到那patent troll的行列里面去了。Detkin现在美国最有名的公司Intellectual Ventures工作，典型的patent troll公司。有这样一句话，讲的很好：Clearly, one person’s patent troll is another person’s champion of patent rights.（来自：Are Patents A Driver of Innovation or Just a Tax? http://www.patentbaristas.com/archives/2009/02/17/are-patents-a-driver-of-innovation-or-just-a-tax/）40专利的最终支柱是国家的法律和政权毛泽东说：枪杆子里面出政权。到了1926年，毛泽东就开始讲，革命不是请客吃饭，不是做文章，不是绘画、绣花，不能那样雅致，那样从容不迫、文质彬彬，那样温良恭俭让，革命是暴动，是一个阶级推翻一个阶级的暴力行动。毛泽东在1958年8月21日北戴河协作区主任会议上说：“不能靠法律治多数人，民法和刑法那一类法律，都不需要了。民法刑法那样多条谁记得了？宪法是我参加制定的，我也记不得。……我们每个决议都是法，开会也是法……我们主要靠会议，一年搞四次会，大跃进，就没有时间犯法！不靠民法、刑法来维持秩序。”西方国家政府不断变换，因为每一届大选的结果，我们国家执政者基本不变。但是西方国家的立法基本不变，而我们国家的一部分法律，或者规定，都是’暂行‘，不断改变，很多是领导拍拍脑袋就改变。看看许多单位的红头文件，就知道我们有多少暂行条例了。民主和法制失败的必然结果是独裁和导致枪杆子里面出政权。在国外，政治家（执政者）立法，而法官执法和自己去理解法律，政府不能干涉。如果政府不喜欢法庭的结论，政府可以修改法律，但不能控制法庭的结论。（Politicians make the law and the judges interpret the law. See: Yes Minister）在Niall Ferguson的2012 BBC Reith Lecture的时候，Geoffrey Robertson QC提了一个问题，就是法律和政权的问题。Robertson讲，他在香港替一个越南人在法庭打官司，他的案件在法庭上赢了。但是，香港当局在行政的体制下，找了一个其它理由，就把法庭的裁决否定了。国内一个报纸的例子，国内地方法庭的执法问题：江苏东台亿万富姐陷害竞争对手屡屡得逞(3 Aug 2012)，这个案例说明了什么问题？？41药物与国家的法律许多人没有认识到，药物化学的最终产物是一个上市的药物。但是药物的使用是需要执政者许可和批准使用，不然，后果可能是违法和犯罪。可以举一个例子，你在从事药物研发中，要服从一个国家的法律，随便给人用药是违法犯罪的，没有药监局的国药准字号批文是不能卖药的。以中国为例子，你需要国家药监局的一个国药准字号，不管这个号是怎么拿到的。浙江药监局的三任局长被逮捕判刑，可见制度的松懈和混乱。药物的研发和使用涉及到政治和法律，并不是一个单纯的理科科学，并不像数学和物理学的研究。42