Technology transfer offices and university patenting in Sweden and Germany

This paper analyses the factors that impact on the decision of researchers to patent their research results. Particular emphasis is put on the role of technology transfer offices. It builds on a survey of university professors in Sweden and Germany. The regression results show that researchers that received support from the public infrastructure and researchers that have experience with the patenting system—through own previous patents or joint patent applications with firms—are much more likely to apply for patents.     

重大突发公共卫生危机下的药品专利强制许可——现实需要、伦理因应与法律安排

新型冠状病毒肺炎于2019年底在我国爆发并迅速扩散,引发了全国性的重大突发公共卫生危机。为实现特效专利药品的充分供给,实施药品专利强制许可是最为高效的选择,不仅可以消解药品专利市场运营中所固有的“反公有地”悲剧,同时也可以有效规避药品专利国际合作中技术劫持与贸易倾轧。对于以人为本的主体性原则和与人为善的有益性原则两项伦理准则的遵循,保证了药品专利强制许可实施的伦理正义;而对于药品专利强制许可申请主体扩展和药品专利强制许可补偿标准细化两项法律完善举措的采取,则使我国药品专利强制许可机制克服了自身缺陷,能够在实践中有序运行,为重大突发公共卫生危机的化解提供制度支撑。     

非法实施发明专利入罪的认识误区及克服

加强专利权保护是形势使然。专利权具有无形性、公开性和非竞争性,容易受到侵害。专利民事司法保护存在刚性不足、赔偿数额认定难等局限。专利行政执法对效率的追求造成程序监督弱化。刑法具有制裁手段的严厉性和“二次保障性”特征,遏制专利侵权优势明显。以专利权系私权、专利权具有不确定性、专利案件审理存在技术性难题为由反对非法实施发明专利侵权入罪的主张并不成立。专利刑事立法应当从“权利救济”转向“法益救济”,重构有关专利犯罪客体,增设非法实施发明专利罪,把故意侵犯发明专利且情节严重的行为规定为犯罪。     

侵犯专利权犯罪刑事立法之比较研究——兼及我国专利权刑法保护的完善

从各国关于专利犯罪的刑事立法模式、罪名体系、保护对象、刑罚设置及追诉方式上看 ,既有许多共性 ,同时各具特色。完善我国大陆专利权刑法保护的基本构想 :第一 ,采取结合型立法模式 ,充分发挥附属刑法的作用 ;第二 ,完善罪名体系 ,将冒充专利和专利侵权行为纳入到刑法调控的范围 ;第三 ,设置多个量刑幅度 ,实行限额罚金制 ;第四 ,建立以自诉为主、公诉为辅的追诉模式     

Universities and Patent Demands

Research universities have made enormous contributions to the field of medicine and the treatment of human disease. Alone or in collaboration with pharmaceutical companies, academic researchers have added to the store of knowledge that has led to numerous life science breakthroughs. A new chapter may be opening for academic researchers, however, that could lead to a darker tale. ‘The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer''s research, by Bubela et al., chronicles one such tale.’ The authors do an excellent job of bringing to life the twisting saga that engulfed numerous academic and non-profit Alzheimer''s researchers over many years. The authors note that the story is an outlier, but sadly, that may not be the case. There are increasing signs that academic researchers and their institutions are being caught up in the rush for gold that is accompanying the proliferation of the non-practicing entity business model. As I have noted before, academic institutions have a dual role, as keepers of the academic flame and guardians of the public monies entrusted to them through state and federal research funding. The specter of taxpayer money being used, not to advance research and for the betterment of society, but as part of schemes to extract money from productive companies may not sit well with voters, and ultimately, with legislators. In that case, researchers and institutions themselves may have much to lose.‘The Mouse that Trolled: The Long and Tortuous History of A Gene Mutation Patent That Became an Expensive Impediment to Alzheimer''s Research’ describes an important case in which a gene mutation patent, owned by a non-practicing entity, was asserted against researchers studying the causes and effects of Alzheimer''s disease. Non-practicing entities (NPEs) are parties whose core activity involves licensing or litigating patents, rather than making products. The article details nearly two decades of litigation—targeted at universities, foundations, and non-profits—and illustrates the immeasurable damage to disease research caused by the battle. Although the authors examine a single example of an NPE targeting biopharmaceutical research, observational evidence suggests that such cases will be neither rare nor uncommon across time, raising concerns about the way in which the public interest may be lost along the way. Particularly troubling is the possibility that universities themselves may increasingly partner with NPEs, in an effort to join the patent gold rush.Universities play a dual role in society, serving both as keepers of the academic flame and as guardians of society''s money. State and federal governments entrust universities with substantial amounts of research funding in the hope that academic minds can contribute to the store of knowledge that will lead to societal improvements in human health, technology, and other fields. And universities have, indeed, made profound contributions to knowledge and innovation, from which all of society has benefitted. In fact, in an effort to facilitate the translation of academic research into products for society, Congress adopted the 1980 Bayh-Dole Act.¹ Prior to Bayh-Dole, commentators had complained that the ‘return on investment’ from public research funding for universities failed to justify the dollars spent.² Bayh-Dole attempted to rectify that problem by allowing universities to control patenting and licensing of inventions created with federal money.³ The goal was to facilitate the creation of actual products from the storehouse of knowledge resulting from public funding of university research. In keeping with the idea that universities are trustees of public resources, Bayh-Dole created an environment in which universities would foster innovation through the commercial application of its patents.Bayh-Dole flowed from the basic principle that patents are granted, not solely to reward the inventor, but rather to incentivize activity that benefits society as a whole.⁴ In granting patents, we temporarily remove items from the store of what would otherwise be free to all and reserved to none in the hopes that this will redound to the benefit of society at large.⁵ Thus, patents are not the natural right of an inventor, but rather are rights created by the sovereign in the United States for limited societal purposes.⁶The federal government itself recently explored this concept in arguments before the Federal Circuit—the appeals court that hears cases related to patents—in Astornet Technologies Inc. v. BAE Systems, Inc. In Astornet, the patent holder claimed that three government contractors had violated its patent with their equipment to authenticate boarding passes at airports.⁷ The court dismissed the claims under 28 U.S.C. §1498, which stipulates that when the government uses a patented invention, any patent infringement action must be taken against the United States and not the individuals of companies with whom it contracts.⁸The government''s amicus curiae noted that the US does not ‘infringe’ when it uses a patented invention without authorization, and commentators have pointed out that according to this characterization, one must never think of the US as an ‘infringer,’ but rather as a sovereign that has simply chosen to offer compensation.⁹ According to the brief, the court cannot interpret the U.S. government''s actions as patent infringement. Rather, 28 U.S.C. §1498 stipulates that the only remedy for damages caused by the government''s use of a patent is just compensation after a complaint has been raised in the U.S. Court of Federal Claims. In other words, the government can always use a patent without permission, as long as it provides compensation at a later date if and only if a court rules in favor of a complaint raised by a patent grantee. Therefore, the government may force compulsory licensing and is never actually a patent infringer. This is not to say that the patent grantee has no remedy against the government. Rather, 28 U.S.C. §1498 waives sovereign immunity and establishes the process by which an inventor can claim royalties. At the end of the day, however, the government''s brief reminds us that patents are not granted for inventors to aggrandize their wealth but rather in the interest of society as represented by the sovereign.Bayh-Dole, of course, is a manifestation of this principle. Having entrusted universities with public funds for research, the sovereign then gives universities the right to patent and license the fruits of that research. The intent is not to further fill the university''s coffers with more money but to fill society''s coffers with new products. In other words, under Bayh-Dole, universities are given control over the licensing system specifically to foster the creation of new commercial products for the benefit of society. NPEs, however, muddy the waters.NPEs are individuals or businesses whose core activity involves licensing or litigating patents, rather than making products. NPEs make no products of their own but generate a return by asserting patents against companies that make products.¹⁰ Over the last few years, at least half of all the patent infringement suits filed in the United States have been filed by NPEs.¹¹ Often referred to as patent trolls, many scholars and commentators have argued that NPEs simply create a tax on production—the production of companies already making products. Although one could conceivably argue that they play some role in the innovation system,¹² whatever role they play, NPEs certainly do not make new products. They also do not appear to connect inventors with others who make new products out of their inventions.¹³Traditionally, universities have avoided engaging in widespread patent litigation. For example, a study of 15,000 patent lawsuits filed across four years in the United States found that NPEs filed a majority of those suits.¹⁴ Universities accounted for only one half of one percent of all first-named plaintiffs, making them almost invisible in the dataset.¹⁵Universities have also traditionally avoided partnering with NPEs. In fact, the Association of University Technology Managers (AUTM) released a public interest statement on ethical technology transfer principles in 2007, which universities could sign. The statement is advisory, not mandatory—setting out guidelines for best practices, rather than requirements. For those universities that signed the statement, the code specified that universities should not operate under a business model that is predicated on infringement litigation rather than commercialization to create products. AUTM, which includes some members who are already licensing technology to NPEs, has decided to reexamine the code.¹⁶ Even if AUTM upholds its original statement, however, it is possible that universities increasingly will license technology to the highest bidder, regardless of whether any new commercial products will result.Money is tempting, and the lure for universities to monetize their patents is becoming irresistible. For example, Intellectual Ventures, one of the largest patent holding companies in the United States and a notorious NPE, claims that it has handled patent licensing for 60 American universities but acknowledges that only two of which (Duke and Caltech) have led to commercial products.¹⁷ Notably, both Duke and Caltech had signed the 2007 AUTM Statement opposing transferring patents to NPEs.¹⁸ In addition, press reports have identified examples of patents funded by federal programs that have been transferred to NPEs.¹⁹ Faced with the incentive to profit from research, at least some universities appear to be shifting away from the policy of avoiding NPEs. As the practice spreads, there is a significant risk that more and more universities will be rushing into the waiting arms of NPEs. In this case, universities may end up fueling the type of litigation that hindered Alzheimer''s researchers, as chronicled in ‘The Mouse that Trolled’.Moreover, these new university commercialization methods may have particularly serious consequences for the life science industry. Many people wrongly believe that biotechnology and the pharmaceutical industry are immune to NPE litigation. However, a study of the patent holdings in the fiscal year 2011 of five universities (the University of California system, MIT, the University of Texas system, Caltech, and the University of South Florida) identified numerous patents that could be deployed with the same techniques that patent trolls have used in the technology sector. These included patents on active ingredients of existing drugs, methods of treatment, screening methods to identify new drugs, manufacturing methods, dosage forms, as well as related technologies.²⁰If universities continue to move toward interactions with NPEs, such portfolios will provide tempting morsels to feed the patent trolling appetite, and could help drive patent trolling more toward the life sciences, a result that cannot be good for life science innovation. It would be troubling if taxpayer money that flows to universities ends up fueling patent trolling, rather than encouraging the creation of new products. In that case, the implicit agreement between the public and the research it funds would be disrupted.‘The Mouse that Trolled: The Long and Tortuous History of A Gene Mutation Patent That Became an Expensive Impediment to Alzheimer''s Research’ tells the cautionary tale of the ways in which NPEs, through patent assertion, hinder progress that affects the public. It is clear, however, that there will be similar examples in the future. The authors’ tale not only casts doubt on the NPE model; it should also make us think deeply about the role that the public expects universities to play in society. The public interest requires that universities act responsibly with public funding and remain dedicated to society''s benefit. University patent monetization via NPEs both fails the spirit of Bayh-Dole and damages the public''s trust.     

从社会价值角度看药品专利保护与公共健康利益的冲突

TRIPS协议将医药产品纳入专利保护范围以后，引发了国际社会对药品专利和公共健康二者利益如何平衡的争执。本文在浅述药品专利保护与公共健康双方争端由来的基础上，浅谈了争执双方的利益所在，然后从社会价值、知识产权制度的利益衡平目标等方面分析后，笔者认为，在当前公共健康不断受到AIDS、SARS、禽流感等高发传染性疾病的挑战的情况下，应在保护药品知识产权的同时，不断加强对公共健康的保护。     

Patent first, ask questions later: morality and biotechnology in patent law

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patents later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.     

影响发明或实用新型专利权稳定性的实质因素

有关专利权稳定性的问题，在实践中表现为：一方面是，申请人不正当地将不符合专利法要求的技术方案拿来申请并获得专利权；另一方面是，审查过程中，由于制度方面的因素，将不应当授权的技术方案错误地授予专利权，造成了劣质专利的泛滥。深入研究专利权稳定性问题，探索提高专利权稳定性的有效途径，具有重要的理论和现实意义。     

Deploying pre-grant patent opposition mechanisms in Africa to monitor abuse of the patent system

This article examines the extent to which African countries could deploy pre-grant patent opposition provisions in their domestic patent regimes to mitigate the abuse of the patent system. The author argues that the public has the right to participate in the patent system in order to oppose the grant of bad patents. Therefore, if African countries were to strengthen legislative provisions on pre-grant opposition civil society and non-governmental organisations that represent the interests and will of citizens would be able to invoke key provisions to challenge any abuse in the patent system in order to protect the public interest.     

Patenting nanotechnology

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. This rush to the patent office is so significant that many law firms have established nanotechnology practice groups and the U.S. Patent and Trademark Office has now created a new technology class designed to track nanotechnology products. Three big differences between the emerging science of nanotechnology and other inventions make the role of patents more significant in this arena than elsewhere. First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. In many of the most important fields of invention over the past century--computer hardware, software, the Internet, even biotechnology--the basic building blocks of the field were either unpatented or the patents were made available to all users by government regulation. In others, patents were delayed by interferences for so long that the industry developed free from their influence. In nanotechnology, by contrast, companies and universities alike are patenting early and often. A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well. This overlap may significantly affect their incentives to license the patents. Finally, a large number of the basic nanotechnology patents have been issued to universities, which have become far more active in patenting in the last twenty-five years. While universities have no direct incentive to restrict competition, their interests may or may not align with the optimal implementation of building-block nanotechnology inventions. The result is a nascent market in which a patent thicket is in theory a serious risk. Whether it will prove a problem in practice depends in large part on how efficient the licensing market turns out to be.     

The nexus between science and industry: evidence from faculty inventions

Knowledge transfer from science to industry has been shown to be beneficial for the corporate partner. In order to get a better understanding of the reasons behind these positive effects, this study focuses on the junction of science and industry by comparing characteristics of academic inventions that are transferred to industry and those staying in the public sector. Academic inventions are identified via patent applications of German academic scientists. We find that academic patents assigned to corporations are more likely to enable firms reaping short term rather than, possibly more uncertain, long-run returns, in contrast to patents that stay in the public sector. Firms also strive for academic inventions with a high blocking potential in technology markets. Academic patents issued to corporations appear to reflect less complex inventions as compared to inventions that are patented by the public science sector.     

中医药技术秘密保护的价值审视和风险规制

现代医药的知识产权保护是建立在以西方科技为发展基点、西医药为主要保护对象、专利保护为核心手段基础之上的产权保护制度.在应对中医药的知识产权保护时,一味遵循西药的专利保护制度无法适应中医药理论体系,依靠专利制度进行中医药知识产权保护往往捉襟见肘.相比之下,长期处于专利制度云翳背后的技术秘密保护手段,能够有效弥补传统以专利为核心的知识产权保护制度不足,成为了中医药产权保护的新常态.同时,技术秘密保护也存在着固有的缺陷,并与涉及社会公共利益的信息公开制度存在冲突.本文致力于主动审视技术秘密保护手段在中医药产权保护领域的独特价值,积极找寻破解中医药技术秘密保护困境的方法,从法律视角提供构建和完善中医药技术秘密保护的思路.     

我国医药发明专利试验例外制度研究

医药发明专利试验例外作为我国专利法上一项新生的侵权抗辩事由,在实施中尚缺乏应有的制度保障。通过追溯医药发明专利试验例外的起源和发展,考察主要国家医药发明专利试验例外制度的具体内容,分析了我国医药发明专利试验例外在实施中将面临的困惑,并从适用范围、专利补偿期限、专利链接制度三方面入手,对我国医药发明专利试验例外制度的完善提出了建议,以期能充分实现专利药物制造商与仿制药物制造商、药物制造商与社会公众之间的利益平衡。     

Using patent filings to measure innovation

Ever since Bennett Woodcroft compiled his seminal index to theearly English patents, it has been recognized that the emanationsfrom Patent Offices contain a wealth of information. Battelle,in their work on patent trends analysis, revealed that approximately50 per cent of patents are used during their lifetime and that80 per cent of the information obtainable from patents is notavailable from any     

标准化中的专利挟持问题研究

标准制度与专利制度具有对立统一性,标准中的知识产权问题越来越复杂,专利挟持是标准与专利融合过程中最为根本的问题。专利挟持有多种表现形式,在美国就有不当披露专利信息,违反FRAND原则,违背前手承诺实施不正当竞争行为等里程碑式的判例。因此,应完善标准制定机构的自律监管机制,即事先披露原则,通过相对确定的FRAND原则,在法律诉讼程序之外建立可选择的ADR纠纷解决机制;由专利权人通过许可协议方式进行交叉许可,以市场为导向建立专利池;用反垄断法规制标准化中专利挟持。     

Idea generation: the performance of U.S. States 1997–2007

Regional prosperity increasingly depends on a region’s capacity to have command over the production of ideas. Measuring the production of ideas with patents, the objective of this paper is to analyze how the number of utility patents granted to inventors in U.S. States in different technologies changed between 1997 and 2007 and how States took advantage of the new opportunities and adapted to the changing technology landscape. The paper uses shift-share analysis, traditionally used in employment studies, for analyzing change in patents by technology categories developed by the NBER. The shift-share results show that only a few states were able to take advantage of the information technology driven increases in patents. California dominates in patent production and may be providing spillover benefits to neighboring states. The shift-share decompositions are used as variables in a fixed-effect panel-regression model of state economic growth. The regression results show that the shift-share decompositions provide statistically significant information in explaining growth after accounting for a State’s stock of patents, suggesting that States should concentrate on effective ways to boost their stock of knowledge in rapidly growing technologies to improve state economic growth.     

The private value of patents by patent characteristics: evidence from Finland

I use renewal rates and fees to estimate the private value of Finnish patents by patent characteristic. I disaggregate the value estimations by applicant, patent breadth, and technology. Firm patents are 1.5 times more valuable than patents owned by individuals. This holds also when controlling for technology and breadth. There are large differences in values between technologies but in contrast to the usual assumption made in the theoretical literature, broader patents are not necessarily more valuable than narrower ones. Patent value is skewed and therefore the number of patents should be weighted by an index when measuring technological change. I construct this index for Finnish patents and find that renewing a patent one more year signals a 1.5 times more valuable patent.      

应对公共健康危机的药品专利强制许可实施困境与对策

药品专利强制许可作为一项应对公共健康危机的制度在国内外均得到了立法与政策体认.鉴于其所关涉利益关系的复杂性,这项制度从产生至今仍然争议不断.具体到这项制度的实施,其程序和效果存在更多不确定性.尽管当前一些国家已经通过实施强制许可以应对新冠肺炎疫情,但是围绕发展中国家能力不足、除了专利之外药品所涉其他知识产权许可的不确定性以及《与贸易有关的知识产权协定》第31条修正案的低援引率等方面仍然存在诸多争议.中国虽然建立了从立法到政策的专利强制许可规则体系,但是对于在公共健康危机背景下由政府部门决定实施的药品专利强制许可仍然缺乏更为明确细化的程序规定.我国需要在谦抑性、审慎性、灵活性的理念指引下,在切实保障专利权人权益的基础上完善药品专利强制许可的实施机制.     

Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule

The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes.