Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Clicking Away Your Speech Rights: The Enforceability of Gagwrap Licenses

Abstract

Software companies would like to be able to control what their customers and reviewers can say about them and their software. To this end, many include in their license agreements “DeWitt” or “gagwrap” clauses which purport to prevent written reviews or disclosure of benchmark test results involving the software without the manufacturer's consent. While the courts have recognized the enforceability of software licenses to protect manufacturers, they have so far not addressed the enforceability of gagwrap clauses. This article examines gagwrap clauses and examines them in a public policy framework arising from contract and First Amendment jurisprudence. It proposes a test for the enforceability of the clauses that leaves in place many agreements not to speak but renders gagwrap clauses suspect on public policy grounds.     

Objectives, Characteristics and Outcomes of University Licensing: A Survey of Major U.S. Universities

This paper describes results of our survey of licensing at 62 research universities. We consider ownership, income splits, stage of development, marketing, license policies and characteristics, goals of licensing and the role of the inventor in licensing. Based on these results we analyze the relationship between licensing outcomes and both the objectives of the TTO and the characteristics of the technologies. Patent applications grow one-to-one with disclosures, while sponsored research grows similarly with licenses executed. Royalties are typically larger the higher the quality of the faculty and the higher the fraction of licenses that are executed at latter stages of development. Sponsored research is more likely to be included in a license if the new technology is at an early stage of development or if the TTO evaluates it as important. We find that additional disclosures generate smaller percentage increases in licenses, and those increases in licenses generate smaller percentage increases in royalties.     

License term for medical use licenses--NRC. Proposed rule

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.     

License terms for medical use licenses--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.     

WTO: US and Argentina settle dispute over patents and data protection

In May 2000, supplementing an earlier complaint filed in May 1999, the US filed a complaint against Argentina, alleging that its patent laws violate the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property (the TRIPS Agreement). The gist of the US complaint was that Argentina's law failed to provide: (1) adequate protection against "unfair" commercial use of undisclosed test data submitted in order to get market approval of pharmaceutical products; (2) certain safeguards for compulsory licences on an invention granted on the basis of inadequate working by the patent holder; and (3) adequate measures to prevent infringements of patent rights. The US also alleged that Argentina denies certain exclusive rights of patent holders, such as the exclusive right to import the patented product into the country. At the end of May 2002, the US and Argentina notified the WTO that they had reached a "mutually agreed solution," without prejudice to their respective rights and obligations under WTO agreements, and the US has withdrawn its complaint.     

由一起违反二次供水设施的日常管理职责案引发的连环案的案例分析

目前，越来越多的五星级酒店和商务楼宇管理单位选择安装涉水产品之一的水质处理器用来净化水质。由于目前涉水产品市场秩序不规范，相当多的涉水产品没有办理市场准人手续，造成鱼龙混杂、良莠不齐的局面。本文通过由一起违反二次供水设施的日常使用管理职责案而引发的两起生产和销售无卫生许可批准文件的涉水产品案的分析研究，谈谈在违法事实和证据的认定上的观点，供参考。     

The failure of effective technological transfer in Polish industry

Central planners in Poland have continuously emphasized the importance of increasing factor productivity as a major goal of Polish development policy and have included this goal as an integral part of every economic reform proposal of the last two decades. In the decade of the 1970s a new development strategy was initiated which counted heavily on the import of more technologically advanced machinery and equipment and the purchase of licenses and production processes from the West. This paper documents the tremendous increase in Western imports and the purchase of licenses which took place in the 1970s, and which would then be expected to generate an increase in joint factor productivity due to technological change. Empirical analysis, however, indicates that there was no effective transfer of the technology. Joint factor productivity for total industry calculated as a residual in estimated production functions, which include imported inputs, has a zero rate of growth from 1970 to 1978 (using quarterly data). Disaggregating and using annual data over a longer sample period yields estimates of the rate of growth of joint factor productivity which increase slightly for total industry in the 1973–1977 period. For the electrical and mechanical branch which received large numbers of license and joint production agreements the rate of growth of joint factor productivity remained unchanged. The results indicate that systemic factors such as central planning, managerial inhibitions and supply bottlenecks out-weighed any potential increase in factor productivity as a result of technology transfer.     

Inaccuracy of height information on driver's licenses.

Height is an important variable in identification. In cases involving decreased individuals, height is measured directly on the corpse or estimated from the skeleton. This postmortem measurement or estimation is then compared with antemortem records, usually the driver's license. The accuracy of the license information, however, has been questioned. To assess the accuracy of driver's license information, volunteers' statures were measured, and then these figures were compared with those printed on the subjects' licenses. Even in our comparatively young, well-educated sample, the license height was significantly greater than the measured height. Some inaccuracies may be caused by failure to update license information when new licenses are issued, but some inaccuracies may be from personal deception. The implications of these results for forensic anthropology cases are discussed.     

An Economic Justification for Open Access to Essential Medicine Patents in Developing Countries

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the "deadweight losses" caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare.     

Corruption and hold-up: the role of intermediaries

Corrupt contracts are illegal and, therefore, vulnerable to hold-up. That is, a bureaucrat who has accepted a bribe from a firm in exchange for a license may still choose not to grant the firm that license (hold-up). This paper develops a model to study the role that intermediaries play in preventing hold-up. There are two types of firms, good firms that are legally entitled to receive a license, and harmful firms that are not. Without intermediaries only good firms enter the market, and harmful firms do not enter because of hold-up. Intermediaries are legally permitted to help firms reduce their navigation costs of obtaining licenses. Thus, intermediaries increase entry of good firms. However, by utilizing the legal aspects of their transaction with good firms as leverage against the bureaucrat, intermediaries can prevent hold-up among harmful firms. Thus, intermediaries increase participation by both good and harmful firms and their welfare costs are ambiguous. Data obtained from occurrences of violations of the Foreign Corrupt Practices Act are broadly consistent with our model.     

临时性许可上升的法律问题——透视地方人大及其常委会的立法和监督职权

地方人大及其常委会在做好涉及临时性许可的政府规章上升为地方性法规工作时,首先要正确理解行政许可法的立法原意,“一年”的期限是地方政府就临时性许可提请地方人大及其常委会启动立法程序的期限;同时还要主动把握立法权限和时机,对临时性许可的合法性和合理性进行“再审查”,切实履行人大的立法和监督职责。     

吊销营业执照的法律问题探析

吊销营业执照是工商行政管理部门常用的一种处罚手段,但这种具体行政行为却引出一系列问题,如被吊销营业执照后,企业是否仍具法人资格?被吊销营业执照后如何进行清算?债权人的利益如何保护?这些问题若得不到明确,大量因吊销营业执照而停止经营的企业无法进入清算程序了结债权债务,从而实现其作为法人的正常消亡过程,这将不利于现代企业制度的完善和市场经济秩序的稳定。对企业被吊销营业执照后的法人资格及其清算问题进行了探讨,以期能对我国公司法制的完善有所裨益。     

撤销许可的法律性质及效力研究——以撤销司法鉴定许可为例

基于撤销的理由、目的和法律效果,撤销许可分为两类:一类是已经生效但在成立时即存在瑕疵的行政许可事后被撤销;另一类是合法的行政许可因被许可人在获得许可后从事违法行为而被撤销。撤销许可很有可能构成一种行政处罚,但并非所有的撤销许可都是行政处罚。司法行政机关以申请人提供虚假信息或隐瞒真实信息而骗取许可登记为由撤销许可,在本质上属于行政处罚。该撤销许可不具有溯及力,也不影响司法鉴定机构在撤销许可前出具的、被司法机关采信的司法鉴定文书的效力。     

论我国知识产权融资许可制度之构建——以美国UCITA法的融资许可为借鉴

知识产权许可交易在经济发展中的重要地位决定了其融资机制必然成为知识经济发展的调节器,故应将其纳入法律规制。美国融资许可的法律规制具有通过设立知识产权融资许可制度来规制知识产权许可融资;采用私法手段;发挥知识财产被许可使用的积极作用等特点。我国应在借鉴美国规制经验的基础上,根据知识产权许可与融资的实践及国情,有的放矢地建立完善的规制机制。然而,我国现行融资制度并不利于知识产权许可交易。因此,应对我国知识产权融资许可法律规制作全新的制度建构,其主要内容包括:明确融资流程,并设立担保制度、被许可人融资合同义务条款限制解除制度、知识产权瑕疵责任制度、资金供给者违约救济制度等。     

International conflicts over patenting human DNA sequences in the United States and the European Union: an argument for compulsory licensing and a fair-use exemption

The thought of a large biotech company holding an exclusive right to research and manipulate human genetic material provokes many reactions--from moral revulsion to enthusiasm about the possibilities for therapeutic advancement. While most agree that such a right must exist, debate continues over the appropriate extent of its entitlements and preclusive effects. In this Article, Professor Donna Gitter addresses this multidimensional problem of patents on human deoxyribonucleic acid (DNA) sequences in the United States and the European Union. Professor Gitter chronicles not only the development of the law in this area, but also the array of policy and moral arguments that proponents and detractors of such patents raise. She emphasizes the specific issue of patents on DNA sequences whose function has not fully been identified, and the chilling effect these patents may have on beneficial research. From this discussion emerges a troubling realization: While the legal framework governing "life patents" may be similar in the United States and the European Union, the public perceptions and attitudes toward them are not. Professor Gitter thus proposes a dual reform: a compulsory licensing regime requiring holders of DNA sequence patents to license them to commercial researchers, in return for a royalty keyed to the financial success of the product that the licensee develops; and an experimental-use exemption from this regime for government and nonprofit researchers.     

应急状态下行政许可的实施

《行政许可法》和《突发事件应对法》未涉及行政许可的效力基于应急状态的变动问题。行政许可的实施在应急状态下面临合法性困境,其纾解应从形式与实质两个层面着手。应急状态下,行政机关原则上具有概括的许可实施职权,在缺乏可预见性的规范时,可在满足基本的形式合法性前提下,通过情事变更原则满足实质合法性。此时,行政许可的条件、审查标准与程序等应与常态有所差异。许可中止制度在应急状态下具有适用空间,其核心在于有效期的中止,适用于被许可人无过错的情况,有必要在《行政许可法》中加以规定。应急状态作为不可抗力,可能但不一定完全导致行政许可废止的结果。此时,行政许可的废止仍需以许可目标完全不可实现或者许可的继续实施极可能导致个人或公共利益的严重损害为前提。现行行政许可有效期延续制度在审查强度和程序等方面规则不明。应急状态下,应当放宽许可延续的申请期,对延续申请可以采用形式和书面审查,并建立依职权延续和临时延续制度。为更好应对应急状态,应当根据应急状态各处置阶段的需要,创设新的许可类型。     

The product-liability-insurance issue in university licensing agreements

As universities become more involved with industry through research and license agreements, and with the change of character of product liability, particularly its becoming a potentially catastrophic event, universities are taking a hard look at product-liability insurance. A brief survey shows universities in three distinct groups in their handling of the issue in their licensing agreements. State schools feel protected and do not generally consider it essential, foundations are more cautious, and private universities are very concerned and require it except in specific cases. Some approaches to the problem are proposed. Previously he was head of the Chemistry Department at Simon Boliver University and director of a university-based industrial research institute. Bertha has also been a research chemist at Dupont Corp. He has a Ph.D. in inorganic chemistry form Florida State University.     

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。     

我国行政审批与行政许可关系的重新梳理与规范

在我国,行政审批、行政许可的涵义及其两者之间的关系极为复杂且极具争议,《行政许可法》最终采纳了同一概念说,从立法上将两者统一起来。但在实际执行中,行政审批与行政许可又出现了分离,大量的行政审批被以非许可类审批的名义从行政许可中分离出去,导致《行政许可法》的调整范围不断被限缩,重新梳理行政审批与行政许可的关系以明确《行政许可法》的调整范围已经成为《行政许可法》实施中迫切需要解决的问题。本文分析了两者之间出现分离的原因,讨论了行政许可行为的识别标准,并对立法上如何规范和约束行政审批行为提出了构想。