Exclusion payments in patent settlements: a legal and economic perspective

Legal context. The application of antitrust law to assess settlementsof patent litigation raises difficult issues concerning theappropriate balance of patent law and competition policy. Recentprivate and public invocations of US antitrust law to challengesettlement agreements covering pharmaceutical patents have broughtthese issues to the forefront. The agreements share the commonfeature of an ‘exclusion payment’ from a brand-namedrug manufacturer (the patentee) to a generic drug manufacturer(the accused infringer) in exchange for a promise by the genericcompany to refrain from marketing its product for some time.US federal courts that have examined these agreements have variedin their approach and conclusions regarding the appropriateantitrust analysis to be applied to these settlements. Key points. This article argues that informed antitrust analysisof such agreements must take due note of the ‘probabilistic’nature of patent property rights. Practical significance. The article concludes that exclusionpayments fall outside the scope of a patent's exclusionary scopeand thus are subject to antitrust scrutiny. It demonstratesthat barring anticompetitive exclusion payments in settlementnegotiation prevents collusive bargains that harm consumer welfarewithout discouraging efficient settlements.     

Patent construction after Amgen: are patent claims construed more widely or narrowly than previously?

Legal context. This article considers the UK Courts' approachto patent construction since the House of Lords' decision inKirin-Amgen Inc v Hoechst Marion Roussel Limited, which washanded down in October 2004, and seeks to examine whether theUK Courts' construction of patents is wider or narrower thanpreviously. Key points. The available data appear to suggest that thereis little difference in outcome, whether the old Improver testis applied or the new Kirin-Amgen test; of more significanceremains the nature of the wording of the patent claims themselvesand the correct identification by the trial judge of the inventionunderlying the patent. Practical significance. By eschewing a literal approach andrefining the test used in order to ensure both compliance withthe EPC and consistency with courts in other European countries,the UK Courts continue to provide an attractive forum for resolutionof patent disputes.     

Design protection for technical products

Legal context. The shape and the function of a product are oftenclosely related (‘form follows function’) whichopens the way for double protection of novel features by a patentand a design. The simultaneous application for both rights canbe done in a fast and cost efficient way by using the figuresof the patent application for the design registration. Key points. With this in mind, the design registration may notcover the novel features in its broadest terms, since designlaw does not apply to ideas, concepts, or methods. However,the design provides protection for a concrete embodiment andthereby offers some relief for a patent applicant in need ofimmediate action against copying. Although, certain conditionshave to be observed where simultaneous protection is sought,there is no doubt that a patent covering an invention in itsgeneral form and a registered design protecting a specific embodimentof the invention may coexist with no mutual negative effectto their respective validity. Practical significance. Having an enforceable protection rightfor an embodiment of an invention at hand a long time beforethe corresponding patent is granted is a valuable asset in anIP portfolio. The additional costs incurred by a design registrationare insignificant in comparison with the costs for the patent.     

Does strong patent protection facilitate international technology transfer? Some evidence from licensing contracts of Japanese firms

This paper examines how patent protection in a technology recipient country affects international technology transfer. A theory suggests that the effect of stronger patent protection on technology transfer is negative if the binding constraint is the imitation profitability and positive if it is the incentive for the licensor to undertake technology transfer. We evaluate these implications by examining the variations of the structure of licensing contracts across countries, based on a newly collected database of licensing contracts by Japanese firms. Our major findings are the following. First, the incidence of know-how licensing, either in the pure or in the bundled form, relative to that of pure patent licensing, declines significantly with the level of foreign patent protection. This indicates a limited role of patents for facilitating know-how licensing. Secondly, the probability and the strength of ownership control by a licensor declines with the level of patent protection, indicating a positive effect of stronger patent protection in expanding the scope of the recipients of technology transfer.

撤销许可证就一定是行政处罚吗?——对一类行政许可行为性质的反思

在行政许可领域中 ,对于一些许可事项 ,法律明确赋予被许可人一定的作为义务 ,这些义务是被许可人取得特定权利、获得特定资格的基础 ,此类许可在性质上属于附法定义务的许可。如果被许可人不依法履行此类法定义务 ,有关行政机关可依法取消赋予其的特定权利或资格 ,终止许可关系 ,这种废止许可的行为不属于行政处罚法所称的“吊销许可证、执照”的调整范围     

Licensing versus selling in transactions for exploiting patented technological knowledge assets in the markets for technology

This paper examines the determinants of the types of technology transactions in the markets for technology. On the basis of the relationship between the characteristics of a firm’s patents and the firm’s decision on whether to license out or sell these patented technologies, we empirically analyze the determinants of the decision. We employ interlocked patent data from the representative Korean market for technology, the National Technology Bank, using a bivariate probit regression model in a theoretical framework that includes the option and transaction cost perspectives. Overall, the results show that the relationship between licensing and selling, the major alternatives in technology transactions, is strongly substitutive. The major finding of this study is that firms in markets for technology tend to prefer licensing their patents when uncertainty is low or transaction cost is high, whereas they tend to prefer selling their patents under opposite conditions.     

The software patent debate

Legal context. This article has practical application for thoseworking in the patent field, particularly with regards to thefiling of software patent applications. Key points. The article provides a detailed explanation of thestate of the art with regards to the legal protection of software,and describes the latest legal developments in the area, includingthe failed Directive on Computer Implemented Inventions andsome recent cases that may shed more light on some of the technicalissues involved in the area of software. The paper also exploressome of the arguments put forward by those in favour and opposedto software patents, in order to ascertain their validity. Practical significance. Existing case law may provide help tosolve the problem of patentability, but it might also be a goodidea to resurrect the idea that there should be a sui-generissoftware right.     

Claim construction and the extent of patent protection: A comparative analysis of the Phillips en banc Federal Circuit decision

Legal context. The United Kingdom's House of Loads in Kirin-Amgenand the United States Court of Appeals for the Federal Circuitin Phillips addressed similar issues with respect to the methodologyof claim interpretation and the fundamental rules and policiesfor determining the extent of patent protection. This articlewill review Phillips and Kirin-Amgen from the comparative lawperspective. It will compare the UK and US rules and patentpolicies with their German and Japanese counterparts, discussingthe bases for these differences and examining them from theperspective of patent policies, specifically with respect tofair protection and legal certainty. Key points. Despite the use of the same rule and methodology,legal commentators and patent professionals emphasize the differencesin the extent of patent protection in different jurisdictions.Such differences result from the availability of the doctrineof equivalents. For jurisdictions such as the UK, the US andJapan, where courts seldom apply the doctrine of equivalents,the differences result from the way in which the courts conductclaim construction. These courts use the perspective of a hypotheticalperson to support a broad or narrow claim construction, reflectingthe weight given to the competing patent policies. Practical significance. This article cites key cases for claimconstruction and the doctrine of equivalents in four major patentjurisdictions: the UK, the US, Germany and Japan. Knowledgeof the case law trends in these jurisdictions is essential fordrafting patents documents and enforcing patents.     

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.     

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.      

Profit Neutrality in Licensing: The Boundary Between Antitrust Law and Patent Law

We address the patent/antitrust conflict in licensing and developthree guiding principles for deciding acceptable terms of license.Profit neutrality holds that patent rewards should not dependon the rightholder’s ability to work the patent himself.Derived reward holds that the patentholder’s profits shouldbe earned, if at all, from the social value created by the invention.Minimalism holds that licenses should not be more restrictivethan necessary to achieve neutrality. We argue that these principlesare economically sound and rationalize some key decisions ofthe twentieth century such as General Electric and Line Material.     

University reputation and technology commercialization: evidence from nanoscale science

We study how the scientific reputations and technology transfer policies of universities affect patenting by university researchers, with particular regard to whether they assign patent ownership to their university or to an outside firm. Using data on the career output of over 33,000 researchers in nanosciences, we find a strongly positive relationship of university reputation in nanosciences with the number of university-assigned patents, but almost a negligible association with firm-assignment of patents. University technology transfer office resources are related positively to both types of patents, but with diminishing returns. In contrast, the share of license revenue offered upfront to researchers is positively associated with university-assigned patents, but negatively related to firm-assigned patents. Taken together, our results suggest that universities that streamline their technology transfer efforts and improve their research reputation through support for basic research will see long-term success in technology commercialization.     

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to monitor the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark schedule.     

The Patents Court's streamlined litigation procedure--two years on

Legal and practical context. The streamlined procedure is asimplified patent litigation procedure that was introduced overtwo years ago in the English Patents Court and Patents CountyCourt. This article looks at the procedure, the way it has beenapplied since its introduction and the effect it has had onpatent litigation in the UK. Key points. The procedure was designed to deal with simple patentcases quickly and relatively cheaply. It is geared towards aone day trial taking place approximately eight months afterthe commencement of proceedings. Under the procedure there isno automatic disclosure, no experiments and cross-examinationis limited to permitted topics only. Although it was designedwith patents in mind, the procedure is available for all appropriateactions heard in the Patents Court and Patents County Court.It is only suitable, however, for relatively simple actionsin which complex findings of fact are not necessary. Conclusions. Not many actions have come to trial under thisprocedure, but its availability is nonetheless of great significanceto patent litigation in the UK. This is because it providesa new point of departure for directions in certain types ofaction and because its availability has increased access topatent litigation in the UK and has renewed interest in thePatents Court and Patents County Court as forums in which toissue patent proceedings.     

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...     

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.     

Jesting at scars that never felt a wound: The US Supreme Court's new doctrine of licensee standing without breach

Until recently, it was assumed that patent licensees in compliancewith terms of their licence agreements would lack ‘standing’to sue their licensors, but in MedImmune v Genentech, the SupremeCourt of the United States held that federal courts in the UShave jurisdiction over declaratory judgment actions by patentlicensees asserting the invalidity, unenforceability, or non-infringementof a licensed patent, even where the licensee is in full compliancewith the licence agreement.     

Patents impediment or expedient to technology transfer

This paper examines the role that patents play in transferring technology. The history of our patent system and the requirements for patentability are reviewed. The option of keeping an invention as a trade secret rather than applying for a patent is presented. The paper also discusses the rationale behind the government’s change in its policy which permits exclusive licensing of public-owned patents. The author concludes that patents are not a barrier but a significant help in promoting technology transfer.     

论疫情防控常态化下的专利申请新颖性丧失例外——评2020年《专利法》第24条第一项立法

2020年《专利法》在专利申请新颖性丧失例外中增加了“国家紧急状态或非常情况下为公共利益目的首次使用”的条款。这一修订体现了专利法在平衡不同位阶公共利益、鼓励发明人积极创新以及对新技术贡献者的正向回馈中的价值取向。虽然该条款与强制许可的规定在条文结构中存在类似之处,但二者在适用范围上却呈现出较大不同,揭示了专利授权制度和强制许可制度的本质差异。对于该条款在实务中的解释,应当做好“紧急状态”在《专利法》与宪法及相关法律中的衔接、为“非常情况”设定宽严相济的判断标准,并正确认识二者的关系。最后,对“公共利益”的理解做到与具体情境相结合,从而最终实现对该新设条款的准确适用。