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What is it about patent legislation? Speaking for the Supreme Court in 1981, Justice Dickson, later Chief Justice, said of the disclosure provision in the Patent Act (now subsection 27(3)) that: "[i]t gives the impression of a melange of ideas gathered at random rather than an attempt to enunciate, clearly and concisely, a governing principle or principles. This is perhaps understandable in that the section is the product of amendment over a period of many years. The language simply does not lend itself to a tight, literal interpretation. It is, and should be treated as, a parliamentary pronouncement, in general terms." Nearly 40 years later nothing much seems to have changed. Take the new section 53.1 of the Patent Act that took effect in 2019. It was not the product of amendment over many years, nor did it present a random melange of ideas. It had only one idea. That was to reverse a 2000 decision of the Supreme Court in Free World Trust v Electro Sante Inc and allow what transpires in the Patent Office (“PO”) during the processing of a patent application — its “prosecution history” — potentially to affect the scope of the patent eventually granted. Subsection 53.1(1) could have simply said that: i.e., a patent’s prosecution history is relevant and admissible to aid in the construction of a patent claim or specification. Instead its drafting suffers from the malady highlighted by Justice Dickson. Its governing principles are not clearly and concisely stated. They seem rather to be “secreted in the interstices of procedure.” To give the section “a tight, literal interpretation,” as some courts have already done, therefore seems inappropriate. That approach runs counter to the Interpretation Act’s direction that all statutory provisions are “deemed remedial” and so require “such fair, large and liberal construction and interpretation as best ensures the attainment of [their] objects.” Patent legislation is not immune from these strictures. An ineptly drafted provision may indeed sometimes need to be treated the way Justice Dickson treated subsection 27(3), as “a parliamentary pronouncement, in general terms.”

The current Japanese Patent Act has set forth special provisions on the calculation of damages since the time of its enactment (1959). Nevertheless, it had been constantly criticized that appropriate remedies were not being extended to right holders by the compensation for damage even under those provisions due to reasons such as the court applying the provisions too rigidly. In response, the provisions related to compensation for damage were amended in 1998. Specifically, Article 102, paragraph (1) of the Patent Act was introduced, and the wording of paragraph (3) of that Article was revised. However, even after the amendment, active discussions took place among practitioners and researchers over the interpretation of the provisions, and legislative studies were continued. Then, in the past few years, three Grand Panel judgments (en banc decisions) of the Intellectual Property High Court (IP High Court) indicated a general view on some issues for which opinions had been varied among court judgments, achieving a unified interpretation of the provisions at least on the second instance level. In addition, in 2019, Article 102 of the Patent Act was amended again. With such progress, the developments concerning the system of compensation for damage caused by patent infringement are regarded to have reached a milestone. This article introduces the outlines of those IP High Court Grand Panel judgments and the 2019 law amendment. In addition, it conducts analysis with a focus on the latest Grand Panel judgment rendered in the Beauty Instrument case.

The growth of industry, especially pharmaceutical industry, calls for intensive and innovative research. The chapter attempts to capture these in the growth of Indian Pharma over the years beginning from Acharya’s foray in 1901 and traces the entry of Indian and multinational companies into manufacturing activities, the latter hedged by protective measures like MRTP ACT and Patent ACT of 1970. Sales turnovers were modest but a small number of Indian companies and even a very few multinationals started new drug discovery research (NDDR). The Government on the other hand, as a measure of self-sufficiency, built national institutions like Central Drug Research Institute with multidisciplinary facilities for NDDR and process development of drugs. In the meantime, Indian Pharma grew strongly under the umbrella of the Indian Patent Act 1970 and established itself as suppliers of affordable generics of quality medicines. The Hatch-Waxman Act 1984 of the USA leading to the promise of obtaining approval for abbreviated new drug applications (ANDA) opened the gates for the lucrative US generics market which India was well set to exploit with its established skills in manufacture of APIs and formulations. Many Indian companies now had the means to venture into NDDR which became a necessity following the implementation of product patent regime since 2005.

With the development of information and communications technology, intellectual property education is expected to become increasingly important. However, it has been shown that intellectual property education is insufficiently conducted in university education faculties of engineering. Therefore, we previously focused on engineering students learning logic circuits to create an e-learning system that displays articles as logic circuits. Evaluation experiments demonstrated the learning effect of this system, but it could not handle all intellectual property laws because it required manually converting law texts into logic circuits in the problem creation process. To address this problem, in this paper we examine a method for converting intellectual property laws into logical formulas. Previous studies have converted law texts into logical formulas to perform consistent tests of law texts, whereas this study aims at more human-comprehensible visualizations. We divide law texts into constituents based on a legal condition–effect structure and convert them into propositional calculus. This paper presents the results of an attempt to convert 101 law texts of typical patent acts in intellectual property law into logical formulas. From the results of integrating the logical formulas into our law text learning system, we describe future policies.

During the COVID-19 outbreak, the United States experienced widespread shortages of patented drugs and goods. But although states negotiated with foreign governments to obtain needed medical equipment, they were seemingly powerless to obtain or produce their own supply of scarce drugs. This Essay proposes an unorthodox solution to drug shortages during public health emergencies: states could disregard the Patent Act and directly produce or import needed patented drugs. The doctrine of state sovereign immunity shields states from having to pay damages when they violate federal law, including patent law. Moreover, courts and agencies are generally unwilling to award injunctions or other prospective relief if it disserves the public interest. State action is admittedly not a perfect solution to patent-related drug shortages and comes with a variety of costs and risks, including retaliation from the U.S. Food & Drug Administration. But at minimum, it could serve as a means for pressuring the federal government and pharmaceutical companies to work to provide drugs to the public.

While intellectual property (IP) may be more important than ever to contemporary businesses, its doctrines are becoming more sophisticated and its remedies are often difficult to obtain, especially for smaller companies and individuals. This Essay investigates the strategies utilized by IP owners to overcome challenging precedents issued in the wake of eBay v. MercExchange and Apple Inc. v. Samsung Electronics, Co., Ltd. It illustrates the complexities of these strategies via an analysis of recent developments in the law governing injunctions, royalties, lost profits, and related matters. Injunctive relief is rare even in the copyright and patent areas. In eBay Inc. v. MercExchange, L.L.C., the United States Supreme Court held that the traditional four-factor test for permanent injunctive relief applies to disputes arising under the Patent Act. The economic and policy-based considerations that drive remedial decisions tend to favor the larger, repeat players in each industry. This trend surfaces in at least three areas of remedial doctrine. First, “implementer” or “practicing” patent owners along with many copyright and trademark owners may enjoy a presumption in favor of injunctive relief absent extraordinary circumstances, or at least do not suffer from the virtual per se rule that non-practicing entities have no right to exclude. By virtue of conceptual shortcuts that help drive equitable relief decisions, they might find it easier to establish irreparable injury and no adequate remedy at law, even when they may be entitled to a windfall in statutory or treble damages. Second, the balance of hardships and public interest factors do not appear to aid small or medium-sized enterprises striving to level the playing field with well-funded, litigious infringers, as one might expect from “equity.” Lastly, firms with lucrative existing intellectual-property licensing or exploitation arrangements are better situated to show the incremental contribution of the infringed right to the respective revenue or anticipated profits of the parties.

Notwithstanding the clarity of the U.S. Constitution’s grant of authority to Congress “[t]o promote the Progress of . . . useful Arts, by securing for limited Times to . . . Inventors the exclusive Right to their . . . Discoveries,” U.S. Const. Art. I, § 8, cl. 8, and Congress’s directive that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title,” 35 U.S.C. § 101 (emphasis added), current § 101 jurisprudence conflates patent eligibility with the substantive requirements set forth in § 103 and § 112 and is getting more confusing by the day. There is no patent law doctrine more in need of clarification. The Federal Circuit’s 6-6 split resulting in the denial of rehearing en banc in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC et al., 966 F.3d 1347 (Fed. Cir. 2020), is just the latest example in a long series of cries for help in interpreting § 101. See, e.g., Berkheimer v. HP Inc., 890 F.3d 1374, 1374 (Fed. Cir. 2018) (Lourie, J., with Newman, J. concurring in denial of rehearing en banc) (expressing that patent eligibility law “needs clarification by higher authority, perhaps by Congress, to work its way out of what so many in the innovation field consider are § 101 problems”). We add our voice to the chorus calling for the Supreme Court and/or Congress to clarify and/or reform patent eligibility jurisprudence. In setting forth a new test of patent eligibility, the panel decision mischaracterized fundamental patent principles and case law on which the modern patent system is built. The claims of the patent in suit present a conventional problem of compliance with the statutory patentability requirements of § 112, which sets forth the requirements of disclosure and claim definiteness. The panel opinion instead forces this case into the § 101 mold, which dispenses with the customary factual predicates for § 112. In so doing, the panel radically altered and expanded the already confused contours of § 101 jurisprudence. Moreover, the panel’s holdings were based on a serious misinterpretation of patent law’s foundational cases, and run counter to this Court’s long insistence that the statutory requirements of § 112 and its predecessor statutes provide the standards to assess whether claims are functional or overbroad. With this latest expansion, the atextual doctrine of patent eligibility threatens to supplant the traditional tests of patentability established by the 1952 Act. The Federal Circuit’s deep split in American Axle presents an excellent vehicle for clarifying the interplay of § 101 and § 112 of the Patent Act.

Artificial intelligence (AI ) has been evolving exponentially, while simultaneously generating excitement about how it has increased prosperity and transformed our lives in multiple ways. The impact of the Industrial and Digital Revolutions has, undoubtedly, been substantial on practically all aspects of society. AI is related to innovation, which in turn is governed by patent laws. This leads to questions regarding the ramifications on patent inventorship in the AI arena. The key question is whether AI (an “artificial” entity) can be considered an “inventor” of a patent application. The United States Patent and Trademark Office (USPTO has provided its answer by clearly rejecting AI as an “inventor,” positing that AI cannot meet certain statutory definitions for an inventor or the jurisprudential tests for determining inventorship. The Patent Act does not expressly limit inventorship rights to humans, but it does suggest that each inventor must have a name and be an “individual.” This paper focuses on AI and patent laws — mainly, on whether AI should be considered an “inventor” under the patent statutes. Unlike other scholars, I argue here for recognizing AI as the inventor. I further argue that allowing AI to be listed as an inventor would incentivize innovation, as AI’s added value would be more clearly recognized. Furthermore, statutory recognition of AI as an inventor would encourage investment in developing inventive AI systems.

National security concerns often arise between the U.S. and the People’s Republic of China (PRC), and routinely involve cutting-edge technology. These include the race to fifth-generation (5G) wireless mobile technology, cybersecurity, and IP theft; but traditionally they have not extended to patent policy writ large. As national security depends largely on innovative technologies, and patent policy fosters or hinders such innovation, the U.S. should modify its patent policies to recognize state-sponsored entities that can use U.S. patents to drain resources from domestic investment into new technologies. For instance, the United States Patent and Trademark Office (USPTO) currently has no mandatory recordation requirement to identify the attributable owners of patent applications. The USPTO receives and publishes only patent ownership information that the applicant or patent owner voluntarily submits, among myriad other concerns. Given that neither the Patent Act nor USPTO regulations require any recordation of assignee information, USPTO records provide poor notice regarding current ownership of patents. Thus, the U.S. government itself does not know how many U.S. patents international companies own, license, control, or could assert in U.S. federal court. While international agreements rightfully prohibit the USPTO from discriminating against foreign applicants, the U.S. cannot be blind to the fact that patents are already serving as a strategic tool for international competitors to harass or to leverage against American companies in court, draining their financial resources by extracting royalty fees and settlements that then flow into overseas coffers. And because the U.S. government has no effective means to record, or even internally track, the number or identity of patents international companies own, license, or could assert in even sensitive technologies, the extent and potentially negative ramifications of this problem are not well understood. We analyze the serious gaps in U.S. patent recordation law and propose basic recordation solutions that U.S. government, and the USPTO in particular, could implement to address, mitigate, or, at a minimum, better understand the magnitude of this issue.

In 1993, the Canadian federal government ratified the North American Free Trade Agreement (NAFTA). Prior to ratification, compulsory licensing was eliminated from Canada’s Patent Act and intellectual property rights (IPRs) were strengthened. Compulsory licensing allows competitors to produce drugs under patent without the consent of the patent holder, challenging drug monopolies and lowering prices, whereas IPRs lengthen patent protections, shielding patent holders from competition and increasing prices. We perform a critical discourse analysis of key provisions in Chapter 17 of NAFTA in light of industry claims that pharmaceutical innovation requires important investments in research and development, justifying high drug prices. We note that since NAFTA, spending in research and development in Canada has decreased and drug prices have increased, becoming a major barrier to equitable access to critically necessary medications. We argue that by modifying the law, the federal government has wronged the Canadian people by discursively appropriating the language of protecting the public good while in practice legitimizing and consolidating private drug development and production, legalizing exorbitant profits, and excluding well-tested publicly financed alternatives. While NAFTA has now been superseded by the Canada–United States–Mexico Agreement, our analysis offers important lessons moving forward.

A fundamental criterion of patentability is that an invention must be new as compared to the prior art—the corpus of preexisting knowledge and technology already available to the public. If an invention is in the prior art, or rendered obvious by it, it cannot be patented. The U.S. Patent Act has traditionally envisioned a categorical approach for deciding what counts as prior art. Under this approach, courts are supposed to decide whether a particular disclosure about the invention (a reference) falls within one of the categories listed in Section 102 of the Patent Act, such as “described in a printed publication,” “in public use,” or “on sale.” Yet the categorical approach lacks a coherent theory of publicness. It is difficult to find guiding principles to explain courts’ decisions about what is, or is not, public. For example, a woman wearing a corset invention at home under her clothing was deemed to be an invalidating “public use” that barred future patenting; yet an employee liberally sharing his invention with others at work was not. We argue that, while courts refer to the statutory categories, they are in reality turning to concepts of publicness that strikingly resemble those of a different legal regime: trade secret law. Indeed, our review of the cases shows that trade secrecy status is dispositive for what counts as prior art in many of the leading cases. At a normative level, we argue that trade secrecy provides a surprisingly effective way to manage the boundary between legally public and legally secret information, and for deciding whether a reference is truly “available to the public” in the ways that matter for patent policy and, indeed, information policy more broadly. Not only does the trade secrecy standard protect peoples’ justifiable reliance on information that is already available to them, but it simultaneously makes inventors’ paths to patenting more efficient.

These comments were presented at the Federalist Society's 2020 National Lawyers Convention at the panel titled "Intellectual Property Rights and the Rule of Law". They address a trending narrative that casts opposition to the demands of patent holders as a form of lawlessness. This narrative specifically takes aim at a practice that has been termed “efficient infringement” – the idea that a firm may rationally decide to infringe patents either because it will be too costly for the patent holder to enforce its rights in court, or because it is happy to take its chances in court, where an asserted patent may be invalidated and where damages eventually assessed against the infringer years later will likely be no higher than the royalties that the infringer would have paid anyway under a licensing agreement. Reasonable people can differ over optimal patent scope and policy. Likewise, the PTO and the PTAB can issue and uphold more or fewer patents, and the courts can interpret the Patent Act in ways that we like or dislike. Reasonable people can also seek change through litigation, legislation and administrative channels. All of these mechanisms are organic parts of our tripartite system of government. We will never have a situation in which all partisan interests are equally happy with the rules or the outcome of every case – this is part and parcel of an adversarial legal system. But this is no reason to question the legitimacy of the system itself. So, far from a departure from the rule of law, what we see today in the patent system is the operation of a well-functioning legal regime seeking to address the interests of competing, but largely law-abiding, stakeholders.

German Abstract: Das Max-Planck-Institut fur Innovation und Wettbewerb nimmt hiermit zum Diskussionsentwurf eines Zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts Stellung, der vom Bundesministerium der Justiz und fur Verbraucherschutz im Januar 2020 vorgelegt wurde. Das Institut begrust die Initiative des Ministeriums, empfiehlt im Hinblick auf die Beschrankung des patentrechtlichen Unterlassungsanspruchs und die Starkung des Schutzes von Geschaftsgeheimnissen in Patentstreitsachen jedoch gewisse Prazisierungen. Mit Blick auf die Beschrankung des Unterlassungsanspruchs nach Masgabe des Grundsatzes der Verhaltnismasigkeit wird vorgeschlagen, die Verhaltnismasigkeitsprufung nicht auf einen Anwendungsfall der Gebote von Treu und Glauben zu reduzieren, sondern im Sinne der ratio legis des Patentrechts zu verstehen; insoweit als Masnahme zur Verhinderung dysfunktionaler Effekte des Ausschlieslichkeitsrecht bzw. des damit verbundenen Unterlassungsanspruchs. Zur Veranschaulichung des Ansatzes wird auf die Fallgruppen der komplexen Produkte, der Patentverwerter und der standardessenziellen Patente Bezug genommen, ohne sie jedoch im Detail durchzuprufen. Mit Blick auf die im Rahmen der Verhaltnismasigkeitsprufung vorzunehmende Interessenabwagung wird darauf hingewiesen, dass die Interessen des Patentinhabers gegenuber jenen des Verletzers keinen grundsatzlichen Vorrang geniesen. Daruber hinaus sind bei der Abwagung nicht nur die Interessen der Streitparteien, sondern auch jene Dritter, insbesondere das offentliche Interesse, zu berucksichtigen. Mit Blick auf den Schutz von Geschaftsgeheimnissen in Patentstreitsachen verweist die Stellungnahme auf Unzulanglichkeiten des Verfahrens in Geschaftsgeheimnisstreitsachen, die durch die angedachte Anwendung der entsprechenden Vorschriften auf das Patentstreitverfahren ubertragen werden. Hingewiesen wird auch auf eine mogliche Regelungslucke in Bezug auf das “Dusseldorfer Verfahren”, die von Patentinhabern fur sog. “fishing expeditions” ausgenutzt werden konnte. English Abstract: This position paper of the Max Planck Institute for Innovation and Competition provides comments on the amendments proposed by the German Ministry of Justice and Consumer Protection in its discussion draft of January 2020 on the modernization and simplification of the German Patent Act. While the Institute generally welcomes the initiative, the paper offers some suggestions aimed at increasing precision in the areas of first, the concept and the implementation of the proportionality test for granting injunctive relief, and, second, the need for enhanced protection of trade secrets in patent disputes. With regard to the proportionality assessment, the Institute suggests that, rather than reducing it to an application of the principle of good faith, the concept of proportionality should be interpreted and applied in light of the ratio legis of patent protection with a view to preventing dysfunctional effects potentially resulting from the exercise of the exclusive right and the associated claim to an injunction. Scenarios involving complex products, non-practicing entities and standard-essential patents are used to illustrate the approach. As regards the weighing and balancing of interests when assessing proportionality, the position paper argues that it is neither desirable nor appropriate to prioritize the interests of the patentee over those of the infringer as a matter of principle. In addition, it is not only the interests of parties to the dispute, but also those of third parties, in particular the public interest, that should be taken into account. With regard to the protection of trade secrets in patent disputes, the position paper refers to certain procedural insufficiencies of the Trade Secrets Act to adequately protect the defendant’s secrecy interests. It also points out a potential loophole in relation to the ‘Dusseldorf proceedings’ that may facilitate ‘fishing expeditions’. Note: Downloadable document is in German.

The modern law of induced patent infringement contradicts the Patent Act and violates the First Amendment. As currently applied, the law unconstitutionally restricts speech, discourages the entry of generic drugs, and helps keep medicine prices high. Under current doctrine, a generic drugmaker is liable for induced infringement if its drug label so much as hints at using a product in a way that is covered by a patent. This is true even when there is no evidence that prescribers read generic drug labels and in cases when only an in-depth inquiry into the language of the label might promote infringement. As I show, this doctrine flies in the face of a simple reading of the statute. And by restricting lawful and non-misleading speech for such an attenuated purpose, it also violates the First Amendment. Modern patent inducement law should be revised because it unconstitutionally prolongs drug monopolies and undermines a key statutory path to generic competition. Revisiting the roots of inducement doctrine also leads to the surprising conclusion that method-of-use patents—a cornerstone of pharmaceutical intellectual property—are weaker than generally supposed.

This position paper of the Max Planck Institute for Innovation and Competition provides comments on the amendments proposed by the German Ministry of Justice and Consumer Protection in its discussion draft of January 2020 on the modernization and simplification of the German Patent Act. While the Institute generally welcomes the initiative, the paper offers some suggestions aimed at increasing precision in the areas of first, the concept and the implementation of the proportionality test for granting injunctive relief, and, second, the need for enhanced protection of trade secrets in patent disputes. With regard to the proportionality assessment, the Institute suggests that, rather than reducing it to an application of the principle of good faith, the concept of proportionality should be interpreted and applied in light of the ratio legis of patent protection with a view to preventing dysfunctional effects potentially resulting from the exercise of the exclusive right and the associated claim to an injunction. Scenarios involving complex products, non-practicing entities and standard-essential patents are used to illustrate the approach. As regards the weighing and balancing of interests when assessing proportionality, the position paper argues that it is neither desirable nor appropriate to prioritize the interests of the patentee over those of the infringer as a matter of principle. In addition, it is not only the interests of parties to the dispute, but also those of third parties, in particular the public interest, that should be taken into account. With regard to the protection of trade secrets in patent disputes, the position paper refers to certain procedural insufficiencies of the Trade Secrets Act to adequately protect the defendant’s secrecy interests. It also points out a potential loophole in relation to the ‘Dusseldorf proceedings’ that may facilitate ‘fishing expeditions’.

A deep split in American innovation policy has arisen between new economy and old economy innovation. In a recent policy statement, the Antitrust Division of the Justice Department takes a position that tilts more toward the old economy. Its December, 2019, policy statement on remedies for Standard Essential Patents issued jointly with the U.S. Patent and Trademark Office and the National Institute of Standards and Technology reflects this movement. The policy statement as a whole contains two noteworthy problems: one is a glaring omission, and the other is a mischaracterization of the scope of antitrust liability. Both positions are strongly relevant to the pending Qualcomm litigation in the Ninth Circuit. First, the Statement say nothing about the conduct of patent holders. The Patent Act authorizes patent injunctions “in accordance with the principles of equity.” Under the equitable principle of “unclean hands,” a patentee who is in serious default of its own legal obligations cannot obtain an injunction, at least not until its own bad conduct has been terminated. Second, the Statement’s declaration that FRAND disputes do not raise antitrust issues is false. In the first instance FRAND disputes are about contracts. But if a firm’s anticompetitive use of FRAND-encumbered patents meets the power and conduct requirements of the antitrust laws it can be unlawful under them as well. Guidelines from the government are very useful when they state the law or an agency’s own enforcement position, or when they clarify ambiguities. But they are not legislation. They do not bind courts, other government agencies, or private plaintiffs, particularly not when they conflict with clearly established law.

The importance of diagnostic tests cannot be understated; they save lives and contribute to the overall health of the economy. However, the current state of subject-matter eligibility does not incentivize the research and development of these life-saving tools. In May 2019, the Senate Judiciary Committee IP Subcommittee released draft legislation to fix subject-matter eligibility, but could not find consensus among the stakeholders. Congress needs to find a middle-ground to fix subject-matter eligibility. This article proposes a diagnostic patent act to allow protection of IVD tests. The proposed diagnostic patent act includes safeguards to allow adequate access to fundamental research while incentivizing return of investment to the patent holder. Safeguards include exceptions to patent infringement claims and compulsory licensing requirements under certain conditions. Exceptions, which limit infringement liability to third parties in specific situations, would be used for narrow experimental use and mandatory processes required to comply with federal regulations. Compulsory licensing, which requires patent holders to allow third parties to use a patent in certain circumstances in exchange for a determined fee, would be permitted when a patent holder acts in an anti-competitive way to restrict access and for governmental or public health uses. The combination of these limitations on a patent holder’s exclusive monopoly will ensure that access to research is available while patent holders are adequately incentivized to develop IVDs.

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, and human dignity. In this article, I offer a close textual analysis of the Myriad decision and respond to both its critics and supporters. I then situate Myriad within the larger context of biotechnology patenting, the commercialization of academic research, and the U.S. healthcare system. In this regard, the failure of public institutions and governmental agencies to constrain the private exploitation of publicly-funded innovations contributed as much to the healthcare access disparities highlighted by the case as the overly broad protection afforded by the Patent and Trademark Office to genetic inventions. I conclude with observations about the ways that cases like Myriad exemplify the manner in which the common law evolves, particularly in areas of rapid technological change.

This research analyses the compatibility of Indonesian Patent Act with the Trade related Aspect of Intellectual Property Rights (TRIPs) Agreement and the Convention on Biological Diversity (CBD) dealing with Genetic Resources Related to Traditional Knowledge (GRTK). The focus this analyses on whether the new Indonesian Patent Act provides a clear policy on the protection of GRTKF and the development of the biotechnology in Indonesia, particularly on the patentability of genetic resources related inventions, including genes patent. This research found that the new Indonesian Patent Act on GRTK is not only to synergise between the TRIPs Agreement obligation and the CBD compliance, but also adopted patent policies derived from other developed countries particularly in examining the patentability thresholds and exceptions from patentability. Even, in the context of patentability of living organisms, Indonesia adopts a very liberal approach compared to most industrialised countries. This research advises that Indonesian patent policy on GRTK should take into account the richness of this country on biodiversity and the level of biotechnology industry development.

This paper attempts to analyse the competitiveness of Indian drug and pharmaceutical industry in the domestic market where multinational pharma companies are entering and expanding in a big way, especially after enforcement of product patent regime in 2005. The study applied data envelopment analysis model to estimate relative efficiency and productivity changes in 141 Indian pharmaceutical firms during 2000–2001 to 2012–2013 which encompass pre- and post-product patent regimes. The present study found negative impact of Product Patent Act on the efficiency scores. The technological change factor is found to have played positive role in the growth of productivity, whereas technical efficiency change depicts the judicious utilization of input resources for improving performance. A sensitivity analysis with the inclusion of R&D expenditure in input variables, confirmed the validity of our selected variables. It found marginal bearing of new patent regime on the efficiency of R&D active firms, though it was found to have significantly impacted efficiency scores of large firms, R&D intensive firms, and group-owned firms. The study reported that large size, R&D intensive, private-foreign owned and those engaged in drug formulations exhibit better performance. Further, it is found that ownership, capital imports intensity and size have a positive and significant relationship with efficiency scores, whereas the age, time dummy and size square variables are inversely related. The results suggest that Indian firms need substantive improvements in efficiency by adopting best managerial practices, ensuring optimum utilization of resources, and investing significantly in the technology and products innovation.

This paper provides a comprehensive introduction to the jurisprudence of patent damages calculation in Korea. It compares Korean patent damages jurisprudence with corresponding foreign systems as far as possible. Further, this paper also summarizes unique and/or important Korean patent damages jurisprudence. Firstly, Sec. 128 of the Korea Patent Act provides three different calculation methods, lost profit, infringer’s profit and reasonable royalty, from which the plaintiff may freely choose any one method. Secondly, para. 2 of Sec. 128 permits the plaintiff to prove lost profit through the number of the infringer’s assigned products, without proving his own reduced sales. Thirdly, under para. 4, the infringer’s profit is presumed to be the plaintiff’s loss. This presumption can be rebutted by the defendant by proving, for example, limited manufacturing capacity of the plaintiff. Therefore, the Korean infringer’s profit method is not effective for the plaintiff whose manufacturing capacity is limited. Fourthly, under para. 5, the plaintiff may request a reasonable royalty, which could have been agreed upon through a hypothetical agreement. The Korean reasonable royalty jurisprudence is not much different from, for example, that of the USA, but the actual average royalty rate decided by the courts is lower than that in the USA.

The new Spanish Patent Act ("Law 24/2015, of July 24, on Patents") was passed by the Spanish Parliament in July 2015, but did not enter into force until 1st. April 2017. Among other important changes in comparison with the previous 1986 Act, the new regulation stablishes a single granting procedure with substantive examination for every patent application. Regarding patent information, some new document kind codes have been created in order to cope with the additional procedures provided for in the new Act. On the other hand, as a consequence of the implementation of substantive examination, the new Act seems to have fostered the use of patent information services as a means to ensure in advance the novelty and inventiveness of the patent applications. This communication informs about both the new types of Spanish patent documents and the apparent surge in the use of patent information services in Spain as a consequence of the implementation of the new regulation.

This article considers the problem of parallel importation of patented products in Thailand in the light of the ASEAN Economic Community (AEC). One of the objectives of the AEC is to promote the free movement of goods and a single market within the Southeast Asia region. But, the exhaustion provision in section 36(7) of the Thai Patent Act 1979 makes it difficult for Thailand to achieve such an objective because it is unclear whether this provision is applied as national exhaustion or international exhaustion. Also, this exhaustion provision can only apply to the petty patent and the patent for invention, but cannot apply to the design patent, so the design patent owner can prevent parallel importation of products embodying the registered design from other ASEAN countries into Thailand. In order to achieve the AEC objective, this article argues that a regional exhaustion approach like that of the EU is appropriate for Thailand, but the wording of the current exhaustion provision does not support the application of a regional exhaustion approach. Hence, this article suggests that changes should be made to several provisions in the Thai Patent Act 1979 in order to make them compatible with the regional exhaustion approach. Such a change should ensure that the exhaustion provision can be applied to the design patent. Also, the proposed change should ensure that if the products are manufactured by the holder of a compulsory licence in another country and imported into Thailand without the consent of the patent owner, then the patent owner in Thailand should be able to prevent it. The additional legal measure, which provides a means of access to the complaints procedures of the relevant safety authorities in the circumstance where the patented products imported from other ASEAN countries are not safe, should be introduced. Also, a change should be made to some border measures provisions in order to allow such provisions to apply where the imported products infringed the patent right in the same manner as they apply in the context of trademark and copyright.

On April 29, 2014, the U.S. Supreme Court issued two decisions addressing the attorney fee-shifting provision of the Patent Act, Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. (“Highmark”) and Octane Fitness, LLC v. ICON Health & Fitness, Inc. (“Octane Fitness”). In tandem, the two decisions have made it easier for a prevailing party to succeed on a motion for an award of attorney fees and increased the deference afforded to a district court’s award of attorney fees on appeal. The predicted result should be an increasing tendency of courts to award attorney fees, and a lower probability that a district court’s decision to award attorney fees (or, conversely, not to award attorney fees) in a patent case will be overturned by the Federal Circuit on appeal. At the three year anniversary of Octane Fitness and Highmark, this installment of the Holman Report takes a quick look at how these decisions are playing out in the courts, specifically through the lens of “biotechnology cases.” The article begins with some background on the Patent Act’s fee-shifting provision, 35 U.S.C. § 285, and then provides a synopsis of the 2014 Supreme Court decisions. I will then delve into the specifics of some recent biotechnology patent cases that have awarded attorney fees and reviewed fee-shifting decisions under the new standards mandated by Octane Fitness and Highmark. For the purposes of this article, I treat any patent litigation that involves either a patent relating to biotechnology, or a party engaged in commercializing biotechnology (including pharmaceutical companies), as a “biotechnology patent case.”

The federal government now has additional powers to override patents for drugs, vaccines and medical equipment as needed to secure critical supplies during the COVID-19 pandemic Amendments to the Patent Act under Canada's COVID-19 Emergency Response Act make it possible for the federal government-or anyone it designates-to make, use and sell patented inventions "to the extent necessary to respond to a public health emergency " Effectively, the act enables Ottawa to combat price gouging or shortages of any needed product, from vaccines to ventilators, by licensing companies to make generic copies of brand-name products without having to negotiate with patent holders These compulsory licenses would last only a year, and patent holders would receive "adequate" compensation, to be determined after the fact

To increase the possibility of patent entitled of artificial intelligence related inventions at the Japanese patent office, this paper analyzes the Japanese patent act and patent examination guidelines. The approach for assessing whether a computer related invention belongs to a eligible subject-matter includes two steps. The first step is whether a computer related invention meets the definition of an "invention" that is "creation of a technical idea utilizing the laws of nature" . The second step is whether a computer related invention meets "idea based on the standpoint of software" . From the perspective of patent analysis, Japan's artificial intelligence technology is leading the world, second only to the United States. In this field, the Japanese patent office is one of the most important intellectual property offices, and its legislation and practice of patent eligibility review for artificial intelligence related inventions have an important impact on the world.

La première version de cet article, déposée en Archive ouvertes comme note de recherche, était intitulée : "Was the French Patent System democratic? France, 19th century"The first version of this article, deposited in the Open Archive as a research note, was entitled : "Was the French Patent System democratic? France, 19th century"; International audience; The influence of the patent system on the economic performance of Western countries during the Industrial Revolution is an important but difficult question to address. With the United Kingdom and the United States, France was one of the first countries to adopt a modern patent legislation in 1791. The aim of this paper is to understand the paradox of such a system, which was based on a democratic and natural-right conception of invention but turned out to be restrictive. It analyses the legal framework and its evolution from 1791 to the late 1850s and reveals its contradictory aspects: a natural right inspiration vs a restrictive access due to the cost of the patent. It shows how the 1844 Patent Act reform did not end the criticism of the French patent system. Then, in a second part, it considers the diffusion of patents in time, in different regions and industries and stresses the heterogeneity of the patent system.

NATIONAL LAW IMPLEMENTING THE ENFORCEMENT DIRECTIVE A. PRIMARY AND SECONDARY LAW The Enforcement Directive was transposed into national law with the Act for the Improvement of the Enforcement of Intellectual Property Rights , which came into effect on September 1, 2008. This Act contained specific amendments to preexisting acts concerning intellectual property rights. According to the explanatory statement by the ministry of justice attached to the fi rst draft of the transposition law, this law did not exclusively serve the purpose of transposing the Directive into national law. Additionally, it was supposed to amend the national law so as to streamline it with the European Regulation no. 1383/2003 of the Council dated July 22, 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights. Additionally, the law was supposed to close the gaps in the criminal liability for the unjustified use of geographical indications and indications of origin for agricultural products and food. The German legislator was of the opinion that with the German Act for Fighting Product Piracy dated March 7, 19902 it had already introduced effective measures and procedures for improving the enforcement of intellectual property rights. According to the German legislator, the Enforcement Directive ties in with this law. The German legislator had previously decided to do without a general intellectual property code, such as for instance the French Code de la Propriete Intellectuelle . The German traditional approach preferred to introduce rules for the different types of intellectual property rights in separate laws, including the Patent Act , the Utility Model Act , the Trademark Act , the Act on the Protection of Topographies and Microelectronic Semiconductor Products (“Semiconductor Protection Act”), the Copyright Act , the Design Act and the Plant Variety Protection Act . This issue was brought up again in the discussion of the transposition law. However, it was decided to continue the traditional approach and to keep the acts separate. The amended pre-existing laws included: – The Patent Act, which was amended in Sect. 140a to Sect. 140e concerning remedies for acts of patent infringement and in Sect. 141a and Sect. 142b concerning customs seizures. – The Utility Model Act, which was amended in Sect. 24 to 24g concerning remedies for acts of infringement.

NATIONAL LAW IMPLEMENTING THE ENFORCEMENT DIRECTIVE A. PRIMARY AND SECONDARY LAW The intellectual property rights, as addressed by the Directive, are all codified under the federal statutes governing Austria's respective intellectual property rights (IPRs). The relevant statutes are the Patentgesetz 1970 (Patent Act), the Halbleiterschutzgesetz 1988 (Semiconductor-Protection Act), the Markenschutzgesetz 1970 (Trademark Act) and the Urheberrechtsgesetz 1936 (Copyright Act). No implementation measures were undertaken for either the Musterschutzgesetz (Design Act) or the Gebrauchsmustergesetz (Utility Model Act), as these statutes each apply the relevant provisions of the Patent Act by reference. Consequently, this chapter on Austria contains no references to these acts, and all statements on rights arising out of a patent infringement apply vice versa to these titles. B. TRANSPOSITION ISSUES The primary source of information in the legislator's view when implementing the Enforcement Directive are the accompanying materials, which are published regularly along with any new legislation (“non-binding explanatory notes”). In these notes, the legislator took the view that Austrian law, even prior to the introduction of these amendments, already largely complied with measures required under the Enforcement Directive, in particular with regard to Article 6. Nonetheless, some provisions required changes and clarifications to avoid any doubts as to what rights are available. The adaptions of Austrian law were carried out through two separate legislator acts: Amendment BGBl. I No. 96/2006, entering into force on June 24, 2006, and implementing amendments and new sections to the Patent Act, the Semiconductor-Protection Act, and the Trademark Act; the same is true for the Copyright Amendment 2006 (BGBl. I No. 81/2006) concerning the Copyright Act, entering into force on June 22, 2006. C. ASSESSMENT REPORTS ON THE IMPLEMENTATION The assessment report to be conducted by Member States within three years aft er implementation, as prescribed under Article 18 Enforcement Directive, is not publicly available for Austria. However, the Support study for the ex post evaluation and ex ante impact analysis of the IPR Enforcement Directive (IPRED) issued in April 2017 by the European Commission offers some guidance as to the implementation and effects in Austria (and all other EU Member States).

During the past year various members of the United States Congress have introduced legislation intended to ameliorate the high cost of pharmaceuticals, as well as to stimulate innovation using alternative mechanisms to the traditional patent system model. Several of the legislative proposals would authorize third-party importation of prescription pharmaceutical products from one or more countries. One issue considered by drafters of these legislative proposals was whether to include amendment of the United States Patent Act to authorize importation of pharmaceutical products first put on the market under the authority of the patent owner outside the United States. In other words, whether to provide for international exhaustion of patent rights, at least as to pharmaceutical products. Consultations on these developments with Congressional staff revealed a novel concept of legislative takings pursued by the pharmaceutical industry. Takings doctrine was advanced as the basis for opposing modification of the US Patent Act to authorize international exhaustion. Because the Supreme Court ruled in favor of international exhaustion of patents and, in the course of doing so, it did not mention anything about takings, the question whether Congress might adopt international exhaustion of patents without triggering the takings issue is formally mooted. However, the question whether Congress is somehow constrained in modifying US patent law by the constitutional prohibition against takings of private property without just compensation remains important.