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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.

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.

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.

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.

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

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.

Patents are the legal rights granted for new inventions employing scientific and technical knowledge. Patent provides protection to new invention from commercial competition for a limited period. In Indian context presently, it is governed by Patenting the Indian patents Act (1970) which came into force in the year 1972. The patent Act (1970) was again amended in 2005 where in product patent was extended to all field of technology including microorganism, microbial organism, chemicals, food, and drugs. Patent laws were initially framed from chemical, mechanical, and electrical invention point of view but later on information technology, electronics, pharmacy, and biotech emerged as chief field of intellectual property right (IPR) resulting in change in prior law. For an invention to be granted a patent, three conditions should be fulfilled. The invention must be novel, it should not be obvious, and it should be useful to society. There are some issues related to microbial patents. In the patent law of most countries, the microorganism has not been clearly defined. As a result, there is a flexibility in a determining what can be patented in microorganism. Patentability of microorganism is governed by various international and national legislation and interpretation of case laws. There are several critical issues related to microbial patent which must be addressed to make it more meaningful.

The Japanese Patent Act follows a first-to-file principle, so it is crucial that important patent applications must be filed earlier than those by other inventors. However, inventors will not be awarded a patent if the description of the invention in the application is insufficient. Regarding this problem, a previous study investigated use of logistic regression in a prediction model for patentability (probability of acquiring patent rights). However, that model used linear discrimination, so the discrimination accuracy was not high. To increase prediction accuracy, this study instead uses a nonlinear support vector machine (SVM) in the predictive model for patentability. Evaluation experiments using the SVM model show that the prediction accuracy of the SVM-based model is better than that of the model used in the previous research. These results suggested that a nonlinear SVM model is effective for constructing a prediction model for pharmaceutical patentability.

Laws protecting the intellectual property (IP) are one of the most obscurely defined laws. All the members of the World Trade Organization abide by the legal agreement signed between the countries to regulate the IP rights between the member countries known as Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Developing countries especially India amended the Patent Act in 2005 in order to strengthen its administration revolving around IP Rights and tuned it according to the TRIPs Agreement, with an exceptional spotlight on the pharmaceuticals. The main idea behind this amendment was to prevent the process called evergreening. Evergreening is a process where pharmaceutical industries try to extend the duration of a patent under the disguise of increasing the therapeutic efficiency of the drug. Public access to the patented drug can also increase as an outcome of this act by shunning redundant guarding to the inventor. India pledged to curb evergreening which was evidently observed by the recent Supreme Court verdict on the case of Novartis AG v. Union of India (UOI) and Ors. The aim of this chapter is to provide a clear understanding of evergreening so that an unbiased view can be established both towards the best of public interest and protection of the inventor’s right.

In recent years, much discussion in patent law has revolved around granting tailored protection to provide better incentives to inventors in different industries and to increase patent quality. For example, the deliberations that led to the enactment of the Leahy-Smith America Invents Act (AIA) focused specifically on the role of the patent system in different industries as well as on modifying remedies and patent terms to reflect the needs of distinct technology sectors. Whereas in the literature there seems to be substantial agreement on the fact that tailored protection would be beneficial for the effectiveness of the patent system, there is no consensus with respect to which entity should be vested with the authority to produce tailored patent policies, standards and rules based on the needs of the various industries. Currently, the United States Court of Appeals for the Federal Circuit and the United States Patent and Trademark Office (USPTO) are the two principal candidates for this role. Some of this debate is connected to the broader issue in legal academia of granting general regulatory authority to administrative agencies with highly specialized knowledge. Contrary to other administrative agencies, such as the United States Environmental Protection Agency (EPA), the Securities and Exchange Commission (SEC) or the Occupational Safety and Health Administration (OSHA), Congress has never granted such authority to the USPTO; scholars have criticized this inconsistency. The strongest argument they have used to question the current status of the USPTO refers to the fact that much could be gained from the information that this agency has accumulated through years of experience working with inventors in different industries, particularly with respect to tailoring patent protection. Historically, the Venetian Republic provided tailored patent protection based on the characteristics of the invention. In that context, the entity entrusted with the power to tailor the protection granted in each case was the Senate, the issuing authority. Moreover, although the Venetian Republic enacted what is widely recognized as the first Patent Act in the world in 1474, the Venetian Senate continued its practice of granting tailored patents until the end of the Republic in 1797. In fact, as explained by Luigi Sordelli in 1974, following the enactment of the 1474 Act, inventors could obtain protection in Venice in two ways: through the newly created statutory system or through the much older customary system of senatorial grants. Conclusive evidence that Sordelli’s view was correct is provided in a separate paper that I co-authored with Ted Sichelman and Toni Veneri, in which we shed important new light on the true origin of patent law. In this article, I focus instead on tailoring patent protection. Specifically, I use original documents from the Venetian State Archives to present a detailed account of how the Venetian Republic used its customary patent system to tailor protection to the unique characteristics of an invention. Furthermore, I provide a full analysis of what can be learned from the Venetian experience to inform the modern debate on tailoring patent protection. Until now, only two other legal scholars have conducted extensive examinations of the original Venetian patents: Ted Sichelman and Sean O’Connor. The Venetian patent system appears to have been a very successful one; it operated for more than 300 years and during the 16th century helped Venice to transform itself from being a nation of sailors to being a nation of artisans and engineers, and ultimately the center of technological development in Europe. Thus, the Venetian customary patent system offers important lessons on how tailored patent protection and higher patent quality can be achieved. An accurate description of this system is crucial to further understanding the specific steps that we should take to reach these goals today.

This article assesses whether abuse by failure to manufacture patents locally remains a valid condition for granting compulsory licences under TRIPS. The author examines Article 27(1) of TRIPS, which stipulates that patent rights shall be enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced, and Article 5(A)(2) of the Paris Convention, which recognises failure to manufacture locally as an example of the abuse of patent rights, and argues that the former is incorporated into Article 2 of TRIPS, thus validating the same as a condition for granting compulsory licences under TRIPS. This argument rests on the notion that India has used Section 84(1) of its TRIPS-compliant Patent Act, related to a requirement that patented inventions be manufactured locally, as a condition for granting a compulsory licence to Natco, and this decision remains unchallenged within the WTO DSU system.

Clustered Regularly Interspaced Short Palindromic Repeats or (CRISPR) for short is touted as a revolutionary technology that can alter the way scientists modify DNA. CRISPR is essentially a laboratory tool that allows scientists to cut and edit strands of DNA at the molecular level. Scientists benefit from this technology because they no longer introduce foreign strands of DNA into genetic materials. This results in a cheaper, quicker, and more efficient process to alter the genes within plants. With promises of altering plants to increases nutrition, hardiness, and production to feed an ever-growing world the agricultural industry flaunts patents and biotechnology. However, the upsides come at a cost because of the patent process in the United States. Plant patents promote all the wrong incentives in agriculture which will inevitably stifle innovation, food security, and monopolize the food supply. The Supreme Court in Diamond v. Chakrabarty held that bacteria used to create living organisms can be patentable. However, recent decisions by the Court limit the scope of patents involving DNA. This paper will attempt to apply the narrowed scope in the field of genetics to plants and the Patent Act. The recent decisions by the Court should restrict the patentability of CRISPR technology and the plant varieties created.

Structurally, Congress in the Patent Act and the America Invents Act (AIA) preserved and established four distinct offices within Covered Business Method proceedings before the Patent Trial and Appeal Board (Board) — (1) accused infringer, (2) patentee, (3) the Patent Office, and (4) an agency which enjoys sovereign immunity and the power of eminent domain. It declared and incorporated the traditional rights and duties of accused infringers and patent owners to initiate and answer to proceedings concerning patent validity, while in the AIA it moved some of those proceedings from Article III courts to administrative proceedings before the Board. Congress extended to those proceedings the Patent Office’s power to initiate the determination of patent validity. All the while, it preserved the power of agencies other than the Patent Office to appropriate patent rights by eminent domain. Because different rights and duties are at stake in each of those four offices, and because the combination of separate powers could jeopardize the due process rights of patent owners and accused infringers, Congress did well to keep them separate. The powers of private parties and the federal government to initiate proceedings that implicate patent rights have important due process implications. The ruling below makes a hash of the procedural and institutional structure that Congress carefully designed. In jurisprudential terms, the Postal Service claims the powers and immunities of the legislative sovereign, who possesses the inherent power of eminent domain and is immune from liability for infringement. At the same time, it claims the powers of an accused infringer and so disavows the legal disadvantages of the sovereign. It cannot have both. In fact, the Postal Service cannot infringe and cannot be charged with infringement. The sovereign who exercises the power of eminent domain and pays just compensation has acted lawfully, not unlawfully, and therefore has not trespassed against the patent. And the Postal Service must pay compensation when it appropriates a license to practice a patented invention. Vested patents are property for Fifth Amendment purposes and a government must pay for licenses taken from them just as it pays for real and personal property that it appropriates.

The Court’s ruling in this case could vastly expand the reach of U.S. patent law. Although the dispute before the Court involves a claim brought under 35 U.S.C. § 271(f), the theory of damages advanced by the Solicitor General and others could allow extraterritorial damages in all patent cases. Expanding patent damages in this way would effectively transform every U.S. patent into a worldwide patent. That result cannot be justified as a matter of doctrine or policy. Damages for patent infringement are limited to acts within the United States—to hold otherwise would contradict the plain text of the Patent Act, which has a clear domestic focus. Section 271(a), which limits infringement to acts “within the United States” and importation “into the United States,” is expressly limited to domestic conduct. And although § 271(f) was enacted in response to an extraterritoriality decision of this Court, that statutory provision does not provide for extraterritorial damages; rather, it remains firmly rooted in conduct “in or from the United States.” The legislative history makes clear that Congress’ sole intention with § 271(f) was narrowly to abrogate that decision of this Court and no more, contradicting the notion that § 271(f) expands patent remedies to overseas use. Thus, contrary to the arguments of Petitioner and some amici, the Patent Act explicitly renders foreign injuries inactionable, an observation sufficient to reject Petitioner’s arguments and dispose of this case. The long-standing assumption of international patent policy is that an innovator who wishes to recover damages for sales or uses in a jurisdiction must apply for a patent in that nation. Disrupting that arrangement will cause a number of harms, many of which would be felt particularly by companies operating in the United States. Extraterritorial damages, especially if imposed under a theory that would apply even to infringement under § 271(a), could expose companies that conduct research and development in the United States to worldwide damages. This would discourage companies from innovating here. International damages could also undermine other nations’ sovereignty. Both the scope of patent law and available remedies differ around the world. This means that allowing damages in U.S. courts for sales and uses overseas could undermine the autonomy of nations that have chosen not to extend patent law to certain fields. Moreover, allowing extraterritorial damages might encourage other nations’ courts to impose damages for sales and use in the United States, thereby undermining U.S. sovereignty.

The positive impact of globalization, the increasing progress of science and technology, such as biological science and information technology. The advancement of science and technology will give birth to creative people who can produce innovative products, such as in the field of bioinformatics so they need legal protection for their work or invention through legal protection system of Intellectual Property Rights. The method of writing this research is normative juridical. The approach of this research is the approach of legislation, conceptual, and comparative. This research includes descriptive research. In this research, used primary data source and secondary data source. Data analysis technique is qualitative normative analysis technique. Software, databases, methodologies and bioinformatics products can only be protected through the copyright regime, this is based on the provisions of Law no. 28 of 2014 on Copyright, Article 40 paragraph (1). A software (software) can still be protected by a Patent mechanism if the software related to the computer program can solve technical problems and related to technology and there is already patent protection from the country of origin. Law no. 13 of 2016, Article 4. Only bioinformatics hardware, patented. In addition, bioinformatics (information) methodologies and products (information) can be protected through a trade secret regime. It is stipulated in the provisions of Article 1 number 1 and Article 2 of Law no. 30 Year 2000. Singapore governing Patents is a Patent Act (Chapters 221, Sections 42, 110 and 115) may be given for the discovery of a product or process. The invention shall meet the following conditions: 1) new; 2) inventive step; 3) Applicable in industry; 4) The publication or exploitation of the invention is generally not expected to encourage violent, immoral or anti-social behavior; Bioinformatics may be protected by Patents if they meet these four conditions. The law governing patent protection in Singapore when compared to Law no. 13 of 2016, has similarities regarding its patentability and protection terms, patent subjects, legal remedies and other types of patents.

The science of genetics and the realm of patents! Can there be a real reconciliation between the two? This is the burning question in the Indian agro-biotech patent space that was played out in the recent high stake litigation (between Monsanto and Nuziveedu in the Delhi High Court); and more particularly the decision focused on whether Monsanto’s particular Bt gene sequence technology (wherein the particular gene sequence of the Bt. Bacteria is inserted into a cotton genome) merits patent protection? In so determining the patent eligibility of Monsanto’s patent (IN 214436) over its Bollgard-II Bt cotton seed technology, concerning modified gene sequence of Bt. Bacteria incorporated into the cotton genome which provides increased boll-worm resistance, the division bench of the Delhi High Court (on April 11, 2018), revoking the patent, pronounced that the claims in contention constitute a patent ineligible subject matter. The case has been appealed to and admitted by the Supreme Court (SC) and the SC (on May 7, 2018) rejected the plea by Monsanto to stay the Delhi HC order, with the next hearing been scheduled for July, 2018. What also emerged through is that this patent chronicle should mark the first-of-its kind determination on the scope of patentability of GM crops. Further, in determining the scope of GM technology in the context of plants and plant material (here seeds) as a patent eligible subject matter, the intricate dynamics of: (i) the “patent exclusions under Section 3(j) of the Indian Patent Act” and, (ii) the applicability of alternate forms of intellectual property protection, viz., the “plant varieties protection” under the Protection of Plant Varieties and Farmers Rights Act (PPVFR Act), 2001, were also scrutinized by the division bench of Delhi HC; in the sense, that whether these GM technologies merit legal protection under the Patents Act or legal protection should be sought only under PPVFR Act, a sui generis legislation to confer limited protection only for the plant varieties (incorporating the genetically modified material).

Introduction: Varietas delectat Diagnostic technologies are one of the major fields in pharmaceutical industry. Diagnostic technology is a key feature for modern medicine such as personalized medicine or tailor-made treatments or companion diagnostics/drugs, as the modern medicine shifts its focus from treatment to prevention. However, patent protection of diagnostic technology is not simple, since a variety of countries have their own, unique protection policy in intellectual property regarding pharmaceutical and medical technologies. Europe and Japan are known to have restriction in obtaining patents relating to medical treatment and diagnostic technologies by excluding methods of treatment, surgery and diagnosis from patentable or patent-eligible subject matter. On the other hand, the USA has been said to have flexibility in obtaining patent protection for medical technologies, and the United States Patent and Trademark Office (USPTO) has been said to allow any category relating to medical technologies, and thus methods of treatment, surgery and diagnosis are not explicitly excluded from patent eligible subject matter in their patent act. Not only is there geographical diversity but also chronological diversity within the same country or region, which could be drastic and game changing. Notably, recent decisions held by the Supreme Court of the United States have stipulated that certain range of diagnostic methods may not be patentable because such methods are excluded from patent protection by excluding such from patent eligible subject matter. In this commentary, I will discuss how recent changes in law/case law have already had and/or will have impact on the patent practice regarding patent protection, f ocusing diagnostic technology.

Corporate officer liability doctrines under both the Patent Act and the Copyright Act diverge markedly from traditional corporate, agency, and tort law doctrines. This manuscript explores why the case law in federal patent and copyright cases differs so markedly not only from traditional legal norms, but from each other as well. It posits that the incorrect articulations of individual officer liability found in both patent and copyright law can be attributed to two factors: (1) the different avenues of appeals that patent and copyright cases take that result in different models of legal decision-making; and (2) judicial reluctance to apply the strict liability standard of patent and copyright law to individuals as opposed to entities. The cumulative effect of these two factors is an erosion of the traditional protection offered to corporate officers that puts active owners of small and closely-held firms at particular risk because of the dual roles they occupy.

Purpose – The purpose of this paper is to examine the trade performance, revealed comparative advantage and trade specialisation indices of Indian pharmaceutical in the post-modified Indian Patent Act. Design/methodology/approach – The main data sources for this paper are United Nations Conference on Trade and Development, PROWESS of Centre for Monitoring Indian Economy, Government of India reports and Reserve Bank of India databases. Revealed comparative advantage index (RCAI) and trade specialisation coefficient (TSC) have been calculated in the study. Findings – India is ranked third in regard of TCS, far behind Ireland and Israel. While Ireland has moved up the value chain faster after 1995, Israel has moved up swiftly after 2000 through global production network and supply chain. The Indian pharmaceutical industry, on the other hand, has largely capitalised on its low-cost production of generic drugs and a large domestic market. The RCAI also supports the results of TSC. India is positioned at 11th place, far behind Ireland, which stands tall at the top with distantly followed by Israel, Switzerland, Belgium, the UK, etc. Practical implications – The study shows the policy implications for future sustainable development of the industry as the new IPR regime has given opportunities as well as threats to both domestic pharmaceutical companies as well as the multinational corporations. The Indian pharmaceutical industry can be a good learning experience for other developing countries hopeful to enter the global market for generic drugs. Originality/value – There are no major studies providing detailed analyses of India’s comparative advantage vis-à-vis other leading exporters of pharmaceutical products in the world. This study endeavours to fill this gap. It also attempts to capture recent trends in exports and imports during the global recession period.

The Patent Act empowers a court to issue an injunction “to prevent the violation of any right secured by patent.” Whether a court will permanently enjoin an infringer depends on whether (1) the patent holder would suffer irreparable harm otherwise, (2) its legal remedies are inadequate, (3) the balance of hardships favors the patent holder, and (4) the injunction would not disserve the public interest. Similar factors inform the grant of a preliminary injunction. The Federal Circuit often says that the harm from patent infringement is irreparable if it cannot be measured. I say that such harm is irreparable because it irreversibly destroys wealth. Patent infringement irreversibly obliterates wealth when it impedes society’s technical progress. Patent infringement does more than transfer wealth involuntarily from the patent holder to the infringer; it also harms third parties by devastating the surplus that consumers would derive from using the product practicing the new technology. Damages are impotent to cure that harm to the public interest. A court’s order of damages can no more recreate the wealth that has been or will be destroyed by an act of patent infringement than it can restore an ancient redwood after the axeman has felled it.

The “monopoly” authorized by the Patent Act refers to the exclusionary power of individual patents. That is not the same thing as the acquisition of individual patent rights into portfolios that dominate a market, something that the Patent Act never justifies and that the antitrust laws rightfully prohibit.Most patent assignments are procompetitive and serve to promote the efficient commercialization of patented inventions. However, patent acquisitions may also be used to combine substitute patents from external patentees, giving the acquirer an unearned monopoly position in the relevant technology market. A producer requires only one of the substitutes, but by acquiring the combination it can impede product market rivals by limiting their access to important technological inputs. Similarly, a patent assertion entity may acquire substitute patents to eliminate inter-licensor competition, enabling it to charge supra-competitive license fees, much like a merger or cartel. For example, by acquiring two or more substitute patents that collectively dominate a market a PAE can effectively monopolize the technology for that market. Such anticompetitive practices are regularly condemned in conventional product contexts, but the courts have not yet applied the same antitrust logic to patent markets. And they passively encourage anticompetitive patent acquisitions by awarding large damages when such patents are infringed.We propose that infringement damages for an externally acquired patent be denied if the acquisition served materially to expand or perpetuate the plaintiff’s dominant position in the relevant technology market. By weakening enforcement, this limits the patent holder’s ability to use such acquisitions to anticompetitive ends. We do not suggest that a dominant patent holder should be prohibited from securing external patent rights in the relevant technology market, but simply that it should obtain them through nonexclusive licensing, not transactions that restrict third party access. This is as valuable to patent policy as it is to antitrust, for it will tend to increase innovation by discouraging systematic monopoly in technology markets.