Traditional Knowledge, Peru and FTAs

'Trend on the protection of traditional knowledge associated with genetic resources within intellectual property chapters of Free Trade Agreements: the Peruvian experience' by Diego Francoise Ortega Sanabria in (2019) 14(9) Journal of Intellectual Property Law and Practice 728–738 comments

During negotiations of Free Trade Agreements, the bargaining power of developed countries has pushed developing countries to yield to higher standards of intellectual property protection in exchange of commercial benefits. However, there is evidence that developing countries can also seek and ensure the adoption of measures aimed at safeguarding their legitimate interests as a result of these negotiations. An example is Peru, which has sought to ensure the inclusion of provisions to require patent applicants to disclose the origin of the genetic resources and the associated traditional knowledge when they are used in the development of an invention, as well as the presentation of the evidence as to the prior informed consent from their legitimate owners and the corresponding equitable benefit-sharing. This article seeks to analyze whether the terms finally adopted have had a real impact on the protection of the Peruvian traditional knowledge associated with genetic resources.

 The author states

Towards the second half of the 1990s, the Andean Community of Nations (CAN), then integrated by Bolivia, Colombia, Ecuador, Peru and Venezuela, adopted a set of rules specifically designed to safeguard the correct access to their genetic resources (GRs) and the traditional knowledge of their indigenous, Afro-American and local communities (TKs), done within the framework of integration under which that regional block regulates its policies. These rules included some sections that link the aforementioned resources and knowledge to the common intellectual property regime, aiming to avoid their misappropriation through the non-consented acquisition of exclusivity rights. 

Thus, in 1996, Decision 391 was issued, establishing a common regime on access to GRs that conditions the legality of any right (including intellectual property rights) to the fulfilment of the access provisions that were set forth in such a legal instrument. Later, in 2000, Decision 486 was adopted, setting up a new common regime on industrial property, which establishes that whenever a patent application or a granted patent covers an invention developed through the use of GRs or/and TKs, its granting or validity, respectively, will depend on the filing of evidence on the prior informed consent of their legitimate holders.3 It should be noted that Decision 486 is recognized as the first regional instrument that includes binding obligations regarding the disclosure of origin and demonstration of legal access to GRs and TKs in patent applications. 

In order to complement the referred regional norms, the Peruvian government has undertaken a series of local actions meant to strengthen and make operational the regional regulations mentioned above. Thus, in 2002, Law No 27811 was enacted (Regime for the Protection of TKs of Indigenous Peoples related to Biological Resources), establishing a sui generis regulation. In particular, this law provides for special registration mechanisms for TKs, as well as for the protection against the disclosure, acquisition or non-consensual use of this knowledge. Additionally, this local law establishes enforcement proceedings before the Peruvian Patent Office (INDECOPI). Furthermore, it was regulated that whoever applies for a patent related to a product or a process obtained from confidential TKs, has the obligation to present a copy of the licensing agreement with the respective Indigenous Peoples as a requisite to the granting of the exclusivity right. 

Likewise, with the purpose of strengthening a defensive protection scheme, in 2004 the Peruvian government created the National Commission for the Protection of Access to Peruvian Biological Diversity and Collective Knowledge of Indigenous Peoples, known as the National Commission Against Biopiracy, whose functions are aimed to prevent acts of misappropriation on a global scale, by monitoring patent applications filed all over the world, related to inventions based on GRs and/or TKs from Peru, for the purpose of taking further steps to object the patentability of those inventions. 

Notwithstanding the above, the Peruvian government recognizes that, in order to prevent acts of misappropriation of GRs and/or TKs, these solutions must be also adopted by other countries, reason why the Peruvian national policies are also addressed to develop a binding international legal framework. In this sense, taking into account the relevance of having an international set of strategic actions to the effect of defending its interests, Peru manages an agenda in the diplomatic forum, which comprises i) the development of negotiations in the forum held by the World Trade Organization (WTO) as a result of the Doha Ministerial Declaration of November 2001, which instructed the Council on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to examine, inter alia, the relationship between TRIPS and the Convention on Biological Diversity (CBD); and ii) negotiations undertaken to subscribe bilateral and multilateral free trade agreements (FTAs), incorporating GRs and TKs aspects into the corresponding intellectual property chapters. 

In this regard, it is worth mentioning that, within the WTO forum, Peru and countries such as Brazil and India have sought to amend of the TRIPS Agreement, with the objective of inserting a mandatory formal requirement within the patent chapter, in relation to inventions dealing with the use of GRs and/or TKs. In fact, it has been proposed to amend Art. 29 of the TRIPS Agreement, so as to include a provision whereby Members shall require patent applicants to disclose the origin of GRs and the associated TKs when the subject of the application is derived or developed from these resources, as well as the presentation of the evidence of prior informed consent and the equitable benefit-sharing resulting from its commercial exploitation. This proposal provides for the adoption of national legal mechanisms to reject or invalidate a patent whenever these conditions are not met. 

However, certain developed economies are very reluctant to adopt these measures. Thus, countries such as USA, Japan, Korea and Australia have expressed their opposition, while others, such as those belonging to the European Union promote the search of alternative solutions to tackle the problem of misappropriation. As a corollary, to date these negotiations have not reached any concrete result. In this context, it seems that the signing of bilateral and multilateral trade agreements remains the only path to achieve the objectives that are not being achieved in the WTO forum, due to the better fluency that negotiations carried out by fewer parties involve. As a matter of fact, for almost ten years Peru has been subscribing agreements with several countries, which include provisions on GRs and TKs. Taking this into account, it is important to assess whether the bilateral forum, in which Peru has deployed significant efforts, has produced effective results. 

In order to carry out the present analysis, first it will be identified what was the corresponding position of the developed countries with which Peru has signed trade agreements and what terms have been finally adopted, to then determine if the Peruvian government has achieved concrete results. For this purpose, the analysis will be focused on the agreements signed with the USA, which turns out to be the most reticent country in terms of linking the protection of GRs and TKs with the intellectual property system. The agreements with the European Union and the States of the European Free Trade Association will also be part of this analysis, taking into account that, as seen above, these economies promote some alternative approaches.

TRIPS, FTAs and access to medicines

'The access to medicine puzzle: scaling back the negative effects of the Jordan–US Free Trade Agreement' by Laila Barqawi in (2019) 14(9) Journal of Intellectual Property Law and Practice 678–686 comments

 Jordan is the first Arab country to have agreed to sign a Free Trade Agreement (FTA) with the USA. The Jordan–US agreement (JUSFTA) contains Trade Related Aspects of Intellectual Property Rights (TRIPs)-plus clauses which affect Jordan’s access to medicine by raising the price of drugs, delaying generic entry of medication into the market and therefore limiting access to medicines. Commentators have noted several concerns about FTAs, including their lack of flexibilities, such as compulsory licensing, and of exceptions for fair or non-commercial use. 

This article examines recommendations by the Jordanian Food and Drug Administration (JFDA) and explains the workability of these recommendations, using examples from countries which have signed FTAs with the USA and have successfully curtailed the negative effects of FTAs. The article also recommends further options which the Jordanian government can utilize to limit the negative impacts of TRIPs-plus clauses within their national laws. These options do not contravene JUSFTA and TRIPs and can increase access to medicines.

Barqawi states

 Jordanian officials have started to recognize the negative impact of data exclusivity as can be seen through the Jordan’s food and drug administration’s (JFDA) submissions to the UN High Level Panel below. We explore their workability in an attempt to scale back the negative effects of TRIPS-plus and data exclusivity. 

Data exclusivity operates as a ‘wholly distinct form of intellectual property rights and could not be overcome by a compulsory license.’ Furthermore, TRIPS protects only ‘undisclosed data’ to prevent ‘unfair commercial use’; it does not confer either exclusive rights or an automatic period of marketing monopoly. TRIPS does not define what constitutes ‘commercial use’. There have been arguments for data exclusivity in that it incentivizes innovation in the field of pharmaceutical drugs and assists pharmaceutical companies in recouping the costs of clinical trials and clinical trial data transparency. These arguments have been refuted on the basis that a few years of patent protection is adequate to recover the cost of clinical trials as US companies, for example, have made an excess of USD 1 billion on 55 ‘blockbuster’ drugs in 2013. 

As part of Jordan’s WTO’s accession package, Jordan agreed to block registration and marketing approval of generic medicine for five years, ‘even when no patents exist’. This has been implemented through the Trade Secrets and Unfair Competition Draft Law, which had been referred to Parliament in November 19998 and is now Article 8 of Jordan’s Law No 15 of 2000 on Unfair Competition and Trade Secrets (UCTS).  This is clearly TRIPS-plus in nature. 

Moreover, restrictions by JUSFTA also require three further years for data exclusivity for new uses, which clearly is an excessive form of protection for an existing TRIPS-plus condition. The effect of this restricted use of data exclusivity is evidenced by the 103 registered medicines which were launched since 2001 and had no patent protection in Jordan; of these, at least 79 per cent had no competition from a generic equivalent as a consequence of data exclusivity. This suggests that data exclusivity limits competition. Beyond implications for competition, there are financial effects as well. For example, an analysis funded by the Medicines Transparency Alliance estimated that the delayed market entry of generics resulting from TRIPS-plus requirements in JUSFTA cost consumers in Jordan’s retail market US$ 18 million in 2004. 

The Jordanian government should implement the recommendations in this article with backing from the USA, because the USA is the main financer to Jordan’s economy. Furthermore, defying the USA means that countries such as India, which challenge the USA on IP, feature regularly on the USA’s ‘Priority Watch List’ in its 301 Reports. For example, the USTR’s 2018 Special 301 Report clearly states that India has ‘Longstanding IP challenges facing US businesses in India’.

 She concludes

 There is policy space that the Jordanian government could utilize to limit the effects of TRIPS-plus. Jordan’s data exclusivity clauses are the most harmful to Jordan’s access to medicine. However, this article offers practical solutions to scale back Jordan’s data exclusivity restraints, following the example of other countries that have signed similar terms with the USA. This article builds on the recommendations of the JFDA by advocating further measures for the Jordanian government to increase its access to medicine. Jordan could restrict definitions such as NCE, patentability criteria and bar second use patenting, a decision that would prevent ‘evergreening’ of existing patents, supporting wide access to medicines. Jordan’s laws could also allow for policy space to be interpreted within its national laws as per Peru’s Amended Article 4 in its Legislative Decree. The Jordanian government could put a cap on the drug prices in comparison with other similar economies. Consequently, Jordan could attempt to overhaul its national legislation to streamline its IP. The Jordanian government should, ideally, have its decisions backed by the USA to maintain its relationship with the USA and not feature in the USTR’s 301 Report’s Watch List.

Algorithmic Bias and Tax Profiling

'The Missteps of the FIRST STEP Act: Algorithmic Bias in Criminal Justice Reform' by Raghav Kohli in (2019) 1 Journal of the Oxford Centre for Socio-Legal Studies comments

Contrary to his tough-on-crime rhetoric, Donald Trump in December 2018 signed the FIRST STEP Act (the ‘Act‘) into law, a criminal justice reform legislation aimed at reducing recidivism and reforming prison and sentencing laws. With a 87-12 vote in the Senate and a 358-36 vote in the House, a bitterly divided Congress approved the Act in a rare display of bipartisanship earlier that month. Apart from triggering an awakening within Congress about the dire need to decarcerate, the Act unified an unusual coterie of proponents, including tycoons such as the Koch Brothers, and celebrities such as Kim Kardashian. Whilst hailed as historic and sweeping in some quarters, the Act only affects the federal system, which houses a small fraction of the United States prison population. Out of approximately 2.1 million people imprisoned, only 180,413 are federal inmates. Nonetheless, the Act aims to introduce several reforms. It mandates the Department of Justice to establish a ‘risk and needs assessment system’ to classify the recidivism risk of prisoners, and to incentivise participation in productive activities. For instance, it allows prisoners to earn ‘time credits’ through their participation and apply them towards early release to pre-release custody. Other proposed changes include retrospective modification of ‘good time credit’ computation, reduced sentences for drug-related offences, and a ban on shackling of pregnant women. 

However, inmates do not benefit equally from these reforms. The risk and needs assessment system employs algorithms to classify each prisoner as having a minimum, low, medium, or high risk for recidivism. The Act only permits prisoners falling within the minimum and low risk brackets to apply for time credits towards pre-release custody. 

This article seeks to critically examine the impact of such algorithmic decision-making in the criminal justice system. Analysing different instances of algorithmic bias and the recent Wisconsin Supreme Court decision of State v. Loomis, it argues that opaque algorithmic decisions violate due process safeguards. In conclusion, the increasing use of such algorithms in the criminal justice system, including the FIRST STEP Act, is found to be undesirable, unless tempered with solutions which meaningfully improve their accuracy and transparency.

'Profiling tax and financial behaviour with big data under the GDPR' by Eugenia Politou, Efthimios Alepis and Constantinos Patsakis' in (2019) 35(3) Computer Law and Security Review 306-329 comments

 Big data and machine learning algorithms have paved the way towards the bulk accumulation of tax and financial data which are exploited to either provide novel financial services to consumers or to augment authorities with automated conformance checks. In this regard, the international and EU policies toward collecting and exchanging a large amount of personal tax and financial data to facilitate innovation and to promote transparency in the financial and tax domain have been increased substantially over the last years. However, this vast collection and utilization of “big” tax and financial data raise also considerations around privacy and data protection, especially when these data are fed to clever algorithms to build detailed personal profiles or to take automated decisions which may exceptionally affect people's lives. Ultimately, these practices of profiling tax and financial behaviour provide fertile ground for discriminating processing of individuals and groups. 

In light of the above, this paper aims to shed light on the following four interdependent and highly disputed areas: firstly, to review the most well-known profiling and automated decision risks emerged from big data technology and machine learning algorithmic processing as well as to analyse their impact on the tax and financial privacy rights through their immense profiling practices; secondly, to document the current EU initiatives toward financial and tax transparency, namely the AEOI, PSD2, MiFID2, and data retention policies, along with their implications for personal data protection when used for profiling and automated decision purposes; thirdly, to highlight the way forward for mitigating the risks of profiling and automated decision in the big data era and to investigate the protection of individuals against these practices in the light of the new technical and legal frameworks; in this respect, we finally delve into the regulatory EU efforts towards fairer and accountable profiling and automated decision processes, and in particular we examine the extent to which the GDPR provisions establishes a protection regime for individuals against advanced profiling techniques, enabling thus accountability and transparency.

Saying Sorry

'Should Public Figures Apologize? Preliminary Evidence and Speculations' by Cass R. Sunstein comments

In the modern era, the statements and actions of public figures are scrutinized with great care, and it often emerges that they have said or done things that many people consider objectionable, hurtful, offensive, or despicable. A persistent question is whether public figures should apologize for those statements or actions. Suppose that an apology has a purely strategic motivation: helping a politician to be elected or reelected, helping an executive to keep his job, helping a nominee to be confirmed by the U.S. Senate. Empirical work presented here suggests that an apology might well turn out to be futile or even counterproductive. One reason is Bayesian; an apology produces updating that can be unfavorable to the apologizer (by, for example, resolving doubts about whether the apologizer actually said or did the objectionable thing, and about whether what the apologizer did was actually objectionable). Another reason is behavioral; an apology triggers the public’s attention, makes the public figure’s wrongdoing more salient, and can help define him or her. But many open questions remain about the reasons why apologies by public figures fail, and about the circumstances in which they might turn out to be effective.

Fake News

'Fake News From A Legal Perspective: The United States And South Korea Compared' by Ahran Park and Kyu Ho Youm in (2019) Southwestern Journal of International Law comments

"Fake news" has emerged as a pressing concern since the 2016 U.S. presidential election. As media columnist Jim Rutenberg of The New York Times noted in November of 2016, "[t]he internet-borne forces that are eating away at print advertising are enabling a host of faux-journalistic players to pollute the democracy with dangerously fake news items."' Similarly, The Washington Post media columnist Margaret Sullivan, a former New York Times public editor, wrote one month later that "the era of fake news causing real trouble" has arrived in the United States. 

Publishing fake news has been around as a legal issue for many years.' As early as the late 18th century, fake news was already addressed by the United States Congress. When Congress passed the Alien and Sedition Act in 1798, one of its objectives was to punish "malicious" falsehoods about the government as a crime. 

Fake news and its counterpart - "real news" - is not limited to the United States. The impact of fake news is global. Freedom House reports that fake news was spread in 30 of the 65 countries examined between June 2016 and May 2017. South Korea is no exception in confronting fake news as a sociopolitical and legal issue. Koreans dealt with fake news during a presidential impeachment in early 20176 and a snap presidential election in May 2017. Fake news has been often abused to calumniate political opponents in Korea. 

In the United States, where freedom of speech and the press is the rule, not the exception, however, "[t]he real question is not whether fake news is protected, but under what circumstances would fake news not be protected." But in other countries, which are less speech-friendly, disseminating fake news is rarely not discussed as a part of free speech. In Ireland, for example, a new law proposed would criminalize spreading fake news on social media. In Germany, a social media law came into force in October of 2017 that requires social media sites to remove fake news promptly.'" The German law gives social media networks twenty-four hours to take actions on fake news after they have been alerted. " 

From a comparative perspective, South Korea and the United States deserve careful attention, given that American law has exerted a considerable impact on Korea's democratic process as a rule-of-law-nation over the years. Fake news and freedom of expression is a timely topic for comparatists, since it illustrates how society approaches evolving free speech issues like fake news. This Article first examines the definitional framework of fake news in the United States and Korea. Second, it analyzes where fake news is placed as a legal issue in the United States and Korea. And finally, the contrast of the United States with Korea is analyzed by looking at how fake news is framed as a new or not so new issue in free speech jurisprudence.

California as a Privacy Catalyst

'Catalyzing Privacy Law' by Anupam Chander, Margot E. Kaminski and William McGeveran comments

The United States famously lacks a comprehensive federal data privacy law. In the past year, however, nearly half of state legislatures have proposed or enacted broad privacy bills or have established privacy legislation task forces, while Congress has scrambled to hold hearings on multiple such proposals. What is catalyzing this legislative momentum? Some believe that Europe’s General Data Protection Regulation (GDPR), which came into force in 2018, is the driving factor. But with the California Consumer Privacy Act (CCPA) scheduled to take effect in January 2020, California has emerged as an alternate contender in the race to set the new standard for privacy. 

Our close comparison of the GDPR and California’s privacy law reveals that the California law is not GDPR-lite: it retains a fundamentally American approach to information privacy. Reviewing the literature on regulatory competition, we argue that California, not Brussels, is catalyzing privacy law across the United States. And what is happening is not a simple story of powerful state actors. It is more accurately characterized as the result of individual networked norm entrepreneurs, influenced and even empowered by data globalization. Our account has implications not just for companies that must comply with both laws, but for policymakers and citizens at both state and federal levels.

Aged Care

Looking for an insight on public/private sector interaction, federation and the exploitation of the elderly? The Royal Commission into Aged Care has released a useful background paper on the Legislative framework for Aged Care Quality and Safety regulation.

The paper states

Aged care quality and safety regulation is intended to protect and enhance the health and wellbeing of care recipients.  

This Background Paper summarises the key aspects of quality and safety regulation provided for in the Aged Care Act 1997 (Aged Care Act), the Aged Care Quality and Safety Commission Act 2018 (Quality and Safety Commission Act) and supporting legislative instruments, including:

• approval of providers, making them eligible to receive government subsidies and supplements to provide aged care 

• the responsibilities of approved providers, including in relation to quality of care, user rights and accountability 

• accreditation and quality review processes 

• enforcement and sanctions 

• complaints processes 

• advocacy and community visitors.

There are some aged care services that are grant funded and operate outside the legislative framework of the Aged Care Act, namely the Commonwealth Home Support Programme and the National Aboriginal and Torres Strait Islander Flexible Aged Care Program. The arrangements in place to regulate the quality and safety of these programs will also be described in this paper. 

The Background Paper does not cover the following aspects of the aged care regulatory framework:

• the allocation of aged care places 

• the approval and classification of care recipients 

• setting of accommodation payments and accommodation contribution levels 

• oversight of refundable deposits and accommodation bonds 

• the role of the Aged Care Pricing Commissioner.

The aged care system also interacts with a broad range of regulatory bodies and frameworks. For example: consumer protection issues are regulated by the Australian Competition and Consumer Commission; health practitioner issues are regulated by the Australian Health Practitioner Regulation Agency; and each jurisdiction has its own work health and safety regulator. Legislation and regulations relating to local planning, building, fire safety, food safety and public health, among others areas, all apply in the aged care context. This broader regulatory context is not the focus of this paper. 

The Background Paper does not provide commentary or a view on the adequacy or effectiveness of the current quality and safety regulatory scheme. 

Legislative framework 

The Aged Care Act and the Quality and Safety Commission Act provide the legislative framework for the Australian aged care system. 

Sitting underneath the Aged Care Act is a suite of principles that contain detail about the operation and regulation of the aged care system. The current principles, which are legislative instruments and can be made and amended by the Minister, are as follows:

• Accountability Principles 2014 

• Allocation Principles 2014 

• Approval of Care Recipients Principles 2014 

• Approved Provider Principles 2014 

• Classification Principles 2014 

• Committee Principles 2014 

• Extra Service Principles 2014 

• Fees and Payments Principles 2014 (No 2) 

• Grant Principles 2014 

• Information Principles 2014 

• Prioritised Home Care Recipients Principles 2016 

• Quality of Care Principles 2014 

• Records Principles 2014 

• Sanctions Principles 2014 

• Subsidy Principles 2014 

• User Rights Principles 2014.

Other legislative instruments made under the Aged Care Act are Aged Care Determinations, including a determination by the Secretary under section 14–6 of conditions that apply to all allocations of places and to allocations of certain flexible care places1F and a determination by the Minister setting the amount of subsidies and supplements payable to approved providers of aged care services. 

Sitting underneath the Quality and Safety Commission Act are the Aged Care Quality and Safety Commission Rules 2018 (Quality and Safety Commission Rules), which contain much of the detail relating to the functions and operation of the Aged Care Quality and Safety Commission.