TPPA and patents

'What is Patentable under the Trans-Pacific Partnership? An Analysis of the Free Trade Agreement's Patentability Provisions from a public health perspective' by Burcu Kilic, Hannah Brennan and Peter Maybarduk in (2015) 40 Yale Journal of International Law comments

On October 16, 2014, WikiLeaks released a complete draft of the Intellectual Property Chapter of the proposed Trans-Pacific Partnership Agreement (TPP). The TPP is a controversial free trade agreement being negotiated behind closed doors by officials from Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, and Vietnam. The commonly understood objective of the agreement, under negotiation since 2006, is to lift trade tariffs and quotas between the negotiating parties. In reality, this agreement would set new rules for many non-trade issues, ranging from food safety to internet freedom, and rewrite important non-trade policy for all counties involved. In fact, only five of the TPP’s twenty-nine chapters cover traditional trade matters, such as tariffs or quotas.

One such non-trade chapter is the agreement’s text on intellectual property (IP) protection—a section that actually restricts rather than frees competition.

The United States’ most recent proposals for the TPP’s intellectual property chapter would require the majority of the negotiating parties to significantly alter the scope of their intellectual property laws — changes that would raise drug and crop costs, therein restricting access to affordable medicines and foodstuffs. For those nations that have already aligned their domestic laws with the TPP’s intellectual property provisions, this agreement would further ossify detrimental standards. This feature examines only one small—but important—piece of the TPP’s intellectual property chapter: the text’s provisions on patentability requirements. We argue that the patentability requirements set forth in the TPP could seriously harm public health and local farming practices in the negotiating countries. Patentability requirements are the conditions that an invention must meet to qualify for patent protection. These requirements can be separated into two different categories: subject matter requirements and substantive patentability requirements. In a given country, certain types of inventions cannot be protected by patent a priori because they relate to a subject matter that the country has excluded from patentability. For example, in some countries, plants are per se excluded from patentability. Accordingly, a patent application on a breed of cactus would be rejected because such an invention (a plant) is excluded from patentability. If a patent applicant succeeds in showing that her invention meets the threshold subject matter eligibility requirements, she must then show that her application also satisfies certain substantive patentability requirements. For example, under the World Trade Organization’s (WTO) Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS), an invention must meet the substantive requirements of newness, inventive step, and industrial application.

The negotiating parties to the TPP have vigorously debated the scope of patentability requirements. The most recent draft indicates that the United States has retreated from its position that patents should be available for medical procedures, but might succeed in obtaining patent protection for plant-related inventions. The proposal to provide flexibility to exclude medical procedures from patentability will help ensure that the populations of the negotiating parties have access to all useful diagnostic, therapeutic, and surgical methods. However, if implemented, the new plant patent provisions could seriously disrupt traditional farming practices in the Pacific Rim and threaten food security in poorer farming communities. The text also shows that the parties are still debating how they should define utility—a substantive requirement that all inventions must be useful.  Furthermore, a provision relating to the practice of drug-evergreening (when drug manufacturers obtain a second term of patent protection on a new form, use, or method of using a known substance) still remains in the agreement. Accordingly, despite some improvements, we contend that the text of the TPP’s intellectual property chapter remains a bad bargain for participating countries from a public health perspective. As government officials indicate that the agreement is nearing completion, careful consideration of the TPP’s patentability provisions becomes imperative.

Schmittian Borders

 'The Embrace of Border Security: Maritime Jurisdiction, National Sovereignty, and the Geopolitics of Operation Sovereign Borders' by Peter Chambers in (2015) Geo Politics 1-34 argues

Border security has become one of the key means by which the sovereignty and security of powerful nation-states is projected. This paper offers a set of observations of the Australian Commonwealth’s descriptions and instructions for its embrace of border security. Border security is legible here as a geopolitics that transforms the rights and responsibilities of maritime jurisdictions into a space of security that projects national sovereignty through the interdiction of boat arrivals. Its intensification as Operation Sovereign Borders is read as a further variation within national sovereignty, one that elevates the decisionist prerogative into total deterrence. Operation Sovereign Borders pushes the limits of sovereignty’s existence in the state toward a total domination of space, perception and human life in Australia’s maritime jurisdictions, in the name of the nation. This necessitates the development, defence and reinforcement of a regionally engaged materiality that is embodied, extended, enacted, and distributed. The intended effect of this coordinated effort is to secure the nation’s sovereignty as a unity, but the broader effect has been to devalue offshore life to secure onshore interests, in a way that now necessitates indefinite offshore detention.

Pharma Data

IMS is reported by News Corp to be "collecting patients prescription data".

News states that

Some chemists are selling their patients prescription information to a global health information company which sells it on to pharmaceutical companies trying to boost their sales.

Doctor and consumer groups have expressed outrage about the practice they fear may impinge on patient privacy. After News Corp drew the Department of Health’s attention to the profit making venture it asked the Privacy Commissioner to investigate.

The Australian Privacy Commissioner Timothy Pilgrim warned chemists against a similar prescription data for profit arrangement in 2013 that involved linking doctors names to the data. “I am concerned about whether pharmacies will be complying with their obligations under the Privacy Act should collection activities commence,” he told the Pharmacy Guild of Australia.

While the name the doctor scheme did not go ahead the Australian general manager of health information giant IMS, Andrew Sutton has confirmed his company is collecting patients prescription data. “We do have arrangements with pharmacists to get prescription information,” Mr Sutton told News Corp. “The purpose is to help us understand how patients and doctors are using medicine in the real world to help our clients, primarily pharmaceutical companies, to get market aligned outcomes,” he said.

Mr Sutton says the information is “all fully encrypted and the anonymous information is not linked to physicians or patients,” he told News Corp. Mr Sutton said he could not reveal how much chemists were making for selling the information to his company. “It’s in the hundreds of dollars at a pharmacy level,” he said.

A spokeswoman for the Privacy Commissioner said he had not been informed about the latest arrangement with IMS. “We requested IMS Health to advise the Office of the Australian Information Commisisoner if it recommenced this program. We have not received any information from IMS Health about the recommencement of this program,” the spokesman said.

The article states that the Australian Medical Association

fears the information may have geographic links to chemists which would allow pharmaceutical companies to target doctors in the same area who were prescribing a rival companies medicine. ...

Consumers Health Forum chief Adam Stanevicius expressed grave concerns about the sale of patient prescription data. “Without some kind of oversight by the Privacy Commissioner we are very concerned about this information changing hands and whether patient identities are protected,” he said. “We have seen nothing to give us any level of confidence to date,” he said.

Mr Stanevicius questioned whether the information was even the chemists to sell given that the government was paying not only for the prescriptions but subsidising the chemists who dispense the scripts, the doctors who write the scripts and the IT system that ensures chemists get paid.

An AMA spokesperson is reported as commenting

it was “an amazing invasion of privacy purely for commercial reasons”

“It’s not for research or in the interests of patients and one has to question the ethics of the pharmacies providing this information”.

When doctors released any patient health information for a medical trials or to an insurer they had to get the patients consent and chemists should also have to tell patients they are selling their prescription information,

Corporations

'The mortality of companies' by Madeleine Daepp, Marcus Hamilton, Geoffrey West and Luís Bettencourt in (2015) 12(106) Interface comments

The firm is a fundamental economic unit of contemporary human societies. Studies on the general quantitative and statistical character of firms have produced mixed results regarding their lifespans and mortality. We examine a comprehensive database of more than 25 000 publicly traded North American companies, from 1950 to 2009, to derive the statistics of firm lifespans. Based on detailed survival analysis, we show that the mortality of publicly traded companies manifests an approximately constant hazard rate over long periods of observation. This regularity indicates that mortality rates are independent of a company's age. We show that the typical half-life of a publicly traded company is about a decade, regardless of business sector. Our results shed new light on the dynamics of births and deaths of publicly traded companies and identify some of the necessary ingredients of a general theory of firms.

The authors state

Publicly traded companies are among the most important economic units of contemporary human societies. As of 2011, the total market capitalization of firms in the New York Stock Exchange was 14.24 trillion dollars, comparable to the entire gross domestic product of the USA. While researchers have devoted considerable attention to the distribution of firm size, the distribution of firm lifespan has been the subject of far fewer studies. Thus, despite the availability of much quantitative information, our understanding of the way public companies live and die remains limited.

At present, there are several arguments addressing the statistics of company lifespans that have led researchers to a range of different conclusions. Some of these considerations hinge on the interpretation of the meaning of the death event for a company. In the framework of this paper, definitions of ‘birth’ and ‘death’ are based on the sales reports available in the Compustat database; details can be found in §4. While liquidation is often responsible for firm deaths, a much more common cause of death relates to the disappearance of companies through mergers and acquisitions. Thus, in our definition, firms may ‘die’ through a variety of processes: they may split, merge or liquidate as economic and technological conditions change. This raises the question of what characteristics of firms may initiate such events. In particular, it has often been suggested that the mortality rates of firms are age-dependent, a proposition that offers significant insight into the forces that determine firm survival. We address this question using a comprehensive database of over 25 000 publicly traded North American companies covering a large spectrum of business sectors over the period 1950–2009. The present analysis provides one of the largest studies of this kind, both in terms of numbers of firms and timespan.

There is a great diversity of perspectives on a theory of the firm, focusing on different aspects of their costs, organization and evolution. In modern economic theory, the existence and boundaries of firms are understood in counterpoint to the dynamics of self-organization in markets. Economists such as Coase and Williamson proposed that firms exist in order to minimize (positive) market transaction costs involved in the production of goods and services. In situations when, for example, there is particular specificity of goods and services exchanged between two economic agents, such transactions may be best organized internally to an organization rather than negotiated in the open market. As such, firms may split, merge or liquidate in response to economic agents evolving new and better ways of dealing with the various costs and revenues of production and exchange. Therefore, at least on the average, the merger of existing companies should be approximately neutral in terms of the balance between costs and benefits. However, this relatively simple picture becomes more complex in the light of behavioural studies of the impact of decision-making and management practices on the growth and viability of actual firms.

A perspective more directly tied to the demography of companies is organizational ecology. In the framework of organizational ecology, organizations that vary in their structure and relationships are modelled as competing for finite resources within a complex ecology of economic interactions. In this approach, which emerged from economic sociology, companies are seen as units of selection in markets and their longevity is the result of their successes of learning and adaptation in these environments. Similar to this approach, we employ mathematical models from theoretical ecology to examine the lifespans and mortality of companies.

Among the most widely replicated results relating to the mortality of firms is Stinchcombe's liability of newness. This is the expectation that young establishments experience higher mortality rates. This scenario is supported by observation of US manufacturing plants, Argentinian and Irish newspaper companies and other types of businesses. Theoretical grounding draws from the adaptive requirements of market entry; it takes time for young companies to gain the competencies and build relationships that will ensure their ability to survive [29,30]. Moreover, new companies are likely to be smaller and less experienced and thus more susceptible to market shocks. Knott and Posen stress the evolutionary character of these arguments by suggesting that liability of newness is evidence for market-based selection.

However, more recent evidence begins to diverge from this hypothesis. In a study of West German business enterprises, Bruderl and Schussler find that companies are, in fact, protected from mortality in the immediate period after founding. This liability of adolescence likely results from the buffer a firm acquires via its capital endowment at birth, which is also a characteristic of firms that have recently entered financial markets. As their initial capital stock is expended, less profitable companies become more vulnerable to environmental changes in market conditions.

A third perspective suggests that mortality rates increase as companies age. This idea is based upon two related concepts: the first is liability of senescence, the idea that as companies age, they accumulate rules and stagnating relationships with consumers and input markets that render them less agile and that re-configuration is increasingly expensive. Arguing instead for a liability of obsolescence, Sorenson and Stuartsuggest that environmental requirements change over time and that, although firms may improve in competence and efficiency with age by becoming more specialized, these specific adaptations also increase the companies’ risk to new kinds of external shocks that will inevitably beset them.

Finally, Coad has argued that these assorted liabilities constitute small deviations, at the tails, from an aggregate lifespan distribution that is generally well approximated by an exponential distribution. This proposition has been confirmed in Italian, Spanish and French firms. As noted by Amaral et al. and Coad, the statistical patterns of firm entry and exit will affect the distribution of firm sizes in any given year and set its form and temporal stability. Thus, a better understanding of the mortality risk of firms is necessary to generate new insights on the empirically observed scaling regularities in firm size frequency distributions.

In this paper, we test these alternative hypotheses of firm lifespan and mortality risk by analysing a large database of North American publicly traded companies between 1950 and 2009. We confirm the hypothesis of an approximately constant mortality rate, finding that the exponential distribution of firm lifespans holds across business sectors and causes of mortality. We apply survival analysis to estimate in a variety of ways that the firms in our dataset have a half-life of approximately 10 years, regardless of age.

Difference and vulnerability

'Equality and Difference - The Restrained State' by Martha Albertson Fineman argues 

for the development of an approach to social justice issues that puts equality aside and brings differences into consideration. The emphasis here is placed not on an abstract and inevitably contested legal principle, such as liberty or dignity, or on an inherently comparative or relative measure, such as equality, but on the ways in which the universal subject who is to be governed by those principles has been constructed in both political and legal discourses. This approach begins with the recognition of universality or sameness among individuals (the fundamental equality position) but also considers the inevitable differences among them. The universality is found in the vulnerability that marks our existence as embodied and finite beings. The differences arise because there are different stages and manifestations of embodiment, as well as from the fact that we are differently embedded in social relationships and within societal institutions. This “vulnerability paradigm.” makes forms of societally-produced differences a predominant focus because they provide the foundation for the assertion that we need a responsive state. Instead, what equality of treatment has provided is the passive toleration of inequality and complicity in the conferral of often unwarranted privilege on the few.

US Legal Realism

'Legal Realism and Natural Law' by Dan Priel and Charles L. Barzun in Maksymilian Del Mar and Michael Lobban (eds) Law, Theory and History: New Essays on a Neglected Topic (2015) comments 

The possibility of any meaningful relationship between the legal realists and natural law looks at first rather far-fetched. When it first appeared on the jurisprudential scene, legal realism was savagely attacked by proponents of natural law theory. To this day legal realism is depicted as a modernist, critical, at times almost nihilist approach to law, the polar opposite of the ancient natural law theory that traces its roots to Greek and Roman philosophy, and insists on unchanging objective values. And yet, two of the most famous legal realists, Karl Llewellyn and Jerome Frank, expressed in some of their writings more than a passing endorsement of natural law theory. The purpose of this essay is to try and explain this seemingly odd aspect of their work and in this way help in reassessing their work. We do so by explaining how they understood natural law and how they incorporated it in their work. Though they did not understand the term in precisely the same way, for both of them natural law was connected to the values of the community, which both of them thought were central to understanding law, for explaining how it could remain relatively certain, and ultimately, how it derived its authority.

Priel and Barzun argue

And yet, when one looks at the works of the people who called themselves ‘legal realists’, matters look less clear cut. Hessel Yntema stated that ‘the classification of American legal realism in the category of positivism along with Austin, Kelsen, etc., is so superficial as to border on the perverse’. This does not yet show that the realists saw themselves as natural lawyers—after all, they might have seen themselves as a new kind of approach to law—but it already somewhat destabilizes the association between realism and positivism. Even more surprisingly, when one turns to the works of the two most famous legal realists one finds in them clear affirmations of a positive connection between legal realism and natural law. As early as 1938 Karl Llewellyn wrote that ‘it is difficult for me to conceive of the ultimate legal ideals of any of the writers who have been called realists in terms which do not resemble amazingly the type and even the content of the principles of a philosopher’s Natural Law’. Even more surprisingly, Jerome Frank, usually considered among the most extreme realists, the one realists whose views are sometimes thought to border on nihilism, stated: ‘I do not understand how any decent man today can refuse to adopt, as a basis of modern civilization, the fundamental principles of Natural Law.’ As these words do not fit the image Frank as the ‘bad boy’ of legal realism, they are not often discussed. When they are, they are explained away as reflecting the views of the ‘later’, mellower Frank (by then a federal appellate judge), troubled by the horrors of World War II.

We will address this claim in more detail below, but already here we will note some difficulties with it. In the same year Frank wrote the words just quoted, he published Courts on Trial, which is hardly a complacent look at the legal system. On the other hand, already in 1932 Frank forcefully denied that the realists are ‘“positivists” who are exclusively devoted to whatever is now happening in the legal world’. The realists, he said, were all ‘eager…to improve the judicial system, to make it more efficient, more responsive to social needs, more “just”, if you like that word’.

One aim of this essay is therefore to make sense of these seemingly odd statements. We will argue below that rather than suggesting a radical change in the views of Llewellyn and Frank, they reflect ideas that can be found in even in their earliest, and seemingly most critical, works. Before we proceed, however, we must add an important caveat. While Llewellyn and Frank were in their day, and remain to this day, among the best-known legal realists, we do not claim that they are necessarily representative of all legal realists, let alone of some abstract construct called ‘legal realism’. Both Llewellyn and Frank often warned against the ‘Schools’ approach to jurisprudence for its tendency to lump together different thinkers who are in fact quite different.

Indeed, what we say below is not meant to deny that some self-described legal realists expressed scepticism about natural law ideas. And as our argument unfolds, it will become apparent that even Llewellyn and Frank understood the term somewhat differently. One incidental aim of this essay is thus to serve as reminder that all attempts to identify what legal realism is should be treated carefully. Such efforts are often illuminating, but they must be understood as constructs of the views of numerous individuals who on many things held quite different views. In this essay we therefore limit our focus to an analysis of the views of two legal realists.

One stumbling block to any meaningful discussion of the question any possible relationship between legal realism and natural law requires some clarification of the possible senses in which Llewellyn and Frank thought of themselves as natural lawyers and (if this is any different) opponents of positivism. In so doing, we must begin by setting aside several possible interpretations of these terms as inadequate. To begin, neither Frank nor Llewellyn believed that consistency with true morality was a condition of legal validity (or, more colloquially, that an unjust law was not valid law). From the vantage point of contemporary jurisprudence, this may seem odd, as the divide between legal positivism and anti-positivism is often defined in terms of legal validity. But from a historical perspective, the absence of a discussion on the matter of legal validity is unremarkable. If one looks at the long history of natural law thinking, one finds the conditions of legal validity rarely discussed. In fact, in English one is hard-pressed to find any discussions that pit legal positivism against natural law before 1930s. Even today, some natural lawyers deny that ‘natural law theory’ is committed to the view that an unjust law is not law. Since many prominent natural lawyers profess a decided lack of interest in the question of legal validity and are willing to countenance the possibility of unjust laws, the absence of a discussion of this question in Llewellyn and Frank’s works does not undermine our suggestion that they endorsed versions of natural law.

After setting aside such questions, is there any remaining interesting connection between legal realism and natural law? Even if so, is the connection of more than antiquarian interest today? Our answer is, Yes and yes. First, by appealing to natural law Frank and Llewellyn both signalled their commitment to the reality of value and the possibility of reasoning about it. Even if they could not come to accept everything carried under the banner of natural law, they maintained a faith in some notion (however vaguely specified) of moral reality. Second, Llewellyn and Frank believed that one could not clearly distinguish between legal and other sorts of norms, whether moral, social, or political. And third, Llewellyn and Frank saw their views about law and jurisprudence as closely related to inquiries about politics, and especially American politics. More specifically, their account of law was an account of American law, which they presented as intimately tied to American democracy, both of which they explicitly connected to natural law.

Not every legal positivist will disagree with all three points; the third one in particular is these days accepted by many legal positivists. But taken together, these three points represent a position clearly at odds with the views of many twentieth century and contemporary legal positivists, including the most prominent Anglophone legal positivist, H.L.A. Hart. Indeed, on all three counts Llewellyn and Frank can count as allies Hart’s primary anti-positivist antagonists, Lon Fuller and Ronald Dworkin, both of whom, at least on occasion, associated themselves with natural law.

'Legal Realism and Legal Doctrine' by Brian Leiter in (2015) University of Pennsylvania Law Review (forthcoming) states

 In this contribution to the symposium on "The New Doctrinalism," I argue that American Legal Realists did not reject doctrine, because the Realists did not reject the idea that judges decide cases in accordance with normative standards of some kind: "doctrine" after all is just a normative standard about what should be done, but one formulated and made explicit by a statute or a court or a treatise. A judge who decides cases based on the norm "this breach of contract is efficient" still decides based on a normative standard, even if it is not one that the law necessarily endorses. But the non-legal normative standards of yesterday can become the legally binding norms of tomorrow. What the Legal Realists taught us is that too often the doctrine that courts invoke is not really the normative standard upon which they really rely. And it was central to Legal Realism to reform the law to make the actual doctrine cited by courts and treatise writers correspond to the actual normative standards upon which judges rely. Doctrine remains so important today, as many of the contributions to this symposium show, precisely because the realist law reform movement was successful in so many arenas.

Less expensive than the Duke of York

Less expensive than the Duke of York but twice as useful?

Today's New York Times item on the UK Freedom of Information regime, drawing on the 2011 Constitution Unit note, comments

The requests come in to local councils with appalling regularity: “How many residents in Sutton own an ostrich?” “What procedures are in place for a zombie invasion of Cumbria?” “How many people have been banned from Birmingham Library because they smell?”

In Wigan, the council was asked what plans were in place to protect the town from a dragon attack, while Worthing Borough Council had to outline its preparations for an asteroid crash.

Government secrecy has long been a hallmark of Britain, where neither laws nor traditions made it easy to obtain the documents and records that are the underpinnings of any bureaucracy. But a decade ago, the doors were swung wide open to allow the sunshine of public scrutiny into agencies, bureaus and councils, and the result has been both gratifying and slightly alarming.

While Britain’s Freedom of Information law has established itself as a potent tool to scrutinize the work of public authorities and hold those in power accountable, it has also had some expensive consequences — and, in some cases, revealed the absurdity of public whim. The hundreds of thousands of requests that have been received at various levels of government in the last decade have not only been time-consuming for agencies and councils, they have also proved extremely costly.

Such, though, is the side effect of transparency, say the proponents of open government, who also argue that the benefits outweigh the burdens.

“What people often forget is just how much F.O.I. saves money, because it exposes wasteful and extravagant spending,” said Paul Gibbons, a freedom of information campaigner and blogger. “Just one example: a local council in Scotland was spending thousands every year sending a delegation to Japan for a flower festival. Once F.O.I. came into force, they quickly realized they couldn’t justify doing that.”

....

In the decade since its adoption, the Freedom of Information act has been exposing incompetence, inefficiency and even corruption across more than 100,000 public bodies. Financial reports, expenses records, meeting minutes and private email correspondence have all been dragged into the public domain.

According to the Ministry of Justice, more than 400,000 requests have been made under the act since its implementation, and central government bodies are now receiving almost 1,000 requests a week.

A slew of political scandals have come to light under the act. It was Ms. Brooke’s F.O.I. request that ultimately led to the parliamentary expenses scandal in 2009, resulting in the imprisonment of five Labour members of Parliament and two Conservative peers.

More recently, Jeremy Hunt, the current health secretary who formerly was culture secretary, was embroiled in controversy after F.O.I. requests revealed his close relationship with Rupert Murdoch’s media empire during News Corp’s approximately $12 billion bid for the broadcaster BSkyB. And Eric Pickles, the minister for communities and local government, landed in hot water for spending about $110,000 on tea and biscuits in a single year.

....

The expense of freedom of information is impossible to calculate precisely. A 2010 survey of the local authorities by University College London, estimated that responding to F.O.I. requests cost councils about $46 million annually. On the national level, rough estimates can be made using research from Frontier Economics, which calculated an individual F.O.I. request takes an average of 7.5 hours and costs about $430 to process. Between October 2013 and September 2014, central government departments received 48,727 requests, which would put the approximate annual cost of freedom of information at over $20 million.

Still, as advocates point out, that represents about 0.0019 percent of the budget — and $20 million is less than what the British taxpayer has paid for the travel expenses of Prince Andrew, the Duke of York. Also, often it pays for itself, they say, in exposing corruption or unreasonable public spending.

It's also, dare one say it, a reminder of the accountability that we should expect in a liberal democratic state.