Pharma Colours, Flavours, Shapes and Trade Dress

'Heart Pills Are Red, Viagra Is Blue — When Does Pill Color Become Functional? An Analysis of Utilitarian and Aesthetic Functionality and Their Unintended Side Effects in the Pharmaceutical Industry' by Signe Naeve in (2010) 27(2) Santa Clara Computer and High Technology Law Journal 299-332 comments

As consumers, we often associate pill color and shape with particular medications. Should that trade dress be protected beyond the expiration of the patent? Legal scholars have recognized some of the tensions and inconsistencies in court opinions when it comes to trade dress protection for pill shape and color. This article focuses on the specific tensions between requiring secondary meaning and nonfunctionality, as well as the potential of "genericide" when generic pharmaceuticals enter the market. Ultimately this article makes some novel recommendations to assess functionality at the time of FDA approval for the pharmaceutical and to have the FDA responsible for determining when a shape and color should be an industry standard, creating an exception to trade dress protection. Some exceptions for allowing protection for pill shape and color could be for flavor and colors that indicate flavor, for medications that indicate dosage, or for medications that are associated with a particular patient compliance or psychosomatic effect.

Naeve writes

Imagine a world without the little blue pill or the purple pill. For pharmaceuticals, colors and shapes not only signify the type of medication to a consumer, they can also represent the source of each medication. Most consumers would identify a shiny, round, brown pill not just as an anti-inflammatory medication or even as Ibuprofen, but as Advil. "The purple pill" is Nexium and the light blue angular pill, Viagra. Relying on trade dress to protect the pill color and shape after the patent term has expired enables the manufacturer to extend its market power via another form of intellectual property protection. Like most medications, however, trade dress protection can have unintended side effects. 

To obtain trade dress protection for shape and color, the design cannot be functional and the owner must demonstrate that it has acquired secondary meaning in the minds of consumers. A problem arises because, as the brand owner develops secondary meaning in the trade dress, the color and shape can begin to cross the line into functionality, which would then exclude it from protection. "The purple pill" not only signifies the brand Nexium, but it also identifies the pill for acid reflux. In other cases, a shape or color may become associated with a particular dosage, efficacy, result or soothing effect. 

Sometimes an element of the medication that was not "functional" in its original design begins to serve a purpose over time and the manufacturer is now potentially a victim of its own success. Additionally, a form of trade dress "genericide" has the potential of occurring to allow generic drugs to enter the market. 

This article will first briefly explain the history of trademark and trade dress protection for color and shape. Second, it will introduce the functionality limitations that have arisen in relation to pill shape and color and introduce the concept of aesthetic functionality. Third, it will consider public interest considerations that justify allowing or disallowing protection. Fourth, it will examine more deeply the protection that has been afforded pill shape and color and assess whether trade dress protection is being preempted in the pharmaceutical context due to functionality, aesthetic functionality, and genericness concerns.

Ultimately, this article will argue that color and shape should not become functional or be subject to genericide as a result of creating secondary meaning; that substitution for generic drugs should not be a reason to find that a color and/or shape are functional or generic; that functionality could be determined when the color and/or shape are adopted, not at the time of assessing secondary meaning; that using color and/or shape to indicate a general type of medication should not be considered functional, unless they are industry-regulated by the FDA; that using industry-accepted color and/or shape to indicate dosage is an acceptable functionality limitation, but it too should be regulated by the FDA; and finally that flavor and colors that indicate flavors should be considered functional due to scarcity concerns. …

"Unlike in other industries, several courts have denied protection where it can be demonstrated that the product design serves any useful purpose to the doctor or patient-including the ability to distinguish the product from others in the marketplace." This useful purpose is being called a functional feature, even when it does not fit the traditional notions ofutilitarian or aesthetic functionality.

My proposed solution is to clearly separate secondary meaning and genericide from functionality so that they serve complementary rather than opposing purposes. Accordingly, one possible solution is to assess functionality at the time when the color/shape is adopted, not at the time of assessing secondary meaning. In addition, if generic drug companies or other competitors are allowed to use the same trade dress as the pioneer company, then this determination should be made by the FDA, not the courts or the USPTO. The FDA could also determine industry standards for a particular medication rather than a determination of genericide by the courts. In addition, the FDA could make decisions regarding industry standards regarding acceptable trade dress for dosage specifications.

Ultimately, a pill's shape or color should be determined to be functional because it meets traditional definitions of utilitarian and aesthetic functionality, not because a court determines that it is functional as a result of the effort expended to create secondary meaning or that there is an "industry standard" because the second comers have intentionally copied the pioneer.

Prisons, Mental Health and Human Rights

'Human Rights Protections for People with Mental Health and Cognitive Disability in Prisons' by Anita Mackay in (2015) Psychiatry, Psychology and Law comments

 People with a mental health or cognitive disability are vastly over-represented in the Australian prison system. Investigatory reports by Ombudsmen and similar organisations reveal that there is considerable scope for improving the treatment of this cohort. One avenue for doing so is using a human rights framework, given that Australia’s international human rights law obligations require (among other things) that imprisoned people be treated with respect for their human dignity and, furthermore, recent international research demonstrating that fair and respectful treatment in prison may improve psychological well-being. However, there are considerable challenges involved in implementing this requirement in overcrowded and hierarchical prison settings. It is even more difficult to comply with the legal requirements given the web of provisions at the international, national and State/Territory levels, causing complexity and a lack of clarity as to their interrelationship. This article condenses the requirements into four principles and discusses how these have been applied by courts in relevant international and domestic cases. This analysis aims to assist correctional managers and policy makers seeking to comply with these legal requirements. Such compliance should form part of a multifaceted approach to protecting these vulnerable individuals from further harm.

Cannibals

'Cannibal Laws' by Rene Provost comments

There is a tension in the very association of cannibalism and law, which speaks to our conception of law as much as it reflects the common reaction to the practice of cannibalism. There are three ways of interrogating that tension, three cannibal laws that each highlights a distinct facet of our understanding of law as a social practice. All three can be read into the jurisprudence of the Sierra Leone Special Court, in both the occurrences and the absences of cannibalism in the proceedings. 

The first cannibal law is the law that seeks to repress the practice of cannibalism. In this relation, law constructs the practice as an object to be regulated. Despite its extreme rarity, a number of domestic criminal codes define cannibalism as a crime. In several SCSL trials, witnesses testified of several occasions of cannibalistic acts of the accused, but no one was specifically convicted or even charged with this act. This reflects a general silence in international criminal law regarding cannibalism, despite the documented occurrence of the practice in several conflicts over the last century. The recent emergence of a much broader concept of war crimes that covers many ‘other violations of the laws and customs of war’ that could arguably cover cannibalism raises new questions about international law’s silence. I argue that the transcultural nature of international criminal law sets one of the limits of formal law in this context. That limit reflects a combination of post-colonial malaise before the law’s civilizing aspiration as well as the law’s inability to construct a rationalized version of cannibalism that permits its reduction to legal fact. 

The second cannibal law is the law that the cannibals make. In this relation, law offers a normative framework for understanding the practice of cannibalism not merely as an irrational or depraved act, but as a part of a system of norms that fulfills a specific function in the context of an internal armed conflict such as Sierra Leone. Anthropologists have shown that the practice of cannibalism is very often linked to magic, as the provider of the most potent ingredients to make ‘medicine’ to make a person bullet-proof, able to fly, all-powerful, and many more wondrous things. Those who engage in this practice claim not only the language of science (witch-doctors speaking of ‘research and development’ to make medicine more effective) but also of law (witch-doctors ‘give the law’ to fighters to explain prohibitions the breach of which will break the magic spell). Cannibalism can be understood as not necessarily the acts of drug-crazed primitive bush fighters, but as a system of norms that communicates meaning, constitutes communities, and regulates certain relationships. This is a provocative expansion of a legal pluralist understanding of law, which tests the limits of social practices which we are willing to construct as law. 

The third cannibal law is the way in which legal discourse relates to other forms of social discourse. In this relation, cannibalism stands as a metaphor for the manner in which legal discourse consumes all other ways of understanding, which are digested and transformed to aliment legal analysis. That which the law cannot digest and transform is simply rejected as irrelevant. There is a degree of circularity to legal reasoning in that law claims an interpretive monopoly over what constitutes legal discourse. There is a need to step out of law’s all-encompassing culture in order to consider it as an artifact of modernity, marked in the field of international criminal law by its nearly exclusively western origins. As a classical trope of savagism, cannibalism stands as international law’s anti-modern other. While some have argued that we must distance ourselves from the law to suspend unquestioned belief in its necessity and centrality, it may be that cannibalism’s radical anti-modernity stands as altogether distant for that purpose. As a concept, cannibalism would be too dyspeptic for law, marking again a limitation of the concept of law as embodied in an international criminal tribunal like the SCSL

Pathology Spycams

Ina nice illustration of problems with narrowly-drafted and device-specific privacy legislation an internal review of SA Pathology - the state's troubled public sector pathology group, being readied for privatisation - has found that covert workplace surveillance of staff using CCTV was inappropriate but not illegal.

During December last year SA Health, the group's parent, admitted that from October two cameras had been hidden in smoke detectors to monitor  staff at SA Pathology's Frome Road premises. The cameras were used as part of an investigation into processing delays for pathology reports. The cameras were removed in December, with replacement by 'regular cameras.

The Health Minister Jack Snelling referred to 'a lapse in judgement' by SA Pathology management, with SA Health's  chief executive David Swan being asked to investigate.

Swan has now stated that the investigation found the use of the covert cameras  breached no laws -

The investigation has found that the camera equipment was installed due to suspicion of tampering with pathology results, therefore putting patient care at risk

The cameras did not have the capability to record audio and therefore did not breach the Listening and Surveillance Devices Act 1972.

However the decision to use covert surveillance equipment was made without consultation or approval from executive level management or human resources.

There is no indication as to whether junior heads have rolled. A formal report regarding the investigation does not yet appear to be publicly available.

Swan indicated that "We're now in the process of developing a new policy governing the use of surveillance equipment across SA Health to ensure this kind of situation does not happen again,"

Under that policy any workplace cameras must be clearly visible, with staff being alerted to their presence. Where criminal activity or misconduct is suspected covert surveillance can be undertaken following guidance from SAPOL and under the SA Health CEO's authority.

Fingerprints

The Adelaide Advertiser reports that South Australian Attorney-General John Rau is moving ahead with legislation criminalising a refusal of a police request for an on-the-spot fingerprint scan. The penalty will be up to three months’ prison or a fine of up to $1250.

Rau indicates that scanning will not be random and that strict criteria must be met before any scan is conducted.

Under current SA law the state's police currently only use mobile fingerprint scanners once a person has been arrested. The proposed legislation would authorise on the spot scanning, underpinned by criminalisation, of any person on the basis that police have to have "reasonable cause" to suspect that the person has committed, is committing or is about to commit an offence or may be able to assist in the investigation of an offence.

Rau is reported as justifying the legislation on the basis that in field trials police were 'able to make arrests instantly', something that

demonstrated that legislative reform is necessary to enable police to use the scanners in wider circumstances, where a person does not have to give consent and police can scan for prints without the need to arrest.

Given the A-G's recurrent disregard of civil liberties and surrender to hyperbole we might wonder whether he'll shortly embrace bureaucratic convenience on a more extensive scale, with comprehensive collection of (and access to) everyone's fingerprints and DNA.

Property, Privacy and the Public

'Privacy as Quasi-Property' by Lauren Henry in (forthcoming) Iowa Law Review comments

Courts and commentators struggle to apply privacy law in a way that conforms to the intuitions of many. It is often thought that the reason for this is the absence of an agreed upon conceptual definition of privacy. In fact, the lack of a description of the interest invaded in a privacy matter is the more substantial hurdle. This article, Privacy as Quasi-Property, fills this gap in the literature.

Quasi-property is a relational entitlement to exclude, that is, the right to exclude specific actors from a resource given a specific event, a given type of behavior, or a given relationship between the actors. There is no freestanding right to exclude from a quasi-property interest; the right to exclude must be trigged by behaviors of the plaintiff and defendant. A defendant is identified based on a trigger arising from a relationship, action, or harm to plaintiff. The law communicates that an actor must not interfere with a quasi-property interest with an exclusionary signal that is independent of the resource. Prominent examples of doctrinal areas that employ the quasi-property model are information misappropriation and trade secret law.

I argue that quasi-property provides the essential model for assessing the interest held by a privacy claimant against a defendant, and whether it has been infringed. The quasi-property model can account for the four privacy torts first advanced by William Prosser and adopted as law in the vast majority of states, and liberate them from the ossification that have stunted their development and ability to adapt to modern conditions. What’s more, the approach has implications for developing privacy rules for enforcement by other actors, such as administrative agencies, and even in conceptualizing other areas of privacy law outside of tort law, such as Fourth Amendment jurisprudence.

'The Self, the Stasi, the NSA: Privacy, Knowledge, and Complicity in the Surveillance State' by Robert H. Sloan and Richard Warner comments

We focus on privacy in public. The notion dates back over a century, at least to the work of the German sociologist, Georg Simmel. Simmel observed that people voluntarily limit their knowledge of each other as they interact in a wide variety of social and commercial roles, thereby making certain information private relative to the interaction even if it is otherwise publicly available. Current governmental surveillance in the US (and elsewhere) reduces privacy in public. But to what extent?

The question matters because adequate self-realization requires adequate privacy in public. That in turn depends on informational norms, social norms that govern the collection, use, and distribution of information. Adherence to such norms is constitutive of a variety of relationships in which parties coordinate their use of information. Examples include student/teacher, and journalist/confidential source. Current surveillance undermines privacy in public by undermining norm-enabled coordination. The 1950 to 1990 East German Stasi illustrates the threat to self-realization. The “hidden, but for every citizen tangible omnipresence of the Stasi, damaged the very basic conditions for individual and societal creativity and development: Sense of one’s self, Trust, Spontaneity.” The United States is not East Germany, but it is on the road that leads there. And that raises the question of how far down that road it has traveled.

To support the “on the road” claim and answer the “how far” question, we turn to game-theoretic studies of the Assurance Game (more popularly known as the Stag Hunt). We combine our analysis of that game with a characterization of current governmental surveillance that in terms of five concepts: knowledge, use, merely knowing, complicity, and uncertainty. All five combine to undermine norm-enabled coordination. The Assurance Game shows how use — both legitimate and not legitimate — leads to discoordination. Enough discoordination would lead to a Stasi-like world. But will that happen? A comparison with the Stasi shows cause for concern. The United States possess a degree of knowledge about its citizens that the Stasi could only dream of. Moreover — perhaps — it arguably surpasses the Stasi in complicity, even though Stasi informants “spied on friends, workmates, neighbours and family members. Husbands spied on wives.” The Stasi only clearly exceeded the United States in repressive use. While it is difficult to predict the future of surveillance, we conclude with three probable scenarios. In only one is there an adequate degree of privacy in public.

Divorce

'The Divorce Bargain: The Fathers' Rights Movement and Family Inequalities' by Deborah Dinner comments 

A vast literature documents the history of the women’s and gay liberation movements in the late twentieth century, but we still know little about how heterosexual men navigated dramatic change in the legal regulation of families. This Article provides the first legal history of the fathers’ rights movement. It analyzes how middle-class white men responded to rising divorce rates by pursuing reform in both family law and welfare policy. This history offers novel insight into the relationship between the private law of divorce, which regulates largely middle-class families, and public welfare state policies, which have the greatest effect on poor families. This Article challenges the assumption that these private and public family law systems operate in parallel, showing instead that they are interdependent.

Through the mid-twentieth century, marriage shaped the relationship not only between men and women but also between middle-class men and the state: men supported children and wives in exchange for legal protection of male familial authority. In the 1960s and 1970s, escalating divorce rates and the emergence of no-fault divorce laws upset this balance. By the mid-1980s, activists and federal and state legislators forged a new political compromise: fathers’ rights activists conceded ongoing child support obligations in exchange for greater access to custody upon divorce. This “divorce bargain” catalyzed a shift from common law presumptions favoring maternal custody to statutory recognition of joint custody. In so doing, it reinforced private rather than public responsibility for children living in nonmarital families.

The divorce bargain promoted formal equality and sex neutrality within private family law, but also entrenched gender and class inequalities. The bargain failed to challenge women’s disproportionate responsibility for childrearing within marriage, yet enabled men to use custody rights as leverage in child support and spousal maintenance negotiations. In addition, tying paternal responsibilities to custody rights advanced middle-class men’s caregiving interests but hurt those of low-income fathers who could not afford to pay child support. The state vilified these men as “deadbeat dads” who did not merit legal protection. The history of fathers’ rights advocacy for the divorce bargain, therefore, reminds us not to confuse liberalism with equality.