Abstract: The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent with—basic scientific information developed in the service of academic research. Much of precision medicine’s IP, however, is held by academic research institutions that employ for-profit surrogate companies, companies responsible both for commercially developing university research and sublicensing university IP to others. This creates an uneasy tension between the public missions of universities and the commercial motives of surrogates, particularly universities’ goals of producing and disclosing scientific information, and surrogates’ goals of exploiting that information for commercial gain.
This essay examines the challenges that surrogate licensing poses for the future of precision medicine. It begins by providing a brief summary of precision medicine and its recent developments. Next, it provides an overview of university patenting and the shift toward surrogate licensing. It then explores some of the difficulties concerning surrogate licensing in the context of precision medicine and, later, suggests modified licensing approaches and best practices that may better promote scientific discovery, the development of human therapies, and overall social welfare. Lastly, the essay discusses some larger doctrinal and theoretical implications arising from surrogate licensing in informationally intensive fields, like precision medicine.
Enjoy an interview with Professor Orly Lobel for a discussion about her best selling new book You Don’t Own Me: How Mattel v. MGA Entertainment Exposed Barbie’s Dark Side, a fascinating page-turner about intellectual property, innovation and who owns creativity. You Don’t Own Me is receiving rave reviews from the Wall Street Journal, The New Yorker, The Financial Times, and many others!
Topic: You Don’t Own Me: How Mattel v. MGA Entertainment Exposed Barbie’s Dark Side by Professor Orly Lobel.
Guest: Professor Orly Lobel of University of San Diego School of Law
Hosts: Professors Michael Mattioli and Mark Janis
Music written and supplied by Dr. Robert L. Eoff, Associate Professor in the Department of Biochemistry and Molecular Biology at The University of Arkansas for Medical Sciences.
Abstract: In September 2014, a few months after a landslide election victory, the Indian Prime Minister Narendra Modi announced the launch of “Make in India,” an ambitious program designed to turn India into a global manufacturing hub. One of the factors widely thought to be responsible for Modi’s victory was support from India’s “neo-middle class”—a young, newly- urbanized section of the electorate seeking employment and improved living standards but struggling amidst an economic downturn. In a speech inaugurating Make in India, Modi linked the program with the aspirations of this section of society. Modi stated the need to elevate the status of the poor-to-middle class as fast as possible, noting that sixty-five percent of India’s population was aged thirty-five and below. He declared that the “[s]traight answer” to achieve this goal would be to create jobs in the manufacturing sector. He emphasized the importance of Foreign Direct Investment (FDI) for this purpose, terming FDI as both a “responsibility” and an “opportunity.” But Modi conceded that India’s poor rank in the World Bank’s Ease of Doing Business Index—below 130 at the time—was an impediment and had to ideally rise to fifty. Modi thus announced that the government would reduce bureaucratic obstacles faced by investors This has been a key focus of the initiative, and various measures have since been adopted. Make in India was followed by the launch of two complementary schemes in 2015 and 2016 respectively: “Digital India” and “Start Up India.” The stated aim of the former is to transfer India into a “digitally empowered society and knowledge economy,” with one of its pillars being the promotion of manufacturing in the electronics sector. The stated aim of the latter includes “fostering entrepreneurship and promoting innovation.”
Make in India and its allied schemes have yielded some dividends, and India’s rank in the Ease of Doing Business Index recently jumped to 100. Yet various challenges to Make in India exist. Crucially, automation technologies, such as 3D printing, threaten to displace millions of low-skilled jobs. As automation is seen as less of a threat in displacing jobs in electronics manufacturing, there is a case for arguing that a strong focus of Make in India should be the manufacture of electronic products like smartphones, tablets and semiconductors. Although India’s electronics industry is growing at a rapid rate, the industry is heavily reliant on foreign imports—a further reason to prioritize the area within Make in India. However, India suffers from low technological preparedness and weak ICT infrastructure. If India is to make improvements on this front, issues involving innovation and intellectual property (IP), such as technology transfer and licensing, are likely to assume much importance. In this regard, Make in India has identified IP as a key policy component, Digital India has included “IP generation in the area of electronics” as an objective, and Startup India has included the commercialization of IP in its agenda. But none of the parameters in the Ease of Doing Business Index factor in the role of IP. Thus, linking the success of Make in India with the Ease of Doing Business Index may neither capture the concerns of foreign investors heavily reliant on IP protection, nor reflect advancements in India’s IP system.
Abstract: This Article analyses the case law of the courts of England and Wales since the introduction of the UKUDR in August 1989, the implementation of the Design Directive in October 2001, and the coming into force of the Design Regulation in March 2002. To this effect, two tables of the decisions were compiled, one listing the UKUDR decisions and the other, the decisions relating to the UKRDR, the CRDR, and the CUDR. The tables can be found in the appendices at the end of this Article. The tables list the name of the parties, the type of design, the date of the decision, the court and the judge(s) who handed down the decision, and whether or not the decision was reported. The tables do not make a comparison of all aspects of the rights as may have been discussed in the cases, but instead only list whether the design was found valid and/or infringed. The list of cases is complete as of November 1, 2012, to the best of my knowledge, but does not include any unreported cases not included one way or another in the legal databases.
Abstract: Despite the high stakes in school name changes, schools seem to be renamed just as often as are traditional goods. A new name might acknowledge a major benefactor, reflect a change in the school’s status or affiliation, seek to clarify existing misconceptions, or serve as a component of a comprehensive rebranding initiative. Yet when an existing institution abandons one name and adopts another, its actions beget a host of trademark issues, some of which cannot be adequately understood by analogy to traditional brand and product name changes. School name changes can confuse or deceive consumers and infringe competitor schools’ marks, affecting alumni of all of the schools involved. Adopting a new name often necessitates that a school abandon a prior name that has acquired extensive goodwill, to the detriment of past, current, and future students. New names, especially those that honor living donors, risk tarnishing schools’ trademarks by associating them with controversial figures. In addition, renaming may deeply harm alumni, who serve as not only their alma mater’s consumers, but as its products. This Essay identifies and explores some of the intellectual property issues that university renaming raises and the trademark ramifications for alumni, including infringement, dilution, and abandonment of goodwill.
Abstract: This Essay briefly reviews the relevant portions of U.S. design patent and copyright law and the limiting copyright doctrines discussed by prior commentators. Based on this preliminary analysis, this Essay concludes that a right to prevent copying designs could be just as broad as— if not broader than—design patent protection. If this is true, then many of the arguments made in support of adopting a copyright-like regime to protect designs need to be reexamined.