Europe is on the verge of instituting a uniform patent regime that will change the landscape of patent litigation in twenty-five member countries. The unitary patent package will include a European patent with unitary effect (“unitary patent”) and the creation of a Unified Patent Court (“UPC”). Patentees will no longer have to litigate in each member country; a single litigation will be binding throughout all of the participating countries. This note argues that the EU should not have removed the substantive patent provisions from the UPR and that their removal will have an unintended negative effect for the UPC by looking at the relevant history and structure of the European patent system, the probable consequences of removing the patent provisions, and that the groups opposed to the provisions exaggerated their concerns over the inclusion of the substantive patent provisions in the UPR. The inclusion of the substantive patent provisions in EU law will provide benefits to the European patent community and EU law that outweigh any negative effects.
For a rule to have an optimally positive impact on society, it must be a valid regulation (a rule that comes to be enforceable); just (with an axiological goal); effective and efficient (that can extract a maximum amount of welfare, however understood, for the people it regulates). This article aims to advance the international regulation of patent protection by improving upon the axiological considerations of global regulation, while contributing to its effectiveness and efficiency. It does so by proposing the introduction of proportionality in the TRIPS Agreement, so that each country will contribute to technological development according to its economic capacity. A formula, which renders a politically feasible result, is used to further explain this theory. The chance of conceiving a healthy globalization based on formulas that encourage the cohesion of humanity should not be overlooked. That being reflected, an event of global generosity without precedent in the history of mankind would be witnessed. Hobbes’s theory would be proven wrong, and cohesion of humanity would be globally envisioned. The Achilles heel of the idea presented in this paper is that it maybe utopian; it would not be surprising that once again it is proven that homo homini lupus.
Association for Molecular Pathology v. Myriad Genetics, Inc. and Its Impact on the Patentability of “Designer” Genes
With the rapid advances in biotechnology and the widespread availability and popularity of assisted reproductive technologies, biologists may soon have the ability to manipulate human gametes and embryos in order to create children with certain desirable characteristics. Despite the fact that this scientific idea is closer to becoming a reality, the question remains whether such techniques or the altered genetic material itself are eligible for patents. After the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., — US. —, 133 S. Ct. 2107 (2013), the court held that isolated DNA was not the proper subject matter for patent under 35 U.S.C. § 101, while holding a patent on synthetic DNA, or “cDNA.” This article argues for a narrow reading of the holding in Myriad Genetics regarding cDNA, which would limit its application to the medical uses and gene therapy.
The de facto steward of U.S. patent law is the United States Court of Appeals for the Federal Circuit, which is the exclusive appellate venue for patent cases. As the perceived importance of the patent system has steadily increased since the court’s formation in 1982, the Federal Circuit’s performance has been closely followed by an ever-expanding group of practitioners, academics, and other interested observers, who have not been shy about pointing out the court’s deficiencies. Common complaints about the Federal Circuit’s case law and the quality of its decision-making include: panel-dependency, formalism, indeterminacy, and the over- or under-enforcement of certain doctrines. The academic literature offers a variety of proposals for remedying or compensating for the Federal Circuit’s perceived shortcomings, such as having specialized patent trial judges, expanding the number of circuit courts that hear patent appeals, and modifying the Federal Circuit’s jurisdiction.
Compared to existing proposals, this Article takes a different approach to analyzing the Federal Circuit’s problems by focusing primarily on the judges themselves and their adjudicatory environment. Lessons from cognitive psychology, management science, and the literature on judicial behavior suggest that many of the complaints about the court are potentially grounded in, or at least aggravated by, the expertise developed by the judges and the internal dynamics of the court, which may adversely affect the Federal Circuit’s ability to reconsider its precedents in a timely manner. This Article explores how the Federal Circuit, in its current form, may have difficulty self-correcting, and proposes that a solution may lie in staffing the Federal Circuit with only district judges who serve staggered terms of limited duration.
3-D Printing Your Way down the Garden Path: 3-D Printers, the Copyrightization of Patents, and a Method for Manufacturers to Avoid the Entertainment Industry’s Fate
What happens when a home user can scan and print a physical item, or download plans to print a physical item from the Internet, as easily as he or she can rip and share a song or movie? With home 3-D printers on the horizon, the question will begin to ring louder. Manufacturers of tangible goods should heed lessons learned about infringement of music, movies and books when these 3-D printers arrive in homes across the country. A key lesson learned from peer-to-peer file sharing of digital content is that once a technological monopoly (being the only one who can efficiently produce an item) on a protected item falls, the legal monopoly of intellectual property law is insufficient to protect property rights. Once efficient and inexpensive 3-D printers arrive, businesses can (1) shift to a market or bifurcated model in pricing goods, (2) seek to persuade people not to misuse intellectual property for moral reasons, (3) seek to use the judicial and legislative systems to (temporarily) slow sharing of protected designs, or (4) fade away. This article argues that the third solution (using the courts and legislatures to protect the legal monopoly once the technological monopoly is lost) sets a price on violations while removing any moral disincentive, and that only a combination of the first two methods—moral persuasion and market model pricing—will in fact protect tangible goods manufacturers from catastrophic losses.
This Article shows how the maturing technology of three-dimensional printing can be used to construct an enforceable open hardware license. Open hardware lacks the legal tools which allow the easy implementation of enforceable open source software licenses. As such, existing licenses cannot successfully implement open hardware principles. The author proposes the “Three-Dimensional Printing Open License” (the “TDPL”). The TDPL draws on the unique characteristics of three-dimensional printing to construct a license that incorporates enforceable documentation, attribution and copyleft provisions. As the technology of three dimensional printing improves and is gradually integrated into a broad range of industries, the scope of the license’s application will increase.
The Recent DOJ and FTC Policy Suggestions for Standard Setting Organizations – The Way out of Standard-Essential Patent Hold-Up
When patent holders employ the threat of an injunction as a weapon against competitors, it raises eyebrows among antitrust lawyers and agencies instinctively. Such is the case when standard-essential patents are used to hold members of standard setting organizations hostage by threatening sunk technology investments. Prominently last year, Google purchased Motorola Mobility Inc., which included 17,000 patents predominately relating to smartphones, and Apple and Microsoft acquired Nortel Networks and its 6,000 telecommunications patents. The FTC and the DOJ reacted with concern about potential patent abuse in light of the ever-more salient “smartphone patent wars.” In this setting, Renata Hesse, Deputy Assistant Attorney General at the DOJ, and Joseph F. Wayland, then Assistant Attorney General of the FTC, published governance suggestions aimed at lessening the likelihood of hold-up in the standardization process. This article applies a law and economics analysis to three of the suggestions: disclosure requirements, cross-licensing provisions, and limitations of exclusion through injunctions. The discussion addresses problems relating to joint negotiation and monopsony, as well as royalty stacking and cournot complements. It demonstrates how cross-licensing among upstream firms can effectively raise their downstream rivals’ costs, and it explores the concept of “reverse hold-up.” The article finally concludes that Hesse and Wayland identify critical issues, but fail to provide a fully satisfying solution to the problem of standard-essential patent hold-up.
Standard-essential patents can be used to hold members of standard setting organizations hostage by threatening sunk technology investments. Renata Hesse, Deputy Assistant Attorney General at the DOJ, and Joseph F. Wayland, then Assistant Attorney General of the FTC, published governance suggestions aimed at lessening the likelihood of hold-up in the standardization process. This article applies a law and economics analysis to three of the suggestions: disclosure requirements, cross-licensing provisions, and limitations of exclusion through injunctions. The discussion addresses problems relating to joint negotiation and monopsony, as well as royalty stacking and cournot complements. It demonstrates how cross-licensing among upstream firms can effectively raise their downstream rivals’ costs, and it explores the concept of “reverse hold-up.” While Hesse and Wayland identify critical issues, they fail to provide a fully satisfying solution to the problem of standard-essential patent hold-up.
Despite the continued reliance on the rhetorical device that modern invention is performed by individual inventors in their garages, few would disagree that today most patentable inventive activity occurs in corporate and university settings and that most individuals who would be labeled “inventors” in the twenty-first century are employees of a corporate entity. Yet, while copyright law’s work made for hire doctrine automatically vests employers with ownership of works made within their employees’ scope of employment, except in a few limited circumstances, patent law continues to require a written assignment of the rights to a patented invention. In order to resolve resulting issues and bring patent law into the twenty-first century, the Patent Act should be amended to borrow from the Copyright Act and adopt a principle similar to the work made for hire doctrine that would grant employers the rights to their employees’ inventions made within the scope of their employment.
The Patent Act’s omission to define inventorship leaves a paramount concept in a legal vacuum. Where courts have stepped in to fill the void, they have largely deferred to the inventor, and joint inventor, status articulated in the patent claims. This fixation fails to accurately reflect the contributions of those who, by common understanding, are inventors. In doing so, the patent system incentivizes not invention, as the Constitution and Congress conceived, but legal claims of invention, playing to the advantage of the legally sophisticated rather than the scientifically innovative. In this article Professor Fellmeth explores this fundamental disconnect, and proposes several legal solutions.
Caught in the Middle: Reducing the Uncertainty Created by the FDA and the Patent System for Genetic Diagnostic Test Makers
The scientific complexity of genetic diagnostic testing produces test results which are often flawed or difficult to interpret. Therefore, increased regulation of these tests is necessary to protect consumers and encourage patient reliance. However, increased regulation is accompanied by increased costs for genetic diagnostic test makers. If such costs are increased with no opportunity for test makers to recoup their investments, the proposed regulations will reduce public access to these genetic tests, and will reduce future innovation in this field. In similar industries, manufacturers can recoup regulatory costs through intellectual property protection—using a patent to prevent competitors from bringing identical products to market. Unfortunately, the law is unclear as to whether genetic diagnostic tests fall within patentable subject matter. Here I suggest five changes that would alleviate consumer concerns while spurring further innovation in the genetic diagnostic test industry: (1) Increase labeling and genetic counseling requirements for direct-to-consumer tests; (2) Provide for statutory data exclusivity (rather than patent protection) for tests that require clinical studies for FDA approval; (3) Create mandatory maximum approval times for certain classes of genetic diagnostic tests to reduce the regulatory burden on manufacturers; (4) Require that manufacturers and regulatory agencies solicit complaints directly from consumers; and (5) Require minimal new regulation for purely software-based genetic diagnostic tests.