Diagnostic tests are a core component of modern health care practice: they determine a patient’s susceptibility to developing cancer and other disorders; they diagnose biological conditions; they monitor the progress of disease; and they can assess the risk of disease recurrence. Ensuring their innovative growth is therefore an important issue in innovation policy. While legal scholarship addresses much about the relevance of patents and other forms of intellectual property protection for diagnostic methods as a general matter, far less attention has been paid to a distinct class of diagnostic tests that deserves its own innovation policy debate: companion diagnostic tests. This note seeks to draw more attention to the economic challenges facing the companion diagnostics industry. It begins by providing the necessary background to understand what companion diagnostic tests are, and why they are vital to the future of modern healthcare. It then explores the unique underlying incentive structure amongst the key industry stakeholders, revealing how the incentives of these stakeholders are misaligned in ways that impede the industry’s growth. Relying on empirical data from case studies collected in pharmacology and biotechnology business literature, this note ultimately argues that the microeconomics of the companion diagnostics industry present a compelling case for invigorated patent protection of companion diagnostic tests.
Correlative Obligation in Patent Law: The Role of Public Good in Defining the Limits of Patent Exclusivity
In light of the recent outrageous price-spiking of pharmaceuticals, this Article questions the underlying justifications for exclusive rights conferred by the grant of a patent. Traditionally, patents are defined as property rights granted to encourage desirable innovation. This definition is a misfit as treating patents as property rights does a poor job of defining the limits of the patent rights as well as the public benefit goals of the system. This misfit gradually caused an imbalance in the rights versus duties construct within patent law. After a thorough analysis of the historical and philosophical perspectives of patent exclusivity, this Article concludes that the extent of exclusivity that patent monopoly currently bestows is unsupported by the philosophy of patent exclusivity that asserts strong public benefits. Alternatively, this Article presents the law of contracts as embodying a framework within which patent law can fit better. By viewing the grant of a patent as a contract with the government in exchange for the patent holder providing a benefit to society, patent owners shall have duties to the society that correspond to their rights under the patent.
Since the enactment of the America Invents Act, inter partes review has been a new pathway for challenging patents. This administrative proceeding at the Patent Trial and Appeal Board has had a pro-challenger bias. IPR proceedings apply a lower standard of proof than federal district courts, use the anti-patentee claim construction standard of broadest reasonable construction, and lack the Article III standing requirement of district court litigation. This Article explains how these differences create great uncertainty in pharmaceutical patents, and what could be done to restore the balance that was created in the Hatch-Waxman Act.
Pharmaceutical patents have their own alternative litigation pathways with the Hatch-Waxman Act, passed by Congress over three decades ago, and the recent Biologics Price Competition and Innovation Act. Both balance between stimulating innovation from brand companies who hold patents and facilitating market entry from generic companies who challenge the patents. Hatch-Waxman and BPCIA litigation occur in the federal district courts, which have significantly lower patent invalidation rates than IPR proceedings. The Article argues that this uncertainty in patent rights will harm pharmaceutical innovation by decreasing incentives. Pharmaceutical companies will not spend the billions of dollars needed to research, develop, and bring a drug to market if patent validity in IPR proceedings is uncertain. In the end, the author proposes several reforms for Congress to enact that can reduce the disparities between IPR proceedings and Hatch-Waxman litigation so the balance between patent holders and patent challengers is restored.
In this interview, Anne Hassett, the Executive Director of NYU School of Law’s Engelberg Center on Innovation Law & Policy, discusses her experience conceiving and bringing to fruition the Trial by Jury of Patent Cases Symposium. The conference was co-hosted by NYU School of Law’s Engelberg Center and the Civil Jury Project on September 30, 2016. Distinguished federal jurists, academics, and practitioners discussed whether the 7th Amendment guarantees a right to a jury trial in patent cases and analyzed, in presentations and roundtable discussions, current issues and trends in how patent jury trials are conducted. Given her rich and varied background in the patent law sphere, Anne Hassett also discusses her own views on the matters brought up in the symposium, including the observations and experiences that shape her perspective on patent jury trials.
This Article examines a patent licensing practice that has hitherto escaped the attention of U.S. antitrust law: the no challenge clauses. Under these clauses, a patent licensee is prohibited from challenging the validity of the licensed patent. These clauses have so far only been examined under patent law in terms of enforceability. This oversight by antitrust law is unfortunate, as no challenge clauses can create consumer harm by protecting an otherwise invalid patent from challenges and artificially extending the exclusive period granted by the patent law. This means that consumers have to bear supra-competitive prices for longer than necessary. A number of factors are relevant to the analysis of the legality of no challenge clauses, such as market power, patent validity, and market structure at the licensee level. This Article proposes a framework based on the Rule of Reason that incorporates all of these relevant factors and structures them in a way that renders the framework easy to apply. Lastly, the Article rejects a number of justifications that have been offered to argue for the legality of these clauses across the board.
While the Patent Trial and Appeal Board (PTAB), a part of the United States Patent and Trademark Office, uses the “broadest reasonable interpretation” for inter partes review proceedings (IPRs), district courts apply the “ordinary and customary meaning” standard for civil litigation. The disparity between standards in similar adjudicatory proceedings is not explicitly justified by existing law and creates uncertain outcomes for practitioners. This note explores the usage of the broadest reasonable interpretation in IPRs, the problems created by dichotomous claim construction standards between the two forums, and possible avenues of correcting this disparity. The Supreme Court acknowledged the issue posed by disparate standards by granting certiorari in Cuozzo Speed Technologies, LLC v. Lee. Therefore, this note argues that the Supreme Court, in this case, ought to require the PTAB to use the district court’s “ordinary and customary meaning” standard.
An invention is patentable only if it is “nonobvious to a person having ordinary skill in the art.” This obviousness determination is prone to two types of errors: type I errors, which are patent rejections that should have been granted, and type II errors, which refer to granted patents that are actually invalid. Although such errors can occur at both the agency level and the court level, this note focuses on errors at the level of patent prosecution at the United States Patent and Trademark Office (PTO). The note proposes that the PTO, in order to clarify its policy position on obviousness issues long before courts have the opportunity to weigh in, should promulgate forward-looking obviousness guidance under its nonlegislative rulemaking authority. This would increase the determinateness of the obviousness doctrine, producing more uniform results and reducing the level of uncertainty and error in patent prosecution. Guidelines of this sort are feasible under the current regime of institutional authority and will withstand judicial challenges. Moreover, they would be particularly suitable for the field of emerging technology, in which legal guidance is the most lacking.
Climate change is a pressing issue confronting the global community. The rapid development and diffusion of clean technologies (i.e., technologies necessary for adapting to or mitigating climate change) must be a central part of the solution. However, a stalemate has persisted in global climate change negotiations at the United Nations, caused by diverging views regarding the role of intellectual property rights “IPR” in the international transfer of clean technologies. Developed nations insist on strong IPR for clean technologies, while developing nations claim that IPR is a major barrier to the international transfer of clean technologies and demand to remove or reduce IPR for clean technologies.
This article explores two questions: (1) Is the existence of IPR a major barrier to the international transfer of clean technologies, and (2) why has the international transfer of clean technologies to developing nations been limited? Analyzing evidential data available, this article concludes that IPR probably has not been a major barrier to the international transfer of clean technologies. However, sustainable international transfer of clean technologies requires the joint efforts of developing and developed nations. To prepare for sustainable international transfer of clean technologies and to advance the effort for addressing climate change, this article proposes a new paradigm based on domestic innovation, international aid and international technology collaboration.
This article highlights the emergence of a new dialectics between the protection of intellectual property and public health in international investment law and arbitration. International investment law is a vital area of international law, which has furthered the protection of intellectual property, considering it a form of investment and providing intellectual property owners access to investor-state arbitration. While investor–state arbitration constitutes a major development in international law and facilitates the access of foreign investors to justice, it may endanger the fundamental values of the international community as a whole, unless arbitrators duly take into account their role as “cartographers” of international law within their role as “adjudicators.” Have arbitral tribunals taken public health considerations into account when adjudicating pharmaceutical patent-related cases? If so, have they considered public health either as an exception to investment treaty standards or as a part of the interpretation of the same standards? What techniques are available to avoid regime collisions between international investment law and other fields including public health law? This article offers a primer on recent investment disputes concerning pharmaceuticals. The underlying assumptions of this article are that adjudication is a mode of governance, and it has a fundamental importance with regard to the concrete implementation of a given legal regime. The article argues that arbitrators should not put an excessive emphasis on the private interests embodied by pharmaceutical patents, but adequate consideration should be paid to the public interest equally embodied in these rights.
Brief of Amici Curiae Law, Business and Economic Scholars in Support of Respondents in Alice Corp. Pty. Ltd. V. CLS Bank International, et. al.
A well-defined § 101 ensures that abstract software patent claims and their attendant notice and patent thicket problems do not undermine the patent system and stymie innovation. It serves as a decisive gatekeeper that the Patent Office and trial courts can use early in administrative proceedings and litigation. Further, it avoids many of the systemic challenges prevalent with the use of §§ 102, 103, and 112 in such cases—the speed of software innovation, the difficulty locating software prior art, and lax, broad claiming standards. Accordingly, this Court should affirm the invalidity of patent claims at issue here and hold that abstract ideas in the form of software are unpatentable and that mere computer implementation of those ideas does not create patentability.