Patent term extension (PTE) is a statutorily-based mechanism to compensate inventors for patent term loss due to regulatory delay during the drug approval process at the United States Food and Drug Administration (FDA). In the context of pharmaceutical products, PTE is only available for the active ingredient of a drug formulation. Case law and interpretation of the relevant statutory text have clearly delineated the boundaries of what qualifies as an active ingredient in a chemical formulation for purposes of PTE. As therapeutics expand beyond simple chemical formulations into cell-based and gene therapy-based formulations, where a chemical compound is not the active ingredient, an interpretation of active ingredient for purposes of PTE is lacking. I term this shortcoming “the active ingredient problem.” In the absence of applicable case law, it has become increasingly important to review FDA guidance and recommendations. Furthermore, the United States Patent and Trademark Office (USPTO) has offered limited indications of how it may interpret active ingredients in these scenarios. Moving forward, it will be essential for inventors to understand how these cutting-edge therapeutics will be protected and how their efforts will be compensated as a result of delays associated with the regulatory approval process. In this paper, I advocate the adoption of “treatment complex protocols” or TCPs, a novel framework for PTE for cellular and gene-based therapeutics. This framework moves away from considerations of an active ingredient and instead embraces the complexities of the production and development of cellular and gene-based therapies. Under this framework, PTE would be granted to a TCP, which is a complete protocol-based description of the inputs, modifications, and outputs required to develop these complex and clinically important therapeutics. Although TCPs are necessarily more complex than determinations of active ingredients for chemically based therapeutics, they have the potential to clarify this increasingly murky, yet clinically relevant, area of the law.
Yang Li Ph.D.* Download a PDF version of this article here. Introduction I. Background of the BPCIA and the Patent Dance A. The Hatch-Waxman Act B. Biologics and the BPCIA C. The Patent Dance Provision II. Sandoz v. Amgen A. Factual Background B. The Federal Circuit’s Decision C. The Supreme Court’s Decision III. Effects of Sandoz on the Applicant Side… read more
There is a latent conflict between the law of employee invention assignment contracts and the Copyright Act’s work for hire doctrine. Countless employees sign contracts specifying that, in most cases, the employer will own trade secrets and patentable inventions, as well as copyrightable works. When employees create in the workplace, these rules are largely uncontroversial. But when employees create something outside the workplace for a new venture, there can be a conflict between these two areas of intellectual property law. The work for hire doctrine is more favorable to employee-ownership than the law of invention assignment contracts. As a perhaps surprising result, where an employee’s outside-the-workplace creation might constitute both a trade secret and a copyrightable work, these two ownership tests can point in opposite directions. Further, when an employee prevails as to copyright ownership, there are good reasons why that result precludes an employer’s conflicting claim to trade secret ownership in the same work. This friction on the boundaries of two areas of intellectual property law has important policy ramifications for employees who create intellectual property on the side, while planning for their next job.
From personalized medical diagnostics to election prediction, recent advancements in machine learning enables unprecedented, powerful applications of big data. Machine learning users can extract insights hidden in massive amounts of data, gaining an indispensable advantage against the competition. Investment in the process of gathering and analyzing data has now become a necessity to maintain a successful enterprise. Yet the difficulty of obtaining software patents since the 2014 Alice decision raises the question whether the current intellectual property framework may adequately protect inventions related to machine learning. This Note explores how we may utilize IP protection to harness the societal benefits we hope to enjoy through the advances in machine learning. The Note discusses the current framework of patent law, copyright, and trade secret in the context of machine learning inventions, and argues that patent rights for computational inventions adequately balances the concern of patent monopoly and promoting innovation. The Note concludes by applying the Alice framework to the proposed computational inventions, and demonstrates that the current patent system may still protect machine learning innovations.
The potential anticompetitive sequences of standard essential patents have been identified by the European Commission as a key area of policy formulation for the Internet of Things. Throughout the process of policy formulation, the input of young innovative companies may require additional consideration as illustrated by the series of thirty-one in-depth interviews undertaken with key figures in young innovative companies (YICs) across Europe. The information gathered shows that that the way the E.C. conceptualized the policy issues at stake is not wrong, but may be incomplete. While it is important to promote a better understanding of what the FRAND promise entails, young innovative companies showed a remarkable disconnect to the patent system as a whole. They not only lacked intellectual property awareness, but many also thought that the Internet of Things could be helped by open source software, rather than a standard essential patents regime. Against this background, this study strongly encouraged the European Commission to better integrate young innovative companies in the process of patent policy formulation. The fair, reasonable and non-discriminatory (FRAND) guideline the Commission issued at the end of November 2017, reflected the findings of this study by recognizing the need to raise FRAND awareness among YICs and SMEs (Small and Medium Sized Companies). Keywords: Internet of Things, patents, standards, FRAND, European Union policy, competition, young innovative companies, governance, patent policy
Since 1980, a series of legislative acts and judicial decisions have affected the ownership, scope, and duration of patents. These changes have coincided with historic increases in patent activity among academic institutions. This article presents an empirical study of how changes to patent policy precipitated responses by academic institutions, using spline regression functions to model their patent activity. We find that academic institutions typically reduced patent activity immediately before changes to the patent system, and increased patent activity immediately afterward. This is especially true among research universities. In other words, academic institutions responded to patent incentives in a strategic manner, consistent with firm behavior, by reacting to the preferences of internal coalitions to capture unrealized economic value in intellectual property. University patent activity, as a response to patent law changes, carries important economic and normative implications. The patent system uses private economic incentives to promote innovation, but academic institutions are charitable organizations intended to promote the public good. This study demonstrates that patent incentives may have encouraged academic institutions to invest in patentable innovation—in ways that potentially limit access to innovation—in order to internalize private economic value.
Patent working requirements exist throughout the world to ensure that the exclusive rights granted through patents result in an economic benefit to the granting jurisdiction. In India, if a patent is not locally worked within three years of its issuance, any person may request a compulsory license, and if the patent is not adequately worked within two years of the grant of such a compulsory license, it may be revoked. The potency of India’s patent working requirement was demonstrated by the 2012 issuance of a compulsory license for Bayer’s patented drug Nexavar. In order to provide the public with information about patent working, India requires every patentee to file an annual statement on “Form 27” describing the working of each of its issued Indian patents. We conducted the first comprehensive and systematic study of all Forms 27 filed in India with respect to a key industry sector: mobile devices. We obtained from public online records 4,916 valid Forms 27, corresponding to 3,126 mobile device patents. These represented only 20.1% of all Forms 27 that should have been filed and corresponded to only 72.5% of all mobile device patents for which Forms 27 should have been filed. Forms 27 were missing for almost all patentees, and even among Forms 27 that were obtained, almost none contained useful information regarding the working of the subject patents or fully complying with the informational requirements of the Indian Patent Rules. Patentees adopted drastically different positions regarding the definition of patent working, while several significant patentees claimed that they or their patent portfolios were simply too large to enable the reporting of required information. Many patentees simply omitted required descriptive information from their Forms 27 without explanation. It is likely that a combination of factors have led to this high degree of non-compliance, namely technical and administrative failures of the Indian Patent Office, and inadvertent or deliberate omissions by patent holders. However, it is also likely that there are more fundamental issues concerning the very notion of working requirements with respect to complex, multi-patent products. In effect, products that embody dozens of technical standards and thousands of patents may not necessarily be amenable to individual-level reporting of working, or even working requirements themselves. We hope that this study will contribute to the ongoing global conversation regarding the most appropriate means for collecting and disseminating information regarding the working of patents.
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.
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.