The Challenging Economics of the Companion Diagnostics Industry: A Compelling Case for Invigorated Patent Protection

The Challenging Economics of the Companion Diagnostics Industry: A Compelling Case for Invigorated Patent Protection

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.

Un-Blurring Substantial Similarity: Aesthetic Judgments and Romantic Authorship in Music Copyright Law

Un-Blurring Substantial Similarity: Aesthetic Judgments and Romantic Authorship in Music Copyright Law

Music copyright disputes have been in the limelight since long before George Harrison subconsciously ripped off the Chiffons. Yet, with copyright holders becoming ever more litigious, disputes over musical rights are revolving around increasingly narrow claims. While copyright law is meant to only protect the expression of an idea, rather than the idea itself, drawing the line is problematic and too often results in overly expansive definitions of “expression.” Lacking any objective definitions of the terms, determining when an idea becomes expression depends entirely on how one defines “art.” A recent case finding that pop-musicians Robin Thicke and Pharrell Williams infringed Marvin Gaye’s 1970s funk song, “Got to Give It Up,” by copying the amorphously defined “feel” and “sound” of the song, exemplifies the stifling affect our law is having on artists. After examining the evolution of the circuits’ current, and varied copyright infringement tests, this note ultimately suggests a unified and more precise approach that utilizes not only experts who are well-versed in the specific genres of art at issue, but also analytic dissection that carefully considers only protectable elements when determining if works are “substantially similar.”

Correlative Obligation in Patent Law: The Role of Public Good in Defining the Limits of Patent Exclusivity

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.

Disrupting the Balance: The Conflict Between Hatch-Waxman and Inter Partes Review

Disrupting the Balance: The Conflict Between Hatch-Waxman and Inter Partes Review

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.

Interview: Trial by Jury of Patent Cases Symposium

Interview: Trial by Jury of Patent Cases Symposium

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.

Antitrust Treatment of the No Challenge Clause

Antitrust Treatment of the No Challenge Clause

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.

Let’s Be Reasonable! The Broadest Reasonable Interpretation in the PTAB

Let’s Be Reasonable! The Broadest Reasonable Interpretation in the PTAB

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.

Interview: The Indigo Book: A Manual of Legal Citation

Interview: The Indigo Book: A Manual of Legal Citation

In this interview, NYU Law Professor Christopher Sprigman discusses his experience conceiving, drafting and producing the Indigo Book, a manual of legal citation that replicates the uniform system of citation expressed by Harvard Law Review’s Bluebook. Formerly known as “Baby Blue,” the Indigo Book is published by Public.Resource.Org under a creative commons license and may be freely modified or distributed without restriction under copyright law. Professor Sprigman details his vision for the Indigo Book, the legal copyright and trademark uncertainties the project faced, and his plans for the citation manual’s future.