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.

Smiley Face
Copyright Symbol
Book
: Emoji as Language and Their Place Outside American Copyright Law

<figure><img src="/wp-content/uploads/2016/04/NYU_JIPEL_Vol-5-No-2_3_Scall_EmojiAsLanguage_Image_Title1.png" alt="Smiley Face" align="left" width="30" height="30" /></figure><figure><img src="/wp-content/uploads/2016/04/NYU_JIPEL_Vol-5-No-2_3_Scall_EmojiAsLanguage_Image_Title2.png" alt="Copyright Symbol" align="left" width="30" height="30" /></figure><figure><img src="/wp-content/uploads/2016/04/NYU_JIPEL_Vol-5-No-2_3_Scall_EmojiAsLanguage_Image_Title3.png" alt="Book" align="left" width="30" height="30" /></figure>: Emoji as Language and Their Place Outside American Copyright Law

As emoji become more ubiquitous in society, users are learning to express themselves through these symbols. Copyright protection of emoji would hamper this growing area of free expression. This note argues that, given the ways in which emoji are used in American culture, they should not receive copyright protection, in order to encourage the use of emoji as an “accessory” to language. Emoji do not readily fit under U.S. copyright protection and their maintenance would be best left to private organizations. This structure would allow people to use emoji freely, in order to develop common meanings for symbols among emoji users and thereby maximize their communicative and expressive functions.

How Rings Fit into the Copyright Scheme: Assessing Their Intrinsic Utilitarian Function

How Rings Fit into the Copyright Scheme: Assessing Their Intrinsic Utilitarian Function

This Note examines how rings fit into the copyright system as sculptural pieces not subject to the separability test under the useful articles doctrine. It focuses exclusive on rings, as they seemingly possess numerous functions; they have been used for mystical purposes, portable bank accounts, and as a signal of socially meaningful codes. Moreover, since jewelry designers consider functional features in the design process, should rings be treated as useful articles? After examining the purposes of the Copyright Act and conversing at length with designers, this Note concludes that rings are more of an art form. Although jewelry designers are limited by a finger’s constraints, they employ a great deal of artistic creativity in expressing a message though the details of a ring.

Obviousness Guidance at the PTO

Obviousness Guidance at the PTO

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.