Quarterly Journal 47-1 Volume 47, Issue 1 June 2019

The PTAB Is Not an Article III Court, Part 3: Precedential and Informative Opinions

When the Patent Trial and Appeal Board (PTAB) designates a decision as “precedential,” “informative,” “representative,” or “routine,” what is the legal effect?  What do the Administrative Procedure Act and the rest of the administrative law say? What does the Patent and Trademark Office (PTO) officially state the effect to be? How does the PTAB actually treat these decisions? These four questions should have the same answer—and this article should be very short. Instead, we have an abundance of differences. Each difference illustrates an important principle arising under the Patent Act, Administrative Procedure Act, related administrative law statutes, and Supreme Court decision.  Each principle is important to applicants, PTAB trial participants, and to the PTAB itself, to ensure the “reasoned decisionmaking” required by the Supreme Court.

 Section II of the article catalogs various laws that govern rulemaking and adjudication throughout the federal executive branch, and integrates them to explain the role of, and limits on, federal agency rulemaking-by-adjudication.  (As this article is going to press, the Supreme Court’s decision in Kisor v. Wilkie, docket 18-15, is pending—that decision will likely change some of the analysis and conclusions of this article.)  Section III applies those general principles to the PTAB and its Standard Operating Procedures to identify potential areas of improvement for the agency, and for appeal by parties. Section IV analyzes a number of specific example PTAB decisions through the lenses of Sections II and III, to identify situations where the PTAB is acting within its authority and for the public interest, and where otherwise. Finally, Section V concludes with recommendations for the patent bar, for the PTO, and for the PTAB. What tools do lawyers have to guide the PTAB to better decisionmaking, and to appeal from bad decisionmaking?  What could the PTO and PTAB do to improve compliance with law?

The Analytical Framework for the Specific Intent to Induce Infringement in Hatch-Waxman Disputes

Patent infringement suits brought under the Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”) often turn on whether the plaintiff can prove induced infringement.  By way of example, if a branded plaintiff sues a generic defendant on a patent claiming a method for prescribing a certain drug, the branded company must allege that by selling its drug, the generic company induces doctors to proscribe the drug in an infringing manner.  To succeed on its claim, the branded company must further demonstrate that the generic company possessed “actual intent” to induce infringement.  Offering such proof of intent can prove uniquely challenging because in the majority of Hatch-Waxman suits, infringement is hypothetical – the generic company has usually not launched its product and may be statutorily barred from doing so.  Thus, proof of intent to induce infringement will focus on the packaging label of the generic product but may also include additional circumstantial factors such as research studies, doctor interviews, and expert testimony.

The purpose of this Article is to evaluate the evidence that courts consider when analyzing intent to induce infringement.  The Article will do so by first describing the history and contours of induced infringement, and then focusing on the Hatch-Waxman context, at both the District and Circuit level.  The Federal Circuit has historically struggled to define induced infringement, and in Hatch-Waxman cases has provided a small body of precedent that is inconsistent on whether it is appropriate to rely on circumstantial evidence unconnected to the drug label.  District courts have followed this divergent precedent to conflicting ends, varying greatly on the framework for analyzing intent to induce infringement.  This Article, having considered the spectrum of possible approaches, will conclude by advocating for a flexible framework, where courts may consider and even rely on circumstantial evidence of intent outside the context of the drug label.

The Keepers of the Culture: How the Creation of a Public Domain Registry Could Prepare Fine Art Museums for the Digital Age

Museums, despite holding the keys to American culture, frequently and flagrantly violate American copyright law. By claiming rights they do not, even could not hold, museums limit the progress of science by restricting images of their fine art, even those works that have long ago fallen into the public domain. While a growing body of scholarship argues a strict set of punitive changes to the copyright law are necessary to rectify this behavior, that solution fails to recognize the incentives museums have to digitize their art collections and make them available to a broader audience. By and large, museums are looking for ways to appeal to a modern audience, and by creating a structure that would provide these institutions with clear and reliable information as to the rights they hold in their works, the copyright law could aid them in the process of digitizing their collections. The structure necessary to provide this information is a registry of public domain works, one compiled and managed by the U.S. Copyright Office. This note demonstrates that the creation of such a registry would allow for the continued digitization of museum collections and could achieve the goal of limiting copyfraud by these institutions without making them vulnerable to costly and unnecessary litigation.

The Misstep Within the Patent Dance That Sandoz Inc. v. Amgen Inc. Revealed and How It Can Be Corrected

The Biologics Price Competition and Innovation Act (BPCIA) attempts to balance the investment backed interests of innovators in recouping their costs associated in reaching the biologics pharmaceutical market with the public concern of facilitating affordable therapies. When disputes inevitably arise in this space the BPCIA’s patent dispute resolution scheme, colloquially referred to as the Patent Dance, steps in to help enable a resolution. However, the recent Supreme Court case of Sandoz v. Amgen has revealed a flaw within the Patent Dance that may call into question the efficacy of this mechanism in its entirety. As it stands, when a party fails to comply with the required disclosures of the Patent Dance the only available federal relief comes in the form of a declaratory judgment action, thus excluding federal injunctive relief and as a consequence perversely encourages the parties to sit the Patent Dance out entirely.

This Note suggests that the BPCIA’s Patent Dance legislation be amended so that participants may instead be compelled by federal injunctive relief, thus inducing their earnest cooperation in this dispute resolution scheme. In reaching this conclusion, this Note describes the practical significance of biologics to show why achieving this cooperation matters, briefly discusses the BPCIA’s de facto predecessor, the Hatch-Waxman Act, and then provides a comprehensive look into the BPCIA including a step-by-step walkthrough of the Patent Dance mechanism, a discussion of the Act’s legislative history, and an outline of the recent Supreme Court jurisprudence interpreting this Act. Finally, this Note provides an example of how the BPCIA can be amended for this discrepancy.