There is growing concern over the pharmaceutical industry’s ability to set and raise drug prices as it sees fit. The price of a drug that has not been protected by a patent for decades can suddenly increase—or “ratchet”—as much as 10,000%. This Note identifies the problem of ratcheting drug prices and considers whether these abrupt changes in drug prices derive from a longstanding problem inherent in the United States’ pharmaceutical regulatory regime. It then considers the most commonly suggested mechanism for countering high drug prices—stimulating competition in the pharmaceutical market—but ultimately concludes that focusing solely on increasing competition constructs an overly simplistic view of ratcheting drug prices. In order to find an effective solution to unexpected increases in drug prices, this Note evaluates a small subset of pharmaceuticals that have recently undergone a sudden price increase and separates the ratcheting events into two categories: (1) those that occur as a result of natural deviations in the market, and (2) those that occur due to business tactics that take advantage of vulnerabilities in the drug market. It concludes that under this categorization, antitrust law may provide an effective solution specifically directed at ratcheting events of the second category— those driven by anticompetitive behavior.
Many biotechnology products are living organisms that are essentially “made” by a trial and error process of directing evolution in a laboratory. Decades ago, the Supreme Court in Chakrabarty settled the threshold question of patent eligibility for life forms, stating clearly that living things are patentable. Nevertheless, the fact that nature assists inventors so heavily in the process of inventing a useful new organism raises the question of whether such organisms meet patent law’s enablement requirement—that a patent application must teach a person of ordinary skill in the art how to make and use the invention without undue experimentation. This Note argues that the enablement requirement has been overlooked for patents to genetically engineered organisms, and proposes solutions for updating this requirement to properly incentivize the creation of socially beneficial living things, without allowing inventors to bar access to products of nature.
This Note argues that the U.S. Patent and Trademark Office’s interpretation of the new grace period under the America Invents Act (AIA), 35 U.S.C. § 102(b)(1)(B), is overly narrow and that an alternative interpretation proposing a broader reading of the grace period is more appropriate. Evidence for a broader reading includes the effect of each interpretation on the administrative burden at the Patent and Trademark Office, speed of patent disclosure, innovative activity by specific inventor groups, and inventor behavior in patent races. This analysis shows that a narrow interpretation of the grace period creates greater administrative burdens, discourages disclosure, disfavors small inventors and universities, and may make blocking firms in a patent race virtually costless. In contrast, a broad grace period is simpler to administer, accelerates disclosure, supports innovation by small inventors and universities, and provides firms with a defensive maneuver in patent races.
The Leahy-Smith America Invents Act effectively repealed aspects of the Federal Rules of Civil Procedure by creating a new statutory section governing joinder of accused infringers and consolidation of actions for trial in most patent infringement cases. This new law codifies a substantial barrier to joinder and consolidation for trial. In so doing, it frustrates the promotion of liberal standards both for evaluating the sufficiency of pleadings and for evaluating the propriety of joinder of parties—two of the primary policies embraced by the drafters of the Federal Rules of Civil Procedure. Remarkably, Congress adopted the new statutory section despite the absence of any detailed scholarly analysis prior to its enactment regarding these issues, sparse legislative history analyzing perceived problems with the relevant Federal Rules of Civil Procedure, and the lack of any consideration of the new statutory section by the Supreme Court’s Advisory Committee on Civil Rules. This Article provides a comprehensive analysis of the reasons for the enactment of the new statutory section, the competing policies animating the Leahy-Smith America Invents Act and the Federal Rules of Civil Procedure, and the appropriate interpretation and application of the new law. Such analyses have, to date, been absent from the legal conversation.
This Note argues that modern-day patent litigation lacks sufficient consideration of public policy concerns. In order to remedy this, I propose three potential solutions that would broaden standing in patent declaratory judgment actions, thereby allowing more plaintiffs who are likely to raise such arguments to have their day in court. First, I discuss expanding standing within the Supreme Court’s MedImmune framework, which requires courts to apply a broad all-the-circumstances test in determining patent declaratory judgment standing. Within this test, I urge courts to consider (1) the degree to which a potential infringer raises important public policy concerns and (2) the extent to which the potential infringer has a unique economic incentive to challenge the patent-at-issue. Second, I consider altering the framework for standing in patent declaratory judgment actions based on a reassessment of the fundamental justifications for standing doctrine generally. Observing that the traditional justifications for a standing requirement—and the separation of powers justification in particular—do not apply in the context of patent declaratory judgment actions, I suggest that the Supreme Court might craft a new standing framework. Third, I explore the extent to which Congress might statutorily expand standing in such cases. I conclude by noting that the post-grant opposition procedure created by the America Invents Act—the patent reform legislation signed into law in September 2011—is insufficient to assuage unease regarding the lack of public policy arguments in patent litigation. Courts might therefore look to standing in order to address this problem.
One of the basic requirements for patenting an invention is that the invention be
nonobvious. Following the Supreme Court’s decision in Graham v. John Deere,
secondary considerations—also known as objective indicia of nonobviousness—
have been considered when determining whether an invention is nonobvious. Secondary
considerations provide tangible evidence of the economic and motivational
issues relevant to the nonobviousness of an invention. Types of secondaryconsiderations
evidence include commercial success, long-felt but unmet need, and
copying by competitors. For many years, the Federal Circuit’s teaching, suggestion,
or motivation test often eliminated the need for the court to rely on secondary considerations
in the obviousness inquiry. Due to the Federal Circuit’s stringent application
of this test, the obviousness inquiry was generally resolved by examining the
In 2007, the Supreme Court decided KSR v. Teleflex, which endorsed a flexible
obviousness analysis and rejected the Federal Circuit’s strict application of the
teaching, suggestion, or motivation test. Following KSR, scholars predicted that
secondary-considerations evidence would provide a critical tool for patentees
seeking to demonstrate the nonobviousness of an invention. Inspired by that prediction,
this Note evaluates how secondary-considerations evidence has been utilized
in the first few years post-KSR. It finds that the Federal Circuit has continued to
impose stringent relevancy requirements on the use of secondary-considerations
evidence, and that it remains difficult for patentees to employ secondary considerations
in favor of a nonobviousness conclusion. Specifically, secondaryconsiderations
evidence has not been used with much success outside of pharmaceutical
patent cases. More often than not, the Federal Circuit has summarily dismissed
secondary-considerations evidence as insufficient in cases involving
mechanical arts patents. This Note concludes by suggesting that the Federal
Circuit’s current practice for using secondary considerations should inform proposals
by scholars for industry-specific tailoring of the patent system and patent
law’s use of secondary considerations, and that the Federal Circuit should continue
to engage with secondary-considerations evidence in order to provide more guidance
to lower courts during the post-KSR transition period.
For the great majority of its history, the written description requirement was an
often-ignored relic of the patent statute. As technology advanced, the written
description requirement developed teeth as a means for invalidating patent claims
during litigation. Written description doctrine reached its peak in Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co., when the Federal Circuit created a significant
setback for groundbreaking innovation. Ariad demonstrated that the written
description doctrine lacked sufficient recognition of the fundamental policies and
purposes of the patent system and that this could have serious consequences for
innovation. This Note attempts to rectify the written description doctrine by
reorienting the doctrine in innovation policy. To do so, I first apply an alternative
version of the “prospect theory” of patents to conventional patent policy. Based on
this policy calculus, I then devise a reformed hypothetical innovation test that looks
outside of the “four corners” of the patent and considers the larger impact that the
written description has on the patent system. Without such doctrinal reform, the
written description doctrine of Ariad and its legacy risks undermining the incentives
that motivate inventors to undertake cutting-edge technology.
Intellectual property protects investments in the production of information, but the relevant literature has largely neglected one type of information that intellectual property might protect: information about the market success of goods and services. A first entrant into a market often cannot prevent other firms from free riding on the information its entry reveals about consumer demand and market feasibility. Despite the existence of some first-mover advantages, the incentives to be the first entrant into a market may sometimes be inefficiently low, thereby giving rise to a net first-mover disadvantage that discourages innovation. Intellectual property may counteract this inefficiency by providing market exclusivity, thus promoting earlier market entry and increasing the level of entrepreneurial activity in the economy. The goal of encouraging market experimentation helps to explain certain puzzling aspects of current intellectual property doctrine and provides a coherent basis for appreciating some of the current criticisms of intellectual property rights.