Law Commons^™

The Federal Circuit As An Institution, Ryan G. Vacca

Law Faculty Scholarship

The Court of Appeals for the Federal Circuit is a unique institution. Unlike other circuit courts, the Federal Circuit’s jurisdiction is bound by subject area rather than geography, and it was created to address a unique set of problems specific to patent law. These characteristics have affected its institutional development and made the court one of the most frequently studied appellate courts. This chapter examines this development and describes the evolving qualities that have helped the Federal Circuit distinguish itself, for better or worse, as an institution.

This chapter begins with an overview of the concerns existing before creation of …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Acting Like An Administrative Agency: The Federal Circuit En Banc, Ryan G. Vacca

Law Faculty Scholarship

When Congress created the Federal Circuit in 1982, it thought it was creating a court of appeals. Little did it know that it was also creating a quasi-administrative agency that would engage in substantive rulemaking and set policy in a manner substantially similar to administrative agencies. In this Article, I examine the Federal Circuit's practices when it orders a case to be heard en banc and illustrate how these practices cause the Federal Circuit to look very much like an administrative agency engaging in substantive rulemaking. The number and breadth of questions the Federal Circuit agrees to hear en banc …

From At&T To Brand X Declining Checks And Balances In An Increasingly Complex Marketplace, Ross G. Hicks

The University of New Hampshire Law Review

When President Clinton signed the Telecommunications Act of 1996, he used the same pen that President Eisenhower used to sign legislation for the Interstate Highway system into law. It was a fitting analogy. In the same way that the interstate road system was expected to open up interstate commerce, the Internet system was expected to open up electronic commerce. In signing the 1996 legislation into law, President Clinton and Congress were updating the regulatory and legislative framework to adapt it to the new realities and opportunities provided by the Internet. The legislation noted that broadband access to the Internet was …

Administrative Agencies: A Comparison Of New Hampshire And Federal Agencies’ History, Structure And Rulemaking Requirements, Scott F. Johnson

The University of New Hampshire Law Review

[Excerpt] "In this day and age it is difficult to think of anything that is not regulated in some way by a state or federal agency. State and federal agencies routinely make decisions that impact our daily lives. The air we breathe, the water we drink, the food we eat, the clothes we wear, and the places where we live and work are all regulated to some extent.

Agencies sometimes regulate things in ways that lead to strange results. For example, New Hampshire, state regulations allow anyone to own a yak, a bison, a wild boar, or an emu, but …

Rule-Making Petition Concerning Eligibility, Under 37 C.F.R. § 11.7 To Sit For The Examination For Registration To Practice In Patent Cases Before The United States Patent And Trademark Office, Thomas G. Field Jr.

Law Faculty Scholarship

This Petition under 5 U.S.C. § 553(e) is filed on behalf of Petitioner and other parties with legally-cognizable interest (hereafter “Signatories”) in the specification of credentials under guidelines promulgated by the PTO Office of Enrollment and Discipline (“OED”) and amended from time without public notice or opportunity to comment. Signatories include individuals likely to be unfairly refused permission to sit, individuals whose status is uncertain, and professors with an interest in whether their students may or may not be permitted to sit. Signatories hereby request that the PTO, in accordance with 35 U.S.C. § 2(b)(2)(D), amplify the qualifications sufficient to …

Judicial Review Of Copyright Examination, Thomas G. Field Jr

Law Faculty Scholarship

Copyright in qualifying United States works has always arisen upon creation. For many years, however, rights could be lost by failing to, e.g., provide notice, register and deposit copies when works were first published. In 1909 formal requirements were reduced, and the Supreme Court, in 1939, concluded that registration with the U.S Copyright Office was unnecessary to retain rights. Despite that, owners could not sue infringers without having registered.

Regarding registration as helpful if not obligatory, this paper compares the burden on moving parties in circumstances in which registration decisions may be challenged in courts.

Zurko, Gartside, And Lee: How Might They Affect Patent Prosecution?, Thomas G. Field Jr

Law Faculty Scholarship

Interactions between the PTO and the courts are more complex than for most agencies. PTO decisions may be challenged not only directly but also collaterally. In the latter context, the Supreme Court has sometimes been critical of the lax standards applied when issuing patents.

While being upheld in collateral review is the ultimate issue of concern to patentees, patents must first be obtained. Thus, this paper focuses on direct challenges to PTO actions--and more specifically, on the review arising under 35 U.S.C. §§ 141-44 as addressed in Zurko, Gartside, and Lee.

Since the Supreme Court reversed the …

Direct Judicial Review Of Pto Decisions: Jurisdictional Proposals, Thomas G. Field Jr

Law Faculty Scholarship

Judicial review of U.S. Patent and Trademark Office ("PTO") decisions is complex-- perhaps more than that of any other agency. One source of complexity is that courts review its decisions both collaterally and directly.

One goal of this article is to map possible routes to judicial review and suggest strategies for avoiding jurisdictional uncertainties and delay. The core thesis of this article, however, is that parties should not need to cope with arcane review schemes. Direct PTO review can and ought to be simplified. This can be accomplished by adjusting the Federal Circuit's original and appellate jurisdiction.

Chevron Deference To The Uspto At The Federal Circuit, Thomas G. Field Jr.

Law Faculty Scholarship

Courts have long deferred to agency views of law, but they have also often refused. The Federal Circuit, too, defers on some occasions but not others. This paper examines the apparent inconsistency in its cases.

How To Achieve Public Participation In Nuclear Waste Decisions: Public Relations Or Transparent Adversary Science, Judy Treichel

RISK: Health, Safety & Environment (1990-2002)

[Excerpt] "Commercial nuclear reactors in the United States have been producing electricity and highly radioactive wastes for more than forty years. Originally, reluctant utilities built reactors at the urging of Congress, acting in accordance with the Atomic Energy Act. The Act called for promotion of nuclear technology and also provided a shield of secrecy allowing for extensive power to classify information. Wiretapping and other surveillance techniques were allowable if nuclear secrets or interference with nuclear programs were involved. During this time the Atomic Energy Commission (AEC) provided films and comic books, and gave speeches in a public relations campaign designed …

Normalizing Novelty: Regulating Biotechnological Risk At The U.S. Epa, Les Levidow, Susan Carr

RISK: Health, Safety & Environment (1990-2002)

Drs. Levidow and Carr examine EPA's regulation of biotechnology in the field of genetically modified organisms.

Zurko Raises Issue Of Patentability Standards, Thomas G. Field Jr.

Law Faculty Scholarship

In re Zurko isolated one of the oldest U.S. agencies from mainstream administrative law because the Federal Circuit has chosen to review the U.S. Patent and Trademark Office more as it would a federal district court. The case is important, if only because the Supreme Court rarely treats the PTO as an agency. Also, regardless of whether the issue or the Federal Circuit itself is the primary target, the decision could have a major effect on the type of case most commonly encountered by that court.

Brief Amici Curiae Of Intellectual Property Professors In Support Of Petitoner, Thomas G. Field Jr., John F. Duffy, Craig Allen Nard

Law Faculty Scholarship

Congress enacted the Administrative Procedure Act (APA) in 1946 as a comprehensive statute to regulate the field of federal administrative law. In holding that the PTO Board of Patent Appeals and Interferences is not subject to the standards of judicial review set forth in the APA, the [Zurko] decision isolates patent law from the rest of administrative law and undermines the APA’s goal of achieving consistency and uniformity in federal administrative law.

Amicus Brief Of Thomas G. Field, Jr., Pro Se Supporting In Principle, On Rehearing The Commissioner Of Patents And Trademarks, Thomas G. Field Jr.

Law Faculty Scholarship

To those unfamiliar with the long, often bitter, struggle over equally compelling needs to provide, on the one hand, innovators with an adequate opportunity to recoup risk capital and to avoid, on the other, erecting unwarranted barriers to competition, a dispute over the proper scope of review for Patent and Trademark Office (PTO) patent appeals will seem both trivial and arcane. This case involves more than semantics -- its resolution turns on the allocation of power among three, and arguably four, branches of government. This Court, itself, has a stake.

The Rationale For Negligible Risk Exemptions In The Telecommunications Act Of 1996: Cellular Phone And Personal Communication System Transmitters, Gregg H. Claycamp

RISK: Health, Safety & Environment (1990-2002)

Dr. Claycamp explains the adequacy of current legislation and regulation.

A Method Of Identifying Hazardous Highway Locations Using The Principle Of Individual Lifetime Risk, Paul J. Ossenbruggen

RISK: Health, Safety & Environment (1990-2002)

Dr. Ossenbruggen presents a scientific framework for identifying hazardous highway locations that may be more easily understood by non-scientists and has potential for comparing highway with other risks to health.

Managing The Iatrogenic Risks Of Risk Management, Jonathan Baert Wiener

RISK: Health, Safety & Environment (1990-2002)

Analogizing to concerns that led the practice of medicine to shift from a specialist to a team-based approach, Dr. Wiener suggests that public and environmental health objectives would be better served if, e.g., regulatory jurisdiction were less atomized.

Promulgating Requirements For Admission To Prosecute Patent Applications, Michelle J. Burke, Thomas G. Field Jr

Law Faculty Scholarship

Among federal agencies, the U. S. Patent and Trademark Office is unique in its ability to require attorneys to submit to special requirements, such as passing a six hour examination, before being permitted to practice before it in patent cases. Indeed, the Supreme Court has held that an individual so admitted to practice before the PTO need not comply with state requirements otherwise applicable to those practicing law.

The first part of this article discusses how this requirement came to be. It then discusses how the PTO determines whether an individual is fit to sit for the patent examination, focusing …

Maximum Individual & Vicinity-Average Dose For A Geologic Repository Containing Radioactive Waste, Thomas H. Pigford

RISK: Health, Safety & Environment (1990-2002)

Explains the basis for his strong dissent to an NAS report on Yucca Mountain.

Dioxin: Reassessing The Risk, Linda-Jo Schierow

RISK: Health, Safety & Environment (1990-2002)

Dr. Schierow briefly summarizes the status of a draft Environmental Protection Agency report reassessing the appropriate treatment of dioxin and describes ongoing intra- and extramural reviews of the reassessment.

Access To And Authority To Cite Unpublished Decisions Of The Pto, Thomas G. Field Jr

Law Faculty Scholarship

This paper begins with the Solicitor [of the U.S. Patent and Trademark Office]'s explanation of the term "unpublished." It then reviews various kinds of published PTO decisions where the precedential effect of unpublished decisions has been addressed. There, we see that the PTO has generally not ignored unpublished precedent--at least, deliberately--and that the Solicitor agrees that this may not be done. Next, this paper examines the almost universal practice of federal appeals courts disallowing use of their unpublished decisions as precedent--and some of the reasons for widespread criticism of that practice. It also discusses some of the reasons that judges, …

Public Participation In Risk Management Decisions: The Right To Define, The Right To Know And The Right To Act, Frances M. Lynn

RISK: Health, Safety & Environment (1990-2002)

It is important to solicit public opinions before making decisions about Risk, but this is seen as only a first step. The author observes that it is also important that the public be involved in defining the problem, identifying needed information, interpreting information, and choosing among the options for action.

Legislative Oversight Of Administrative Rulemaking In New Hampshire, Scott F. Eaton

RISK: Health, Safety & Environment (1990-2002)

This paper explains how administrative rules are made in a small state. It also analyzes the role of a joint legislative committee which oversees the process and concludes that such oversight generally increases opportunities for public scrutiny of rules and public participation in rule making.

Public Participation In Risk Regulation, Thomas O. Mcgarity

RISK: Health, Safety & Environment (1990-2002)

After discussing the increasing recognition of different kinds of claims for public participation in Risk regulation, this paper discusses a spectrum of approaches and examines six points along its range.

Scientific Conventions, Ethics And Legal Institutions, Carl F. Cranor

RISK: Health, Safety & Environment (1990-2002)

This article examines the use of epidemiology to evaluate Risks posed by toxic substances. Using illustrations drawn from an elaborate example, it argues that scientists applying usual conventions in doing statistical studies tend to ignore important normative issues.