Law Commons^™

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Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes.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 …

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 …

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.