Fall 1999

3 credits; Monday, 4:00 to 5:50 p.m.

Mr. Gellhorn   Tel. 202/319-7104
Fax: 202/319-7106


This seminar involves an in-depth examination of two basic issues of statutory construction in administrative law: the first, a determination of the scope of an agency’s organic authority and the second, the meaning of a previously unanalyzed section of the Administrative Procedure Act. You will examine these questions in class discussions and through briefing and argument on two problems: (1) the authority of the Food and Drug Administration to regulate tobacco products, and (2) the standard of review applied to fact-finding by the U.S. Court of Appeals for the Federal Circuit when reviewing patentability determinations by the Board of Patent Appeals and Interferences. Both problems are based on current Supreme Court cases except that the assignment has been modified for purposes of this seminar.

The first problem, which will be the focus of the first ten weeks of the seminar, will involve preparation of a brief on the merits either for petitioner (the FDA) or respondents (the tobacco industry) on appeal from a decision of the U.S. Court of Appeals for the Fourth Circuit. For purposes of this seminar, the petition for a writ of certiorari was granted limited to the following question: "Whether the court of appeals should have deferred under step two of the Chevron doctrine to the FDA’s interpretation of its authority under the FDCA to regulate tobacco products where Congress also has enacted a series of specific statutes authorizing other agencies to regulate the marketing of such products?"

The second problem, which will be completed in the last four weeks, will involve an oral argument on the question: "Whether the U.S. Court of Appeals for the Federal Circuit should review PTO fact-findings under the APA standard of review instead of the presently applied ‘clearly erroneous’ standard?" The briefs of the parties and the opinion of the court below are included in the Source Materials attached to this Syllabus.

Class sessions will be devoted to exploring the legal issues involved in each of these problems. For example, on investigating the FDA’s authority to regulate tobacco, we will examine the Chevron doctrine and its application where more than one set of statutes is involved or where the agency is seeking authority substantially outside its usual mandate. Similarly, the Zurko oral argument will require an understanding of the history of the APA and how statutory saving clauses (in this case, the provisions of 5 U.S.C. § 559 providing that "additional requirements" either "imposed by statute or otherwise recognized by law" were not "limited or repealed" by the APA) are to be read. These assignments will involve original research and require familiarity with research materials in administrative law.

You will represent the agency (either the FDA or Patent and Trademark Office) in one problem and a private party in the other (either the tobacco industry or a disappointed inventor). You will act as the sole representative of your client; teams will not be formed.

  • For the first problem, your brief shall comply with the rules of the Supreme Court of the United States except as modified herein. Colored covers are not required and a Joint Appendix will not be prepared. Each party will submit a brief which is limited to 50 pages (8½ by 11 inches, double-spaced, and 12 point type with standard 1 inch margins. No reply brief shall be filed. Due dates are set forth in the attached Calendar.

  • For the second problem, your oral argument will be to the Supreme Court of the United States. Each side is allotted 20 minutes.

  • Your grade will be based on your brief (which will be your writing grade), oral argument, and class presentations, discussion and attendance. All papers, presentations and arguments will be submitted to me at class on the due date. Your briefs will be submitted to opposing counsel at class on the due date. Plan your schedule (with a margin for error) according to the attached Calendar; extensions will not be granted.

    Calendar (dates, topics and assignments subject to change)

     CLASS # 1: AUGUST 23, 1999

    Introduction: Review of seminar subject and assignments.

    Distribution and Discussion: Course Syllabus.

    CLASS # 2: AUGUST 30, 1999

    Discussion: Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (M.D.N.C. 1997).

    Designation of client representation.


    No Class

    CLASS # 3: SEPTEMBER 13, 1999

    Discussion: Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155 (4th Cir. 1998), rehearing den., 161 F.3d 764.

    CLASS # 4: SEPTEMBER 20, 1999:

    Discussion: Review of Chevron decision and doctrine (e.g., steps one and two; statutory scope).

    CLASS # 5: SEPTEMBER 27, 1999:

    Discussion: Application of Chevron to FDA interpretation of authority under FDCA.

    CLASS # 6: OCTOBER 4, 1999:

    Discussion: Application of Chevron doctrine to FDA interpretation of tobacco-specific statutes and application of such statutes and FDCA to FDA authority to regulate tobacco.


    Fall Recess (No Class)

    CLASS # 7 OCTOBER 18, 1999:

    Discussion: Brief writing.

    CLASS # 8 OCTOBER 25, 1999

    Submission of Draft Brief for the Petitioner to Opposing Counsel

    CLASS # 9: NOVEMBER 1, 1999

    Submission of Final Brief for the Petitioner

    Discussion: In re Zurko, 142 F.3d 1447 (Fed. Cir. 1998)(en banc).

    CLASS # 10 NOVEMBER 8, 1999

    Submission of Final Brief for the Respondents

    Discussion: Brief for the Petitioner, Dickinson v. Zurko, S.Ct. Docket No. 98-377.

    CLASS # 11 NOVEMBER 15, 1999

    Discussion: Brief for the Respondent, Dickinson v. Zurko, S.Ct. Docket No. 98-377.

    CLASS # 12: NOVEMBER 22, 1999

    Discussion: Reply brief for the Petitioner, Dickinson v. Zurko, S.Ct. Docket No. 98-377. Considerations in preparation for oral argument.

    CLASSES 13 & 14: NOVEMBER 29 & DECEMBER 1, 1999

    Oral Arguments on Standard of Review by CCPA of PTO Fact-Finding.