The experimental use exception and undergraduate engineering projects.

• Author: Welch, Henry L.

INTRODUCTION I. CAPSTONE SENIOR DESIGN PROJECTS A. The Accreditation Board for Engineering and Technology B. Exemplary Capstone Senior Design Projects 1. Typical Characteristics of Capstone Senior Design Projects 2. Typical Projects in the Computer and Software Engineering Degree Programs at MSOE 3. Typical Projects in the Mechanical Engineering Degree Program at MSOE C. Comparing Graduate Research to Undergraduate Capstone Senior Design Projects 1. Characteristics of Graduate Research 2. Characteristics of Undergraduate Capstone Senior Design Projects II. PATENT INFRINGEMENT AND THE EXPERIMENTAL USE EXCEPTION A. Origins and Development of the Experimental Use Exception B. Narrow Interpretation of the Experimental Use Exception and the Federal Circuit C. New Life: The Food and Drug Administration Safe Harbor III. THE EXPERIMENTAL USE EXCEPTION AND CAPSTONE SENIOR DESIGN PROJECTS A. Industry-Sponsored Projects B. Design-Competition Projects C. Student-Sponsored Projects CONCLUSION INTRODUCTION

Following four long years of higher education, Joe Engineering Student is looking forward to graduation and reaping the benefits of his education. After countless hours spent reading textbooks, answering homework problems, studying for and taking exams, and working on laboratory projects, Joe is finally ready to take his proud stroll across the graduation stage. He is especially proud of the fine work he and his partners have done on their capstone senior design project over the past nine months. Joe is, in fact, so proud of his team's fine engineering work that he has included a brief description of the project on the resume he has been using during his search for employment, and his team has taken the time to chronicle their efforts using a web page. (1) It is only a matter of days before Joe and his partners will be giving their final presentations to the rest of their classmates and taking part in the annual senior design show. Joe has been looking forward to this day because not only will it represent the culmination of this hard-won education, but he will also have the opportunity to show off the project to his fiance and the rest of his family. On this day, like many others, he stops by his mailbox on the way to class. Within the mailbox he finds a letter from Brown & Smith. Joe cannot recall sending a copy of his resume to an engineering firm by that name, but he opens it immediately thinking it might include a job offer. His hopes are quickly dashed. Brown & Smith have sent Joe, and the rest of his project teammates, a cease and desist letter. According to Brown & Smith, Joe's project appears to infringe upon one or more of their client's patents. The letter further informs Joe that failure to immediately cease the infringing activity makes him liable for treble damages. What is Joe to do? If he heeds the letter, then he cannot present his project. If he does not present his project, then he cannot graduate. And there simply is not time to figure out how the project may be infringing upon the indicated patents, much less re-engineer the project so that it is no longer infringing. What can Joe do?

After panicking, Joe calms down and calls his aunt, an intellectual property attorney. His aunt explains to him the unlikelihood that he and his team will, in fact, be sued for this alleged infringing use. (2) While this may be of some comfort to Joe, it really does not help Joe answer the real question regarding his legal options should he and his team be found to be infringing. Assuming, arguendo, that Joe's project does infringe some of these patents, what substantive legal advice can be given to Joe?

In general, U.S. patent law provides a patent holder only with negative rights with respect to a patent. (3) More specifically, the United States Code describes infringement as any unauthorized activity that "makes, uses, offers to sell, or sells any patented invention." (4) The Code does not make any specific provision that the intent of the infringer is a factor in any analysis of infringement. (5) Nevertheless, there is a long tradition of a judicially created exception to this rule, referred to as the "experimental use exception." (6) The Circuit Court of Appeals for the Federal Circuit [hereinafter Federal Circuit], in its recent decisions in Madey v. Duke University (7) and Integra Lifesciences I, Ltd. v. Merck KGaA, (8) has very narrowly interpreted the extent of the experimental use exception. (9) There has been much commentary on the effect these decisions will have on the university research community, but so far no one has substantively addressed the experimental use exception in the context of undergraduate education and, more specifically, how the exception might be applied to capstone senior design projects. This Comment will address this issue and explain how the exception is likely to be applied to capstone senior design projects.

Part I of this Comment will describe the characteristics of typical capstone senior design projects. They will be compared with the graduate research programs that are generally addressed by other commentary on the experimental use exception, and the relevant elements of these undergraduate projects will be identified. Part II of this Comment will review the history and evolution of the experimental use exception to identify the rationale and criteria under which the Federal Circuit is basing its decisions. The experimental use exception will then be applied to capstone senior design projects to determine if and when it is available as a defense to infringement in Part III. The results of this analysis will then be summarized in Part IV.

1. CAPSTONE SENIOR DESIGN PROJECTS

   Undergraduate engineering education in the United States is driven by a number of complex, interweaving concerns and demands. Chief among these concerns is that a university with an engineering degree program is expected, in a relatively short four-year period, to transform a high school graduate with a strong mathematics or science background and little or no knowledge of either engineering or engineering principles, into a work-ready graduate who is prepared to practice engineering upon graduation. In fact, engineering is one of the few professions that provides the bulk of its formal training at the undergraduate level, (10) with most other professions requiring additional years of graduate school training. (11)

   Colleges and universities in the United States graduate over 73,000 engineers each year. (12) As is natural among all professions, both prospective engineering students and the industries hiring those graduates would like some assurances that the engineering education being provided meets certain standards for quality and thoroughness. To satisfy this requirement, the vast majority of engineering programs in the United States voluntarily participate in an accreditation process coordinated by the Accreditation Board for Engineering and Technology ("ABET"). (13) To achieve this lofty goal, ABET promulgates a series of accreditation criteria that programs must meet to satisfy the accreditation process. (14) A common requirement among all engineering programs is a "major design experience," (15) which most engineering degree programs incorporate into their curricula as a capstone senior design project. The following Sections will further examine the capstone senior design project by describing the ABET accreditation process, looking at the characteristics of some common types of capstone senior design projects, and then comparing the capstone senior design project to graduate research.

   1. The Accreditation Board for Engineering and Technology

      ABET is the recognized accreditation agency for degree programs in engineering, computing, applied science, and technology. (16) Its primary responsibility is to ensure that the graduates of these degree programs have received a quality education. (17) ABET was founded in 1932, and it is comprised of a federation of twenty-eight technical and professional societies covering the broad range of degree programs it accredits. (18) Using, primarily, a labor force of more than 1500 volunteers, ABET accredits approximately 2700 degree programs at over 550 colleges and universities across the United States. (19) During the 2004-2005 academic year, ABET was responsible for accreditation activities that affected 664 degree programs across the country. (20)

      Over the years, ABET has promulgated a series of criteria for the various programs it is responsible for accrediting. Because ABET believes that each of the technical specialties is in the best position to determine which criteria should be applicable to specific degree programs, it has divided the accreditation criteria into two components: general criteria applicable to all accredited programs and program criteria applicable to various degree programs based upon the name of the degree granted. (21) To accomplish this goal, ABET has divided itself into four accreditation commissions with each responsible for one of ABET's four main areas. (22) Most engineering degree programs fall under the responsibility of the Engineering Accreditation Commission (EAC). (23) The last major revision to the engineering accreditation guidelines was developed at the end of the twentieth century and is colloquially referred to as "Criteria 2000." (24) Since its adoption in the late 1990s, Criteria 2000 has undergone a series of regular revisions. (25)

      Engineering degree programs subject to accreditation under Criteria 2000 must satisfy eight general criteria (26) in addition to criteria specific to the degree program. (27) While each of the eight criteria are of equal importance, the most comprehensive and time consuming to evaluate is Criterion 3. (28) Criterion 3 identifies eleven specific abilities that engineering students must demonstrate upon graduation and serves as a general description of the abilities that an engineer...