Resolving uncertainty in biotechnology patent law: foreword to the second annual journal of high technology law symposium.

• Author: Beckerman-Rodau, Andrew

On November 18, 2005, Suffolk University Law School's Advanced Legal Studies program presented a conference entitled: "Safe Harbour/Experimental Use, Inherency, Obviousness, and Utility: Resolving Uncertainty in Biotechnology Patent Law." The conference was co-sponsored by the Intellectual Property Law Concentration at Suffolk University Law School, the Boston Patent Law Association, Hamilton, Brook, Smith & Reynolds, P.C., and the Journal of High Technology Law (JHTL). The conference brought together distinguished patent attorneys, corporate counsel for biotechnology companies, and officials from the United States Patent and Trademark Office in Alexandria, Virginia.

As advisors to the JHTL and Directors of the Intellectual Property Law Concentration at Suffolk University Law School, we are pleased to introduce the Second Annual JHTL Symposium issue. The articles in this issue, first presented at the above conference, are doctrinal, policy-driven, and reform-minded. Together, they offer insightful commentary on recent Supreme Court and Federal Circuit decisions that affect both the patentability and the scope of protection afforded biotechnology innovations.

The title of the symposium issue reflects the dilemmas faced by the biotechnology industry in light of unclear messages from the federal judiciary. The articles focus on important biotechnology patent law issues such as the statutory safe harbor exemption, common law experimental use, utility, written description, nonobviousness and anticipation. This introduction will briefly review the four articles comprising this Symposium issue.

"In re Dane K. Fisher: An Exercise in Utility," by N. Scott Pierce

As America enters the new millennium, the future of biotechnology patent law remains in doubt because recent Federal Circuit decisions do not appropriately balance the rights of inventors against the needs for scientific innovation. Pursuant to the Patent Act (3) an invention must satisfy the novelty, utility, and nonobviousness requirements to receive patent protection. (4) The role of the United States Patent and Trademark Office (PTO) patent examiner is to determine whether a patent application fulfills these requirements. In the field of biotechnology patents, unlike other areas of technology, utility is often a difficult issue.

N. Scott Pierce, a partner at Hamilton, Brook, Smith & Reynolds P.C. in Concord, Massachusetts and an adjunct professor of law in the Intellectual Property Law Concentration at Suffolk University Law School, authored a monograph length study of the concept of utility in the wake of the recent Federal Circuit decision in In re Dane K. Fisher and Raghunath V. Lalgudi. (5) The Court "denied patentability to expressed sequence tags (ESTs)" (6) because they were "only tools to be used along the way in the search for a practical utility" and therefore lacked "an immediate real world benefit" (7) which is a requirement for a finding of substantial utility. (8) Pierce contends that In re Dane K. Fisher and Raghunath V. Lalgudi misconstrues the utility concept. Worse yet, the Federal Circuit's decision threatens the long-term viability of the biotechnology industry by blocking "the patentability of many inventions, the benefit of which may be immediate but not fully appreciated until much later." (9)

Part I of Pierce's article is a magisterial historical study of the utility concept tracing the path of the law from the Patent Act of 1793 to 2005 cases. He cites the bellwether decision by Circuit Justice Joseph Story in Bedford v. Hunt, et. al. (10) which defined utility to mean that an invention only be "capable of use," and not contrary to "sound morals and policy," to satisfy Section 1 of the Patent Act of 1793. Next, he examines other Justice Story opinions construing the statutory interpretation of utility. (11) Nineteenth century opinions concurred in whole with Justice Story's circumscribed view of utility. (12)

Pierce next demonstrates that English common law interpretations of utility were consistent with Justice Story's perspective. (13) He provides sure-footed historical and doctrinal evidence that the historical meaning of utility drawn from early jurisprudence is at odds with the Federal Circuit's recent reconceptualization of utility. Pierce's article next completes a content analysis of Patent Law treatises of the late nineteenth century. His unequivocal conclusion is that that the Anglo-American concept of "new" was equated with "comparative and relative utility," (14) at odds with recent Federal Circuit jurisprudence.

Early twentieth century cases occasionally considered the concept of "utility" to be separate and distinct from "suitability for an intended use." (15)...