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Journal of Technology Law & Policy

Document Type

Article

Abstract

Every so often a case comes along that is equally interesting for its non-legal oddities as it is for its legal merits. Association for Molecular Pathology v. U.S. Patent and Trademark Office (BRCA Lawsuit) is one of those cases. The BRCA Lawsuit is significant enough that scholars, bloggers, pundits, students, scientists, politicians, and many others have provided comments on the BRCA Lawsuit, ranging from in-depth analyses to unsubstantiated opinions.

While many peculiarities can be found in the BRCA Lawsuit, one noteworthy oddity relates to the affidavits submitted by several of the individual plaintiffs and the plaintiffs’ arguments that gene-related patents are non-statutory subject matter. The reason that the plaintiffs’ position is so bizarre is that several of the individual plaintiffs are also inventors on isolated-sequence-related patents or patent applications. Thus, on one hand, these plaintiffs submit that Myriad’s BRCA isolated-sequence-related patents are directed to non-statutory subject matter; yet, on the other hand, they submit that their own isolated-sequence-related patents are directed to patentable subject matter.

This Article asks some very simple questions in view of this apparent schism. Namely, what happens when an inventor applies for a patent for an invention that the inventor does not believe to be patentable, yet withholds that information from the U.S. Patent and Trademark Office (USPTO or PTO)? Correspondingly, what happens when the inventor’s attorney, or other entity that is substantively involved in prosecuting the patent, has information that the subject matter is non-statutory, yet withholds that information from the USPTO?

We begin this Article by providing background information on the general entities that are involved in the isolated-sequence-patenting controversy. Hopefully, this historical context helps the reader understand why the BRCA Lawsuit is significant. In the background part, we also discuss specific academic institutions and the general process by which those institutions apply for patents.

After setting out the background information, we describe our methodology for determining which issued patents and published patent applications are relevant to our analysis, and provide the results as they relate to specific academic institutions.

Once our methodology and results are tallied, we next discuss the cases that are central to our Article. First, we review the relevant portions of the proceedings, focusing particularly on several individual plaintiffs, their positions in the BRCA Lawsuit, and sworn statements filed by those plaintiffs in the BRCA Lawsuit. Second, we discuss the law relating to inequitable conduct, specifically reviewing the highly divided en banc opinion in Therasense v. Becton, Dickinson & Co. This review of inequitable conduct provides the legal context in which we examine the plaintiff's statements. Thereafter, we analyze the isolated-sequence-related patent portfolios of the relevant institutions to determine the extent to which the isolated-sequence-related patents are susceptible to allegations of inequitable conduct.

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