Black Box Biotech Inventions: When a "mere Wish or Plan" Should Be Considered an Adequate Description of the Invention

• Citation: Vol. 17 No. 3
• Publication year: 2010

Black Box Biotech Inventions: When a "Mere Wish or Plan" Should Be Considered an Adequate Description of the Invention

Robert A. Hodges

Introduction

Consider two inventors. The first inventor discovers a new way to allow a modem to switch between modes of operation.[1] Prior modems would send and detect special codes called "escape sequences" to signal when the modem should switch modes.[2] The problem was how to distinguish authentic escape sequences from spurious escape sequences embedded in the data being transmitted by the modem.[3] The inventor solves this problem by requiring that his modem recognize an escape sequence as authentic only if it is preceded and followed by a one-second pause in the signal.[4] The first inventor contemplates that the modem should use a timer to determine when the required pauses have occurred.[5] In his patent application, the inventor describes the modem in electronic terms, including the use of a microprocessor to control the modem.[6] The inventor refers to the timer only in terms of a "timing means" without providing any description of a structure for the timing means.[7] This limited description is not a problem for others wishing to make the new modem because computer engineers know how to create timers by programming microprocessors.[8] Many different programs can serve this function, each having a different structure (i.e., different program steps).[9] None of the possible programs was described by the first inventor in his patent application, and only some of them were contemplated by him at the time.[10]

The second inventor has, through laborious effort, obtained a clone of a rat gene.[11] This inventor is interested in the rat gene because it corresponds to a human gene involved in diabetes and because the product of the human gene can be used to treat diabetics.[12] Specifically, this inventor is interested in the rat gene because she knows it will allow her to obtain the corresponding human gene with much less effort than it took to obtain the rat gene.[13] Because of the evolutionary relationship between rat and human genes, the inventor knows that she can use routine molecular biological techniques to obtain a clone of the human gene using the rat gene.[14]

Significantly, should the inventor disclose the sequence of the rat gene to other researchers or make the rat clone available to them, the other researchers could just as easily obtain the corresponding human gene.[15] The key event is the cloning of the first gene in a family of corresponding genes.[16] Once a researcher accomplishes this very difficult task, the researcher can typically obtain other members of the gene family with much less effort.[17] The second inventor has essentially opened the field of the gene family to which the rat gene belongs.[18]

In her patent application, the second inventor describes the rat gene, including its sequence, and detailed procedures for using the rat gene to clone the corresponding human gene.[19] After filing her patent application, the inventor uses the rat gene and the procedure described in her application to obtain a clone of the human gene.[20]

The two inventors have both provided new inventive concepts that can be embodied in numerous forms (i.e., many different timing programs and different members of a family of related genes).[21] In both cases, the numerous forms flow from the initial contribution of the inventors (i.e., flanking pauses to be timed and the initial gene in a family of related genes).[22] That is, others skilled in the relevant technologies can produce the numerous additional forms of the inventions without unusual effort.[23] Despite the similarities in the inventive activities of the two inventors and the similar significance of their contributions for extending the invention to additional embodiments, the Court of Appeals for the Federal Circuit has treated the two inventions differently when assessing whether the inventor has "described" the extended embodiments of the invention.[24] Thus, the first inventor can obtain a patent while the second inventor cannot.[25]

One of the basic requirements for obtaining a patent is to fully describe the invention in the patent application.[26] This description requirement originally served only a "notice function," that is, the function of simply establishing exactly what the inventor has invented.[27] More recently, the description requirement has grown in importance and specificity and is used as a means of keeping inventors from later claiming subject matter that they had not invented at the time they filed their patent applications.[28] Courts use this form of the description requirement to find that inventors, such as the first inventor above, have adequately described more than the specific form of their inventions.[29]

In 1997, the Federal Circuit applied a new, stricter form of the written description requirement to a biotech invention.[30] The court held that when claiming a DNA the specification must describe its structure.[31] The court in Regents of the University of California v. Eli Lilly & Co.[32] used this stricter standard to find that the inventors in that case, like the second inventor above, had not adequately described other forms of the original gene obtained by the inventors.[33] However, this analysis creates a problem because the resulting standard for the description requirement creates a disconnect between what is required to describe a biotech invention and the amount of information needed (by those in the art) to produce such an invention.[34]

Biotech inventions, such as the one at issue in Eli Lilly, belong to a class of inventions which this Note refers to as "black box" inventions.[35] Black box inventions are those that are made by a process in which results are generally or functionally predictable, but the exact structure or composition of the results is not predictable.[36] The term "black box" comes from electronics and refers to boxes on circuit diagrams where a function, but not the underlying circuitry, is defined.[37] The term is applied to biological systems in its broader metaphorical sense.[38] The study of complex biological processes often begins with an analysis of the starting materials and end products of the process (the black box) where the details of the process are unknown.[39]

This Note explores the application of the description requirement to different inventions and argues that the nature of some biotechnology inventions need not be described by their structure. Part I reviews and discusses the development of the description requirement of 35 U.S.C. Sec. 112. Part II discusses the purpose of the written description requirement and its relationship to the doctrines of conception, reduction to practice, and enablement. Part III analyzes different ways to describe inventions. Part IV describes black box inventions and compares them to other inventions. Part V argues that a black box method should be considered an acceptable basis for describing a black box invention.

I. Development of the Written Description Requirement

Inventors have always been required to describe their inventions.[40] However, the way in which inventors have been required to describe their inventions has not stayed the same.[41] Over time, courts have changed the nature and application of the written description requirement.[42]

A. The Written Description Requirement Originally Served a Notice Function

The original written description requirement served to inform the public of what the inventor had invented, that is, to put the public on notice of what was protected by the inventor's patent.[43] The written description requirement also served to distinguish the invention from what was known before.[44] This "notice function" flowed from the language of early patent statutes.[45] The Supreme Court discussed this form of the written description requirement in Evans v. Eaton,[46] and the Court found a distinct requirement that a patent specification put the public in possession of what the applicant claims as his invention.[47] Under this form, an inventor could claim patent protection for what was described in his patent specification, but not the subject matter that was not described.[48] The need to give the public notice of what is protected by a patent is important. Lack of notice would prevent the public from knowing what they are free to use and what infringes the patent rights of another.[49]

Another case pointing out the notice function of the specification is Merrill v. Yeomans.[50] The Court in Merrill noted that the patent specification must clearly describe what the inventor intends to claim and that the public should not be deprived of the use of subject matter thought to be in the public domain without clearly delineating the limits of such use.[51] The Supreme Court in Gill v. Wells[52] stated that two of the purposes of the description in the specification were "[t]hat the government may know what they have granted and what will become public property when the term of the monopoly expires" and "[t]hat other inventors may know what part of the field of invention is unoccupied."[53] Another purpose was "[t]hat licensed persons desiring to practice the invention may know, during the term, how to make, construct, and use the invention."[54]

B. Claims Replaced the Notice Function

In the middle of the nineteenth century, changes in patent laws and patent practice gave rise to claims as a means of defining what an inventor considered to be his invention.[55] These claims became the stylized, invention-defining objects that are still in use today.[56] Current patent law provides that patent applications "shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention."[57] Claims are a vital and contentious area of patent law today.[58]

Because claims replaced the...