PATENTING THE UNEXPLAINED.

Author:Seymore, Sean B.

Abstract

It is a bedrock principle of patent law that an inventor need not understand how or why an invention works. The patent statute simply requires that the inventor explain how to make and use the invention. But explaining how to make and use something without understanding how or why it works yields patents with uninformative disclosures. Their teaching function is limited; one who wants to understand or figure out the underlying scientific principles must turn elsewhere. This limited disclosure rule does not align with the norms of science and tends to make patent documents a less robust form of technical literature. To address this problem, this Article proposes a two-tiered disclosure paradigm. While compliance with the extant statutory disclosure requirements would still be sufficient to obtain a patent, the inventor could opt to provide a mechanistic disclosure--one that describes how and why the invention works. Providing a mechanistic disclosure would have several upsides for the inventor, improve patent (examination) quality, enrich the public storehouse of technical knowledge, and promote broader goals of the patent system.

TABLE OF CONTENTS INTRODUCTION I. PATENTS AS TEACHING DOCUMENTS A. Disclosure and Patent Law's Teaching Function B. The Enablement Requirement II. PERMISSIBLE IGNORANCE IN PATENT LAW A. Understanding the Nondisclosure Rule B. Early Disclosure as a Justification C. The Transparent-Opaque Invention Dichotomy III. TOWARD MECHANISTIC ENABLEMENT A. New Disclosure Paradigm B. Inducing Disclosure with Broadened Claim Scope 1. Enabling Generic Claims 2. Illustrations a. Opaque Generic Claims b. Transparent Generic Claims C. Reinvigorating an Absolute Experimental Use Privilege D. Complications 1. Difficult-to-Understand Inventions 2. Risky Disclosures 3. Incorrect Mechanisms IV. POLICY CONSIDERATIONS A. Patents as Technical Literature B. Reducing the Information Deficit C. Aligning Patent Law with Scientific Norms D. Tensions CONCLUSION INTRODUCTION

It might be surprising that an inventor can invent something and obtain a patent without understanding how or why it works. Yet such knowledge is not required. (1) If the patent document's disclosure is sufficiently detailed to explain to those skilled in the technology of the invention how to make and use the invention, that is enough to satisfy patent law's so-called enablement requirement. (2) But this minimal disclosure threshold can produce patents that are uninformative from a technical standpoint, meaning that they provide little meaningful information to truly fulfill patent law's disclosure function. (3) Uninformative patents have far-reaching and perhaps unintended consequences that, until now, have been unexplored.

To illustrate, consider the following hypothetical. Suppose that an inventor-researcher seeking to address the prevalence of stomach ulcers discovers how to cure them by administering penicillin to affected individuals. (4) Although the inventor can describe how to provide a therapeutically effective dosage and disclose data from successful use in human subjects, the inventor does not know how or why penicillin works. Although penicillin is an antibiotic, the inventor cannot even identify which (if any) bacteria are involved. (5) While figuring out these details might be demanded for acceptance of the inventor's claim by the scientific community, (6) this minimal disclosure would be sufficient to satisfy patent law's enablement requirement. (7)

Yet while enabling, the resulting patent raises several concerns that cannot be overlooked. First, the patent document merely explains how to practice the invention (8) (or replicate what the inventor did). (9) Arguably this does not go far enough--to be sure, scholars have criticized the current enablement standard as being de minimis. (10) Interested researchers must fill this knowledge void. Because they can rely on neither their own knowledge nor knowledge in the technical field to figure out the omitted information, interested researchers must engage in their own experimentation. But experimental activity by anyone other than the patentee might require a license to avoid liability for infringement. (11)

Second, any subsequent experimentation may come at a point far into the future--perhaps at the end of the twenty-year patent term (12) --or maybe not at all. But what if the inventor could have easily figured out how and why the invention works and disclosed that information in the patent? That would provide an enormous benefit to the public, which otherwise will get nothing more than a "cookbook recipe" replicating what the inventor did. (13) This knowledge void should be a cause for concern given the tremendous societal benefits that emanate from a robust patent disclosure. (14) In the case of drugs, for example, unraveling mechanistic information can lead to more effective or less toxic versions. (15) Relatedly, it is easier to develop new drugs when researchers understand how old ones work. (16)

But figuring out how and why an invention works--what I now define as mechanistic enablement--can also benefit the inventor. At present, inventors have an incentive to claim as much as possible while disclosing as little as possible. (17) Such "overclaim[ing]" creates a statutory enablement problem; (18) nonetheless, inventors argue that broad claim scope is warranted because the minimal disclosure provided can be extrapolated to other embodiments of the invention (19) that have not been made or tested. (20) This argument is often suspect and unsuccessful. (21) But it would be much more plausible if the inventor provided mechanistic enablement--thereby tying everything together. (22) Thus, mechanistic enablement could actually bolster statutory enablement. (23) So broader claim scope could be used as a carrot to induce inventors to provide mechanistic enablement. This inducement could also work in voluntary nondisclosure paradigms--scenarios where the inventor knows mechanistic details but opts for nondisclosure because of some perceived value of maintaining secrecy. (24)

This Article explores uninformative patents, which have largely escaped the attention of legal scholars and commentators. It also makes the normative case for mechanistic enablement and explains how mechanistic enablement aligns with broader policy goals of the patent system. This Article is part of a larger project that seeks to develop a more robust disclosure function for the patent system and to bridge the disconnect between patent law and the norms of science. (25)

The remainder of the Article proceeds as follows. Part I explores the teaching function of patent documents. It begins by discussing the primacy of disclosure in patent law and then explains how the enablement requirement seeks to ensure that the disclosure is meaningful. Next, Part II examines the rule that permits uninformative disclosures and explores the problems that arise from it. Part III proposes a new disclosure paradigm with mechanistic enablement. It also describes how to induce inventors to provide mechanistic enablement, including its ability to bolster statutory enablement and yield broader patent scope. Finally, Part IV discusses the policy implications of the proposal, with a particular emphasis on how it would promote patent law's disclosure function and help bridge the disconnect between patent law and science.

  1. PATENTS AS TEACHING DOCUMENTS

    A principal function of the patent document, aside from providing notice of the invention and its claimed scope, (26) is to disclose details about the invention to the public. (27) An often-overlooked aspect of disclosure is teaching. (28) The basic idea is that, while the patentee can exclude others from practicing the invention until the patent term expires, the technical information disclosed in the written description (29) has potential immediate value to the public, (30) which can use the information for any purpose that does not infringe upon the claims. (31) Thus, the patent document is a form of technical literature. (32)

    1. Disclosure and Patent Law's Teaching Function

      The essence of the U.S. patent system is a quid pro quo between the patentee and the public. (33) The basic idea is that in order to promote the full disclosure of information about the invention to the public, the patentee must receive something in return. (34) What the patentee gets is the limited period of exclusivity conferred by the patent grant. (35) The public gets detailed knowledge about the invention as soon as the patent document publishes (36) and possession of the invention at the end of the patent term. (37)

      The inventive act produces two things that are potentially useful to the public: the invention itself, which will be defined here as the subject matter claimed in the patent (i.e., machine, product, process, composition of matter), (38) and the disclosure, which furnishes technical details about the invention (i.e., how to make it, how to use it). (39) Though the invention is probably the first thing that comes to mind when patents are discussed, the importance of the disclosure cannot be overlooked. Indeed, the Supreme Court has said that "the ultimate goal of the patent system is to bring new designs and technologies into the public domain through disclosure." (40)

      Why is disclosure so important? First, since the public gets many new and useful things through trade secrecy, (41) the patent system incentivizes the disclosure of information that the public might not otherwise get. (42) This is particularly important for "non-self-disclosing" inventions like complex molecules or industrial processes, which cannot be easily replicated or reverse engineered. (43)

      Second, the disclosure conveys technical information (and becomes a part of the technical literature), (44) which "add[s] to the sum of useful knowledge" (45) immediately--not at the end of the patent term but as soon as the...

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