The Completeness Requirement in Patent Law

INTRODUCTIONSuppose that, after several years of laboratory work, a researcher discovers a novel way to make a certain type of chemical bond faster and with higher efficiency.1 This invention adds to other chemists' toolkits and paves the way for making an entirely new class of molecules, opening up possibilities of discovery of new drugs, useful materials, and so on. The inventor assembles a kit based on the new method and commercializes the invention, making it available to other scientists who wish to take advantage of the method. Worried that potential infringers can easily design around patent claims directed merely to a specific kit, the inventor attempts to patent the general method of making the chemical bond.Or, consider a case where biomedical investigators discover that interfering with the function of a certain receptor in the human body can reduce "inflammation associated with diseases such as arthritis."2 In contrast to earlier work, which had proceeded without the knowledge of this receptor's role, this approach treats the inflammation while avoiding "undesirable side effects such as stomach upset [sic], irritation, ulcers, and bleeding."3 The discovery is highly valuable; as one commentator noted, "there is little question that the pioneering . . . work paved the way for a new generation of painkillers that would be easy on the stomach," including Celebrex.4 Realizing that a patent to a method of finding a drug might be of little value, the inventors attempt to claim a method of treating the inflammation based on the discovery of the receptor function and a roadmap for finding drugs that would interfere with it.Finally, consider a discovery that enables doctors to optimize dosages of a certain drug based on the concentration of a particular chemical compound (called a "probe molecule") in a blood sample taken from a patient.5 The inventors license the technology to a company, which designs and sells kits for optimizing the drug dosages.6 Experts hail the invention as a significant development in the treatment of inflammatory bowel disease,7 and researchers and doctors use the kit to make further discoveries.8 Again, unsatisfied to claim merely a kit, the inventors attempt to claim a general method of optimizing drug dosage based on the measured concentration of the probe molecule.Because all of these inventions required significant investments, constituted important scientific advances, and promoted further research and development, it is difficult to fault the inventors for seeking valuable patent claims to protect them.9 But courts held that none of them could be patented in view of what the inventors claimed and what they disclosed (or, rather, failed to disclose) in their patent applications.10 As to the first invention, the patent applicant did not show that the chemicals made with the novel process would be useful to ordinary consumers (as drugs, for example) rather than to other researchers.11 The Supreme Court therefore ruled that the process was not "useful" within the meaning of Section 101 of the Patent Act.12 As to the second, because the inventors did not yet know what specific drugs would reduce the inflammation, the U.S. Court of Appeals for the Federal Circuit held that the patent failed to provide adequate "written description" under Section 112.13 And as to the third, the Supreme Court determined that the patent claims did not "confine their reach to particular applications of" the correlation that the inventors discovered.14 Thus, the Court concluded, the claims could not be patented because they were directed to a law of nature-one of the judicially recognized exceptions to patent eligibility.15This Article posits that the doctrines represented by these three cases are best understood as products of courts' attempts to test the patent claims at issue against the same unwritten requirement of patentability, herein termed "completeness."16 In general, the completeness requirement is concerned with whether, given the scope of the claim at issue and the disclosures in the patent's specification,17 the invention is too foundational to qualify for a patent. …