Academic journal article Santa Clara High Technology Law Journal

The Test of Primary Cloning: A New Approach to the Written Description Requirement in Biotechnological Patents

Academic journal article Santa Clara High Technology Law Journal

The Test of Primary Cloning: A New Approach to the Written Description Requirement in Biotechnological Patents

Article excerpt


To secure a patent for an invention, one of the most fundamental requirements is an adequate description of the invention in words. (1) Not only does the description help a patent examiner determine whether the invention meets the requirements for patentability, (2) but more importantly, it tells the world what has been invented as of the filing date of the patent application. (3) It serves one of the main objectives of the patent system: fostering the exchange and sharing of ideas such that others may build and improve upon the creations of others. (4) The written description requirement is codified in the patent statute (5) and has been interpreted by courts in various ways throughout history within the context of specific technological fields.

In the biotechnology arena, the Court of Appeals for the Federal Circuit (CAFC) has interpreted the written description requirement in the context of claims to nucleic acid sequences on several occasions. Each decision seems to bring forth a new pronouncement regarding the sufficiency of a written description for such claims. This has lead to confusion in the legal community, even among members of the court as evidenced by a reversal, three months after the first decision, by the same panel of judges. (6) Thus, it is currently not clear whether an inventor must demonstrate possession of the invention, (7) list the sequence of the claimed nucleic acid, (8) or support the claim by describing functional properties of the sequence correlated with other known attributes. (9)

The conflicting decisions and lack of clear standards has led to debate in the legal community regarding how the written description requirement should be applied to nucleic acid sequence claims. (10) This comment will explore the controversial CAFC decisions as well as the two sides of the debate. Then, noting that both sides of the debate have merit, this paper concludes with a proposal reconciling the sides by providing a novel test for nucleic acid sequence claims, dubbed the primary cloning test. The primary cloning test addresses the dual nature of nucleic acids as molecules amenable to scientific discovery and isolation from their natural sources, and, secondarily, as molecules of laboratory experimentation. This test is then applied to the Enzo patent (11) currently pending before the district court on remand from the CAFC. (12) The primary cloning test creates a new, bright-line criterion to guide consideration of the adequacy of the written description supporting nucleic acid sequence claims.

A. Some Basics of the Science Underlying the Biotechnology Industry

Before discussing the written description requirement as it relates to nucleic acid sequence claims, a basic review of the underlying science and its application to biotechnology is provided. The starting point for the modern biotechnology industry was the discovery that deoxyribonucleic acid (DNA) can be recombined in a way allowing for the inexpensive and efficient mass production of proteins encoded by the recombined DNA. (13) DNA is the informational chemical found in each living cell that determines the physical characteristics and properties of that cell and provides the basis for transmission of heritable traits to progeny. (14) The informational aspect of DNA is inherent in its chemical structure. (15) Four different types of chemical building blocks known as nucleotides (adenine [A], guanine [G], cytosine [C] and thymine [T]) are linked together via a phosphate backbone. (16) The now-famous DNA double helix structure consists of two complementary DNA strands paired together through chemical bonds between the nucleotides. (17) The nucleotide A always pairs with T and the nucleotide G always pairs with C. (18) The structure allows for the faithful copying of genetic information and transmission of copied information to progeny. (19) DNA is divided into functional units called genes. …

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