Copyright Protection Of Biotechnology Works: Into The Dustbin Of History?

Starting in the early 1980s, and ending in the very beginning of the 1990s, a number of scholarly commentators proposed that biotechnology works are proper subject matter for copyright protection.[2] Typically, these commentators focused on the idea that DNA sequences may be copyrightable works of authorship. Many commentators argued that copyrighting biotechnology might be a good idea because it would allow protection of works that would not qualify for patent protection. The idea of copyrighting biotechnology arose in the early 1980s at the time when patent protection of biotechnology seemed doubtful. Analogies of computer programs and DNA sequences were often made. The argument was that because DNA sequences are a type of biological computer program, and computer programs are copyrightable, then DNA sequences should also be copyrightable. Thus, to a number of commentators, the concept of copyrighting DNA sequences was an untapped and powerful alternative to patent protection.

Nearly 20 years after the first proposal, this concept has seen little development. A review of the literature reveals neither cases nor statutes dealing with the issue, and the Copyright Office has unofficially stated that it will not grant copyright registration to gene sequences or DNA molecules because they are not copyrightable subject matter.[3]

This article explains the legal reasons why copyright protection for biotechnology works is either impermissible or of severely limited scope. In particular, this article will present the illustrative issue of copyright protection for DNA sequences engineered by scientists.

What presumably prompted the concept of copyright protection for biotechnology was the fact that in the 1980s patent protection of biotechnology inventions seemed doubtful or very limited. Although Diamond v. Chakrabarty, 447 U.S. 303 (1980) held that altered living organisms were indeed patentable, there were various difficulties involving patent grants by the Patent Office. Issues of utility, obviousness and enablement hindered the biotechnology field, throughout the 1980s and 1990s, in obtaining patents.[4] As the cited references show, many of these issues have been more clearly determined since the mid-1990s. During the 1980s, when these issues were unsettled, patent protection of biotechnology inventions seemed highly restricted . As a result, scholars looked to alternatives to patent protection.

Concurrently, the computer industry had difficulty in obtaining patent protection. The Supreme Court decision of Gottschalk v. Benson, 409 U.S. 63 (1973) held that computer programs, by themselves, were not patentable subject matter. This unfortunate decision left the computer programming industry with little patent protection for years. Thus computer programmers sought alternative protection in the form of copyright. In 1980, they succeeded when Congress amended the Copyright Act of 1976 to expressly provide for copyright protection for programs.[5] This success in finding alternative protection other than patents inspired proponents of copyright protection for biotechnology.

Therefore, the idea of copyright protection for biotechnology works became a powerful notion. Specifically, commentators proposed the copyright of DNA sequences using a variety of arguments. These arguments are generalized as: (1) copyright subject matter, (2) analogy of literary works and computer programs, (4) DNA as a compilation, and (5) the “sweat of the brow” doctrine.

Copyright protection exists for “original works of authorship fixed in a tangible medium of expression of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated.”[6] In simpler terms, to be copyrightable, something must be (1) original, (2) a work of authorship, and (3)fixed.

Enumerated works of authorship include: (1) literary works, (2) musical works, (3) dramatic works, (4) pantomimes and choreographic works, (5) pictorial, graphic and sculptural works, (6) motion pictures and other audiovisual works, (7) sound recordings, and (8) architectural works.[7] Additionally, the legislative history of the Copyright Act of 1976 encourages an expansive reading of works of authorship.[8] Unless the work is completely outside congressional intent, the form of expression may be considered copyrightable subject matter.[9]
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For a work to be fixed, it must be: (1) Embedded in a “copy” (the material object in which the work is fixed), (2) under the author’s authority, for (3) more than a transitory period.[10] The type of medium used is flexible. Computer programs, for example, are properly fixed on ROM chips, RAM, or magnetic discs.[11]

The copyright subject matter argument for DNA sequences states that when a scientist creates a new sequence of nucleotides to form a DNA strand, then she creates a work of authorship.[12] The rationale is that a new DNA sequence, designed by a scientist, qualifies as a work of original authorship because the specific order or sequence of the base pairs in DNA is conventionally written out and is fixed in a tangible medium of expression (the DNA itself).[13] In simpler terms, the copyrighted expression is the actual DNA sequence, regardless of whether the sequence is fixed on paper or in a DNA strand.

For example, when a biologist assembles a genetically engineered plasmid (a self-replicating circular strand of DNA) for human insulin production, she is embedding her work in DNA. DNA acts as the “copy” for the expression of the nucleotide sequence for producing a protein. The DNA can be stored for long periods of time in DNA libraries or in actual living organisms like bacteria. Thus, the DNA copy is fixed for more than a transitory time.

Proponents also point out that even if DNA sequences do not specifically fit any of the categories of works of authorship specified in § 102, that is not a per se exclusion.[14] Since, Congress intended an expansive reading of works of authorship, and (in essence) DNA sequences are close to literary works (which include computer programs), there seems no logical reason to exclude them just because they are not specifically mentioned or obviously fit in a certain category of work of authorship.

The category of literary works, in particular, has been a focus of supporters of copyright protection of DNA sequences.[15] Literary works are defined as works, “expressed in words, numbers, or other verbal or numerical symbols or indicia, regardless of the nature of the material objects, such as books, periodicals, manuscripts, phonorecords, film, tapes, disks, or cards, in which they are embodied.”[16] Essentially, a copyrightable literary work can be merely a string of numbers or symbols if it is original and fixed.
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Also, computer programs are deemed to be proper copyrightable literary works, whether in source code (human readable computer languages in which programmers write computer programs) or object code (only machine readable binary code version of source code).[17] Of much note is that the Franklin Computer Court rejected the argument that object code should not be protected because it only communicates directly with the computer and is effectively unreadable to humans.[18] The Copyright Act defines a computer program as a “set of instructions to be used directly or indirectly in a computer in order to bring about a certain result.”[19]

DNA sequences easily fit into the literary work category of copyright subject matter, especially since computer programs fall into this category. As argued, genetic sequences are simply strings of symbols of the nucleotides of DNA: adenine, thymine, guanine, and cytosine (symbolized as “A”, “T”, “G” and “C”).[20] For example, if a biologist arranges a gene in a plasmid, he can be considered to have arranged a string of specified symbols. This seems to match the definition of a literary work.

There also is the inevitable comparison of DNA sequences to computer programs. It is argued that DNA sequences act as a program to produce specific proteins.[21] The DNA sequence that contains the coded genetic information for the synthesis of a particular protein is a sort of application program of a computer.[22] An application program dictates the desired task to be performed by the computer hardware. When a DNA sequence (in a plasmid form) is inserted into a cell (acting as the computer hardware) it dictates the task of protein synthesis. Just as a program in object code is only readable to the computer, so too is the DNA only readable to the cell.

The nucleotides are the instructions and the protein, resulting from the particular DNA sequence, is an indirect result. If a biologist splices a gene for producing human insulin into an E. coli plasmid and transfers that modified plasmid into some bacteria for production, she is in fact introducing instructions to cause bacteria to produce human insulin. This indeed closely resembles the statutory definition of a computer program. Therefore, it is argued that such close similarity warrants copyright protection.

The subject matter of copyright further includes “compilations.”[23] A compilation is a work formed by the collection and assembling of preexisting materials or of data that are selected, coordinated, or arranged in such a way that the resulting work as a whole constitutes an original work of authorship.[24] Thus, if the selection and arrangement that the “author” chooses are original, then the compilation is copyrightable.
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Proponents of copyrighting DNA sequences promoted compilation works as valid for DNA sequences.[25] It is argued that combing various bits of DNA (e.g., combining the gene for human insulin, with a promoter from E. coli, with a pX02 plasmid and inserting into a Bacillus cell) constitutes a compilation.[26] This, like a compilation, is an assembling of preexisting materials. Regardless of the originality of the individual components, the selection and arrangement are original and copyrightable. Thus, in our example, although the idea of a plasmid that codes for human insulin inserted in a bacterium is not copyrightable, the scientist’s exact selection of the human gene with the E. coli promoter with the pX01 plasmid, within the Bacillus cell should be copyrightable. Since a compilation is sufficiently original to fit copyright subject matter, so should arranged DNA sequences be sufficiently original.

Originality is a constitutionally mandated prerequisite for copyright protection.[27] Before the United States Supreme Court’s decision in Feist there was uncertainty of what constituted “originality.” Ambiguous language in the Copyright Act of 1909 led some courts to develop the “sweat of the brow” doctrine.[28] This doctrine finds originality in the labor expended in the collection and assembling of data.[29] Thus, a copyright was the reward for the hard work that went into compiling facts.

Some proponents for copyright protection of biotechnology works suggested that the sweat of the brow doctrine allowed the copyrighting of biotechnology works.[30] The concept is easily adaptable to DNA sequences. A researcher who spends considerable time and effort to discern the sequence of a gene should have a copyright in the sequence by virtue of his hard work. That he did not creatively conceive of the sequence himself is irrelevant. Originality is in the industriousness of the act of collection of the DNA sequence, not in the presentation and expression of the sequence.

Some proponents of copyright protection for DNA sequences expend much effort showing such copyright protection exists, but do not give more than a cursory review to why such protection might not be warranted.[31] Such proponents merely espouse the concept and do not seriously consider contrary case law or look in depth to the Copyright Act of 1976. An ill considered assumption is made that such protection exists. There is no detailed analysis that looks at all perspectives and addresses any possible arguments against copyright protection of DNA sequences.

Careful analysis of all possible arguments yields a number of persuasive legal arguments that preclude or severely curtail copyright protection of DNA sequences. These main arguments are: (1) facts lack originality, (2) doctrine of merger and the nonequivalence of DNA and computer programs, and (3) utilitarian prohibitions.

By constitutional requirement and statute, copyright protection exists only for original works of authorship.[32] In Feist, the Supreme Court conclusively defined the term “original” in relation to copyright. The Court stated that original, as the term is used in copyright, means, “that the work was independently created by the author (as opposed to copied from other works), and that it possesses at least some minimal degree of creativity.”[33] Additionally, no author may copyright his ideas or the facts he narrates.[34] This is because facts do not owe their origin to an act of authorship.[35] The Court persuasively puts forth the following logic:

With the sweat of the brow doctrine removed from the analysis, there is no originality for generating DNA sequences. Labor is not a substitute for originality. Sequences obtained from nature (e.g., the sequence for a gene of some sort) are not original. The biologist who sequences a gene is merely discovering facts. There is no independent creation as is required for originality. The biologist is merely copying from nature the genetic sequence that codes for proteins. Thus there is no minimum creativity. So long as a researcher constructs a DNA sequence based on a sequence discovered in nature, there is no independent creation, no minimum creativity and thus no originality.

Since almost all DNA sequences used in science and research are based on sequences discovered in nature, copyright protection of DNA sequences is of dubious benefit. At best, a biologist can independently create an “artistic” string of nucleotides based on his own imagination and not based on a sequence he knows of in nature. There is an astronomically slim chance that such an artistically conceived DNA sequence could code for any protein or have any use other than as art. Furthermore, simply stringing together nucleotides (e.g., CTCTCTGAGAGA), although clearly a literary work, might lack the minimum creativity required by Feist to be original.

Hand-in-hand with the originality requirement, there is no copyright protection for, “any idea, procedure, system, method of operation, concept, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or embodied.”[38] This provision codifies the long-established understanding, originating from the case Baker v. Seldon, 101 U.S. 99 (1879), that there is no copyright protection for ideas or procedures. In Baker, the plaintiff claimed copyright in a book detailing a particular method of bookkeeping and included blank forms for use with the method.[39] The defendant made his own book that included the same forms for use in the plaintiff’s bookkeeping method and the plaintiff sued for copyright infringement.[40] The Baker Court found no infringement and held that when the “art” taught by a work of authorship cannot be used without copying some aspect of the work, then that aspect of the work will not be protected by copyright.[41] The plaintiff was not allowed to assert copyright in his forms. The Court stated that if the plaintiff could prohibit others from using his forms and his forms were the only way to practice the bookkeeping method, then the plaintiff would have a de facto monopoly in that method.[42] The Court reasoned that to get a monopoly in a method/procedure should require satisfying the stringent requirements of patent law.[43] Thus, when the use of an idea or procedure requires copying of a plaintiff’s expression, there is no copyright infringement.

The Baker holding eventually developed into the “merger” doctrine. In the merger doctrine, when there are no or very few ways of expressing a particular idea, then the expression merges with the idea.[44] Since the can be no copyright of ideas, the merged expression/idea is uncopyrightable. If copyright protection was allowed to the single or limited expression, then no one could practice the idea or procedure expressed.
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In the example provided that proposed the compilation argument for copyright of DNA sequences (Section B3, above), the combination of various bits of DNA (e.g., combining the gene for human insulin, with a promoter from E. coli, with a pX02 plasmid and inserting into a Bacillus cell) warranted copyright protection. The selection can be argued to be original if the researcher independently creates the selection (e.g., she combines genetic components that are not known to exist in nature or that she does not know of existing in nature) and the selection has minimal creativity. Such a selection of genetic components, however, most likely has no minimal creativity because the creator is only considering what is scientifically known and necessary.

Assuming such a selection was original and the compilation was thus copyrightable, it still may clash with the merger doctrine. The idea of combining promoters, plasmids, genes and bacteria can only be expressed in limited ways. Therefore, there is merger and no copyright protection. For example, since the production of human insulin in bacteria can only be “expressed” in a limited amount of ways (only a limited amount of combinations of genetic elements), there is a merger. Although contestable, this argument could arise amongst reasonable people and only highlights that DNA compilation works are confusing and easily open to legal attack.

As explained above, most proponents of copyright protection of DNA sequences make the analogy of computer programs to DNA sequences as a premise for copyrightability. There are some casual similarities in that a gene and a computer program act as instructions for something to be done. That is where the similarities end. On a scientific factual basis, DNA differs from computer programs in fundamental ways that have legal consequence. The most important and stark difference is that there is only one way to express a “genetic program.” This is by various combinations of the four nucleotide bases. The DNA instructions for producing proteins can only exist in the form of nucleotide sequences. In essence, there is only one “program language” to express the method of producing proteins in cells. Computer programs, on the other hand, can have a single instruction expressed in numerous ways via different program languages.

In Apple Computer, the case most often cited by proponents, the Court stated that computer programs are subject to the doctrine of merger.[45] The court reasoned that, “If other programs can be written or created which perform the same function...then that program is an expression of the idea and hence copyrightable.”[46] Therefore, regardless of whether a DNA sequence in the form of a gene is the same as a computer program, because a particular sequence is the only way to express the underlining idea of the gene, there is a merger. As such, the merger doctrine precludes the copyrighting of DNA sequences that actually code for a protein. One is left with only having a copyright in “useless” DNA sequences that the researcher does not know to exist in nature. The whole issue of originality then arises as discussed above.

Where a work of authorship is a useful article, it may be precluded from copyright protection.[47] The Copyright Act defines a “useful article” as an, “article having an intrinsic utilitarian function that is not merely to portray the appearance of the article or to convey information.”[48] Thus, purely utilitarian objects are not copyrightable. This prohibition is to prevent copyrighting of works which should undergo the rigors of the patent system before any protection is granted.
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The Copyright Act of 1976, however, does allow protection of aesthetic features of useful articles where such features, “can be identified separately from, and are capable of existing independently of the utilitarian aspects of the article.”[49] A feature is separately identified and independent where it is “physically separable,” or “conceptually separable.”[50] Physical separability occurs when the aesthetic features are physically removable from the utilitarian parts of an article.[51] A good example is a jaguar figurine on the hood of a car. Conceptual separability is a more elusive concept. The influential United States Court of Appeals for the Second Circuit has adopted a “purpose” test. The Court has stated, “Where design elements can be identified as reflecting the designer’s artistic judgment exercised independently of functional influences, conceptual separability exists.”[52] Thus, if aesthetic features were influenced by utilitarian considerations, there is no conceptual separability.

In Brandir, an artist developed a twisted wire sculpture which he later discovered could be expanded into a bicycle rack.[53] This artist then created a bent metal tubing version of the wire sculpture, but altered the original design to better suit the purpose of a bicycle rack.[54] The Court held that the design features of the bicycle rack were significantly influenced by functional considerations.[55] Thus, the aesthetic elements were not conceptually separable from the utilitarian elements and not copyrightable.[56]

DNA sequences only have a utilitarian function that is neither physically nor conceptionally separable. For DNA sequences that code for proteins (and thus are of interest for copyright protection) the sequence must be specific to produce a protein. The sequence cannot be physically removed from the DNA strand otherwise there would be no DNA at all. Thus, the aesthetic features are also the utilitarian features and are not separable.

Additionally, a coding DNA sequence is not conceptionally separable because the design of the sequence is definitely influenced by utilitarian considerations. A particular sequence is scientifically required to produce a protein. Any significant variation will result in no protein or production of a useless protein. Therefore, there is no conceptual separability because DNA sequences coding for proteins are rigidly required to be of a certain configuration to code for a protein.

This reasoning also applies to genetic compilation works. The selection and arrangement of certain genetic elements (e.g., genes and promotors), as described above, are not physically removable. If such elements were physically removed, there would be nothing. There is nothing aesthetic to remove. Also, each individual genetic element is not copyrightable on its own. All the elements are entirely utilitarian.
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The selection and arrangement are not conceptually separable because the very selection and arrangement are based on functional concerns as, for example, producing a protein. A selection and arrangement made for purely aesthetic reasons (e.g.., does not produce a protein) might receive copyright protection, but would be of little use to a scientist who wishes to protect a useful genetic combination. Yet again, it is seen that where the intent is to obtain copyright protection of useful DNA sequences that code for proteins, there is no copyright protection. Only “useless” DNA sequences or genetic element combinations, developed for artistic pleasure, receive any protection.

Copyright protection of DNA sequences at first seems unusual. A copyright is erroneously thought as protection for mostly artistic works on all manner of media. Thus, relating DNA sequences engineered by scientists to artistic works seems a stretch of logic. However, copyright protection of DNA sequences is a realistic concept when one considers the Copyright Act of 1976 and existing copyright protection for computer programs. Yet, when one carefully examines the Copyright Act, case law (old and recent), and the actual science of DNA, the illusion of copyright protection of DNA sequences disappears. It is not possible to obtain copyright protection of DNA sequences that are useful and worthy of protection because they code for proteins. There is no originality because such useful DNA sequences must, in almost all likelihood, be copied from nature. The idea merges with the expression because DNA sequences can be expressed in only one manner and with the same nucleotides. Finally, all such DNA sequences are purely utilitarian articles that are certainly influenced by functional concerns. Therefore, one is left with copyright protection of only “useless” DNA sequences having no scientific purpose. As such, there is no incentive to further promote the idea of coprighting DNA sequences.

[2] See e.g., Irving Kayton, Copyright in Living Genetically engineered Works, 50 GEO. WASH. L. REV. 191 (1981); Donna Smith, Copyright Protection for the Intellectual Property Rights to Recombinant Deoxyribonucleic Acid: A Proposal, 19 ST. MARY’S L.J. 1083; Doreen M. Hogle, Copyright for Innovative Biotechnological Research: An Attractive Alternative to Patent or Trade Secret Protection, 5 HIGH TECH. L.J. 75 (1990).

[4] See e.g., In re Brana, 51 F.3d 1560 (Fed. Cir. 1995); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367 (Fed. Cir. 1986); In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995); Amgen, Inc. v. Chagai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991). See also Hogle, 5 HIGH TECH. L.J. at 77 (discussing the difficulties of obtaining patent protection for certain biotechnology works).