The words you now are reading are a work of authorship [2]protected from unauthorized reproduction by the copyright laws of the United States. [3] Molecular biologists and genetic engineers may be surprised to learn (as may most everyone) that their expressions of intracellular genetic information, novel or otherwise, within living microorganisms or eukaryotic cells [4]are also works of authorship protected from unauthorized reproduction by the terms of the Copyright Act of 1976 (1976 Act). [5] Although this conclusion may appear startling, a careful examination of the statutory and constitutional requirements

* Professor of Law and Director of the Patent Law Program, The National Law Center, The George Washington Univ., B.A., Cornell Univ., 1951, L.L.B, New York Univ., 1981s LLM., Columbia Univ., 1957, J.S.D., 1967.

[1] Intellect, in 2 The Works of Ralph Waldo Emerson 318 (1883).

[2] The Copyright Act of 1976, 17 U.S.C. §§ 101-810 (1976 & Supp. IV 1980), affords copyright protection for “original works of authorship fixed in any tangible medium of expression.” 17 U.S.C. § 102 (Supp. IV 1980). ‘Literary works” are included in this expansive definition. Id.

[3] Copyright Act of 1976, 17 U.S.C. §§ 101-810 (1976 & Supp. IV 1980).

[4] Eukaryotic cells are complex cells that have a true nuclear membrane surrounding a nucleus that contains two or mare chromosomes. Eukaryotic cells contain certain structures that are lacking in simpler cellular organisms such as bacteria and blue-green algae. F. Ayala & J. Kiger, Modern Genetics 4-6 (1980).

[5] 17 U.S.C. §§ 101-810 (1976 & Supp. IV 1980). The Copyright Act went into effect on January 1, 1978.

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for copyright protection indicates its likely validity. The central thesis of this article are that virtually all original works of a genetic scientist are copyrighted automatically when he creates them; the scientist generally can enforce his copyrights;those copyrights may provide more effective protection than other forms of intellectual property in many circumstances; and copyright protection for genetically engineered works appears within the constitutional limits on Congressional power.

Index

II. The Advantages of Copyright Protection

Shock value to the reader aside,what is the value in copyrighting genetic information? The answer is that it depends! Under certain circumstances, from a practical as well as legal viewpoint, copyright protection may be the only or the most effective way an “author” can protect a valuable genetic “work”. Furthermore, even when forms of legal protection other than copyright suggest themselves as generally more appropriate, the unusually attractive remedies [6]and long life [7] of copyright protection may tip the scales in its favor. A few examples will illustrate the attractiveness of copyright protection.

At this time, two of the major methods for recombinant DNA engineering [8] with greatest commercial potential appear to be hybridoma methodology [9]and the Cohen-Boyer process of DNA cleavage and ligation or gene splicing. [10] The Cohen-Boyer process has been patented [11]and licensed widely by the assignee, Stanford University. Hybridorna techniques are apparently in the public domain as a consequence of their publication. [12]

Policing a patented process or method of manufacture that is car-

[6] See infra notes 26-39 and accompanying text.

[7] See infra notes 40-48 and accompanying text.

[8] DNA. deoxyribonucleic acid, is the primary genetic material of all cells. It Is composed of a 5 carbon sugar, phosphoric add and four bases or amino acid molecules, adenine, guanine, cytosine and thymine. These components are arranged in repeating units called nucleotides which are attached in linear chains. These chains are in the form of a double helix, a ladder-like configuration rotated on a central axis. See L L. Mays, Genetics 31 (1981). Recombinant DNA is ‘a synthetic DNA molecule containing genes from two or more different organisms.” Id. at 349.

[9] The genetic engineering of cells of higher organisms is a far more difficult undertaking than the engineering of simple one-celled organisms. Recently, however, success has been obtained through hybridoma methodology. The hybridoma process is the fusion by chemical means of a cell from a malignant tumor with a normal cell whose function is to produce a useful protein, such as an antibody for a specific disease. The fused cell reproduces with the rapidity of cancer cells and produces the useful antibody, not the cancerous protein. See J. Falkinham, Principles of Genetic Engineering, § II, at 22.24, (Patent Resources Group 1961).

[10] A cell will function in precisely the way in which its DNA molecule directs it to. Artificial or synthetic DNA molecules can now readily be created by the Cohen-Boyer process. One natural DNA molecule in a test tube is broken at a predetermined site simply by mixing a specific protein (restriction enzyme) with it. The same thing is done to another natural molecule in another test tube. After the cleavage of the two, they are combined in one test tube where, in the presence of a ligating enzyme and with sonic shaking of the tube, the DNA fragments recombine. Many of the new combinations comprise fragments from the different molecules they form an artificial, spliced DNA sequence. See J. Falkinham supra note 9, at § II, 4-9.

[11] U.S. Patent No.4.237,224.

[12] See Kohler & Mllstedn. Derivation of Specific Antibody-Producing Tissue Culture and Tumor Lines by Cell Fusion, 6 Eur. J. of Immunology 511, (1976).

192 Index

ried out within the quiet of an infringer’s plant usually is either impossible or too expensive to justify. The Cohen-Boyer process creates an exception to this wisdom because of its pioneering nature. Absent a decision to give the process away and absent the possibility of effectively policing a pioneering process, however, the only way an inventor or his investors can benefit from a novel genetic engineering process is to maintain it as a trade secret The owner of a trade secret can either use it exclusively or license it to others for use (with appropriate restrictions to maintain secrecy). [13]

Assume the secret process allows the owner to create two genetically novel microorganisms, A and B. The first, A, is both novel and nonobvious to a microbiologist of ordinary skill and therefore patentable. [14] The second, B, is both novel and valuable, but obvious to those of ordinary skill and, therefore, unpatentable. [15] How can A and B best be protected so as to provide their creator and his financial backers an appropriate return on their efforts, money, and risk-taking?

The answer for protecting A, patentable though it may be, cannot be patenting if the process for making it is to be kept secret. To obtain a valid patent, the applicant will have to disclose in the patent, and thus to the world, how to make A. [16] The trade secret in the process for making A will be lost. [17] That secret process may be far more valu-

[13] See 2 R. Callman, The Law of Unfair Competition, Trademarks and Monopolies, § 53.3, at 388-89 (3d ed. 1968).

[14] See 35 U.S.C. § l03 (1976).

[15] Se. id

[16] Id. § 112, pars. 1. The creator of A may be able to obtain patent protection without disclosing the secret process in one narrow and impractical situation. Section 112, paragraph 1, 35 U.S.C. (1976) requires disclosure in the patent specification of both “the manner and process of making” and “the best mode contemplated by the inventor of carrying out” the invention. This almost invariably requires the patentee to disclose the secret process sufficently to enable those skilled in the art to make the patented invention without undue experimentation. See In re Cook, 439 F.2d 730, 733, 735 (C.C.P.A. 1971). If the inventor of A is satisfied to protect it very narrowly, however, he can deposit a culture of microorganism A in one of the established and recognized depositories and assert as his invention in his patent the microorganism deposited and identified by the depositary acquisition number. This approach probably will eliminate the need to disclose the secret process, because scientists can learn how to make the invention and the “beat mode’ for carrying it out by culturing a sample of the deposited microorganism. This method of patent protection, however, poses serious enforcement problems. First, the scope of protection will be limited to the precise microorganism deposited with little or no room for variation as is permitted when drafting patent claims for inventions of varying scope under Section 112, paragraphs 2 through 6.35 U.S.C. § 112, paras. 2-6 (1978). Moreover, if the deposited microorganism mutates or becomes nonviable, it will become virtually impossible to determine whether an accused microorganism infringes the patent. In short, the patent protection likely will be narrower in scope and more doubtful in enforceability than obtainable copyright protection. See infra. text accompanying notes 181-89. Depositories recognized by the United States Patent and Trademark Office are American Type Culture Collection (ATCC), Rockville, Maryland;Agricultural Research Culture Collection (NRRL), Peoria, Illinois, Centraalbureau voor Schimmel cultures (CBS), The Netherlands, Fermentation Research Institute (TERM), Japan.

17. See R. Callman, supra note 13, § 53.3(b).

193

able as a “golden goose” than any of the individual golden eggs it lays.

A and B probably cannot be protected as trade secrets themselves, since the use of DNA sequencing” and DNA-DNA hybridization’ may well disclose their DNA code. [20] Copyright, however, can protect both DNA sequences to the extent that others will not be allowed to plagiarize (by culturing or otherwise) the organism in which the genetic information is fixed. On the other hand, if others independently invent a process (different from or the same as the secret one) for making A and B, then their use of that process to create and reproduce A and B will not infringe the copyrights to A and B, so long as they did not use the copyrighted work as a guide to compiling the genetic information needed to make A or B. [21] In short, “a work is original and may command copyright protection even if it is completely identical with a prior work provided it was not copied from such prior work but is rather a product of the independent efforts of its author.” [22]

To further demonstrate the benefits of copyright protection, assume a microbiologist engineers an organism that is superior in important ways to previously engineered microorganisms or to naturally occurring microorganisms. As with microorganism B, the organism’s advantageous properties may not be so dramatic as to make it patentable;it may be obvious to those skilled in the art. [23] Nonetheless, it may be quite valuable commercially and much time, effort, insight, and money may have been expended to create it.

Although the scientist may not be able to obtain a patent, he may be able to secure a copyright. [24] The copyright precludes another from using the DNA sequence that the scientist originated and fixed in the microorganism to make an identical or substantially similar copy. [25] Preventing others from reproducing the DNA information fixed in the organism can be very profitable, even though the scope of protection may be narrower than that afforded by patent.

Index

A. Copyright Remedies and Damages

The range of benefits open to a copyright owner is truly impressive. The Justice Department may criminally prosecute anyone who will-

[18] DNA sequencing is a process or technique that reveals the order of nucleotides within the DNA molecule. See F. Ayala & J. Kiger, .supra note 4 at 750. The process is carried out with laboratory procedures which, very recently, have become partially automated through application of digital computer technology.

[19] DNA-DNA hybridization, a complicated laboratory procedure is “a technique that estimates the overall similarity between the DNA of various organisms” Id.

[20] The use of DNA sequencing or DNA-DNA hybridization is directly analogous to other forms of “reverse-engineering,” such as chemically analysing a product to determine its Ingredients. Reverse engineering is a fair and legal method of discovering another’s trade. secret. See ] See 2 R. Callman, supra note 13, § 53.3(a), at 393.

[21] See infra notes 175-81 and accompanying text.

[22] 1 M. Nimmer, Copyright § 2.01 [A], at 8.

[23] 35 U.S.C. § 103 (1976).

[24] See infra notes 65-92 and accompanying text.

[25] For a discussion of the term “substantial similarity” see infra text accompanying notes 187-89.

194 Index

fully infringes a copyright [26]for purposes of commercial advantage or private financial gain.” [27] In addition, upon conviction a court must order the destruction of all “implements, devices, or equipment used in the manufacture” of infringing copies. [28] The convicted copyright infringer is not only out of the copying business, but also out of any microbiological business for want of an industrial plant.

A copyright owner can recover both his own actual damages and the infringer’s profits. [29] Moreover, he need only prove the infringer’s gross revenue; the burden then shifts to the infringer to prove his deductible expenses and profits not allocable to the infringing work. [30] If actual damages plus infringer’s profits are small, a copyright owner can elect to receive statutory damages, which can range between $250 and $10,000 in the judge’s discretion. [31] If the court finds that the “infringement was committed willfully,” it can increase the award of statutory damages to not more than $50,000. [32]

During litigation, infringing copies and all “articles by means of which such copies... may be reproduced” can be impounded. [33] For example, courts have recently ordered the impounding of video games because of copyright infringement of the computer programs that implement the games. [34]As part of a final decree, the court may also order the destruction of all copies and articles used to make the copies. [35] Thus, even without a finding of a criminal violation, a substantial part of the infringer’s manufacturing equipment may be ordered destroyed.

A copyright owner may also obtain a temporary or permanent injunction. [36] Temporary injunctions are more readily obtainable in copyright cases than in patent cases because the popular life of a copyrighted work is often short. [37] Finally, reasonable attorney’s fees are available to the prevailing party in a copyright action. [38] The copy-

[26] See 3 M. Nimmer, supra note 22, § 15.01, at 3 n.l3.

[27] 17 U.S.C. § 508(a) (Supp IV 1960). The penalty far conviction is a fine of not more than $10,000 or imprisonment for net more than one year or both. Id.

[28] Id. §506(b.

[29] Id. §504(b.

[30] Id

[31] Id, §504(c) (1).

[32] Id § 504(c) (2). In this context, “willfully’ means with knowledge that the defendant’s conduct constitutes copyright infringement” 3 M. Nimmer, supra note 22, § 14.04 [B] at 28 (footnote omitted).

[33] 17 U.S.C. §503(a) (Supp. IV 1980).

[34] See, e.g., Stern Electronics, Inc. v. Kaufman, 533 F. Supp. 625, 642 (E.D.N.Y. 1981), affd Pat., Trademark and Copyright J., (BNA), No. 565, § A, at 1-2 (3d Cir. Jan. 20, 1982).

[35] 17 U.S.C. § 503 (b) (Supp. IV 1980). See 3 M. Nimmer, supra note 22, § 14.08.

[36] 17 U.S.C. § 502 (b) (Supp. IV 1980).

[37] See, e.g, Midway Mfg. Co. v. Drikschneider, Pat., Trademark and Copyright J., (BNA), No. 541 § A, at 3, 5 (D, Neb. July 15. 1981) (preliminary injunction necessary to safeguard the copyright in a video game, which enjoys short-lived commercial popularity).

[38] 17 U.S.C. § 505 (Supp. IV 1980).

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right laws do not require the prevailing party to prove that the case at bar is “exceptional,” as is required in patent infringement suits to obtain attorney’s fees. [39]

B. Life of the Copyright Property

Patent protection exists for seventeen years. [40] Trade secrets last for as long as they can be kept secret, [41] a problematic physical activity, at best. [42] Copyright exists from the time of the work’s creation [43] until fifty years after the death of the author. [44] In the case of joint works, [45] the fifty years begins after the death of the surviving co-author. [46] Most importantly for present purposes, the copyright of works made for hire, e.g., by an employee of a corporation, [47] endures for one hundred years after the creation of the work or seventy-five years after publication of the work, whichever is earlier. [48] Thus copyright’s last much longer than patents and impose none of the problems or expense attendant to physically safeguarding the integrity of a trade secret.

Index

C. The Research Scientist’s Need or Desire to Publish Immediately

Most scientists in molecular biology are or until recently have been employed by universities, non-profit research institutions, or the federal and state governments. In the past, these employers rarely restricted the scientists’ right to publish their work. Occasionally, modest delays were imposed or requested to ensure that a United States patent application could be filed prior to scientific publication the filing ensured that foreign patent rights would not be jeopardized. [49]

The situation has changed rapidly. Universities recognize that gold

[39] 35. U.S.C. § 285 (1976).

[40] 35 U.S.C. § 154 (1976).

[41] See 2 R. Callman,, supra note 13, § 53.3, at 387; S. Oppenheim & G. Weston, Unfair Trade Practices and Consumer Protection 300 (3d ed. 1974),

[42] ] See 2 R. Callman,, supra note 13, § 53.3 (a); S. Oppenheim & G. Weston, supra note 41, at 301.

[43] 17 U.S.C. § 302(a) (Supp IV 1980). For a brief description of when a work is created, see supra notes 53-56 and accompanying text.

[44] 17 U.S.C. § 302(a) (Supp. IV 1980). This term specifically applies to works created on or after January 1,1975. id. Separate rules govern the length of copyright in works created, but not published or copyrighted, before January 1, 1978, id. §303, and in works that had subsisting copyrights on January 1.1975. Id § 304.

[45] A “joint work” is a work prepared by two or more authors with the intention that their contributions be merged into inseparable or interdependent parts of a unitary whole,” Id. § 101

[46] Id §302(b).

[47] A “work made for hire” includes “a work prepared by an employee within the scope of his or her employment.”

[48]Id § 101.

[49] Most industrialized countries are signatories of the International (Paris) Convention for the Protection of Industrial Property a multilateral treaty of 1883 which has been revised several times, the last revision being that of Stockholm in 1967. 2 J. Baxter & J. Sinnaott, World Patent Law and Practice 132.3(1961). Each country has implementing legislation analogous to that of the United States, 35 U.S.C. § 119 ([976), which provides that patent rights will accrue in the patenting country when a foreign patent application is filed in a signatory country (subject to certain ministerial conditions subsequent to the filing in the foreign country). See. 2 J. Baxter & J. Sinnaott, supra, at 132.4-39.

196 Index

mines as well as test tubes and Ehrlenmeyer flasks are scattered around their microbiological laboratories and that the gold is recoverable only by perfecting their property rights. Moreover, business arrangements between research institutions and private corporations always center on effectively protecting innovation. The net result is massive ambivalence on the part of scientists and university and research administrators concerning the right of scientists to publish immediately and freely. Half of their being says publish immediately, and half says be sure to obtain protection so that funds for further research will be forthcoming.

Fortunately, immediate publication and copyright protection are completely compatible. As will be seen, [50] “creation” of the genetically engineered work itself generates the protection provided by copyright. Publication of research findings on the day they are made will in no way impair copyright protection of those results. [51]

Index

III. Copyright Protection of Genetic Works Under the 1976 Act

The discussion thus far may convince some of the desirability of copyright as one of the array of property rights available for protecting genetically engineered works. If so, we may now proceed to address questions of whether genetically engineered works are registrable for copyright;if registerable, whether the copyright is enforceable; and if enforceable, whether infringers can be brought to task?

A. Copyrightability of Genetically Engineered Works

1. Statutory Requirements

All genetically engineered works that came into existence on and after January 1, 1978, are already protected by copyright. Whether the copyright owner wishes to enforce those rights is a matter of choice for him.

[50] See infra notes 53-57 and accompanying text.

[51] A problem may arise if copyright proves to be a viable form of property for a genetic work, either in lieu of, or in conjunction with, patent protection. Employment and consulting contracts between researchers in molecular biology and nonprofit or profit organizations have typically carefully defined rights in the researchers’ inventions and patents. The researchers usually receive no interest or a small interest in the inventions or patents, with the researchers’ salaries viewed as consideration for their work. The researchers receive their salaries whether or not they invent or obtain patents. Those contracts typically do not address the ownership of copyrights in the researchers’ works or expressly provide that title belongs to the researchers. If copyright becomes a viable property in genetic works, future contracts should define to whom the property belongs. Old contracts should be redrafted to eliminate any ambiguity. Existing contracts may have to be renegotiated.

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Unlike its predecessor statute, [52] the Copyright Act of 1976 provides copyright protection from the moment a literary work is created. [53] A work is created when it is fixed in a tangible medium of expression.” [54] In turn, a work can be “fixed” in any “form, manner, or medium” [55] as long as it is “sufficiently permanent or stable to permit it to be perceived, reproduced, or otherwise communicated for a period of more than a transitory duration.” [56] The act of creation may take place in the quiet and secrecy of a private laboratory. Property rights immediately accrue, which may be enforced once the copyright is registered. [57]

Libraries of spliced DNA fragments [58]and cultures of engineered cells with a foreign DNA sequence introduced therein are certainly “fixed intangible... medi[a] of expression.” Certainly, they are permanent; a cell that reproduces by fission, for example, is potentially eternal as is the original cell itself even if it never fissions. [59} Moreover,genetic works are stable enough to be perceived and reproduced. Reproduction, in the case of the cell,, is the entire point of genetic engineering and the first fission may take place within twenty minutes after the introduction of the DNA fragment or entire plasmid. [60] Perception is currently feasible by the process of DNA sequencing. [61] Under the 1978 Act,perception may be direct or “with the aid of a machine or device.” [62] Although most genetic works cannot be seen, [63]the 1976 Act does not require visual perception. To obtain full statutory protection for a work that is either directly or indirectly visually perceivable, a notice of copyright must be affixed to the work when it is published. [64] Because genetic works are not visually perceivable, the genetic engineer is free from the burden of copyright marking in almost all instances.

With this definitional background, consider the direct statutory fiat for copyrightability:

[52] Copyright Act of 1909, ch. 320, 35 Stat, 1075 (repealed 1976). The 1909 statute required publication with an affixed notice of copyright.

[53] 17 U.S.C. § 102(a) (Supp. IV 1960).

[54] The 1976 Act specifically provides that “[a] work is ‘created’ when it is fixed in a copy or phonorecord for the first time…” Id § 101. ‘A work is fixed’in a tangible medium of expression when its embodiment in a copy or phonorecord… is sufficiently permanent or stable…” (emphasis added),see infra text accompanying note 56. Consequently, a work has been created if it is fixed in a tangible medium of expression.

[55] H.R. Rep. No. 1476, 94th Cong, 2d Sess. 52, reprinted in l976 U.S .Code Cong., & Ad News 5659, 5665.

[56] Id.

[57] Generally, “no action for infringement of the copyright in any work [can] be instituted until registration of the copyright claim has been made…” Id. § 411(a). If registration of a work is refused by the Register of Copyrights, the author may sue for infringement and have the issue of registerability resolved in the same action. Id.

[58] Spliced DNA fragments are fragments of DNA chemically bonded together. See supra note 8.

[59] J. Falkinham, supra note 9. § I, at 5-7.

[60] Id § I, at 8.

[61] See supra note 18.

[62] 17 U.S.C. § 102(a) (Supp. 1V 1060).

[63] See infra notes 132-36 and accompanying text.

[64] 17 U.S.C. §§ 401, 405 (Supp. IV 1900). See. infra notes 135-36 and accompanying text.

198 Index

Section 102. Subject matter of copyrlght In general. (a) Copyright protection subsists, in accordance with this title, in original works of authorship fixed in any tangible medium of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device. Works of authorship include the following categories; (1) literary works; (2) musical works, including any accompanying words; (3) dramatic works, including any accompanying music (4) pantomimes and choreographic works; (5) pictorial, graphic, and sculptural works; (6) motion pictures and other audiovisual works; and (7) sound recordings. [65]

To the uninitiated, the works of a genetic engineer apparently do not fall into any of the enumerated categories and the quest for protection has ended unsuccessfully. This is not the case.

The enumerated category of “literary works” directly corresponds to engineered genetic works. ‘“Literary works’ are works… expressed in words, numbers, or other verbal or numerical symbols or indicia, regardless of the nature of the material objects… in which they are embodied.” [66] A digital computer program or data base is a literary work within the statutory definition. [67] It can be expressed in “indicia,” such as magnetic impulses or holes in a punch card; moreover, it is “fixed in… tangible medi[a] of expression,” such as magnetic tapes or punch cards. [68] Similarly, genetically engineered works are expressed in “Indicia,” the nucleotides that make up DNA. [69] Genetic works are fixed in tangible media of expression, such as cells and cultures of cells. [70] Indeed, “libraries” of DNA sequences currently exist in hundreds of test tubes; each tube may contain thousands of copies of a DNA sequence awaiting splicing to another sequence or insertion into a cell.

An engineered bacterium stores information, the sequence of nucleotides, in the DNA double helix configuration. [71] It processes that information through messenger RNA [72] and transforms it at the ribosome [73]into a sequence of amino acids. [74] Through the intermediary of

[65] 17 U.S.C. § 102(a) (Supp. 1V 1960).

[66] Id. §101.

[67] H.R. Rep. No.1479, 94th Cong., 2d Sess. 54, reprinted in 1976 U.S. Code Cong. & An. News 5659, 5687.

[68] See Boorstyn, Copyright, Computers and Confusion, 63. J. Pat. Off.. Soc’y, 276, 277 (1981).

[69] See supra note 8.

[70] See sepra 58-63. “Genes can be thought of as the molecular ‘sentences in which the ‘words’ consist of certain sequences ci nucleotide ‘letters.” F. Ayala &.J. Kiger, supra note 4, at 340.

[71] See supra note 8.

[72] RNA. ribonucleic acid, is a long molecule consisting of repeating units. The process whereby the gene sequence in DNA is copIed to form messenger RNA is called transcription. 3. See J. Falkinham supra note 9, § I, at 10-11.

[73] A ribosome is a subcellular particle containing a type of RNA. Id. § I, at 11.

[74] Each different protein has a unique sequence of amino acids. Id.

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transfer RNA, the engineered bacterium produces a protein. [75] The mathematics and underlying bases or radices of the number systems used in all cells correspond directly to those of artificial automatic systems, such as digital computers. In most digital computers, the internal operations are carried out using a two-valued radix: each digit can take on one of only two values^.[76] In a cell, the genetic code in the DNA molecule is earned in a quarternary radix: each base location can have one of only four nucleic acid molecules. [77]

Computers output their operations in a number system or radix that is useable by people. Thus, within the computer the binary notation is converted to decimal just prior to printout. [78] In a cell, the genetic information contained in DNA is also transferred into something useable – proteins. [79] Every protein has its structure dictated by a specific gene. [80] Because usually only twenty different amino acids are possible in a protein and only four different nucleotides in DNA, the quaternary notation of the DNA sequence is converted at the ribosome into a number system of base twenty. [81]

Thus, like a computer program, a genetic work uses indicia to transfer information. [82] Whether the genetic scientist or engineer takes pen in hand, invents something patentable or does both, he apparently authors a literary work when he applies the techniques of recombinant DNA to create original DNA sequences.

Even if genetically engineered works are not literary works within the meaning of the 1976 Act, they may be copyrightable. Section 102(a) states that “works of authorship include” the enumerated categories. [83] The statute expressly defines the term “including” as “illustrative and not limitive. [84] Thus, regardless of whether a genetically engineered work fits conveniently into one of the seven statutory categories, it can be a work of authorship so long as the information conveyed is original with the creator and is “fixed in any tangible medium of expression, now known or later developed…” [85] Through the italicized phrase, the statute expressly provides for the development of new media in which a work can be fixed. [86] As has been demonstrated, [87] the media within which genetically engineered works are fixed certainly conform to this statutory dictate.

[75] Id..

[76] See A. Kindred, Introduction to Computers, 117-18 (1976).

[77] . See J. Falkinham note 9, § I, at 16-17.

[78] See A. Kindred, supra note 76, at 117-21.

[79] See F. Ayala & J. Kiger, supra note 4, at 368.

[80] Id.

[81] Id.

[82] “The hereditary information for the specification of a cell’s proteins is encoded in the nucleotide sequence of the cell’s DNA in a 4-letter alphabet (an appropriate term because an alphabet is a sett of symbols used to convey information). That information is also contained in the amino acid sequence of the proteins in a 20 letter alphabet. The genetic code... relates… ‘the nucleic acid language and the protein language.’” Id.

[83] 17 U.S.C. § 102(a) (Supp. IV 1950) (emphasis added).

[84] Id.. § 101,

[85] Id § 102(a) (emphasis added).

[86] See H.R. Rep. No. 1476, 94th Cong, 2d Sess. 52, reprinted in l976 U.S. Code Cong., & Ad News 5659, 5685.

[87] See supra notes 58-83 and accompanying text.

200 Index

But are the genetic engineers’ forms of expression comprehended by the statute?

The legislative history of the 1976 Act clearly indicates that Congress intended the phrase “original works of authorship” to be open-ended. The House Report reasoned that “[a]uthors are continually finding new ways of expressing themselves, but it is impossible to foresee the forms that these new expressive methods will take.” [88] An author’s form of expression can be copyrightable as long as it is not “completely outside the present congressional intent.” [89] As one leading commentator has observed, a new form of expression should be regarded as within the congressional intent if it is sufficiently analogous to the seven categories of works enumerated in the statute. [90] As previously demonstrated, [91] genetically engineered works are certainly analogous, if not nearly identical, to computer programs; the mode of expression is simply animate, rather than inanimate. Because of this similarity and because genetically engineered works are fixed in the statutory sense, they should be copyrightable.

Index

a. Compilations

Some may argue that recombinant DNA work is not sufficiently original to be copyrightable. Every DNA fragment combined with any other and every plasmid introduced into a host cell already exist in nature. The so-called author is dealing with preexisting information. This argument is analogous to one suggesting that this article is not original because the words the author is stringing together are all well-known and appear in standard dictionaries. Simply to state this analogy is to render baseless by reductio ad absurdum the attack on the originality of uncopied DNA base pair sequences.

Moreover, the 1976 Act states that a compilation of preexisting materials may itself be original: “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.” [92]

If each DNA fragment or plasmid wants for originality, each combined by man with others does not. At the very least, splicing of DNA fragments and introduction of DNA materials into a host cell are original and often novel compilations. [93]

[88] See H.R. Rep. No. 1476, 94th Cong, 2d Sess. 51, reprinted in l976 U.S. Code Cong., & Ad News, 5659, 5664.

[89] Id.

[90] l M. Nimmer, supra note22, § 2.03 [A], at 27.

[91] See supra notes 66-82 and accompanying text.

[92] 17 U.S.C. § 101 (Supp. 1V 1980).

[93] See 1 M. Nimmer, supra note 22, § 3.03, at 8 (“A collective work will qualify for copyright by reason of the original effort expended in the process of compilation, even if no new matter is added.”) (footnote omitted).

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Prior to being recently amended, Section 117 [94] possibly blocked enforcement of a copyright in genetic works. Congress attempted to address in section 117 the problems of copyright protection for digital computer programs. [95] Although Congress intended computer programs to be copyrightable under the 1976 statute, [96]it could not decide whether copying a computer program by inserting it into a computer should be considered an infringement. [97] As a consequence, section 117 originally specified that the statutory or common law in effect on December 31, 1977 would determine the legality of such copying. [98] Under that law, entering someone else’s copyrighted program into a computer did not infringe the copyright because the copy produced could not be visually perceived. [99]

In 1980, Congress completely rewrote section 117. [100] The new provision, which went into effect on December 12, 1980, eliminates ocular perceivability as a necessary characteristic of a copy and as a prerequisite for infringement. [101] In short, new section 117 applies to computer programs what the 1976 statute previously applied to all other original works and their copies, namely, the sufficiency of perception, reproduction or communication that occurs “either directly or with the aid of a machine or device.” [102]

What does all of this have to do with genetically engineered works? Unfortunately, original section 117 included language sufficiently broad under a somewhat strained reading [103]to encompass genetic works as well as digital computer programs. Consider the words of original section 117:

Section 117. Scope of exclusive rights: Use in conjunction with computers and similar information systems... [T]his title does not afford to the owner of copyright in a work any greater or lesser rights with respect to the use of the work in conjunction with automatic systems capable of storing, processing, retrieving, or transferring information, or in conjunction with any similar device, machine, or process, than those afforded to works under the law, whether title 17 or the common law or statutes of a State, in effect on December 31,

[94] 17 U.S.C. § 117 (Supp. III 1979) (current version at 17 U.S.C. 9117 (Supp. IV 1980)).

[95] See H.R. Rep. No. 1476, 94th Cong, 2d Sess. 52, reprinted in l976 U.S. Code Cong., & Ad News, 5659, 5731.

[96] Computer programs have always been copytightable under the 1976 Act. See supra notes 67-65 and accompanying text.

[97] See Boorstyn, supra note 88. at 280.

[98] 17 U.S.C. § 117 (Supp. III 1979) (current version at 17 U.S.C. § 117 (Supp. IV 1980)).

[99] See Data Cash Systems Inc. vs. JS&A Group Inc., 480 P. Supp. 1063, 1068 (ND. Ill. 1979), aff’d on other grounds, 628 F.2d 1038 (7th Cir. 1980).

[100] Act of Dec. 12. 1980, Pub. L. No. 98-517 § 10(b), 94 Stat. 3015, 3028 (amending 17 U.S.C. § 117 (Supp. III 1976)).

[101] See Boorstyn, supra note 68, at 282.

[102] 17 U.S.C. 9102(s) (Supp. IV 1950) (emphasis added).

[103] The legislative history of section 117 concerns only copying of computer programs. H.R. Rep. No. 1476, 94th Cong, 2d Sess. 116, reprinted in l976 U.S. Code Cong., & Ad News, 5659, 5131.

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1977. [104]

A living microorganism is arguably a “similar information system” to that of a computer and it certainly is an automatic system capable of storing, processing, retrieving, or transferring information. [104] If old section 117 had been construed to encompass genetic works, such works could not have been meaningfully protected before December 12, 1980; unauthorized copies of the works could not have been visually perceived and hence would not have been infringements.

If some doubt existed as to whether genetic works were included within the ambit of old section 117, no question should exist about new section 117. Genetic works are certainly excluded because new section 117 by its terms is limited exclusively to “computer programs” and their use in conjunction with a “machine.” [106] Moreover, new section 117 dispenses with the requirement of ocular perceivability even for computer programs. [107] At the very latest, therefore, December 12, 1980 is the date when nonocularly perceivable, reproducible or communicable genetically engineered works enjoy full copyright protection. They may have been protected as early as January 1, 1978.

Index

2. Constitutionality

The United States Constitution authorizes Congress “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” [108] Would the current Supreme Court view the 1976 Act, construed to comprehend genetically engineered works, as a constitutional exercise of Congressional power?

The question can best be answered by dividing it into two component parts. First, does the constitutional term “writings” comprehend the statutory subject matter of copyright - “original works of authorship fixed in any tangible medium of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device”? [109] Second, assuming the answer to the first question is yes, does the aliveness of a tangible medium of expression (in which the original work of authorship is fixed) preclude it from being a “writing” within the meaning of the Constitution?

The traditional mode of constitutional construction provides per-

[104] 17 U.S.C. 9117 (Supp. III 1979) (emphasis added) (current version at 17 U.S.C. § 117 (Supp. 1V 1980)).

[105] See. supra notes 68-82 and accompanying text.

[106] 17 U.S.C. § 117 (Supp. IV 1980).

[107] Se. Boorstyn, supra note 65, at 262.

[108] U.S. Const. art 1, § 8, cl. 8. This provision is commonly termed the copyright and patent clause of the Constitution.

[109] 17 U.S.C. § 102(s) (Supp. IV 1980).

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haps the strongest reason for believing that the subject matter of copyright under the 1976 Act satisfies the constitutional requirements for a writing. Constitutional language, unlike its statutory counterpart, is not construed in the United States exclusively as defined by its authors. Courts typically interpret constitutional terms to include unanticipated meanings that are required for developments basically consonant with the general purpose of the original language.” [110] The Constitution’s flexibility in meeting the conditions of life in the United States for a period of almost 200 years stems specifically from this mode of construction.

In regard specifically to the copyright clause of the Constitution, the Supreme Court has construed the term “‘writings” broadly to include numerous tangible media of expression. [111] Indeed, courts have upheld the constitutionality of copyright protection for media of expression that were not at the time explicitly designated by statute as copyrightable. [112] Thus, there can be little doubt that Congress stayed within constitutional limits when it broadly defined the subject matter of copyright.

We now address the second question: if the term “tangible medium of expression” were construed to include live media, would it fall outside the constitutional term “writings”? The Supreme Court has recently provided helpful guidance on this question. In Diamond v. Chakrabarty, [113] the Court considered whether the patent statute’s term “manufacture or composition of matter” includes genetically

[110]In discussing the copyright clause of the Constitution, Learned Hand stated that

its grants of powers to Congress comprise, not only what was then known, but what the ingenuity of men should devise thereafter. Of course, the new subject matter must have some relation to the grant; but we interpret it by the general practices of civilized peoples in