Copyright status of genetic sequences

Date

The topic of whether genetic sequences can be protected by copyright is being discussed by companies, legal experts, and government officials. In recent years, the development of synthetic biology has led to interest in using copyright as a way to protect man-made DNA sequences instead of patents. Supporters of this idea argue that DNA sequences, like computer programs, store information and are often treated as "literary works" in many countries, which are protected by copyright.

The topic of whether genetic sequences can be protected by copyright is being discussed by companies, legal experts, and government officials. In recent years, the development of synthetic biology has led to interest in using copyright as a way to protect man-made DNA sequences instead of patents. Supporters of this idea argue that DNA sequences, like computer programs, store information and are often treated as "literary works" in many countries, which are protected by copyright.

Background

DNA contains genetic information that determines the structure and function of living things. This information is stored in sequences of molecules called nucleotides, which are usually represented by the letters A (adenine), C (cytosine), G (guanine), and T (thymine). During gene expression, DNA is first copied into messenger RNA and then used to create proteins, which are made of amino acid sequences. Some genes do not make proteins and instead produce non-coding RNAs (ncRNAs), such as transfer RNAs (tRNAs) and ribosomal RNAs (rRNAs), which help with processes like protein production. Other parts of DNA, such as promoters, enhancers, silencers, and insulators, control how genes are turned on or off. Some DNA regions also serve structural roles in chromosomes, like telomeres and centromeres.

Some scientists compare DNA to computer programs. For example, Nina Srejovic describes cells as "protein-producing machines" that use DNA like an "operating system" to direct the creation of proteins based on the cell's conditions. Gary Marcus, in The Birth of the Mind, compares an organism's genome to a computer program that guides the development of an embryo, with each gene acting like a line of code. Pradeep Mutalik explains that parts of DNA, such as genes, promoters, and regulators, function similarly to computer commands like if-then statements, loops, and subroutine calls.

DNA can also store digital data, such as books, images, and music. In 2012, scientists created 54,898 pieces of DNA containing binary code (0s and 1s) from a book written by George Church, along with images and JavaScript code. The 0s were encoded using A and C nucleotides, while the 1s used G and T nucleotides. This DNA was later decoded using sequencing techniques. More recent methods use a base-3 (ternary) system to avoid issues with repeated nucleotides, which can complicate DNA sequencing.

Since the 1980s, some scholars have suggested that synthetic DNA might be protected by copyright, similar to computer software. In the United States and other places, computer programs are considered "literary works" under copyright law. The legal definition of "literary work" includes any work expressed in words, numbers, or symbols, regardless of the medium used, such as books, disks, or cards. In the 1983 court case Apple Computer, Inc. v. Franklin Computer Corp., a court ruled that computer programs are protected as literary works whether written in source code, object code, or stored in memory.

However, copyright law protects only the creative expression in a computer program, not the methods or processes it uses. Section 102(b) of the Copyright Act of 1976 clarifies that copyright does not cover ideas, concepts, or functional details like procedures, systems, or methods. This rule helps prevent copyright from overlapping with patent protections, which require stricter requirements. The "merger doctrine" further limits copyright for functional works, such as computer programs, because when there are only a few ways to express an idea, the idea and its expression are considered "merged" and neither is protected by copyright.

Copyrightability of DNA

In 1982, law professor Irving Kayton said that engineered DNA compounds could be protected by copyright as literary works. According to the Copyright Act of 1976, computer programs are considered literary works because they use "verbal or numerical symbols," like the data stored on a magnetic device. For genetically engineered works, the symbols are the nucleotides (A, C, G, and T) that make up DNA. Kayton also suggested that genetically engineered works might belong to a unique category of copyrightable material. He noted that the Copyright Act lists eight categories of copyrightable works in 17 U.S.C. § 102(a), but these are not the only possibilities. Kayton argued that cells or cell cultures could act as "tangible media of expression," meaning physical forms where genetic works can be stored.

Kayton claimed that copyright might also apply to recombinant DNA molecules—DNA created by combining fragments from different sources. These DNA sequences could be seen as "compilations," which are works made by arranging existing materials. For example, a plasmid containing genes from two bacteria and an E. coli bacterium with that plasmid could both be considered copyrightable compilations.

As of 2016, no jurisdiction recognized genetic sequences as copyrightable. The U.S. Copyright Office stated that DNA sequences and other biological or chemical substances are "ideas, systems, or discoveries," not works of authorship.

Nina Srejovic argued that DNA molecules themselves are not works that can be copyrighted, but rather a way to store information. Copyright protects the information in a work, not the material it is stored on. For example, a movie is copyrightable whether stored on a DVD, film, or DNA. Srejovic disagreed with the Copyright Office, saying its position would prevent works from being copyrighted simply because they are stored in DNA. However, she also said that DNA used for cellular processes, like making proteins, should not be copyrighted because they are part of a method or system.

In 2012, the company DNA 2.0 tried to register a copyright for an engineered DNA sequence called "Prancer," working with law professors Christopher Holman and Andrew Torrance. The U.S. Copyright Office denied the request. The team appealed, saying human-designed DNA sequences, like computer programs, should be considered "literary works" under copyright law. Section 102(a) of the Copyright Act lists eight categories of copyrightable works, such as literary or musical works. The team argued that these categories were meant to be flexible and not limited to those listed.

Naturally occurring DNA sequences are not protected by U.S. copyright law because they are "discoveries," not works of human creation. Holman et al. (2016) noted that this is a shared view among supporters and critics of copyrighting engineered DNA. However, supporters said that arranging naturally occurring DNA sequences in a creative way could create an original, copyrightable work.

In contrast, UK copyright law protects works created through an author’s skill, judgment, and effort, as long as they are not copied. San Martin and Hurdle (2017) said that a DNA sequence written as a string of letters (A, C, G, and T) might be copyrightable in the UK, similar to translating a work into another language. However, this would not stop someone else from independently creating the same DNA sequence and claiming their own copyright, even if it matches another’s version.

Policy arguments

The public policy advantages and disadvantages of extending copyright protection to DNA sequences have been discussed. Supporters believe that copyright offers better protection for engineered DNA sequences than patents for several reasons.

First, copyright is easier for creators of synthetic DNA sequences to obtain and use against others who copy or use them without permission. Unlike patents, which require approval from a patent office and can take years to get, copyright is automatically granted when a work is "fixed in a tangible medium of expression," such as being written down or recorded. In cases where genetically engineered products are copied illegally, Christopher Holman says proving copyright infringement would be simpler than proving patent infringement if DNA were protected by copyright. Also, copyright law allows for more types of legal actions against infringement, such as criminal penalties and stopping the import of illegal copies.

Second, Holman argues that copyright is less strict, so it would still protect DNA sequences from copying without harming innovation in synthetic biology as much as patents. Because of the "idea–expression divide," copyright would only cover a specific DNA sequence, not its function. This means another researcher could create a different DNA sequence with the same function without breaking copyright rules. Similarly, two researchers could independently create the same genetic sequence without violating each other’s copyrights, since independent creation is a complete defense under copyright law but not under patent law.

However, law professor Dan Burk says the weakness of copyright makes it a poor tool for protecting DNA sequences. Burk argues that courts have struggled to separate the function of computer programs from their expression, and would face similar challenges in determining whether engineered DNA can be protected by copyright.

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