Biotechnology. For many, the mere mention of the word stirs up a thought of people in white lab coats working in underground bunkers trying to create superhuman mutant weapons, with beakers of green goo bubbling in the background. But, as is often the case, reality is far less sinister. Many scientists will tell you that working in a lab typically entails moving very small volumes of clear liquids from one tiny test tube to another and occasionally generating some smelly bacterial cultures. The work rarely involves the creation of super weapons or human clones, and there are never any beakers of bubbling green goo. Not even on St. Patrick’s Day.
There is one thing that is universally true about the biotechnology industry. It is full of brilliant people who are constantly innovating. Because of that, scientists and companies alike are always on the lookout for ways to protect what they create. As a patent attorney who practices in biotechnology, I’m often called upon to protect engineered nucleic acid (DNA or RNA) sequences. By “engineered,” I mean exactly what you expect – DNA or RNA sequences that have been created by scientists in a lab; products of human ingenuity that require a lot of thought and have been created for a specific purpose. I do not mean DNA or RNA that exists in nature. Protection for these engineered sequences has been traditionally accomplished through the patent process, which takes several years to complete and requires a lot of time, money, and effort.
However, with the United States Supreme Court ruling in Myriad, obtaining patent protection for nucleic acid sequences has become challenging. This decision has called into question the validity and/or enforceability of numerous U.S. patents, and has left some wondering if it is still possible to get patent protection for nucleic acid sequences.
This has caused people to revisit the concept of making copyright available as a form of intellectual property protection for nucleic acid sequences. Chris Holman, a professor at the University of Missouri-Kansas City Law School, has written extensively on this topic. His first piece published in 2011 and earlier this year he penned a three-part series covering this topic for GQ Life Sciences. However, the idea of copyrighting DNA is not new. It was first discussed in 1982 in a law review article written by Professor Irving Kayton.
Both Kayton and Holman make compelling cases in favor of expanding copyright to cover nucleic acid sequences. One of the points they raise is that it will not require a shift in the copyright paradigm; the proper avenue for protection already exists. Critics of this point assert that copyright was created to protect things like books and music, not something purely functional like a nucleic acid; because of this, they argue that copyright is inappropriate for nucleic acids.
But, we’ve heard that argument before – these same critics raised it when opposing the expansion of copyright to cover software. Software is copyrightable. It’s also functional. It’s a code read by a computer in order to produce some useful result. Holman and Kayton argue that nucleic acids operate similarly, just in a different medium. DNA, like software, is a code. It’s a series of A’s, T’s, G’s and C’s, that is read by a cell in order to generate something useful. Both Professors conduct thorough comparisons, each concluding that there are enough similarities between software and nucleic acids to warrant copyright protection for nucleic acids.
Importantly, the expansion of copyright to include software was done without amending the Copyright Act to expressly state that software is copyrightable material. Even though the Act was amended to include a definition for “computer programs,” software was never added to the list of examples of copyrightable material. Instead, Congress considered software to be a form of “literary work” falling within the scope of an “original work of authorship.” Because of that, there was no need to amend the Act to recite “software” (see Nimmer on Copyrights §§ 2.04(C)(1) & (2)). Because one can think of nucleic acids the same way as one thinks of software for purposes of copyright, the Act is already broad enough to include nucleic acids. They are “literary works” falling within “original works of authorship,” just like software, and are properly copyrightable.
Nonetheless, as of the date of this post, the U.S. Copyright Office will not register a copyright in a nucleic acid sequence. As Kayton and Holman argue, this cannot be because the Copyright Act is insufficient or unable to cover nucleic acids. It is because the Office has determined that nucleic acids are not copyrightable.
There are many who disagree with the Office and the debate is heating up. Holman himself recently helped a private company submit an application to the Office to register a copyright in an engineered nucleic acid sequence. The application was intended to “advance the conversation on the copyrightability of DNA.” Predictably, the Office refused the registration. In response, Holman submitted a petition to the Office arguing in favor of the copyrightability of nucleic acids, which was similarly rejected.
Holman is presently writing about this experience and intends to publish a “detailed response which … refutes the Office’s stated rationale for denying registration.” (Id.) He hopes to garner enough interest from the biotechnology community such that someone will challenge the Office’s position in court. As for the success of such a challenge, Holman states “frankly, I think the Copyright Office would have a hard time defending its position.” (Id.)
I agree. It is time for copyright to be expanded to cover engineered nucleic acid sequences. Unfortunately, for now we have to wait and see if there is a willing challenger out there who will take on the Office and settle this dispute. Until then, keep filing your patent applications!