LONDON, May 13 - Genomic companies could be forgiven for asking whether patenting really is the best way to protect their IP. The costs of obtaining a biotech patent are large, the prosecution period is often lengthy--not to say uncertain-and, following grant, the lifetime of a patent may only be a decade or so. Furthermore, defending the patent in court exposes a company to even greater costs and there are no guarantees of a successful outcome.
Organizations may instead shy away from the whole patenting process and prefer instead to keep their genomic sequences out of the public domain as confidential information. This approach flies in the face of the aim of patenting: placing technical advances in the public domain in the interests of promoting industrial development to the benefit of society. It is also not without risk since once confidentiality is breached it is lost forever.
Willem Stemmer, vice president of R&D at Maxygen, recently proposed an alternative to using patents to protect genomic sequences. His suggestion is to encode sequences as digital music files that can then be transferred between users as copyright-protected music files. Though the DNA sequence itself would not be protected by copyright, Stemmer argues that IP protection arises because the only way an external user could obtain the DNA sequence would be by copying the copyright protected music file. Could Stemmer be on to something or is this a leap too far for copyright law?
The idea of copyright as a means to protect DNA sequences is not a new one. In fact, it is one that has sparked a significant amount of debate in the UK, even causing a leading text on copyright law to change its stance on the matter.
Under UK law, copyright exists in works that are original, recorded (in writing or otherwise), and either literary, artistic, dramatic, or musical.
The work must be original in the sense that it has not been copied and it must not be too trivial. Unlike patents there is no need to show novelty or industrial application, the latter often being a problem in case of gene-sequence patents.
In addition, there is no formal registration procedure and generally copyright lasts the life of the author plus 70 years, although this figure can vary. Copyright is infringed when someone, without permission of the copyright owner, does certain acts including copying, adapting, renting, or broadcasting the work.
One can argue that recording the order of bases in a sequence of DNA found in nature can in theory amount to a literary work, and that work may be considered as original despite the sequence being present in nature, since only the involvement of some knowledge, labor, judgment, skill, or taste is required. What is more difficult, though, is proving infringement of copyright.
An alleged infringer must have reproduced a substantial part of that which is original in the copyright work. When a researcher uses the written sequence of letters to synthesize the DNA sequence it represents, that DNA molecule itself is clearly different from the written string of As, Ts, Gs, and Cs so it will not infringe copyright. Under US law, as Stemmer notes, the analysis of DNA copyright does not get even this far since natural DNA sequences are generally not considered as being covered by copyright as they do not satisfy the requirement of authorship.
Stemmer's proposal attempts to get around the difficulties of using a recorded sequence as a copyrighted literary work by producing a copyrighted musical work instead. Genomic companies could transform sequences into music files, for instance by using the MP3 format, so that external users could copy the music file and then convert it back into the DNA sequence using a back-translation program. An obvious advantage here is that genomic companies would be able to customize the software involved, seek subscription fees, and employ encryption techniques to prevent unauthorised access to their IP.
DNA (and protein) music has been up and running for the last few years. A variety of techniques are available but basically they involve converting the coding strand of DNA into music in a digital form using free or inexpensive programs like Bio2Midi. Melodic complexity may be added by using a particular base's chemical properties to determine the octave of the note to which it is associated.
Although pioneers of the technique may frown on its use by genomic companies, litigation surrounding the Napster copyright case in the US has shown that music files are protected by copyright and that unauthorized copying of a digital music file can amount to copyright infringement.
But will it work?
Stemmer's suggestion is an innovative proposal to extend copyright law by using modern music techniques and the aim of getting more genomic sequences published is a laudable one. However, many may view such attempts at controlling genomic sequences as a worrying development, especially as copyright protection is so much longer lasting than patent protection.
Genomics companies may also find it difficult to prevent their proprietary sequences leaking to third parties after they have been unencrypted by initial end users. Though it may be obvious that the latest U2 CD has been copied, it will be a lot harder for a company who has released a digital DNA music file to prove that a third party has not discovered that particular DNA sequence independently. This reinforces the intrinsic problem that only the digital music file itself, and not the DNA sequence, is protected against copying.
With these considerations in mind, it would appear that companies may still be well advised to follow the patenting route for protecting proprietary sequences rather than trying to rely on copyright. The days when MP3 players are as vital in the lab as DNA sequencing machines may be some time off yet.
Penny Gilbert is a partner at the law firm Bristows (www.bristows.com) in London. She has a DPhil in molecular biology and specializes in advising on IP rights in the biotech field. Robert Fitt, an Assistant Solicitor at Bristows, has a degree in molecular and cellular biochemistry and also specializes in advising on IP rights in the biotech field.