Myriad of Possibilities for Biotechnology Patent Protection
Scientists often cringe when lawyers dabble in science. One of the most famous examples is when the U.S. Supreme Court, in Nix v Hedden, 149 U.S. 304 (1893), ignored biological fact and declared tomatoes a vegetable rather than a fruit because tomatoes “constitute the principal part of the repast, and not, like fruits generally, as dessert.” On June 13, 2013, the Supreme Court dabbled in science again with its decision in Assoc. for Molecular Pathology v. Myriad Genetics --- S.Ct. ---, 2013 WL 2631062, *11 (2013) (“Myriad”). And as has been the case in the past, many in the scientific community are disappointed with the decision. It is apparent in the aftermath of Myriad that a patent applicant, with the advice of patent counsel, must thoroughly understand the technology’s application to ensure patent claims are drafted and prosecuted correctly.
In Myriad, the Supreme Court ruled that isolated DNA is a product of nature and, therefore, not patent-eligible subject material. The Supreme Court rejected the idea that isolating DNA from the genome severs chemical bonds and creates a non-naturally occurring molecule. Although the Supreme Court acknowledged that isolation of DNA segments “technically creates new molecules with unique chemical compositions,”1 the court failed to recognize that isolated DNA does not occur in nature. Like Nix, the Supreme Court reached a conclusion at odds with science.
While rejecting the argument that isolated DNA is not patentable, the court accepted the argument that DNA is more informational than molecular and acknowledged that Myriad “is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.”2 The Supreme Court also acknowledged that “isolation [of a molecule] is necessary to conduct genetic testing.”3 If DNA were merely informational and not molecular, the result would be that the written expression of a DNA sequence would be as useful as an isolated DNA molecule. Those in the scientific community do not believe that to be the case. Although one could read the entire human genome one nucleotide at a time, most scientists would agree that having information by itself is not the same as having an isolated protein or diagnosing a single disease.
Myriad Genetics did not patent information; Myriad Genetics patented a molecule. In exchange for a patent on a molecular composition of matter, Myriad Genetics provided additional information to the public about the BRCA1 and BRCA2 gene sequence and cancer. The information Myriad Genetics provided has been publicly available for anyone interested in preventing, treating and ultimately curing breast cancer. Based on the Myriad decision, however, life sciences companies may choose to preserve information as a trade secret rather than share it publically in a patent.
Although many life sciences companies and investors may be reassessing the strength of their patent portfolios in light of Myriad, the application of Myriad may have a minimal impact on pending and future patent applications. Myriad will likely have its greatest impact on patents and applications filed before completion of the Human Genome Sequence Project in 2003. With the completion of the Human Genome Sequence Project in 2003 and advances in DNA sequencing, the number of published nucleotide sequences has skyrocketed. Complete genome sequences of over 100 organisms have been published, as have numerous individual gene sequences. The sheer quantity of publically available sequences makes it increasingly unusual for an inventor to identify and isolate a novel DNA sequence. As a result, the potential benefit of claiming a genomic sequence that encodes a particular polypeptide has largely been offset.
Myriad may have its greatest impact on patents and patent applications with broad nucleotide sequence claims. Patent examiners and private litigants may use the disclosure supporting these broad genomic claims to render future claims obvious and not novel. And claims reciting non-coding sequences (e.g., claims to promoters or regulatory regions) may be at risk as non-statutory subject matter. That being said, narrow claims that specifically recite only the coding sequence of a DNA molecule clearly lacking introns should remain patentable subject matter.
In Myriad, the Supreme Court recognized that “the lab technician unquestionably creates something new when cDNA is made”4 and determined that cDNA is patent-eligible subject matter. The Supreme Court left open the question of how much intervention by a lab technician would be sufficient to yield a patent-eligible, non-naturally occurring molecule similar to cDNA. Arguably, plasmids, expression cassettes or vectors comprising an isolated DNA molecule with a naturally occurring sequence would not themselves be considered naturally occurring. And an expression cassette comprising a viral promoter operably linked to a heterologous mammalian nucleotide sequence created by a lab technician and cells comprising an isolated DNA molecule foreign to the host cell arguably would also be a non-naturally occurring composition. In the future, rewriting dependent patent claims in independent form covering expression cassettes or cells comprising an isolated nucleic acid molecule may suffice as separate patentable subject matter. It remains to be seen whether courts and the United States Patent and Trademark Office (“USPTO”) will conclude that organisms containing genes rendered dysfunctional by human intervention are patentable. For example, the USPTO may allege that the remaining unmodified sequence is naturally occurring, thereby barring patent protection. Alternatively, the USPTO may conclude that the absence of a portion of the genomic DNA segment is sufficient to conclude the molecule is non-naturally occurring and patent-eligible.
For more information in this biotechnology area, please contact Dr. Adelaide K. Leitzel, patent agent, or any member of Taft's Patent Prosecution practice group.
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