Biopharmaceutical manufacturers have successfully patented isolated DNA molecules for some time. The Biotechnology Industry Organization recently described these patents as critical tools that enable the research and development of new biotech therapies. A new development in a federal court case, however, could redefine what legitimately can and cannot be patented. The court’s decision could have ramifications for all biopharmaceutical manufacturers.
In an amicus brief filed on Oct. 29, 2010 with the US Court of Appeals for the Federal Circuit, the US government declared that isolated and unaltered genomic DNA is not patentable. In the brief, the government likened genomic material to coal, which does not become patentable after a company isolates it from its natural environment. The relevant question is whether an inventor has created something through ingenuity or merely exposed something in nature that had not been appreciated, according to the brief. The government concluded that genomic DNA is a natural product, and therefore not patentable.
The brief surprised observers because it represents an about-face from the government’s previous position. For years, the US Patent and Trademark Office (PTO) has issued patents for isolated genomic DNA. It’s uncertain whether the PTO will put the government’s position into effect immediately. It may take a federal court decision to codify it.
The US government filed its brief as the US Court of Appeals for the Federal Circuit considers Association for Molecular Pathology, et al. v. US Patent and Trademark Office, et al. Myriad Genetics (Salt Lake City), one of the defendants, is asking the court to overturn a decision that isolated and purified gene sequences are not patentable.
I think the government’s change of tune is admirable and eminently reasonable. Its analogy between genomic data and coal is apt—would anyone try patenting unaltered quartz or egg yolks? To extend patent protection to DNA would restrict access to basic scientific information, which can have the most benefit only if it is kept in the public domain.
The US government’s position would not stop a company from patenting synthetic DNA or recombinant plasmids, which do not occur in nature and must be fabricated. Likewise, a company also could patent its own process for extracting and purifying DNA molecules. The government’s position also would not affect anyone’s ability to patent a diagnostic test.
Invalidating patents on genomic DNA might sound like an alarming prospect to the biopharmaceutical industry, but I don’t think it would unduly harm their business. If the Federal Court accepts the US government’s argument, biopharmaceutical companies could earn revenue by developing patentable processes and products based on genomic data. Keeping these data in the public domain would help to foster science, understanding, and innovation—and that would be to the industry’s advantage.