Gene Splicing & Biofuels: The Myriad Decision

DNA Sequences

DNA Sequences

Is DNA the next great "invention" for biofuels?

The Federal Court of Appeals’ decision last summer in Ass’n for Molecular Pathology v. U.S.P.T.O (herein referred to as Myriad) is a must read for those in the developing world of biofuels. To summarize, the court held that:

1) Isolated DNA sequences are not naturally occurring and are therefore patentable. The court reasoned that DNA sequences in their natural state are always covalently bonded with another molecule and if cleaved [i.e. separated from the other molecule], the isolated DNA sequence is patentable.

2) Methods of detecting DNA sequences in a human sample entail no act in the physical world. Thus, they are purely mental processes and are barred from being patentable subject matter.

3) Methods of screening organisms, however, could be patentable subject matter. If a person swallows a pill containing a host cell and the invention in question measures the host cell’s growth within the body, this constitutes a “transformation” that is patentable.

What does the Myriad decision mean for the field of biofuels?

Myriad opens the door for a whole host of biofuels patents surrounding DNA sequences. In the realm of algae or E. Coli production of biofuels, for instance, there may be DNA mutations in these microorganisms that increase reproductive efficiency, produce oil that is easier to extract, or create more attractive fuel compositions. As Adam Wolek of the Chicago-Kent Law Review points out, the biofuels industry has a need for patents that increase efficiency, and these DNA sequences fit the bill.

Mere detection of these novel DNA sequences is not patentable subject matter under Myriad. The court in Myriad did not foreclose the possibility, however, that a method claim describing the detection of certain DNA mutations may be written in a manner that includes some sort of machine or transformative step. As long as the machine or transformative step is not a “merely insignificant extra-solution activity,” a diagnostic method may be patentable.  Patent Law-Patentable Subject Matter-Federal Circuit Invalidates Diagnostic Method Claims As Drawn to “Abstract Mental Processes.”-Association for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed, 125 Harv. L. Rev. 658, 665 (2011). For example, in the realm of biofuels, there may be patents on ways to extract oil from a microorganism with a mutated DNA sequence. Here, the act of altering a microorganism’s DNA and then using a method to extract oil could be transformative enough to be patentable subject matter under Myriad.

Since the biofuels field is still developing, “platform patents” for large-scale production of a product are especially valuable. Adam Wolek, Biotech Biofuels: How Patents May Save Biofuels and Create Empires, 86 Chi.-Kent L. Rev. 235, 236-37 (2011). If new method and composition inventions prove commercially viable, inventors could be in the position to create industry standards and dominate the field. Id. The immense potential value of “platform” biotech patents is illustrated by examples like Roundup Ready and Hoffman-La Roche. By being the first to patent the standard herbicide and genetically modified plants resistant to that herbicide, Roundup Ready was able to control 93% of the U.S soybean planting market. Id. Likewise, Hoffman-La Roche, by aggregating all the patents for the method used in DNA cloning, was able to use its market power to make billions through licensing. Id.

In conclusion, Myriad opens the door for biofuels companies to stay ahead of the competition via patents on isolated DNA sequences and transformative processes. The biofuels industry should stay updated on developing case law following Myriad and other biotech patent cases such as Prometheus.



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