Currently, Canada has over 40 renewable fuel producing companies and the federal government has mandated an average of 5 per cent renewable content in gasoline. Companies developing technologies for the production of alternative fuels face several issues that need to be considered regarding patent protection. Two key issues are protecting feedstocks for biomass production, for example plant and algal biomass and expression systems for enzyme production; and protecting isolated nucleic acids that may be used for ethanol or bio-oil production.
Feedstocks and Expression Systems
In the U.S. in 1980, the question arose as to whether a biological organism — a Pseudomonas bacterium altered to contain plasmids capable of degrading different oil components and which could be used for treating spilled oil — could be patented. The U.S. Patent Offi ce initially rejected the application, however, the U.S. Supreme Court determined that the altered organism was patent-eligible subject matter.1 Following this decision, the U.S. considers other organisms, including multicellular, higher life forms such as plants and animals, as patent eligible.
About the same time, a microbial culture useful for digesting spent sulfi te liquor from pulp and paper waste streams was found patentable in Canada by the Patent Appeal Board.2 However, the decision was directed to life forms “produced en masse … [and that] possess uniform properties” and left open the question as to whether higher life forms may be patentable. The patenting of higher life forms was subsequently considered by the Supreme Court of Canada (Harvard), where it was held that an animal is not patentable subject matter.3 A second Supreme Court decision considered the scope of claims to a recombinant DNA molecule and to plant cells comprising the recombinant DNA molecule (Monsanto).4 In Monsanto, it was held that by growing a plant comprising a patented gene and patented cells, these claims were infringed. As a result, a unique situation emerged in Canada. Even though a higher life form such as a plant is not patentable under Harvard, a higher life form may be protected if it comprises a patentable gene or cell.5 The Canadian Patent Offi ce considers plants, seeds and mushrooms as higher life forms.6
Following extensive consultation with stakeholders for over a decade, the European Patent Convention was amended to state that plants or animals are patentable if the invention is not limited to a particular plant or animal.7
As discussed later in this article, a recent decision in the U.S. (Myriad)8 has questioned whether isolated natural products are patent-eligible subject matter. If this decision is maintained and interpreted broadly, it may have an impact on the protection of isolated natural organisms that have been selected on the basis that they over express an enzyme, or other product of interest, such as a type of oil.
Therefore, providing that algae and fungi (i.e., lower life forms) meet the standard criteria for patentability (novel, non-obviousness and exhibit utility), they are patent eligible in many countries. However, novel feedstocks, or organisms used for protein expression that involve multicelluar organisms such as fungi or plants, are not patentable in Canada. The impact of Myriad on the protection of naturally occurring organisms in the U.S. will also need to be monitored.
In many countries, in addition to patent protection, feedstocks may also be protected using plant variety protection (Plant Breeders’ Rights). In the U.S., a plant patent may also be obtained.9
While the patentability of nucleic acids has been hotly debated in many countries over the last decade, nucleic acids are generally patentable provided the nucleic acid has been isolated, characterized (i.e., sequenced) and is useful, or has an industrial application.10 However, Myriad11 has caused several countries, notably Australia,12 to revisit the question of patentability of DNA. In Myriad, composition claims pertaining to an isolated, and otherwise unmodifi ed DNA were held to be patent-ineligible subject matter, since the sequence of the isolated DNA is the same as the native DNA, and the DNA was considered a product of nature. Claims directed to hybrid or chimeric sequences, vectors and cells comprising the sequence would still be considered patent eligible. The Myriad decision has been appealed, and interestingly, the U.S. Department of Justice presented arguments in an amicus brief that, while genomic DNA should not be patenteligible subject matter, cDNA is patent eligible.13 The Federal Circuit heard arguments on Myriad on April 4, 2011.
In most countries, nucleic acids are considered patent-eligible subject matter. However, developments in the U.S. and Australia should be monitored carefully as the scope of protection for nucleic acids in these countries may be limited to chimeric nucleic acids, or nucleic acids that are otherwise modifi ed. Constructs, vectors and the like that contain non-native associations of elements (for example heterologous promoters, signal sequences, etc.) should also be considered patent eligible.
Developments in biofuel and bioenergy technology are rapidly growing and key to our future. In order to ensure proper patent protection of these developments, it is important to address differences across various countries in your patent strategy.