30 Oct 2017 in Newsletter
Oktoberfeisty: An Emerging Row over Patenting GMO 2-row
By: A. Rusty Rogers
Following the issuance of a number of patents over genetically modified barley to Carlsberg and Heineken, controversy has erupted regarding unfair monopolies over European beer markets and fears of accidental infringement. With similar patents in the U.S. and a number of other jurisdictions, it may be a matter of time before patents over living organisms are once again brought into the spotlight.
Carlsberg and Heineken are two of the world’s largest five breweries and, in 2016, the two companies obtained several joint patents on a series of barley strains at the European Patent Office (EPO), including EP2384110, EP2373154, and EP2575433. The patents are directed to strains of barley that minimize the production of dimethyl sulfide, a compound responsible for unpleasant off flavors in some beer styles, and are also touted as improving the energy efficiency of the brewing process by reducing the overall heating requirements for beer production. The patented strains were discovered by a process termed “random mutagenesis” in which barley kernels are irradiated or chemically treated to induce random mutations in the genomic DNA of the plant, followed by cultivation of the kernels by conventional means and screening for desirable genetic traits.
Activist groups including “No Patents on Seeds” have waged a campaign to have the patents invalidated as seeking to monopolize barley production that has otherwise been a “centuries-old tradition.” The groups contend that the patents are not inventions, and unjustly protect strains of barley that were generated through random mutagenesis, which is a technique that mirrors random genetic combination in conventional breeding techniques. Intertwined with the technical arguments against patenting a widely used cereal crop, is the general concern that the breweries are positioning themselves to monopolize the market using patents that are broadly worded to cover functional enzymatic processes that are not necessarily limited to any particular mutation discovered in the issued patent claims. The groups have had some success in raising awareness of the issue, but the EPO has yet to take affirmative action against the contested patents.
The EPO currently forbids patents on “plant varieties and animal species as well as on essentially biological processes for the breeding of plants and animals” under Article 53 of the European Patent Convention and Article 4.1 of the EU Directive 98/44, while patents on plants and animals that have been genetically engineered are permitted. However, the current law is less clear on conventionally bred plants and animals, and parties opposed to the patents attempt to compare patents on plants generated by random mutagenesis as being too close to those generated by natural selection and cultivation.
Recently, the European Commission, a body of the European Union, presented its interpretation of the disputed law in November of 2016 that no patents should be issued on products obtained by essentially biological processes, and affirmed that only methods of genetic engineering that directly intervene in the genome of plants or animals can be patented. If taken as law, the statement would likely invalidate the barley patents. However, the EPO is not under the sole jurisdiction of the European Union and not required to conform to EU directives and continues to draw a distinction that the underlying technology of random mutagenesis is not a conventional breeding technique. Thus, there appears to be somewhat of a deadlock until the EPO can be persuaded or legally forced to redefine what constitutes “essentially biological processes” for plant breeding. Meanwhile, despite calls to disclaim the patents, Carlsberg and Heineken continue to defend the patents as the legitimate products of genetic engineering and that the claim scope is sufficiently limited to a particular strain of barley.
The patenting of genetically modified organisms (GMOs) is a contentious issue that may spark a legal firestorm in any jurisdiction where genomic modification is patentable. Particularly, in the U.S., patents to genetically modified organisms and genes are allowed, where it can be shown that the genetic modification is not otherwise present in nature. In the landmark case Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013), concerns with aggressive protection of a discovered gene related to breast cancer resulted in considerable backlash from clinics and universities that were targeted with infringement suits, which ultimately resulted in the gene patent being challenged and invalidated. As discussed Myriad, patents to organisms and genes that occur naturally fall within judicially created “products of nature” exception to patent eligible subject matter under 35 U.S.C. § 101 and “lie beyond the domain of patent protection.” However, patents to compositions having “markedly different characteristics from any found in nature” are patent eligible.
Myriad has been a controversial case that has left many unanswered questions, which has left the USPTO scrambling to define the boundaries of §101 and has led to the issuance of at least three guidance documents that seek to provide workable examination guidelines. While the case appears clearer for genomic manipulation techniques in which novel genes are inserted or deleted from a genome through human intervention, such as the oil-degrading bacteria in Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Carlsberg and Heineken patents may fall in a gray area that is unnerving to some critics.
The techniques utilized in generating the patented barley strains induce random genetic mutations to seeds through radiation or chemical exposure and generate “novel” organisms, but otherwise follow standard cultivation techniques. The fear is that, because natural mutations also occur in nature, natural species containing similar mutations may exist and unsuspecting cultivars could stumble upon the same genetic differences in the wild or by “traditional” breeding techniques and unknowingly infringe patents on the particular barley mutant. Given the passions stoked by the Myriad case and the patenting of living organisms and the issuance of at least one of the controversial patents in the U.S. (U.S. Pat. No. 9,587,210 corresponding to EP 2384110), it is likely only a matter of time before the unrest over barley patents reaches across the pond and continues.