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Do-It-Yourself Synthetic Biology Punishable in Germany

By Bartlomiej Kolodziejczyk

Do-It-Yourself synthetic biology is a rapidly evolving and emerging social biotechnology movement in which individuals, community groups, and small organizations study biology and life science using methods similar to those of traditional research institutions. DIY synthetic biology is primarily undertaken by individuals with extensive research training from academia or biotech and pharmaceutical corporations, who then mentor and supervise novice DIY biologists with little or no formal training.

The movement has become so prominent that many large cities have designated “biomarker spaces” run by citizen scientists and eager DIY synthetic biology enthusiasts. Complete, ready-to-use DIY synthetic biology kits can be purchased online from a variety of sources and savvy scientists have used these tools to alter biological organisms, i.e. E. coli bacteria, plants and more, and engineer them to, for example, glow in the dark.

These developments bring many opportunities, but at the same time present peculiar challenges. The fact that some of these organisms can be hazardous to the environment, biodiversity, and human health cannot be overemphasized. Moreover, inexpensive genome modification methods that are easily implemented by novices could create new channels for bioterrorism, which may be especially concerning given recent terrorist activities.

On 25 January 2017, the Federal Office for Consumer Protection and Food Safety of Germany (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) issued a statement prohibiting the use of DIY synthetic biology and genetic engineering kits outside of the specialized facilities and research institutions.

Whoever disobeys the law by ordering a DIY kit and utilizing that kit outside of the designated facilities will be liable to a fine up to 50,000 Euros in accordance with § 38 (1) (2) Genetic Engineering Act (GenTG). Furthermore, if Genetically Modified Organisms (GMOs) are released due to the use of the DIY kits, the offender can face imprisonment of up to three years or a fine as stated under Section 39 (2) (1) GenTG.

The statement sent a wave of shock through the DIY bio community. The enactment of laws governing the proliferation of biotechnology, such as the regulation of genetic engineering (Gentechnikgesetz – GenTG), ratified on 20 June 1990, is not new. However, recent developments and the growing movement of biohackers pushed the Federal Office for Consumer Protection and Food Safety to enforce these regulations. In accordance with § 8 para. 1 sentence 1 GenTG, genetic engineering work may only be carried out in genetic engineering facilities, i.e. in suitable, officially designated laboratories under the supervision of a qualified project manager or researcher.

Germany is not the only state trying to regulate this new movement. A few days prior to the German statement, the U.S. Food and Drug Administration (FDA) quietly proposed regulations that would require any genetically engineered organism to go through a strict regulatory procedure. In essence, the FDA wants to define any organism that a scientist purposefully genetically modifies as a “drug”, and such development would have to pass strict and lengthy clinical trials to be approved.

Europe is generally stricter than the United States in regulating genetic engineering and genetically modified products. In certain European states, the legality of DIY genetic engineering is ambiguous. Germany’s statement may inspire other European and non-European nations to take similar, firm stances to regulate the activities of the social biotechnology movement. Recent events indicate that precautionary measures will be embraced by more nations across the globe.

U.S. Supreme Court rules on patentability of DNA

On 13 June 2013 the Supreme Court ruled in the Association for Molecular Pathology v. Myriad Genetics case that DNA is a product of nature and not patent eligible merely because it has been isolated. However, cDNA is patent eligible because it is a product that is not naturally occurring. Thereby the Supreme Court affirmed in part and reversed in part the decision of the Federal Circuit.

Myriad Genetics (“Myriad”) discovered the precise location and sequence of the BRCA1 and BRCA2 genes; mutations of these genes can increase the risk of breast and ovarian cancer.  This discovery enabled Myriad to develop medical tests to detect mutations in these genes in patients to assess their cancer risk. Myriad obtained several patents which would give it the exclusive right to isolate a patient’s BRCA1 and BRCA2 genes and would give the respondent the exclusive right to create BRCA cDNA.

A group of plaintiffs, which included doctors, breast cancer patients and researchers, joined a lawsuit by the Association for Molecular Pathology (“AMP”) seeking a declaration that Myriad’s patents are invalid under 35 U.S.C. §101.

The District Court granted summary judgment to the plaintiffs since Myriad’s patents covered products of nature and were therefore invalid. The Federal Circuit however, found that both isolated DNA and cDNA were patent eligible.

The Supreme Court held that the principal contribution of Myriad was its uncovering of the precise location and genetic sequence of the BRCA1 and BRCA2 genes. According to Diamond v. Chakrabarty it is central to the inquiry for patent eligibility whether the action was new “with markedly different characteristics from any found in nature”.  In this case Myriad did not create or alter the genetic information or the genetic structure. Even though it found these important genes, a §101 patent eligibility inquiry is not by itself satisfied with a groundbreaking, innovative or brilliant discovery.

The Supreme Court further describes how Myriad’s patent descriptions highlight the problems with its claims:

Firstly, they describe in detail the process of discovery, but §101 demands are not satisfied by extensive effort alone.

Secondly, even though the isolation of DNA from the human genome severs those chemical bonds that bind the gene molecules together, Myriad’s claims are not saved by the fact.

Finally, Myriad cites J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., a case where Congress has endorsed a PTO practice in subsequent legislation, arguing that the past practice of the PTOin awarding gene patents is entitled to deference.  In this case however, there has not been such an enforcement and the United States argued in both the Federal Circuit and the Supreme Court that isolated DNA was not patent eligible under §101.

cDNA is patent eligible since it is not a product of nature. DNA takes the shape of a double helix and consists of two chemically joined nucleotides. The sequences of DNA nucleotides contain information to create the strings of amino acids which are used to build proteins in the body. Nucleotides coding for amino acids are exons and nucleotides not coding for amino acids are introns. Composite DNA (cDNA) are synthetically created exons-only strands of nucleotides, i.e. cDNA omits the introns.

The Supreme further notes that this case neither involves method claims, patents on new applications of knowledge nor the patentability of DNA where the order of naturally occurring nucleotides has been altered. [Nicole Daniel]

European Group on Ethics (EGE) asks European Commission to embed ethical principles in agriculture policies

The European Group on Ethics (EGE) today met with Mariann Fischer Boel, the Commissioner responsible for Agriculture and Rural Development to present the main recommendations of the Group’s opinion on the ethical implications of modern developments in agriculture technologies. Following a request from President Barroso, the EGE adopted in December an opinion on the ethical implications of modern developments in agriculture technologies, in order to address the new challenges and opportunities which lie ahead for EU agriculture. The group decided to focus primarily on agriculture technologies and methods for primary production of food of plant origin. In this opinion the EGE shows its awareness for the need for promoting innovation in agriculture in order to be able to feed the growing world population. It adds that technologies alone cannot provide final solutions to the challenges modern agriculture is facing in the EU and worldwide. [European Commission Press Release]

European Commission launches public consultation on medical devices

The European Commission launched a public consultation with the aim to modernise and simplify the legislation on medical devices. Since the nineties the safety of medical devices in Europe has been guarded by a series of medical devices Directives. Their introduction also contributed to free trade, innovation and competitiveness within Europe. However, in recent years a number of drivers have come into play that require a revisit of this legislation. Experience indicates that the current system does not always offer a uniform level of protection of public health in the European Union. New and emerging technologies present new challenges to the current framework, highlighting gaps and pointing to a certain scarcity of expertise. In addition, in recognition that the medical devices market is a global one, to keep European industry competitive, the European Community regime needs to further converge on globally applied rules. And finally, the legal framework has been criticised as being too fragmented and difficult to follow and fraught with national variation. This situation has motivated the European Commission to consider a revision of the legal framework in order to meet the growing expectations from European citizens. [European Commission Press Release]