Patent Issues in Synthetic Biology Research

Dr. Jörg Schwartz, Contributing Editor, joerg.schwartz@photonics.com

Synthetic biology aims to design and engineer biologically based parts, novel devices and systems as well as to redesign existing, natural biological systems – often with support from photonic tools. For “synbio,” a relatively new and emerging field that intersects with biotechnology, software and electronics, a number of issues on whether and how to protect intellectual property have surfaced, some of which also may become relevant to other scientific areas.

Synbio’s promoters – for example, members of The Royal Academy of Engineering in the UK – say that synthetic biology has the potential to create another raft of major new industries. They believe that there is enormous potential, ranging from innovative biofuels to enabling products from cheap, lifesaving new drugs. Others, such as the ETC Group in Ottawa, however, see the field as “genetic engineering on steroids” and describe the social, environmental and biological weapons threats of synthetic biology as surpassing the possible dangers and abuses of (conventional) biotechnology.

Synthetic biology is an emerging field that intersects with biotechnology, software and electronics, so intellectual property protection is unclear. Some activists say that granting commercial ownership to someone isolating something created by evolution is like giving an entomologist the right to patent a butterfly caught in his net.

Despite these concerns, synbio is attracting attention from venture capitalists, major corporations and startup companies. Some say investment is attracted because of the ability to claim patent rights for the “discovery” of things that exist in nature, while others see the need to offer appropriate – commercial – protection of inventions in this field to keep it going.

At a November 2009 event called “Patenting Synthetic Biology – A Trans-atlantic Perspective,” hosted by the Synthetic Biology Project at the Woodrow Wilson Center in Washington, the audience discussed factors influencing policies on the evolution of intellectual property protection for synthetic biology with Dr. Berthold Rutz of the European Patent Office (EPO) and with John LeGuyader of the US Patent and Trademark Office (USPTO).

Morality vs. commerce

The question as to whether something that already exists in nature is patentable is clearly answered in Europe by the Regulations of the European Patent Convention (EPC), which state in part that any biological material – i.e., any material containing genetic information and capable of producing itself or of being reproduced in a biological system – shall be patentable. However, this applies only if it has been isolated from its natural environment or produced by means of a technical process; i.e., has been made technically available.

The same applies in the US and, based on case law in the 1980s, the USPTO “considers nonnaturally occurring, nonhuman multicellular living organisms, including animals, to be patentable.” However, if the broadest possible interpretation of an invention as a whole encompasses a human being, a rejection must be made, “but pieces are OK,” LeGuyader said. Europe has similar rules, with the EPC prohibiting patents from modifying the germ line genetic identity of human beings and processes for cloning human beings.

“Making” parts of humans may sound scary, and clearly there is an ethical aspect to the whole argument, despite the fact that the Washington discussion stayed mainly at the level of patent technicalities, with both speakers stating that they are not policymakers. Nevertheless, in Europe there are explicit connections between ethics and intellectual property in the morality clause in the EPC (Article 53), excluding inventions contrary to “ordre public” or morality from being patentable. “Biologic weapons would be an example,” Rutz said.

In addition, there is the European Group on Ethics in Science and New Technologies (EGE), which published its “Opinion Nr. 25 Ethics in Synthetic Biology” just recently. The EGE proposes that debates on the most appropriate ways to ensure the public access to the results of synthetic biology be launched. These debates should include what can be objects of patent and what should be available through open access.

However, as Rutz explained, although this group has been tasked by the European Commission, the role of the EGE is “legally not fully clear,” and its recommendations are not binding for the EPO but “are taken, of course, into consideration.”

Same engineering tools?

Beyond that, anyone applying for a potentially unethical patent must be in “possession” of the invention and must very clearly state what he or she does – namely, in a description forming part of the patent application that gets published. A slight difference is that, in the US, for any patent, the best way must be described, whereas in Europe, at least one way of carrying out the invention – not necessarily even a good way – must be included in the application. Also in Europe, there are further requirements, including clear and concise claims and disclosure of the invention in a manner sufficiently complete that it can be carried out by a person skilled in the art, a process used if claims are too broad, Rutz said.

The flip side of patents making all this public is that they offer the owner exclusivity and protection – and commercial gain via license fees. This begs the question of whether applying the rules of patenting – proved in other fields of engineering – to synthetic biology is such a good idea. Some activists say that giving exclusive commercial ownership to someone isolating something that evolution has created is like giving an entomologist the right to patent a butterfly that ends up in his catcher.

But even for those closer to the technology, there are open questions. In his presentation, Rutz quoted professor Joachim Henkel from Technical University Munich, who sees that, in synthetic biology, “building blocks such as genes that have a certain function are synthesized and put into a cell so that a cell starts to produce a certain substance. To arrive at this result, you need sometimes hundreds of these building blocks. Now if each of these building blocks is protected by a patent, any innovation which is based on any of them is blocked.” He suggests excluding biological building blocks from being patentable and allowing this only for the complex biological structures that result from these building blocks.

An open source arrangement – as used in software development – could be a potential route. Asked whether this would be compatible with patents, the USPTO’s LeGuyader referred to a study by the US Department of Health and Human Services on how gene patents affect medical applications with a “neutral” outcome, but he also admitted that only time will tell.

And Rutz expresses hope that some form of arrangement can be reached between industry and research to keep research going. Many see this as crucial, and the same applies from a photonics perspective because only active research will stimulate the need for photonic tools, including using light to identify networks of protein for cellular engineering (see “Light Reveals Neuron Function,” Photonics.com, Sept. 17, 2009).

For more information on the synbio event or to view the webcast, visit: www.synbioproject.org.