Participants

In order to discuss the issues around intellectual property rights and synthetic biology, we attended an event hosted by BioPeople called "The Basics and the Best"". We had a question and answer session with the following speakers following a set of lectures. Our discussion focused around the impact that the recent Myriad Genetics US Supreme Court ruling would have on synthetic biology.

• Jakob Krag Nielsen, IP lawyer at Rønne & Lundgren
• Michael Cohen, IP lawyer at Gray Plant Moody
• Thomas Tscherning, director at TTO of Aarhus University

Background: Myriad Genetics Ruling Summary

This ruling states that while naturally occurring human genes cannot be patented, cDNA which is derived from a human gene can be.

Summary

The discussion gave us an interesting perspective on the way that people outside academia view patents and IP law.

Patents can be granted on any useful technology that is novel and not obvious.

If patents are granted on the raw genes, this means that the gene is not available for other researchers to use.

Companies want to patent their technologies, because this gives them the ability to prevent other companies using these technologies without paying a licensing fee. Having a patent does not necessarily grant the holder "freedom to operate", or, the ability to use the technology explained by the patent.

License agreements between parties may grant the rights to manufacture and distribute, but do not necessarily grant the right to use a technology.

License agreements between a patent holder and a licensee may change the terms of payment of royalties, and an interpretation of contract law will determine whether these agreements are enforceable. Example of Listerine who agreed to a payment in perpetuity was required to continue paying fees even though the formulation was used by competitors for no fee. Example of someone else, who had agreed to pay a reduced fee for longer duration was not upheld.

We also dug into the terms of the Biobrick Public Agreement, and ...

Interview

Why aren't genes subject to copyright instead of patent law?

Jakob: According to IP law in Denmark, technology can only be patented, it cannot be copyrighted. Michael: In the US, no one has tried to copyright genes, but it could be possible.

The ruling was applied only to the non-patentability of human genes; is it reasonable to expect that it will be extended to all natural genes?

All: Not going to speculate

Are the mutants that we are creating patentable?

Jakob: Recombining genes in a novel order is sufficient modification to expect that a patent would be granted

Is this ruling in the best interest of society?

Michael: At the end of the day, funding for genetic research is not going away.

Are there provisions in patent law for academic or personal use?

Jakob: In Europe, you cannot prevent reverse engineering for interoperability

Part of the ruling states that the splicing of introns from the genes is a factor in the 'artificiality' of the cDNA construct -- does this limit patentability of prokaryotic genes since they don't have introns?

All: Declined to comment

The information content of cDNA is the same as the template RNA (after intron splicing) and is patentable, but mRNA which has the same information content as the original DNA is not patentable. Thoughts?

Michael: Agree, the information content is not the important part.

At the workshop. Left to right: Jakob Krag Nielsen, iGEM team, Michael Cohen, Thomas Tscherning.