Participants

In order to discuss the issues around intellectual property rights and synthetic biology, we attended an event hosted by [http://biopeople.dk/ BioPeople] called "The Basics and the Best". This event consisted of a series of three lectures:

• "What is IP and how do I use it for my company development?" by Jakob Krag Nielsen, IP lawyer at Rønne & Lundgren
• "Navigating the legal landscape in the United States - How is it different than Europe" by Michael Cohen, IP lawyer at Gray Plant Moody
• "IP strategy in case of external financing and licensing" by Thomas Tscherning, director at TTO of Aarhus University

We had a question and answer session with the following speakers following their lectures. Our discussion focused around the impact that the recent Myriad Genetics US Supreme Court ruling would have on synthetic biology.

Lecture 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. An example is Listerine who agreed to a payment in perpetuity was required to continue paying fees even though nearly the same formulation was used by competitors for no fee. Another example is a company whose agreement to pay a reduced licensing fee for a longer duration than the patent was struck down.

The biggest take away here is that if you want or need to engage in IP agreements, it is imperative to have good lawyers.

IP related to iGEM

We dug into the terms of the Biobrick Public Agreement, and found that this is an agreement similar to the GPL (a software license for free software), but with a slightly different implementation because biotechnology is protected by patents, not by copyright. Also, the BPA does not include a viral clause like the GPL does (which states that if I modify your software that is covered by the GPL, then my new modified version must also be covered by the GPL).

The BPA states that a user who uses a part from the Parts Registry agrees to provide proper attribution to whoever submitted it, and additionally agrees to respect biological safety practices and applicable laws. Someone who contributes a part to the BPA agrees to "not to assert any existing or future intellectual property rights" (such as demand licensing fees) against any user of the part that they contributed. This means that Biobricks will remain free for anyone to use, and doing so will not carry any risk of drawing a patent infringement lawsuit. Parts that are submitted to the Parts Registry may be under patent, but the above terms will still apply -- if you submitted a patented Biobrick to the parts registry, you would not be able to charge a licensing fee to any user of your part from the registry (though you are free to have other licensing agreements with other parties).

We assume that we have agreed to the BPA when we signed up for an iGEM and Parts Registry account, but we were not able to find this information on the iGEM website. This information is also not available on the distribution plates, and it does not seem to be available in the [http://parts.igem.org/Help:2013_DNA_Distribution help information available in the parts registry]. We would recommend that iGEM make this information more visible since knowing the legal terms under which we are using parts from the registry is important.

Background: Myriad Genetics Ruling Summary

[http://www.myriad.com/ Myriad Genetics] manufactures a genetic test for BRCA1 and BRCA2, which relies on detecting cDNA. They held a patent that granted them exclusive right to use and generate derivatives of these genes. This patent was challenged by the American Civil Liberties Union ([http://www.aclu.org/‎ ACLU]), who held that genes should not be patentable.

Recently, the US Supreme Court [http://www.law.cornell.edu/supremecourt/text/12-398 ruled] on the Myriad Genetics case stating that while naturally occurring human genes cannot be patented, cDNA which is derived from a human gene can be.

This is potentially confusing for anyone working in synthetic biology, because it is not clear whether the information content of the cDNA (with introns spliced out) is what is being protected, or if instead just the physical new cDNA molecule is being protected.

Interview with the Speakers

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.
• He is implying that this ruling isn't going to hamper genetic research. People will continue to fund this sort of work even though genes themselves cannot be patented.

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

• Jakob: In Europe, you cannot prevent reverse engineering for interoperability [in contrast with the US], but if an academic wanted to research the BRCA1 cDNA, they would need to pay a licensing fee.

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.