Team:HZAU-China/Intellectual

Abstraction:

In our study, in addition to the exploration of the project itself, laws,policies and social point of our project were considered. With the development of gene technology and related industries, intellectual property protection genetic research and products are more and more attention. For which stakeholders and established laws that we conducted in-depth study and research, and consultation with experts in patent law. We study basic legal knowledge and we make this analysis report try to understanding the patent problem we face in project.

In this report ,we also develop some point from intellectual property in synthetic biology. Hope that could help us meditate the effect on economic,industry and synthetic biology in a comprehensive way.

The things we face is our design rewairable circuit,may automatic variation and produce new significative gene. The new gene may be significative in industry and application, also may have potential security problem. The belonging intellectual property right and responsibility of potential security problem would be controversial. According to Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, there is no doubt our team can hold the intellectual property right as co-inventors.

We can divided the problem in to several simple question. First ,can we hold the intellectual property right of our design of rewairable circuit ? The general rule in the US (§ 101)is that laws of nature and naturally occurring phenomena are not patent-eligible subject matter. Synthetic biology creates DNA that does not occur naturally — and so the court's ruling explicitly allows such human-designed DNA to be patented. Legally, therefore, synthetic-biology sequences and techniques can be patented, at least in the United States. But because of we participate iGEM competition, we are glad to share our work as a open resource in iGEM registry .

Second problem is that the new gene is produce in a automatic variation way by cell itself, could it be patented as an independent human-design product ? Synthetic genomes are patentable in the normal course. Selected, concentrated or extracted naturally occurring genes may be patentable in certain circumstances.

Then here cames question that Can we hold the intellectual property right of the new gene that produced by our design? What if the cell produced new gene with our parts is raised by other people who get our design from iGEM registry? Those problem are complicated and trivial , but we may found that the core of those problem is that Does the design change the intrinsic relationship from normal genetic works?

So here cames two ways of understanding : We may definition the new gene as a byproducts of our parts. So the new gene’s intellectual property right should following the parts and belonging to co-inventors of the parts. But if we definite our parts as a tool, then the new gene is a product produce by the person who use the tool. And certainly the second one is a important condition of iGEM‘s tentative plan.

After our study,here cames conclusion : we think the new gene created by cell with our parts should belong to the person who raise the cell. We hope our work could help to others research, and if the product are develop to Commercialization application, we hope our work could be mention.

Our research about intellectual property in synthetic biology didn’t stop with our problem sovled. In our study we found that is hard to balance the research and application in synthetic biology.

From the start, the field of synthetic biologyhas been an amalgam of disparate influences, each with different cultures of intellectual property. On one side sit software design and engineering, which introduced the idea of encoding desired functions in pieces of DNA and joining together a standardized set of biological widgets, much like bricks or Lego pieces. Software engineers also brought with them the philosophy of sharing their work using open, public registries or only lightly restrictive licensing agreements, such as copyrights.

On the other side sit molecular biology and biotechnology, which supplied know-how about messy and unpredictable biological systems. They also brought the practice of patenting genes, molecules and technical processes. Half of the papers published in Nature Biotechnology between 1997 and 1999, for example, were linked to a patent.

Patent advocates say that protecting intellectual property is necessary to spur innovation.But open-source advocates argue that patents squelch innovation.

It may not matter what the data say, according to Hans Sauer, deputy general counsel for intellectual property at BIO. “For better or worse, we're just committed to a system that depends on the availability of patents, at least to some extent, for greasing the wheels that put the biotech business model in motion.” In other words, whether patents actually spur innovation may be trumped by the widespread view of entrepreneurs and investors that they are key to minimizing risk in the start-up phase. “These people, rightly or wrongly, all act on their beliefs and their convictions,” says Sauer.

Resource:

The BioBrick™ Public Agreement (BPA) https://biobricks.org/bpa/

Bryn Nelson. Synthetic biology: Cultural divide. Nature, 7 May 2014; doi:10.1038/509152a

United States Code Title 35 - Patents

Justices debate gene patenting issues: In Plain English

Far more reading

1.Justices debate gene patenting issues: In Plain English
http://www.scotusblog.com/2013/04/justices-debate-gene-patenting-issues-in-plain-english/#more-162400

2.Supreme Court Oral Arguments in ACLU Myriad Gene Patent Case
http://www.pharmapatentsblog.com/2013/04/15/supreme-court-oral-arguments-in-aclu-myriad-gene-patent-case/

3.Biotechnology Industry Organization
http://www.bio.org/category/intellectual-property