Team:Tufts/app scenario

Whoever invents or discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful improvement thereof,
may obtain a patent.
—US Law

  As we developed our 2015 iGEM project -- delivery of the CRISPR-Cas9 system via a bacterial toxin -- we came across a legal battle between Dr. Jennifer Doudna and Dr. Feng Zhang, of The Broad Institute of MIT, fighting for the intellectual property rights for the clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9 system. CRISPR and the associated Cas9 protein comprise a bacterial immune system engineered as a genome-editing platform. As our interest in the lawsuit developed, we became aware of the ethical and legal issues arising from rapid development of novel biotechnologies. By studying the current patenting issues over the general CRISPR/Cas9 lawsuit and general IP issues faced in the technological developments, we isolated some of the major patenting issues we could potentially face: the first being patent processing issues concerning competing patent claims and documentation of evidence, the second being ethical issues regarding DNA patents and claims for technology to be open source.

  We used the Doudna v. The Broad Institute of MIT, suit as case study to identify the benefits of the privatization of biological elements. Claims for ownership of the CRISPR-Cas9 genome-editing system date back to 2012, when Dr. Jennifer Doudna (UC Berkeley) and Dr. Emmanuelle Charpentier (University of Vienna) published a paper in Science showing that CRISPR-Cas systems (a driving force in bacterial adaptive immunity) could be programmed for genome editing. In 2013, Dr. Feng Zhang (Broad Institute of Massachusetts Institute of Technology and Harvard University) published a paper showing that the CRISPR-Cas9 system could be used to edit DNA in eukaryotic cells. One year later, the Broad Institute was granted a patent over the CRISPR-Cas9 system, listing Zhang as the inventor of the technology. Doudna is suing over the patent rights of CRISPR, claiming that she was the first to invent the technology as well the first to file for a patent over the CRISPR-Cas9 system – seven months before Zhang [1]. Winning this lawsuit and the patent right to CRISPR-Cas9 has immense implications; the patent is essentially worth billions of dollars, seeing as CRISPR-Cas9 is a breakthrough technology potential for successful gene therapy. Furthermore, the owner of the patent will be credited as the inventor of this novel technology, and will be able to control the usage of the technology by other scientists.

  The Doudna/Zhang lawsuit over patent rights juxtaposes the values of the iGEM foundation because of the foundation’s emphasis on open biology. The foundation encourages collaboration between teams and is committed to fostering a global and open research community. Although iGEM teams compete at the Jamboree each year, open biology allows teams to build off of one another’s projects, encouraging students to contribute their unique perspectives in order to develop projects even further year after year. This competition is, in many ways, an experiment to test the waters of open biology.

  The field of synthetic biology has grown at an exponential rate compared to many other STEM fields, partially because of the pace at which students are encouraged to produce biobricks and share them publically. Teams have developed useful technologies such as a spoiled meat detector that could benefit the food industry, while foregoing the potential profit as well as potential lawsuits should the product fail. This could lead to a system that exists as a zero-sum game with no risk and no reward. CRISPR-Cas9 is a breakthrough idea in science and would allow synthetic biology to progress at an incredibly fast pace. Academics can build off one another’s achievements without a need to engage in legal battles, while allowing scientists to turn their findings into affordable tools for everyday use.

  While this experiment is a great success for synthetic biology, it is unclear whether the model will function among professionals. Without privatization, scientists cannot claim ownership of their work -- or profit from it -- which could stifle innovation. The scientific “free market” would be passive; and a decline in novel technologies would follow – decreasing the benefits to the general public. The lack of risk could also serve as a benefit if there is no risk of liability or of being sued.

  Lawsuits have historically been a pressing issue for small biotechnology and pharmaceutical companies. Over the past decade there has been an increasing number of “patent trolls”; companies which patent ideas for the sole purpose of suing other corporations for infringing on their intellectual property. To curb the number of patent trolls, Congress passed the America Innovates Act in 2012 creating the inter partes review (IPR). IPR simplifies the court system so that if a patent troll were to sue a company, a judge would look over the case and determine if the suit is just a patent troll being frivolous, or if there is a legitimate case to be heard. The case is then settled in a quick, timely manner which is cost effective for the company being sued. The IPR system, however, has benefited some industries more than it has benefitted others. High technology companies have hundreds or thousands of patents, so if a patent troll sues them they still have many other patents they can depend on for revenue. biotechnology and pharmaceutical companies on the other hand, often invest millions of dollars into a single drug, rendering themselves more vulnerable to a lawsuits. Even though IPR reform was poised to help both industries, hedge funds have found a loophole to manipulate the system. Hedge funds sue biotech or pharma companies (whose profits depend on few patents), buy their stock after the price drops with the lawsuit -- lowering the company’s ability to make a profit -- and then dropping the suit: short selling the stock.

  Patent issues do not always negatively impact biotechnology companies. In the Supreme Court case, Bowman v. Monsanto Co: Monsanto, a large chemical and agribusiness, sued Vernon Bowman, a farmer in Indiana, on the grounds that patented seeds cannot be saved and planted in the next growing season without permission of the patent owner. The Supreme Court sided with Monsanto, holding that farmers must buy new seeds each year to avoid patent infringement [2]. The greater implication of the case is that it established a standard that it is legal to hold a patent over living organisms and their genetic code. This ruling protects the biotechnology industry by ensuring that inventors maintain ownership over their products and their products progeny if initial product can self-replicate, however it raises many ethical concerns:

        Can large biotechnology and pharmaceutical companies abuse these patent rights? Monsanto, for example, has filed over 140 patent infringement cases over farmers, including cases in which a farmer’s crop is accidentally contaminated with Monsanto’s seeds [2]. Legal suits have forced private farms and small businesses into using the company’s products -- or worse driving them bankrupt.
        Can either Dr. Doudna or Dr. Zhang decide to prevent drugs from coming to market if they use the CRISPR/Cas9 system? If so, they could be denying the public of a greater good because of a contract negotiation with the company that develops the drug. Had Jonas Salk done so in the 1950s, the world would not have had as wide access to the polio vaccine.
        If we switched to a system based on open biology, would scientists in academia, biotech, and pharma industries continue to do groundbreaking work? Research is expensive, requiring numerous grants and external funding. If companies cannot afford to pay their employees for work, how can they expect to attract top notch researchers and continue developing drugs?

  We have concluded that a mixture of open and private biology is the best option for the field of synthetic biology. The courts need to establish a legal distinction between engineering biological systems to perform new functions, and discovering the functionality of an existing element. Manipulating systems to carry out novel functions still requires the discovery of new materials, but in order to encourage the brightest minds to science, there needs to be an incentive for new researchers to join the field. Companies that alter the genome of an organism have the right to that intellectual property; however, we begin going down a slippery slope when we allow naturally occurring genes to be patented -- as a company may want to patent the human genome. We must also establish recourse for companies that invest millions into drugs in order to prevent them from being “falsely sued.” We hope to discuss many of these issues and generate potential solutions at our conference: Intellectual Property in the Age of Synthetic Biology.

[1] Regalado, Antonio. “Who Owns the Biggest Biotech Discovery of the Century?” MIT Technology Review. N.p., 04 December 2014. Web. 09 August 2015.
[2] Pollack, Andrew. “Farmer’s Supreme Court Challenge Puts Monsanto Patents at Risk.” The New York Times. N.p., 15 February 2013. Web. 10 August 2015.