Team:Santa Clara/Practices
Practices
The SCU iGEM team has performed three case studies involving human practices.Case study 1
Anaerobe Systems is a company that specializes in finding ways to maximize anaerobic culture techniques and is also the only company in the United States that produces the only true Pre-Reduced Anaerobically Sterilized (PRAS) plated and tubed culture media. After connecting with Mike Cox, the CEO of Anaerobe Systems, students from Santa Clara University’s iGEM team analyzed the fermentors utilized by Anaerobe Systems to degrade organic waste and realized there was room for improvement.
The primary issue that the Santa Clara University iGEM team identified was the constant acidification of the culture which compromises cell vitality. Anaerobe Systems adds a large amount of base to neutralize the acid but this process greatly damages the cells and slows the growth kinetics, while also adding extra costs.
Therefore, Santa Clara’s University’s iGEM team set out to create a system that will allow the cells to be able to survive in the increased acidity so that no or, at the very least, less base will need to be added. This new system could hypothetically lower operation costs while also decreasing culture run time. The team’s primary goal was to build a BioBrick that is capable of introducing Escherichia coli’s cyclopropane fatty acid defense system into other organisms in order to increase their survival under low pH conditions.
Case study 2
Research being conducted in universities across the globe has the potential to be the impetus for many of the private sector’s most innovative and successful technologies. Such research can help generate the building blocks for new commercial products, new products that can help the community at large and new patents that can be taken advantage of by the private sector. The relationship can begin when a private company simply provides funding for a new research product, or the relationship can begin when a university takes the current product or technology of a private company and provides modifications and improvements.
Arguably, the relationship has the opportunity to be so successful because of the different viewpoints, motivations and capabilities of the two sides - the private sector and the university. The private sector often has the means, typically in the form of capital or intellectual property assets, such as patents, to fund and begin specific research ventures and to provide the necessary equipment or technology. Universities, on the other hand, while not always having the means to conduct research on their own, possess the manpower, time, creativity and desire to conduct research and development that a company may simply not have the bandwidth or desire to direct its employees to conduct its own, all while bolstering their own prestige. Aside from the disparity in resources, generally, universities and the private sector also come to the table with different motivations. Specifically, the private sector is usually concerned with generating capital through the development of new products or intellectual property assets. Universities are often concerned with bolstering their standing in the creative community and their ability to attract new talent to build upon that standing.
The differences in motivation and resources may foster a creative relationship, but also presents a unique set of challenges for both of the players involved. Both companies and universities should take care to protect themselves before, during and after the relationship begins. Both sides often have intellectual property assets which they wish to protect. In order to begin a collaborative relationship, both sides often insist upon the a non-disclosure agreement - the mutual NDA. The agreement attached as Exhibit A represents a sample non-disclosure agreement with short explanations and suggestions that may hopefully provide a working understanding of the different facets of the agreement.
In addition to protecting information through the non-disclosure agreement, the two parties may want to both protect themselves and place concrete limits and boundaries on the relationship through an array of different agreements, including material transfer agreements and patent licensing agreements. Material transfer agreements can be beneficial in setting the specific terms and conditions by which either party may transfer their product or research materials/results while setting the boundaries on the rights of the receiving party. The agreement attached as Exhibit B represents a sample material transfer agreement with short explanations and suggestions that may hopefully provide a working understanding of such an agreement. A patent licensing agreement typically grants the right to one party to use the invention or method protected under a patent owned by the other party. Often times, the research conducted through these relationships is entirely dependent on material or methods that are owned exclusively by one party. Thus, the patent licensing agreement provides the core tool that enables such research. The agreement attached as Exhibit C represents a sample material transfer agreement with short explanations and suggestions that may hopefully provide a working understanding of such an agreement.
Case study 3
Currently, there does not exist a close relationship between Santa Clara University’s iGEM team and Anaerobe Systems and there has been very little recent contact between the students and the CEO, Mike Cox. The Santa Clara University iGEM team has been involved in pursuing an independent project in order to solve a problem that is encountered by many scientists and other companies. Therefore, the Santa Clara University iGEM team’s strategy has not been in danger of infringing upon any of Anaerobe System’s intellectual property rights due to the limited amount of interaction. Anaerobe System’s strategy of adding a large amount of base to neutralize acid is something that many biotech companies do and Santa Clara’s attempt to create a new system to find a solution to this problem does not constitute any kind of infringement.
Nevertheless, it is not uncommon for many student groups to be in a similar situation characterized by limited contact with a biotech company. Under these circumstances, the possibility always exists that the students may be infringing upon the intellectual property rights owned by the company.
Although the costs associated with patent litigation can be very high, the ramifications for an infringer can be severe. When an infringer loses a patent case, that party can sometimes become, in effect, a licensee and may be required to pay a reasonable royalty for any future sales derived from the patented product, method, or technology. Furthermore, a court may issue a post-trial injunction, which is an order for the infringer to stop infringing the patent currently and in the future. A patent holder can also request a preliminary injunction from the court, which is an order that prevents the alleged defendant infringer from using or selling the patent during the trial.
Therefore, it is important for a university or student group to learn how to avoid infringing on a patent or any intellectual property rights in order to not be forced to defend a costly and time-consuming patent infringement lawsuit in the future. The most important thing to do is to identify which patents, if any, there is a chance you may be infringing. The first step is to conduct an online patent search via the U.S. Patent Office. When conducting the search, it is important to search for patents that are in any way related to your technology. Using keywords that describe your technology and searching the assignee records for patents owned by other companies as well are good strategies. Many small companies may not assign a patent to their company, so it is imperative to also search using the names of any known inventor, typically the owner or CEO of the small company. In the case of larger companies, some do not own their patents directly. Instead, they may be associated with an intellectual property holding company that that owns their patents. Thus, you will have to research whether or not one of these holding companies is involved, find out their name, and conduct another search via that additional route.