From 2012.igem.org

British Columbia - 2012.igem.org

iGEM Guide to Intellectual Property

Introduction

The iGEM competition is heavily dependent on both the development of new ideas and the use of existing intellectual property. For this reason we, the 2012 UBC team, have decided to create a concise but hopefully useful resource to answer intellectual property questions pertinent to the iGEM community. We hope that this FAQ page will serve as a good starting point for people trying to understand intellectual property laws and will guide you in determining the right direction for your project. The contents of this page has been tailored to address issues most relevant to iGEM, which was informed by our iGEM-wide survey.

The main focus of this FAQ is patents, as they are the most common type of intellectual property that iGEM teams deal with. We have tried to present the information in a country-neutral manner, but keep in mind that patent laws vary from place to place. The content here is often a generalization, and will likely be lacking in jurisdiction-specific details.

What is intellectual property?

Intellectual properties (IP), according to the Canadian Intellectual Property Office, are "legal rights that result from intellectual activity in the industrial, scientific, literary, and artistic fields" [http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00011.html ¹]. These rights can come in forms such as patents, copyrights, and trademarks. Intellectual properties are typically exclusive rights, meaning that the holder is the only one who can use or authorize use of the property. Rights-holders can thus gain economic advantage (make money) by having exclusive use of their IP or by licensing it to others.

For example, a company with a patent for a drug manufacturing process could manufacture the drug themselves, gaining advantage from being the only ones able to legally use the process, or they could license the process to other manufacturers, who would pay for the right to use the patented process.

What are copyrights?

Copyrights give creators of original, dramatic, artistic, musical, and literary works exclusive rights to use them [http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00003.html?OpenDocument ²]. These are perhaps most pertinent to iGEM in respect of its applicability to computer programs. Unlike patents, you do not need to apply for a copyright. Instead, copyrights typically come into existence automatically at the time of a work's creation. However, you can still register your copyright to obtain a certificate for proof of ownership in court.

What are trademarks?

Trademarks are indicators (usually words or designs) that are used to mark goods or services. They are used to inform people of the source of the product and to distinguish it from the competitors’ in the market. Many biotechnology companies employ the use of registered trademarks to associate their goods and services with their company brand. For example, New England BioLabs has trademarked their own line of high-fidelity DNA polymerase under the name Phusion®.

What are patents?

Patents are the "right[s], granted by government, to exclude others from making, using, or selling your invention" [http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00001.html ³]. An invention is, according to the World Intellectual Property Organization, "a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem" [http://www.wipo.int/patentscope/en/patents_faq.html#patent ⁴]. You will need to submit an application to the patent office of they jurisdiction in which you seek to patent your invention, and approved patents can be held for a set number of years (e.g., 20 years from submission of application) before it becomes public domain. The time period for which you can hold a patent depends on regional laws.

What exactly can I patent?

This question involves the most difficult concepts in the understanding of intellectual property. To qualify for a patent, the invention must fulfill certain criteria:

Utility: The invention must do what you claim it does.
Novelty: The invention must be unique and not previously mentioned in any literature or publications.
Non-obviousness: The invention must not be of something that can easily be thought up by experts or non-experts, depending on your jurisdiction. You can also fulfill this criterion if your invention involves a "surprising effect" (i.e., your experimental results show effects/functions that have not been observed in past literature).
Material Patentability: The subject matter must be considered patentable by the government issuing the patent. This also varies greatly by jurisdiction and is probably the greatest concern for iGEM teams that wish to patent their inventions. The boundaries that outline what is patentable subject matter can be controversial, especially when concerning biotechnology. Generally, higher life forms, laws of nature, and other things readily found in nature are not patentable. However, definitions of what inventions fall into these categories are often up for debate. For example, the OncoMouse was a type of genetically engineered laboratory mouse that resulted from work done at Harvard. The United States granted Harvard patents to the OncoMouse and its "manufacturing" process. On the other hand, Canada rejected the patent application on the grounds that the mice were higher life forms whose existence transcends their genetic makeup. This criterion for patentability is constantly shifting, and a few recent court rulings have drastically changed the legal landscape of biotechnology. We recommend that you consult patent professionals about the patentability of your iGEM project.

As time goes by, patenting biotechnological inventions require more and more experimental data to support your application. The more data you have, the stronger your application is.

See below for issues concerning patenting of BioBricks.

Are BioBricks or other DNA sequences patentable?

The monopoly of rights to use genetic material is currently under much debate. Several landmark cases have recently been ruled and have changed the legal stage for the life sciences. However, the line delineating what is or is not patent material is still not universally defined. In general, it appears that a DNA sequence itself cannot be patented. However, specific functions and uses for these sequences are frequently qualified for patenting.

As for BioBricks, your team should have signed two agreements. One is the User Agreement and the other is the [http://biobricks.org/wp-content/themes/bbf/bpa-sample.php Contributor Agreement]. The former requires users to credit contributors, while the latter states that contributors will release their power to legally enforce their patent rights when others utilize their BioBricks.

How are patents used?

Patents basically give you exclusive rights to control the usage of your invention. Once you are granted a patent, you get to dictate how, where, and when your invention is used for as long as the patent is valid. Here are some typical ways patents are used:

Revenue: Making a profit from your invention is one of the most common reasons for seeking a patent. Patent holders can sell or license out their inventions. Revenue generation may often involve demanding a royalty from users of your invention.

Access: Some inventors use their patents to assert control over how their patents are used and who accesses them. They may only permit their inventions to be used for certain research or grant user rights to certain organizations or people under pre-determined terms. This control allowed by patents can exclude competition from research or markets.

What should I consider before I whether or not I should apply for a patent?

There are many things to consider, and they may be different for each case. Some main points to think about, however, are:

Cost: Do you have enough money for the initial investment of applying for the patent? Are the costs of getting and enforcing a patent worth the return it is projected to give?
Purpose: For what purpose are you getting your patent? Is the patent necessary for the vision you have for your invention? If so, is the cost worth the fulfillment of this vision?
Time: Is the potentially long time that it takes to get a patent going to affect the end goal I wish to achieve with my invention/patent? For how long would my monopoly over the invention be useful to me?

Talking to your institution's UILO or TTO is recommended, as they will help you in these assessments.

Does my university own my idea?

Institutions usually adopt one of two typical types of policies: 1. The institution owns all inventions done in its facilities or produced by its employees (i.e., faculty members and graduate students). 2. The inventor associated with the institution, but not the institution, owns the invention. Universities in the United States tend to adopt the first type of policy, while Canadian institutions are more varied. Depending on your university, patents resulting from undergraduate student work may or may not be subjected to university ownership. Generally, producing inventions are regarded as part of the job description of faculty members and graduate students. On the other hand, institutions often feel that undergraduate students work for the purpose of learning and that any invention resulting from this is the property of the student.

As a person affiliated with my university, does the institution have any claim over patenting rights for inventions resulting from my side projects separate from what I do at the university?

The institution will evaluate the ownership claim of such patents on a case-by-case basis. Usually, if the invention is well outside of the area of focus the inventor is employed to work in, then the university will not be considered to have right to hold the patent. However, boundaries delineating what is or is not outside this area of focus can be debatable and may be subjected to investigation by the university before any conclusion can be made.

Does the university still own my invention if it turns the idea down for patenting?

Sometimes the work you do at the university produces a patentable invention, but the institution may refuse to invest in patenting it. This may be the result of financial considerations or a divergence of principles. Either way, once the invention has been turned down, the university relinquishes its claiming rights.

How much does a patent cost?

Patent cost can vary case to case. Some influencing factors are country issuing the patent and nature of invention. Some cases may also encounter legal complications, which can slow down and raise the cost of your patent. The coverage you desire your patent to have, as well, will affect how much money you need to invest. For example, if you want ownership over rights to use your invention in more than one country, then you will need to apply and pay for patents in each of them.

For patents in the United States of America, it generally costs $30,000 or more for a standard application. Obtaining legal protection for your invention, as you see, is costly. Thus, you should assess whether your initial investment is worth it in the context of your plans for the invention.

To get a better invention of the financial implications and commitments of your specific patentable invention, we recommend that you discuss it with someone from your UILO/TTO.

How long does it take to get a patent?

Again, the length of time it takes to get your patent approved depends much on your specific case. If the patent examiner and the applicant continue to disagree on the terms of the patent, then the process can be dragged out and delayed. The typical patent takes around 3 to 6 years to obtain.

What regions is my patent effective in?

Your patent is only effective in the legal jurisdiction to which you submitted your application. If you wish to own the invention in other countries, you must simultaneously apply for patents in those respective countries in which you want control of your invention.

One route you can take, if you intend on going international, is to take advantage of the [http://www.wipo.int/pct/en/texts/articles/atoc.htm Patent Cooperation Treaty (PCT)] and apply to the [http://www.wipo.int/portal/index.html.en World Intellectual Property Organization (WIPO)]. Doing so will allow you to reserve your inventorship claim in the 146 countries that have signed onto the PCT [http://www.wipo.int/pct/en ⁵]. You will get 30 to 31 months to decide which countries of the PCT you wish to get patents in.

If you decide to get patents in other jurisdictions after you have filed the application in your original country, there may still be able to get them. Some countries give inventors grace periods, during which the patent offices will still accept applications even if they are not submitted at the same time as when your original one. This will allow you some time to consider whether or not you want to enter into these countries.

How much information can I disclose about my idea before I get a patent?

The less about your invention that you make public, the better chances you have of claiming inventorship. However, your yet to be patented invention can still be eligible for patenting if key information is withheld. As long as you do not give away the crucial pieces of information for other people to replicated your invention, you are probably safe. For example, you can claim that you have found a compound, nicknamed "WonderDrug," that can cure all types of cancer. However, if you disclose the real chemical name of the compound or any other key information that may inform others of its actual identity, then it is considered public knowledge and you can no longer own it exclusively.

Does using my invention in a collaboration with others before I obtain a patent for it count as disclosing the information?

It really depends on the situation. If you are employed by the university and wish to use your invention in a collaborative project with someone else within your institution, it may be fine. This is because the universities will often make employees sign contracts that state they agree to not disclose any sensitive information at the time of hiring. However, you should always check with your university to see what their policies are.

Working with labs and iGEM teams from other universities may pose a bigger problem. It may, nonetheless, still be possible for you to use your invention without risking your patent eligibility. In these cases, people from both parties will need to work out the legal details beforehand, usually through representatives from your universities.

If I have already disclosed my idea before I applied for a patent, is there anything I can still do to protect my invention?

Generally, it is not a good idea to disclose information about your invention before you have submitted a provisional application. There is no guarantee that you can still claim any rights over the use of your invention without doing so. However, depending on how much is actually disclosed, you may still be able to retain your eligibility for a patent.

For select countries, you may get a grace period. This grace period allows you a limited time to submit your provisional patent application.

What happens if I need to make my invention public before my project is ready for patenting?

Sometimes, such as for the iGEM jamborees, you may need to publicize your invention before you are done working out the finer details of it. For these occasions, you can submit a provisional patent application first. A provisional patent application allows you to reserve claim over your invention for a certain amount of time before you must submit the actual patent application. In addition, you may wish to draw up a provisional application if you desire some time to consider whether or not you want to go through with the patenting process before you commit.

Who should I talk to if I want to determine the patentability of my invention?

Universities usually have their own Technology Transfer Office (TTO) or University-Industry Liason Office (UILO). They handle intellectual property owned by the institution and assist university groups in protecting their inventions. If your learning institution has such an office, it would be the best starting point for you. They will guide you through the patenting process step by step from there and can provide you with any consultation you may need. In addition, they are also able to put you in contact with professionals, such as patent lawyers, whose expertise you may need.

When should I approach patent professionals about patenting my invention?

Although it is never a good idea to start the patent process a few days before you need to publicize your invention, you still need to have enough of your project worked out before you can do anything legally. It is advised to approach professionals once you reach the point where you are only working out a few minor details or collecting the last little bit of data. This is because the patent application will require you to outline the specific details surrounding your invention.

What do I need to do if my project, which I do not plan to patent, uses a patented product?

An important aspect of any project is to ensure that it does not infringe on any patents. It is your team's responsibility to do so. Many reagents are actually patented, but allow for research use. This may, however, may cause a problem is you use this product in the process of making the invention you intend to patent (see below). For other components of your project that is owned by someone, you will need to contact the owner and legally get permission to use them. Obtaining permission can entail various things, such as monetary compensation to the owner or acknowledgements. Once you and the patent holder has reached an agreement on the terms of use, then you will be able to legally utilize their invention.

What do I need to do if my invention, which I do plan to patent, incorporates patented components?

Any part of your invention that involves the use of already patented material must be dealt with, lest you face legal repercussions. You will need to reach some sort of legal agreement on the terms of use of the patents with each of their respective patent holders. Many inventors will require you to pay them money for the rights to use their invention, depending on the nature of your patentable invention. It is only once you have obtained permission for all of them that you can obtain a patent for your own invention. If you cannot get the right to use any one part, then you may be sued for infringement.

How will I know if something I used is patented or protected material?

There is no real shortcut. You just need to go through the list of things you used and do a bit of research. These things include, but are not limited to, reagents, reaction kits, cell strains, and specific methods.

Reagents from biotechnology companies are often patented. Frequently, they have made it so that buying the product will also grant you a non-transferable license to use it. You may not even be aware of this transaction, since the companies have commonly set it up so that you legally acknowledge and agree to the terms of use by opening the package or simply purchasing the product.

Use of many special strains of cells, such as ones from ATCC or the Keio Collection, may require you to sign various papers that outline usage and restrictions. This is not true for all cases, so you will need to check your all sources independently for more information. Also see Material Transfer Agreements for more relevant information.

What are Material Transfer Agreements?

Material Transfer Agreements (MTAs) are legal documents that define the usage of tangible materials by the recipient of the transfer. It outlines the terms agreed upon by both the recipient and the provider concerning [http://www.research.utoronto.ca/for-researchers-administrators/managing-your-research-project/sharing-information-equipment-and-materials/material-transfer-agreements/ ⁵]:

Ownership of derivatives/modifications of the materials
Transfer of risk
Limits of use
Confidentiality of information related to transferred material(s)
Rights to inventions and research using transferred material(s)

Examples of some types of materials dealt with by MTAs are reagents, strains, cell lines, plasmids, and computer software. For instance, ATCC has a [http://www.atcc.org/Portals/1/Pdf/2012_MTA_with_Explanatory_Notes.pdf Material Transfer Agreement] that limits who and what you can transfer to other people.

Where can I find additional information about IP and patents?

[http://www.patentlens.net/daisy/patentlens/landscapes-tools/explore-landscapes.html Patent Lens: A free public resource for patent system navigation worldwide]

[http://www.piug.org/offices.php Patent Information Users Group: List of patent office websites worldwide]

[http://www.wipo.int/about-ip/en/iprm/ WIPO Intellectual Property Handbook]

[http://www.uilo.ubc.ca/pages/knowledge-mobilization/ip/patenting UBC University-Industry Liaison Office's Patenting Page]

[http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/home Canadian Intellectual Property Office]

[http://www.uspto.gov/ United States Patent and Trademark Office]

[http://www.epo.org/ European Patent Office]

[http://lp.espacenet.com/?locale=en_LP The LATIPAT Project: Collection of patents from Latin American countries (in Spanish and Portuguese)]

[http://www.chinatrademarkoffice.com/about/laws2.html China Patent & Trademark Office]

[http://www.jpo.go.jp/index_e/patents.html Japan Patent Office]

[http://www.kipo.go.kr/kpo/user.tdf?a=user.eng.main.BoardApp Korean Intellectual Property Office]

[http://www.ipaustralia.gov.au/get-the-right-ip/patents/ IP Australia]

[http://www.gccpo.org/ Patent Office of the Cooperation Council for the Arab States of the Gulf (in Arabic)]

Acknowledgements

We would like to thank the following people for helping us learn about intellectual property and their assistance in the creation of this guide:

Dr. Emma Macfarlane, Patent Agent, Gowlings

Ian Bell, Technology Transfer Manager, UBC University-Industry Liaison Office

Special thanks to the following team for helping us by providing feedback:

INSA Lyon, 2012 iGEM Team

Team:British Columbia/Human Practices/IP FAQ