The Business of Science

Investigators are often encouraged to publish their scientific results as quickly as possible, not only for career prestige, but also to ensure future funding remains possible.  Unfortunately, publishing quickly can be detrimental to securing intellectual property and therefore to ensuring research is picked up by companies and translated into therapies.  The following interview with Dr. Brian Laden, Associate Director of Technology Transfer and Enterprise Development at Vanderbilt University and Vice President of the Association of University Technology Managers, addresses investigator questions about the right time to think about intellectual property, and how to go about obtaining it. - AU

Alison Urkowitz: What is IP as it relates to scientific research?

Brian Laden: Generically, Intellectual Property, or “IP”, is the ownership of ideas and control over the representation or use of those ideas. For scientific research at not-for-profit institutions, IP most typically takes the form of patents and in some cases, copyrights.  Patents are the best way to protect tangible inventions or methods of doing something (such as inhibiting a receptor or treating a disease). From the earliest days of our country, patents were intended to reward the risk taken to create new inventions by granting a period of exclusivity to the patent owner.   As such, an issued patent gives the owner the right to prevent others from doing what is described in the “claims” portion of the patent. Generally speaking, an invention must be novel, non-obvious and useful to be patentable.  Inventions such as new chemical entities, biological reagents, diagnostic tests, medical devices, new uses or improvements of known items, and much more constitute patentable material, so it’s best to consult an expert if you are unsure about whether an idea or invention is patentable.  Copyrights are also used to protect IP.  They protect the form of a written expression, not the content of it.  In the context of scientific research, copyrights are most often used to protect software code.  Trademarks, service marks, and trade secrets are other common forms of IP, but are not often used in the context of protecting IP arising from research at not-for-profit research institutions.

AU: When is the right time to start thinking about obtaining IP? 

BL: The earlier, the better.  Because public disclosure – including publications, abstracts, presentations, etc. – can negatively affect the ability to obtain patent rights, it’s better to approach the IP or technology transfer professionals at your institution whenever you think you may have a new invention.  Even if the invention is not developed enough to warrant filing a patent application at that time, the institution will at least be aware of the developing IP and may be able to give you some useful advice going forward.  Many times researchers want to be guided as to what experiments would make the invention more likely to be patentable and licensable.  Anytime you are planning to publish or otherwise disclose material you think may contain a patentable invention, you should talk to the Technology Transfer Office at your institution.  It is important to note that I have never seen a case where that office has asked a scientist to hold or delay a publication or presentation.  We would simply work to file a patent application prior to the disclosure occurring if the principals involved all thought that was a good idea.  Federal grant applications are considered to be public documents upon receipt of the Notice of Grant Award, because that is when the grant is available under the Freedom of Information Act.  Therefore, a funded grant application can become a public disclosure as well.  If you are going to include information in a federal grant application that could constitute a new invention, such as “preliminary data” that is another good time to talk to the Technology Transfer Office at your institution.   

AU: What are the potential consequences of waiting until after publishing results to take steps towards obtaining IP? 

BL: In most countries outside the U.S., the ability to obtain patent protection is lost immediately upon disclosure, unless a patent application has been filed prior to the publication or any other public disclosure.  In the U.S. the public disclosure starts a one-year clock, during which time it is possible to file for patent protection on the disclosed material.

To complicate things further, the standards used by the United States Patent and Trademark Office (USPTO) to determine if an invention is patentable are more stringent than the standards used to site a piece of public information (such as an awarded grant application or publication) as rendering the subject matter in a patent application not patentable.  What does this mean?  Suppose an investigator discloses some preliminary data in a poster at a scientific meeting.  There may not yet be enough data to support the granting of a patent application, and thus it may not make sense to file for patent protection at that point.  However, if more data were generated in the following months and a patent application was later filed, the USPTO could use the poster presentation to render the invention unpatentable.  There are ways to deal with situations like this, and it is best to consult an IP professional at your institution to devise an appropriate strategy to present the data without loosing patent rights.

AU: Within a university, who is the best person/what is the best department to approach to help you obtain IP? 

BL: Most research institutions have a “Technology Transfer Office” (or “TTO”), sometimes called “Technology Licensing Office” or “Technology Management Office”.  Such offices employ people who are experienced at evaluating, protecting and licensing intellectual property.

AU: What information should one gather to get ready for this process?

BL: Most research institutions will have “invention disclosure forms” that are typically available on the TTO’s website.  That form will usually ask for:

• a written description of the invention (which is often readily available in the form of a grant application or a manuscript being submitted for publication);
• a list of funding sponsors (so that the institution can meet its requirements for how to report, patent and license inventions based on the funding source);
• a list of any third-party materials such as cell lines, plasmids, transgenic animals, compounds, antibodies, etc., were used in the creation of the inventions (because there may be obligations to the provider regarding inventions made using such material);
• a list of the possible inventors (generally those people who contributed to the conception of the invention).

Different institutions often ask a series of other questions that could help evaluate the patentability and marketability of the invention.

AU: What is the approximate time and cost for obtaining a patent?  

BL: For biotechnology and pharmaceutical patents, it can cost about $25,000 to obtain a patent in the U.S.  To also obtain rights in the countries around the world with relevant market sizes, the cost can rapidly exceed $100,000.  The process can typically take anywhere from 2 to 5 years and sometimes longer, depending on the nature of the invention.

AU: What are the high level steps required for an investigator to obtain a patent? 

BL:

1. Disclose the invention to your TTO. 
2. You will need to work with the licensing professional in that office to make a decision about whether to file a patent application.  This is usually based on two primary factors: i) the likelihood of useful claims being obtained and ii) the likelihood of licensing the patent to a commercial partner (or new startup, as the case may be). 
3. A patent attorney engaged by or employed by your TTO will create a draft patent application, but you will need to provide as much written material as possible to get them started (grant applications, manuscripts, etc.).  You will also need to review and edit the application with the attorney. 
4. The attorney will submit the patent application. 
5. Next, you wait… and wait… and wait some more until the United States Patent and Trademark Office (USPTO) sends the attorney an “office action”. 
6. This begins the back and forth process with the USPTO where they reject the claims you are putting forth as being unpatentable.  You and your patent attorney eventually hope to negotiate some solution that involves the issuance of useful patent claims.  A good patent attorney is a critical component to obtaining successful results.

AU: What does obtaining IP allow one to do in the future? 

BL: Good question.  Filing and obtaining a patent is a means to an end.  Most often, the goal is to leverage a patent by licensing the exclusivity afforded by the patent to a commercial entity who will make, use or sell a product covered by the patent and pay various fees and royalties (or sometimes equity) to the patent’s owner (the “licensor”).  Since a patent gives the owner the right to prevent others from doing what is claimed in that patent, it provides the commercial partner (the “licensee”) with the assurance that the patent holder will not press them to stop making, using or selling what is covered in the patent.  In that sense the license is a covenant not to sue the licensee for infringing the patent.  In the case when the licensor grants an exclusive license to the licensee, the licensee will usually have the right to enforce the patent against other companies who may be infringing on the patent.  It is also possible to license the patent rights non-exclusively, which generally will not grant the licensee the right to pursue infringers.

AU: What terms are covered in license agreements? 

BL:

• Is it an exclusive or non-exclusive grant of rights?
• Will the licensee be permitted to further license the patent rights to other companies (known as “sublicensing”)?
• What is the territory of field of use for the rights being granted?
• What will the cost of the license be: Upfront fee? Milestones? Annual payments? Minimum royalties?  Royalties on sales?  Equity ownership in the licensee?  Etc.
• If it is an exclusive grant, what sales or developmental milestones will the licensee need to meet to keep the license?
• Who will be responsible to defend lawsuits or pursue possible infringers?

AU:  Does one have to secure IP before discussing their research with potential investors/interested companies? 

BL: Not necessarily.  It depends upon the level of protection one wants to have before such discussions.  From a purely patentability standpoint, the research institution could sign a non-disclosure agreement, sometimes also called a confidentiality agreement, which would prevent the disclosed material from becoming a public disclosure.  However, it may be prudent to file a patent application prior to such discussions to have more confidence that the ideas you plan to disclose have the most protection possible and limit the ability of the other party to use the information discussed for their own purposes without compensation to the discloser.  Anytime you wish to disclose IP to someone outside the university, you should talk with your TTO first to be sure there is an appropriate plan in place to protect you and the university.