BLG News Fall 2000

FAQs Regarding Patenting of Inventions

The focus of this FAQs section is the patenting of inventions disclosed to the Baylor Licensing Group. Please be aware that the goal of BLG is to license inventions not obtain patents. BLG will obtain a patent only if it enhances licensing and commercialization opportunities for the invention. Ordinarily, those inventions with diagnostic or therapeutic applications need patent protection. Research tools like cell lines or mouse models do not need patent protection to be commercially viable.

1- Who should be listed as contributors on the disclosure form?

Those listed as contributors on the disclosure form should be determined by those who contributed to the project. All people listed on the disclosure form will receive compensation arising from income gained from licensing the technology. The contributors' share of revenues will be distributed according to the Baylor Patent Policy using the percentages listed on the disclosure form.

2- Who is designated as an inventor on a patent?

The inventorship on a patent is a decision made by legal counsel with the input of the people contributing to the project. These inventors can be all or some of those listed on the disclosure form. Each person listed on a patent as an inventor must have been responsible for one or more claims in that patent.

3- What is a claim?

A claim is that portion of the patent which describes, step by step, the details of the invention. Usually listed numerically at the back of the published patent, claims define the scope of the patent protection. The remainder of the text of the patent is called the specification, which supports the claims by giving background information, description and data in the form of examples.

4- Why are patents useful?

Patents allow the owner of the patent to block others from practicing what the patent claims. For example, if the claims of an issued patent describe the chemical structure and uses of a novel drug to treat disease, others will not be able to use the drug until they get permission from the owner of the patent. In most cases, that permission is granted through a license agreement. In the license, the owner of the patent requests monetary consideration from the licensee for the term of the patent. Pharmaceutical companies generally will not develop a product from a compound that is not covered by patent protection. In addition, pharmaceutical companies prefer having method to treat claims for the compound as well, protecting use of the compound in therapeutic applications.

5- What is the inventors' involvement in obtaining a patent?

The patent prosecution process requires cooperation from the lead investigator and all others involved during the development of the invention. In order to streamline the process, the patent counsel may request electronic copies of any manuscripts, data, and figures associated with the work. They may also request copies of reference articles relevant to the invention. These references will include papers by your group as well as others in the field. A review of the draft patent application will also be requested to check for accuracy. During prosecution, the patent application, signatures and/or input will be requested on various documents related to the patent. In addition, any new data, whether published or not, should be forwarded to BLG to send to patent counsel for support of the patent.

Having access to new data as it is developed can enhance the ability of patent counsel to formulate and present responses to the patent office during prosecution of the patent. A patent prosecuted with the input of the inventor is more likely to contain the most relevant information and result in a licensee who is more interested in the patent and what it protects. In addition, the licensee may be better able to develop a product or therapeutic utilizing the patent.

6- How much does a patent cost?

Patent costs can vary based on many factors. Typically, the cost to bring a patent from the initial filing through prosecution to issuance in the United States ranges from $20,000 to $50,000. Patent prosecution of the same invention in other countries significantly increases the costs due to translation fees and prosecution fees of the additional patents. Foreign patent costs can range from $50,000 to more than $150,000 depending on the number and choice of countries pursued.

7- When is it too late to obtain patent protection?

In the United States, a patent can be filed up to one year after the date of first disclosure describing or discussing the invention (public presentation, oral or written). In general, outside of the US, an absolute novelty rule applies, and a patent will not be granted on an invention which was publicly disclosed prior to the date of filing.

8- Is it difficult to get a patent granted?

Yes, patenting inventions has become more difficult. The patent office has become more strict in its interpretation of guidelines regarding patentability, as well as the criteria that must be met to obtain a patent. Inventions today are being held to a higher standard for what is required to obtain a patent. These standards are comprised of Utility and Enablement.

9- What is Utility?

Utility relates to the usefulness of an invention, what it can be used for, and whether such use is feasible. There are three main components to Utility:

"Credible Utility" requires that the stated Utility be believable to a person with ordinary skill in the art or field. In addition, this person should also believe that the invention, as it is claimed, is available for such use.

"Specific Utility" requires that the Utility be specific to a particular real world use. For example, an oligo or other polynucleotide cannot be claimed as a "gene probe" or a "chromosomal marker" without denoting the specific DNA target.

"Substantial Utility" requires that a Utility define a real world use. In many cases, these are written as claims to "modify the function of a gene or gene product to treat a condition in humans." For example, making a transgenic or knockout mouse and elucidating a gene's function is not necessarily demonstrating a real world use for that gene. A patent that would require further research to identify or confirm a real world Utility fails the Substantial Utility test. Substantial Utility is one of the most difficult hurdles for patenting results from basic scientific research.

10- What is Enablement?

Enablement is tied to Utility in that it is the requirement that there be sufficient data or examples to allow others to practice what is claimed. Enablement is defined as, "a description sufficient in technical detail so that a person of ordinary skill in the art can use or make the invention." For example, if steps are left out of the description of a multistep invention, the invention has not been sufficiently enabled.

More detailed information can be found on our website at research.bcm.tmc.edu/ota/ under the heading "Protecting Your Intellectual Property" or by calling BLG at 713 798-6821.

BLG Welcomes Lisa Beveridge

Lisa Beveridge joined BLG in July 2001 as Senior Licensing Manager. She brings with her over 20 years of experience in various functions in the medical field. Her past medical experience includes positions in clinical, sales, technical support, marketing, market research and business development in various companies including BioRad Laboratories, Abbott Diagnostics Division, and Aventis Pharmaceuticals Products Inc. (formerly Rhone-Poulenc Rorer). She has authored two medical market research reports for Frost & Sullivan Market Intelligence and negotiated many licensing agreements for Aventis. Lisa has a B.S. in Medical Technology from the University of Delaware and has done postgraduate work at Temple University and the Medical College of Pennsylvania in hematology.

(Left to Right) Michael Dilling, Ph.D., Licensing Associate in BLG, Ruxandra Draghia-Akli, M.D., Ph.D., Assistant Professor in the Shell Center for Cell and Gene Therapy, Malcolm K. Brenner, M.D., Ph.D., Director of the Shell Center for Cell and Gene Therapy, and Lynne D. Schaefer, Director of BLG.

BLG Receives the 1000th Invention Disclosure from Dr. Ruxandra Draghia-Akli in the Shell Center for Cell and Gene Therapy

BLG recently received the 1000th invention disclosure from Ruxandra Draghia-Akli, M.D., Ph.D., Assistant Professor in the Shell Center for Cell and Gene Therapy. This technology will be licensed to ADViSYS, Inc., a BCMT start-up company, which is developing novel approaches to modulate growth hormone in animals for therapeutic and performance enhancement applications. BLG received its initial invention disclosure in February 1984 after its inception, and 17 years later the 1000th invention disclosure marks an important milestone. To commemorate the occasion, BLG awarded Dr. Draghia-Akli a gift certificate for dinner at Ruggles. n

Who Do I Call?

If you have a question about ideas you feel might have commercial value, or if a company has expressed interest in licensing your research findings, call BLG at 713-798-6821, or visit our website at research.bcm.tmc.edu/OTA/.

If you have a question on start-up companies, call BCM Technologies at 713-795-0105 or visit their website at http://www.bcmtechnologies.com.

If you have a question on material transfer agreements, sponsored research agreements or confidential disclosure agreements, call the Office of Research at 713-798-5184 or visit their website at http://intranet.bcm.tmc.edu/index.cfm?tmp=research/oor/index.