OTML (formerly OTMC) Articles
from the MRI Newsletter
Department Name Change
(April 2008)
We are proud to announce that our department has changed its name to better reflect the services we provide to Moffitt Cancer Center faculty and staff. We were formerly known as the Office of Technology Management and Commercialization (OTMC), and our new name is the Office of Technology Management and Licensing (OTML).
As a reminder, our office is responsible for protecting and licensing the valuable inventions and discoveries made at Moffitt Cancer Center. We also review and negotiate a wide array of research agreements including Material Transfer Agreements and Collaboration Agreements. If you wish to inquire about a specific intellectual property matter, please visit our office on the fourth floor of MRC (suite 4051) or call our main number at 745-6828.
License Agreement Announcement
(May 2007)
On May 2, 2007, Moffitt Cancer Center entered into an exclusive license with BioGene Life Science a Singapore-based company, which was successfully negotiated by the staff of the OTMC. This license agreement grants BioGene Life Science exclusive IP rights to Dr. Mokenge Malafa's discovery involving the use of delta-tocotrienol, a natural product, to treat pancreatic cancer. Under this license agreement, Moffitt Cancer Center will receive upfront cash payment, milestone payments, and a running royalty rate based upon net sales. BioGene Life Science also will be providing Dr. Malafa with funds to support his translational laboratory-based research related to this discovery. BioGene Life Science is a wholly owned subsidiary of Davos Life Science, which has the world's largest R&D center dedicated to tocotrienols and is capable of producing the largest quantity of natural tocotrienol concentrates in the world.
From Bench to OTMC: Reporting Inventions
(March 2007)
As a mission-focused institution, Moffitt researchers conduct investigations into the prevention and cure of cancer, where some discoveries may evolve into inventions that have economic utility. Examples of these inventions include chemical compounds, medical devices, mouse strains, methods of diagnosing disease, and methods of treating disease. OTMC helps Moffitt investigators evaluate their discoveries as to whether an invention may be at hand, and helps determine the next steps. Depending on the level of development, the inventors may be asked to report their invention using an Invention Disclosure Form. This form is sent upon request, or can be downloaded from Moffitt’s OTMC web site, under Moffitt Research Institute/Patents and Inventions/Researcher Information. The form is easy to complete, asking such information as a brief description of the invention, names of inventors, funding sources, and plans to publish. In the future inventors will be able to submit this information to OTMC via a dedicated web portal.
The Invention Disclosure Form starts the process of evaluating the discovery or invention for commercial potential and possible protection as intellectual property. If the invention is at a very early stage, OTMC may suggest that the investigator develop it further before moving the process forward. If, however, OTMC and its steering committee determine that the invention has commercial value and is potentially patentable, then OTMC will engage outside patent counsel to seek patent protection. OTMC maintains a portfolio of external firms with individualized expertise for this purpose.
Since inventions must be new to be patentable, investigators should consult with OTMC before presenting their ideas and results in a public forum. Failure to file a patent application before public disclosure may result in loss of certain patent rights. For example, some Moffitt investigators may present their research findings at a national or international conference, such as the upcoming AACR meeting to be held in April. If you have ideas or results that potentially are inventions, please contact OTMC before attending such meetings or sending abstracts, so protection can be pursued as appropriate prior to public disclosure. OTMC may be reached by telephone at extension 6828, or by email to Robert.deLorimier@moffitt.org or to Jarett.Rieger@moffitt.org.
If you have any questions about these processes, licensing or commercialization strategies, please visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
An example of the Contribution of Academic Intellectual Property to Drug Development by Big Pharma: Prophylactic Vaccines for Cervical Cancer
(February 2007)
A prophylactic vaccine for HPV (human papillomavirus)-induced cervical cancer is now sold in the US and Europe by Merck, and another has been submitted for marketing approval in Europe by GSK. Both vaccines appear to be highly efficacious and safe. A substantial positive impact on public health is anticipated, as cervical cancer is the second-most common cancer in women worldwide.
Both HPV vaccines have their roots in academic research. The finding that cervical cancer might be caused by certain strains of HPV raised the possibility that this cancer could be prevented by vaccination. Further academic discoveries eventually proved that recombinant capsid protein from papillomaviruses can self-assemble into non-infectious VLPs (virus-like particles) that can be used to immunize against the virus. Research at the University of Queensland first reported recombinant VLPs of HPV. Scientists at Georgetown University demonstrated that a recombinant capsid protein from HPV was recognized by an antibody to intact virus. In an animal model of vaccination the National Cancer Institute showed that VLPs from bovine papillomavirus induced neutralizing antibodies when used to immunize animals. At the University of Rochester it was shown that recombinant capsid from HPV self-assembled into VLPs which induced neutralizing antibodies. Both the Merck and GSK vaccines are based in large part on these discoveries.
The respective research institutions sought patent protection in order to attract commercial interest to develop vaccines for HPV. Two companies initially obtained these academic inventions to develop commercial vaccines: CSL in Australia, which collaborated with U. Queensland and co-owns some of the patents; and Medimmune in the US, which licensed patents from U. Rochester, Georgetown U. and the NIH. Each company collaborated with a large pharmaceutical firm, CSL with Merck and Medimmune with GSK, to advance the vaccines into clinical trials and eventual marketing. Because of uncertainty over the validity of the various HPV patents, GSK and Merck cross-licensed the patents to be able to continue commercialization of their respective vaccines.
The HPV vaccines are one example of academic experimentation continuing to the point that commercial value is created, attracting companies to license for further development. OTMC works to identify, protect, and, with Moffitt Technologies Corp., commercialize inventions arising from Moffitt-based research.
If you have any questions about these processes, licensing or commercialization strategies, please visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Can Academic Research Infringe a Third Party's Patent?
(January 2007)
Many researchers utilize various research tools and techniques without regards to third parties’ patents. A common belief by academic investigators is that patents can not preclude academic research. For over a hundred years, an exemption existed that shielded academic institutions from patent infringement. This exemption was established by court cases, however, many recent court decisions have dwindled the scope of this exemption. One of the recent court cases that narrowed this exemption was Duke University v. Madey, which was decided in 2002. The facts of this case are as follows. Dr. Madey was a prominent scientist in the field of laser technology, and he joined Duke University in 1988. He built a lab at Duke University that contained several pieces of equipment some of which were covered by patents owned personally by Dr. Madey. Dr. Madey was employed by Duke University for nearly a decade before resigning due to a dispute with Duke University regarding his lab. Despite his resignation, other researchers at Duke University continued to use the lab equipment including the equipment covered by Dr. Madey’s patents. Based upon Duke University’s unauthorized use of the lab equipment covered by Dr. Madey’s patents, Dr. Madey sued Duke University for patent infringement. The court held that Duke University infringed Dr. Madey’s patents, and that Duke University could not rely on the experimental use exemption. The court held that the experimental use exemption can only be used when an institution uses patented technology solely for amusement, to satisfy idle curiosity, or for strict philosophical inquiry. In this case, Duke University continued to utilize the electron lasers for its business (e.g. research and education) and thus the court held that Duke University does not qualify for the experimental use exemption.
Not all of the recent court cases have negatively impacted the experimental use exemption. One such case, Merck v. Integra, was decided in 2005 and held that institutions are exempt from patent infringement if the research will yield data that will be included in an FDA submission (e.g. IND). As is obvious from this article, this area of patent law is extremely complicated and continues to evolve. If you know about a patent that covers your research, please contact OTMC so that we can determine if you qualify for the research use exemption or if OTMC will need to contact the patent owner to obtain permission.
If you have any questions about licensing or commercialization strategies, please visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
License Agreement Announcement
(December 2006)
On November 9, 2006, Moffitt Cancer Center entered into an exclusive license agreement with Introgen Therapeutics, Inc. The licensed invention is directed to the use of a tumor vaccine and chemotherapy to treat a variety of tumor types includes small cell lung cancer. The Moffitt inventors named on the invention are Dr. Dmitry Gabrilovich and Dr. Scott Antonia. This tumor vaccine and chemotherapy combination has already been tested in clinical trials involving patients afflicted with small cell lung cancer, and future clinical trials have already been designed. The license agreement provides Introgen Therapeutics, Inc. with rights to the invention in exchange for an upfront fee, a milestone payment, annual fees, and royalties based upon product sales.
If you have any questions about licensing or commercialization strategies, please visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Patent Cooperation Treaty Application: Protecting Your Intellectual Property Worldwide
(November 2006)
A United States patent grants the owner of a patent a temporary monopoly for a particular invention, or in other words, the right to exclude others from making, using, or selling the invention described in a patent. A patent issued in the United States only affords the above rights within the United States, and if these rights are desired in foreign countries, then foreign patents need to be pursued. Filing multiple patent applications in many countries can be quite costly due to attorneys’ fees, language translation costs, and government fees. To simplify the process of securing patent protection in multiple countries and to delay incurring substantial patent fees, many countries became signatories to the Patent Cooperation Treaty (PCT), which went into force in 1978. The PCT permits the filing of an international patent application, which only needs to be filed with one patent office in one language. The biggest benefit of filing a PCT patent application is that it remains pending for 30 months, and for this period of time few patent costs are incurred. After the expiration of the 30 months, a decision needs to be made as to extent of foreign countries where patent protection will be sought. Unfortunately, the PCT patent application cannot mature into a worldwide patent capable of being enforced in any jurisdiction; however, the PCT patent application eliminates the need of filing numerous national patent applications at the same time and considerably delays the incurrence of the bulk of the patent fees for 30 months.
For commercially valuable Moffitt inventions, OTMC files PCT patent applications. As stated earlier, significant patent costs are incurred when the application enters the national phase after 30 months from PCT patent application filing. Generally speaking, companies that obtain licenses are responsible for paying patent costs, and thus the goal is to license technology before the end of the 30 month period. Thus, the national phase is generally entered if a given invention is licensed. Moreover, strong consideration is given in entering the national phase for a particular invention if this invention is the subject of license negotiations.
If you have any questions about PCT patent applications or intellectual property, please contact OTMC at 813-745-6828.
Protecting and Commercializing Inventions Developed at Multiple Participating Institutions
(October 2006)
Collaboration among investigators at different institutions is becoming more common due to increasing specialization of expertise and resources. A common situation arising from such collaborations is joint development of intellectual property. How do the respective inventors and institutions handle the issues of determining inventorship and ownership of patents, managing patents, marketing patent rights, and eventually distributing commercialization revenues? There are three hard-and-fast rules to keep in mind:
First, inventorship on a patent is a legal determination: a person is an inventor if he or she contributes to the conception of any claim, regardless of institutional affiliation. Names of inventors are suggested upon disclosure of the invention to one or more of the institutions, but they must be confirmed when the invention is specifically described in the claims of a patent application.
Second, ownership follows inventorship. Inventors typically have employee/faculty contracts with their respective institutions that require assignment of intellectual property rights to the employer. Therefore the patent is jointly owned by the institutions that employ the respective inventors.
Third, the institutions cooperate in patenting and commercialization. In terms of who manages the patent process and markets the rights, the joint owners (i.e. institutions) typically enter into an inter-institutional agreement that spells out the rights and responsibilities of each in patent management and commercialization. Usually one institution will take the lead but keep the other informed of all proceedings, which is usually accomplished by periodic reports. The inter-institutional agreement also defines how commercialization is to be conducted and revenues are to be apportioned. Typically patent costs are reimbursed to the managing institution before residual revenues are distributed.
While each case is unique, successful inter-institutional collaboration toward protection and commercialization of discoveries depends on open and prompt communication between the institutions. OTMC has established templates to expedite the process of completing the inter-institutional agreements.
If you have any questions about these agreements and processes visit the OTMC Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Academic Inventions and Technology information Day
(September 2006)
Although the path from discovery to the clinic is long and uncertain, the goal of developing a useful product or process is brought into focus by studying the successes. Here are three of particular significance. Cisplatin and Carboplatin. In 1965 Michigan State University (MSU) physicist B. Rosenberg and colleagues observed inhibition of E. coli cell division in the presence of charged platinum electrodes. After dogged experimentation an inorganic platinum compound (now called cisplatin) was identified as the inhibitor. The same group found that cisplatin suppressed tumors in mice, and discovered the analog carboplatin. Bristol-Myers Squibb licensed the patents on these discoveries, bringing revenue to MSU exceeding $160M. PSA Test. T. M. Chu et al. of Roswell Park Cancer Institute discovered a new prostate-specific protein in 1979. In 1980 they demonstrated the presence of the antigen in the sera of prostate cancer patients and devised an assay for it. Hybritech was the first company to license the assay. Now millions of PSA tests per year are administered throughout the world. Neupogen. In 1985 K. Welte et al. of Memorial Sloan-Kettering Cancer Center (MSK) purified a human pluripotent colony-stimulating factor, now called G-CSF. Samples of G-CSF and tumor cells overproducing the protein were provided to Amgen, which cloned the gene and expressed recombinant G-CSF in E. coli. The MSK researchers demonstrated efficacy of Amgen's recombinant G-CSF in animal models of chemotherapy-induced myelosuppression. Amgen licensed MSK's patents and developed the product Neupogen. The financial returns to MSK from this collaboration have surpassed $500M.
A common thread in these cases is that academic experimentation continued to the point that patent applications were filed and companies saw value in licensing the inventions for further development. As a result these discoveries have benefited patient care as well as the institutions and inventors. Moffitt researchers can get further insights into this process by attending the Technology Information Day event on Sept. 11 in SRB Conference Room 2 from noon to 2:30 p.m. One of the speakers will be Mr. Andrew Maslow, Director of Industrial Affairs at MSK.
OTMC and Moffitt Technologies Corporation work to identify, protect, and commercialize inventions arising from Moffitt-based research. If you have any questions about these processes visit the OTMC Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Dr. Mark Danzi Presentation & Technology Information Day
(August 2006)
OTMC is pleased to announce two upcoming events. On August 18, there will be a Grand Rounds presentation on insider trading given by Mr. Mark Danzi. Mr. Mark Danzi is a securities lawyer for Hill, Ward, & Henderson, P.A. located in Tampa. He will discuss the law of insider trading and the improper uses of clinical trial data by clinicians and researchers.
On September 11, OTMC's second annual Technology Information Day will occur, which purpose is to enlighten and educate Moffitt faculty and staff on technology transfer. OTMC will be having two stellar speakers: Dr. Frank Jones and Andrew Maslow. Dr. Frank Jones is the CEO and founder of Etubics Corporation, a new start-up created by in-licensing IP from the University of Michigan. His presentation will cover what an inventor needs to do to start a biotech company. Mr. Andrew Maslow is the director of Industrial Affairs at Memorial Sloan-Kettering. He will discuss invention development and licensing at Memorial Sloan Kettering. According to the AUTM survey, Memorial Sloan Kettering's adjusted gross license income for fiscal year 2004 was 75 million dollars.
For information about OTMC's IP related services, please visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Licensing Success Story (July 2006)
OTMC and Moffitt Technologies Corporation (MTC) are proud to announce that on June 23, 2006 successful negotiations resulted in an exclusive license agreement between Moffitt Cancer Center (MCC) and Florida-based, Tigris Pharmaceuticals, Inc. (Tigris). This license agreement grants Tigris the exclusive rights to commercially develop GFB-204, a potent and selective inhibitor of VEGF and PDGF. In animal models, GFB-204 is active orally against a wide spectrum of human tumors. This compound was co-developed by Dr. Said Sebti at MCC and Dr. Andrew Hamilton at Yale University. The exclusive license agreement grants rights under the GFB 204 patent applications filed by OTMC to Tigris. In consideration for granting such rights, MCC will receive a combination of equity in Tigris, an upfront fee, development- and sales-based milestone payments, as well as royalties on drug sales. Moreover, Tigris will reimburse OTMC for all patent costs incurred to date, as well as pay all future patent costs. OTMC and MTC are pleased that Tigris has agreed to further develop GFB 204, with the intent of bringing this potent, oncology drug to the market. If you have any questions about licensing or other commercialization strategies, visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Adding Value to Early Stage Biomedical Inventions (June 2006)
Basic and clinical researchers who report early stage inventions to OTMC should continue to develop them during the process of intellectual property protection. Typically OTMC files a provisional patent application when public disclosure (e.g., publication of abstract or article, meeting abstract, oral presentation) of the invention is imminent, even though much development may remain to be done. The provisional application expires after a one year period; however, OTMC together with Moffitt Technologies Corporation (MTC) assesses the technology after six to nine months to decide whether it has sufficient potential to warrant the conversion to and filing of a non-provisional patent application. Technologies can also be assessed if a provisional patent application has not been filed.
During this period investigators can add value to their inventions in several ways. Thinking in terms of achieving milestones can help drive this effort, with the particular milestones being specific to the invention. As examples, in developing cancer biomarkers, important milestones could include validation with resected human tumors, or the demonstration of some minimum accuracy in prospective clinical trials. In developing pharmaceutical inventions, important milestones may include efficacy using human cancer cell lines, animal models of the disease, and mouse xenografts of human tumors. A critical milestone in developing a medical device is the fabrication of a working prototype. In developing any invention, inter-institutional collaborations demonstrate reproducible utility across laboratories and clinics. Another sign that an invention is worth protecting is the attraction of commercial interest, and perhaps even corporate support for research. In this regard, MTC is responsible for marketing inventions to commercial interests.
The achievement of such milestones will aid in the decision of pursuing further patent protection. However if patent protection is not pursued, this is not a reflection of the scientific merit of the research, and, in certain cases, the inventor(s) may be encouraged to seek other venues for their technology. Contact OTMC at 813-745-6828 if you have questions about adding value and reducing uncertainty for your invention.
Technology Transfer and Mouse Models (May 2006)
Mouse models are valuable research tools in both academic and commercial settings. Like most research tools, they lie “upstream” in the value chain leading from idea to product. Because mouse models are applied in the early stages of research and development, and because they are expensive and time-consuming to generate and validate, commercial entities are often willing to offer considerable sums to license mouse lines, and to do so on a non-exclusive basis. Hence most genetically engineered mouse lines are not patented. On the other hand if the model is unique and fills a large need, then patent protection may be called for.
The invention of a mouse model that could attract wide interest should be disclosed to OTMC before it is publicly described. OTMC will facilitate transfer of the mouse model to academic and commercial researchers. The latter may not express interest until the utility of the model is confirmed in publications. Moffitt researchers who get requests for their mouse lines from academic or commercial organizations should refer the contacts to OTMC, which will then negotiate and execute a material transfer agreement (academic) or a license (commercial). The licensee may be permitted to propagate the line itself, or through an outside breeding contractor, but will not be permitted to transfer the line to other entities. In the case of a commercial non-exclusive license, up-front fees for mouse models typically range from $10,000 to $100,000. Added to this are yearly license maintenance fees that are about half the up-front fee. Non-exclusive licenses may generate more revenue than an exclusive license because the total fees could be higher. Ideally the revenue is sufficient to recoup the costs of mouse model development and maintenance.
If you have any questions about commercializing mouse models, visit our Web site at www.moffitt.org/otmc or call us at 813-745-6828.
Robert de Lorimier joins OTMC (April 2006)
Please join us in welcoming Dr. Robert de Lorimier to the OTMC team from Duke University. Dr. de Lorimier received his Bachelor's degree in Biochemistry from the University of California at Berkeley, received his Doctorate in Biochemistry and Molecular Biology from Harvard University, and received his MBA from the University of North Carolina at Chapel Hill. Dr. de Lorimier's first day at Moffitt was April 3, 2006.
Dr. de Lorimier will be focusing his efforts on managing Moffitt's rapidly growing patent portfolio. He will be interacting closely with investigators to learn about their scientific research and to aid such investigators in identifying potentially patentable inventions. Dr. de Lorimier will be instrumental in carefully evaluating the patentability and commercial potential of each discovery submitted to OTMC in order to provide OTMC with a recommendation on whether or not patent protection should be pursued for a given discovery. All of the patent applications filed with the patent office are prepared and prosecuted by outside patent counsel, and Dr. de Lorimier will aid outside patent counsel in ensuring that the claims in the patent application properly describe the invention as well as to assist outside patent counsel in preparing responses to the patent office during patent prosecution
If you have any questions about what discoveries are patentable or the patent process, please contact OTMC at 813-745-6828 or visit OTMC's Web site at www.moffitt.org/otmc.
Marketing Technologies to VCs (March 2006)
The Cancer Center , through OTMC and Moffitt Technologies Corporation (MTC), recently had an opportunity to showcase some of its promising technologies to several Venture Capital Firms. OTMC/MTC and the University of Florida co-organized a "Sneak Peek" presentation session at the recently held, 2006 annual Florida Venture Capital Conference in Ponte Vedra Beach, Florida. Quite a few venture capitalists who attended the Florida Venture Capital Conference also attended the Sneak Peak to learn about early stage technologies that are being developed at the Cancer Center and Florida Universities . The former comprised the University of Florida , the University of Miami and the University of South Florida .
Both Drs. Timothy Yeatman and Gerold Bepler participated in this event. Dr. Timothy Yeatman pitched the invention directed towards a colon cancer signature while Dr. Gerold Bepler pitched the invention for selection of treatment based upon RRM1 expression levels in lung cancer. Many of the attending venture capitalists showed interest in and enthusiasm for the quality of research and intellectual property opportunities at our Cancer Center .
Venture capitalists are viewed to play an important role in identifying and funding in Cancer Center technologies protected by OTMC and commercialized through MTC. If the Cancer Center and inventors elect to spin out a new company, this entity will need seed money to get established as well as to raise capital to achieve various milestones. Venture capitalists are a common source of cash to start-up companies. MTC and OTMC are currently in discussions with several venture capital firms who are quite interested in our available technologies. Moreover, MTC is building its own internal seed fund for potential supplemental investments in start-up companies.
If you would like further information about this event or spinning out a company, please contact OTMC at 813-745-6828 or visit OTMC's Web site at www.moffitt.org/otmc.
Steps to Protect Your Invention (February 2006)
According to U.S. law, any novel, non-obvious and useful invention or discovery may be patented. Any person working at Moffitt potentially could conceive a patentable invention. Some common inventions include compounds, therapeutic targets, vaccines, antibodies, assays, a new use for a known compound, medical devices, tests for predicting response to treatment, tests for determining cancer staging, business methods, machines, and software.
If you have an invention that is distinct from what is known in the public and has some commercial viability, please submit your new invention to OTMC using the standard disclosure form. Shortly after receiving the completed form, OTMC conducts a prior art search by examining the scientific literature and the patent literature as well as determines the commercial value of the invention to ascertain its market demand. Moreover, OTMC meets with the inventor(s) to learn as much about the invention as possible. Afterwards, OTMC uses all of the gathered information to prepare a formal assessment of the invention, which is provided to the OTMC Steering Committee for review and decision as to whether U.S. and foreign patent protection should be pursued.
OTMC highly encourages you to contact its office if you have a new invention because commercializing it may have significant financial value with potential revenue sharing. Moffitt's IP Policy and the Research Addendum between Moffitt and USF provide for a portion of the net revenue from commercializing an invention to be shared with the inventor(s).
If you would like to obtain a copy of an invention disclosure form (form to report a new invention to OTMC), please contact OTMC at 813-745-6828 or visit OTMC's Web site at www.moffitt.org/otmc.
IP Policy (January 2006)
The Cancer Center’s Executive Leadership Council has recently adopted a new Cancer Center Intellectual Property policy (“IP Policy”). The IP Policy now supersedes the Cancer Center’s Patent and Copyright policy. The IP Policy sets forth general information about trademarks, copyrights, and patents along with setting forth policies and procedures relating to technology evaluation, protection, dissemination, and commercial development. Pursuant to the IP Policy, a portion of the net revenue from the commercialization of the Cancer Center’s inventions will be shared with the inventors. The revenue allocation formula in the IP Policy shall govern the situation where the invention is completely owned by the Cancer Center; however, if the University of South Florida or another institution owns the invention completely or in part, then the revenue split might be different.
The IP Policy refers to the Office of Technology Management and Commercialization as the department that is responsible for identifying and protecting intellectual property arising from research performed at the Cancer Center. The new Cancer Center’s wholly owned for profit subsidiary, Moffitt Technologies Corporation, is the entity that is responsible for commercializing the Cancer Center’s intellectual property by negotiating licensing agreements, establishing partnerships/joint ventures, or spinning out new companies with input from the inventor(s).
The Cancer Center’s Executive Leadership Council has also approved a Patent and Copyright Agreement to be signed by certain current Cancer Center employees as well as all future Cancer Center employees. The main purpose of the Patent and Copyright Agreement is to obtain a written acknowledgment from a Cancer Center employee that he/she will assign to the Cancer Center his/her part of any intellectual property generated at the Cancer Center. The current employees that will need to sign the Patent and Copyright Agreement are employees in the Information Technology department along with certain employees in the Moffitt Research Institute. University of South Florida faculty who perform research at the Cancer Center will not need to sign the Patent and Copyright Agreement because this Agreement pertains to Cancer Center employees only.
If you have any questions about the IP Policy or the Patent and Copyright Agreement, please contact OTMC at 813-745-6828.
Trademarks and Copyrights (December 2005)
Copyrights and trademarks are two commonly used vehicles for protecting intellectual property. Copyright law protects the expression of ideas, not the ideas themselves. To be eligible for copyright protection, a work must be original and fixed in a tangible medium. The work need not be novel or useful, only original. A copyright arises automatically as soon as the work is fixed and does not require publication or registration; however, registering the work with the government provides certain advantages such as the ability of the copyright owner to seek enhanced damages. For works created by employees in the scope of their employment, copyright protection extends for 95 years from the date of publication or for 120 years from the year of its creation, whichever expires first. In the event that OTMC is successful in licensing or selling copyrightable works, the Cancer Center may share a portion of the net revenue with the creators of the copyrightable works.
Trademarks identify the source of goods or services and the main purpose of a trademark is to distinguish a company's goods and services from its competitors. Registration of trademarks may be obtained on both the state and federal levels. To obtain a federal registration of a mark, it must be used in interstate commerce. A company may maintain a federal trademark in perpetuity provided that the company is continuing to use the trademark in interstate commerce. The following represent a few Cancer Center federally registered trademarks: TODAY’S TOMORROWS, MOLE PATROL, and LIFETIME CANCER SCREENING.
For more information about copyrights and trademarks, please call OTMC at 813-745-6828.
Inventorship vs. Authorship (November 2005)
The rules for inventorship are much stricter than the normal rules used for determining co-authorship. Typically, anyone who has any involvement in a development is listed on publications relating to that development. However, many such individuals would not be considered inventors under U.S. patent law. Inventorship is a legal determination based upon the claims in a patent. Under U.S. patent law, an "invention" is broken down into two parts. The first is the "conception" of the invention, which is the mental formulation of the complete idea of the invention. The conception must be complete enough to enable anyone with ordinary skill in the pertinent art to reduce the invention to practice. "Reduction to practice" is the second part of an invention. An invention is actually reduced to practice when it is demonstrated experimentally to operate in its intended environment.
In order to be an inventor, an individual must have made a material contribution to the conception of the invention. Simply taking part in the reduction to practice of the invention does not make an individual an inventor. However, the conception must be so complete such that any person skilled in the art would be able to reduce the invention to practice using no more than routine experimentation. If more ingenuity is required to reduce the invention to practice, it is likely that the person employing such ingenuity has made a material contribution to the conception of the invention. In certain cases, the conception and reduction to practice occur simultaneously. In such cases, there was no preconceived conception and the unexpected invention was made in the course of actual experiments.
It is of paramount importance that a patent identifies all of the true inventors because a patent listing incorrect inventors or not listing proper inventors may be invalidated.
If you have any questions about inventorship, please contact OTMC by phone at 813-745-6828.
Material Transfer Agreements (October 2005)
A Material Transfer Agreement (“MTA”) is a legal contract that governs the specific terms and conditions associated with a transfer of Materials (e.g. tissue, vectors, transgenic mice, compounds, cell lines) into or out of the Cancer Center, and a careful analysis of the agreement is needed to protect the Cancer Center’s intellectual property. In general, the MTA defines the specific Materials being transferred, imposes restrictions on recipient’s use of the Materials, defines intellectual property rights of the parties, imposes certain restrictions on publishing data and results, and provides legal protection to the provider from litigation arising from recipient’s use, storage, or disposal of Materials.
MTAs originated in the 1970s with the rise of biomedical research that created closer ties between universities/non-profit organizations and industry. They became more important with the passage of the Bayh-Dole Act in 1980, which allowed universities and non-profit institutions to retain title to inventions developed from federally funded research.
For Incoming Materials: If you receive an MTA from a for profit company or university/non-profit institution, you will need to contact our office. We will review the MTA and negotiate the best terms possible for the Cancer Center. In a majority of the MTAs, the investigator is required to use the Material for a particular research project and not to transfer the Material to another lab or third party. The investigator must comply with each and every term of the MTA to avoid the possibility of breach, which may lead to exposing the Cancer Center to civil liability.
For Outgoing Materials: Again, you are required to notify our office before you send Materials to another for profit corporation or university/non-profit institution in order for our office to complete an MTA.
If you have any questions about MTAs, please feel free to contact us at 813-745-6828.
Your IP Before Public Disclosure (September 2005)
One of the responsibilities of the Office of Technology Management and Commercialization (OTMC) is to protect inventions and discoveries by obtaining patents. A patent is a grant issued by the United States Patent and Trademark Office giving the owner of the patent the right to exclude all others from making, using, selling, offering for sale, or importing the claimed invention within the United States for a limited period of time. Patents may also be granted in foreign countries and have potential commercial value to the inventor(s). To be patentable in most countries, an invention must be new, useful, and non-obvious. In the United States, a grace period of 12 months from the first written public disclosure of an invention is allowed to file a patent application. In most foreign countries, however, an invention is not patentable if it has first been disclosed publicly (written or oral). If one has filed a patent application in the United States prior to disclosure of the invention, the applicant has 12 months from the date of filing to file in most non-U.S. countries without losing patent rights. If you have an invention or discovery that might have commercial value, please contact OTMC before you make a public disclosure such as giving a presentation or having a manuscript published.
If you have any questions about MTAs, please feel free to contact us at 813-745-6828.