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Protecting Research Results
This section outlines the process of protecting research results (through patents or otherwise) as it takes place at Temple. Patents are, in most cases, the preferred intellectual property protection mechanism for research results. Not infrequently, however, it is more appropriate to take advantage of other intellectual property protection mechanisms such as copyrights or trade secrets. For example, a new cell line may be most effectively protected by simply not distributing it to anyone except a licensee, while the products of that cell line may be freely made available to other researchers. In this case, patent protection would be in practice less effective because its cost would necessarily limit the territory in which protection could be obtained. Additional information on patents and a wide variety of other intellectual property resources on the web (including online patent searching) may be used to complement the information given here. Also of interest is Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts.
Warning: Research results that are published or otherwise divulged before a patent application is filed cannot be patented in foreign countries and, depending on the timing, not in the U.S. either. Please read more about publication issues below.
1. Records
It is important that each inventor keep detailed dated records, preferably in bound notebooks, of the progress of the research and the development of the invention. These records are evidence which may be needed later on to prove inventorship. Ideally, the most significant records should be witnessed (i.e., read, signed and dated) by someone familiar with the contents but who is NOT a co-inventor.
2. Inventions and Patents
If you invent something which may have commercial potential, the first question you will want to answer is whether the invention is patentable. Patent protection is an absolute requirement for most inventions to be commercialized successfully. However, please keep in mind that many unpatentable inventions may nevertheless have great commercial potential. It is a good idea to informally contact OTT to discuss a potential invention even in the very early stages of research which appears promising, even if the invention is clearly not yet completely defined.
For an invention to be patentable it must be novel, non-obvious and useful. Before proceeding, it is always a good idea to investigate the issue of novelty by searching the "prior art" through the scientific literature and patent records. You may easily conduct FREE online searches of several U.S. patent databases on the Web, using a great variety of search criteria (combinations of keywords, names of inventors, assignees, patent numbers, time periods, countries, etc.).
3. Invention Disclosures
If you decide to proceed, the next step is to file an Invention disclosure according to established Invention Disclosure Guidelines. Submission of an invention disclosure to OTT establishes a claim to inventorship and should be made as early on as possible.
The invention disclosure requires much detailed information which will serve as the basis for an evaluation of the patentability and of the commercial potential of the invention. The more accurate and complete this information, the better OTT will be equipped to proceed quickly. In particular, you should recognize that OTT and Temple's patent attorneys do not have ready access to the scientific literature; therefore, it is imperative that you append to any Invention disclosure copies of all pertinent references.
4. Preliminary Assessments
The patent application process is a time consuming and costly one; a recent, rather complex patent application cost in excess of $20,000 just to prepare and file in the U.S. alone. In order to minimize legal costs (and, therefore, to make more patent applications possible within its limited budget), OTT first conducts a marketing survey and a patent search "in-house" as a preliminary assessment of the invention. The information gathered in this step is communicated to the inventors and often leads to significant refinements to the Invention disclosure.
Based on the preliminary assessment, a decision is made either: (a) not to pursue the commercialization of the invention, in which case Temple formally releases the invention to the inventors to do as they wish, or (b) to investigate further the market potential and the patentability of the invention. In the latter case, the Invention disclosure is forwarded by OTT to an outside patent law firm retained by Temple, while OTT pursues further marketing analysis.
5. Inventorship and Ownership
Inventorship is not a reward, but a legal determination. It is the patent attorney's responsibility to determine, based on the information provided, who is in fact an inventor. The inventors themselves cannot decide who is or who is not an inventor; it is their responsibility only to provide accurate information about the nature and extent of the contributions of those involved in developing the invention. The determination of inventorship should be made after the patent claims defining the invention are finalized. A patent issued to other than the true inventors is invalid; thus it is crucial that inventorship be properly established.
The following are a few basic guidelines. Anyone named as an inventor must have made a contribution to the concept of the invention. One who reduces the invention to practice should be named as an inventor only if his or her contribution results in a modification of the concept by the exercise of more than ordinary skill; simply having done some (even most) of the work leading to an invention does not automatically make one an inventor. Suggestion of a desired result by a supervisor without any particularization of the means by which it is to be obtained does not make the supervisor an inventor; if the assistant, by the exercise of more than ordinary skill, discovers a means to the desired result, this assistant and not the supervisor is an inventor. A member of a research team who participates in the stimulating give-and-take which results in the formulation of an inventive concept by the team is entitled to inventorship. Lesser contributions to a concept do not rule out inventorship.
As required by the Invention and Patent Policy, inventors assign to Temple all their rights to the invention; this is done at the time the patent application is submitted. This assignment gives Temple sole ownership of the invention and the right to license it for commercial use, although the inventors are named as such in the patent application and in the resulting patent when it issues.
6. Publications
Publication or even just oral presentation of any kind prior to the filing of a patent application may jeopardize patent protection. Dissertations are considered publications when made available to the public, typically when listed in the institution's library catalog. The text of a proposal funded by a federal agency (obtainable by the public under the Freedom of Information Act) constitutes a publication unless steps were taken to preserve the confidentiality of specific information contained in the proposal. Determination of what constitutes a publication may not always be a simple matter. For example, the abstract of a talk to be presented at a future meeting may or may not constitute a publication. Divulging the invention to a third party (perhaps a potential licensee) without a prior confidentiality agreement can also be a bar to patentability. The need to disseminate and discuss research results in the scientific community demands that publication not be unduly delayed. OTT assists inventors in facilitating the compromises required to meet these two conflicting demands.
The following are a few basic guidelines. In the U.S., a patent application may be filed up to one year after publication; this grace period does not exist in most foreign countries. However, publication after submission of a U.S. patent application will not preclude foreign patents, provided that the foreign applications are made within one year of the U.S. application.
7. Patent Applications
A patent application is a document filed with the U.S. Patent and Trademark Office requesting patent protection for an invention. It contains very detailed information about the novel and unique aspects of the invention.
Before beginning the preparation of the patent application, the patent attorney will give OTT an opinion of the likelihood that patent protection can be obtained. At that point the decision either to proceed or to release the invention to the inventors is considered again in light of the strength of the application and of the market potential of the invention.
Preparing the application may take several months. During that time, OTT coordinates the contacts between the inventor and the patent attorney. OTT is making a serious effort to keep legal fees down and needs the cooperation of inventors. Many inventors do not realize that patent attorneys charge fees often well in excess of $200 an hour. In the event of a successful marketing effort, these (and other) costs will be deducted from gross royalty income, half of which would otherwise go to the inventors. Therefore, it is important not only that the Invention disclosure that the patent attorney receives be as complete as possible, but also that correspondence or phone communication between inventors and the patent attorney be kept to a reasonable minimum.
The University almost never files foreign patent applications until a license agreement for the invention is in the final stages of negotiation. The reason for this is the staggering filing and maintenance costs in even just a few foreign countries; for example, the additional cost of filing in just Europe, Canada and Japan often exceeds $30,000.
8. Patent Issuance
A patent gives its owner (the "assignee"), for twenty (20) years from the application date (prior to GATT, patents were valid for 17 years from the issuance date), a monopoly on using the invention; this means that no one except legitimate licensees may exploit the invention. It takes an average of two years (but often much longer) between the filing of a patent application and the issuance of a patent. In the meantime, the application is reviewed by a patent examiner who may raise numerous questions about technical aspects of the application; this is the patent prosecution stage. Response to these questions and all other communication with the patent examiner is handled solely by the patent attorney, in consultation with the inventors and with OTT. Most of the cost of obtaining a typical patent is incurred, not in the preparation and filing of an application, but in the subsequent prosecution!