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A. How far should you go?
It is important to recognize that a patent does not do something for you or for the product (except perhaps add value); rather, the primary function of a patent is that it prevents anyone else from making, using, offering for sale, selling or importing your invention. However, it does this only in the countries in which you file for and receive a valid patent. It also serves its function only if the patent is well written. Most often, a valuable patent (i.e., a valid and broad patent) is filed by a patent attorney specializing in the scientific or engineering area of the particular patent, with considerable input from the inventor. For that reason, good patents are expensive and must be filed in each country in which protection is desired. For patent applications and issued patents existing as of 8 June 1995, a U.S. patent is enforceable for 17 years from the date of issue. But very recently, as part of the General Agreement on Trade and Tariffs (GATT), U.S. patent law has been changed in this respect. That is, U.S. patents based upon applications filed after June 8, 1995 are valid for 20 years from the first date of filing the patent application. This will result in either increasing or decreasing the life of the patent, depending upon the time elapsed between the patent application and the issue of the patent.. Limited extensions can be granted for certain delays (e.g. FDA approval).
Certainly, not all ideas or inventions are worth patenting. The decision as to whether to file for a patent or not depends primarily on how much chance there is of someone trying to copy and sell the particular product or process. And this, in turn, depends upon a number of factors, such as cost of production, size of the market, and the financial returns likely to be made. Naturally, large companies (with a staff of attorneys) are more likely to attempt this sort of action (i.e., designing around your patent or simply risking infringement litigation), particularly if the market is large and if there is considerable profit to be made. In the field of rehabilitation, however, the likelihood is not as high as in the general field of consumer products.
Within the rehabilitation field, we hear different viewpoints regarding the value of patents, but if a considerable investment of time, money, and effort is required to launch a product, then some sort of protection seems appropriate if available, particularly for larger markets (which are unusual in rehabilitation).
In the case of inventions to be licensed to other parties, it is often worth initiating the preparation of a patent application, but not worth filing formally with the U.S. Patent Office. The primary reason is that the licensee, if one can be found, is not only in a better financial position to pursue the patent, but actually often prefers to do that so that the licensee can control the process from beginning to end (e.g., how it is written, what is claimed, and what countries to file in). In addition, the contents of the patent are not published (and are therefore unavailable to competitors) until the patent is issued, which is usually many months, or even years, after filing.
With regard to patents, especially in a research environment, it is important to recognize that the rules of patenting are often at odds with the wishes and interests of the researcher (or even of the institution). For example, once a full public disclosure of the invention is made (such as in a publication or a public presentation), one then has only one year in which the U.S. patent application must be filed. Furthermore, once such a disclosure is made, all foreign patent rights are immediately forfeited. On the other hand, if there is no such disclosure, one can file for a U.S. patent, and then, up to one year later, file for foreign patents.
In the event that one plans to disclose a new invention (e.g., at a forthcoming meeting or exhibit), but has not yet filled a patent application and has insufficient time to file, there is still another possibility for protection of at least some rights, primarily an early filing date. This can be accomplished by filing a Provisional Patent, for which the procedure is easier, faster, and much less expensive than filing for a U.S. patent. However, it is valid for only one year, during which a full patent application must be filed. The procedure and forms for filing a Provisional Patent are given in Appendix O, along with a number of questions and answers regarding such patents.
B. What is patentable?
There are essentially four specific requirements for patentability [35 USC 101,102,103) see Samuels, 1993]:
The determination of whether an invention is novel is important in two respects: (1) It is a factor in determining whether we might wish to file a patent or to claim patentability to a potential TT partner; and (2) It may in fact already have been patented, in which case we may not have a product we can transfer (depending on the date of the patent), since the manufacturer might then be infringing on an existing patent. Such a situation could be embarrassing and possibly very expensive, and is definitely to be avoided. To avoid such a possibility, a patent search using first one of the computerized services can be quite valuable. If the issued patent is more than seventeen years old (from date of issue), then the invention reverts to public domain and is not an infringement threat.
Note that a public disclosure is defined as a disclosure which would enable one skilled in the trade to duplicate the invention. (This is called an enabling disclosure). A non-enabling disclosure (one of insufficient detail to meet the foregoing criterion) is not considered a public disclosure. It should also be noted that even the submission of an abstract of a paper for publication may constitute a public disclosure. In fact, submission of a proposal to a funding agency may also constitute a public disclosure. Therefore, one must be careful, realizing that publication and patenting may have conflicting requirements. The inventor (or his/her supervisor) is therefore often forced to make a decision early in the game. But disclosure to your attorney (or to the General Counsel of a Federal Agency by a Federal employee) is not considered a public disclosure.
In the laboratory setting, it is not unusual to have visits by colleagues who are sufficiently knowledgeable to copy an invention if shown and explained in sufficient detail. One must therefore consider how much to disclose, and to whom, and whether to ask such visitors (and others) to sign a nondisclosure agreement or confidential disclosure agreement before making a full disclosure. A confidential disclosure agreement appropriate for a potential CRADA partner is shown in Appendix B. But such an agreement would have to be modified for the case of showing the invention to a colleague or a research group. For example, if a new device or prototype is loaned out to an institution for evaluation, the agreement should state the purpose of the loan and should require some sort of informational feedback, such as test data or suggestions for improvement, in exchange for the loan of the equipment. (You should always keep a signed copy of any such agreement.) The signing of such a nondisclosure agreement automatically ensures that this is not a public disclosure.
A good backup resource for checking existing patents is the local Patent Library (in our case in Sunnyvale, CA) which is computerized, easy to use, and has human assistance for locating materials or answering questions. Anyone can scan patent abstracts on microfilm there, or even print out copies of complete patents if needed. However, if the stakes are high, as in an important medical discovery or a consumer product, one should probably have an exhaustive search performed by a competent patent attorney. This library and other resources related to TT are listed in Appendix C.
C. Who is an inventor?
This question is not a trivial one. A patent is not like a publication, on which authorship may be offered as an acknowledgement or a courtesy. Rather, the definition of an inventor on a patent is a legal matter, and the inappropriate naming of an inventor (or failure to name a legitimate inventor) can be grounds for a court ruling that the patent is invalid. It is therefore a matter to be taken seriously.
By definition, an inventor is one who has contributed substantially to the invention, in the sense that it would not work or would not be as valuable without that contribution. A more specific criterion is that one is an inventor if and only if at least one of the claims listed in the patent is attributable to that person.
There is a clear distinction, then, between an inventor and a pair of hired hands. That is, if a persons contribution could have been made by anyone skilled in the trade, then that person is not an inventor. For example, a machinist who makes a prototype is not ordinarily an inventor, unless he has introduced a new idea which actually made the invention feasible.
One final point on this issue: An inventor is free to share royalties with anyone he/she chooses (e.g., someone who has furnished valuable services but is not a legal inventor). All such arrangements, of course, should be in writing and signed by both parties, to avoid future misunderstandings.
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