The initial phase of the process of transferring inventions from the laboratory to industry and the public is invention recognition and disclosure. Invention recognition or identification is the single most important step in the invention based technology transfer process, and can often be accomplished by the simple application of two questions; namely, "Is the discovery new?" and "Is the discovery or finding useful?" When an investigator obtains a positive answer to both of these questions, disclosure to the appropriate institutional administrator responsible for handling inventions or intellectual property is clearly indicated.
When should investigators invoke these two questions? Earlier is nearly always better than later. The optimal times to ask the questions - "Is it new?" and "Is it useful?" - are each time an experiment or line of inquiry has been completed. Other critical periods are during the preparation of manuscripts, presentations and proposals. The submission of a manuscript represents a late, but obvious event that should also trigger invention recognition. Asking these questions after public disclosure of a discovery or invention in the form of an oral presentation, an article, an abstract, a poster session, or a thesis or dissertation may be too late.
An invention disclosure is a written document prepared to describe an invention. Disclosure should be in sufficient detail to permit evaluation of 1) the scientific and technical merit of the invention, 2) whether and how the invention can be protected, and 3) its commercial value.
Click here to download The University of Denver Invention Disclosure Form.
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PATENTS AND PATENTABILITY CRITERIA
WHAT IS A PATENT?
A patent is a grant from the federal govern-ment that entitles the patent owner to prevent others from practicing an invention for a limited period of time. In the case of U.S. utility or plant patents, the term is 20 years. For example, a patent covering a product or a process entitles the patent owner to prevent others from making, using or selling the patented product or process. In return for the granting of the patent, the law stipulates that the invention be made public. Thus, by reading the patent and by obtaining any relevant materials required by the Patent Office to be on deposit, others are able to prac-tice the invention if given a license or other legal right to do so by the patent owner. No additional information or material is required.
DOES A PATENT PROVIDE THE RIGHT TO PRACTICE AN INVENTION?
Technically speaking, no. The owner of a patent has the right to prevent others from practicing the invention covered by a patent. The owner has no absolute right to practice the invention. By way of example, the practice of a patented invention may also infringe a dominat-ing patent owned by another party. The fact that it is often necessary to obtain approval from a federal agency, such as the United States Food and Drug Administration, to sell a patented pharmaceutical product or medical device is a second example showing that a patent owner has no absolute right to practice an invention.
WHAT KINDS OF INVENTIONS ARE PATENTABLE?
Under U.S. law, "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent..." U.S. patent law defines process as "process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter or material." Some examples of inventions that may be patentable are:
- New Compounds
- New uses of known compounds
- Mechanical devices
- Chemical processes
- Methods of making and using genetically engineered products as well as the products themselves
- Novel computer systems and software
- New life forms
Bare ideas or mental processes cannot be patented. Patents can be obtained only on a tangible embodiment of an idea.
WHAT ARE THE CRITERIA FOR PATENTABILITY?
An invention must meet three criteria to be patentable. It must be novel, useful and not obvious.
- This simply means that the invention must be new, i.e., different from what has been done or known previously.
- New uses of known processes, machines, compositions of matter and materials are patentable.
- An invention must perform or satisfy a useful purpose.
- The invention need not have commercial value nor be superior to other means for achieving the same or similar purposes to be patentable. Superiority, however, may help show that an invention was not obvious to those skilled in the art at the time it was made.
- Frivolous inventions are not patentable.
- An invention must not be obvious.
The nonobvious criterion is determined from the perspective of a person having ordinary skill in the art of the invention at the time the invention was made. Art or prior art includes patents, publications and general knowledge in the field(s) of the invention as they existed at that time.
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NEED FOR CORRECT INVENTORSHIP
From the standpoint of U.S. law, a patent is a personal entitlement of the legal inventor(s) which comes directly from the U.S. Constitution. A patent may issue lawfully only in the name of those who meet the criteria of inventorship discussed below. Willful failure to identify correctly all legal inventors on a patent application is regarded as fraud against the Patent Office. A patent application incorrectly specifying inventorship is defective; such error must be corrected since it gives a basis for invalidating the patent.
WHAT IS MEANT BY INVENTORSHIP:
Inventorship has a strict legal meaning under the laws and regulations of the U.S. patent system. The law specifies that only those who have made independent, conceptual contributions to an invention are legal inventors in the United States.
- An inventor is one who, alone or with others, first invents a new and useful process, machine, composition of matter (or other patentable subject matter).
- If an invention involves more than one inventor, it is a joint invention; multiple inventors are called joint or co-inventors.
- Inventorship and authorship are not the same. All co-inventors are co-authors of a publication describing an invention. Co-authors may not necessarily be co-inventors.
- The most important consideration in determining inventorship is initial conception of the invention. The courts have ruled that, unless a person contributes to the conception of the invention, that person is not an inventor.
- Conception of the invention under patent law has been defined as "the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is thereafter to be applied in practice."'
- An invention is complete and operative "if the inventor is able to make a disclosure which would enable a person of ordinary skill in the art to construct or use the invention without extensive research or experimentation."'
Patent Claims and Co-inventorship
- A patent application consists of three parts:
- Its specification including one or more claims,
-A drawing, where necessary, and
-An oath by the applicant(s), as specified by law.
- The specification is a narrative presentation of the invention, including the prior art which preceded it. The specification enables a person of ordinary skill in the art of the invention to practice the invention. The specification must include the best mode of practicing the invention known by the inventor.
- Each claim represents one or more of the essential conceptual elements which make up the invention. Taken together, the claims of a patent define the scope of the invention by describing the specific features that distinguish the invention from the prior art. The claims also provide the basis for legal enforcement of the patent. Anyone who practices the claims of a patent without approval of the patent owner becomes subject to the charge of patent infringement.
- Legal determination of inventorship is made in relation to patent claims. The test of inventorship is whether a person has made an original, conceptual contribution to one of the claims of the patent. Only those who meet this test qualify as inventors.
- To be an inventor, a person must have made an original, conceptual contribution to at least one of the patent claims or its elements.
- To be a sole inventor, a person must be responsible for the conception of the invention as described in all the patent claims.
JOINT INVENTORS: SPECIAL CONSIDERATIONS
Joint inventorship requires communication (in some form) between the inventors. It is, however, not necessary for the inventors to physically work together, for the ideas to have occurred to both inventors at the same time, for each inventor to have conceived the same part of the ultimate invention or made the same type of contribution, or for the inventive contributions to be of equal importance.
Do joint or co-inventors have equal rights to their invention?
- All inventors have made an original, conceptual contribution to at least one of the patent claims or its elements.
- Such independent, conceptual contributions are identified in the patent without reference to the contributor and without regard to their relative importance to the total invention. The patent system does not attempt to evaluate or rank the relative contributions of individual co-inventors.
- Each co-inventor is considered to have the same legal interest in a joint invention as any other co-inventor.
- For legal and practical reasons, the status of co-inventor may not be conferred merely as a reward for hard work, friendship or even outstanding science. This means that colleagues, students, research assistants, technicians, machinists, or those who supervise them, even though they may gather essential data or construct a practical embodiment of the invention, are not inventors unless they have made an inventive contribution.
Who will ultimately determine inventorship?
- In determining inventorship under the law, there are gray areas where such assessment is difficult. However, it is important that this issue be settled, insofar as possible, before the patent application is filed.
- As we have seen, determining inventorship requires expert knowledge of the legal criteria on which inventorship is based.
- Definitive inventorship determination is done by the patent attorney or agent at the time the patent application is prepared for submission to the U.S. Patent and Trademark Office.
- Institutional investigators involved in the invention disclosure process should understand that preliminary determinations of inventorship made prior to the preparation of a patent application are tentative and subject to change based on the advice of the patent attorney or agent who prepares the application.
CREDIT AND RECOGNITION
Personal contribution to an invention can be recognized in several ways:
- By designation as one of the legal inventors in whose names the patent will issue,
- By participation through sharing in any income from subsequent commercialization of the invention, and
- By recognition through publications and presentations.
As already explained, the determination of inventorship is carefully defined by the U.S. patent law. Thus, it is not within a university's discretion or authority to determine who shall be named an inventor. On the other hand, the constraints of patent law do not apply to the sharing of financial return from an invention. This provides an alternative mode by which to recognize the contributions of co-inventors and others.
Income from the commercial development of an invention belongs to the owner of the invention and can be used or assigned as the owner determines. At the time the patent application is filed, university inventors are often required by the terms of their employment to assign their entire interest in the invention to the university, which thereby becomes the sole owner. In return for such assignment, university policy often provides that a specified share of any resulting income shall be returned as personal income to the inventors, i.e., the entitlement to share in university invention income is often a vested right of the legal inventors. With the concurrence of the co-inventors, such division may also include shares to meritorious co-workers who did not qualify as legal co-inventors.
Passages enclosed in quotations are excerpts from court decisions involving inventorship questions. References to specific cases will be provided upon request.
This Invention Tip was adapted from material used by the University of Illinois, Research Administration, Office of the Vice Chancellor for Research. Dillon Mapother, Ph.D., Associate Vice Chancellor for Research, initiated the preparation of this statement about inventorship determination.
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PATENTING AND PUBLISHING
LOSS OF PATENT RIGHTS BY PUBLICATION AND DIVULGATION
Generally well known is the fact that a publishing inventor has a grace period of one year following release of an enabling printed publication to file a U.S. patent application. Less well known are the laws of most foreign countries which foreclose any possibility of patenting following public divulgation.
WHAT IS LOST?
An inventor forfeits rights to a U.S. patent if an enabling printed publication is released more than one year prior to the time a U.S. patent application is filed.
Requirement of "enabling"
- Publication must describe the invention in sufficient detail and specificity to enable a person of ordinary skill in that art at that time, to make, construct and practice the invention without an unreasonable amount of experimentation.
- Publication need not describe details which would be obvious to one skilled in that art at that time.
- In the case of a new chemical compound described by name or structural formula, the publication is not enabling unless a method of making the compound is either described in the publication or obvious to one skilled in that art at that time. However, a subsequently published method of making the compound can render the originally nonenabling publication enabling as of the date of the subsequent publication.
Requirement of "printed"
- Under U.S. law, oral disclosures per se have no effect, even when accompanied by slide presentation.
Publication must be in a tangible form customarily used in making a large number of copies.
- Handwritten documents generally do not qualify as "printed." Exception to this qualification is made where document is in a language which is characteristically handwritten due to its pictorial style and vast number of characters, e.g., Japanese.
- Drawings in readily reproducible form qualify as "printed."
- Typewritten documents qualify as "printed."
- Microfilms and slides themselves qualify as "printed," but their mere projection on a screen (e.g., accompanying an oral presentation) does not.
Requirement of "publication"
- Document must be made publicly available and accessible, at least to that segment of the public skilled in the art or trade to which the invention relates.
- Degree of public accessibility and dissemination required to qualify as "
publication" depends upon the type of documents in question and the circumstances of their distribution.
Documents of limited circulation which have been held to qualify as "publications."
- Single copies of books, periodicals, university theses and dissertations, microfilms and slides deposited and shelved in a public library, provided that they have been properly catalogued or indexed.
- Preprints or printed abstracts of scientific or technical papers distributed to participants at a scientific or technical meeting.
- Documents circulated among a rather limited number of commercial organizations without any confidentiality agreement or restriction on their use of the document.
- Manufacturers' catalogs, brochures, flyers, leaflets, and the like, distributed generally to the relevant trade.
Documents of limited circulation which have been held not to qualify as "publications."
- Documents circulated among a limited number of commercial organizations on a confidential basis, either expressed or implied.
- Reports of private or semiprivate research institutes that are intended for those purchasing their services, but not for general distribution.
- Intracompany documents, no matter how large the company, and no matter how widespread the internal circulation (e.g., the U.S. government).
- Government documents which are either expressly classified or implicitly restricted by reason of limited governmental or contractor circulation.
LOSS OF PATENT RIGHTS BY DIVULGATION
What is divulgation?
Divulgation can be interpreted as any nonconfidential disclosure of the critical aspects of an invention by means of a written or oral description, by use, or in any other way. Merely displaying the invention, where the critical features of the invention are readily discernible, will amount to divulgation. Distributing samples of the invention (e.g., a compound), where the critical features of the invention are discoverable by analysis, will amount to divulgation, even if it could be proven that analysis had never actually taken place.
WHAT IS LOST?
Under foreign laws (most countries other than the U.S.), an inventor forfeits rights to patents if the invention is divulged prior to filing a U.S. patent application. Under these foreign laws "divulgation" has a much broader interpretation than "printed publication" under U.S. law.
EFFECTS OF DIVULGATION
Divulgation of an invention prior to filing a U.S. patent application will result in loss of right to file patents in most foreign countries.
HOW DO I PRESERVE MY PATENT RIGHTS AND STILL PUBLISH OR TALK ABOUT MY WORK?
Simply file a U.S. patent application before you publish or divulge your invention.
You may publish or talk about your invention after you have filed a U.S. patent application and not forgo any foreign patent rights. However, you must file corresponding foreign patent applications on this invention within one year of the date of your U.S. application.
You can publish and protect the commercially valuable parts of your research by:
- Planning ahead
- Coordinating publication-divulgation with patent filing
- Preparing and submitting disclosure of your invention as early as possible
Patent protection is essential to successful commercialization of many inventions.
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RECORDS CAN WIN OR LOSE PATENTS
Disputes sometimes arise over who first made an invention. This issue is usually decided on the basis of records kept by the parties to the dispute. But for the lack of witnessed notebooks describing his device, the man known as the inventor of the telephone would have been a talented mechanic named Daniel Drawbaugh. Although Drawbaugh was able to testify that he had talked over a crude telephone long before Alexander Graham Bell filed a patent application in 1875, Drawbaugh had not a scrap of paper dating and describing the invention. The Supreme Court rejected Drawbaugh's claim of prior inventorship in 1888 by a narrow margin of four votes to three. Similar disputes have raged over who invented the automobile. the electric light and the laser and, in all of them, records or the lack thereof played a deciding role.
As the Drawbaugh case shows, U.S. patent practice places a premium on witnessed records when two or more parties claim the same invention. The date
the idea occurred, called conception, and the date it was put into practice form, called reduction to practice, are vital. The U.S. Patent and Trademark Office conducts proceedings, called interference proceedings, to determine who is the first inventor when this is in dispute. Because the first inventor must be able to prove his or her case by means of appropriate evidence, it is important to have good records of conception and reduction to practice, corroborated by witnesses other than inventors. Equally important to the U.S. Patent Office in such proceedings is the diligence shown by a contending inventor. Diligence refers to work done between the conception and reduction to practice stages of invention. A contending inventor must show work was diligently undertaken on the invention, i.e., the invention was not abandoned. Here too, these efforts should be documented on a day-by-day basis and witnessed by a knowledgeable third party.
A FICTIONAL INTERFERENCE PROCEEDING
We describe a fictional interference proceeding to illustrate how important witnessed laboratory records can be.
Inventor "A" ("Andrews") had an excellent idea for an improved building material. After entering the conception in his notebook and having it witnessed, he diligently set about reducing it to practice. After two years of work he actually mad
e samples of the substance and applied for a U.S. patent.
A fly in the ointment! Other pressures prevented Andrews from maintaining records on the invention in more than cursory fashion. None of his entries. after the first. was witnessed.
Meanwhile, the identical idea had occurred to inventor "B" ("Baker"). She was equally diligent, followed the same trail and created the same material shortly after
Andrews. Baker, however, filed her U.S. patent application first.
Needless to say, Andrews was placed at a serious disadvantage by this action. To win the patent now, he would have to provoke an interference in the Patent Office by copying into his patent application, in exact detail, at least one of Baker's claims for the building materials and then shoulder the entire burden of proving his priority.
Since the materials were the same, there was no trouble in making identical claims. And Andrews did have the idea first: a witness could testify to it and support his statements with the witnessed notebook entry. "But what proof," the Patent Office asked, "did Andrews have that he had diligently labored to reduce his idea to practice?"
THE FIRST INVENTOR MAY LOSE
Here inventor "A" paid dearly for poor records and lack of witnesses. He could not prove, as the Patent Office demanded, that he had been diligent; that he had worked faithfully day in and day out to produce the building material.
Still Andrews had made the new material before Baker, even though his notebook entries were unwitnessed. Could others present in the laboratory on those dates testify in his behalf? Andrews' colleagues, eager to help, did indeed swear they had seen him prepare materials and place them in a molding machine, but they were unable to name the ingredients used or specify what pressures were involved in molding. Andrews had even conducted the strength tests himself, eliminating the possibility of another valuable witness.
Without lifting a finger, Baker won on the basis of her earlier filed patent application. Her earlier filing date was all that was required in the absence of corroborating evidence showing Andrews' diligence and prior reduction to
Had Andrews, our first inventor, maintained adequate, witnessed records to establish his diligence, he would have won the patent, and he might have won even
if he had been the last to reduce the invention to practice rather than the first.
The last statement seems paradoxical, but it reflects the intent of U.S. patent laws to recognize the first inventor: the one who originated the idea. Under these U.S. laws, the first to conceive and reduce to practice will receive the patent if the records bear out his claims. The first to conceive, even if last to reduce to practice, may win if the records show diligence.
RULES FOR RECORD KEEPING
The careful recording of ideas and laboratory activity and data is a matter of routine for industrial researchers, Each entry is often complete and up-to-date, signed and witnessed: a legal record of the day's work. Record keeping is not always so routine for academic investigators, who may work at odd hours or on weekends in a laboratory, an office or at home, often lacking easy accessibility to suitable witnesses. Still, the routine maintenance of a witnessed laboratory notebook is an important task. Additionally such records can serve as valuable repositories of new ideas.
- Ideal practice is to use bound notebooks for records, making entries on a daily basis on consecutively numbered pages. This diary format provides a day-to-day chronology.
- Use the notebook to record a conception (a complete description of a means to accomplish a particular purpose or result), laboratory data and drawings. Each entry should be headed with a title and continued on successive pages.
- Make entries in ink and do not erase; draw a line through text or drawings to be deleted and enter the material in corrected form. Draw a line through blank spaces on the page.
- Separate sheets and photographs pasted to notebook pages should be referred to in an entry. Material that cannot be incorporated in the notebook should be keyed to an entry.
- Sign and date all entries at the time they are made, and have them signed and dated by a witness. A witness must be someone who has read the material and is capable of understanding it, yet had nothing to do with producing it.
- Secure additional witnesses when something important or highly unusual is discovered. Remember that an inventor and co-inventors cannot serve as their own witnesses.
- Set aside a time for making notebook entries and faithfully observe it. Arrange to have two or more colleagues serve as witnesses on a regular basis.
Records, when made routine, take little time and effort, become an invaluable asset to work in progress, and ultimately may protect those rights to which the inventor is entitled.
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BENEFITS OF PATENTING
The benefits of patent rights may be considered in commercial, economic and societal terms.
COMMERCIAL AND ECONOMIC BENEFITS
- Assuming a patented invention has commercial value, the owner of the patent may choose to make and sell the product, taking advantage of the monopoly rights afforded by the patent.
- The owner of the patent may lack the background, incentive or the resources to make and sell the product. The owner still can benefit commercially by waiving those rights to another party for consideration. For example, the patent owner can license the patent to another party. Patent owners can also sell a patent outright.
- The value of patents must be interpreted in relation of the economic structure of the society under which patent rights are practiced. In many countries of the world, manufacturers of patented products expect to gain financially by making and selling products protected by patents.
Patents are essential to the successful commercialization of some types of inventions; namely, inventions that require large expenditures to develop to commercial stage, such as pharmaceutical products. There is little likelihood that inventions of this type will ever become available to the public without benefit of patent protection. Patent protection provides the developer of such products market exclusivity long enough to recoup the costs of bringing such products to market.
Patents provide several important benefits to society.
- Society-at-large benefits whenever patented products important to a significant number of people become available to the public.
- When a patent is allowed or issued, publication is mandatory. Patent publication is freely available to the public. Society benefits by learning about inventions through this publication process. Society benefits by obtaining something it lacked previously and which would not have been obvious to members of that society. It is important to realize that the invention might never have been made available to the public except for publication of the patent.
- An often unrecognized feature of the patent system is that it is structured to encourage people to invent around the patent; i.e., to provide alternative solutions to the problem toward which the invention is directed. This attribute of the patent system often serves as a powerful stimulant to make further inventions that may also benefit society.
- After a patent has expired there may be significant residual benefits to society. If a successful product has been launched through the benefit of patent protection, there is a strong likelihood the product will continue to be manufactured and sold to the public, not only by the original developer who depended upon patent protection, but by other manufacturers who benefit by making and selling the product when the patent expires. This is all part of the benefit to society that flows from the patent system.