Details of the Tech Transfer Process
INTRODUCTION
The Technology Transfer Program (TTP), which is part of the Office of the President, is responsible for implementing the Patent and Invention Policy for
Northwestern
University, and fostering the transfer of novel technologies from the University to industry. TTP policies and procedures for technology transfer reflect the University's practice of preserving traditional rights to disseminate research results, while at the same time providing a basis for protecting creative ideas for commercialization opportunities to introduce new products in the market for public benefit.
Transfer of innovative ideas from the laboratory to the marketplace is a complex endeavor that depends on the close cooperation of individuals and institutions. Companies capable of developing, producing, and marketing innovative products or processes usually require that ideas are protected by patents or other means before risking the often substantial investment required to support development, manufacturing, marketing and sales costs. However, without intellectual property protection of one kind or another there would be little incentive for industry to commercialize important innovations.
When an invention is commercialized under license to a company, a number of benefits may flow to the inventor, the laboratory, and the institution. These can include royalty income, research support, recruiting of students, and consulting arrangements, not to mention unique opportunities for collaboration.
THE PROCESS
Disclosing an Invention
Principal investigators and researchers are encouraged to report (disclose) to TTP their discoveries or inventions that arise from research conducted with Northwestern University resources or using University space and facilities. An Invention Disclosure form or other appropriate disclosure form should be completed and returned along with a detailed description of the invention and with signatures of all inventors. On the basis of the disclosure, patenting or other means of protection will be explored. The University's patent policy requires researchers to assign their rights to all such inventions to the University.
The Invention Disclosure form is submitted once an inventive concept can be fully and precisely described, even if a physical embodiment of the idea has not been realized. If the invention meets patent law requirements and appears to be commercially attractive, a patent application may be filed before actual reduction to practice.
Inventorship
In addition to including a precise description of the invention on the disclosure form, investigators should take special care to name all others who have made a creative contribution to the inventive concept, including inventors at other institutions or sponsoring organizations. Individuals who carried out work at the direction of those creating the concept ordinarily would not be designated as inventors. The naming of inventors on a patent, however, is a legal determination made with the aid of patent counsel . It should be noted that all issues surrounding intellectual property and its protection are complex and should be reviewed with TTP professionals.
Effect of Publication on Preserving Patent Rights
Northwestern investigators are free to publish and present the results of research, subject only to delay for short periods of time required to protect intellectual property. According to patent law, publication or public disclosure of an invention means the non-confidential transfer of knowledge, orally or in writing, by exhibits, demonstrations, or public use of the invention in a manner that would permit others skilled in the art to duplicate the knowledge without undue experimentation. Any "printed publication", including, but not limited to, manuscripts, abstracts, theses, papers, on-line electronic versions, slides, as may be distributed or discussed, or oral presentations with printed viewgraphs or slides or written notes disseminated during a presentation, at non-confidential meetings, conferences, seminars, or forums are examples that may constitute publication or public disclosure. The date of publication in a journal or an abstract for a conference is typically the mailing date of the journal or the abstract books to its subscribers, or when the article is in print and made available through the internet.
In the
United States
, patents may be filed up to one year after an invention's first public disclosure.
In contrast, most foreign countries require that patent applications be filed before any public disclosure on an invention. Further, because most foreign countries have very broad definitions of public disclosure, even the most casual disclosure of inventions may eliminate the possibility of patent protection. It should be noted that European patent rights are lost immediately upon either the written or oral disclosure of the invention.
Despite these strict rules, if a
U.S.
patent application is filed before any publication, most foreign countries permit filing of corresponding applications for up to one year after the
U.S.
filing date, even if a public disclosure of the invention was made after the
U.S.
filing. In practice, then, the filing of a
U.S.
patent application prior to publication preserves both
U.S.
and foreign patent rights.
Therefore, it is important to disclose inventions to TTP before any public disclosure is made of the invention.
Reporting Inventions to Research Sponsors
TTP is required to report all inventions to sponsors, whether public or private. Certain rights to inventions vary according to the specific terms and conditions of the research agreements, and it is the responsibility of TTP to manage relevant issues so that conflicting interests, if they occur, are resolved.
When the sponsor is an agency of the
U.S.
government, federal law grants the University the right to commercialize technology subject to certain conditions. If the University is unable to arrange suitable commercial agreements with industry, or decides not to pursue developing the technology for commercialization by other means, rights revert to the government. The agency, in turn, may choose to make the invention public or otherwise dispose of ownership rights to the inventors.
When an invention is the result of corporate funds, it is the obligation of the University to report such invention to the corporate sponsor.
Promoting Inventions to Industry
After TTP has received an invention disclosure, and after consultation with the inventor, non-confidential material is prepared for distribution to selected companies or pertinent industry representatives who have particular market expertise.
Technical details of an invention may be disclosed to interested parties under a confidential disclosure agreement. If further evaluation of the invention by the company, which often involves direct communication with the inventor, lead to an interest for development and commercialization, discussions may begin for potential license deal negotiations. When additional University research is needed to determine the merit of the invention, a research agreement with an option to license may be appropriate. If the response from industry is unfavorable, TTP will re-evaluate the invention and seek other opportunities. The commercial attractiveness of an innovative idea is determined by two considerations:
- The idea must be protectable (e.g., by valid patents or other means), so the company taking the risk and expense of development, seeking regulatory approval, and/or marketing, can control its use (and sale) for the life of the patents or long enough to receive a return on investment.
- The idea must appeal to a potential market that is large enough to justify investment in development, manufacture, and marketing.
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Inventions and Patents
An invention is a novel and useful idea resulting from study and experiment, and may relate to a process, machine, article of manufacture, composition of matter, or any improvement thereof. An invention may be made by a sole inventor or by more than one inventor. In the legal sense, the inventor must be involved in the conception of
the invention.
A patent secures to its owner, who is not necessarily the inventor, the right to take legal action to prevent others from making, using, and selling the invention for a limited period of time. A patent is granted for a term of twenty years from the date on which it is filed. This term can be extended for some pharmaceutical products or processes that are subject to federal regulatory delays.
Conception and Reduction To Practice
The term conception describes the intellectual act of creating a complete inventive concept, and includes methods for making and using the invention. The term reduction to practice is defined either as (a) constructive reduction to practice, which means completing a written, formal description of an invention in a patent application, even though physical embodiment of the invention may not have been realized; or (b) actual reduction to practice, which means making a physical embodiment of an invention and using it successfully for its intended purpose.
Patentable Inventions
As previously mentioned,
United States
patent law states that patents may be granted on a new and useful process, machine, article of manufacture, composition of matter, or any improvement on these. (A patent may be granted on a distinct and new variety of plant that is asexually reproduced and any new, original and ornamental design for an article of manufacture.) In addition, patent law also requires an invention to meet the following three criteria:
- Novel: The invention must be demonstrably different from any existing prior art. This means it cannot be described in prior public disclosures, which include publications and/or availability of the invention to the public, as in a commercial product.
- Useful: The invention must be useful in ways that represent improvements over existing products and/or techniques.
- Non-obvious: The invention cannot be obvious to a person of "ordinary skill" in the art. Non-obviousness usually is demonstrated by showing that practicing the invention yields surprising, unexpected results.
Each of the previous criteria is open to the judgement and interpretation of the patent examiner, so much of the persuasion is on these criteria between the U.S. Patent and Trademark Office and the applicant. This phase, known as patent prosecution, may last between 3 - 10 years. Patent law also requires that inventions be made enabling or reduced to practice in order to be patentable, but some extrapolation about an inventive concept can be included in a patent application. For example, an invention that claims a broad class of chemical compounds is rarely granted a patent, unless evidence is presented that several different representative members of the class have actually been made. A claim, even to a single new compound or plasmid vector, must include a detailed description of its actual synthesis or construction, in order to receive patent protection. Patent protection of novel genes requires the complete sequence and its biological utility.
Record-Keeping
Maintaining complete records of the development of an idea from conception through reduction to practice is an essential step in the formal, legal protection of intellectual property. Records define the invention and establish the dates of its conception and first reduction to practice. They may be needed to prove, for example, that an invention was conceived before a specific publication appeared or a competing invention was made. Laboratory records also may be needed for legal proceedings where issues of definition and legal ownership of intellectual property are to be determined.
The best evidence of conception is a complete and precise description of an invention, including appropriate sketches, and directions on how to make and use it. It is particularly important to include clear, dated statements of the ideas and experiments that led to an invention.
It is also important to ensure that records are witnessed or corroborated by a person who has the ability to understand the data and the methods used, but who is not a co-inventor. At regular intervals, investigators should have a witness sign and date records and explicitly state that the data were observed and understood. Recommended record-keeping procedures.
Applying for a Patent
Inventions disclosed to TTP will be reviewed and a patent search made to determine the probability that meaningful patent protection can be achieved, and to assess the commercial appeal that the invention might have to companies capable of manufacturing and marketing the invention. A literature search, if not already conducted, is requested of the inventors. If a literature search and a patent search fail to find prior art that could render the invention unpatentable, then a patent application is usually filed and the invention is promoted to the private sector in order to identify a potential partner for further development and commercialization. Legal expenses and other fees for such filings are paid by the University.
Review of the Invention Disclosure by TTP, in consultation with the inventor, usually takes several months. When it is known that the inventor is planning a publication in the near term, the process of reviewing, drafting, and filing a patent application can be accelerated in order to preserve patent rights.
Whether or not an invention has been constructively or actually reduced to practice, the process by which the
U.S.
Patent and Trademark Office eventually awards a patent is rarely simple or straightforward. The process usually involves extensive prosecution, much of which centers on whether the invention is non-obvious. The patent application, submitted on behalf of the inventor and the University by patent counsel, consists of (a) an abstract; (b) the specification (an explanation of the invention, described in broad terms that teach the public how to make and use the invention); and the claims (precise, numbered statements describing exactly what the inventor claims as the invention).
The U.S. Patent Office issues its first "office action" or reply to the initial patent application in approximately twelve months or longer. This first office action usually rejects most or all of the inventor's claims of invention on the grounds of obviousness; several references (either issued patents or scientific papers) are cited to support the examiner's contention. The inventor and patent attorney then present their case to the patent examiner that the references do not render the invention obvious. Such an exchange continues until a patent is either granted or denied. The entire process may take from three to ten years. The cost of a single
U.S.
patent typically ranges from $35,000 to $50,000. Foreign patents cost from $30,000 to $40,000 per country. Maintenance costs add several thousand dollars per patent.
In the absence of a signed license agreement with a company for the development and commercialization of Northwestern inventions, patent protection of those inventions outside the United States is not continued by Northwestern.
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Licensing Deals
Once an invention has been made and disclosed, TTP with the aid of the inventor can begin seeking potential licensees. In cases where discussions with industry representatives are necessary before a patent application can be filed, potential licensees often receive the technical details of an invention under a confidentiality agreement, which is executed by TTP. A license is an agreement under which the licensor (
Northwestern
University) grants a licensee (the company) the right to make, use and sell products based on the licensed invention. In licensing an invention, TTP has several options, that include licensing exclusively or nonexclusively. The license agreement may be based on patent rights, copyrights, proprietary material, know-how, and/or trademark.
Licenses may extend for a few years or for the life of patents. Important license provisions include the University's right to take back the technology if the licensee is not aggressively pursuing its development; reimbursement to the University of all patent costs to protect the licensed technologies; financial terms including a license fee (or "up-front" payment) or equity in the case of spin-off companies; minimum annual royalties; and royalties on net sales of products. Occasionally, a company will want a short-term, exclusive option for a license while either it or the inventor conducts further tests of an invention's efficacy. Success of a license agreement depends on both parties satisfying some basic goals. For example, the inventor and the University must be assured that the technology will be diligently developed for public use, and it will receive an equitable share of the financial rewards resulting from the invention's commercialization. The licensee, in turn, must have sufficient rights to develop a product that will be profitable for a certain period of time. License agreements are negotiated, maintained and monitored by TTP.
Negotiation of Agreements
Although each industrial agreement is unique, there are common steps in every negotiation. The process begins with exploratory discussions between Northwestern investigators and TTP licensing professionals and representatives of a potential licensee or industry research sponsor. The purpose of these meetings is to evaluate common interests and determine if a basis for a relationship exists. It is important that the respective parties are represented by at least one person who is authorized to make binding commitments for their organization. Otherwise, negotiations can easily become over-extended and may end without constructive result. Clear definitions of innovative ideas and the goals of the parties are crucial, if discussions are to proceed. Initial discussions are typically conducted without formal written proposals on the table.
The second step in the process is agreement in principle that the innovative ideas and the shared goals of the parties are sufficient to form the basis for a formal agreement. The third step consists of negotiations between the parties, which may or may not include the University inventor, aimed at reaching a formal agreement. Whether the proposed agreement establishes a license to a Northwestern invention or initiates sponsored research, negotiations focus on the following issues: term of the agreement, exclusivity or non-exclusivity, field of use, ownership, compensation (such as royalties, license fees, research budget), publication, confidentiality of information, and provisions for indemnification, warranty, infringement, termination, and extension. The final step in the negotiation process is execution of the agreement by the parties concerned.
The entire process can take a few months or a year or more. Patience and perspective are essential to working successfully through all of these steps. Once agreements are fully negotiated, the institutions and individuals involved can work toward the common goal of developing important and beneficial technologies for public use, and receive the recognition and compensation that is due when the technology is successfully developed and marketed.
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