Research Guidelines - Intellectual Property: Office of Technology Transfer

A. Introduction

The Office of Technology Transfer (OTT) within the Temple Research Administration (TRA) is responsible for protecting and commercializing the results of all research conducted at the University. Although this entails primarily patenting and licensing inventions developed entirely at the University, there are other important aspects of OTT's activities. For example, it is increasingly desirable to reserve, by contractual agreement in advance, the ownership of research results obtained by the University faculty in collaboration with colleagues at other universities. Additionally, it is necessary to protect not just intellectual property (the information contained in the research results), but also tangible property (the physical embodiment of the research results) such as laboratory notebooks, disks containing computer data or programs, as well as samples of novel chemical or biological materials (Appendix CC).

B. Invention & Patent Policy

The University Invention and Patent Policy (Appendix Y) governs the disposition of inventions (including all patents and most software copyrights) developed by University employees and students on University time and/or using University facilities. The Patent Policy, adherence to which is a condition of employment at the University, provides that the University is the sole owner of any such inventions. It also sets forth important policies regarding ownership rights, inventorship, royalty distribution and other relevant information. The Patent Policy provides, in particular, that inventors are entitled (even after leaving the University) to 50% of all net royalty income derived from each patent.

While OTT is charged with the day-to-day management of invention-related matters, oversight of its activities rests with an eight-member Invention and Patent Committee, five of whom are faculty members. All disagreements concerning invention-related matters are resolved by the Patent Committee, whose decisions are final under the Patent Policy.

C. Patenting

A patent gives the patent owner the right to prevent others from practicing the invention for seventeen years after it is issued. Important information of a general nature about patents is found in a booklet entitled "What is a Patent?" which may be obtained from OTT. Details of the patenting process follow as it takes place at the University, including guidelines for documenting, recording and protecting intellectual research.

INVENTION DISCLOSURES

It is important that inventors keep detailed notes on the progress of their research and the development of each invention. These notes are evidence which may be needed later on to prove inventorship. Ideally, the most significant notes should be witnessed (i.e., read, signed and dated) by someone who is familiar with the contents but who is NOT a co-inventor.

As soon as something which may have commercial potential and which may be patentable is discovered, the inventor should discuss it informally with OTT staff. A preliminary literature search (by the inventor) and patent search (by OTT) will be helpful at this point. If the inventor decides to proceed, the next step is to file an Invention Disclosure with OTT, the guidelines and cover page of for a disclosure are found in Appendix Z.

Submission of an Invention Disclosure to OTT establishes a claim to inventorship and should be made as early 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.

Since inventions often have more than one inventor, the Invention Disclosure designates one of the inventors as the contact with OTT; all communications relating to the invention will be made through this inventor, who has the responsibility of keeping the other inventors appraised of all developments concerning their patent application.

PRELIMINARY ASSESSMENTS

The patent application process is time consuming and costly; the cost of preparing and filing a patent application just in the U.S. very often exceeds $20,000. In order to minimize legal costs (and, therefore, to make more patent applications possible with a 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 inventor and often leads to significant refinements of the Invention Disclosure.

Based on the preliminary assessment, a decision is made either: (a) not to patent, in which case the University formally releases ownership of the invention to the inventor, 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 the University, while OTT pursues further marketing efforts.

INVENTORSHIP AND OWNERSHIP

Inventorship is not a reward, but a legal determination. It is the responsibility of the University's patent attorney to determine, based on the information provided, who is in fact an inventor. Inventors cannot themselves decide who is or who is not an inventor; it is their responsibility only to give the patent attorney accurate information about the nature and extent of the contributions of all those involved in developing the invention. The determination of inventorship should be made after the 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. To be considered an inventor, one must have made a contribution to the concept of the invention. Those who reduce the invention to practice should be named as inventors only if their contributions resulted in modifications 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 particular direction as to the means by which such result is to be obtained does not make the supervisor an inventor; if the subordinate, by the exercise of more than ordinary skill, discovers a means to the desired result, this subordinate 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 Patent Policy, the inventor assigns ownership of the invention to the University; this is done at the time the patent application is submitted. The assignment gives the University sole ownership of the invention and the right to license it for commercial use, although the inventor is named as such in the patent application and in the patent when it is issued.

Inventors wishing to reward significant but non-inventive contributions of collaborators may give up a portion of their share of royalties by asking OTT (in writing) to pay that portion directly the collaborators.

PUBLICATIONS

Publication or oral presentation of any kind prior to the filing of a patent application may jeopardize patent protection. However, the need for prompt dissemination and discussion of research results in the scientific community demands that publication not be unduly delayed. Determination of what constitutes a publication is not always a simple matter. For example, the abstract of a talk to be presented at a future meeting may be considered, by itself, a publication as of the date of mailing of the book of abstracts to those registered for the meeting. Except for abstracts and other rapid publications, submission of an Invention Disclosure to OTT at the same time a manuscript is submitted for publication provides ample time for a patent application to be filed without undue haste.

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 date.

PATENT APPLICATIONS

A patent application is an official document which is filed with the United States Patent and Trademark Office requesting patent protection for an invention. It contains extremely detailed information about the novel and unique aspects of the invention. Before beginning preparation of a patent application, the patent attorney will give OTT an opinion of the likelihood that patent protection can be obtained. At that point the decision to proceed or to release ownership of the invention to the inventor is considered again in light of the strength of the application and of the market potential of the invention.

Preparing the application usually takes several months. During that time, OTT coordinates the contacts between the inventor and the patent attorney. OTT makes a serious effort to keep legal fees down and needs the cooperation of inventors. Many inventors do not realize that patent attorneys may charge fees in excess of $200 an hour. In the event of a successful marketing effort, these (and other) costs will be deducted from royalty income, half of which would otherwise go to the inventor. Therefore, it is important not only that the Invention Disclosure which is forwarded to the patent attorney be as complete as possible, but also that correspondence or phone communication between the inventor 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. This is due to the staggering cost of foreign filing and maintenance, typically $20,000 just for filing in Canada, Japan, France, Germany, Great Britain, and Italy. These costs are in addition to the comparable costs of preparing and filing the U.S. parent patent.

PATENT PROSECUTION

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 almost invariably raises numerous questions about the technical aspects of the application and rejects most if not all claims. Response to these questions and rejections, and all other communication with the patent examiner, is handled solely by the patent attorney, in consultation with the inventors and with OTT. The cost of this prosecution usually far exceeds the cost of preparing and filing the original application. When a patent issues it is kept by the University in its vault, and notice of issuance along with copies of the patent are forwarded to the inventor.

D. Marketing

THE ROLE OF OTT

One of OTT's primary goals is to enter into royalty-producing license agreements, i.e. contracts allowing companies to make, use, develop and/or sell University-owned inventions (either patented or copyrighted). With this aim, OTT is constantly refining marketing information which has the dual purpose of establishing the commercial value of inventions and of locating potential licensees. This information is shared with inventors on a regular basis.

Once potential licensees are identified, OTT undertakes a variety of activities designed to bring about a license agreement: Development of materials describing University technologies available for licensing, mailings to companies individually targeted for each invention, visits to the University by company representatives, attendance by OTT staff at technology transfer meetings, etc.

THE ROLE OF INVENTORS

Inventors' contributions to OTT's activities usually go far beyond the creation of inventions. The assistance of inventors in OTT's activities is always of great value, but inventors need to be involved only as much as they wish to be. Most often inventors perform additional research, either to assist a potential licensee in evaluating the invention or to contribute to the development of a product already under license. In addition, inventors may have long-standing relationships with company scientists who have similar research interests. Thus, inventors may be able to identify early on companies interested in licensing their inventions. Such relationships have led to many of the license agreements currently in place and are expected to continue to do so in the future.

The importance of the inventors' role in all of OTT's activities cannot be overemphasized. OTT recognizes this and endeavors to involve inventors closely in the development and day-to-day implementation of the overall strategy to market their inventions. However, it is also important that inventors recognize that their dealings with companies may lead to awkward situations if some care is not taken. Typical problems include premature disclosure of confidential information and agreeing to contractual terms without clearance from OTT. Just as inventors have the technical expertise regarding their inventions, OTT staff have expertise in marketing and negotiating the best possible terms. Optimum results, both in obtaining continued support for the inventor's research and in securing royalty income, will be achieved only through the coordination of efforts by inventors and by OTT staff.

THE ROLE OF THE UNIVERSITY COUNSEL'S OFFICE

Inventors accustomed to research grants from agencies such as NSF or NIH often do not realize that very real legal dangers (both to themselves and to the University) may be found in even simple research agreements proposed by corporate sponsors. In the vast majority of cases, a contract provided by a company includes clauses which give every advantage to the company, and often restrict the investigator in subtle ways. It is common industry practice that such unbalanced clauses are subject to change through negotiation. The role of the University Counsel's Office is to assist OTT in protecting faculty's rights as well as those of the University by reviewing all agreements and by negotiating final drafts with companies. Important legal issues which must be carefully considered in every agreement include (among others): publication rights; inventorship and ownership rights to future inventions; and liability protection.

Inventors do not have the legal authority to sign any contractual agreement for the University. Any agreement with a company must be reviewed first by OTT and then by the University Counsel's Office, so as to protect the interests of the inventor and the University, before being signed on behalf of the University by the Vice President, Chief Financial Officer and Treasurer or the President (the only authorized signers).

CONFIDENTIALITY AGREEMENTS

A Confidentiality Agreement (also commonly referred to as a Secrecy Agreement, a Confidential Disclosure Agreement, or a Non-Disclosure Agreement) is a legally binding contract between the University (representing an inventor) and a third party. The third party is usually a company (but could be another university) that wishes to receive specific information about the invention in order to determine its interest in supporting further research or in licensing the invention.

A Confidential Disclosure Agreement (Appendix AA) limits the use by the company of technical information about a particular invention. In order to provide protection, however, this document must be signed by the company before discussions which are confidential in nature take place. OTT is responsible for drafting the appropriate agreement and for coordinating its execution. Once the agreement has been executed, OTT informs the inventor that confidential information may be communicated. The scope of such agreements is usually quite narrow, so that more than one agreement may have to be executed for the same inventor and the same company. The actual wording of the agreement depends on the circumstances of the disclosure.

Although a Confidential Disclosure Agreement provides a measure of protection, it is preferable to disclose critical information only after a patent application has been filed. The extent and timing of the disclosure of specific information should be part of the marketing strategy the inventor and OTT devise together. When in doubt concerning the need for confidentiality, inventors should consult OTT. Under no circumstances should copies of pending patent applications or of critical manuscripts in press be sent to companies without clearance from OTT. It is important to label as "Confidential" all written communication of confidential information; oral disclosures must be reduced to written form and sent to the company usually within thirty days of the disclosure date.

LICENSE AGREEMENTS

A license agreement is a legally binding contract between the University and a company that wishes to make, use, develop and/or sell a University-owned invention. License agreements contain terms which establish royalty rates, license fees, product liability insurance coverage, publication rights, and other critical provisions.

Negotiations for a license agreement typically progress in two main stages, according to a strategy which coordinates the efforts of the inventors and those of OTT staff. In the first stage, the inventors discuss with the company (under a Confidentiality Agreement) the technical aspects of the invention and of the proposed commercialization, until a clear picture of what is intended has emerged. If the license agreement is to contain a research component intended to develop the invention, the inventors also clarify with the company the scope of the work to be performed and their funding needs. Throughout this stage OTT is kept informed of the progress but plays only a minor role.

The second stage consists of negotiations between OTT, representing the University and the inventors, and the company for the commercial terms. The success of the negotiations for the commercial terms usually requires walking a fine line combining toughness and flexibility. In order to do this without jeopardizing existing and future relationships of the inventors with scientists at the company, inventors are not normally present during the actual negotiating sessions. Before negotiations start, OTT staff meets with the inventors to discuss the desired terms and any other goals, and to map out with them a strategy which includes designated fall-back positions. OTT staff will then meet with company representatives to negotiate the terms of the agreement. The inventors are kept informed of the progress of the negotiations and are consulted before any critical decisions are made.

OPTION AGREEMENTS

An option, if exercised, gives a company the right to negotiate a license to commercialize the technology covered by the option. The wording of the option agreement is critical because the duration and breadth of an option may vary widely. The agreement may include key provisions of the license to be negotiated; it does not, however, commit either the company or the University to a license. The company uses the period during which the option is valid (usually one year) to assess, often based on the results of further research being sponsored, whether it wants to license the invention. Options may be combined in the same agreement with a research component or be stand-alone agreements covering existing University technology. The "right of first refusal" is frequently used in conjunction with options; it insures that another company will not receive a more favorable offer from the University, in the event license negotiations are unsuccessful.

E. Research

RESEARCH AGREEMENTS

A research agreement sets forth the terms and conditions for research sponsored by companies. It describes the research to be done and the level and timing of the support being provided; however, just as importantly, it outlines ownership, publication, and other rights regarding any new inventions which may develop as a result of this support, confidentiality, and important questions of liability.

In many cases, the research relates to an existing University-owned invention which requires further development, and the agreement may be coupled with a license or option agreement. In other cases, however, the research may simply cover an area of investigation of common interest to a faculty member and a company, with no connection to any prior invention.

Where a University-owned invention does not exist, research agreements nevertheless contain an option provision, since the company wants to have preferred access to any new technology which may arise from the research it sponsors. It is not unusual for companies to demand ownership of all research results, a demand which must be resisted from the outset; it is appropriate for a company to own the research results only if all critical materials (such as a new drug) are proprietary to the company and the research protocol is provided by the company. For example, this should not be the case if the research is based on a potential new use for a drug owned by the company and the idea for the research originated with a University investigator. (Appendix BB)

It is important that, while discussing a potential research agreement with a company, investigators make clear to the company that indirect costs and the non-technical terms of the agreement will be handled by OTT, in consultation with the University Counsel's Office. In order to expedite setting up new research accounts, investigators are urged to send OTT a copy of the proposal (including a line item budget) and a completed Sponsored Projects Approval Form (SPAF), found in Appendix A, as they would for an NSF or NIH grant. The University Counsel's Office will review corporate research agreements only when accompanied by this form (signed by all appropriate individuals) and only when forwarded through OTT. Use of company funds without an executed research agreement would entitle the company to dictate later on any reasonable terms it wishes; for this reason, company funds cannot be used until an agreement is executed.

COLLABORATION AGREEMENTS

It is becoming increasingly common for investigators collaborating with colleagues at other universities to find out only too late that their joint research results are not free of legal entanglements. For this reason, University investigators are urged to consult OTT before they engage in informal collaborations with colleagues at other universities. Depending on the circumstances, OTT may advise entering, in advance, into a simple collaboration agreement with the other university so as to safeguard the rights of the University and of its investigators. Similar precautions should be taken even more seriously when the collaboration is with colleagues at corporate R&D laboratories.

Problems arise in a wide variety of situations. Perhaps the most common one (and also the most serious) arises when the other university already has patent rights in the area of the collaboration. For example, suppose that researchers at another university synthesize a non-toxic Molecule X and find it to be useful in treating a rare Condition A. The other university obtains Patent A covering both the molecule itself and its use for Condition A. When University researchers read about this work, they realize (based on their still unpublished results with a similar but toxic Molecule Y) that Molecule X should be useful in treating Condition B, which is extremely widespread and for which there is no known treatment. The University researchers communicate their ideas to the other university's researchers and the two groups collaborate and eventually prove the usefulness of Molecule X in treating Condition B. The two universities obtain Patent B, owned jointly, covering the use of Molecule X in treating Condition B. At this point it may not be readily apparent that, although the University is a joint owner of Patent B, it may very well never derive any benefit from it unless some precautions had been taken at the outset. This is because, in order to be able to use Patent B, a company will have to gain access to Patent A as well, both of which the other university, but not the University, can provide under a license. Therefore, unless a prior collaboration agreement existed between the two universities which gives the University a share of the income derived from Patent B, the University is not entitled to anything.

A different type of problem arises when University researchers provide to colleagues at another university (or a company) ideas, data or samples without any confidentiality or other restrictions. It is possible for the recipients to conceive and reduce to practice inventions (and obtain patents) independently of the University researchers. The latter will derive no benefit, even though their contribution may have been an essential one.

MATERIALS TRANSFER AGREEMENTS

University ownership extends not only to intellectual property (the information contained in research results) but also to tangible property (the physical embodiment of intellectual property). Such tangible property includes, but is not limited to: original and duplicate laboratory notebooks; computer printouts or other computer storage media in which data are recorded; biological or chemical samples such as cell lines and strains, recombinant DNA molecules, synthetic peptides, monoclonal antibodies; and prototypes of devices and equipment.

Access to tangible property is required for the University to fully protect its rights to the corresponding intellectual property through patents or other means; such access may also be required for the University to document its compliance with various regulatory requirements.

In the event that samples of novel chemical or biological materials owned by the University are to be provided to a colleague at another university and no collaboration is otherwise contemplated, a Materials Transfer Agreement (see Appendix CC) should be signed first by an authorized representative of the other university.