Office of Technology and Business Development

What is the Office of Technology and Business Development? [back]
The purpose of the Office of Technology and Business Development is to strengthen the relationship between Mount Sinai's scientific community and the business community, and to facilitate the transfer of technology from the laboratory to the marketplace. The Office of Technology and Business Development manages all activities related to the protection and commercial promotion of inventions and discoveries made under the auspices of the University. The goals of the Office include:

• securing patent protection for Mount Sinai Medical school inventions;
• evaluating the commercial potential of and generating industrial support for ongoing applied research projects;
• negotiating, concluding, and monitoring research and license agreements to ensure the development and commercialization of the University's technologies.

What is intellectual property? [back]
Intellectual property is an intangible-such as an invention or discovery-that can be bought, sold, or licensed. It can be protected by patents, trade secrets, copyrights, and trademarks, which protection may be used to prevent others from the unauthorized manufacture, copying, use or sale of the property in tangible form.

Whose property is it? [back]
Mount Sinai Medical School's Statement Policy on Patents provides that any invention developed at the University or resulting from research conducted under University auspices must be disclosed and assigned to the University. Nonetheless, the University has one of the most generous policies in the country with regard to the distribution of invention-related income: It shares equally with the inventor(s) all net royalties and other net income from the commercialization of such inventions. If the University declines to patent the invention, the invention becomes the exclusive property of the inventor(s).

Patents
How are inventions and discoveries protected? [back]
Intellectual property in the form of an invention or discovery is protected by a patent, which excludes other from making, using, or selling the property for seventeen years from the patent-issue date in the United States; outside of the United States the period of protection varies.

What is patentable? [back]
Any process, machine, manufacture, compound, or composition of matter, or a new and useful improvement on any of those, may be patentable, provided the inventor is capable of making a disclosure which would enable a person or ordinary skill in the art to make and use the invention without extensive research or experimentation. The invention must be useful, novel, and not obvious.

Utility - A patentable invention must not be frivolous. In general, an assertion of utility will not be challenged. Certain claims, however, such as perpetual motion machines and cures for baldness, usually are treated with skepticism and require proof. The utility must be a practical utility. A mere laboratory curiosity (for example) may not be patentable.

Novelty - An invention cannot be considered novel if it has been known or used by others in the U.S. or patented or published by others anywhere in the world before the date of invention by the applicant. A new use of an existing product, however, can be considered novel.

When and how the invention is publicly disclosed will affect the novelty criterion. Premature disclosure (see below) may disqualify the patent application. Similarly, keeping the invention secret for too long may cause it to be regarded as abandoned, suppressed, or concealed, which are also disqualifying factors.

Unobvious - An invention must not, at the time it was made, be obvious to a person of ordinary skill. It may not be merely a collection of known elements or steps, nor may it consist of known equivalents in an old machine, compound, composition, or process. Since the terms obvious and person of ordinary skill are subjective, frequently there is disagreement about the fulfillment of this requirement. Expert legal opinion is helpful here.

What are the prerequisites of a valid patent? [back]
In order to be valid, a patent must correctly identify the inventor(s) and the invention or discovery must not have been prematurely disclosed. Furthermore, the inventor(s) must have been the first to invent the subject matter. Because the details of these prerequisites are complex and involve legal determinations that might affect the validity of the patent application, we will consult with our patent attorney before attempting to establish inventorship and disclosing the invention. A brief discussion is provided here merely to introduce the issue.

Inventorship. - The inventive is the person or persons who conceived of the invention. To be an inventor a person must have made a contribution to an original concept. In determining inventorship, the contribution of faculty who lead the laboratory in which an invention is conceived, students who have implemented the work, and authors of papers should be considered.

Inventorship may include more than one person. Anyone who has contributed something original to the concept-who has added value to it,-is a co-inventor. Joint inventors need not have worked together or at the same time, but they must have communicated and been aware of each other's work. The contribution of joint inventors need not be equal; the contribution may be partial, but it must be original.

Disclosure - Premature disclosure of an invention may jeopardize the right to patent protection. Although a patent law in the United States allows a one-year grace period between the first public disclosure of an invention and the filing of a patent application, many other counties (including Japan and members of the European Economic Community) do not. In those countries, the right of patent protection is lost immediately upon disclosure. It is wise, therefore, not to make any public disclosure before submitting a patent application.

Often premature disclosure occurs unwittingly. Because disclosure is defined as written or oral communication of details of the invention, or its public sale or use, its appearance in University newsletters and publications, or through the public exchange of materials will be considered disclosure. Even if an invention has been prematurely disclosed, a patent application made within the one-year grace period will be valid in the United States (See below, How is foreign patent protection secured?)

If proprietary information or biological materials are to be exchanged, the invention can be protected from premature disclosure by securing an agreement beforehand specifying that the transmitted information or materials are for use only in the designated laboratory, for academic research only, and not for distribution to others. Such an agreement makes disclosure confidential, not public. (See discussion of the transfer of proprietary materials below.)
Priority - The first to invent an idea is the one who will obtain a U.S. patent, regardless of the date of filing.
Because several groups worldwide may be simultaneously working on the same problem, it is extremely important to maintain meticulous records during all states of the invention process. Such records should also detail the extent of involvement of all contributors to the invention. Researchers are often advised to keep chronological notes on their progress in such a way that later additions and alterations are not possible. Every state of the invention's development should be described and each entry witnessed, signed, and dated by two people unrelated to the researchers and able to understand the meaning of the work. In addition, calendars, diaries, and communications with colleagues are often useful.

How is foreign patent protection secured? [back]
A patent is valid only within the boundaries of the country that grants it. In order to get -patent coverage in foreign countries, it is necessary to file each one. The United States belongs to an international patent treaty that provides that once an application has been filed in a member country, all applications for the same invention filed in other member countries within one year will receive the filing date of the first filed application. In order to preserve the possibility of foreign patent coverage, an application must be filed in the United States before any written or oral public disclosure is made. Thereafter, the invention may be freely published or publicly disclosed without jeopardizing domestic or foreign patent rights.

What is the disclosure process?[ back]
Following the procedures outlined below will go far toward protecting your proprietary rights and those of the University.

Notification - The Office of Technology and Business Development should be notified as soon as a faculty member comes up with an invention believed to be patentable. To enable the Office to make a judgment about the invention's commercial potential, certain information is needed. To help faculty prepare this information, a form for the confidential disclosure of invention has been prepared and is available from the Office. The confidential disclosure should include:

• A summary telling exactly what the invention is-Is it a compound, process, machine, manufacture, composition; a new use for, or an improvement on, a known item or process?
• A description of the benefit or use of the invention-What problems does it solve?
• A list of pertinent literature, including patents-If there is no pertinent literature, list the closest known. Copies of all listed literature (called "references" in patent jargon) should be included, along with a brief explanation of the difference between each reference and the invention, describing the advantages of the invention over the references.

· Other research collaborators and finding sources-If you were collaborating with other scientists (whether from the University or from other institutions) or if your research project has been funded by an agency, foundation, or another source, include all details.

· Response - The Office of Technology and Business Development will acknowledge receipt of a confidential disclosure. Next it will seek a recommendation on the patentability of the invention from the University's Technology Transfer and Patent Committee. Once the University decides whether or not it intends to seek patent protection, the faculty research will be notified of the decision. If the decision is to proceed, the Office of Technology and Business Development will coordinate the application process, relying on the inventor's participation and the services of a patent attorney. The inventor(s) will assign all rights to the University, but will share equally with the University all income resulting from the commercialization of the invention. If the University declines to pursue a patent, all rights shall revert to the inventor(s).

What goes into a patent application? [back]
The patent application will be prepared by patent counsel, working with the Office of Industrial Liaison. The inventor plays an important role in providing much of the material required for the application.

• A patent application has much in common with a scientific article: an abstract, a general discussion of the problem, a summary of related developments in the field, and a description of the materials, methods, and conditions necessary to reproduce the invention.
• A significant difference, however, between a patent disclosure and a scientific article is that the results should be phrased very positively, rather than subject to cautious interpretations. Furthermore, it is permissible, and often desirable, to make predictions so as to cover, for example, related materials, conditions, and utilities. To facilitate the preparation of the patent application, the inventor should forward information covering the following to the Office of Technology and Business Development:

Abstract - A brief summary of the invention.
Background - This consists of a full discussion of existing art in the field of the invention, including an explanation of the differences between such art and the invention, and a description of the advantages of the invention over such art.
Detailed Description - The description of the invention must be detailed enough to enable someone skilled in the art to make and use the invention. The inventor must disclose the "best model" of practicing the invention known at the time of filing. A patent will not be issued on any application that fails to provide such an enabling description or to describe the best mode.
Examples - Applications for chemical compounds or compositions may, and nearly always do, provide written examples of the invention. The examples describe experiments that demonstrate a reduction to practice; they are written in the same way as for scientific publications. In a description of an actual experiment that led to physical data, it is not permissible to select only the favorable data, omitting unfavorable or less favorable data. Purely theoretical examples are permitted so long as they do not lead the reader to believe that the experiment has actually been performed.
Illustrated Material - Although not always mandatory, including drawings, pictures, and other graphic material often facilitates understanding of the invention. When the invention includes apparatus, such drawings are required. Claims - The legal heart of the application, each claim must be written as a single sentence to, in the words of the patent statute, "particularly point out and distinctly claim the subject matter which the applicant regards as his invention. Counsel will ensure that the language of the claims is legally sound, but the inventor must provide the information on which the claims are to be made.
Oath of Declaration - Prepared for signature by counsel, this is a sworn statement by the inventor that to the best of his or her knowledge, he or she is the first and true inventor, is not aware of any bar to patentability, and is aware of his or her duty to disclose any information which is relevant to the determination of patentability of the Patent Office.

Commercial Agreements
In addition to working with faculty to protect all proprietary rights to inventions evolving from their research projects, the Office of Technology and Business Development promotes the commercial applications of such projects and assists faculty to generate research support from the industrial and investment community. The following questions will briefly touch on ways that the Office of Technology and Business Development serves these functions:

What is a commercial agreement?
Commercial agreements ensure the development and commercialization of technologies by licensing such technologies to companies in return for royalties and/or funding for continued research in the field of the invention. The Office of Technology and Business Development will work with faculty to attract corporate sponsors for their research and to identify companies that can bring their ideas to the marketplace. The Office will negotiate and conclude commercial agreements with such corporate sponsors or companies.

What are the guidelines for a commercial agreement?
In negotiating agreements, we strive to ensure that the needs and interests of our faculty, the University, and the corporate sponsor are met. We are particularly concerned that no agreement limit the right of faculty to publish or present the results of research. The aim is to negotiate and conclude an agreement under which a research project is supported and the technology developed and commercialized. Although the terms of individual agreements may vary, there are several provisions designed to reflect the major concerns of all involved. These include:

• freedom from interference in the conduct of the research;
• no limitation on publications or the right to publish;
• support for the ongoing research project;
• obtaining a royalty-bearing license to practice the invention and/or the results of the research.

Other Considerations
How should the transfer of proprietary materials be handled? [back]
Biological materials (probes, clones, antibodies, cell lines, viruses, proteins, plasmids) are considered to be proprietary. In order to protect both faculty publication rights and the University's patent rights, the sharing and transmittal of such materials should be governed by agreement. Faculty who intend to transfer or receive materials are urged to consult with the Office of Technology and Business Development, which has sample agreements on file. Every effort will be made to negotiate material transfer agreements promptly so that research work can proceed without delay.

How can the Office of Technology and Business Development help with consulting agreements?[back]
Although it is not a requirement that the Office of Technology and Business Development handle consulting agreements-most faculty negotiate and conclude these arrangements themselves-the Office is available to offer guidance in this complex area. It is also advisable to retain a lawyer before entering into a consulting agreement with a company. If desired, the Office can review any consulting agreement before it is signed. Because consulting agreements are often fraught with difficulties, the following suggestions may be of help.

Avoiding the Pitfalls of Consulting Agreements

• Avoid working with different companies on the same subject matter.
• Ensure the freedom to consult with more than one company on different subject matters.
• Ensure that the area of consulting and scope of work are well defined.
• Ensure freedom to publish.

Inform the company that rights belonging to the University cannot be transferred; in case of conflict, University policy prevails. Because of the complexity of this issue, it is strongly advised that the Office of Technology and Business Development review the matter.

• Do not consult on University premises.
  
• Negotiate in advance the ownership of inventions that may result from the performance of the consulting agreement.
  
• Ensure adequate provisions for the termination of the consulting agreement.