Technology Commercialization Workflow

Technology Commercialization Workflow

Commercializing a technology requires a series of coordinated steps, each unique in terms of required due diligence. Together, it keeps the cycle of innovation and commercilization running. Click on each of these steps below to learn more about them.

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What is an Invention?

An invention is a newly established device, method, composition, or process. An invention is patentable if it is novel, not obvious, and useful.

Contact the OBBD at the earliest stages of development for guidance on all phases of the process.

Disclose an Invention

What is an Invention Disclosure?

An Invention Disclosure is used to describe a newly developed technology. The process of technology commercialization formally begins with the submission of a written new Invention Disclosure Form, or IDF for short. The new Invention Disclosure paperwork is strictly confidential and should fully document the invention so that all options for commercialization can be evaluated. An explanation of the IDF and its intended uses can be found in the presentation Disclosing the Unexpected: The Invention Disclosure Process.

Why should I submit an Invention Disclosure?

Most inventions in academia are in their early stages of development. The protection offered by intellectual property rights is often an incentive for investors to have confidence in funding the development of the invention. Disclosing an invention is the very first step in the process leading up to obtaining an intellectual property right. In fact, inventions resulting from federally funded research must be disclosed under federal law. See the Bayh Dole Act at 37 C.F.R. 401 et seq. Importantly, the Einstein Official Policy on Intellectual Property and Licensing Agreements dictates that an Einstein Inventor has the “obligation to file an invention disclosure statement with Einstein”. Such Policy also provides for each employee of Einstein to be compensated for his or her inventive contribution through royalty sharing.

Einstein’s background on Invention Disclosure

Albert Einstein College of Medicine has an Official Policy on Intellectual Property and Licensing Agreements (established on December 3, 1985, and revised on April 18, 2007, transitioned on August 3, 2015 and revised on July 18, 2018), as required by federal law of all institutions where individuals are applying for federal funding. Einstein encourages and supports research relating to the advancement of medical knowledge and the publication and the use of the results of such research, and it also recognizes that research conducted by its faculty, technical staff and students may lead to inventions and discoveries that may be patentable and commercially applicable.

In order to comply with federal and campus policies, all individuals applying for sponsored research must sign an Intellectual Property Assignment Agreement. This document verifies that each individual has read and agrees to abide by Einstein’s Official Policy on Intellectual Property and Licensing Agreements (Patent Policy), including promptly disclosing and assigning all related rights in any resulting inventions to Einstein.

When I should submit an Invention Disclosure?

As stated in the Official Policy on Intellectual Property and Licensing Agreements, an Einstein Inventor has the “obligation to file an invention disclosure statement with Einstein as soon as it is possible to do so simultaneously with or prior to the submission of a paper for publication disclosing the Intellectual Property. In all events, the Inventor shall disclose his or her invention to Einstein a minimum of 90 days in advance of any printed or oral public disclosure.”

The Invention Disclosure Form requests that sufficient information be provided, which serves several important purposes, such as:

  • compliance with sponsor obligations on invention reporting (i.e., the NIH and/or foundations);
  • the evaluation of your invention by management and patent counsel;
  • the assessment of the potential market value of your invention; and
  • the preparation and filing of a patent application, if that route is chosen.

Steps involved in submitting an Invention Disclosure:

The online Invention Disclosure Form can be accessed here. All Invention Disclosures must follow the directions as indicated in the Invention Disclosure Form.

An important note is that without filing a patent application in advance of a publication (journal, abstract, or pre-print server) or presentation at a conference, seminar, etc. foreign intellectual property rights have been compromised. In the United States, there is a period of one year where the author/inventor may still file a patent application to claim the intellectual property rights of the disclosed invention. Therefore, please submit your Invention Disclosure Form prior to any publication or public disclosure. Ideally, submit a disclosure prior to submission of any manuscripts or abstracts to journals or conferences. Please inform the Office of Biotechnology and Business Development if a manuscript has been accepted for publication and the date of publication, if available.

When submitting your disclosure to the Office of Biotechnology and Business Development, attach the names of three faculty members at Einstein or Montefiore who you believe can evaluate this research.

If you have any questions regarding the above, please email biotech@einsteinmed.edu or call the committee office at 718.430.3357.

Assessment of Invention

A description of the invention disclosure form, as well as the process by which technologies are evaluated, can be found in the presentation Disclosing the Unexpected: The Invention Disclosure Process.

What are the different forms of Intellectual Property or IP Rights?

Patents:
A patent is an official document granted by the U.S. (or foreign) Patent Office that grants an inventor specific rights that exclude others from making, using or selling the patentee’s invention. In practice, it is difficult to know whether someone is making or using an invention for personal use. Thus, a patent primarily protects an inventor from someone else deriving any commercial benefit from the invention in the country in which the patent is issued.

Copyrights:
Copyright protects original works of authorship (can include literary works, pictorial and graphic works, motion pictures and other audio/visual works, sound recordings, etc). from being reproduced without authorization.

Trade secrets:
Trade secrets are confidential strategies or information that give their users a competitive advantage.

Trademark:
A trademark includes any work, name, symbol, device, or combination that is used in commerce to identify and distinguish the goods of one manufacturer or seller from those manufactured or sold by others. In short, a trademark is a brand name.

How long is a patent viable?

In the United States, a patent has a life of 20 years from the date the patent application is filed. Thus, if a commercial product is developed 10 years after the patent filing date then it will be protected for only 10 years.

What is novelty?

A novel invention is one that is currently not for sale or public display. A description of the invention in a written publication or public presentation more than 12 months prior to the filing date of a patent application disqualifies the invention from being considered novel in the United States. In many foreign countries any public disclosure at any time prior to patent filing removes the novelty factor.

What is useful?

To be considered useful, an invention must perform a useful function, must actually work as described and must be of some benefit to society. If one can establish from biological data that a specific invention, such as a drug or gene therapy, has a reasonable chance of working in humans then it is not necessary to provide data from clinical trials in order to apply for a patent.

What is nonobvious?

An invention would be considered obvious if "prior art," defined as anything published or patented anywhere in the world or known or invented in the United States, is similar enough to the current invention that anyone skilled in the field, knowing this prior art, would consider the current invention obvious.

What is assignment of a patent?

Assignment of a patent is the transfer of the inventor’s rights and titles to his or her employer. In most institutions, employees are required to assign their rights to their employers. Under the Official Policy on Intellectual Property and Licensing Agreements (Patent Policy), the college assumes the costs of patenting the assigned invention and shares any net proceeds derived from the commercialization of the patent with the inventors based on the policy.

What is a Bar Date?

A Bar Date is the date beyond which a patent application can no longer be filed.  In the United States, the Bar Date would be one year after the first public disclosure of the invention.

What is the difference between inventorship and authorship?

In general, the rules for inventorship are much stricter than the normal rules used for determining co-authorship.  Typically, anyone who has any involvement in a development is listed on publications relating to that development. However, many such individuals would not be considered inventors under U.S. patent law.

Under U.S. patent law, an "invention" is broken down into two parts. The first is the "conception" of the invention, which is the mental formulation of the complete idea of the invention. The conception must be complete enough to enable anyone with ordinary skill in the pertinent art to reduce the invention to practice.

"Reduction to practice" is the second part of an invention. An invention is actually reduced to practice when it is demonstrated experimentally to operate in its intended environment. There can also be a constructive reduction to practice, which occurs when a U.S. patent application with an adequate enabling disclosure is filed on the invention. A constructive reduction to practice is considered the equivalent of an actual reduction to practice for most legal purposes.

In order to be an inventor, an individual must have made a material contribution to the conception of the invention. Simply taking part in the reduction to practice of the invention does not make an individual an inventor. However, the conception must be so complete that any person skilled in the art would be able to reduce the invention to practice using no more than routine experimentation. If more ingenuity is required to reduce the invention to practice, it is likely that the person employing such ingenuity has made a material contribution to the conception of the invention. In certain cases, the conception and reduction to practice occur simultaneously. In such cases, there was no preconceived conception and the unexpected invention was made in the course of actual experiments.

As such, it is well established that it is the conception of the claimed invention, rather than the reduction to practice, that establishes inventorship. We note, however, that a person suggesting a desired goal, but knowing of no way to achieve this goal, is not an inventor. Stating the result desired but leaving it to others to discover the means by which the desired result can be attained, does not amount to an invention.

Once a patent application is filed, the marketing team at Einstein will initiate a marketing strategy for the technology. The first step in the process is to develop a non-confidential summary of the technology, (referred to as a marketing brief) which is used in several ways. First, it is posted on the OBBD website, to allow those interested in relationships with Einstein to review what is currently available for licensing. Second, it is used in active marketing efforts when contacting companies that may have potential interest. Third, it may be displayed at industry events and relevant conferences, including but not limited to, the Biotechnology Innovation Organization (BIO) conference and AUTM meetings.

For most Einstein technologies, the marketing team of OBBD works with the inventor to establish a marketing strategy, and the case manager (who is also the licensing associate) works with the inventor to identify potential licensees. The process involves market research to identify prospective licensees, based on the nature of the technology, market space, and industry contacts. The potential licensees could be start-up companies, venture groups, biotech companies, pharma, or other entrepreneurs.

In addition, throughout the year the OBBD marketing team undertakes outreach efforts to connect to industry partners to learn about their therapeutic and other areas of interest. This outreach is crucial in understanding industry trends, building and engaging industry partners, and sharing of relevant technologies. Additionally, taking part in bio-accelerators, pitch events, and other company outreach and partnership programs are also great ways to market a technology and receive valuable feedback.

What is a License?

A licensing agreement typically involves the licensor (Einstein) granting rights to intellectual property to another party (licensee) for a defined period of time. This providesthe licensee the rights (whether exclusive or non-exclusive) needed for the commercial development of patented inventions or any other intellectual property.

The ultimate goal of the Office of Biotechnology and Business Development (Einstein’s technology transfer office) is to facilitate transfer of Einstein inventions to business and industry for it to reach the people who need it most for the betterment of mankind. Technologies are licensed with the goal to develop them further. Once commercial partners are identified, the licensing team negotiates terms for a license agreement, with such terms including the nature of the license (exclusive versus non-exclusive), diligence of product development, milestone payments, royalties, and other terms.

If the goal is to create faculty driven startup based on the technology, the licensing team and the OBBD office will provide all support.

Distribution of Income

The management and distribution of the licensing income is determined as per Einstein’s Official Policy on Intellectual Property and Licensing Agreements (Patent Policy). We strongly encourage you to go through the policy document to understand the allocation of revenue generated from licensing Einstein technologies.

What is an MTA?

A Material Transfer Agreement (MTA) is a legal contract between two entities governing the transfer of any proprietary research material from the owner of the material (Provider) to the party requesting permission to obtain and use the material for research purposes (Recipient).¬† We should always use an MTA or equivalent when sending out Einstein’s or Montefiore’s proprietary material. The process of MTA submission starts with the determination whether the research involves human-derived material (including bacterial, viral, or parasitic specimen isolated from human host). If so, the PI should always initiate a request for an MTA (either incoming or outgoing) at the Research Agreement Request Portal to allow the Office of Human Research Affairs (OHRA) to screen for IRB compliance before OBBD can process the MTA request. All other MTA requests can be submitted by directly accessing the online portal, MTA Share. Any question (including general questions regarding MTAs, may be directed to MTA@einsteinmed.edu.

Why we need an MTA?

MTAs are important because they protect the rights of both parties. They address issues such as:

  • Ownership of the original materials and modifications or derivatives made by Recipients
  • Limitations of use of the material by the Recipient and the Recipient’s liability
  • Limitations of further distribution of material and derivatives or modifications by the Recipient
  • Publication rights
  • Rights to inventions arising out of the use of materials.
Road to Technology Transfer

Road to Technology Transfer

Click on the link below for a visual cartoon of the technology transfer process.

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