Working Effectively with Your TTO: Technology Evaluation Process and IP Protection

(Kathleen A. Denis, Rockefeller University)

Traditional mechanisms for technology transfer from academia include: graduate student and postdoctoral fellow training, publications and presentations, faculty consulting, sharing of materials, and industry-funded research.

A TTO promotes and supports the research enterprise at the University by creating relationships with the private sector to develop, protect, transfer and commercialize research results for the public benefit. Goals of a TTO:

  • To commercialize research for public good
  • To reward, retain, and recruit faculty
  • To induce closer ties to industry
  • To promote economic growth
  • To generate income for research and education

Bayh-Dole Act of 1980 – The title to inventions made with federal funding by small businesses and universities/non-profits belongs to the grantee, not to the government.

  • University obligations under the Bayh-Doyle Act:
    • Must file patents on inventions they elect to own and report on their utilization
    • Preference for small business licenses
    • Licensed products are required to be manufactured in the U.S. (if to be sold in the U.S.)
    • Royalties must be shared with inventor, with the remainder reinvested in research
    • Government retains non-exclusive right

Intellectual property – Enables further development of research results by a commercial partner, which generally requires some exclusivity prior to the investment.

  • An inventor/author is granted the exclusive right to the discovery or writing for a limited period of time. In return, the inventor/author discloses the work and adds to the base of knowledge.
  • Types of IP:
    • Patent
    • Copyrights
    • Trademarks
    • Tangible materials
    • Know how
    • Trade secrets (usually not applicable for academic institutions)

The tech transfer process starts with the disclosure of a research discovery to the TTO, moving on to an assessment of commercial opportunity and protectability before IP protection is filed (see FIG. 1).

  • Keep in mind that good science does not equate to good business.

Patent – legal and scientific document that provides a “negative right”

  • When a patent is issued, the right granted is that to exclude others from using the patented matter. This right is earned by teaching the public how to practice the invention. The patent right is granted by the federal government to an inventor to exclude others from making, using or selling an invention.
  • Patent term is 20 years from the date of the filing; most patents in the U.S. (excluding biotech) take 2-3 years from filing to issuance. Biotech patents can take much longer (5+ years).
  • A patent must be filed in each country in which you seek patent protection. This step can be delayed by filing of an international application (PCT). Laws differ by jurisdiction as to what is patentable
  • Patentable inventions
    • 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…” (Article I, Section 8, Clause 1)
    • Examples:
      • New compounds
      • New uses for known compounds
      • Mechanical devices and instrumentation
      • Chemical processes
      • Methods for making and using genetically engineered products
      • Plants
  • Contents of a Patent:
    • Background – history of the art, the problems that the inventor set out to solve, descriptions of other inventions and work of others to solve similar problems
    • Summary – advantages of the invention, detailed technical description of the invention.
    • Claims – define the inventor’s rights, describe each element of novelty, utility and non-obviousness; the only legally enforceable part of a patent
  • Timing is very important. After the first filing (including provisional application):
    • 12 months until first international filing (PCT)
    • 18 months until publication of the application
    • 30 months until national phase filings (individual applications in every country where patent protection is desired) – extremely expensive process, academic institutions generally will not do this without a licensee
  • Cost:
    • A provisional patent filing can cost 10-20K
    • An international filing can cost approximately 100K

Elements of Patentability

  • Novel – Not known, used, described, published, in public use or offered for sale.
    • Prior art – Publication or other means of public disclosure by the inventor can constitute prior art.
    • Public disclosure – Any non-confidential communication of an invention, including a formal speech, informal talk, abstract, paper, article or book, to anyone in enough detail that someone “skilled in the art” could practice the invention, or such that the true invention is now obvious.
    • In the U.S., there is a 1 year grace period after public disclosure to file a patent; however, patent rights are lost internationally. Confidentiality agreements can be used to prevent disclosure (e.g. talk invited by a company).
  • Useful - provides a function
    • Process (e.g. methods of diagnosis and treatment)
    • Composition of matter (e.g. genes, proteins, small molecules, chemical compounds)
    • Method of manufacture
    • Machine
  • Non-obvious – Differences in invention and prior art must be non-obvious to one “skilled in the art”
    • Can combine all known publications
    • This factor is one of the more common rejection reasons (especially in biotechnology).
  • Enabled – Can be well described and taught
    • Must be able to describe in writing exactly how the end product would be used.
    • Need to demonstrate possession of the claimed invention
    • TTO can sometimes file a provisional patent that provides 1 year to gather enough additional information for patent enablement

Importance of patent protectability

  • TTOs will file patents that cover useful commercial products in which there is commercial interest.
  • Patent law and recent court interpretations have left little room to reasonably protect:
    • Novel targets for drug discovery (can be patented but very difficult to protect)
    • Screening assays for new drugs (hard to enforce)
    • Mechanisms of action/biological pathways
  • Reasons to not file a patent are usually related to the inability to adequately define and protect the future products and a lack of current commercial interest and market demand.

Licensing agreements to a commercial partners

  • IP can be assigned (sold) or licensed (rented). Under the Bayh-Dole Act, academic institutions can only license. Options (“test-drive”) are becoming increasingly common as industry is becoming more cautious.

Communication is key – inventor input is very important for many parts of the process:

  • To define the invention
  • To suggest potential applications
  • To help draft and prosecute patent applications
  • To identify potential licensees
  • To “market” the invention
  • To help evaluate potential licensees
  • To work with companies on proof-of-concept and commercial applications
  • Inventors are not involved in: final decision on patent filings, negotiation of licenses and financial terms, and license administration.

Academic faculty should know:

  • Policies on IP and conflict of interest at the institution
  • Royalty-sharing program (usually ~30% goes to the lab’s research funding)
  • How to report an invention
  • Impact of publishing on patent rights
  • How the tech transfer process works
  • Difference between scientific and commercial significance
  • Realistic licensing goals
  • How the commercialization process works

Incentives for inventors:

  • Royalty sharing (personal income, research funding)
  • Access to sponsored research
  • Consulting arrangements, including scientific advisory boards
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