1. HARVARD UNIVERSITY Office of Technology Development
Introduction to Technology Transfer and Intellectual Property Responsible Conduct of Research Harvard School of Public Health September 19th, Jen Rice, Ph.D. Business Development Associate Office of Technology Development

2. Agenda What is technology transfer? The Bayh-Dole Act
Technology Transfer at Harvard
What is Intellectual Property (IP)?
Patents
Introduction to Patents
What is patentable?
The Patenting Process
HARVARD UNIVERSITY Office of Technology Development

3. What is technology transfer?

4. The Bayh-Dole Act (1980) In the 1970s…
$75 billion spent (per year) in government sponsored R&D
Federal government held approximately 28,000 patents
Fewer than 5% of those were licensed to industry for development/commercial products
Companies did not have exclusive rights and therefore were reluctant to invest and as a result, taxpayers were not maximally benefiting from their contributions
Bayh-Dole permitted universities and small businesses to elect ownership of inventions made under federal funding and to be come directly involved in the commercialization process
HARVARD UNIVERSITY Office of Technology Development

5. Technology Transfer
The process of transferring scientific findings from one organization to another for the purpose of further development and commercialization
Why do universities have technology transfer offices (TTOs)?
Recognition to the University
Compliance with federal regulations
Attraction and retention of talented faculty and students
Local economic development
Attraction of corporate research support
Licensing revenue to support further research and commercialization
HARVARD UNIVERSITY Office of Technology Development

6. Technology Transfer at Harvard
Faculty exposure to industry interests & practices
CDAs & MTAs
FACULTY
Business Development Team
INDUSTRY
Invention Disclosures
& Meetings
Areas of Interest & Project Feedback
PROTECT IP
CDAs & MTAs
Industry exposure to faculty and PIs
Business Development Team
Faculty Integration
Understand active programs in the lab
Industry Outreach
Network with industry to determine on areas of interest
IP Protection
Confidential Disclosure Agreement (CDA) to allow free discussion of opportunity
Marketing
Actively market opportunities (faculty projects)
Background IP, capability, concept
Face to face meetings w/PI to discuss potential partnership
Market Opportunity
HARVARD UNIVERSITY Office of Technology Development

7. Technology Transfer at Harvard
LICENSES
STAND ALONE ISRAS
STRATEGIC ALLIANCES
ACCELERATORS
COMPANY
COMPANY
COMPANY
OTD
OTD
OTD
OTD
Stand Alone Industry Sponsored Research Agreement (ISRA): one off agreement negotiated for a specific project for a Harvard PI
Alliance Agreement: OTD has negotiated a master agreement between Harvard and industry sponsor
Blavatnik Biomedical and Physical Science/Engineering Accelerators: internal OTD program for Harvard innovators to fund the development of a more partner-ready end product PI PI PI PI PI PI
HARVARD UNIVERSITY Office of Technology Development

8. Intellectual Property (IP)

9. Intellectual Property (IP)
Refers to creations of the mind
Inventions
Literary and artistic works
Symbols, names, images, and designs
Used in commerce
Intellectual property is protected by
Patents
Copyrights ©
Trademarks ® TM
Trade Secrets
HARVARD UNIVERSITY Office of Technology Development

10. Patents

11. What rights does a patent provide?
The U.S. Constitution states the congress shall have the power… To promote the Progress of Science and useful Arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.
A patent provides exclusionary rights
The right to exclude others from making, using, selling, or importing the patented invention for a limited time (limited monopoly)
The rights are granted in exchange for full disclosure of the details of the invention
The rights are NOT affirmative
Term is 20 years from the filing date
HARVARD UNIVERSITY Office of Technology Development

12. What rights does a patent provide?
Drug Delivery Technology
HARVARD UNIVERSITY Office of Technology Development

13. Parts of a Patent HARVARD UNIVERSITY Office of Technology Development
Specification
Claims
Specification – Provides written support for the claims (must be sufficient to enable a skilled worker to make and use)
Claims – Defines the scope of the exclusionary right
HARVARD UNIVERSITY Office of Technology Development

14. Breadth of Claims HARVARD UNIVERSITY Office of Technology Development
Broad
Narrow
Claim 1
Claim 4
Claim 5
HARVARD UNIVERSITY Office of Technology Development

15. What is patentable?

16. Patentable Subject Matter
“Congress intended statutory subject matter to include anything under the sun that is made by man.” U.S. Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 (1980)
HARVARD UNIVERSITY Office of Technology Development

17. Types of Patents Utility Patent (functional)
Legal Categories
Utility Patent (functional)
Any new and useful process, machine, manufacture, or composition of matter (or any new and useful improvements thereof)
One invention can be protected through multiple legal categories e.g. a chemical invention
Compound
Pharmaceutical formulation
Design Patent (ornamental)
Any new, original, and ornamental design for an article of manufacture
Plant Patent
Any new and distinct, invented or discovered asexually reproduced plants
Method of making the compound
Method of using the compound
Composition of Matter
Process
HARVARD UNIVERSITY Office of Technology Development

18. Patentability Hurdles
Disclosure /Enablement
(35 USC 112)
Non Obviousness
(35 USC 103)
Novelty
(35 USC 102)
Utility
(35 USC 101)
HARVARD UNIVERSITY Office of Technology Development

19. Unpatentable Subject Matter
Laws of Nature
Physical phenomena
Abstract ideas
Inventions solely used in atomic weapons
Information in the public domain*
HARVARD UNIVERSITY Office of Technology Development

20. Patentability Hurdles and Prior Art
Prior art – Knowledge or information existing (and publicly available at the time of invention)
Claims may not cover what is found in the prior art
Prior art includes…
Presentations
Publications
Databases in public domain
Website content (including tweets, videos, etc.)
Theses
Patents
Sales/Offers for sale
Public Disclosures
HARVARD UNIVERSITY Office of Technology Development

21. Patentable = Marketable
No market / No one wants to buy this
HARVARD UNIVERSITY Office of Technology Development

22. Marketable = Enforceable
Even if demand/useful, not necessarily enforceable
1. An animal toy, comprising: (a) a solid main section having a diameter and a longitudinal length and extending a predetermined distance along said longitudinal length; and (b) at least one protrusion attached at one end thereof said main section and extending a predetermined distance therefrom and wherein said at least one protrusion includes a second longitudinal axis that is not in parallel alignment with a first longitudinal axis of said solid main section; and wherein said animal toy is adapted to float on the water.
HARVARD UNIVERSITY Office of Technology Development

23. Harvard University Revenue Sharing*
IP – Who owns what?
Inventors are owners unless there is a contractual arrangement
In the U.S., each joint patent owner has a right to license without accounting to the other (unless there is a contract)
If created under University employment…
University-owned
University shares $$$
Traditional academic works (©) usually not University-owned
Manuscripts
PowerPoint slides
Lecture notes
Other considerations
Sponsored Research
Usage of University equipment and facilities
Harvard University Revenue Sharing*
35%
20%
15%
Research
University
School
Dept.
15%
15%
Inventors
*less 15% administrative fee
Personal
HARVARD UNIVERSITY Office of Technology Development

24. Inventors vs. Authors Authorship is NOT the same as inventorship
You are an inventor if…
You made a creative contribution
You solved a non-routine problem
You have contributed to at least one claim
Inventorship is defined by U.S. patent law
You may NOT be an inventor if…
You contributed routine skills
You provided mere consultation
Order of inventors on a patent carries no legal weight
HARVARD UNIVERSITY Office of Technology Development

25. The Patenting Process

26. The Patenting Process at OTD
Once Report of Invention (ROI) filed, OTD will work with inventor to asses
Patentability (including enablement, prior art, public disclosures)
Market and commercial potential
Ability to license (to existing company or start up)
Ability to detect infringement and/or enforce patent
Typically filling path…
Provisional Patent Application
PCT Patent Application
Publication of PCT
US Utility Application?
Europe? Japan? Others?
T=0
12 months
18 months
30 months
Examination Begins
months
till claims
issue
HARVARD UNIVERSITY Office of Technology Development

27. Thanks! Jen Rice, Ph.D. jennifer_rice@harvard.edu