1. Responsible Conduct of Research
Harvard School of Public Health
Intellectual Property
February 7th, 2014

2. Topics for Today Concept of Intellectual Property (IP)
Harvard’s IP Policy
Patents and patent applications
IP in academic setting
Harvard’s Office of Technology Development
What is it?
How do you find us?
When do you contact us?

3. What is Intellectual Property?
Creations of the mind subject to legal protection
Patents, copyrights, trademarks & trade secrets
Patents confer right to exclude others from making, using, selling or importing the invention
Copyrights protect expression or presentation of ideas but not the ideas themselves
Trademarks identify and distinguish goods/services of one commercial provider from those of others; e.g. logo, brand name, tagline
Trade secrets are any valuable commercial information that is not made public & that can be used for competitive advantage; no formal registration process
Also: unpublished data & results, materials, protocols

4. What is a patent?
A form of monopoly granted by the federal government.
Means for converting intangible assets (e.g., research results) into a property right.
Property rights which may be assigned, licensed, and given as security.
Patentees have the exclusive right to prevent others from practicing the patented invention and/or to obtain damages from infringers.

5. Academic IP: Before 1980
Federal agency that funded research had principal authority over patenting decision
No unified federal patent policy across agencies
Patchwork of waivers and agreements between some universities and government agencies
Federal government owned rights to thousands of patents but would not grant exclusive licenses
Lack of clear ownership & rights to commercialize was disincentive for technology development

6. Academic IP: Bayh-Dole Act
Patent & Trademark Law Amendments Act (1980)
Co-sponsored by Senators Birch Bayh & Robert Dole
Congress’s objectives:
promote dissemination and commercial development of inventions arising from government-funded research
foster collaboration between universities and industry
Major provisions:
Universities can own inventions resulting from federally-funded research
Universities encouraged to partner with industry
Universities expected to file patent applications and license them to companies
Royalties to be shared with inventors and to be used to fund research/education

7. Why have a patent system?
Why give monopolies which can potentially be used to keep the general public from using useful technologies?
Reward inventors and encourage innovation.
Encourage investments in research and development.
Establish a body of technical literature.

8. An interesting example
A method for reducing hematologic toxicity in a cancer patient undergoing taxol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about mg/m2 taxol over a period of about three hours.
Taxol annual sales for BMS peaked in 2000 at $1.6B

10. Statutory requirements for a patent
Utility—An invention must be useful.
Novelty—An invention must be new.
Non-obvious—An invention cannot be suggested by the “prior art.”
Enablement—An invention must be fully disclosed in the patent application (“how to make” and “how to use”).
Written description—the specification must describe invention in a manner demonstrating “possession” of the invention.

11. Anyone can obtain a patent
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.

13. Patent Overview Does not grant an affirmative right to do anything
Dominating patent owned by another party?
Right to exclude others from making, using, selling, offering for sale, or importing the patented invention for the term of the patent (now 20 years from the application filing date)
OTD mostly concerned with “Utility” patent applications
Patentable subject matter
Compositions of matter, manufacturing processes, chemical synthesis routes, methods of treating, devices, algorithms
March , US changed from “first to invent” system to a “first inventor to file” system
1-year US grace period concept weakened
Want to file early and BEFORE public disclosure

14. Harvard IP Policy - Overview
Covers ownership of patents, copyrights, software, and unpatented materials
In general, Harvard has ownership of patentable inventions, software, and unpatented tangible materials made with funds provided by or administered by Harvard, or made with non-incidental use of Harvard’s resources
In most cases, authors have ownership of copyrights in books, films, works of art, musical works, etc.
Copyright in software handled more like patentable inventions
Obligation to report inventions to OTD
Must sign Participation Agreement:

15. Harvard IP Policy – Royalty Sharing
Sharing of net royalties on inventions reported after 10/04/2011
Administrative fee – 15%
Of the remainder:
Creator personal share – 35%
Creator research share – 15%
Creator Department/Center share – 15% *
Creator School share – 20%
President’s share – 15%
* If within FAS, or if no Department or Center, to be allocated by Dean of the Creator's School for research purposes

16. Report of Invention (ROI)
Click on “Report of Invention Form”
Information on Contributors
Funding sources
3rd party materials or code
Public disclosures (posters, presentations, publications)
Upload detailed description or draft manuscript
Once submitted, you will receive a ed confirmation, it will be assigned a case number at OTD, and someone from OTD will follow up with you

17. Patent Application Process
Once ROI filed, OTD will work with inventor to:
Assess patentability -- subject matter, prior art, public disclosures
Assess commercial potential
Assess ability to license – existing company, start-up
Assess ability to detect infringement and/or enforce patent
Provisional Patent Application
PCT Patent Application
Publication of PCT
US Utility Application?
Europe? Japan? Others?
T=0
30 months
Examination begins
12 months
18 months
Typical Filing Path at a University
Can’t enforce pending patent application – only an issued patent

18. Agreements with IP Provisions (1)
Material Transfer Agreements (MTAs) (1,873 in FY13)
Ownership of IP resulting from use of material
Provider’s rights to review manuscript before publication
Ownership of derivatives and modifications of material
Submit MTAs to OTD for processing online:
click “incoming” or “outgoing”
Confidential Disclosure Agreements (CDAs)
Common when exchanging confidential information with a company
unpublished data, results, methods, inventions
Contact OTD whenever a CDA might be required or has been sent to you

19. Agreements with IP Provisions (2)
Industry Collaborations or Sponsored Research Agreements
Confidentiality
Publication rights
Material sharing and ownership
Rights in results and IP
Foundation Grants
Royalty sharing
IP reporting obligations
Sponsored Programs Office (SPA, OSP) or other offices (e.g. OER) will consult with OTD to ensure protection of investigator’s IP rights

20. Harvard OTD: Where is It?
Cambridge
Smith Center, Suite 727E
Harvard Medical School
Gordon Hall, Suite 414
Harvard affiliated hospitals have separate offices

21. OTD Mission
Society
OTD

22. Industry Outreach
• Expose industry and investors to Harvard research and PIs
• Market and commercialize specific technologies
OTD
• Attract industry to collaborate and fund research
• Expose faculty to industry and investor interests/practices

23. OTD Organizational Structure
Chief Technology Development Officer
Business Development
Staff: 15
Accelerator Fund
Staff: 3
Life Sciences
Physical Sciences
FAS
HMS
HSPH
HSDM
Wyss
VCs/ Industry
Faculty
Technology Transactions
Staff: 7
Finance & Administration
Staff: 9
Intellectual Property
Staff: 8
Alliance Management
Staff: 3
Total staff: 45

24. Business Development: Key Activities
Protect IP and market to industry
License to established organizations
Execute Industry Sponsored Research Agreements & Strategic Alliances
Create start-ups 24

25. License to Established Organizations

26. Execute ISRAs & Strategic Alliances

27. Create Start-ups

28. When Do You Contact OTD? You feel you have a new invention
Assays, methods, instruments
Compositions of matter
Algorithms, software, databases
New and useful improvements of the above
Please report potential inventions to OTD, and certainly before:
Submitting an abstract
Presenting a poster
Giving a talk
Publishing a paper
Sharing information about the work with a third party on a non-confidential basis

29. When Do You Contact OTD? Company wants to speak with you
Company requests confidentiality agreement
Institution/Company requests transferable material
You want material from Institution/Company
You seek non-federal funds
You are unsure about need to contact OTD

30. Harvard University Office of Technology Development
Grant Zimmermann, PhD Director of Business Development
Office of Technology Development Gordon Hall, Suite 414 Tel: otd.harvard.edu

31. Additional Slides

32. Academic IP: Bayh-Dole Effect
In 1980
Government held title to 28,000 patents
Fewer than 5% licensed for commercialization
Universities held ~500 patents
By 2005
US university tech transfer programs increased 8X
Over 8,000 patent filings
Universities held ~3,300 patents
Thousands of university-licensed products & new US companies from federally funded research
Nature Methods (2011) 8(10):1728

33. University IP Success Stories
University of California: recombinant DNA technologies that launched biotech industry
Stanford: Google
NYU: therapy for rheumatoid arthritis (Remicade)
MGH: therapies for rheumatoid arthritis (Enbrel) and age-related macular degeneration (Visudyne)
Harvard/MIT: Cardiolite cardiovascular SPECT imaging agent
MIT: one of the largest internet content delivery networks (Akamai)
Yale: Stavudine anti-retroviral treatment for HIV/AIDS
Florida State University: synthetic method for paclitaxel