harvard university office of technology development responsible conduct of research harvard school...

HARVARD UNIVERSITY

Office of Technology Development

Responsible Conduct of Research Harvard School of Public Health

Intellectual Property

February 7th, 2014

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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?

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What is Intellectual Property?Creations of the mind subject to legal protectionPatents, 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• Also: unpublished data & results, materials, protocols

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• 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.

What is a patent?

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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

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Academic IP: Bayh-Dole ActPatent & Trademark Law Amendments Act (1980) Co-sponsored by Senators Birch Bayh & Robert DoleCongress’s objectives:

– promote dissemination and commercial development of inventions arising from government-funded research

– foster collaboration between universities and industryMajor 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

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• 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.

Why have a patent system?

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• 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 135-175 mg/m2 taxol over a period of about three hours.

Taxol annual sales for BMS peaked in 2000 at $1.6B

An interesting example

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• 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.

Statutory requirements for a patent

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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.

Anyone can obtain a patent

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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 16 2013, 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

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Harvard IP Policy - Overview

http://otd.harvard.edu/resources/policies/IP/ 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:

http://otd.harvard.edu/resources/agreements/participation/

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http://otd.harvard.edu/resources/policies/IP/






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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

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Report of Invention (ROI)

http://otd.harvard.edu/faculty/ 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 emailed confirmation, it

will be assigned a case number at OTD, and someone from OTD will follow up with you

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http://otd.harvard.edu/faculty/


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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

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Can’t enforce pending patent application – only an issued patent

Provisional Patent

Application

PCT Patent Application

Publication of PCT

US Utility Application?

Europe? Japan? Others?

T=0 30 months

Examinationbegins

12 months 18 months

Typical Filing Path at a University

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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: http

://otd.harvard.edu/faculty/

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

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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 Publication rights Sponsored Programs Office (SPA, OSP) or other offices (e.g.

OER) will consult with OTD to ensure protection of investigator’s IP rights

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Harvard OTD: Where is It?

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• Cambridge– Smith Center, Suite 727E– 617-495-3067

• Harvard Medical School– Gordon Hall, Suite 414– 617-432-0920

• www.otd.harvard.edu• Harvard affiliated hospitals have separate offices

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OTD Mission

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OTD Society

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Office of Technology Development22

• Expose industry and investors to Harvard research and PIs

• Market and commercialize specific technologies

• Attract industry to collaborate and fund research

• Expose faculty to industry and investor interests/practices

Industry Outreach

OTD

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OTD Organizational Structure

Intellectual Property

Staff: 8

Alliance Management

Staff: 3

Technology Transactions

Staff: 7

Finance & Administration

Staff: 9

Business Development

Staff: 15

Accelerator FundStaff: 3

Life SciencesPhysical Sciences

Chief Technology Development Officer

Total staff: 45

FacultyVCs/

Industry

FASHMS

HSPHHSDMWyss

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• Protect IP and market to industry

• License to established organizations

• Execute Industry Sponsored Research

Agreements & Strategic Alliances

• Create start-ups

Business Development: Key Activities

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License to Established Organizations

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Execute ISRAs & Strategic Alliances

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Create Start-ups

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• 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

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When Do You Contact OTD?

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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

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Harvard UniversityOffice of Technology Development

Grant Zimmermann, PhDDirector of Business Development

[email protected]

Office of Technology DevelopmentGordon Hall, Suite 414

Tel: 617.432.8231otd.harvard.edu

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Additional Slides

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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

32 www.autm.netNature Methods (2011) 8(10):1728

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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

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