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Responsible Conduct of Research

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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information that is not made public & that can be used for competitive advantage; no formal registration process Also: unpublished data & results, materials, protocols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:

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

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