Presentation on theme: "Responsible Conduct of Research"— Presentation transcript:
1 Responsible Conduct of Research Harvard School of Public HealthIntellectual PropertyFebruary 7th, 2014
2 Topics for Today Concept of Intellectual Property (IP) Harvard’s IP PolicyPatents and patent applicationsIP in academic settingHarvard’s Office of Technology DevelopmentWhat is it?How do you find us?When do you contact us?
3 What is Intellectual Property? Creations of the mind subject to legal protectionPatents, copyrights, trademarks & trade secretsPatents confer right to exclude others from making, using, selling or importing the inventionCopyrights protect expression or presentation of ideas but not the ideas themselvesTrademarks identify and distinguish goods/services of one commercial provider from those of others; e.g. logo, brand name, taglineTrade secrets are any valuable commercial information that is not made public & that can be used for competitive advantage; no formal registration processAlso: unpublished data & results, materials, protocols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 1980Federal agency that funded research had principal authority over patenting decisionNo unified federal patent policy across agenciesPatchwork of waivers and agreements between some universities and government agenciesFederal government owned rights to thousands of patents but would not grant exclusive licensesLack 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 DoleCongress’s objectives:promote dissemination and commercial development of inventions arising from government-funded researchfoster collaboration between universities and industryMajor provisions:Universities can own inventions resulting from federally-funded researchUniversities encouraged to partner with industryUniversities expected to file patent applications and license them to companiesRoyalties 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 applicationsPatentable subject matterCompositions of matter, manufacturing processes, chemical synthesis routes, methods of treating, devices, algorithmsMarch , US changed from “first to invent” system to a “first inventor to file” system1-year US grace period concept weakenedWant to file early and BEFORE public disclosure
14 Harvard IP Policy - Overview Covers ownership of patents, copyrights, software, and unpatented materialsIn 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 resourcesIn most cases, authors have ownership of copyrights in books, films, works of art, musical works, etc.Copyright in software handled more like patentable inventionsObligation to report inventions to OTDMust sign Participation Agreement:
15 Harvard IP Policy – Royalty Sharing Sharing of net royalties on inventions reported after 10/04/2011Administrative 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 ContributorsFunding sources3rd party materials or codePublic disclosures (posters, presentations, publications)Upload detailed description or draft manuscriptOnce 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 disclosuresAssess commercial potentialAssess ability to license – existing company, start-upAssess ability to detect infringement and/or enforce patentProvisional Patent ApplicationPCT Patent ApplicationPublication of PCTUS Utility Application?Europe? Japan? Others?T=030 monthsExamination begins12 months18 monthsTypical Filing Path at a UniversityCan’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 materialProvider’s rights to review manuscript before publicationOwnership of derivatives and modifications of materialSubmit MTAs to OTD for processing online:click “incoming” or “outgoing”Confidential Disclosure Agreements (CDAs)Common when exchanging confidential information with a companyunpublished data, results, methods, inventionsContact OTD whenever a CDA might be required or has been sent to you
19 Agreements with IP Provisions (2) Industry Collaborations or Sponsored Research AgreementsConfidentialityPublication rightsMaterial sharing and ownershipRights in results and IPFoundation GrantsRoyalty sharingIP reporting obligationsSponsored 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? CambridgeSmith Center, Suite 727EHarvard Medical SchoolGordon Hall, Suite 414Harvard affiliated hospitals have separate offices
22 Industry Outreach• Expose industry and investors to Harvard research and PIs• Market and commercialize specific technologiesOTD• Attract industry to collaborate and fund research• Expose faculty to industry and investor interests/practices
28 When Do You Contact OTD? You feel you have a new invention Assays, methods, instrumentsCompositions of matterAlgorithms, software, databasesNew and useful improvements of the abovePlease report potential inventions to OTD, and certainly before:Submitting an abstractPresenting a posterGiving a talkPublishing a paperSharing 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 agreementInstitution/Company requests transferable materialYou want material from Institution/CompanyYou seek non-federal fundsYou are unsure about need to contact OTD
30 Harvard University Office of Technology Development Grant Zimmermann, PhD Director of Business DevelopmentOffice of Technology Development Gordon Hall, Suite 414 Tel: otd.harvard.edu
32 Academic IP: Bayh-Dole Effect In 1980Government held title to 28,000 patentsFewer than 5% licensed for commercializationUniversities held ~500 patentsBy 2005US university tech transfer programs increased 8XOver 8,000 patent filingsUniversities held ~3,300 patentsThousands of university-licensed products & new US companies from federally funded researchNature Methods (2011) 8(10):1728
33 University IP Success Stories University of California: recombinant DNA technologies that launched biotech industryStanford: GoogleNYU: therapy for rheumatoid arthritis (Remicade)MGH: therapies for rheumatoid arthritis (Enbrel) and age-related macular degeneration (Visudyne)Harvard/MIT: Cardiolite cardiovascular SPECT imaging agentMIT: one of the largest internet content delivery networks (Akamai)Yale: Stavudine anti-retroviral treatment for HIV/AIDSFlorida State University: synthetic method for paclitaxel