Intellectual Property March 4, 2015 Don Keach Director, Intellectual Property Development and Technology Transfer Office Copyright University of Kentucky 2015

Patent Decision Process IPD-TTOPursue Provisional Application Drop Utility Application Patentability Assessment Drop Utility Application Drop

Patentability Opinion A patentability opinion is a summary and discussion of the prior art that might affect the patentability of a disclosure. The patentability opinion provides the patent attorney’s opinion as to whether patent coverage would be available and, if available, the likely scope of that coverage.

Patents A patent is a constitutionally authorized grant of ownership made by the federal government to inventors conveying and securing to them the exclusive right to exclude others from making, using and selling an invention for a period of 20 years from the application filing date. The Congress shall have power…to promote the progress of science and useful arts, by securing for limited times to…inventors the exclusive right to their discoveries. U.S. Const., Art. 1, Sec. 8

Patentability Criteria In order to be patentable a discovery must meet three criteria: – It must be useful Lacking - New compound with no real world purpose Sufficient - New compound with therapeutic activity in cultured cells – It must be novel Not patentable if each and every element of the invention previously known – It must be non-obvious Not patentable if, considering the prior art that existed at the time of invention, the invention would have been obvious to a person of ordinary skill in the art All elements found in a combination of prior art references and a reason to modify/combine to obtain the claimed invention

Disclosure Requirement Written Description – Sufficient description to inform a skilled artisan that the applicant was in possession of the claimed invention as a whole at the time the application was filed – Example - Discovery of a new target in a biochemical pathway; contemplate method for treating disease by inhibiting activity; no example of inhibitors Enablement – Sufficient description to inform a skilled artisan how to make and use the claimed invention without undue experimentation – Example - Discovery of a compound having anti-cancer activity for one type of cancer; contemplate class of compounds for treating cancer

Patent Eligible Subject Matter Not Patent EligiblePatent Eligible Product of Nature Isolated Genes (naturally occurring sequence) Artificial/Enhanced Product cDNA Methods involving principle, without adding significantly more (correlation between biomarker & outcome; certain diagnostic methods) Certain diagnostic methods making use of novel regents, novel methods, and/or adding something significantly more to natural principle Abstract Ideas Algorithms Certain Business Methods Software?

Preserving Patent Rights What actions can limit or destroy the ability to obtain patent protection? – Public Use – Public Sale – Publication – Offer for Sale

Publication = Publically Accessible Has the information been made “Publically Accessible”? Factors: – Length of time the information was exhibited, – Expertise of the target audience, – Existence of reasonable expectation that the information would not be copied, and – Simplicity or ease with which the information displayed could have been copied.

Examples of Publications Journal articles Grants or studies made publicly available Dissertation catalogued in a university library Public dissertation defense Poster presentation Oral presentation Pretty much anything put on the internet except where password protected

Provisional Patent Applications Provides a priority date Must be converted to a utility application within one year or the priority date is lost Does not require claims

Developments in Patent Law America Invents Act – Change from “First to Invent” to “First to File” – Changes to inventor’s own publication “exception” One year grace period may be affected – Technical changes to reexamination rules Ex parte reexamination Inter Parties Review Post Grant review

Commercialization I A major purpose of university tech transfer is to make the results of research available for the public good. In order to fulfill that mandate universities have to work with commercial partners.

Commercialization II Intellectual Property Development and Technology Transfer, like other university tech transfer offices, relies heavily on the inventors to identify potential commercial partners. This is in large part because the inventors are publishing, attending conferences and networking with colleagues, all activities that can lead to contact with interested potential partners.

What is in it for Inventors? After patent expenses are recouped the royalties are distributed as follows: – 40% divided among the inventors – 20% to the inventor’s department(s) – 20% to the inventor’s college(s) – 20% to the university

MTAs & CDAs Material Transfer Agreement – Use when sending or receiving research materials Confidential Disclosure Agreement – Use when confidential/proprietary information will be shared with or by another party (university, company, individual, etc.) – a.k.a. nondisclosure agreement and secrecy agreement

MTAs and CDAs Forward to the IPD-TTO for review and approval – Contact Natasha Jones, ASTeCC A140 ph Authorized signatory:IPD-TTO Director Not faculty, staff or students