The Anatomy of a Biotechnology-Related Patent Biotechnology: Technology based on biology biotechnology harnesses cellular and/or biomolecular processes to develop technologies and products that help improve our lives and the health of our planet. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Conflict of Interest Kansas Board of Regents policy requires faculty and unclassified staff of Regents institutions to file a conflict of interest report upon employment and at least annually thereafter. In addition, federal policies require assurances that all investigators on a research project are in compliance with institutional conflict of interest reporting procedures at the time a proposal is submitted. • https: //research. ku. edu/policies_ concerning_conflicts_interest • http: //www. kumc. edu/complianceservices/office-of-compliance/conflict -of-interest. html Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
What Could Create a COI? • Receipt of or an Entitlement to Receive Royalties Relating to Research Activities. • Business or Significant Financial interests Related to Instructional and Outreach Activities. • Business or Significant Financial Interests Related to Research Activities. • Business or Significant Financial interests Related to Administrative Responsibilities. • Professional Referrals. • Purchasing. If you are founder of a startup • Clinical Care. – you have a conflict! Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
No Conflict – No Interest • Disclosing COI: o Required to file State of Kansas Statement of Substantial Interests (KS SSI) with Kansas Secretary of State. o KBOR policy requires faculty & staff to file COI report annually • COI Committee o Manages these conflicts o Creates management plans Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Steven A. Soper, Ph. D. COI Disclosure • Equity in and serving on Board of Directors for Bio. Fluidica, Inc. (seeks to commercialize technology for isolation of rare cells) • Receiving consulting fees • Joint SBIR/STTR grants • Has equity in Digital Nano. Genetics, LLC and serves as Chief Science Officer (commercializing DNA/RNA sequencing technology) • This is not legal advise – Soper/Nagel are not patent lawyers Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
• Works with Faculty/Staff to identify, assess and protect KU’s intellectual property • Works across KU – All campuses • KUMC Office: Fairway • Lawrence Office: BTBC • Matt Koenig, JD: IP Management (mekoenig@ku. edu) • Rajiv Kulkarni, Ph. D: Disclosures, Licensing (rkulkarni@ku. edu) • www. kuic. ku. edu Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Four Types of Intellectual Property (IP) Patents Copyrights Trademarks Trade secrets Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
IP Rights are Provided for in the Constitution Article I, Section 8: “Congress shall have power to …promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries” Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Four Types of Intellectual Property Patents cover compounds, machines, and processes • Give the right to exclude others from making, using, offering for sale, selling, or importing your invention (in the country in which the patent was issued) Copyrights cover works of authorship reduced to a tangible means of expression • Give exclusive rights to copy, distribute, perform, display, make derivative works Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Four Types of Intellectual Property Trademarks indicate source of goods and services • prevent others from “passing off” Trade Secrets are legally protected secrets • misappropriation is unlawful, but reverse engineering is fair game Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
What is a Patent? • A right to exclude others from: making, using, offering for sale, selling or importing the patented invention • Not a right to use the invention • Not a “seal of approval” from government • Good for 20 years from date of filing Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Requirements for Patentability Search patents, publications, } Utility – it must be useful public uses (news, } Novelty – it must be new * internet, USPTO website, } Non-obviousness – it can’t be a mereetc. ) variation of what was done before } Enabling Description -- application must: – fully disclose invention (including “best mode” contemplated at time of filing); and – allow a person having ordinary skill in the art to make and use the invention Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Different Patentable Inventions • Medical Devices • Processes • Articles of manufacture • Compositions of matter Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
What is Patentable? “Anything under the sun made by man” New chemical compounds, e. g. , drugs, pesticides Methods of producing new compounds Methods of diagnosing or treating diseases, including biomarkers, delivery systems, and vaccines (no gene therapy in humans) New uses for old compounds Purified natural materials, e. g. , DNA, enzymes New formulations or mixtures, e. g. , alloys, shampoo Transgenic animals or plants (excluding humans) Devices (stents, machines, orthopedic devices, prosthetics, etc. , and novel and non-obvious modifications thereof) Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
WHAT IS NOT PATENTABLE? • perpetual motion device; • anti-gravity device; • abstract ideas or mental processes; • laws of nature or scientific principles; • naturally occurring substances; • invention disclosed publicly more than 12 months ago (includes sale, offer to sell, exhibit at a trade show, publication); • substituting superior material for inferior material; Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
WHAT IS NOT PATENTABLE? • a mere change in size, form, or shape; • data structures or programs per se; • mere mathematical algorithms; • nonfunctional descriptive material; • electromagnetic signals; • human beings; • an invention that is inoperative; • an invention which can only be used for illegal or immoral purposes (such as a torture device); • an invention solely useful in making atomic weapons. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Your Publications Can Void Your Patent Avoid selling, offering for sale, or using the invention in public. For a U. S. patent – a one year grace period to file a patent application For international patents – typically, no patent for that which was disclosed Publish/Present your work after filing your patent! Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Correlation Between Patentability and Commercial Value of an Invention NONE! A patentable invention may have little or no commercial value An invention with a lot of commercial value my have little chance of being patented Dilemma- Without the potential for adequate patent protection, most companies will not invest in a technology Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
How do Universities Use Patents? Universities patent and license the invention (allowed by Bayh-Dole Act) A license is a contract in which the patent owner allows a company to make, use, offer for sale, sell, and/or import the patented article or use the patented method In exchange, the “licensee” company pays the patent owner royalties (usually a % of sales) and other payments (e. g. , up-front fees, milestone fees) Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Ownership of IP Patents • University owns inventions by contract • Bayh-Dole Act (allows universities to own federally funded research) • Co-ownership with other entities • MTAs, sponsored research agreements, consulting can modify ownership Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
At the University: Process of Vetting http: //kuic. ku. edu/faculty/protect-your-ideas Invention Disclosure Steven A. Soper; KU-L/KUMC Triage Provisional Patent Julie Nagel; KU-L/KUMC
Invention Disclosure - KU • • • Brief Description of invention Prior art Commercialization potential Funding history Contribution Allocation Invention history (what has been disclosed to the public Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Provisional Patent Application • Can consist of a composite of grant application, manuscript in preparation and/or slides • Not formally reviewed, but gives you a priority date • Can be converted (modified) to full patent within 1 year • The current USPTO filing fee is $110 Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
What Happens After Provisional Is Filed? • Market assessment report prepared by 3 rd party consultants • Initial target marketing of invention • Together with patent search – these data provided to members of KU Faculty IP Committee • Committee meets to vote on conversion and investment of KU $$ • Positive vote – file non-provisional application Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Patent Application Timeline Your Article Publishes “filing date” “publication date” 20 Oct 2011 One year from priority date – file optional “international” patent application(s) 20 April 2012 1. 5 years from priority date – publication of patent application “priority date” 20 Oct 2010 file U. S. patent application Examination of the Patent Application and Claims Begins by a U. S. Patent Examiner Steven A. Soper; KU-L/KUMC time Examination Continues Julie Nagel; KU-L/KUMC
Conversion of a Provisional Patent Application to a PCT Application This decision requires more effort and is tougher to make because the expenses are much higher at this point (about $5 k just in government filing fees) Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
U. S. vs Foreign Patents • U. S. patents only provide protection in the U. S. for: • Products and processes made, used, sold or offered for sale in the U. S. • • Imports into the U. S. Foreign patents must be obtained to provide protection for products and processes not made, used, offered for sale, sold, or imported in the U. S. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Loss of Foreign Patent Rights Foreign Patent, Application Must Be Filed Before: • Any public disclosure of invention. • Use Non-Disclosure Agreements • BEST POLICY: FILE IN U. S. FIRST, if possible, to preserve foreign filing rights. • Applicant then has a one year period from U. S. application filing date to file in foreign countries. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
How and When You Made Your Invention Inventors should keep notebooks – numbered pages, signed, dated and witnessed - to document their work. Why? • “First to invent wins the patent” rule in the U. S. (v. “first to file” elsewhere) Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Parts of a U. S. Patent A. Specifications – detailed description of invention and background; can give examples of its use(s) B. Drawings – diagrams, flow charts, data C. Claims – define “boundaries of practice” of invention Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
The “CLAIMS” are key… Claims – provide the “boundary” of the right that the patent confers to exclude others from “trespassing” on the invention The Claimed Invention Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
PRIOR ART LIMITS THE SCOPE OF PATENT CLAIMS The requirement for novelty of 35 USC § 102 means that a patent claim cannot include what is already in the prior art. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Patent Claims The “Claims” of a patent define the scope of the invention. In the U. S. , peripheral claiming is used. That is, the claim language defines the “edge” of the property right. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
USPTO Review Process – Case Example • Priority date: 02/13 • Filing date: 02/14 (Filed under PCT) • May, 2014 – Initial response from Review – 6 citations to invalidate Claims 1 -84; 3 were self citations • September, 2014 – Refute of prior art citations was filed to the International Searching Office. • April, 2017 – European Patent Office action: rejected claim 1 from NIH abstract (grant funded in 2011) and claims 1 -10 from published meeting abstract (Soper) due to obviousness. • September, 2017 – Response to EPO rejections submitted. • October, 2017 – Patent Issued! Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
PATENT MYTHS Myth #1: An inventor needs to know how an invention works The inventor does not need to understand how or why their invention works. If an inventor discovers a new method of curing cancer, it does not matter how the method works, just that it works. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
PATENT MYTHS Myth #2: An inventor needs a prototype If the invention is such a simple device that drawings and a description will allow one of ordinary skill in the art to make or practice the invention, that is all that is needed. In fact, if the invention is simple enough, actual reduction to practice may not be necessary. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
PATENT MYTHS Myth #3: An idea is patentable Although an idea is not patentable, if that idea has been formulated in such detail that it can be so clearly described in the specification that one of ordinary skill in the art could make or practice the invention based on the details provided in the specification, then it might be possible to get a patent on the idea. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
PATENT MYTHS Myth #4: The preferred or best way of practicing an invention can be kept secret by exclusion from a patent application Required that the “best mode” of practicing the invention be included in the application, if a best mode is known. Failure to comply can result in invalidation of a patent. Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Exercise • Use your team project as the invention, and compose some claims for a patent you would submit. • Do a patent search for your invention at www. uspto. gov Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
U. S. PATENT AND TRADEMARK OFFICE http: //www. uspto. gov/ Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
Acknowledgements • Dr. Rodney Sparks, J. D. – Senior Patent Counsel at University of Virginia • Boston College Office of Technology Transfer and Licensing • KU Innovation & Collaboration • Mr. Guriqbal Jaiya, Director SME Division of World Intellectual Property Organization Steven A. Soper; KU-L/KUMC Julie Nagel; KU-L/KUMC
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