1. ORED Research Seminar Series “Lab Notebooks” Chase Kasper, Associate Director Office of Entrepreneurship and Technology Transfer March 21, 2012

2. 2 Office of Regulatory Compliance Sponsored Programs Administration OETT Office Of Research & Economic Development Support Units Support Units

3. Discovery! Assess Protect Market License Steps Toward Commercialization

4. Provides a property right in intangible products of investment, creative intellect, or labor Mechanisms include: Copyrights * Patents * Plant Variety Protection Trademarks Trade secrets Intellectual Property Overview

5. Legal definition: “copyright protection subsists…in original works of authorship fixed in a tangible medium of expression” In other words: an original work of authorship that has been placed on paper, film, canvas, etc. Examples: Literary works (includes computer software); musical works (and lyrics); dramatic works; pictorial works; sculptural works; filmworks; sound recordings; architectural works; etc. Copyrights

6. Owner has the “right” to: To reproduce the work To prepare derivative works based on the work To distribute copies or phonorecords of the work To perform the work publicly To display the work publicly To perform sound recordings by means of digital audio transmission Copyrights (cont.)

7. What you need to know: Copyright happens at moment of “fixation of the expression” In the event of joint authors, they are also co-owners and can grant non- exclusive licenses to entire work Registration with the U.S. Copyright office is necessary to make a public record of claim to copyright and file suit in the event of infringement Duration for individual authors is life of author plus 70 years (or last author to die, if more than one author) In cases of a “work made for hire,” the employer is considered to be the author of a work created by an employee within the scope of his or her employment. Copyrights (cont.)

8. Legal definition: “a set of exclusive rights granted to an inventor for a fixed period of time in exchange for the regulated, public disclosure of the invention” Types of patents: 1.Utility – covers new and useful processes, machines, manufactured items, etc. 2.Design – covers a new, original, and ornamental design for manufactured items 3.Plant – covers asexually reproduced new varieties of plants Patents

9. What can be patented? Patentable Subject Matter Any machine, manufacture, composition of matter, process, or improvement thereof NOT Patentable Subject Matter: Laws of nature (“facts”); World-ending weapons Must display the following characteristics: 1.Utility (or usefulness) - Any utility will suffice, just have to show that someone may consider it useful 2.Novelty (or “new”) – Use a “prior art” search is used to determine how novel the idea is 3.Not Obvious- Could someone “skilled in the art” have foreseen the invention? Patents (cont.)

10. What you need to know: Rights to exclude others from making, using, selling, offering to sell the invention within the U.S., or importing into the U.S. for a limited period of time. Term: ~20 years from earliest filing of an application A “publicly disclosure” could limit or prevent patent rights from being be granted! Inventorship is factually determined and the process may be simple…or complex. Patents (cont.)

11. Who is an “inventor?” Individual(s) who contribute(s) to the conception of an invention and reduce it to practice. – Conception – Happens when a definite idea of an invention, including every feature of the subject matter claimed, is known and able to be applied in practice. – Reduced to practice – An invention constructed and sufficiently tested to prove its usefulness for the intended purpose OR filing of an application for a patent directed to the invention. Inventorship

12. Who is NOT an“inventor?” A person who suggests a desired send result with proving the means for achieving said result. A person who follows the instructions of others for performing routine acts. A person who simply identifies a problem…without providing any solution. “Money does not an inventor make.” There is NO such thing as “courtesy inventorship.” MOST IMPORTANTLY…A patent that misstates the names of the inventor(s) may be declared INVALID and UNENFORCABLE resulting in the LOSS of the patent rights. Inventorship

13. What’s the difference? Authorship involves copyright law and is not synonymous with inventorship. For papers and publications, authorship is defined one who contributes to the creation of the paper/publication (“the final product”). Contributions can include: algorithims, equations, figures, images, words, etc. Co-authors of a paper or a publication are not necessarily co-inventors of an invention, regardless of position. There is NO such thing as “courtesy inventorship.” Inventorship vs. Authorship

14. Public disclosure can include, but are not limited to, the following: 1. Written or oral disclosure, can be considered a public disclosure, unless the information was communicated in confidence (i.e. NDA). Disclosures to employees are not considered to be public disclosures. 2.Poster sessions, slides, lectures, seminars which are open to the public, letters, even conversations can count as a bar to patentability. 3. An "offer for sale" counts as a bar to patenting (after the one year "grace period") in the U.S. For example: Showing a product at a trade show could be considered as such. Disclosing the Innovation

15. The basic act of informing a party that one has made an invention is not considered a "public disclosure" of the invention. In order to act as a patent bar, the disclosure must be enabling – in other words, it must teach someone "of ordinary skill in the art" how to actually duplicate the invention. Disclosing the Innovation

16. A trade secret is a scenario where the process, formula, design is hidden. ( Examples: Coca-Cola formula, KFC’s 11 “secret” herbs and spices, etc.) Tips for “keeping a secret” Use reasonable efforts to maintain secrecy Files locked away in a secured venue Have only one person know a key component Have a non-disclosure agreement, a conflict policy and an employment agreement These tactics indicate that corporate information was confidential and was a trade secret Trade Secrets

17. Can I publish AND patent? Yes -- you can do both! – U.S. Patents can be applied for up to 12 months after an initial public disclosure. – Worse case scenario: You published we need to patent in 12 months – Best case scenario: You disclosure early to OETT and we can work together so that you can publish and patent at your discretion

18. IMPORTANT Conversations between and OETT staff and MSU employees regarding the disclosure of their invention are considered to be confidential in nature and do not constitute a “public disclosure.” Disclosing the Innovation

19. Wait… What does this have to do with lab notebooks??!!

20. © 2006 Despair, Inc. www.despair.com

21. Central issue: In this famous case, the federal circuit considered whether a medical student should have been named a co-inventor on a patent for a method of treating hypertension and glaucoma. Stern v. Trustees of Columbia University Stern v. Trustees of Columbia University U.S. Court of Appeals, Federal Circuit – Decided January 17, 2006

22. Background information: Columbia University owns a patent naming Lazlo Bito as the inventor. In 1980, Stern (a medical student) performs a one semester ophthalmology research elective in Bito’s laboratory. Experiments that Stern conducted while working in Bito’s laboratory showed that topical application of a single dose of prostaglandin reduced intraocular pressure (IOP) in rhesus monkeys. Stern v. Trustees of Columbia University Stern v. Trustees of Columbia University U.S. Court of Appeals, Federal Circuit – Decided January 17, 2006

23. Background information: After Stern’s departure from Columbia, Bito conceives the patent while studying the effects of repeated prostaglandin application on the IOP in rhesus monkeys. Bito applies for the patent in 1982 and, in 1986, it was issued by the USPTO. Stern v. Trustees of Columbia University Stern v. Trustees of Columbia University U.S. Court of Appeals, Federal Circuit – Decided January 17, 2006

24. Why the lab notebook became important: Stern’s notebooks were not co-signed or witnessed. Stern argued that his experiments showing that topical application of a single dose of prostaglandin reduced IOP in a rhesus monkey rendered him a co-inventor. The courts disagreed. It noted that the medical student simply carried out an experiment previously done on a different animal by the named inventor. It ruled that unwitnessed laboratory notebooks on their own were insufficient to support his claim of co-inventorship. Stern v. Trustees of Columbia University Stern v. Trustees of Columbia University U.S. Court of Appeals, Federal Circuit – Decided January 17, 2006

25. The painful lesson: It is important to get inventorship right, and, equally as important, to be able to prove it is right. Remember: A patent that lists improper inventors is invalid. While it is possible to correct inventorship if someone is inadvertently included (or excluded) as an inventor, it is fraud on the USPTO to deliberately list the wrong inventors. The patent will become unenforceable. Stern v. Trustees of Columbia University Stern v. Trustees of Columbia University U.S. Court of Appeals, Federal Circuit – Decided January 17, 2006

26. Take away: If Stern properly maintains his lab notebook, the outcome of the case may well have been decidedly different. Stern v. Trustees of Columbia University Stern v. Trustees of Columbia University U.S. Court of Appeals, Federal Circuit – Decided January 17, 2006

27. Scientifically – Allows your research to accurately reproduced – Ensures accuracy in reporting and publications – Protects potential intellectual property – Supports future research efforts Ethically – Translate research into the development of new technologies – Newly created technologies are developed for the public benefit. This includes the people of Mississippi, the United States, and those in the international community. Very practical reasons for keeping a good lab notebook

28. The Laboratory Notebook is the property of MSU. – Investigators’ notebooks and any additional primary data records / files should remain on MSU grounds – In general, departing investigators should be able to take copies of their notebooks and other data upon leaving MSU, with limited exceptions. Report the loss or theft of a Laboratory Notebook immediately! Without proper approval, the Laboratory Notebook should not leave MSU premises. Ownership; Loss or Theft

29. Thank you! Any Questions? For additional details see MSU Operating Policies and Procedures, OP 76.01 http://www.msstate.edu/dept/audit/7601.html

30. Contact information Offices:100 Research Park Blvd. Suite 120 Phone:662-325-9263 Fax:662-325-0667 Website:www.oett.msstate.eduwww.oett.msstate.edu