2.  Intellectual Property (IP) is the basis for research commercialization.

3.  What is Intellectual Property (IP)? › Intrinsic to the work of a university, intellectual property refers to ideas, processes or inventions that are the products of intellectual endeavor. › This often intangible form of property can be protected from unauthorized use, and it can be bought, sold or licensed.

4.  Under UPR’s policy (Cert. 132, 2002-03) the University owns IP that is generated through research conducted with the use of its facilities and resources.  All royalties and most fees resulting from the IP are shared between UPR and the individuals involved in its discovery. › 33 1/3 % - inventor(s) › 56 2/3% - inventor’s UPR unit(s) › 10% - UPR special fund › Any remaining amount – will be used to support additional research and academic programs.

5.  Patents  Copyrights  Trademarks  Trade Secrets

6.  UPR’s Vice President for Research and Technology makes the final decision as to whether to file a patent application or seek another form of protection › With the recommendations made by:  the patent attorney or patent agent  the UPR Office of Intellectual Property and Commercialization, and  IP-TTO (in the case of UPRM inventions)

7.  Patents  Copyrights  Trademarks  Trade Secrets

8.  Article 1, Section 8, of the U.S. Constitution states that Congress is empowered 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“  Covered by Federal law (Title 35 of U.S. Code)

9.  It is a grant from the U.S. federal government: › to the INVENTOR › to EXCLUDE others › from making, using, offering for sale, selling or importing the invention › into the UNITED STATES

10.  But no protection until applied for and received from government  No rights unless make an application and get it successfully issued  Until patent issued, others can exploit without infringing  They can make, use or sell invention during interim period  In some areas, by time patent issues, invention may be obsolete

11.  Patent does NOT give inventor the right to make, use or sell invention  Only the right to exclude others  So, if making invention infringes on someone else patent or other rights, patent doesn't give inventor the right to avoid the rights of others

12.  Utility Patent – for new and useful process (method), machine, manufacture, composition of matter or improvement  Design Patent – for new, original and ornamental design for an article of manufacture  Plant Patent – for one who invents or discovers and asexually reproduces any distinct and new variety of plant

13.  Useful › Having utilitarian or commercial value  Novel › No one else has done it before › If someone has done it before, even if you didn't know about it, not patentable  Non-Obvious › To someone having ordinary skill in the art

14.  Mere idea for new invention › Only concrete embodiment of idea that meets requirements;  i.e., “reduced to practice”  Formula, or newly discovered law or principle of nature not patentable

15. Can't patent if:  At time of invention, if invention was known or used by others in US, or other patented or described in printed publication anywhere  One year prior to application  Patented or described in printed publication anywhere  Or, in public use or sale in US  Even by inventor himself/herself  If once abandoned invention

16.  Not non-obvious (i.e., is obvious) if differences to “prior art” would have been obvious at the time of invention to “one having ordinary skill in the art to which said subject matter pertains”

17.  In US, “first to invent” entitled to patent  In other countries, “first to file” entitle to patent  If 2 conflicting claims for “First to Invent” Look to:  dates of conception,  date or reduction to practice,  reasonable diligence of first to conceive, but not first to reduce to practice  Reduction to Practice  Actual and constructive (filing application with complete disclosure so one with ordinary skill in the art could make it) ‏

18.  Important to create and preserve evidence to prove 3 things 1.date of conception 2.date of reduction to practice 3.diligence between 1 and 2  Crucial to have lab notes/records and disinterested witnesses to bear witness to notes and records

19.  Application filed with US Patent and Trademark Office (USPTO) ‏ http:// www.uspto.gov/  Two ways : › Regular Patent Application › Provisional Patent Application  Protects filing date  Need to do regular within one year

20.  Only INVENTORS may apply for patent  i.e., conceives or contributed to conception of invention  Employer is not inventor  Investor is not inventor  Not naming one of the Inventors or adding someone who didn't invent can invalidate a patent, even if issued

21.  Can do without patent lawyers or patent agents (can't litigate before court) ‏  But requires knowledge of patent law and PTO practice  Quite stylized document

22.  A utility patent application has four main parts: › The cover page › The drawings › The specification (the written descriptive part) typically including:  Background, Summary, Description of the drawings, and Detailed description of the embodiments › The claims

23.  Written in narrative form  Should teach the invention to a person “of ordinary skill in the art”  Manner or process of making and using it  Best mode contemplated by inventor for carrying out invention  The subsections of the Specification help satisfy the legal requirements for a patent: › The Field of the Invention describes the technical field covered by the invention.

24. › The Background  explain what the background is of the invention, and will explain the problem that the invention was designed to overcome. › The Summary  provides a short description of what is included in the product or method described in the Specification. › The Description of the Drawings  will list each drawing and provide a short summary of what is shown in each.

25. › Detailed Description of the Preferred Embodiment of the Invention  Is an extended narrative that should explain how the invention works  Should use and reference each of the drawings at one or more points.  The “preferred embodiment” is typically the one that best reflects the new and hopefully patentable properties of the invention  Often the Specification will also describe other embodiments of the invention. These may be ones that were invented during the development process, but were considered to be less favorable than the preferred embodiment.

26.  Most important part of patent because define the invention  Set what courts look at when they make infringement determinations  Recite all features of the invention which distinguish it from prior art

27.  Claims need to show novelty and patentability  Need one or more claims pointing our and claiming the subject matter of the invention  If you describe an invention in the specification (the narrative part of the patent application) but do not cover that invention in the claims, the patent does not protect that invention

28. 28

29. 29  Must convince another that you have created the claimed invention  Must enable another to perform or make the claimed invention (with some experimentation)  Must describe the best mode (at the moment of writing) of the claimed invention  Requirements the same for both utility and provisionals

30. 30  A provisional patent application has to include › The specification (the written descriptive part) typically including:  Background, Summary, Description of the drawings, Detailed description of the embodiments › The drawings

31. 31  A provisional patent application expires after 1 year from filing. It must be converted to a utility or it goes abandoned

32. 32  1 year to commercialize or get funding  Low cost ($100 filing fee for small entity)

33. 33  You create an invention-make a product  You offered the invented product for sale  There is a one-year period to file a patent  You (and your patent attorney) file a quick provisional patent application  The provisional patent application sits unexamined in the Patent Office  Exactly 1 year from the provisional, you file a full patent (utility) application

34. 34  Your patent is granted  Five years later, an infringer copies your patented invention  You sue for infringement  The infringer looks up your provisional application  The provisional application does not provide a written description of the claim asserted  The infringer invalidates the patent  Infringer goes scot-free, you have no patent!!

35. 35  Moral of the story- › Have some broad claims in mind when you write the provisional patent application › Include as complete a description as you can

36. 36  Each claim of the patent is compared to a potentially infringing product  A product must have all the limitations of a claim in order to infringe the claim (make claims with few limitations!! Less is more in this case)

37.  Utility: 20 years from date of filing  Design: 4 years from date of issue  Maintenance fee is due:  3 ½ years  7 ½ years  11 ½ years  Lose patent if don't pay maintenance fees before deadlines (including grace periods) ‏

38.  Yes, and it’s your job and the job of others.  The public benefits when new products are developed.  Development usually requires patent protection to enable companies to take necessary financial risks.  Patent prosecution can always be (and often is) abandoned - but cannot be (re)started when it’s too late and disclosures have been made.

39.  Won't it interfere with sharing of my reagents? (It need not!)  What about the culture of publish or perish? (Can have both patents & publications!)

40.  Provides means getting innovative products to the market for public benefit  Commercial & public recognition of important technologies  Attracts new R&D resources & partnerships for University  Obtains return on investment  Stimulates economic development

41. Intellectual Property Commercialization Discovery

42. TECHNOLOGY TRANSFER BUSINESS DEVELOPMENT ATTORNEYS DiscoveryIntellectual Property Technology Transfer Financial Capital Corporate Partnership R&D Clinical trials Regulatory Manufacturing Sales & Marketing Product Commercialization: From Lab Bench to Customer

43.  University evaluate inventions for patenting  University work closely with inventors  Work with law firms and management of patents  Identify and negotiate with a commercial partner for license or collaboration agreements  Managing relationship with commercial partners

44.  Answer - yes and no!  Academic & Federal labs share license and royalty payments with individual inventors.  There are payment caps or restrictions on the level of commercial involvement at most institutions.  Largest rewards (and risks!) and level of involvement come from entrepreneurial activity separate from the lab.

45.  New and emerging companies founded by researcher/entrepreneurs have driven the development of innovative products.  Funding & training scientists (especially at academic research centers) can provide the next wave of innovative small companies in the U.S. or elsewhere.  Business & entrepreneurial training programs can provide the spark for such developments.

46.  Scientific knowledge & research alone will not generate economic prosperity.  New ideas from research are complex & not always understood and commercialized by existing firms.  Often entrepreneur is needed to facilitate development of new ideas from research labs.

47.  Entrepreneurship enables investment to seed new knowledge & a means of harvesting research results.  Commercialization leads to news firms & industries, job creation and economic growth.  “Ivory Tower-only" image of scientists changing.  Now “local heroes of the global village”.  Difference between U.S. and many other countries. Source: Kauffmann Foundation

48.  Not due to geographic origin (many not native U.S.).  More about institution, legal and organizational support for entrepreneurship.  Bayh-Dole Act seen as stimulus for commercializing federally-funded research in U.S.  Grants a proven engine for entrepreneurship.  25% of NCI grant recipients from 1998-2003 started their own company.

49.  SBIR grants foster the kind of research that translates new science findings into product opportunities.  Incubators, technology parks, start-up programs, entrepreneurial training programs, social networks all have assisted the process. Source: Kauffmann Foundation; Washington Post

50.  Keep accurate lab notebooks - bound lab notebooks are essential - dated and signed.  Disclosure - abstracts, meeting talks, publications online all constitute disclosure, you risk loss of non-U.S. rights!

51.  Work with tech transfer office staff, law firm and commercial partners.  CDAs/MTAs (Confidential Disclosure Agreements / Material Transfer Agreements) - are essential for the transfer of information and reagents - don’t aim to please interested third parties without first contacting your tech transfer office.

52.  Increasing integrated into program goals of the research enterprise.  Can increase public impact of your research.  Institutional staff available to support commercialization of your inventions.  Highest opportunity for control and/or reward come from entrepreneurial activity away from the lab.