Intellectual Property Overview for the Academic Researcher AMSTER ROTHSTEIN & EBENSTEIN LLP December 9, 2008 Kenneth George

2 Intellectual Property is property created from the mind What is intellectual property

3 Copyrights: Original expressions of ideas Trademarks: Words, symbols or sounds that identify source Patents: New, useful and non- obvious products or uses Types of Intellectual Property

4 What is a patent? A patent is a limited right granted by the U.S. (or other) government to exclude others from practicing an invention. the claims of a patent define the invention covered by the patent

5 What is a patent? Applies to the first and true inventors of a new, not obvious and useful product or use in exchange for the public disclosure of the invention. Lasts for 20 years from filing date

6 Why seek patent protection?  Patents protect your development work  Patents are important to commercialization of your technology  Patent licenses to third parties potentially provide research support and/or royalty income for AECOM and inventors

7 What do you get from a patent?  A patent is a right to exclude others from practicing the claimed invention. Does not guarantee that you can practice the invention, only that others can not.  You are entitled to at least some compensation if other companies practice your patent.  You may be entitled to stop others from using your invention.

8 What is an invention?  An “invention” occurs when there is a “conception” and “reduction to practice.” Conception is the mental part. Coming up with the idea. Reduction to practice is actually making the invention.  Filing of an application is considered a type of reduction to practice. Invention

9 Who is an inventor?  An inventor is someone who contributed to the conception of an invention claimed in one or more of the claims of the patent.  Someone who merely acts as the “hands” of an inventor without more is not an inventor.  Authorship and inventorship are different I think we should … We could … Inventors I’ll build it … Not an inventor

10 What is the criteria for patentability?  New or novel  Useful or have utility  Not obvious

11 New (or novel) No one else came up with the exact same idea before. No single reference has all of the elements of your claim. What is claimed: 1. A compound having: A B C and D Prior Art 1 A compound having A and B. Prior Art 3 A compound having A, B, C and D. X Not new Prior Art 2 A compound having A and C.

12 Useful Your invention must be useful. Most biotech and pharmaceutical inventions satisfy the utility requirement (i.e., they are useful). Exception: Expressed Sequence Tags (ESTs) -- short nucleotide sequences that represent a fragment of a cDNA clone of unknown function (e.g., massive sequencing of genes as Humane Genome Sequences (HGS) without determination of function)

13 Not obvious It would not be obvious to one of ordinary skill in the art to come up with your invention. Obviousness is determined by combining prior art references: What is claimed: 1. A compound having: A B C and D Prior Art 1 A compound having A, B, C and E. Prior Art 2 Suggest that D and E are equivalent. Substituting D for E would be obvious

14 What is Prior Art in the U.S.? “Known or used by others” in the U.S. before the invention Published or patented by others before the invention Published or patented by anyone more than one year before the earliest effective filing date On sale or offered for sale in the U.S. more than one year before the earliest effective filing date In public use or display (e.g., poster or power point presentation) more than one year before the earliest effective filing date

15 What is Prior Art outside the U.S.? Lack of novelty and inventive step (i.e., obvious) requirements Publication before filing date (even by one day) is generally considered a bar to obtaining foreign patent protection Critical to file before disclosure to preserve foreign rights

16 Examples of Pharmaceutical/Biotech Inventions  Novel compounds  New uses of old compounds  Processes for making compounds  Methods for screening for compounds against certain targets  Novel nucleic acids / proteins / antibodies  Methods for treating / diagnosing diseases  Transgenetic non-human animal models  Recombinant cell line  Vaccines

17 The Patent Process  Communicating the Idea  Preparing and filing an Application  The Patent Prosecution Proceedings  The Issued Patent  Licensing the Patent

18 Communicating the Idea Invention Prepare an invention disclosure data sheet

19 Parts of the Invention Disclosure Descriptive Title

20 Parts of the Invention Disclosure Non-confidential description of the invention

21 Parts of the Invention Disclosure Provide “Detailed Description”

22 Parts of the Invention Disclosure Provide historical record of invention

23 Parts of the Invention Disclosure Provide historical record of invention (cont)

24 Parts of the Invention Disclosure Commercial possibilities?

25 Parts of the Invention Disclosure Related Contracts

26 Parts of the Invention Disclosure Collaborators

27 Parts of the Invention Disclosure Inventors

28 Parts of the Invention Disclosure Additional Inventors

29 Parts of the Invention Disclosure Witnesses

30 Submit Invention Disclosure to Office of Biotechnology Evaluation of Invention Disclosure By Patent Committee

31 Upon Approval by Patent Committee, Submission of Invention Disclosure to Amster, Rothstein & Ebenstein LLP for Evaluation Ken George Craig Arnold Alan Miller

32 Preparing and filing a Patent Application USPTO Ken George Craig Arnold Alan Miller

33 Parts of an Application Application Data Sheet

34 Parts of an Application Title

35 Parts of an Application Preliminary Statements

36 Parts of an Application Background of the Invention

37 Parts of an Application Summary of the Invention

38 Parts of an Application Brief Description of Figures

39 Parts of an Application Figures

40 Parts of an Application Detailed Description

41 Parts of an Application Claims

42 Parts of an Application Abstract

43 The Patent Process Assignment

44 The Patent Process Filing Receipt

45 The Patent Process Notice to file Missing Parts

46 The Patent Process Declaration

47 The Patent Process Information Disclosure Statement

48 The Patent Process Office Action

49 The Patent Process Office Action

50 The Patent Process Office Action

51 The Patent Process Office Action

52 The Patent Process Office Action

53 The Patent Process Amendment and Response

54 The Patent Process Amendment and Response

55 The Patent Process Amendment and Response

56 The Patent Process Amendment and Response

57 The Patent Process Declaration

58 The Patent Process Notice of Allowance

59 The Patent Process Patent Issuance

60 The Patent Process Patent License

Copyright Issues

62 Copyrights Copyrights are original works of authorship fixed in any tangible medium of expression from which they can be perceived, reproduced, or otherwise communicated. Copyrighted materials are protected from being copied without authorization (hence they give a “right to copy”).

63 Registration Procedures for Copyrights  Can take the form of a registration or be unregistered; but without prompt registration cannot enforce in a U.S. Court  Rights are based on first publication  No Need for foreign registration  Form is deceptively simple; an inexperienced applicant can nullify copyright rights

Trademark Issues

65 Trademarks/Service Marks Trademark/Service mark is a word, symbol or device which indicate a single source of origin of goods or services. TM ® SM

66 Registration Procedures for Trademarks/Service Marks  Can take the form of a registration or be unregistered  Rights are based on use, advertising and promotional literature, product packaging is important to review to identify full range of marks used  Need to consider filings around the world where company does business or wants to do business

67 Kenneth George Park Avenue New York, NY Main: Fax: AMSTER ROTHSTEIN & EBENSTEIN LLP