VLP Virtual Law School
            IP for Non-Lawyers
                     March 4, 2009

Ellen Leznik, Founding Partner, Virtual Law Partners LLP
           eleznik@virtuallawpartners.com
                   (650) 321-1393
   Dianna DeVore, Partner, Virtual Law Partners LLP
          ddevore@virtuallawpartners.com
                   (415) 963-4362
Select IP Issues in Licensing


Ellen Leznik, J.D.
ELeznik@VirtualLawPartners.com



March 4, 2009

VIRTUAL LAW PARTNERS LLP
What is Intellectual Property?
       Patents
        Exclusive rights granted by Federal Government for a specific period of time.

       Copyrights
        Protection provided to a wide range of “original works of authorship” that are fixed in a
        tangible form of expression, such as software, literary works, photographs, audio and
        video recordings and other forms of intellectual works.
        Example of notice: © 2009 Virtual Law Partners LLP

       Trademarks
        Words, names, symbols or other devices used to identify and distinguish business, goods
        or services.
        State and Federal registration.
        ™ - not yet registered
        ® - registered

       Trade Secrets
        Confidential business information which provides an enterprise a competitive edge.


3                                  March 4, 2009                       Virtual Law Partners LLP
Importance of Definitions
       Ability to define terms

        Often a sign of whether the deal has been sufficiently well understood and
        defined.

       “Nesting” definitions vs. circular definitions

        Example of a “nesting” or “hierarchical” definition:

         “Collaboration Patents” shall mean all foreign and domestic patents (including
        extensions, reissues, re-examinations and inventors certificates relating
        thereto) that issue from patent applications (including substitutions,
        provisionals, divisionals, continuations and continuations-in-part of such
        applications) that claim inventions in the Collaboration Know-How and that are
        filed by or on behalf of one or both of the parties hereto.

        “Collaboration Technology” means the Collaboration Patents and the
        Collaboration Know-How.
4                               March 4, 2009                  Virtual Law Partners LLP
Importance of Definitions (cont’d)

       “Nesting” definitions vs. circular definitions
        (cont’d)

        Example of a circular definition:

        “Licensed Products” means all products the manufacture, use or sale
        of which involves the use of Licensed Technology.

        “Licensed Technology” means all patents and know-how owned and
        controlled by Company which are necessary or useful in the
        manufacture, use or sale of Licensed Products.


5                            March 4, 2009           Virtual Law Partners LLP
IP Rights: Inventorship vs. Ownership

       Inventors/Creators
        Employees
        Consultants
        Contractors
        Researchers (academic, non-profit, government)
        Collaborators

       Transfer of ownership
        Assignment
        License
        Reserved rights

6                         March 4, 2009         Virtual Law Partners LLP
IP Rights: What is Included?

       A bundle of rights
        Use
        Territory
        Time
        Exclusion of others




7                      March 4, 2009   Virtual Law Partners LLP
IP Rights: License Grant
       Recipient

        Single entity

        Affiliates
               Can also be done through a sublicense
               Consider what effect it may have on other terms, such as
        minimum royalties

        Joint Ventures
              Consider issues relating to license termination issues, such as
        when your JV was not properly established, JV is dissolved, or
        one party purchases all JV interests


8                           March 4, 2009               Virtual Law Partners LLP
IP Rights: License Grant (cont’d)

       Purpose

        Patent license: use, make, have made, offer
        for sale and sell.

        Copyright license: copy, make derivative
        works and reproduce.

9                   March 4, 2009    Virtual Law Partners LLP
IP Rights: License Grant (cont’d)
        Scope

         Territory
               Be precise when defining Territory
               Example: China
               “Territory” shall mean the People’s Republic of China, including
               all provinces and regions thereof, but excluding Hong Kong.

         Field of use
               Need to specify if licensed technology has applications in more
               than one field
               Potential pitfall – indication splitting (“Amgen/Ortho” problem)



10                           March 4, 2009               Virtual Law Partners LLP
IP Rights: License Grant (cont’d)

        Exclusivity

         Exclusive vs. non-exclusive
         Exclusive option vs. exclusive license
         Exclusive option vs. right of first refusal



11                     March 4, 2009      Virtual Law Partners LLP
IP Rights: License Grant (cont’d)

        Sublicense Rights

         “Have made” implies sublicense rights
         Restrictions on sublicensing
         Impact on other provisions: royalties, termination,
         confidentiality, inventions

        Transferability

         Potential pitfall: conflict with the Assignment provision


12                          March 4, 2009             Virtual Law Partners LLP
IP Rights: License Grant (cont’d)
        Royalty/Fee

         Royalty-bearing
         Fee-bearing
         Royalty-free
         Fully-paid

        Term

         Patent license vs. blended license (patent plus know-how)
         Term of license grant vs. term of royalty


13                         March 4, 2009          Virtual Law Partners LLP
IP Rights: License Grant (cont’d)

        Sample license grant clauses
         Biotech:
         “BiotechCo grants to PharmaCo and its Affiliates an
         exclusive, royalty-bearing license under Licensed
         Technology to research, develop, make, have made,
         import, export, market, sell and distribute Licensed
         Products in the Territory in the Field.”



14                      March 4, 2009       Virtual Law Partners LLP
IP Rights: License Grant (cont’d)

        Sample license grant clauses (cont’d)

         Software:
         “Subject to the terms and conditions of this Agreement,
         SoftwareCo hereby grants to Customer a fee-bearing, royalty-
         free, nonexclusive, nontransferable license to use the Software
         through the SoftwareCo Servers. Except as specifically
         authorized by this Agreement, no license is granted under this
         Agreement to Customer to distribute the Software for use,
         whether or not as part of the SoftwareCo Services. SoftwareCo
         shall be responsible for obtaining all third party software
         licenses required to provide the SoftwareCo Services.”

15                         March 4, 2009           Virtual Law Partners LLP
Collaborations with Government
        Company’s existing inventions

         Template:

         “Background Invention” means an Invention conceived and first
         actually reduced to practice before the effective date of this
         Agreement. Background Inventions shall be included in Appendix B.

         Negotiated:

         “Background Invention” means an Invention conceived or reduced to
         practice before the effective date of this Agreement.



16                          March 4, 2009             Virtual Law Partners LLP
Collaborations with Government
     (cont’d)

        New inventions resulting from collaboration
         Template:

         “CRADA Subject Invention” means any Invention of a VA Employee, of
         Collaborator, or of both a VA Employee and Collaborator, conceived or
         first actually reduced to practice in the performance of the Statement of
         Work [15 U.S.C. 3703(9), (10)].

         Negotiated:

         “CRADA Subject Invention” means any Invention of a VA Employee, of
         Collaborator, or of both a VA Employee and Collaborator, conceived
         and reduced to practice in the performance of the Statement of Work
         [15 U.S.C. 3703(9), (10)].

17                            March 4, 2009              Virtual Law Partners LLP
Collaborations with Government
     (cont’d)

        Government reserved rights - third party license
         Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if VA grants an exclusive license to a
         CRADA Subject Invention made solely by a VA Employee or jointly with a
         Collaborator employee, the Government retains the right to require Collaborator
         to grant to a responsible applicant a nonexclusive, partially exclusive, or
         exclusive sublicense to use the CRADA Subject Invention in Collaborator’s
         licensed field of use on terms that are reasonable under the circumstances, or,
         if Collaborator fails to grant a license, to grant a license itself. The exercise of
         these rights by the Government will only be in exceptional circumstances and
         only if the Government determines (i) the action is necessary to meet health or
         safety needs that are not reasonably satisfied by Collaborator, (ii) the action is
         necessary to meet requirements for public use specified by Federal regulations,
         and such requirements are not reasonably satisfied by Collaborator, or (iii)
         Collaborator has failed to comply with an agreement containing provisions
         described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the
         Government under this paragraph is subject to administrative appeal and
         judicial review under 35 U.S.C. § 203(2). [Negotiated: No license or sublicense
         shall be granted to a third party prior to the final outcome of such appeal.]


18                               March 4, 2009                   Virtual Law Partners LLP
Collaborations with Government
     (cont’d)

        Government reserved rights – non-exclusive royalty-free
         license to collaboration inventions.

         Consistent with the definition of a DAP and pursuant to 15 U.S.C. §
         3710a(b)(1)(A) for CRADA Subject Inventions owned solely by VA or
         jointly by VA and Collaborator and licensed pursuant to the option of
         Paragraph 6.2 or 6.3, Collaborator grants to the Government a
         nonexclusive, nontransferable, irrevocable, paid-up license to practice
         the CRADA Subject Invention or have the CRADA Subject Invention
         practiced throughout the world by or on behalf of the Government. In
         the exercise of this license, the Government shall not publicly disclose
         trade secrets or confidential commercial or financial information that is
         privileged or confidential within the meaning of 5 U.S.C. § 552(b)(4) or
         which would be considered privileged or confidential if it had been
         obtained from a non-Federal party, except where authorized by law.


19                            March 4, 2009               Virtual Law Partners LLP
Collaborations with Government
     (cont’d)

        Government reserved rights – non-exclusive royalty-free
         License to collaboration inventions made solely by the
         collaborating company

         Template:
         Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject
         Inventions made solely by an employee of Collaborator,
         Collaborator grants to the Government a nonexclusive,
         nontransferable, irrevocable, paid-up license to practice the
         CRADA Subject Invention or have the CRADA Subject
         Invention practiced throughout the world by or on behalf of the
         Government for research or other Government purposes.


20                         March 4, 2009            Virtual Law Partners LLP
Collaborations with Government
     (cont’d)

        Government reserved rights – non-exclusive royalty-free
         License to collaboration inventions made solely by the
         collaborating company (cont’d)

         Negotiated:
         Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject
         Inventions made solely by an employee of Collaborator,
         Collaborator grants to the Government a nonexclusive,
         nontransferable, irrevocable, paid-up license to practice the
         CRADA Subject Invention throughout the world by the
         Government for research purposes only.



21                         March 4, 2009            Virtual Law Partners LLP
Collaborations with Government
     (cont’d)

        Know what you have
         when working with academic institutions
         when using government grants
         when licensing out the resulting technology

        Government contracts and M&A
         transactions


22                      March 4, 2009       Virtual Law Partners LLP
IP Warranty
        To give or not to give?
         Biotech vs. Software


        Sample provisions

         Biotech:
         “BiotechCo represents and warrants that it owns or holds
         licenses to the BiotechCo Patents and BiotechCo Know-How
         and has sufficient rights and power to grant the licenses to
         PharmaCo which it purports to grant herein.”


23                         March 4, 2009           Virtual Law Partners LLP
IP Warranty (cont’d)

        Sample provisions (cont’d)

         Software:
         “SoftwareCo represents and warrants to Customer that:
         (i) SoftwareCo is the sole and exclusive owner of the
         Software; (ii) SoftwareCo has full and sufficient right, title
         and authority to grant the rights and/or licenses granted to
         Customer under this Agreement; and (iii) the Software
         does not infringe any patent (to SoftwareCo’s
         knowledge), copyright, trade secret, trademark or other
         intellectual property rights of a third party.”

24                        March 4, 2009           Virtual Law Partners LLP
Reversion of rights
        Failure to meet diligence obligations

        Commercialization of the Product is not
         scientifically or commercially reasonable

        Bankruptcy

        Material Breach
25                    March 4, 2009     Virtual Law Partners LLP

Ip For Non Lawyers March 4, 2009

  • 1.
    VLP Virtual LawSchool IP for Non-Lawyers March 4, 2009 Ellen Leznik, Founding Partner, Virtual Law Partners LLP eleznik@virtuallawpartners.com (650) 321-1393 Dianna DeVore, Partner, Virtual Law Partners LLP ddevore@virtuallawpartners.com (415) 963-4362
  • 2.
    Select IP Issuesin Licensing Ellen Leznik, J.D. ELeznik@VirtualLawPartners.com March 4, 2009 VIRTUAL LAW PARTNERS LLP
  • 3.
    What is IntellectualProperty?  Patents Exclusive rights granted by Federal Government for a specific period of time.  Copyrights Protection provided to a wide range of “original works of authorship” that are fixed in a tangible form of expression, such as software, literary works, photographs, audio and video recordings and other forms of intellectual works. Example of notice: © 2009 Virtual Law Partners LLP  Trademarks Words, names, symbols or other devices used to identify and distinguish business, goods or services. State and Federal registration. ™ - not yet registered ® - registered  Trade Secrets Confidential business information which provides an enterprise a competitive edge. 3 March 4, 2009 Virtual Law Partners LLP
  • 4.
    Importance of Definitions  Ability to define terms Often a sign of whether the deal has been sufficiently well understood and defined.  “Nesting” definitions vs. circular definitions Example of a “nesting” or “hierarchical” definition: “Collaboration Patents” shall mean all foreign and domestic patents (including extensions, reissues, re-examinations and inventors certificates relating thereto) that issue from patent applications (including substitutions, provisionals, divisionals, continuations and continuations-in-part of such applications) that claim inventions in the Collaboration Know-How and that are filed by or on behalf of one or both of the parties hereto. “Collaboration Technology” means the Collaboration Patents and the Collaboration Know-How. 4 March 4, 2009 Virtual Law Partners LLP
  • 5.
    Importance of Definitions(cont’d)  “Nesting” definitions vs. circular definitions (cont’d) Example of a circular definition: “Licensed Products” means all products the manufacture, use or sale of which involves the use of Licensed Technology. “Licensed Technology” means all patents and know-how owned and controlled by Company which are necessary or useful in the manufacture, use or sale of Licensed Products. 5 March 4, 2009 Virtual Law Partners LLP
  • 6.
    IP Rights: Inventorshipvs. Ownership  Inventors/Creators Employees Consultants Contractors Researchers (academic, non-profit, government) Collaborators  Transfer of ownership Assignment License Reserved rights 6 March 4, 2009 Virtual Law Partners LLP
  • 7.
    IP Rights: Whatis Included?  A bundle of rights Use Territory Time Exclusion of others 7 March 4, 2009 Virtual Law Partners LLP
  • 8.
    IP Rights: LicenseGrant  Recipient Single entity Affiliates Can also be done through a sublicense Consider what effect it may have on other terms, such as minimum royalties Joint Ventures Consider issues relating to license termination issues, such as when your JV was not properly established, JV is dissolved, or one party purchases all JV interests 8 March 4, 2009 Virtual Law Partners LLP
  • 9.
    IP Rights: LicenseGrant (cont’d)  Purpose Patent license: use, make, have made, offer for sale and sell. Copyright license: copy, make derivative works and reproduce. 9 March 4, 2009 Virtual Law Partners LLP
  • 10.
    IP Rights: LicenseGrant (cont’d)  Scope Territory Be precise when defining Territory Example: China “Territory” shall mean the People’s Republic of China, including all provinces and regions thereof, but excluding Hong Kong. Field of use Need to specify if licensed technology has applications in more than one field Potential pitfall – indication splitting (“Amgen/Ortho” problem) 10 March 4, 2009 Virtual Law Partners LLP
  • 11.
    IP Rights: LicenseGrant (cont’d)  Exclusivity Exclusive vs. non-exclusive Exclusive option vs. exclusive license Exclusive option vs. right of first refusal 11 March 4, 2009 Virtual Law Partners LLP
  • 12.
    IP Rights: LicenseGrant (cont’d)  Sublicense Rights “Have made” implies sublicense rights Restrictions on sublicensing Impact on other provisions: royalties, termination, confidentiality, inventions  Transferability Potential pitfall: conflict with the Assignment provision 12 March 4, 2009 Virtual Law Partners LLP
  • 13.
    IP Rights: LicenseGrant (cont’d)  Royalty/Fee Royalty-bearing Fee-bearing Royalty-free Fully-paid  Term Patent license vs. blended license (patent plus know-how) Term of license grant vs. term of royalty 13 March 4, 2009 Virtual Law Partners LLP
  • 14.
    IP Rights: LicenseGrant (cont’d)  Sample license grant clauses Biotech: “BiotechCo grants to PharmaCo and its Affiliates an exclusive, royalty-bearing license under Licensed Technology to research, develop, make, have made, import, export, market, sell and distribute Licensed Products in the Territory in the Field.” 14 March 4, 2009 Virtual Law Partners LLP
  • 15.
    IP Rights: LicenseGrant (cont’d)  Sample license grant clauses (cont’d) Software: “Subject to the terms and conditions of this Agreement, SoftwareCo hereby grants to Customer a fee-bearing, royalty- free, nonexclusive, nontransferable license to use the Software through the SoftwareCo Servers. Except as specifically authorized by this Agreement, no license is granted under this Agreement to Customer to distribute the Software for use, whether or not as part of the SoftwareCo Services. SoftwareCo shall be responsible for obtaining all third party software licenses required to provide the SoftwareCo Services.” 15 March 4, 2009 Virtual Law Partners LLP
  • 16.
    Collaborations with Government  Company’s existing inventions Template: “Background Invention” means an Invention conceived and first actually reduced to practice before the effective date of this Agreement. Background Inventions shall be included in Appendix B. Negotiated: “Background Invention” means an Invention conceived or reduced to practice before the effective date of this Agreement. 16 March 4, 2009 Virtual Law Partners LLP
  • 17.
    Collaborations with Government (cont’d)  New inventions resulting from collaboration Template: “CRADA Subject Invention” means any Invention of a VA Employee, of Collaborator, or of both a VA Employee and Collaborator, conceived or first actually reduced to practice in the performance of the Statement of Work [15 U.S.C. 3703(9), (10)]. Negotiated: “CRADA Subject Invention” means any Invention of a VA Employee, of Collaborator, or of both a VA Employee and Collaborator, conceived and reduced to practice in the performance of the Statement of Work [15 U.S.C. 3703(9), (10)]. 17 March 4, 2009 Virtual Law Partners LLP
  • 18.
    Collaborations with Government (cont’d)  Government reserved rights - third party license Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if VA grants an exclusive license to a CRADA Subject Invention made solely by a VA Employee or jointly with a Collaborator employee, the Government retains the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances, or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by Federal regulations, and such requirements are not reasonably satisfied by Collaborator, or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(2). [Negotiated: No license or sublicense shall be granted to a third party prior to the final outcome of such appeal.] 18 March 4, 2009 Virtual Law Partners LLP
  • 19.
    Collaborations with Government (cont’d)  Government reserved rights – non-exclusive royalty-free license to collaboration inventions. Consistent with the definition of a DAP and pursuant to 15 U.S.C. § 3710a(b)(1)(A) for CRADA Subject Inventions owned solely by VA or jointly by VA and Collaborator and licensed pursuant to the option of Paragraph 6.2 or 6.3, Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on behalf of the Government. In the exercise of this license, the Government shall not publicly disclose trade secrets or confidential commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. § 552(b)(4) or which would be considered privileged or confidential if it had been obtained from a non-Federal party, except where authorized by law. 19 March 4, 2009 Virtual Law Partners LLP
  • 20.
    Collaborations with Government (cont’d)  Government reserved rights – non-exclusive royalty-free License to collaboration inventions made solely by the collaborating company Template: Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made solely by an employee of Collaborator, Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on behalf of the Government for research or other Government purposes. 20 March 4, 2009 Virtual Law Partners LLP
  • 21.
    Collaborations with Government (cont’d)  Government reserved rights – non-exclusive royalty-free License to collaboration inventions made solely by the collaborating company (cont’d) Negotiated: Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made solely by an employee of Collaborator, Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention throughout the world by the Government for research purposes only. 21 March 4, 2009 Virtual Law Partners LLP
  • 22.
    Collaborations with Government (cont’d)  Know what you have when working with academic institutions when using government grants when licensing out the resulting technology  Government contracts and M&A transactions 22 March 4, 2009 Virtual Law Partners LLP
  • 23.
    IP Warranty  To give or not to give? Biotech vs. Software  Sample provisions Biotech: “BiotechCo represents and warrants that it owns or holds licenses to the BiotechCo Patents and BiotechCo Know-How and has sufficient rights and power to grant the licenses to PharmaCo which it purports to grant herein.” 23 March 4, 2009 Virtual Law Partners LLP
  • 24.
    IP Warranty (cont’d)  Sample provisions (cont’d) Software: “SoftwareCo represents and warrants to Customer that: (i) SoftwareCo is the sole and exclusive owner of the Software; (ii) SoftwareCo has full and sufficient right, title and authority to grant the rights and/or licenses granted to Customer under this Agreement; and (iii) the Software does not infringe any patent (to SoftwareCo’s knowledge), copyright, trade secret, trademark or other intellectual property rights of a third party.” 24 March 4, 2009 Virtual Law Partners LLP
  • 25.
    Reversion of rights  Failure to meet diligence obligations  Commercialization of the Product is not scientifically or commercially reasonable  Bankruptcy  Material Breach 25 March 4, 2009 Virtual Law Partners LLP