NIH Web Based Survey of DNA-Based Patents
Below is a copy of the survey.
Microsoft Word File Description of Web Based Survey of DNA-Based Patents 5/2/03
Note: CAPITALIZED WORDS in the questions are defined in INSTRUCTIONS AND DEFINITIONS.
The Survey has been divided into 10 steps, summarized here:
- Read Instructions and Definitions (Transmitted separately)
- Complete Basic Information and Policy Questions
- Select patents that are not managed by your institution
- Enter which institution is managing the patents selected in #3.
- Select Never Licensed patents
- Describe why your institution elected to pay maintenance fees on 3 Never Licensed Patents
- Select patents with more than 10 licenses
- Complete questionnaire for patents selected in #7 above
- Associate remaining patents with licenses
- Complete questionnaire for 12 licenses
Step 2.
Basic Information:
1. Biographical and contact info
2. Name of Institution
3. Fiscal Year 2001 for your institution covers the period __________2000 to __________2001.
Step 2 Continued:
Policy and Philosophy: Please provide, if available, references, electronic, or paper, as appropriate, which document i) your institution's policy regarding the patenting and licensing of DNA-based patents (see Definitions) and research tools (either define yourself in part h below, or note that you are working off of the NIH definition), or ii) your office's general practice or operating philosophy regarding such patents and/or research tools.
Confidentiality Provision for Part 1: Check Here __ if we may publish your responses to question 3 below, but without attribution. (The researchers will approach you on a case by case basis for permission to use an attributed quote.)
- Please describe the general practice and/or operating philosophy of your office concerning the patenting and licensing of:
- DNA-BASED PATENTS as defined in the attached Definitions and Instructions.
- a fully sequenced human gene? Example: The human growth hormone gene.
- a fully sequenced human gene which codes for a protein of known function.
- a fully sequenced human gene which codes for a protein which itself is a therapeutic drug.
- a fully sequenced human gene which codes for a protein which is a target for drug discovery.
- a partial human genetic sequence, not a fully sequenced gene, which is a marker for a phenotype.
- Please suggest useful categories of patents which claim nucleic acids sequences from a licensing policy point of view:
- How would your office define research tool?
- Please describe the general practice and/or operating philosophy of your office concerning the licensing of Research Tools, as defined by you above. Is the practice and/or philosophy different if the tool is patented than if it is biological material only? Please comment
Step 3:
Select patents that are not managed by your institution.
Using the web interface, move patents from the starting box “All Patents” which are not managed by your institution to the box “not managed by your institution”
Step 4:
Identify the institution managing the patents selected in Step 3.
Using the drop down menu on the web interface, identify the institution managing the patents selected in Step 3.
Step 5:
Select never licensed patents.
Using the web interface, move patents which have never been licensed from the starting box “All Remaining Patents, after sorting in step 3” to the box “Never Licensed”.
Step 6:
Describe why your institution elected to pay maintenance fees on never licensed patents.
Self explanatory. The computer selects 3 from those identified in step 5, and provides a text entry field.
Step 7:
Select patents with more than 10 licenses.
Using the web interface, move patents to which more than 10 licenses have been granted from the starting box “All Remaining Patents, after sorting in step 3 and 5” to the box “Broadly Licensed”.
Step 8:
Complete questionnaire for patents selected in step 7 above:
A2. For these patents in this license:
Was the funding (please check one)
Primarily U.S.Government ï¿
Some U.S.Government ï¿
No U.S. Government ï¿
A3. Do most of these licenses contain a license to nonpatented biological material, or to other patents not in this survey ?
Yes ï¿ No ï¿
A4. If the answer to (A3) above is “yes”, in your judgment, does the biological material and additional IP provide
Most ï¿
Some ï¿
A Neglible amount ï¿
of the value of the licensed property.
A5. How many total licenses were granted to these patent(s)? ________
How many of the total were Non-Exclusive (see definitions) _________
If a substantial majority were not non-exclusive, please contact the survey administrator, as this alternate form may not be appropriate.
FY First Lic in group became Active _________
FY Last Lic in group became Active _________
FY, if any, First Lic became Inactive _________, All still active ï¿
FY, if any, Last Lic became Inactive _________, All still active ï¿
A6. Reason that First Lic in the group to become inactive became Inactive (please check one):
All the patents in the License Expired ï¿
Terminated by Institution for Nonperformance ï¿
Terminated by Licensee for business reasons ï¿
Other ï¿, if Other, please comment _______________
A7. Reason that Last Lic in the group to become inactive became Inactive (please check one):
All the patents in the License Expired ï¿
Terminated by Institution for Nonperformance ï¿
Terminated by Licensee for business reasons ï¿
Other ï¿, if Other, please comment _______________
A8. If more detailed information is available on the numbers of licenses granted over time (e.g. 10 per year for the first 10 year of life of the patents, rising to 50 per year over the next 6, declining to 20 in the last year of patent life), please provide.
A9. Types of companies which licensed the patent(s) (please review Definitions and check one).
NUMBER OF START-UP’S WHICH LICENSED THE PATENT(S) _____
NUMBER OF SMALL COMPANIES WHICH LICENSED THE PATENT(S) _____
NUMBER OF LARGE COMPANIES WHICH LICENSED THE PATENTS(S) _____
A10. FY, if any, there was a liquidity event regarding a START-UP LICENSEE. ________
A11. Revenue Generation [Web has option to check “not to date”]
FY, if any, all Licenses to these patents generated > $1M GROSS LICENSE INCOME, cumulative _________
FY, if any, all Licenses to these patents generated >$10M GROSS LICENSE INCOME, cumulative_________
A12. Revenue Composition, for $1M < License Income Received cumulative < $10M :
If the group of licenses generated License Income >$1M, what was the revenue composition of all the License Income received starting from the first $1M through and up to $10M License Income received?
Mostly RUNNING ROYALTIES ï¿
Mostly CASHED-IN EQUITY ï¿
Mostly neither RUNNING ROYALTIES nor CASHED-IN EQUITY ï¿
A13. Revenue Composition, for License Income Received > $10M, cumulative
Mostly RUNNING ROYALTIES ï¿
Mostly CASHED-IN EQUITY ï¿
Mostly neither RUNNING ROYALTIES nor CASHED-IN EQUITY ï¿
A14: Qualitative comments on your institution’s approach to diligence for this broadly nonexclusively licensed patent(s):
A15. Diligence, consult Instructions and Definitions and check all that apply to several (at least 3 or 10%, which ever is greater) licenses in the group: [Web has three radio buttons for each question, Yes, No, Information not available]
a) A default other than a financial one will result in termination of the license Y,N, NA
b) A default other than a financial one will result in significant loss of rights under the licenses Y, N, NA
c) The licenses have dated REQUIREMENT(S)) to raise money. Y, N, NA
d) The licenses have dated REQUIREMENT(S) to spend money toward product development. Y, N, NA
e) The licenses have dated REQUIREMENT(S) to submit products for FDA approval. Y, N, NA
f) The licenses have dated REQUIREMENT(S) to sell product. Y, N, NA
A16 . Product Sales. For the licenses in the group:
(i) Earliest FY, if any, any Lic has REQUIREMENT(S) that product must be sold:
Web has a date field, and options to answer “no requirements”, or “information not available”
(ii) FY that the license in (i) was executed
Web has a date field, and the option to answer “information not available”.
(iii) Earliest FY, if any, any product was sold (even if it was not under the license referenced in
Web has a date field, and options to answer “product not yet sold” or “information not available”.
Step 9:
Associate remaining patents with licenses.
Using the web interface, bundle patents into licenses, taking care to use dummy names for the licenses. More than one patent can be in a license, and a patent can be in more than one license. Once this step is completed, the computer will select 12 licenses which form the main questionnaire, step 10 below.
Step 10:
Quantitative information on licenses of DNA-based Patents
For each license, please answer the following questions:
1. Does LICENSE#X contain a license to NON-PATENTED BIOLOGICAL MATERIAL, or to other patents not in this survey?
Yes ï¿ No ï¿
2. If the answer to (1) above is “yes”, in your judgment, does the NON-PATENTED BIOLOGICAL MATERIAL and additional IP provide
Most ï¿
Some ï¿
A Neglible amount ï¿
of the value of the licensed property.
If most of the value of the license comes from IP (other patents, or NON-PATENTED BIOLOGICAL MATERIAL not in this study) then please skip this license)
3. For the patents in LICENSE# X:
Was the funding (please check one)
Primarily U.S. Government ï¿
Some U.S. Government ï¿
No U.S. Government ï¿
4. For LIC#X:
a) FY LIC became ACTIVE _________
b) FY, if any, Lic became INACTIVE _________ License still active ï¿
5. Reason for LICENSE AGREEMENT becoming INACTIVE (please check one):
only required if answer to 4(b) is a year not “still active”
All the patents in the LICENSE AGREEMENT expired ï¿
Terminated by Institution for nonperformance ï¿
Terminated by licensee for business reasons ï¿
Other ï¿ Please Explain: _____________________
6. Type of company that licensed the patent (please review Definitions and check one).
START-UP ï¿
SMALL COMPANY ï¿
LARGE COMPANY ï¿
7. FY, if any, there was a LIQUIDITY EVENT regarding the START-UP. ________
8. (a) Type of exclusivity in license (please review Definitions and check one). Please also, if possible, answer the question about competitive bids for the rights, if there were multiple parties interested in the licensed rights at the time the license was executed.
Exclusive,all fields of use ï¿
EXCLUSIVE, BY FIELD OF USE. ï¿
CO-EXCLUSIVE ï¿
NONEXCLUSIVE ï¿
(b) were there competing interested parties at the time the license was signed? Y ï¿ N ï¿
Comments_____________________________
9. Revenue Generation
a) FY, if any, Lic generated >$100,000 LICENSE INCOME RECEIVED, including patent reimbursement, cumulative
OR, if easier to answer
FY, if any, Lic generated income in excess LEGAL FEES EXPENDITURES ________, Not to date: ï¿
b) FY, if any Lic generated > $1M LICENSE INCOME RECEIVED, cumulative ________, Not to date: ï¿
c) FY, if any, Lic generation >$10M LICENSE INCOME RECEIVED, cumulative ________, Not to date: ï¿
10. Answer only if answer to 9(b) above is a date:
If the license generated LICENSE INCOME RECEIVED > $1M, what was the revenue composition of all the LICENSE INCOME RECEIVED starting from the first $1M through and up to $10M?
Mostly RUNNING ROYALTIES ï¿
Mostly CASHED-IN EQUITY ï¿
Mostly neither RUNNING ROYALTIES nor CASHED-IN EQUITY ï¿
11. Answer only if the answer to 9 ( c ) above is a date:
If the license generated LICENSE INCOME RECEIVED > $10M, what was the revenue composition of the LICENSE INCOME RECEIVED in excess of $10M?
Mostly RUNNING ROYALTIES ï¿
Mostly CASHED-IN EQUITY ï¿
Mostly neither RUNNING ROYALTIES nor CASHED-IN EQUITY ï¿
12. Diligence, consult Instructions and Definitions and check all that apply:
a) A default other than a financial one will result in termination of the license Y, N
b) A default other than a financial one will result in significant loss of rights under the license Y, N
c) Earliest FY, if any, the license has dated REQUIREMENT(S)) to raise money.
_________, NO REQUIREMENTS: ï¿
d) Earliest FY, if any, the license has dated REQUIREMENT(S) to spend money toward product development.
________, NO REQUIREMENTS: ï¿
e) Earliest FY, if any, the license has dated REQUIREMENT(S) to submit products for FDA approval.
________, NO REQUIREMENTS: ï¿
f) Earliest FY, if any, the license has dated REQUIREMENT(S) to sell product.
________, NO REQUIREMENTS: ï¿
g) FY, if any, product was sold. ________, No product has been sold: ï¿