SOW-Payment of Patent Maintenance and Annuity Fees - 01062022.pdf

Statement of Work

Payment of Patent Maintenance and Annuity Fees

1.0 INTRODUCTION/OVERVIEW

The purpose of the project is to provide payment of United States (U.S.) patent maintenance fees and foreign annuity fees for the patent protection of inventions of the National Institutes of Health (NIH) and the Centers of Disease Control and Prevention (CDC) employees in the United States and foreign countries.

1.1 BACKGROUND

Pursuant to the Federal Technology Transfer Act (FTTA) of 1986, the NIH Office of Technology Transfer (OTT) is responsible for certain aspects of the technology transfer programs for the NIH and CDC. An important part of the Act is obtaining and maintaining patent protection for the inventions of NIH and CDC employees. The OTT assists in pursuit of patent prosecution in the United States and a number of foreign countries primarily under the terms of the Patent Cooperative Treaty (PCT), but may file patent applications in countries not under the terms of the PCT. Worldwide patent filings may provide an incentive for a company to license the technology and bring the drug/therapy to market.

Countries worldwide, including the United States, typically require that patent annuity and/or maintenance fees be paid. If the fees are not paid in a timely manner, patent applications or patents will lapse and have no further enforcement or intellectual property value. These worldwide patent applications may be licensed to companies who may use the patent or sell commercial products in one or more countries and remit royalties to the NIH. The licensing royalties are provided to the IC and the inventors. The NIH and CDC could lose millions of dollars in potential royalties if these patent application/patents were to lapse due to non-payment of annuity fees.

1.2 SCOPE

The nature of the activities is for the Contractor to undertake the part of the Government tracking of patent cases in order to pay the approximately 3,000/year annuity or patent fees to maintain the patents and patent applications in the United States and foreign countries.

The United States and each foreign country have different requirements, time frames, and fees to pay. Payment of annuities is not an inherent Governmental function.

Failure to follow the appropriate steps will cause the U.S. Government to lose intellectual property rights in the United States and foreign countries. Such a loss has a serious and direct effect on the Government. First, there would be a dramatic loss since all costs and efforts to date to establish the patent(s) would be lost. This would be a substantial amount since years of efforts may have been undertaken and significant financial investments have been made to establish the patent rights in the United States and the foreign countries.

Second, there is a direct loss of income from licensing of the patent in the United States or the foreign countries. Depending on the technology, this can amount to millions of dollars annually for the past period of patent protection, which may be up 20 years from date of initial patent filing. Third, there is the cost of damage to the marketability of the product in the United States and the foreign countries. If the OTT, on behalf of the NIH and CDC fails to maintain a patent, any entity in that country may take the technology and manufacture it without concern as to the rights or payment fees to the inventors and/or assignee, in this instance, the U.S. Government.

1.3 OBJECTIVES

Safely and efficiently maintain, monitor, and effect annuity, maintenance fee, and/or renewal fee of NIH and CDC patent portfolios. Establish efficient means of communications between the NIH and the Contractor.

2.0 REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work described herein:

1. Contractor shall provide the professional services and personnel with the expertise to maintain the database, perform data integrity checks to verify critical patent numbers and dates against available public information, pay patent maintenance fees and annuity fees on behalf of the NIH and CDC. The Contractor will respond to inquiries regarding specific client questions and providing access to information about worldwide patent laws.

2. Upon award of contract, the Contractor shall provide a timely updated transition plan of data ensuring all the data is accurately uploaded after consultation with OTT. To include, at a minimum, identifying those patents and patent applications where immediate payments are required, performing integrity data checks, identify formatting or data type problems or potential errors. Resolve any issues identified in the data review.

3. Maintain records of all patents and patent applications that have been filed with the United States Patent and Trademark Office (USPTO) and/or foreign countries either by

NIH or CDC, or on behalf of the OTT, or by a third party where there are government co-inventors.

4. Provide OTT Contracting Officer's Representative (COR) with reports listing U.S and foreign patents and patent applications that require maintenance or annuity fees to be paid with the estimate of cost in U.S. dollars for each.

5. Pay annuities as determined by country laws and regulations by the due date as designated from the reports submitted to and agreed to by the OTT COR. In the event no instructions are provided to the Contractor not to pay, the Contractor will pay the maintenance or annuity fee.

6. Examine the impact of adjustments or revisions in the patent annuity or maintenance fees of the United States and foreign countries with whom the NIH has activity and advise the OTT COR as to the action that needs to be taken to meet those changes.

7. Treat all information as strictly confidential.

8. Maintain all such information with the full understanding that they are the exclusive property of the Government. At the completion of the contract, this information shall be delivered to the Government or the successor Contractor at the direction of the OTT

COR.

9. The Contractor’s field naming conventions may vary, but it will have fields that can be utilized to accommodate the client’s internal designations for querying, reporting, and filtering of data. The deliverables will be provided in specified formats as the Government intends to import, for cost tracking purposes, the annuity/maintenance fee data from the Contractor's Periodic Report of Annuities (PRA), invoice reports, and resolution reports into its own proprietary database. Example data such as estimated cost, actual cost, resolution changes, related dates, and invoice numbers into the organization’s proprietary database to track the individual patent related expenses. Minimally required fields for all Excel and delimited text files are: WIPO Country Abbreviation, Case Type, Application Number, Filing Date, Patent Number, Issue Date, Annuity Due Date, related annuity financial amount (e.g. annuity cost, invoiced amount, resolution), Annuity Number, Comments/Remarks, IC Division, NIH POC, NIH Base Reference Number (e.g.

E-123-2000), Full NIH reference number (e.g. E-123-2000/0-US-01).

10. Provide access to real-time secure web database(s) and tools for web based decision making.

11. Provide a secure web site to allow OTT to provide documents or files to Contractor, e.g. text files for uploading data into Contractor’s database or invoice submission.

2.1 DELIVERABLES

The Contractor shall notify, via email, the OTT COR of the reports availability listed below via secure website(s). The Contractor shall provide these deliverables in PDF for the reports, and use Excel and text formats for the data files. OTT intends to electronically import annuity/maintenance data from the Contractor's Periodic Reports of Annuities (PRA), invoice reports, and resolution reports into its proprietary database. The reporting field requirements identified below are criterial for these reports, but do not represent the entirety of the report data.

Upon execution of the contract, the actual formatting and fields for the reports will be determined.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

Annuities and maintenance fees will herein be referred to as Annuities Patents and Patent applications will herein be referred to as Patents

NOTE: The naming conventions used herein are being used as examples. The timelines listed below are constructed for NIH’s ability to coordinate the internal review from the various components of the NIH and CDC (herein referenced as ICDiv) of their filing decisions/approvals, the funding allocations, and notifications to the Contractor.

The following deliverables shall be completed and submitted electronically as stated herein:

Item Description

Delivery Schedule

Deliverable Types

1. Periodic Report of Annuities (PRA)

The PRA will identify the 3 or 4 months (TBD) of the Patents and the Annuities that will need to be paid during the reporting period.

Client’s Points of Contact will begin to review and submit Pay/Don’t Pay decisions for 3 months.

Five (5) months prior to the start month of the PRA

A notification email shall be sent to denote the document’s availability.

Web accessibility for PDF, Excel and Text http://www.hhs.gov/web/508/index.html

2. Invoice Reports of Patents:

a. Summary – By ICDiv, For foreign countries, and the amount due to the Contractor for each country.

b. Detail – ICDiv, A listing of the total amount due to the Contractor for each Patent and Annuity.

c. Invoice (formal) – ICDiv Invoice header Information to be provided post contract award.

Two (2) months prior to the PRA start date.

A notification email shall be sent to denote the document’s availability.

Invoice deliverable via a secure web portal.

Web accessibility for PDF, Excel and Text

3.

Invoice Processing:

The OTT COR will return a copy of the invoices to the Contractor. It may indicate any last minute decision changes and will include a detailed listing showing which cases are to be added or deleted.

Contractor shall begin the contract administration to include delivery of orders and payments as stated in Section G. The Contractor shall follow the instructions for invoice submission as stated in Section G of the contract.

One (1) month prior to the start month of the PRA

Web accessibility for providing PDF, Excel and Text

4. Post-Patents Invoice Reports:

a. Paid Patents – A listing of the Annuities identifying the Patents paid and the actual Annuities amount paid. For foreign countries, the exchange rates will be identified.

b. A listing of Annuities Debits or Credited by ICDIV

c. Non-paid Patents – A listing of the Patents where

Annuities were due, but were not paid by the Contractor.

After payment of Annuities has been made the document’s availability.

Web accessibility for PDF, Excel and Text

5. Invoice Resolution Reports:

a. A listing of the Patents and Annuities with the actual amount paid and any related Debits or Credits. For foreign countries, the exchange rates will be identified.

b. Individual Debit and Credit Invoices by ICDIV that have occurred since the invoice date.

After payments have been made the document’s availability.

Web accessibility for PDF, Excel and Text

6. Instruction Confirmation Reports: Monthly A notification email

A list of the Patents and Annuities Paid, Non-Paid, Expired, or Not Responsible for Payment the document’s availability.

Web accessibility for PDF, Excel and Text

Each report shall be identified with the following data:

1) Contract Number

2) Date of Report

3) Report Title

4) Performance Period

4.0 SECURITY REQUIREMENTS

Electronic web based system(s) to be provided by the Contractor must provide NIH with a secure web based, multiuser web site(s) that incorporates security levels for various user level access and will allow secure file and data transfer. User access shall require, at a minimum, a user account name and password. The software shall be used to provide secure notices of future annuity due dates at a minimum of 6 months in advance. The user role access privileges shall, at a minimum, include: Administrator/DBA(s), regular user accounts with “Read Only”, or “Edit” functionality.