NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

Intellectual Property | License Grants
Intellectual Property | Ownership of IP
Intellectual Property | Protection of IP

Structural Questions

Ownership of IP

Is the ownership of background intellectual property impacted by this agreement?
What is the scope of background intellectual property?
How will sideground intellectual property be treated?
Who will own new intellectual property arising from the project?

License Grants

Are any licenses granted for the use of background, sideground or foreground intellectual property?
What is the scope of the licensed intellectual property?
What is the territory of the license?
Is the license exclusive or non-exclusive?
Are there any restrictions on the use of the licensed intellectual property?
Are there any specific obligations to exploit the licensed intellectual property?
Can the licensee grant sublicenses to third parties?
Will products manufactured under license be marketed as branded or generic? (i.e. will they bear the licensor’s trademarks/trade dress)

Protection of IP

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
Can the IP owner abandon the prosecution or maintenance of a patent?
How should IP protection expenses be allocated between the parties?

Summary of Approaches

Ownership of IP

Who will own new intellectual property arising from the project?
- IP ownership for this agreement is governed under FAR Clause 52.227-11, which includes the following provisions:
  - Fluidigm has the right to retain ownership of any inventions made under the agreement, provided that it discloses the invention to the government and elects to retain ownership.
  - The government can request that Fluidigm assigns title to the government if Fluidigm fails to disclose the invention, elects not to retain ownership, or fails to file patents.

License Grants

Are any licenses granted for the use of background, sideground or foreground intellectual property? Is the license exclusive or non-exclusive?
- Under FAR Clause 52.227-11:
  - The government must receive a license a worldwide, nonexclusive, nontransferable, irrevocable, paid-up license to practice, or have practiced for or on its behalf, any inventions in which Fluidigm retains ownership.
  - If the government retains ownership of any inventions, then Fluidigm receives a worldwide, nonexclusive royalty-free license under those inventions.
- Under FAR Clause 52.227-14:
  - The government will have Unlimited Rights to use data first produced under the contract and all other data delivered under the contract, unless it is designated as Limited Rights Data.

Protection of IP

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
- Under FAR Clause 52.227-14, Fluidigm must file a patent application within one year of electing to retain ownership of an invention.
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
- Under FAR Clause 52.227-14, Fluidigm must inform the government if it decides not to file a patent application or defend a patent opposition.

Annotations

This agreement between Fluidigm Corporation (“Fluidigm” or “Contractor”) and the U.S. National Institutes of Health (“NIH” or “Government”) was entered into on July 30, 2020. The agreement is part of NIH’s Rapid Acceleration of Diagnostics Advanced Technology Platforms (“RADx-ATP”) initiative which was created to accelerate innovation, development and commercialization for new COVID-19 diagnostics. The scope of work under the agreement includes completion of validation, approval, and production processes to deliver scaled up capacity for a viable diagnostic product.

The agreement was initiated as a Letter Contract with a fixed price of $12,151,000 to enable expedited timelines. It was converted to a definitive contract through an amendment on September 28, 2020, with a fixed price of $34,016,056. Further amendments were made in February and May 2021.

The tests manufactured under the agreement must be sold within the U.S. unless there is insufficient demand in the U.S. for the tests produced with the additional manufacturing capacity funded under the agreement. Additionally Fluidigm must provide tests to end users at a fair market rate that is consistent with objectives to increase and improve COVID-19 testing in the U.S.. Some other aspects of the agreement, including data and patent ownership are governed by the U.S. Federal Acquisition Regulation (FAR).

Provision Language

SECTION I – CONTRACT CLAUSES

Selections will be made by the Contracting Officer during definitization.

I.1. ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

[…]

(p) FAR Clause 52.227-11 Patent Rights-Ownership by the Contractor (May 2014).

(q) FAR Clause 52.227-14, Rights in Data – General (May 2014).

(r) FAR Clause 52.227-14, Rights in Data – General (May 2014) Alternate II (Dec 2007).

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NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

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NIH – Fluidigm, COVID-19 Diagnostic Development Agreement

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