Merck – MPP, Molnupiravir License Agreement

Intellectual Property | Protection of IP

Summary of Approaches

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
- The Sublicensee will have no rights in relation to the filing, prosecution and maintenance of the Patents.
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
- MPP and the Sublicensee shall immediately notify MSD of any infringement of Patents and provide cooperation in such legal action taken by MSD to defend the Patents.

Annotations

This agreement between Merck Sharp & Dohme Corp (“MSD”) and the Medicines Patent Pool Foundation (“MPP”), effective from October 26, 2021, provides license grants related to molnupiravir, an investigational oral COVID-19 antiviral medicine (“MSD-MPP Agreement”). Under the terms of the agreement, MPP may grant royalty-bearing Sublicenses for the manufacture and sale of molnupiravir (defined with chemical structure and molecular formula in all forms as the “Substance”) and Product containing monulpiravir. The license grants are restricted to use for the treatment of COVID-19 caused by SARS-CoV-2 (“Field”) in a Territory of 105 lower- and middle-income countries (see Exhibit B, p.29, of the agreement for details). For South Africa, the Territory is restricted to sales through Public Sector channels only. A full list of the Patents applicable to the agreement is provided in Exhibit A (p. 26) of the agreement.

The Form of Sublicense Agreement is attached as Exhibit C to the MSD-MPP agreement. We have included terms from both agreements in our analysis in order to provide a complete overview of how key issues are addressed – the provision sections are sub-titled with either MSD-MPP Agreement or Form of Sublicense.

On January 20, 2022, MPP announced that it had signed sublicense agreements with 27 manufacturers located in 11 countries (Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam) in order to facilitate rapid access to Monulpiravir in LMICs. The resulting products produced by some of the licensees have now been added to the WHO’s list of prequalified medicines.

Provision Language

Definitionsi>b>p>
“span>Patents b>” means Patents shall mean any unexpired letters patent or any patent applications as span>set forth in Exhibit A hereto, that are granted or pending, relating to the Substance and/or Product and made a part of this Agreement, including divisionals, continuations, continuations–in–part, reissues, renewals, substitutions, registrations, re–examinations, revalidations, extensions, supplementary protection certificates, pediatric exclusivity, and the like of any such patents and patent applications, and international (e.g. WIPO), regional (e.g., EPO, EA), and foreign national equivalents of the foregoing.span>p>
MSD–MPP Agreementi>b>p>
2. Scope Of The Grantb>span>p>
2.13b> If MPP becomes aware of a possible infringement of the Patents by a Third Party in any country, MPP will notify MSD immediately so that MSD may decide, in its sole discretion, whether any action is necessary. For the avoidance of doubt, MPP shall ensure that the Sublicensee is aware and abide by the notification requirements of this Section 2.12.span>p>
2.14b> In the event that MSD institutes an action at its expense against alleged third– party infringers with respect to Substance or any Product, or takes action to defend the Patents , MPP agrees to cooperate in good faith with MSD in such action, upon the request of MSD and at MSD’s cost. Any recovery obtained by MSD as a result of such a proceeding or other action shall be retained by MSD.span>p>
Form of Sublicense Agreementi>b>p>
5. Intellectual Propertyb>span>p>
5.4 b>The Licensee shall have no rights in relation to the conduct of any matter relating to the Patents , including the filing, prosecution, and maintenance thereof.span>p>
5.5b> If Licensee becomes aware of a possible infringement of the Patents by a Third Party in any country, Licensee will notify MSD, through MPP, immediately. The decision on whether any legal action is necessary or appropriate shall belong to MSD.span>p>
5.6b> In the event that MSD institutes an action at its expense against alleged third–party infringers with respect to Substance or any Product, or takes action to defend the Patents , Licensee agrees to cooperate in good faith with MSD in such action, upon the request of MSD and at MSD’s cost. Any recovery obtained by MSD as a result of such a proceeding or other action shall be retained by MSD.span>p>

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Merck – MPP, Molnupiravir License Agreement

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Merck – MPP, Molnupiravir License Agreement

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