Novartis – MPP, Nilotinib, Non-Exclusive License Agreement

Intellectual property | Protection of IP

Summary of Approaches

Novartis – MPP License

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
- Novartis maintains the exclusive right, but not obligation, to maintain, prosecute, defend and enforce the licensed patents.

Form of Sublicense

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement? How should IP protection expenses be allocated between the parties?
- The Sublicensee has no rights related to the conduct of any matter relating to the licensed patents.
- Novartis has the sole right, but not obligation to defend any suits for patent infringement or to bring infringement actions at its own expense.
- The Sublicensee is responsible, at its own expense, for the selection, registration, maintenance, defence and enforcement of the trademarks that it uses in relation to the Product.
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
- The Sublicensee will notify MPP and Novartis in writing in the event that a third party brings a suit against the Sublicensee for patent infringement.
- The Sublicensee will cooperate with Novartis in any litigation.

Annotations

This License Agreement, effective as of 18 October 2022, is between Novartis Pharma AG (“Novartis”) and the Medicines Patent Pool (“MPP”). MPP is a non-profit organization with a mission to improve the health of people by increasing access to quality, safe, efficacious and affordable medicines by facilitating access to intellectual property to allow for the rapid development and manufacturing of these medicines. Under the Agreement, Novartis grants MPP a freedom-to-operate license to grant non-exclusive sublicences to suitably qualified manufacturers to use certain Patents (registered in Egypt, Guatemala, Indonesia, Morocco, Pakistan, the Philippines, and Tunisia) and a Manufacturing Patent (registered in India) to develop, manufacture and supply pharmaceutical products containing nilotinib (“Product”). Sublicenses must be consistent with the Form of Sublicense attached as Schedule 1 to the Agreement. A list of sublicensees and copies of the related sublicense agreements are published on MPP’s website.

Sublicensees may only sell the Product for a use approved by the relevant regulatory authority (“Field”) in 44 low- and middle-income countries (“Territory”). India is permitted as a Manufacturing Territory only. Sublicenses are royalty-bearing, with royalties payable at 5% of Net Sales to the Access to Oncology Medicines (ATOM) coalition, a global collaboration of private and civil society partners which aims to address the barriers to availability, affordability and appropriate use of oncology medicines in low- and lower-middle income countries. Novartis is an ATOM partner, and MPP is an official observer.

Provision Language

Novartis – MPP License

8. INTELLECTUAL PROPERTY

[…]

8.2 Novartis shall have the exclusive right, but shall be under no obligation, to maintain, prosecute, renew, defend or enforce the Manufacturing Patent or any of the Patents. MPP shall have no rights to maintain, prosecute, renew, defend or enforce the Manufacturing Patent or any of the Patents and nor shall it purport to grant any such rights to any Sublicensee or Third Party.

Form of Sublicense

10. INTELLECTUAL PROPERTY

[…]

10.3 The Licensee shall have no rights in relation to the conduct of any matter relating to the Manufacturing Patent, the Patents or any other patents or patent applications owned or controlled by Novartis, including the filing, prosecution and maintenance thereof.

10.4 If any suit or claim by a Third Party is instituted against the Licensor or the Licensee for patent infringement involving the Products and/or the Raw Materials, the party sued shall promptly notify the Licensor and Novartis in writing. Novartis shall have the sole right, but not the obligation, to defend or to conduct the defence of such suit or claim at its own expense. The Licensee shall assist Novartis and co-operate in any such litigation at Novartis’s request and expense.

10.5 Novartis (and in no circumstances the Licensee) shall have the exclusive right, but not obligation, to bring infringement action at its own expense. To the extent Novartis decides not to bring any such infringement action, Novartis shall not be liable to the Licensee in any respect for such decision. The Licensee shall assist Novartis and co-operate in any such litigation at Novartis’s request without expense to the Licensee.

11. TRADEMARKS

[…]

11.2 Licensee, at its expense, shall be responsible for the selection, registration, maintenance, defence and enforcement of all trademarks which it employs in connection with the Products to be sold by the Licensee in the Territory under this Agreement and shall own and control such trademarks. Nothing in this Agreement shall be construed as a grant of rights, by licence or otherwise, to the Licensee to use the name (alone or as part of another name) or other designation or any other trade name, trademark, logo, or other words, names, symbols or devices owned or licensed by the MPP, Novartis, and/or any of their Affiliates anywhere in the world for any purpose.

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Novartis – MPP, Nilotinib, Non-Exclusive License Agreement

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Novartis – MPP, Nilotinib, Non-Exclusive License Agreement

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