Preparation of draft licensing agreements and agreements on the alienation of exclusive rights in pharmaceutical sector and healthcare

Amendments to the registration documents of medical devices

BRACE Law Firm, within the framework of the “Healthcare and Pharmaceuticals” practice, provides legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law. We provide legal assistance in the areas of business support, dispute resolution and litigation, government and corporate procurement, competition law, international trade law, regulatory aspects, and compliance issues.

One of the important areas of legal services in the framework of the “Healthcare and Pharmaceuticals” practice is advising on the preparation of draft licensing agreements and agreements on the alienation of exclusive rights.

Licensing and Alienation Agreements

When concluding these agreements, it is important to take into account both the general requirements for concluding and regulating the terms of the agreements and the particularities of the transferred result of intellectual activity / exclusive rights. This is since most of the invented drugs and medical devices are unique and have strictly individual features that are of high importance and value, both for the manufacturer and for potential patients. In this regard, when preparing a license agreement and / or an agreement on the alienation of exclusive rights, it is recommended to seek legal assistance.

According to the license agreement, one party - the holder of the exclusive right to the result of intellectual activity or the means of individualization (licensor) grants or undertakes to provide the other party (licensee) the right to use such a result of such means to the extent provided for in the agreement. The licensee may use the result of intellectual activity or a means of individualization only within the framework of those rights and in the ways provided for by the license agreement. The right to use the result of intellectual activity or means of individualization, not expressly specified in the license agreement, should not be considered granted to the licensee. The exclusive right to the result of intellectual activity is a set of rights to use the results of intellectual activity.

Depending on the type of the result of intellectual activity, the conclusion of licensing agreements and agreements on the alienation of exclusive rights has its characteristics.

In recent years, in the pharmaceutical field, the number of disputes related to the protection of exclusive rights has increased significantly. This is facilitated by the factor of active development of the generic market and the desire of manufacturers of original drugs to protect their rights to the sole production of drugs within the terms of patent protection, as well as through the application of the legal institution of data exclusivity of clinical trials.

Settlement of possible disagreements in the event that a pharmaceutical company has decided on the voluntary alienation of exclusive rights, possibly on a contractual basis. Also, in some cases, such agreements (license agreement and agreement on the alienation of exclusive rights) are subject to the conclusion with distributors.

Legal services

    1. Development of licensing agreements and / or agreements on the alienation of exclusive rights for pharmaceutical companies, organizations involved in the circulation of medical devices and other organizations.
    2. Legal audit of the submitted draft license agreements and agreements on the alienation of exclusive rights with the preparation of protocols of disagreements, as well as legal opinions, revealing possible legal risks.
    3. Advising on the conclusion of licensing agreements and agreements on the alienation of exclusive rights.
    4. Representation of interests of a client when participating in negotiations within the framework of concluding licensing agreements and agreements on the alienation of exclusive rights, assistance in resolving disagreements with counterparties.

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