Legal Alliance Company is pleased to inform you of new services, that we have developed for pharmaceutical companies running business in Ukraine.

Due to the growing competition among the participants of the pharmaceutical market (competitive cases, public procurement, etc.), the winner is the one who is aware beforehand of the risks that threaten its products being circulated in the market. Accordingly, it is possible to take preventive actions related to the legal protection of your products from competitorsat pre-registration and registration stages.

According to our practice, the state registration of medicines is frequently completed without conducting a comprehensive patent search. Hence, upon the registration in Ukraine themanufacturer company will be engaged in a dispute. It is not a secret that it is much cheaper to eliminate competitor's product from the market by means of cancellation of its registration within the court procedure , than to invest in the promotional activity of the medicine with a purpose of leaving behind a direct competitor. On the other hand, as a rule, the difference in price between the generic and the original version of the product is so significant that money losses due to correction of the price to the original drug is ten times greater than the expenses for the court proceedings. As an example of similar situations may serve well-known cases for the protection of products containing escitalopram, ritonavir, abacavir, perindopril and others.

In order to ensure stability and success of medicinal product at its market segment, we would recommend to take care of it reliable legal backup being provided with the following legal services:

• implementation of the patent search prior to drug registration in Ukraine;
• monitoring of applications for patents, utility models, industrial designs (layout packages) and trade marks for goods and services (trade marks) for medicinal products;
• protection of the design of primary and secondary packaging and trade name of the product;
• analysis of registration risks and maintenance of the registration process (preparation of a reasonable responses to the remarks of the State Expert Center, assuring the effective patent protection for medicinal product at the State Expert Center);
• legal assistance in the preparation and submission of the registration dossier - this support will reduce the regulatory risks and avoid delays and protractions within theexamination of the registration dossier;
• support for submission of registration dossiers to the State Expert Center;
• development and analysis of instruction for medical use for an existence of competition (antitrust) violations, the elimination of unmotivated contraindications and remarks recommended by the State Expert Center for inclusion thereto;
• support for import of unregistered medicinal products, standards and reagents for registration in Ukraine;
• provision of a reasonable conclusion of pharmaco-legal expertise of the bioequivalence of generic medicine to the medicine of comparison;
• legal control over the registration of generic drugs in Ukraine;
• support on issues of quality control and GMP certification prior to starting the process of state registration of medicines in Ukraine

Should you be interested in a more detailed proposal, please contact a Partner with Legal Alliance Company Ilya Kostin (kostin@l-a.com.ua) by e-mail or phone +38 044 220 15 84(85, 86).