Life Sciences 2020

Last Updated March 18, 2020

Uzbekistan

Law and Practice

Authors



Dentons is one of the leading, full-service legal practices in Uzbekistan, with a fully qualified team of over 25 legal and professional staff. Being part of the world's largest law firm, Dentons (Tashkent) builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size around the world. The firm provides a broad range of legal services to major pharmaceutical and medical companies both domestic and global and advises clients in the healthcare and pharmaceuticals sector. Clients are advised on market entry, placing on the market and use of healthcare products; protection of patents and trade marks and other aspects of intellectual property law; various regulatory matters in the healthcare and pharmaceuticals sector; corporate and M&A deals in life sciences; and compliance and data protection.

In Uzbekistan, they key legislation on medicines and medical devices is the Law “On Medicines and Pharmaceutical Activities” No ORQ-399, dated 4 January 2016 (the Law), which is complemented by a number of supporting regulations and orders.

The main regulatory body in charge of application and enforcement of regulation on medicines and medical device is the Ministry of Healthcare of the Republic of Uzbekistan along with the Agency for Development of Pharmaceutical Industry (the Agency) subordinated thereto. The Agency has both regulatory and executive functions and the latter is performed by the Agency’s unitary enterprise: the State Centre for Examination and Standardisation of Medicines, Medical Devices and Medical Machinery (the Centre). The Centre comprises several departments specialising in different aspects of medicines and medical devices including, among others, the Pharmacological committee, the Pharmacopeial Committee, the Pharmaceutical Inspection unit, the Narcotics Control Committee and a number of specialised laboratories.

Decisions of the Ministry of Healthcare and its departments can be challenged by way of judicial review in the Administrative Court. To challenge a decision, an application must be made to the Court promptly, and, in general, within three months of receipt of the challenged decision. The claim can be brought by applicants whose rights and legally protected interests have been infringed; where barriers have been created to the exercise of those applicant's rights, freedoms and lawful interests; where obligations have been imposed unlawfully; or where barriers have been created to engaging in lawful activity.

The Court’s function is to assess the decision made by the regulator or public authority for compliance with the law and infringement of the applicant’s rights and lawful interests. The court can recognise the decision as invalid in part or in whole, or the action (or inaction) pertaining thereto as illegal, but the court cannot remake the decision of the regulator/public authority.

The general statutory term for reviewing the application is 35 days.

The Law differentiates between medicines, medical devices and medical machinery. That being said, it should be noted that, under the laws of Uzbekistan, medical devices and medical machinery are regulated similarly. For the distinguishing criteria for these three categories, please refer to 3.1 Assessment Process and Criteria.

General requirements with respect to the purpose and procedure of clinical trials are established by the Law, which differentiates between pre-clinical studies and clinical trials. Notably, under the Law, medicines and pharmacological substances are subject to both pre-clinical studies and clinical trials, whilst medical devices only to pre-clinical studies.

Detailed procedure for clinical trials is set forth by the Instruction for Performance of Clinical Trials of Medicines and Expert Examination of Trial Materials (the Instruction), which was approved by the Order of the Minister of Healthcare No 334 dated 25 July 2001, and O’z DSt 2765:2018 “Good Clinical Practice” (GCP) national standard, which was developed in accordance with the ICH GCP. The GCP is being implemented gradually, by compulsory certification thereunder of all clinical sites of the Ministry of Healthcare by 1 January 2022.

For securing authorisation, the sponsor submits its application and materials for a planned clinical trial to the Centre. The Centre then conducts expert examination of the provided materials and takes a decision on the authorisation of the clinical trial. Expert examination is conducted on the basis of the contract concluded between the Centre and the sponsor.

In accordance with the Law, clinical trials may be authorised on the following grounds:

  • results of pre-clinical studies confirming safety and efficiency of pharmacological substance or medicine;
  • existence of data evidencing that possible risk of side effects resulting from application of pharmacological substance or medicine will be significantly lower than expected positive effect.

Moreover, performance of clinical trials is subject to approval of the Ethics Committee composed of representatives of medical organisations, research and development organisations, higher education institutions, mass media, NGOs and other civil society institutions.

The laws of Uzbekistan do not provide for a public database or register of conducted or pending clinical trials.

However, under the GCP, clinical trials shall be conducted in accordance with the World Medical Association (WMA) Declaration of Helsinki, which, inter alia, provides that every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Thus, registered clinical trials may be found at the International Clinical Trials Registry Platform.

There is no general express restriction on using online tools to support clinical trials, provided that such online tools comply with the GCP requirements as to audit trail and electronic trial data handling and/or remote electronic trial data systems.

However, it should be noted that, under the Instruction, certain documentation (eg, informed consent) requires the handwritten signature of the subject.

The data resulting from clinical trials will be considered as personal data under the Law “On Personal Data” if it contains information on identifiable natural persons. In this case, the data will also be considered as a medical secret. Therefore, any transfer of such data is subject to the consent of the person to whom it relates; consent that is given for a concrete term and a concrete purpose.

The owner of a database containing personal or sensitive data has to register, with the national data protection authority (the State Personalisation Centre under the Cabinet of Ministers of Uzbekistan), the fact that they maintain such a database.

In Uzbekistan, there is no separate assessment process and criteria for determining whether a product should be classified as a medicine or as a medical device. However, the Law differentiates between medicines, medical devices and medical machinery.

The Law defines these three notions as follows:

  • Medicines — products manufactured based on medical substances and auxiliary substances, medical substances by themselves, or drugs; allowed for use in medical practice for prevention, diagnosis and treatment of illnesses, as well as to change a human organism’s condition and functions.
  • Medical devices — devices; allowed for use in medical practice for prevention, diagnosis and treatment of illnesses, as well as to change a human organism’s condition and functions.
  • Medical machinery — apparatus, equipment, appliances, instruments, tools and systems; allowed for use in medical practice for prevention, diagnosis and treatment of illnesses, as well as for detection and to change a human organism’s condition and functions.

From the definitions above, it may be concluded that all three items have a common purpose (ie, prevention, diagnosis and treatment of illnesses, as well as to change a human organism’s condition and functions) with medical machinery also being used for detection of the same. However, the distinguishing line may be drawn based on the material form of the item, as the medicines are chemical and biological substances, whilst the medical devices and machinery are special tools or equipment. Moreover, taking into account similar regulation of medical devices and machinery, it may safely be concluded that the distinction between these two categories is blurred.

Marketing authorisation (MA) is granted as a result of the state registration of a medicine or medical device by the Centre.

The following are the subject to state registration:

  • medicines;
  • new combination of medicines registered in Uzbekistan;
  • medicines previously registered in Uzbekistan, but produced in new forms, doses or by other producers; and
  • medical devices/medical machinery.

Although the procedure for all types of medicines and medical devices is the same, the content and volume of documents may vary. For example, registration of medicines requires submission of administrative documents; chemical, pharmaceutical and biological information on the medicine; and reports of pre-clinical and clinical trials, whilst the list of documents required for registration of medical devices is less extensive.

Notably, submission of a good manufacturing practice (GMP) certificate along with the report of the last instruction is compulsory for foreign producers.

Moreover, upon submission of documents confirming that a medicine has been produced in accordance with GMP, clinical trials thereof have been conducted in accordance with GCP and that a system of pharmacovigilance is implemented in accordance with good pharmacovigilance practice, the Centre registers the medicine without conducting clinical trials in Uzbekistan. The only exceptions are immunobiological medicinal products, which require WHO pre-qualification for being registered without pre-clinical studies. 

The registration of medicinal herbal raw materials requires indicating binominal scientific names for the plant, the chemical type and the active parts, as well as a definition of the herbal substance.

At the same time, the registration of animal-derived medicines requires the applicant to provide data on the animals used for production of the medicine, the risk of prions content, the technological process involved, and source materials control.

MAs are issued for five years, both for medicines and medical devices, with a possibility of renewal for another five years upon submission of an application and supporting documents three months prior to the MA’s expiration. The procedure for MA renewal is the same used to obtain an initial MA with the following differences:

  • the holder is not required to submit reports of pre-clinical studies and clinical trials; and
  • in the case of medical devices, the holder is obliged to submit reports of hospitals confirming the safety and efficiency of the medical device.

As a general rule, suspension of an MA is possible only by court decision if the holder violates permissive requirements applicable to the MA or refuses to obey a decision of the Centre to eliminate a revealed violation. However, if the suspension is required to prevent emergencies – epidemic or other real threats to the life and health of a population – the Centre is entitled to suspend the MA for the term not exceeding ten days. The right to terminate the MA also belongs to the Centre or to the courts, depending on the type of violation committed by the holder. Thus, the Centre may terminate the MA for, inter alia, holder’s avoidance of compliance checks conducted by the Centre or causing harm to the life or health of a person.

The holder may initiate variation of the MA by submitting an application and supporting documents. The Centre will refuse to vary an MA if the requested variation would lead to a deterioration of the quality, efficiency or safety of the medicine or medical device in question.

MAs may be annulled by the Centre upon the written application of the holder thereof, or by a court if the MA is issued based on forged documents. The annulment is announced through mass media and the Centre’s website.

The procedure for obtaining marketing authorisation for medicines and medical devices from the Centre may be summarised as follows:

  • an applicant submits the application, registration dossiers and samples;
  • the Centre conducts preliminary expert examination;
  • following the positive results of a preliminary examination, the Centre conducts the expert examination under the contract concluded with the applicant;
  • the Centre examines the registration dossier and sample’s compliance with normative documents;
  • based on the examination materials, the Centre issue its opinion and passes it to the Expert Council under the Ministry of Healthcare;
  • the Expert Council decides on registration of the medicine; and
  • following the positive decision of the Council, the Ministry of Healthcare issues the MA.

During the registration procedure, the Centre or Council may require inspection of production facilities. In practice, such inspection is required if the manufacturer does not have a GMP certificate or other doubts exist as to the conditions of production. The Centre may also require additional examinations and studies to be conducted in order to verify the efficacy and safety of medicines or medical devices.

The aggregate term for registration of a medicine or medical devices is 155 working days, exclusive of time required for removing shortcomings in the submitted documents.

Variation of the MA requires the holder to submit the application and supporting documents adjusting such variation. The scope and contents of supporting documents is not stipulated in law and is therefore determined by the Centre on a case-by-case basis.

The laws of Uzbekistan are silent on the possibility of the transfer of an MA from one holder to another and no formal procedure for such a transfer is contemplated therein. In practice, the decision on a transfer is taken by the Centre, which in some cases allows a transfer to be conducted through variation of the MA, whilst in other cases it requests new registration of the medicine or medical device.

From 2018, Uzbekistan has recognised the registration of medicines performed in countries with high regulatory requirements (as per a list approved by the President) and by the European Medicines Agency. The recognition process is less burdensome than registration. However, the applicant is still required to provide certain materials, including the certificate of pharmaceutical document, the medicine’s normative document and samples of the medicine in quantities sufficient for trials in accordance with the normative document.

The Law provides for limited instances where unauthorised medicines and medical devices may be imported to Uzbekistan, including for the purposes of:

  • research and development;
  • pre-clinical studies and clinical trials;
  • state registration;
  • exhibitions, expositions and international forums; and
  • personal use in limited quantities.

In addition, the Law allows the import of orphan medicines intended for treatment of rare diseases as per the list approved by the Ministry of Healthcare.

Under the Law, MA holders are obliged to inform the Ministry of Healthcare on new data available with respect to the safety, quality and efficiency of relevant medicines, medical devices and medical machinery. In the case of medical devices and medical machinery, the laws of Uzbekistan do not provide for any other technovigilance obligations. As such, holders of MAs for medical devices do not have any other technovigilance obligations imposed upon them.

At the same time, for medicines, a pharmacovigilance obligation to report all side reactions to the Ministry of Healthcare is imposed on healthcare institutions, pharmacies and all other entities producing, selling and applying those medicines. Upon receiving such a report, the Ministry assesses the side reactions with a view to discovering whether there is a causative link between the medicine and the side reactions.

As a result of such assessment the Ministry may either oblige the producer, or representative thereof, to take measures to mitigate negative effects and minimise the harm or decide on the withdrawal of the medicine in question and the suspension of application thereof.

Under the laws of Uzbekistan, public bodies are obliged to disclose any available information, unless that information is marked as confidential. In practice, all contracts concluded between the Centre and applicants provide for confidentiality of all information contained in the application and registration documents. Therefore, the Centre considers all applications and information contained therein as confidential and, consequently, does not disclose information on refused or pending applications to third parties.

The Law prohibits the import, production, supply, procurement and use of substandard, falsified, unregistered or counterfeit medicines and medical devices.

At the same time, the Law provides for the withdrawal from circulation, and the destruction, of only those substandard, falsified, unregistered or counterfeit medicines and medical devices that have adverse effect on human health.

The owner of illegal drugs is obliged to withdraw them from circulation and eliminate them within 30 days following their discovery, as per the procedure approved by the Cabinet of Ministers. This destruction is done under supervision of a special commission, which should include representatives of the State Committee for Ecology and Environmental Protection, sanitary and epidemiological authorities, and the Ministry of Healthcare. 

Medicines and medical devices are subject to compulsory certification under Regulation No 122. Therefore, it is compulsory to submit a certificate of conformity, issued or recognised by the National Certification Agency of Uzbekistan, to the customs authorities during the import of medicines or medical devices. The customs authority checks whether the actually imported goods correspond to the submitted certificate of conformity.

Moreover, under the Regulation No 185, if the medicines and medical devices are recognised as counterfeit during customs clearance or certification, they should be either removed from the territory of Uzbekistan or cleared into a customs regime of destruction.

Production of both medicines and medical devices is considered to be pharmaceutical activity, which is subject to licensing by the Agency. Applicants may choose between a general or an expedited licensing process, the latter being more burdensome in terms of fees collected. A licence for production of medicines and medical devices also entitles the holder to engage in the wholesale of the medicines and medical devices produced thereby. At the same time, the licence is issued for production of a specific type of pharmaceuticals or medical devices.

The application for the licence shall be submitted to the Agency, together with data evidencing compliance with the requirements approved by the Ministry of Health of the Republic of Uzbekistan with respect to material and technical base, including equipment and other technical means necessary for the production of medicines and/or medical devices, as well as availability of sufficiently qualified personnel.

Following the submission of documents, the Agency passes them to the expert commission, which then reviews the documents and arranges for an in situ inspection, conducted in order to verify the applicant’s compliance with licensing requirements. Currently, compliance with O’zDST 2766:2018 “Good Manufacturing Practice” is not included in the licensing requirements. However, all domestic manufacturers will be subject to compulsory certification thereunder by 1 January 2022.

Following the results of the inspection, the expert commission decides on granting the licence, which is issued for five years based on the licensing agreement executed between the applicant and Centre.

The wholesale of medicines and medical devices is subject to licensing by the Centre. Applicants may choose between a general or an expedited licensing process, the latter being more burdensome in terms of fees collected. The wholesale of medicinal-plant raw material requires separate licensing procedures, which may be performed simultaneously with licensing procedures for the wholesale of medicines and medical devices.

The application for the licence shall be submitted to the Agency, together with data evidencing compliance with the requirements approved by the Ministry of Health of the Republic of Uzbekistan with respect to material and technical base, including equipment and other technical means necessary for the wholesale of medicines and/or medical devices, as well as the availability of sufficiently qualified personnel.

Following the submission of documents, the Agency passes them to the expert commission, which then reviews the documents and arranges for an in situ inspection, conducted in order to verify applicant’s compliance with licensing requirements.

Following the results of the inspection, the expert commission decides on granting the licence, which is issued for five years based on the licensing agreement executed between the applicant and Centre.

In addition, the laws of Uzbekistan provide for the concept of “social pharmacies”, which are arranged for by the Ministry of Healthcare, primarily for the sale of pre-determined socially important drugs and provision of free medicines to the persons entitled thereto. (see 7.3 Reimbursement from Public Funds). The activities of social pharmacies are regulated by the Resolution of the Cabinet of Ministers No 334 dated 03 May 2018, which, inter alia, allows the establishment of social pharmacies on a public-private partnership basis.

The Law classifies two types of medicines:

  • over-the-counter medicines; and
  • prescription medicines.

The list of over-the-counter medicines is approved by the Ministry of Healthcare and the medicines not included on this list are only available by prescription.

Medicines containing narcotic and psychotropic substances fall within the scope of the Law “On narcotics and psychotropic substances” and additional requirements are therefore imposed on their circulation under Uzbek legislation.

In addition, the Resolution of the President No PP-4438 dated, 6 September 2019, has introduced the notion of “potent substances”, the list of which is approved by the Cabinet of Ministers upon recommendation of the special commission. Medicines containing certain potent substances are sold only by "social pharmacies" holding a licence for storage and sale of narcotics and psychotropic substances.

The import of medicines and medical devices is regulated by the Law and the general customs legislation of Uzbekistan, which consists of the Customs Code and a number of decrees, resolutions and regulations adopted by the President, Cabinet of Ministers and Customs Committee.

The State Customs Committee is the main governmental agency charged with enforcing the import regulations, including those related to medicines and medical devices.

Only legal entities may act as importers of record, as the import of medicines and medical devices requires a licence for pharmaceutical activities (see 6.3 Prior Authorisations). Physical persons may import medicines and medical devices in limited quantities, as per the list approved by the Customs Committee. Apart from this, the law does not impose any specific requirements for acting as the importer of medicines and medical devices.

Under Uzbek law, the import of medicines and medical devices is not a licensable activity per se. However, as all other activities related to the circulation of medicines and medical devices, including wholesale and retail supply, require a licence, the customs authorities do not allow them to be imported by persons without such licences.

Non-tariff restrictions are imposed based on the Harmonized Tariff Schedule (HTS) Code in accordance with the national laws of Uzbekistan and international agreements concluded thereby.

Uzbekistan is a party to a free trade agreement concluded between member-states of the Commonwealth of Independent States on 18 October 2011. However, it should be noted that a wide-scope reservation made by Uzbekistan before ratification of the Agreement significantly limits the application thereof.

In Uzbekistan, maximum marks-ups are established for both wholesale and retail supply of medicines and medical devices by the Resolution of the President No PP-2647. Mark-ups apply irrespective of the number of intermediaries involved in a transaction. For wholesale, the maximum mark-up is 15%, calculated from the import price or from the cost price in the case of domestically produced medicines and medical devices. Retail mark-up for the “social pharmacies” is 10% from import or cost price. 

There is a list of socially significant medicines, approved by the President, that state medical institutions are obliged to procure at a fixed price – determined by the special Republic Commission upon submission of estimated demand figures by the Ministry of Healthcare and price analytics by the Ministry of Investments and Foreign Trade.

Control over the prices in pharmacies is imposed on the territorial bodies of the Ministry of Healthcare, whilst the Anti-monopoly Committee oversees both wholesale and retail.

Under the Resolution of the President No PP-4554, starting from 1 July 2020, a reference pricing system for medicines is to be introduced, which will provide for the following:

  • registration of maximum prices for each trade name of a medicine;
  • selection of at least ten reference countries belonging to the group of high, above average or below average per capita incomes; and
  • submission to the Agency of data on the manufacturer’s selling price in the country of origin, reference countries and the Republic of Uzbekistan.

The Law “On Protection of Citizens’ Health” provides that certain categories of citizens have a right to free provision of medicines and medical devices during ambulatory (outpatient) care in state medical institutions. The list of such categories is approved by the Cabinet of Ministers and includes, inter alia, persons living with AIDS, single pensioners and veterans. The free medicines and medical devices are provided upon prescription of the attending physician by either the state medical institution itself or the pharmacy, whose costs are then reimbursed by state medical institutions. At the same time, the costs of medicines and medical devices freely provided by the medical institutions are reimbursed from the state budget.

Moreover, certain categories of patients, as per the list approved by the President, have a right to free treatment in state medical institutions. The costs for the medicines and medical devices used for such treatment is reimbursed from the state budget as well.

The laws of Uzbekistan do not provide for the use of cost benefit analysis in determining the prices of medicines and medical devices, nor for determining whether the costs of pharmaceuticals or medical devices should be reimbursed.

The prescription of medicines to patients in medical institutions is carried out by the attending physician by determining one-time, one-day or course doses based on diagnosis and treatment standards and taking into account the type, severity and characteristics of the disease and the age of the patient.

The prescription should include details of the medicines prescribed to the patient; the international non-proprietary name of the medicine, one-day dose, method of consumption, amount and duration are entered into his or her medical documents (medical history, ambulatory medical record, child development history, etc) and signed directly by the physician in charge.

The attending physicians are obliged to get approval of their supervisors in cases of: (i) prescribing more than five medicines at once; (ii) complication of the disease or the emergence of concomitant diseases; or (iii) prescribing dangerous combinations of medicines as per the list approved by the Ministry of Healthcare.

Pharmacies are generally obliged to dispense the medicines stipulated in the prescription in the amount and form conforming therewith. At the same time, whilst the physicians and pharmacies use non-proprietary international names, the pharmacies are encouraged to offer domestically produced medicines first.

There are no specific rules governing the use of medical apps in Uzbekistan. It is unlikely that medical apps will be classified as medical devices or medical machinery under the laws of Uzbekistan, as both of these categories apply to items that have tangible form and therefore cannot be applied to software. 

As of first quarter of 2020, telemedicine remains unregulated under the laws of Uzbekistan as acknowledged in the Concept of Healthcare System Development for 2019-2025 (the Concept 2025) approved by the Decree of the President No UP-5590, dated 7 December 2018. At the same time, there is no prohibition on physicians providing medical attention through a mobile device in the context of ambulatory care.

There are no special rules for the promotion and/or advertising of medicines and medical devices through online portals, company webpages and social networks. However, such activities are subject to general advertising regulations, which prohibit the promotion and advertisement of prescription medicines and require special permission to be obtained from the Ministry of Healthcare for the promotion of medicines intended for minors.

Currently electronic prescriptions are not used, and consequently not regulated, in Uzbekistan as acknowledged in the Concept 2025. It is planned that electronic prescriptions will be implemented by 2025, following the procurement of the relevant infrastructure by all medical institutions, which will necessitate the emergence of a relevant regulatory regime. 

The laws of Uzbekistan allow the retail trade of medical devices and over-the-counter medicines only. The sellers are obliged to obey all storage and transportation requirements applicable to conventional sales, as well as follow relevant documentation and recording procedures.

Currently electronic health records are not used, and consequently are not regulated, in Uzbekistan as acknowledged in the Concept 2025. It is planned that electronic health records will be implemented by 2025, following the procurement of the relevant infrastructure by all medical institutions, which will necessitate the emergence of a relevant regulatory regime. Similarly, cloud platforms are not regulated in Uzbekistan.

Generally, patient’s health-related information is considered to be a medical secret and is prohibited from being disclosed to third parties. The Law “On Protection of Citizens’ Health” contains a limited number of instances, which are mostly related to protection of a patient’s or public health, that make such disclosure permissible. In all other instances, the transfer of information constituting a medical secret to third parties is possible only with the patient’s consent.

Overall, the protection of medical secrecy enjoys regulatory protection similar to that of commercial or proprietary secrets.

Different deal structures (eg, options for licences based on generation of satisfactory data that is sufficient to justify a payment of option exercise fee, co-development and licence, co-commercialisation agreements, split territory or split field) are used without any one dominating amongst them.

If the parties are two residents of Uzbekistan, then they cannot opt for foreign arbitration venues for dispute settlement. The parties may provide for litigation through local courts or may choose local arbitration with the involvement of technical and legal arbitrators or mediators.

In case of cross-border transactions, the parties may opt for international arbitration with Uzbekistan being a party to the New York Convention on the Recognition and Enforcement of Foreign Arbitral Awards. If the parties prefer to opt for litigation with a foreign court, then it is wise to check whether that foreign court's decision can be enforced in Uzbekistan.

It is customary for the parties to define each party’s diligence obligations using the English law standards of "commercially reasonable efforts", or "best efforts" clauses. There is no statutory definition of efforts clauses and, therefore, they are usually defined as contractual terms in order to bring legal certainty to the parties' intentions and expectations. 

Licensors usually seek unilateral termination rights of the licence in case of a change of control of the licensee.

The termination leads to the termination of contractual obligations and the parties do not have the right to demand the return of what has been performed, unless otherwise agreed. The licensor may obtain the rights to the clinical data and IP generated by the licensor prior to termination, unless otherwise agreed by the parties.

Patents are mainly regulated by the Law “On Inventions, Useful Models and Industrial Samples” No 1062-XII, dated 6 May 1994, and the Civil Code of Uzbekistan.

Uzbekistan is also a signatory to the Patent Co-operation Treaty 1970 (PCT). The PCT is administered by the World Intellectual Property Office and provides a single route for filing an application in all of the contracting countries. However, examination and granting is in the competence of the relevant national patent office.

There are no special patentability requirements for pharmaceuticals and medical device products under Uzbek law. An invention (pharmaceutical or otherwise) is patentable if it is new, involves an inventive step, is capable of industrial application, and is not specifically excluded from patent protection.

Claims to second and subsequent medical uses, claims to new dosage regimens, or to new or selected patient populations are patentable as long as they fulfil the usual requirements of patentability (see 10.1 Applicable Laws).

Furthermore, the general provisions related to infringement apply in relation to infringement of second and subsequent patents of pharmaceutical products.

Patent term extensions in Uzbekistan are governed by Regulation No 1678, dated 5 May 2007 (Regulation 1678).

Regulation 1678 allows a patent’s term to be extended for a period equal to the period between the date of filing of the patent and the date of grant of the first authorisation to place the product on the market in Uzbekistan, but in any case up to five years.

Patent term extensions can be challenged by bringing an action against the extension decision of the National Patent Office in the Administrative Court.

It is an infringing act to produce, apply, import, sell, offer to sell, or otherwise introduce into civil circulation or store for such purposes a product containing a patented industrial object.

It is not an infringing act to apply for marketing authorisation before patent expiry. However, the patent holder may apply to the court requesting the prevention of the threat of infringement (by application for marketing authorisation) of patent rights.

The Patent Law lists an exhaustive list of circumstances which are not recognised as patent infringement, some of which might apply to pharmaceutical products and medical devices.

For example, acts carried out privately and for purposes which are not recognised as an infringement act. Furthermore, acts carried out for scientific research or experimental purposes on products containing patented objects are also specifically recognised by the statute as non-infringement.

A compulsory licence for a patent is available if the patent-holder does not use, or does not adequately use, the patented object within three years of its registration date and any person intending and ready to use the patented object requests that the court provide a compulsory non-exclusive licence, provided that the patent-holder refused to conclude a licence agreement when the claimant initially approached them (before the court filing was made). The compulsory licence route is rarely asserted and is of limited relevance in practice.

An action for infringement may be brought by the patent-holder.

The remedies available for infringement are a prohibition of actions infringing the patent, and recovery of damages (or, at the discretion of the patent-holder, an account of the infringer’s profits).

An action for infringement can be brought in the Economic Court. A claim for infringement is first filed with the court. The Court then decides whether the case should be accepted based on formal grounds and appoints a date for the first hearing. The alleged infringer then submits its statement of counterclaim, which may include a counterclaim for invalidity. If the alleged infringer raises a counterclaim, then the patent-holder will in turn serve its own statement of defence. Expert evidence is typically exchanged during the process in written witness statements, and the experts are cross-examined on the content of those statements. The court usually makes the decision, after a few hearings, within one to two months from the date of accepting the case for proceedings.

Invalidity is available as a defence to an infringement claim. However, invalidity claims are in the jurisdiction of the Administrative Courts whereas the infringement claim is filed with the Economic Courts.

A potential generic entrant can start an action to invalidate a patent to “clear the way” in advance of its attempted market entry. There is no practice or requirement of prelaunch declaratory actions for clearing the way. Nor does the authorisation procedure for pharmaceuticals and medical devices take account of patent protection.

A rights-holder has a number of options for tackling counterfeit pharmaceuticals and medical devices.

Trade mark infringement can constitute an administrative offence with a non-significant financial sanction. The holder of a trade mark can also bring a civil action for trade mark infringement under the Law “On Trade Marks, Service Marks and Names of Goods Origins”. As with a patent infringement claim, a trade mark action can be brought in the Economic Courts. Civil proceedings may be appropriate when dealing with counterfeiting on a large scale, or where the rights-holder wishes to take advantage of the procedural tools and remedies offered in civil proceedings.

A trade mark-holder can also submit an administrative complaint to the Anti-monopoly Committee for unfair competition through trade mark infringement under the Law “On Competition”. Unfair competition complaints may be appropriate when dealing with infringers who are likely to cease their infringements if legal action is taken (compared to civil court action, which could be more appropriate against persistent infringers).

Where the counterfeit product also infringes a patent then the patent-holder can commence an action for patent infringement as discussed in 10 Patents. However, for counterfeit products, a trade mark infringement action may be more straightforward.

Counterfeit pharmaceuticals can also be detained by the Uzbekistan customs authorities on entry into the country from outside if the right-holder registered its right with the Customs Committee’s “Register of IP Objects” and requests that the Customs Committee detain the goods which are suspected of infringing that right.

There are no special restrictions on the trade marks that can be used for pharmaceuticals and medical devices, and the general rules under the trade mark laws apply.

As a general rule, the trade mark-holder’s right to object to the resale of goods within Uzbekistan is exhausted after the goods bearing a trade mark have been placed on the market within the country by or with the consent of the trade mark-holder. Hence, the trade mark-holder can object where products are imported from outside to Uzbekistan. However, in judicial practice, it is rare to see courts apply a universal exhaustion principle to trade mark rights finding that any non-counterfeit, genuine goods can be imported and distributed in Uzbekistan irrespective of the trade mark-holder’s consent.

Intellectual property protection is available for the trade dress and design of pharmaceuticals, medical devices or their packaging, subject to the normal restrictions on the relevant intellectual property laws and the labelling requirements of the pharmaceutical laws. The packaging of a product, the precise design of a tablet or the design of a medical device are capable of being protected as registered designs, subject to the usual requirements for such protection.

There is no period of regulatory data protection and marketing protection to protect investments made under Uzbek law. However, an application for marketing authorisation can mark the information as confidential and the regulator has an obligation not to disclose data which qualifies as confidential.

Dentons

58-a Bobur Street
Tashkent
Uzbekistan
100022

+99 878 150 3105

ulugbek.abdullaev@dentons.com https://www.dentons.com/en
Author Business Card

Law and Practice

Authors



Dentons is one of the leading, full-service legal practices in Uzbekistan, with a fully qualified team of over 25 legal and professional staff. Being part of the world's largest law firm, Dentons (Tashkent) builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size around the world. The firm provides a broad range of legal services to major pharmaceutical and medical companies both domestic and global and advises clients in the healthcare and pharmaceuticals sector. Clients are advised on market entry, placing on the market and use of healthcare products; protection of patents and trade marks and other aspects of intellectual property law; various regulatory matters in the healthcare and pharmaceuticals sector; corporate and M&A deals in life sciences; and compliance and data protection.

Compare law and practice by selecting locations and topic(s)

{{searchBoxHeader}}

Select Topic(s)

loading ...
{{topic.title}}

Please select at least one chapter and one topic to use the compare functionality.