Analytics Legal analytics Pharmaceuticals and life sciences

28
April
2018

Commercial policy of pharmaceutical company: objectives and conditions

In the recent years, the interest of the pharmaceutical industry participants in the matters related to drafting and application of commercial policies is not declining. Within the framework of this overview, we shall do our best to answer some topical issues relating to application of commercial policies by the business entities that occupy a dominant position on the pharmaceuticals markets and on the medical products markets.
7
November
2017

VEGAS Academy: regulatory updates for the Russian pharmaceutical sector, October 2017

Within the framework of VEGAS Academy platform, we continue our monthly series of video updates on the key regulatory developments in the Russian pharmaceutical sector (in English language).
Сollective of authors, VEGAS LEX
4
September
2017

VEGAS Academy: regulatory updates for the Russian pharmaceutical sector, August 2017

Within the framework of VEGAS Academy platform, we continue our monthly series of video updates on the key regulatory developments in the Russian pharmaceutical sector (in English language).
Сollective of authors, VEGAS LEX
11
July
2017

VEGAS Academy: regulatory updates for the Russian pharmaceutical sector, June 2017

In terms of development of VEGAS Academy inner platform we introduce a new instrument created for supporting internal information space of our growing Life sciences practice. That is monthly series of video with comments on news and current legal framework of pharmaceutical industry in Russia (in English language).
Сollective of authors, VEGAS LEX
23
September
2016

Usage of court injunctions in IP disputes. What may be done by market players?

The mechanism of court injunctions may effectively protect the exclusive rights of market players. The APC provides enough instruments to protect the business. Therefore, it is not necessary to change the existing laws and regulations. However, the usage of court injunctions in IP-related pharmaceutical disputes is not that simple. The court’s opinion in such cases is influenced by the complexity of pharmaceutical patents and the social factor. Thus, it is crucial to form a positive judicial practice to protect the IPR of pharmaceutical manufacturers (specifically in cases related to IP protection during state procurement of medicines). Below, we provide the roadmap on current practical gaps in this sphere, and possible ways to move things forward.
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
24
June
2016

Exclusive rights of copyright owner during a tender: law enforcement practice

In this review, we consider when requirements for owning exclusive rights may be made for a tender participant, and what opportunities are there for the protection of the copyright owner’s exclusive rights, when these are violated as a result of a tender.
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
23
November
2015

New developments in patent cases in pharma

In November 2015 the Arbitration court of Moscow region rejected the originator's patent claim against the local drug manufacturer. Following the decision of the Supreme Arbitration Court in well-known Imatinibum case in 2009 the Arbitration court of Moscow region decided that no patent infringement may occur prior to state registration of a pharmaceutical product. Furthermore, the court gave several potentially important interpretations of IP regulations applied to pharmaceutical products. The relevant conclusions of the court may influence the future development of IP practice in pharmaceutical sector in Russia.
Alexander Sitnikov, Managing partner
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
20
February
2015

Wholesale and retail mark-ups in VED trading: price regulation and state procurement

Federal Law dated 5 April 2013 No. 44-FZ “On the contract system in the area of procurement of goods, works, and services for state and municipal needs” (hereinafter – the Law No. 44-FZ) for the first time consolidated in federal legislation special rules governing the purchase of vital and essential drugs (VED). Nevertheless, already in the first year of application of these provisions, conflicting interpretations arose on the part of government customers, regulators, and market participants. (This legal update is available only in Russian)
Alexander Sitnikov, Managing partner
20
October
2014

The practice of state procurement of drugs and medical devices. New rules of the game

Adoption of the Federal Law dated 05 April 2013 No. 44-FZ “On the contract system in the procurement of goods, works, and services for state and municipal needs” (hereinafter – the Law No. 44-FZ) substantially changed the procedure for holding public auctions. For more details, read this research report. (This legal update is available only in Russian)
1
August
2014

Interchangeability of biologic drugs in Russia. Future challenges for gene therapy

Today most European countries prohibit automatic substitution of biologic drugs. However, it seems not to be the case in Russia. High-cost breakthrough biological drugs are still procured by the state at public auctions under their INNs and not their trade names, which in most of the cases makes biologic drugs of different manufacturers automatically interchangeable. Furthermore, the HCPs in Russia must prescribe the drugs under their INN, unless a healthcare commission decides that no alternative therapy exists for a particular patient (then the necessary drug may be prescribed under its trade name).
21
March
2018

From equivalence to interchangeability and vice versa

Interchangeability of medicines has always been of concern to pharma market participants. However, year by year, this issue brings up more questions than answers. From January 2018 the information on interchangeability of medicines will be subject to inclusion into the state register of medicines.

9
October
2017

VEGAS Academy: regulatory updates for the Russian pharmaceutical sector, September 2017

Within the framework of VEGAS Academy platform, we continue our monthly series of video updates on the key regulatory developments in the Russian pharmaceutical sector (in English language).
Сollective of authors, VEGAS LEX
9
August
2017

VEGAS Academy: regulatory updates for the Russian pharmaceutical sector, July 2017

Within the framework of VEGAS Academy platform, we continue our monthly series of video updates on the key regulatory developments in the Russian pharmaceutical sector (in English language).
Сollective of authors, VEGAS LEX
17
November
2016

IP Court interpreted IPR protection provisions stipulated in the Federal Law "On Circulation of Medicines"

Intellectual Property Rights Court in its judgment dated 20.09.2016 on case No. A40-158999/2015 ruled on the issue of what constitutes grounds for the cancellation of state registration of a drug, which was in violation of the rights of the patent holder.
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
Dmitriy Borodin, Project manager of corporate direction
8
August
2016

Long-term procurement arrangements in the pharmaceutical sector: new options or additional risks?

From 1 September 2016, investors under special investment contracts (SPICs), as well as regional investors, may benefit from additional preferences during the procurement of various types of product for state and municipal needs. Whether these preferences will create long-term procurement options in the pharmaceutical sector is one of the key questions for pharmaceutical companies planning to invest in localisation in Russia.
Alexander Sitnikov, Managing partner
21
June
2016

Public procurement: protecting the exclusive rights of copyright holders

We present, for your information, a collection of articles on issues in the field of exclusive rights protection for copyright holders in the course of public procurement.
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
4
March
2015

Advertising of drugs: risk matrix

Advertising and promotion of pharmaceuticals is a delicate and difficult task, since in this sphere intersect the art of attracting attention to the product, ethical principles and mandatory rules contained in advertising legislation as well as legislation on the protection of competition. In this regard, in order to facilitate the work of advertising and creative departments of pharmaceutical companies, as well as to simplify the work of advertising agencies – the counterparties of such companies, we prepared a summary matrix of the main risks, based on the analysis of law enforcement practice in the field of advertising of medicinal products. (This legal update is available only in Russian)
Alexander Sitnikov, Managing partner
2
February
2015

Regulatory developments in pharmaceutical sector in Russia: February 2015

According to MoH, starting on 1 March 2015, it is prohibited to sell medicines included into the EDL for 2015, if the drug manufacturers fail to register the maximum sale prices for such medicines. Further to the Federal Law “On Drug Circulation”, this prohibition applies to drug manufacturers, wholesalers and pharmacies. It also means, that such essential drugs (with no price registered) will not be admitted to state tenders subject to the direct provisions of the Federal Law “On Contractual System for State Procurement”.
Alexander Sitnikov, Managing partner
3
October
2014

IP Immunities For Drug Manufacturers On The Russian Market

On 23 September 2014 the Court of Appeal ruled that IP immunities may not be regarded as a valid excuse for a patent holder/trademark holder in case of abuse of dominance on the drug circulation market, inter alia in those cases where a drug manufacturer refuses to enter into a supply agreement with its distributor.
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
2
July
2014

Court sought lost profits from a foreign company, caused by the violation of antimonopoly legislation

On 24 June 2014, Arbitration Court of Moscow decided to recover from a foreign manufacturer of medicines damages in the amount of 408.375 million roubles in favour of their Russian counterpart (Case No. A40-14800/14). (This legal update is available only in Russian)
Alexander Sitnikov, Managing partner
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