Analytics Legal analytics Pharmaceuticals and life sciences

24
June
2014

Russian court satisfies the claim for recovery of loss of profit from a foreign pharmaceutical company

On 24 June 2014 Moscow City Arbitrazh court satisfied a claim for the recovery of damages in the amount of RUB 408,375,000 from the foreign pharmaceutical company (case No. A40-14800/14).

Alexander Sitnikov, Managing partner
14
May
2014

Medical devices market. Managing antimonopoly risks

Today, “compliance” policies have been implemented by many companies operating in the medical devices market. Most of these policies are aimed at minimizing the risks of violations of international anti-corruption legislation and sectoral codes of conduct. Nevertheless, these policies should also be designed to minimize the risks associated with the requirements of the peremptory norms of Russian law, and in particular, legislation on the protection of competition. (This legal update is available only in Russian)
24
March
2014

Commercial policies of pharmaceutical companies and medical device manufacturers: new lessons for market players

Federal Antimonopoly Service (FAS) and Russian court practice in addressing unreasonable refusals to enter into a supply agreement continues to develop. Several new cases considered by the FAS and the courts at the end of 2013/beginning of 2014 have enabled the identification of new trends in legal implementation policies.
3
March
2014

What is the future of IP protection during state procurement of drugs?

The issue on the balance of interests of the holders of rights and producers of generic drugs in the lack of legal clarity as to the limits of permitted use of the patented substances is again high on the agenda (after adoption of the Resolution of the Presidium of the Supreme Arbitrazh Court of the RF of 17 February 2014).
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
1
April
2013

Pharma legislative developments review

Legislative initiatives. Regulatory changes. Public Discussions. Court practice.
26
April
2011

Promotion of pharmaceutical products shall be limited

On 21 April 2011, the State Duma received for review from the Ministry of Health and Social Development draft law No. 534829-5 “On the basis of health protection of citizens in the Russian Federation”, which among other things, sets limits on individual ways for the promotion of drugs and medical devices by pharmaceutical companies. (This legal update is available only in Russian)
10
June
2014

Interchangeability of biological drugs. Analysis of foreign experience

We present to your attention a new analytical review “Interchangeability of biological drugs. Analysis of foreign experience.” (This legal update is available only in Russian)
Alexander Sitnikov, Managing partner
6
May
2014

Interchangeability: regulation by manual drive

The issue of interchangeability of drugs has been discussed for a long time already. The positions of regulators and enterprises working in this sector can vary widely and are evolving, but in practice, government customers and physicians regularly face this question. (This legal update is available only in Russian)
18
March
2014

Protection of intellectual property rights on medicines. New practice

In December 2012, the auction commission of the Regional Ministry of Health rejected the application of a supplier of generic drugs, due to patent infringement of the manufacturer of the original drug. FAS Russia, the courts of first and appellate instances found the actions of the auction committee justified. However, on 17 February 2014, the Federal Arbitration Court of the Moscow District sent the case back for a new trial in the Court of First Instance, pointing out that the lower courts had not thoroughly examined the evidence in the case. (This legal update is available only in Russian)
Alexandra Vasyukhnova, Partner, Head of Technology and Investment group
30
May
2013

Pharma and MDS. Latest developments

On 28 May 2013 the Russian Ministry of Justice has registered the order of the Ministry of Economic Development dated 17 April 2013 No. 211 «On the conditions of access of the goods produced in foreign countries for state procurement purposes» (registration number 28536). Today it’s the only document relating to implementation of localization concept in Russia.

12
September
2011

Pharmaceutical Industry: Entering the distribution network. The position of the FAS Russia.

Summer 2011 witnessed the end of 2 major proceedings of the Federal Antimonopoly Service of Russia against OOO Novo Nordisc and Johnson & Johnson LLC. The appeal of the said judgments confirmed the legality of antimonopoly agency decisions, which constitutes a precedent for the companies developing their distribution network in Russia. In fact, in order to eliminate further risk of liability for violation of antitrust law in Russia it is necessary to work out, accept as standard and publicize the requirements for the companies wishing to become a distributor in Russia.
Alexander Sitnikov, Managing partner
1
March
2011

Trade and commercial policies of pharmaceutical market participants. Risk areas

In 2010, the Federal Antimonopoly Service conducted a series of tests, the results of which indicate certain general trends in the approach of the antimonopoly authority to the qualification of provisions of trade and commercial policies. In particular, FAS considered a test case against the two pharmaceutical companies: Johnson & Johnson and Novo Nordisk LLC, the analysis of which allowed identifying key areas of risk for the manufacturers of medicinal products and medical devices. (This legal update is available only in Russian)
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