Analytics Legal analytics

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
23
May
2013

Appeal of warnings issued by FAS Russia. Review of practices

A warning is a written notice from FAS Russia to stop actions (or inactions) that contain signs of violation of antitrust laws. Moreover, if the conditions of the warning are fulfilled, then no antitrust case will be launched. It is important to note that SAC RF has not yet stated its position on the possibility of challenging a non-normative act, such as a warning, but rather has refused to transfer a number of cases appealing the warnings from the antimonopoly body to the Presidium for review. (This legal update is available only in Russian)
23
November
2012

Recovery of damages for breach of antitrust laws: Are there any prospects?

(This legal update is available only in Russian)
Alexander Sitnikov, Managing partner
1
November
2012

Private antitrust suits. Perspectives in Russia

Private antitrust suits: what's behind? Private antitrust suits: any precedents? Conclusions and recommendations.

Alexander Sitnikov, Managing partner
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)
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.

1
April
2013

Pharma legislative developments review

Legislative initiatives. Regulatory changes. Public Discussions. Court practice.
5
November
2012

Cartel agreement. Can there be circumstantial evidence?

October 17, 2012, FAS of the Moscow District reversed a lower court decision and confirmed the cartel connection between the bidders on the basis of circumstantial evidence presented by the antimonopoly authority. October 18, 2012, the Ninth Arbitration Court of Appeal adopted a similar decision in another case of collusion in the auction, citing the above practice, and reversed the decision of the court of the first instance.
30
October
2012

Ways of the Federal Law-223 development

October 25, 2012, the Committee on Land Relations and Construction of the State Duma of the Russian Federation helda round table discussion on "The implementation and ways of improving of the Federal Law of July 18, 2011, № 223-FZ "On the procurement of goods, works and services by certain categories of legal entities" (hereinafter - the Law 223-FZ).
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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