OM Weekly Digest (10-02-2017)

2 May, 2017

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COLOMBIA | Patents, Regulatory | Inclusion of Glivec® under Colombian price control regime for pharmaceuticals affected by Declarations of Public Interest entered into force

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On 3 February 2017, entered into force Resolution (Circular) 4 of 2016, through which the National Pharmaceutical Price Commission (NPPC) included Glivec® -of Novartis- to the direct control of prices established in Resolution (Circular) 3 of 2016 by the Colombian Ministry of Health, for medicines affected by Declarations of Public Interest (DPI)

The methodology established in Circular 3/2016 is highly controversial, by stipulating that the medicines subject to price control must have as maximum sales value, the lowest price of all competitors in the countries of reference (using generic imatinib prices).

COLOMBIA | Intelectual Property | Modification to the Colombian foreign investment regime has implications in Intellectual Property

On 26 January 2017, the Colombian Government issued Decree 119/2017, which modifies the foreign capital investment regime in that country (contained in Decree 1068/2015)

The new Decree considers that all direct investments of “non-Residents” (natural and legal persons that do not have their man domicile in Colombia, or natural persons that do not remain in the country more than 183 calendar days a year) made on intangible assets acquired for the purpose of being used to obtain an economic benefit in the country (as royalties), shall be understood as foreign capital investments.

As a consequence of the above, any non-resident who acquires trademarks, patents, copyright protected works, etc., must be registered before the Colombian Central Bank (Banco de la República) to expatriate royalties.  These obligations only apply if royalties are paid.

USA | Copyright | USA: Copyright Alert System ends

 

On January 2017, US Internet Services Providers (ISPs) and Copyright titleholders subscribed to the Copyright Alert System stopped its application (implemented by themselves in 2013 through the Center for Copyright Information -CCI-).
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The system was based on six strikes for users accessing to protected content in an unauthorized manner, and included “mitigation measures” as temporary slow-down of internet access speed, or temporary redirection to an educative page in copyright.
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The oficial statement about the conclusion of the Copyright Alert System does not indicate reasons for its end.  However, it is believed that this could be because the system was only capable of monitor content shared in peer-to-peer networks, excluding other means of distribution (as streaming).

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COLOMBIA | Intellectual Property, Copyright, Regulatory | New Minor Offences Law entered into force in Colombia: provisions related to intellectual property and regulatory

Approved by Law 1801 of 2016, on 30 January 2017 started the application of a new Minor Offences Law in Colombia, replacing the previous one (issued on 1970).

In intellectual property matters, the new regulation reiterates and/or includes sanctions in the following areas:

  • If payment of royalties in copyright to holders of protected content is not met.  As an example, in the case of economic activities in establishments where musical copyrighted works are publicly executed, it is required as a mandatory requirement for the development of the economic activity, the presentation of up-to-date proof of payment in favor of its titleholders or representants (such as Collective Management Societies).

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In regulatory law, there will be sanctions:

  • If behaviors that threaten public health are committed (as the storage and commercialization of foods that do no comply with the sanitary regulations of the Colombian Regulatory Authority)

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Failure to comply with any of the provisions, implies the temporary or definitive suspension of the commercial activity, as well as fines depending on the severity of the behavior.

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COLOMBIA | Intellectual Property | Colombian Patent and Trademark Office updates its internal administrative procedure in accordance with procedural laws issued in the last 5 years

On 30 January 2017 -and by means of Regulation 2356/2017– the Superintendence of Industry and Commerce (SIC) updated its principal regulation (Circular Única) in accordance with the procedural laws issued in Colombia during the last 5 years.

Its main novelty is in its update in accordance with the provisions of Law 1755 of 2015, which regulates the “Petition Right” (Derecho de Petición in Spanish) procedure before public entities in Colombia.

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