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COLOMBIA | Patents, Regulatory | Colombia starts a Declaration of Public Interest Procedure (seeking a Compulsory License) for Hepatitis C antivirals
By means of Resolution 5146/2017, the Colombian Ministry of Health (MoH) announced that it will evaluate if there are reasons for a Declaration of Public Interest -DIP- seeking a Compulsory License -CL-) regarding direct-acting antivirals for the treatment of hepatitis C.
The decision was adopted, since a NGO asked the MoH to declare the public interest of patents covering medicines against Hepatitis C which are based in the following active principles (but not limited to):
– Boceprevir; Daclatasvir; Dasavubir; Elbasvir; Faldaprevir; Gazoprevir; Ledispasvir; Ombitasvir; Paritaprevir; Simeprevir; Sofosbuvir; and Telaprevir.
For now is unknown which patents would be subject of this DIP Procedure, because the Colombian Patent Office (SIC in Spanish) and the Regulatory Authority (INVIMA in Spanish) have not yet established the relationship between those and medicines (Marketing Approvals) covered.
Accordingly, the start date of the DIP Procedure would be made known to patent holders only until the SIC and INVIMA (in an internal procedure) inform MoH about the patent-medicine relationship.
There will be a period of 15 working days (counted from the notification date) for patents titleholders to intervene in the DIP Procedure. Within that same term any third party may intervene.
Documentation related to the DIP process for LO purposes is available in the following links (one and two).
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COLOMBIA | Regulatory | Colombia will establish criteria for centralized purchase and supply of medicines
The Colombian Ministry of Health released a Draft Resolution, through which it will establish criteria for the centralized purchase, distribution and supply of medicines.
Specifically, it will establish the mechanism to carry out the centralized purchase and distribution of medicines for the treatment of prioritized diseases.
The draft Resolution can be viewed in the following link.
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COLOMBIA | Regulatory | Requirements for the manufacture and commercialization of alcoholic beverages in Colombia will be updated
On 29 December 2017, the Ministry of Health of Colombia announced a Draft Decree through which would partially amend Decree 1686/2012, which establishes the requirements for the manufacture, marketing, export and import of alcoholic beverages for human consumption.
Specifically, the Draft Decree proposes that alcoholic beverages manufactured and marketed in Colombia must comply with Good Manufacturing Practices (GMP) requirements.
Comments may be submitted until 26 January 2018.
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COLOMBIA | Patents, Trademarks| Colombian Patent and Trademark Office made effective Fees Increase
Starting 1 January 2018, the increases made by the Colombian Patent and Trademark Office (SIC in Spanish) became effective.
As we announced in a previous OM Weekly Digest edition, the fee updates meant an average 6% increase in all filing and prosecution fees of patents, trademarks and others distinctive signs and new creations.
As a novelty, the Resolution expressly stated that there will be no refund of fees paid for any reason.
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COLOMBIA | Consumer Law | New Regime of Protection for Colombian Telecommunications Users entered into force
Starting 1 January 2018, Colombia has a New Regime for the Right Protection of the Communications Services Users, issued by the Communications Regulation Commission (CRC).
Although the New Regime was released on 24 February 2017 (through CRC Resolution 5111/2017), it has been updated on different occasions during 2017.
The New Regime is applicable to telephony, internet and television services, and its socialization will be carried out with the help of the Superintendence of Industry and Commerce.
