Approval of follow-on biologics in Mexico

por Armando Arenas y Juan Luis Serrano The Mexican General Health Law was reformed on 11th June 2009 to include Article 222bis, which defined biotechnological drugs and allowed for the approval of so-called “biocomparables”.  The decree came into force on 8th September 2009 and the Ministry of Health had a 180-day period to issue all the specific regulations pertaining[...]
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Patent Prosecution Highway in Mexico

Managing Intellectual Property, April 2011 There is good news for applicants in Mexico of patents claiming Paris Convention priority or PCT applications.  As of March 1st, 2011, the Mexican Patent and Trademark Office launched a pilot program whereby they Patent Department will accept as valid the examination carried by an Examiner of the United States Patent[...]
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Congress Amends IP Law

BY ERWIN CRUZ On 20th September 2010 a new decree came into force, reforming several provisions of the IP Law related to patent practice. The main amendments are as follows: The industrial application requirement for patentability was modified to include a need to demonstrate the possibility of the “practical utility” of the invention and to support such[...]
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MEXICAN SUPREME COURT DECIDES ON BROAD INTERPRETATION OF LINKAGE REGULATIONS

BY JUAN LUIS SERRANO Back in 2003, Mexico enacted linkage regulations to avoid the granting of marketing authorizations in violation of patent rights.  The system created by these regulations is far less elaborate than the one set forth by the Hatch-Waxman act in the U.S., as there is no extension/term restoration, and there is no possibility[...]
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Mexican Congress Amends IP Law

BY JUAN LUIS SERRANO, PATENT DOCS, 2010 On June 18, 2010, a decree was published in the Federal Official Gazette, reforming several provisions of the Mexican IP law related to patent practice.  The main amendments are the following: a) The industrial application requirement for patentability was modified to include a need to demonstrate the possibility of “practical[...]
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Mexico to Issue Regulations for Approval of “Biocomparable” Drugs

BY JUAN LUIS SERRANO The Mexican General Health Law was reformed on June 11, 2009 to include an article 222 bis, which defined biotechnological drugs, and allowed for the approval of “biocomparables.”  The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all specific regulations pertaining[...]
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