(BRPTO’s IP gazette of March 1st, 2017)Phase II of the pilot program for fast track applications with Brazil priority excludes some technical fields and introduces a PPH-like approach.An applicant requesting fast track of an application first filed in Brazil must submit a search report and a technical opinion on the patentability of his or hers […]
(BRPTO’s IP gazette of March 1st, 2017)The BRPTO issued on March 1st, 2017, and made available on March 2nd, a new rule related to the assignment of rights for PCT national phase applications, which revokes Rule #174/2016, issued on December 6th, 2016.Article 16, paragraph 6, of the Brazilian patent statute establishes that when a Brazilian […]
(Federal Official Gazette of February 20, 2017)On February 20 th , 2017, the Ministry of Health (MoH) issued Ordinance #542 of 2017 (Ordinance#542), reallocating the market shares of the PDPs involving monoclonal antibodies (adalimumabe,bevacizumab, infliximab, rituximab and trastuzumab) and etanercept. The market share of thePDPs was distributed between Tecpar, Fiocruz and Butantan, which are government-ownedpharmaceutical […]
After a long waiting, the Ministry of Health published the List of Strategic Products for the National Healthcare System (SUS), indicating the products eligible to receive proposals for PDPs in the 2017’ roundThe Ministry of Health’s Office published on January 27, 2017, a new list of strategic products for the SUS, Ordinance #252/2017, amended on […]
Further comments on the Rule #174 issued by the BRPTO on December 6, 2016.Rule #174 of November 30, 2016, which amends procedures related to the entry of PCT application into the national phase, establishes that:• If the applicant of the Brazilian national phase application is different from the applicant of the earlier application claimed as […]
The BRPTO issued on December 6, 2016, the long awaited Rule #158/2016 implementing the Guidelines for the examination of patent applications claiming computer-implemented inventions.This guideline was under public consultation in 2012, and since then its publication was expected. It makes official the practice that the BRPTO had been applying, since the examiners already examined according […]
Rule # 175, of November 5, 2016, published in December 6, 2016 established the fast-track prosecution program for green patent with the same terms of the pilot program that ended early April this year.The program has proven to be a good alternative against the BRPTO’s backlog. The average time for the BRPTO to grant a […]
On February 10, 2016, the BRPTO granted priority examination to the first set of patent applications under the Patent Prosecution Highway (PPH) pilot program. Applications include BR 10 2013 000290-9 filed by Suncoke Technology and Development LLC on January 4, 2013; BR 10 2013 032934-7 filed by Afton Chemical Corporation on December 20, 2013; and […]
Decree #8,854, published in the Federal Official Gazette (DOU) of September 23rd, 2016, which should be applied on October 10th, 2016, cuts the number of management positions in the Brazilian Patent and Trademark Office (BRPTO). It eliminates two Director positions and creates a new position of Executive Officer. Some functions of the eliminated positions will […]
New pricing guidelines for biosimilars issued by the Brazilian regulatory authorities without an opportunity for public comments reachesthe market with con icting statements.IntroductionOn August 11, 2016, the Brazilian Pharmaceutical Market Regulation Chamber (CMED) issued Notice #9/2016, which established the pricing criteria for biological products approved by the Brazilian Food and Drug Administration (BRFDA) through abbreviated […]
It took the Brazilian Food and Drug Administration (ANVISA) 13 years to update its rules on over-the-counter status requirements and proceduresIntroductionOn August 3, 2016, the ANVISA issued Rule #98 of 2016, containing the administration’s new guidelinesfor a drug to obtain the OTC status, which allows it to be sold without a medical prescription.This rule revokes […]
(BRPTO Official Gazette #2,377, of July 26, 2016)The BRPTO published today, July 26, 2016, the awaited Rule #169/2016 implementing the guidelines for the examination of patent applications on patentability requirements (Block II of the Patent Examination Guidelines).The BRPTO has issued three guidelines for the examination of patent applications.On April 2013, the BRPTO published Rule #85/2013, […]
