{"id":25786,"date":"2026-05-11T10:47:35","date_gmt":"2026-05-11T10:47:35","guid":{"rendered":"https:\/\/ponsip.com\/ip-case-law\/the-case-of-genentech-key-points-on-the-analysis-of-inventive-step-in-colombia\/"},"modified":"2026-05-11T10:48:31","modified_gmt":"2026-05-11T10:48:31","slug":"the-case-of-genentech-key-points-on-the-analysis-of-inventive-step-in-colombia","status":"publish","type":"ip-law","link":"https:\/\/ponsip.com\/en\/ip-case-law\/the-case-of-genentech-key-points-on-the-analysis-of-inventive-step-in-colombia\/","title":{"rendered":"The Case of Genentech: Key points on the analysis of inventive step in Colombia"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Nicol\u00e1s Carvajal Reyes.<\/strong> Technical Director of Patents. PONS IP Colombia <\/p>\n\n<p class=\"wp-block-paragraph\">In a recent decision (27 November 2025), the Colombian Council of State upheld the refusal of the patent right by the Superintendency of Industry and Commerce (SIC) for patent application No. 10099320 filed by the applicant Genentech, Inc., relating to antibody compositions targeting domain II of the HER2 receptor. The ruling, handed down last November in case number 11001-03-24-000-2014-00486-00, constitutes a significant decision in the field of industrial property, particularly regarding the assessment of the requirement of inventive step in biotechnological inventions.<\/p>\n\n<p class=\"wp-block-paragraph\">The case focuses on the patent application entitled \u201cCOMPOSITIONS COMPRISING ANTIBODY THAT BINDS TO DOMAIN II OF HER2 AND ACIDIC VARIANTS THEREOF\u201d, for which the SIC refused the patent right on the grounds that it lacked an inventive step in light of the prior art. Having exhausted all administrative remedies, the company filed a lawsuit seeking the annulment of the decisions that refused the patent, seeking its granting as a restoration of the right. <\/p>\n\n<p class=\"wp-block-paragraph\">The grounds for the refusal and subsequent upholding of said refusal centred on compliance with the requirement of inventive step, as set out in Article 18 of Decision 486 of the Andean Community, according to which an invention must not be obvious to a person skilled in the art on the basis of the prior art.<\/p>\n\n<p class=\"wp-block-paragraph\">In this case, the SIC based its analysis of inventive step on two relevant prior art documents, D1 (US2006\/0018899) and D2 (Free Sulfhydryl in Recombinant Monoclonal Antibodies), which, when considered together, made it possible to derive the claimed invention. Document D1 had already disclosed anti-HER2 antibody compositions with variants, while document D2 described structural modifications in antibodies, particularly in disulphide bonds, including reduced and non-reducible variants.<\/p>\n\n<p class=\"wp-block-paragraph\">The Council of State requested a preliminary ruling from the Court of Justice of the Andean Community on Articles 14 and 18 of Decision 486. Based on the preliminary ruling on Article 18 of Decision 486, the Council of State applied the problem-solution approach. Based on this analysis, it concluded that the difference between the invention applied for and the prior art lay in the inclusion of certain acidic variants of the antibody. Nevertheless, it concluded that this difference did not result in an unexpected technical effect or a verifiable substantial improvement.   <\/p>\n\n<p class=\"wp-block-paragraph\">A key aspect of the ruling is the assessment of the technical evidence. Although the claimant argued that their invention offered pharmacokinetic advantages\u2013a claim supported by an expert opinion provided by a professional in the field of pharmaceutical chemistry\u2013the Council of State found that the data submitted did not demonstrate a significant improvement over what is already known. The concentration curves and other parameters analysed were equivalent to those of the prior art, which undermined the argument that significant technical progress had been made.  <\/p>\n\n<p class=\"wp-block-paragraph\">Furthermore, the Court emphasised that the acidic variants cited in the application were foreseeable to an expert in biotechnology, as they arise from post-translational processes commonly found in antibody production, as also explained by the expert witness called by the SIC. Consequently, their inclusion in a pharmaceutical composition did not involve any additional inventive skill, but was an obvious alternative given the existing knowledge. <\/p>\n\n<p class=\"wp-block-paragraph\">The ruling also reinforces a fundamental principle of patent law: the burden of proof lies with the applicant when seeking to rebut an objection regarding lack of inventive step. In this case, the evidence presented by Genentech failed to demonstrate a distinguishing technical difference or convince a person skilled in the art that the modification constituted progress or an improvement in light of the prior art identified. <\/p>\n\n<p class=\"wp-block-paragraph\">This decision sets an important precedent in the field of pharmaceutical and biotechnology patents; however, beyond the specific outcome of this case, the decision offers several valuable lessons for patent applicants. Firstly, it highlights the importance of drafting applications backed by solid experimental evidence that demonstrates unexpected technical effects or verifiable advantages over the prior art, which can facilitate the processing of applications by various patent offices. <\/p>\n\n<p class=\"wp-block-paragraph\">Furthermore, decisions of this kind reflect a trend that has been gaining ground for several years in the field of intellectual property, covering both patents and other intangible assets: the importance of integrating an IP strategy from the early stages of business development and growth. Drawing up a comprehensive prior art report that includes a thorough analysis of the relevant literature on the prior art. Correctly identifying the closest prior art documents and anticipating potential objections can make the difference between a patent being granted or refused.  <\/p>\n\n<p class=\"wp-block-paragraph\">In environments where technological advances and the development of new solutions are occurring at an ever-increasing rate, and where patents are key strategic assets, such rulings compel inventors and companies to raise the bar in terms of innovation and preliminary studies of technologies. It also strengthens the role of the authorities and courts in ensuring that the patent system protects only genuine technological advances, thereby preventing unjustified monopolies on obvious developments. <\/p>\n\n<p class=\"wp-block-paragraph\">Lastly, regardless of the specific outcome of this case, decisions of this kind provide insight into how patentability criteria are being interpreted and applied in Colombia, offering useful guidance for both applicants and intellectual property advisers. At the same time, it reaffirms the role of inventive step as one of the key mechanisms for ensuring that patent protection is granted to developments that represent genuine technical contributions. <\/p>\n","protected":false},"featured_media":25783,"template":"","categorias-ip-litigations":[115],"class_list":["post-25786","ip-law","type-ip-law","status-publish","has-post-thumbnail","hentry","categorias-ip-litigations-inventions"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The Case of Genentech: Key points on the analysis of inventive step in Colombia<\/title>\n<meta name=\"description\" content=\"In a recent decision (27 November 2025), the Colombian Council of State upheld the refusal of the patent right by the Superintendency of Industry and Commerce (SIC) for patent application No. 10099320 filed by the applicant Genentech, Inc., relating to antibody compositions targeting domain II of the 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