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Patent Litigation
On July 25, 2025, Silimed Industria de Implantes LTDA, or Silimed, filed a patent nullity lawsuit against Establishment Labs, S.A., a Costa Rica subsidiary of the Company, or ELSA, in the 1st Regional Federal Court (the Brazilian Federal Court), alleging that ELSA’s Patent No. BR112018072963-9 (the Process Patent), which is one of ELSA’s process patents concerning the manufacturing process for producing the surface architecture of its SmoothSilk silicone breast implants, is invalid. This matter will soon enter the evidence phase. It is estimated that, around the middle of 2027, the Brazilian Federal Court will hold a hearing on the merits.
On August 1, 2025, ELSA filed a patent infringement lawsuit against Silimed in the 2nd Regional Court for Business Jurisdiction and Disputes Related to Arbitration, Sao Paulo, Brazil (the Brazilian State Court) alleging that Silimed infringes ELSA’s Process Patent. It is estimated that, around the middle of 2027, the Brazilian State Court will hold a hearing on the merits.
On October 30, 2025, ELSA filed a patent infringement lawsuit against GC Aesthetics ParentCo Limited, et al., or the GCA Group, in the Unified Patent Court, Brussels Local Division, Belgium (the UPC Court), alleging that GCA infringes ELSA’s Patent No. EP 3 107 487 B1 (the UPC Patent), which is one of ELSA’s patents concerning the surface architecture of its SmoothSilk silicone breast implants. On February 16, 2026, GCA filed a statement of defense and counterclaim alleging, among other things, that the GCA Group does not infringe the UPC Patent and ELSA’s UPC Patent should be revoked in relevant jurisdictions. This matter is in the discovery, or disclosure, phase. On September 21, 2026, the UPC Court will hold a case management hearing. On December 2, 2026, the UPC Court will hold a hearing on the merits.
On February 13, 2026, GC Aesthetics Holdings (Brazil) Ltd (GCA (Brazil) filed a patent revocation lawsuit against ELSA in the Business & Property Court of England & Wales, Chancery Division, Patents Court, in England, United Kingdom (the UK Court), alleging that ELSA’s Patent No. EP (UK) 3 107 487 B (UK Patent) is invalid. On April 28, 2026, the Company served a defense against GCA (Brazil) and a counterclaim against four separate GCA defendants, or GCA Defendants, alleging that the GCA Defendants infringe ELSA’s UK Patent. This matter is in the discovery, or disclosure, phase. Expert evidence is due in November 2026. In April 2027, the UK Court will conduct a liability trial on the merits.
The Company is currently unable to predict the ultimate outcome of these matters. Legal proceedings, including claims regarding potential infringement or misappropriation of intellectual property, often involve complex, technical issues and have outcomes that require judgments, estimates and involve inherent uncertainties. Given the inherent uncertainties associated with legal proceedings, there can be no assurance that these matters, or any future legal proceedings, will be resolved in a manner that does not adversely affect the Company’s business, financial condition, results of operations, or cash flows.