Onyx Therapeutics v. Natcofarma: Appeal Dismissed by São Paulo Court
Onyx Therapeutics Inc. brought a declaratory judgement action against Brazilian generics manufacturer Natcofarma do Brasil Ltda over BR112012028726B1, a patent covering methods of preparing low-chloride pharmaceutical compositions. The Court of Justice of São Paulo declined to hear the appeal, closing the case on 25 June 2025.
São Paulo court refuses appeal in low-chloride pharma composition dispute
Onyx Therapeutics Inc., the originator patent holder, initiated a declaratory judgement proceeding against Natcofarma do Brasil Ltda, a Brazilian generic pharmaceutical manufacturer, before the Court of Justice of São Paulo (Case No. 2116005-03.2025.8.26.0000). The dispute centred on BR112012028726B1, a granted Brazilian patent protecting a method of preparing a pharmaceutical composition with low chloride content — a formulation technique directly relevant to generic drug equivalence and regulatory approval pathways in Brazil.
The case reached an appellate posture, but the Court of Justice of São Paulo issued a ruling stating ‘IT IS NOT KNOWN of the appeal,’ a procedural formula under Brazilian civil procedure indicating the appeal was not admitted for substantive review. The basis of termination is recorded as ‘Appeal Dismissed.’ This means no merits determination was made: neither party received a judicial ruling on the validity or infringement of the underlying patent through this proceeding.
Because no filing date is available in the public record, the full duration of the dispute cannot be assessed. The dismissal of the appeal without merits adjudication is a notable procedural outcome — it leaves the substantive patent dispute unresolved at this level. What drove the non-admittance (procedural defect, jurisdictional bar, or untimely filing) is not specified in the available public record, and the parties’ next steps remain unknown.
Filing to Appeal Dismissed in 0 days
Case closed 25 June 2025; filing date not available in the public record
Appeal not admitted: what the São Paulo ruling means for both parties
Appeal dismissed without merits: a procedural, not substantive, end
Under Brazilian civil procedure, a court declaring ‘IT IS NOT KNOWN of the appeal’ means the appellate body declined to admit the appeal for substantive review. This is a procedural non-admittance — the court did not rule on patent validity, infringement, or the merits of the declaratory judgement claim. The underlying legal question therefore remains unresolved through this specific proceeding.
No merits rulingOnyx Therapeutics: no enforceable win, but no adverse merits ruling
For Onyx Therapeutics, the dismissal of the appeal is procedurally neutral on patent validity. BR112012028726B1 remains a granted Brazilian patent with no adverse court ruling against it from this proceeding. However, the failure to obtain a substantive judgment means the dispute with Natcofarma over this formulation method has not been conclusively resolved, and the patent’s enforceability against this specific defendant remains untested at the merits level.
Patent status unchangedNatcofarma: no invalidity declaration, litigation risk persists
Natcofarma do Brasil did not secure a declaratory judgement of invalidity or non-infringement through this proceeding. While the appeal’s dismissal ends this case, it does not resolve Natcofarma’s exposure to the underlying patent. The generic manufacturer may face renewed enforcement action from Onyx Therapeutics, or may need to pursue separate administrative or judicial routes — such as an INPI administrative challenge — to contest the patent’s validity.
Merits dispute unresolvedLow-chloride formulation patents remain a live risk for Brazilian generics
The non-admittance of this appeal without a merits ruling suggests that procedural strategy matters significantly in Brazilian pharmaceutical patent disputes. For generics manufacturers operating in Brazil, the case is a reminder that originator patent holders can use declaratory and injunctive proceedings to delay or complicate market entry. BR112012028726B1’s validity and scope remain untested judicially, leaving commercial uncertainty for any party working in low-chloride pharmaceutical composition methods.
Brazilian pharma IP riskFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Onyx Therapeutics Inc | Company | Originator pharmaceutical company — holder of BR112012028726B1Search in Eureka ↗ |
| Defendant | Natcofarma do Brasil Ltda | Individual | Natcofarma do Brasil Ltda — Brazilian generic pharmaceutical manufacturerSearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Justice of Sao PauloSearch in Eureka ↗ |
Official order — verbatim text
The phrase ‘IT IS NOT KNOWN of the appeal’ is a standard Brazilian procedural formula indicating non-admittance at the appellate level — the court declined to review the appeal on its merits, typically due to a procedural defect such as untimely filing, lack of standing, or failure to meet formal admissibility requirements. This is not a ruling on patent validity or infringement. Neither Onyx Therapeutics nor Natcofarma do Brasil receives any substantive determination from this outcome; the underlying declaratory judgement dispute over BR112012028726B1 remains unresolved.
BR112012028726B1 — method of preparing a pharmaceutical composition with low chloride
BR112012028726B1 is a granted Brazilian patent protecting a method of preparing a pharmaceutical composition with low chloride content. The patent entered the Brazilian national phase under application number BR112012028726, suggesting an international PCT origin with a priority date likely in the 2010–2011 period. Low-chloride formulation methods are technically significant in pharmaceutical manufacturing — chloride levels can affect drug stability, tolerability, and regulatory bioequivalence assessments, making such formulation know-how commercially valuable for both originator and generic drug development.
For Onyx Therapeutics, BR112012028726B1 represents a formulation-layer patent that can extend market exclusivity beyond the primary compound patent by protecting the manufacturing process itself. In the Brazilian pharmaceutical market, where ANVISA requires bioequivalence data and generic manufacturers rely on replicating formulation methods, a granted process patent of this type can create a meaningful barrier to generic entry. The patent’s survival without any adverse judicial ruling to date — despite active litigation with Natcofarma — suggests it remains a live enforcement asset in Brazil.
Should you run an FTO analysis against BR112012028726B1?
Any pharmaceutical developer, generic manufacturer, or contract development and manufacturing organisation (CDMO) preparing low-chloride pharmaceutical compositions for the Brazilian market should treat BR112012028726B1 as a material FTO concern. With no invalidity finding on record and no merits ruling from the São Paulo court proceedings, the patent carries full presumption of validity in Brazil. This is particularly relevant for companies seeking ANVISA registration for generic equivalents or biosimilars involving chloride-sensitive formulation methods.
PatSnap Eureka’s FTO Search Agent allows R&D and IP teams to map claim coverage for BR112012028726B1 against their specific process parameters, identify related family members across PCT and national phase filings, and monitor any post-grant administrative challenges filed at INPI. Running a targeted FTO analysis before committing to formulation development or regulatory filings in Brazil is the most cost-effective way to de-risk exposure to this patent family.
Run a freedom-to-operate analysis on BR112012028726B1 to assess your product’s exposure
Run FTO in Eureka →Similar pharmaceutical composition patent disputes in Brazilian courts
Related declaratory judgement and patent infringement cases involving pharmaceutical formulation patents before the Court of Justice of São Paulo and Brazilian federal courts.
What this case signals for the Brazilian pharmaceutical patent landscape
Procedural dismissals in Brazilian appellate courts leave patent disputes unresolved — and commercial risk live for both sides.
Procedural non-admittance in Brazil does not resolve underlying patent risk
When a Brazilian appellate court declines to know of an appeal, no merits judgment is issued. For IP teams monitoring BR112012028726B1, this means the patent’s enforceability against generic competitors in Brazil has not been judicially tested. Enforcement or challenge through alternative routes — including INPI administrative proceedings — remains fully available to either party.
Declaratory judgement strategy is a key tool in Brazilian pharma patent disputes
The use of a declaratory judgement action by Onyx Therapeutics against Natcofarma is consistent with originator strategies to proactively establish patent rights before a generic product launches. Monitoring declaratory judgement filings at the Court of Justice of São Paulo can provide early warning of where originator-generic tensions are escalating in the Brazilian market.
Onyx v Natcofarma — key questions answered
This phrase is a standard Brazilian civil procedure formula indicating the appellate court declined to admit the appeal for substantive review. It is a procedural non-admittance — not a ruling on patent validity or infringement. The underlying declaratory judgement dispute over BR112012028726B1 was not decided on its merits.
BR112012028726B1 is a granted Brazilian patent held by Onyx Therapeutics Inc. It protects a method of preparing a pharmaceutical composition with low chloride content. The patent entered the Brazilian national phase from an international PCT application, likely with a priority date around 2010–2011. It covers a formulation process relevant to pharmaceutical manufacturing and generic drug development in Brazil.
No. The dismissal of the appeal without merits adjudication does not affect the validity of BR112012028726B1. The patent remains granted and in force in Brazil with full presumption of validity. No court in this proceeding issued any ruling on the patent’s validity or on infringement by Natcofarma do Brasil.
Yes. Brazilian law provides for administrative nullity proceedings before the INPI (Instituto Nacional da Propriedade Industrial), which is separate from judicial proceedings. Natcofarma could potentially file or join an administrative nullity action against BR112012028726B1 at INPI, independent of the São Paulo court proceedings that have now been closed.
In Brazil, a declaratory judgement action (ação declaratória) allows a party to seek judicial confirmation of a legal right or status — such as the invalidity or non-infringement of a patent — before or alongside commercial activity. Originator companies like Onyx Therapeutics can use such proceedings proactively to establish patent rights, while generics manufacturers may use them to seek freedom-to-operate declarations. The Court of Justice of São Paulo is a common venue for such disputes given Brazil’s major pharmaceutical market presence.
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