Argentine Patent Law establishes that certain subject matter is not considered an invention and therefore cannot be patented:
- Abstract Knowledge and Methods
- Discoveries of natural phenomena or substances existing in nature.
- Scientific theories and mathematical methods.
- Presentations of information without technical character.
- Artistic and Aesthetic Creations
- Literary, artistic, or aesthetic works.
- Purely ornamental designs.
- Organizational and Business Methods
- Plans, rules, and methods for intellectual activities, games, or business.
- Commercial or administrative methods.
- Medical and Veterinary Methods
- Methods of diagnosis, surgical treatment, or therapeutic treatment applied to humans or animals.
- Computer Programs
- Software and algorithms are expressly excluded.
- Inventions Contrary to Public Order or Morality
- Any invention whose commercial exploitation would be contrary to health, safety, the environment, or public morals.
Regarding pharmaceutical products, in May 2012, the Argentine Patent Office together with the Ministries of Industry and Health issued Joint Regulation Nos. 118/2012, 546/2012 and 107/2012, which introduced new guidelines for examining chemical‑pharmaceutical patent applications. Published in the Official Gazette on May 8 and effective May 9, the regulation imposed strict limitations on what can be patented in the pharmaceutical field.
The rules exclude polymorphs, hydrates and solvates as they are considered natural properties of matter, and single enantiomers when the racemic mixture is already known, although inventive processes for obtaining them may be patentable. Markush claims are only accepted if supported by representative examples with full physicochemical data. Selection patents are not recognized as novel, and salts, esters, amides, complexes and other derivatives of known substances are treated as the same substance. Active metabolites are excluded because they are naturally produced in the body, and prodrugs must be fully supported and characterized in the specification.
New formulations, compositions and preparation processes are generally deemed obvious, with exceptions only when they solve a long‑felt need in a non‑obvious way. Combinations of known active compounds, second medical uses and dosage regimes are treated as methods of treatment, which are excluded from patent protection. Additional data during prosecution is accepted only if it does not broaden the original disclosure, and manufacturing methods must be reproducible on an industrial scale.
Although formally presented as examination guidelines, in practice these rules function as binding provisions, significantly narrowing the scope of pharmaceutical patentability in Argentina.