As of March 18 2026, the Guidelines for Examination of Patent Applications relating to Pharmaceutical Inventions adopted in 2012 (the Guidelines) and applied by the Argentine patent office are no longer in force in the country.
For more than a decade, the Guidelines significantly restricted the patentability of chemical-pharmaceutical inventions and shaped examination practice in a manner that differed substantially from that of most major patent offices. Their repeal is expected to have a significant impact on pharmaceutical patent prosecution in Argentina.
Impact of the 2012 guidelines on pharmaceutical patentability
Under the 2012 framework, several categories of pharmaceutical inventions were systematically rejected in practice. The Guidelines raised the threshold for patent eligibility and inventive step to such an extent that most pharmaceutical subject matter beyond novel active compounds faced substantial obstacles during prosecution.
Throughout the duration of the Guidelines, the number of pharmaceutical patent applications decreased. Most of the patents granted during this period related to novel active ingredients, including both small molecules and biologics, the latter also being affected by separate biotechnology-related examination criteria. By contrast, inventions typically developed during life-cycle management stages – such as formulations, compositions, salts, crystal forms, polymorphs, enantiomers, and other so-called secondary inventions – were generally considered unpatentable.
Claims drawn to crystal forms (‘polymorphs’), for example, were frequently considered simultaneously:
Not qualifying as patentable subject matter;
Not novel; and
Non-inventive.
The Guidelines also adopted a particularly restrictive approach to selection inventions in chemistry, often treating generic disclosures such as Markush formulae as novelty-destroying for claims directed to specific compounds. This approach departed from established case law and from standards commonly applied in Europe and other jurisdictions. The effects of these criteria extended to other technical fields where Markush-style claiming is frequently employed.
In practice, even the inclusion of secondary pharmaceutical subject matter in dependent claims could trigger objections. In some cases, examiners considered dependent pharmaceutical compositions containing novel compounds to lack inventive step, despite the fact that the active compound itself was not part of the prior art. In other cases, process claims relating to novel crystal forms were considered allowable only if a reference to the crystal form itself was omitted from the claims.
Only a limited number of applications directed to these types of inventions were granted under the Guidelines, generally following significant restrictions or disclaimers, which limited enforceability. Applicants were often required to limit claims to narrowly defined formulations or to exclude therapeutic indications of use altogether. In some instances, patentability could be established where the invention solved a long-standing technical problem, although the patent office provided limited guidance regarding the applicable standard.
This prosecution environment was often challenging for applicants and practitioners. Examination tended to rely heavily on the prima facie exclusions set forth in the Guidelines, while substantive technical arguments frequently received limited consideration. As a result, prosecution strategy often focused less on persuading the examiner and more on preserving arguments for a potential appeal.
Post-repeal practice and unresolved issues
Following the recent repeal of the Guidelines, practitioners expect Argentine examination practice to move towards a more case-by-case assessment of pharmaceutical inventions, more closely aligned with the standards of major international patent offices. Several applications directed to subject matter that would previously have faced inventive step objections have already proceeded to grant.
Many practitioners also expect examiners to rely once again on the pre-2012 examination approach and on the 2003 guidelines, under which novelty, inventive step, and industrial applicability were assessed in a manner broadly influenced by European practice. Applicants should nevertheless continue to expect objections relating to clarity, claim breadth, and the lack of qualitative or quantitative limitations in composition claims, which remain common across technical fields.
One major unresolved issue concerns second medical use claims. While the 2012 guidelines were in force, these claims were considered unpatentable in part because the therapeutic use of a known product was not regarded as a technical feature capable of re-establishing novelty. More generally, use claims were often considered not to fall within the categories of inventions recognised by the patent office, which traditionally focused on product and process claims.
This issue remains particularly significant in the pharmaceutical field because therapeutic use claims may also be regarded by the patent office as methods of treatment applied to the human body, which are excluded from patentability under Argentine law. While some European-style purpose-limited product claims have occasionally been accepted when drafted in dependent form, these do not amount to full recognition of second medical use claim formats, since a purpose-limited claim dependent on a novel product claim is not a ‘true’ second medical use claim.
To date, the Argentine patent office still does not appear to be granting patents directed to second medical uses, dosage regimens, or certain pharmaceutical combinations that continue to be treated as excluded methods of treatment. Similar approaches remain present in several other Latin American jurisdictions, where the combined effect of treatment exclusions and the limited recognition of use claims substantially restricts protection for medical use inventions.
Nevertheless, Argentina’s pharmaceutical patent practice now appears to be moving towards greater alignment with international standards. As discussions regarding accession to additional patent treaties such as the Patent Cooperation Treaty and the Patent Law Treaty continue, applicants and practitioners should monitor developments closely.
For pharmaceutical companies, the repeal of the 2012 guidelines may reopen opportunities for protecting life-cycle pharmaceutical innovations in one of Latin America’s most attractive markets.
