Article: “Protecting Pharma Patents in Italy: TAR Lazio Confirms Strict Assessment of Drug's Pharmaceutical Forms”

Abstract

By judgement No. 12274 of 2026, the Regional Administrative Court of Lazio (TAR Lazio) has reaffirmed a key principle regarding the Transparency List, stating that to include a generic drug in this list, all requirements set forth in Article 7 of Legislative Decree No. 347/2001, as amended, shall be fully met. Most notably, the relevant drugs must possess the exact same pharmaceutical form, strictly according to the classification approved by the Official Pharmacopoeia.

Regulatory Framework

The reimbursement of medicines by the Italian National Health Service (SSN) is ruled by specific legal provisions and scientific assessments. The Italian Medicines Agency (AIFA), acting as the competent technical-scientific body, is entrusted with overseeing this process.

For the purpose of drug reimbursability, the Italian legislator (under AIFA's supervision) divides drugs into two main categories: Class A (which encompasses Class H) and Class C.

• Class A includes essential drugs and treatments for chronic diseases. The State generally bears the cost, although a co-payment by the citizen may be required, depending on regional provisions.
• Class C includes all other drugs, such as those treating minor pathologies, or non-life-saving conditions. The cost is entirely borne by the citizen.

To optimize public healthcare expenditure, Italian Legal system encourages the use of generic (or equivalent) medicines. Under Article 7 of Legislative Decree No. 347/2001, Class A medicines shall have the same active ingredients, pharmaceutical form, way of administration, manner of release, and number of unit doses, as the originator drug. Of course, any patent protection on the originator drug shall have expired before marketing the generic version.

Beyond these requirements, AIFA also assesses therapeutic equivalence between the originator and the generic drug. This assessment complies with the law and administrative case-law (e.g., Council of State decision No. 2666 of March 31, 2025), and AIFA's own Determination DG 166/2021. Finally, AIFA shall verify actual therapeutic replaceability.

Once listed, the SSN reimburses up to the lowest price of the corresponding generic drug, available in the regional distribution cycle (the "reference price"). A patient can request a more expensive equivalent product, but he shall cover the price difference. The "Transparency List, containing all equivalent Class A drugs and their reference prices, is monthly updated by AIFA.

The Facts of the Case

Sandoz S.p.A., proprietor of the psoriasis drug Zoripot (ointment, 60 g), has filed a petition before the TAR Lazio. Sandoz challenged AIFA's decision, denying the inclusion of Zoripot in the Transparency List, alongside LEO Pharma's originator drug Enstilar (medicated foam, 60 g), which is a patented drug also for treating psoriasis.

Sandoz argued that AIFA's Scientific and Economic Commission for Pharmaceuticals (CSE) failed to properly consider the scientific documents. According to the petitioner, this evidence would show that both drugs actually shared the same pharmaceutical form (an ointment), when applied on the patient. Legally, Sandoz claimed AIFA would have relied on an overly formalistic reading of the Official Pharmacopoeia, ignoring the specific facts of the case.

AIFA and LEO Pharma (this latter as interested party) requested the rejection of the petition. They argued that, based on both the Official Pharmacopoeia and scientific findings, the two drugs do have a completely different pharmaceutical form: and namely a medicated foam for Enstilar and an ointment for Zoripot. Furthermore, Enstilar has proved superior effectiveness, in treating psoriasis.

AIFA and LEO Pharma succeeded also in highlighting that Sandoz's interpretation clashed with established legal frameworks. In this respect, by way of example, TAR Lazio decision No. 2295/2014, recalling the EU Court of Justice ruling C-106/01— assessed that the "pharmaceutical form of a product " is defined as the synthesis of the form presented by the manufacturer and the form administered, including its physical form.

The Principles set by the Decision

The TAR Lazio fully rejected Sandoz's petition, confirming the correctness of AIFA's assessment and LEO Pharma's arguments. The ruling affirmed the following key principles:

• Strict Compliance: To be inserted in the Transparency List, a generic drug shall simultaneously meet all requirements of Article 7, paragraph 1, of Law Decree No. 347/2001.
• Definition of Equivalent Medicine: Article 2, paragraph 1, letter e) of AIFA Determination No. 166/2021 specifies that "pharmaceutical form" strictly refers to the current classifications in the Official Pharmacopoeia, covering both the way of administration of the drug and its physical form.
• Exclusive Reference: For pharmaceutical form classifications, the Official Pharmacopoeia is the sole reference, a principle previously confirmed by the Council of State’s decision No. 8030/2021.
• Distinct Categories: Under the Pharmacopoeia, Zoripot ointment falls under "semi-solid preparations for cutaneous application," whereas Enstilar foam belongs to "liquid preparations for cutaneous application". Therefore, they cannot be listed together.

The Court concluded that AIFA correctly evaluated the physical and technical differences between the drugs. AIFA's assessment followed criteria of "logic, congruity and reasonableness" without any "macroscopic illegitimacies, such as serious, abnormal evaluation errors or errors induced by mistakes of fact" (Council of State, Section III, February 18th, 2025, Nos. 1355, 1356, 1362 and 1366).

Impact on the Pharmaceutical Sector

This ruling by the TAR Lazio confirms and substantiates well-established principles regarding the Transparency List. For market operators holding innovative pharmaceutical patents, this decision represents a significant support of the legal mechanisms available to protect their investments in the Italian market.

Article published in today’s Lexology newsletter written by our partner Paola Gelato and our associate Giovanni Pira.