Laboratorios Leon Farma SA v The Comptroller-General of Patents

For the purposes of Article 3 of the SPC Regulation, “product” has one meaning across all four conditions. It means the active ingredient or combination of active ingredients, rather than the claimed invention or its therapeutic use.

Under Medeva, an authorisation for a medicinal product containing A+B may constitute an authorisation to place A, or B, on the market. That principle applies to Article 3(d) as well as Article 3(b). The Regulation leaves no discretion to grant an SPC where its conditions are not met. Courts must apply the statutory scheme and must not conduct an ad hoc teleological balancing exercise.

Laboratorios Leon Farma SA appealed against the Comptroller-General’s refusal of SPC application SPC/GB22/02. The application concerned drospirenone, the active ingredient in the contraceptive product Slynd, which contains no oestrogen.

The earlier products Angeliq and Yasmin contained drospirenone with an oestrogen. The Hearing Officer held that their marketing authorisations were earlier authorisations to place drospirenone on the market as a medicinal product, so Article 3(d) was not satisfied. The appeal concerned the meaning and application of “product”, the scope of Medeva, the relevance of later authorities and an auxiliary proposed description of the product.

1. Appeal dismissed. The Hearing Officer was essentially right, although the court supplemented her reasons.
2. The term “product” in the SPC Regulation has the same meaning throughout Article 3. It means the active ingredient or combination of active ingredients. It is not confined by the claimed invention or by a claimed therapeutic use. The relevant medicinal products were Slynd, Angeliq and Yasmin, while the product was drospirenone.
3. Medeva established a generally applicable rule. An authorisation for a medicinal product containing A+B may be treated as an authorisation for A alone, or B alone, for the purposes of Article 3(b). The rule is not confined to multivalent vaccines or to Article 3(b). There was no logical justification for giving “marketing authorisation” a different meaning under Article 3(d).
4. Applying that rule, the Slynd authorisation was not the first authorisation to place drospirenone on the market. The earlier Angeliq authorisation was sufficient, although Angeliq also contained estradiol. The same applied to Yasmin, although it was later than Angeliq. Articles 3(a) to 3(c) were satisfied, but Article 3(d) was not.
5. Article 10 conferred no discretion. The application had to be rejected once the statutory conditions were unmet. The court rejected an ad hoc teleological balancing exercise. Newron confirmed that the balance between pharmaceutical research, public health and generic manufacturers was struck by the Regulation itself.
6. The authorities relied on by Leon did not displace Medeva. The relevant reasoning in Generics v Daiichi was inconsistent with it. Santen, Newron and Merck concerned different points or supported application of the strict statutory scheme. The auxiliary description, “drospirenone (not containing any estrogen)”, described the same product and could not cure the Article 3(d) defect.

• High Court (Patents Court): Appeal from the Comptroller-General’s decision dated 31 July 2025, reference BL O/0705/25. Appeal dismissed.