UK and EU SPC law remains aligned after latest ruling

Gareth Morgan and Catherine Drew, experts in life sciences regulation at Pinsent Masons, said that while alignment gives businesses certainty, the way it could be applied to certain types of pharmaceutical products could create challenges for industry.

SPCs enable pharmaceutical patent holders to effectively extend the period for which they can exercise monopoly rights over the sale of medicinal products they have invested a lot of time and money into developing.

Patent protection lasts 20 years but it takes pharmaceutical companies several years to develop new medicines, carry out mandatory clinical trials and gain marketing authorisation. This means that the period of patent protection available to pharmaceutical manufacturers during which they can commercialise their products is typically much shorter than that which applies in other, less regulated, sectors. The SPC framework, in force in the EU and UK, was developed to account and compensate for that.

Pharmaceutical companies are only eligible for SPCs for their medicinal products if they meet four criteria.

SPCs can only be granted if: in the country in which the application is submitted, the product is “protected by a basic patent in force” – as stipulated by article 3(a) of the EU’s SPC Regulation and UK equivalent; a marketing authorisation has been issued to place that product on the market as a medicinal product – as stipulated by article 3(b); the product has not already been the subject of an SPC – as stipulated by article 3(c); and the marketing authorisation relied on is the first to place the product on the market as a medicinal product – as stipulated by article 3(d).

The case before the High Court concerned whether the article 3(d) requirement was met by Laboratorios Leon Farma SA (Leon Farma) in the context of its contraceptive product Slynd.

Slynd contains one active ingredient, the compound drospirenone. Leon Farma applied to the UK’s Intellectual Property Office (IPO) for an SPC for the product. It was the first SPC application for a product consisting of drospirenone only. However, a hearing officer at the IPO refused the application.

The hearing officer considered that, on the basis of EU case law assimilated into UK law at the point of Brexit, the fact that other marketing authorisations had been granted for other products containing drospirenone – in those cases, in combination with estrogen – precluded Leon Farma from obtaining an SPC for Slynd.

Leon Farma challenged this decision. Among other things, it argued that the concept of a ‘product’, for the purposes of assessing SPC eligibility of that product, should be interpreted as differentiating between a situation where one product is comprised solely of one compound and another product is comprised of that same compound mixed with another.

In Leon Farma’s view, the EU case law that the hearing officer relied on as providing for an exception to that position was, at best, to be construed narrowly.

The EU case law in question was set by the Court of Justice of the EU (CJEU) in the so-called Medeva case.

Medeva was a policy-driven ruling whereby the availability of SPCs to holders of patents that only protected one, or subsets, of multiple active substance components in medicinal products was traded for the legal fiction, from a regulatory sense, that the first marketing authorisation of any particular active substance for the purposes of article 3(d) had to be the first product marketing authorisation containing that active substance, whether used in combination or not. 

The CJEU’s decision in the Medeva case was made in the context of multi-valent vaccine products. If the CJEU had not ruled the way it did, most SPC applications on such products would be refused because the basic patents underlying those applications almost always do not protect all active substance components of each individual multi-valent vaccine product.

The Medeva ruling is assimilated EU law in the UK and so still binds the lower courts until it is disapproved or departed from. The Court of Appeal in England and Wales and the UK Supreme Court can depart from this law if certain conditions are met.

In the Leon Farma case, the High Court, considering the Medeva case law, upheld the IPO hearing officer’s view that the earlier marketing authorisations for drospirenone in combination with forms of estrogen were the first authorisations for drospirenone – not, as Leon Farma claimed, the authorisation it was granted for Slynd.

Leon Farma had asked the court to rule on whether amending the Slynd product literature would assist its appeal. It proposed describing the active substance in Slynd in its product literature as "drospirenone (not containing any estrogen)". The High Court, however, said it did not matter how the company described the product – it remained the case that drospirenone was the only active substance in Slynd and that, in its view, it had already been subject to earlier marketing authorisations.

Gareth Morgan of Pinsent Masons said: “This refusal of Leon Farma’s application for SPC protection on Slynd is the latest in a line of English court decisions that maintain the status quo in UK SPC law and aligns the UK with the EU as regards SPC availability. No applicant has yet been able to convince the English judges to depart from the current settled CJEU SPC case law that is now assimilated EU law in the UK.”

“Leon Farma now has the option of appealing this decision to the Court of Appeal which is at liberty to depart from this ruling – the High Court specifically noted that the company reserved the right to do this in its appeal documents before the court,” he said.

Catherine Drew, also of Pinsent Masons, added: “Possibly the approach taken in the case of Medeva, which may be thought to be a principled approach in the context of multi-valent vaccines, now creates challenges when applied in other therapeutic areas, though the judge in this case did not consider the decision in Medeva to be limited to this field.”

“Fundamentally, the decision reconfirms that all research into medicinal products may not be meritorious of SPC protection. Potentially, the SPC Regulation is a slightly blunt instrument to determine which research is and which is not meritorious of such a reward, but the court in this case was clear on the law to be applied,” she said.