SPC protection for second medical uses – hope on the horizon?

We expect the Court of Appeal soon to have an opportunity to review the law on Supplementary Protection Certificates (SPCs) for second medical uses of approved medicines, following the UK’s departure from the EU.

An SPC may be issued by a national patent office (for example, the UK Intellectual Property Office) granting an extended period of protection of up to 5 years and 6 months beyond a granted patent’s usual 20-year term. This extended protection is to compensate the patent owner for the time taken in gaining regulatory approval for a pharmaceutical or plant protection product.

Pharmaceutical businesses may commit considerable investment to researching medical uses of approved medicines. These can offer a faster route to innovative treatments where there is unmet need, as well as avoiding some of the extensive testing required for a completely new drug. Currently an SPC will not be granted where a marketing authorisation (MA) for a second medical use of an approved medicine is not the first MA for that product.  

There has been uncertainty around this issue in the European courts.

In 2012, the CJEU’s judgment in Neurim (C-130/11) overturned then previous European case law and facilitated grant of SPCs for second medical uses of approved medicines.  However, this decision was essentially reversed by subsequent a judgment in Santen (C‑673/18). This later ruling confirmed that the MA relied upon for an SPC application must be the first MA for the approved medicine, regardless of therapeutic use.

In 2018, before the CJEU handed down Santen, Merck Serono SA (Merck) applied to the UK IPO for an SPC to protect a second medical use of an approved medicine, cladribine based on a MA indicated for a form of multiple sclerosis. The UK IPO considered Merck’s application following Santen. It refused the application on the basis that previous MAs in respect of cladribine already existed, albeit for a different therapeutic use (hairy cell leukaemia).

Merck appealed to the High Court, which upheld the UKIPO’s decision but Merck has been granted permission to appeal to the Court of Appeal.  Merck lodged three grounds of appeal with the High Court:

• Santen should not be applied retrospectively. The High Court rejected this because the Santen judgment did not say that it should not apply retrospectively.
• Santen was factually distinct. This was rejected because the High Court took the view that Santen should apply generally.
• Santen was wrongly decided. The High Court said that although it had no power make this decision, following the UK’s departure from the EU it would be within the remit of the UK Court of Appeal or Supreme Court to do so.

It is interesting to note that Arnold LJ, a current Court of Appeal judge, has previously given a view on these issues. Arnold LJ has suggested that the Explanatory Memorandum to the relevant SPC Regulation indicates that “SPCs should be available for new applications (i.e. new therapeutic [(medical)] uses) of old active ingredients” (Abraxis Bioscience v Comptroller-General, paragraph 63).

We will be watching the progress of this case with interest.