Newron Pharmaceuticals has failed in its attempt to overturn two UKIPO and UK High Court decisions regarding the coverage of a marketing authorisation for Parkinson’s treatment drug, Xadago, which uses the active ingredient safinamide (case ID: CA-2023-001357). In aligning their approach with current SPC and CJEU case law, the UK patent courts are demonstrating that despit Brexit they will diverge from the status quo only in compelling situations.
Treatment for Parkinson’s
Newron owns EP (UK) 1 613 296, which covers the active ingredient safinamide for the “methods and treatment of Parkinson’s disease”. The company filed the patent on 8 April 2004, with the EPO granting it in 2009. It will expire on 7 April 2024. Safinamide is authorised for the disease’s treatment as an add-on therapy to another drug, levodopa. Healthcare professionals can administer Xadago alone or in combination with other Parkinson’s disease medicines.
Parkinson’s disease is a neurodegenerative disorder which gradually invokes, among other things, uncontrollable or involuntary movements, difficulty with balance, and can cause mental ill-health. The use of safinamide in combination with levodopa can increase the period of time in which the medication can effectively control a patient’s symptoms.
One or three
In December 2022, a UKIPO hearing officer appearing on behalf of the UK Comptroller General of Patents, Trademarks and Designs refused to grant an SPC based on EP 296 (SPC/GB15/046). The officer, Lawrence Cullen, held that the marketing authorisation for Xadago covers one ingredient, rather than a combination thereof, meaning it differs from the patent’s scope. Claim one of EP 296 references safinamide as being in combination with levodopa and/or a peripheral decarboxylase inhibitor (PDI).
Newron disputed the UKIPO decision – first with an appeal to the High Court, and subsequently via a second appeal to the Court of Appeal. But the second-instance judges have confirmed that the product covered in the marketing authorisation is not the same as the patent’s description: the former covers just safinamide, while the patent covers safinamide in combination with th two other substances.
Under Article 3(b) of Regulation (EC) No. 469/2009 of the SPC regulation, the UKIPO can therefore not grant an SPC. Court of Appeal presiding judge Colin Birss noted that he was “quite sure both the Hearing Officer and the [first-instance] judge interpreted the marketing authorisation in this case correctly.”
Newron fights back
But while Newron accepted that the use of safinamide in combination with levodopa is a known treatment for the disease, it put forward several arguments. Most importantly, it claims the phrase “the product” has a broader meaning under Article 3(b) compared to Article 3(a) of the SPC regulation.
Martin Maclean
The company also argued that, in having granted the marketing authorisation, the European Medicines Agency was effectively confirming the add-on product as being a safe and effective treatment for Parkinson’s. Thus, if safinamide is always used in combination with levodopa, the UKIPO should assume it falls under the same marketing authorisation as the patent.
In the earlier instances, Newron also pointed to its engagement in research. This, it argued, merits the UKIPO granting Xadago an SPC.
But, while the SPC regulation seeks to support investment in, and development of, pharmaceutical products, the judgment points out that it is “not a balancing exercise which courts are invited to undertake on a case-by-case basis”.
The Court of Appeal thus decreed that the marketing authorisation only authorises Newron to market Xadago as safinamide. It does not cover the marketing of any other active ingredient, including levodopa, meaning the UKIPO was right to refuse an SPC. Newron may petition the Supreme Court for a third appeal.
From UKIPO to appeal
Throughout proceedings, Newron has instructed UK patent attorney firm Mathys & Squire, which has been a client of the firm for around five years. Lead partner Martin Maclean is dual qualified as a patent attorney and litigator, and specialises in biotechnology.
Junior barrister Stuart Baran represented HM Comptroller-General in his capacity as one of two Standing Counsel to HM Comptroller-General of Patents, Designs and Trade Marks. Otherwise known as a ‘treasury junior’, Baran takes on IP cases on behalf of the UKIPO and the UK. He is also available for consultation by government departments on IP issues.
For Newron Pharmaceuticals
Mathys & Squire (London): Martin Maclean (partner); associate: Lionel Newton
For the Comptroller General of Patents, Trademarks and Designs
Three New Square (London): Stuart Baran (treasury barrister)
Court of Appeal of England and Wales, London
Colin Birss, Kim Lewison, Andrew Moylan
