SPCs in the spotlight: Court of Justice of the EU rules in Neurim on Thursday
Managing IP is part of the Delinian Group, Delinian Limited, 4 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2024

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

SPCs in the spotlight: Court of Justice of the EU rules in Neurim on Thursday

The Court of Justice of the EU will rule in a dispute between Neurim Pharmaceuticals and the UK Intellectual Property Office on Thursday, clarifying whether pharmaceutical companies can obtain supplementary protection certificates (SPCs) for second medical use patents. Here’s the background to the case

Click here for the latest on this story.

How it began

At the end of 2009, a hearing officer at the UKIPO refused an SPC for its product Ciracadin (melatonin).Circadin is used to treat insomnia and the basic patent concerns the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of humans.

The Office said that melatonin had already been marketed since 2001 (by CEVA Animal Health under the name Regulin) and so Neurim’s product was not eligible for an SPC. In particular, the hearing officer said that the intended use of the medicinal product could not be taken into account when considering the relevance of an earlier marketing authorisation.

The patent owner took the case to the High Court. Mr Justice Arnold upheld the IPO’s decision that Neurim is not entitled to an SPC, writing: “I conclude that the hearing officer was correct to interpret Article 3(d) [Council Regulation 1768/92/EECnow Regulation 469/2009/EC] as requiring the authorization referred to in Article 3(b) to be the first authorization to place the product on the market as any medicinal product.”

At a glance

Patent number

EP (UK) 0 518 468

Invention

Melatonin to treat insomnia

(branded as Circadin)

Technology

Pharmaceuticals

Patent owner

Neurim Pharmaceuticals

Other party/ies involved

UK IPO

Court/judge(s)

Court of Appeal (Smith, Jacob, Patten)

Jurisdiction

UK

Decision

Questions referred to CJ EU

Key terms

Supplementary protection certificates;

pharmaceuticals; second medical use

Neurim Pharmaceuticals appealed again and the Court of Appeal ruled in March last year. Lord Justice Jacob, who gave the decision for the Court, said it would refer questions to the Court of Justice of the EU. He added: “We consider that Neurim's arguments are not only tenable: in our view they are right. Many kinds of valuable pharmaceutical research will not get the encouragement or reward they deserve if they are not. Pharmaceutical research is not confined to looking for new active compounds. New formulations of old active substances are often sought. Most are unpatentable but from time to time a real invention is made and patented … It would be most unfortunate if second medical use patents could not get the benefit of an SPC. In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU's highest court.”

What questions will the Court answer?

The Court of Appeal in London referred five questions to the CJEU.

1. In interpreting Article 3 of Regulation EEC No 1768/92 [now Regulation (EC) No 469/2009] ("the SPC Regulation"), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4?

2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, "the first authorisation to place the product on the market in the Community" needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4?

3. Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication?

4. Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)?

5. Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?

How is the Court likely to rule?

In May this year, Advocate General Trstenjak, the Court’s legal adviser on the case, backed Neurim. Sherecommended the Court rule that the fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the member state for which the application is made does not preclude the grant of an SPC based on a later authorisation to place that product on the market as a new medicinal product (as long as the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent).

The Court is not obliged to follow the advocate general’s opinion, but does so in most cases.

Who is advising the parties?

Neurim is represented by barrister Andrew Waugh QC and Carpmaels & Ransford. The Comptroller-General of Patents is represented by barrister Charlotte May and the Treasury Solicitor.

more from across site and ros bottom lb

More from across our site

The court criticised Oppo’s attempts to delay proceedings and imposed a penalty, adding that the Chinese company may need to pay more if the trial isn’t concluded this year
Miguel Hernandez explains how he secured victory for baby care company Naterra in his first oral argument before the Federal Circuit
The UPC judges are wrong – restricting access to court documents, and making parties appoint a lawyer only to have a chance of seeing them, is madness
The group, which includes the Volkswagen, Seat and Audi brands, is now licensed to use SEPs owned by more than 60 patent owners
Managing IP’s Max Walters appeared on the latest episode of ‘Two IPs in a pod’, a regular podcast hosted by the UK patent attorney body, to discuss AI, awards and more
Sources at law firms say they have spent more than three years waiting for IP regulations and explain how the delay is affecting their business
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
Managing IP will host a ceremony in London on April 11 to reveal the winners of the EMEA Awards 2024
Lawyers reveal what trends they have noticed in the Western District of Texas and the advice they have been giving clients as a result
Concerns over the EU’s proposed SEP Regulation are based on little empirical support, say Benno Buehler and Kilian Mueller of Charles River Associates
Gift this article