Pharma patent

Generics manufacturers gain vital victory at UK Supreme Court

In a landmark decision for the generics industry, the Supreme Court has dismissed Warner-Lambert’s claims of insufficient disclosure, invalidity and infringement against generic pharmaceutical manufacturer Actavis and Generics UK, trading under Mylan. In applying the concepts of plausibility and insufficiency, the Supreme Court has set a new precedent for cases concerning generics products in the UK going forward (case IDs: UKSC 2016/0197, 2017/0069 and 2017/0078).

4 December 2018 by Mathieu Klos

UK Supreme Court ©VictorMoussa/AdobeStock

Proceedings against Actavis and Mylan were launched in 2014 by Warner-Lambert, subsidiary of global pharmaceutical company Pfizer. Although patented in second medical use for neuropathic pain treatment under the brand name Lyrica, generics manufacturers Actavis and Mylan sought to launch a new generic pregabalin product following the expiration of Warner-Lambert’s first medical use patent. Introduced as a ‘skinny label’ product, Actavis and Mylan’s product focused on the treatment of generalised anxiety disorder (GAD) and epilepsy.

Actavis and Mylan’s product, Lacaent, excluded the indications of pain treatment. This allowed Actavis to market pregabalin as a generic product following the expiration of Warner-Lambert’s patent. However, in 2015, Warner-Lambert launched an interim injunction against Actavis to prevent the ‘skinny label’ product sale.

With this refused by High Court judge Richard Arnold, and a subsequent Court of Appeal case upholding the proceedings against Warner-Lambert, the Pfizer subsidiary proceeded to challenge Actavis before the Supreme Court.

Word art

The Supreme Court upheld the 2015 Court of Appeal judgment and dismissed Warner-Lambert on all three counts. Judge Jonathan Sumption gave the leading majority judgment. This included the decision that, even if Warner-Lambert’s claims were valid, Actavis would still not be guilty of infringement. The Supreme Court also upheld the Court of Appeal’s ruling that Warner-Lambert’s post-trial attempt to amend its patent from ‘neuropathic pain’ to ‘peripheral neuropathic pain’ amounted to an abuse of process.

However, despite what is being touted as a ‘surprising’ result in favour of generics, it is the implementation of a new ‘outward presentation test’ most likely to impact the Swiss-form patent specification for second medical use patents.

The judgment concerns re-evaluation of the wording on patents for second medical use, concerning the conjunctive ‘for’ as demonstrated in the Swiss-form ‘X for use in treating Y.’ Determined in the High Court’s initial ruling to mean ‘subjectively intended,’ the Supreme Court decision sees the adoption of an ‘outward presentation test’ for infringement adopted by all courts.

With ‘for’ previously regarded as a test of intention, the court has ruled it is a test purpose. The test refers to plausibility in such claims, with the court decision approving plausibility as a non-statutory test for sufficiency of disclosure. Plausibility is especially important for second medical use patents, whereby a person ‘skilled in the art’ must reasonably consider the invention as effective in its second medical use as in its first medical use.

With this in mind, the ruling of insufficiency in plausibility of pregabalin’s second medical use patent was upheld. There is now worry among the patent community that this higher threshold of plausibility put forward by the Supreme Court will heighten the difficulty in obtaining pharmaceutical patents in the UK. The court has made it clear, however, that it recognises imperfections in the updated test and it may be ineffective in providing patentee protection.

Not over yet

With no European Union law involved in the case, Warner-Lambert cannot be referred to the Court of Justice of the European Union and is thus unable to appeal points of the Supreme Court judgment. However, proceedings against the innovator are not over.

Following publication of NHS guidance on the prescribing and dispensing of pregabalin as Lyrica-patented pain medication, the invalidity ruling sees Warner-Lambert liable to pay around £500 million to the NHS on ‘groundless threats of patent infringement.’ The action taken by Warner-Lambert led to loss of earnings for Actavis, with the patent infringement accusations discouraging UK pharmacies from selling the pregabalin drug under the generic name.

In Germany, Warner-Lambert is also fighting with generics manufacturers over pregabalin. The company initially obtained a preliminary injunction against various generic drug manufacturers at the Regional Court Hamburg in 2015. The majority of generic drug manufacturers accepted the Hamburg ruling, while Ratiopharm appealed.

Hexal opted for a different tactic and accepted the ruling, but sought a decision on a nullity suit against the Warner-Lambert patent. This was successful before the Federal Patent Court. The Pfizer subsidiary appealed against this in the Federal Court of Justice. In the Netherlands and France, Warner-Lambert also dealt with pregabalin with generics manufacturers. JUVE Patent has no current information on this matter.

Nicola Dagg, Kirkland & Ellis

Nicola Dagg

European dimension

Allen & Overy is responsible for the pregabalin processes for Warner-Lambert in the UK, as well as Germany and France. The mandate is probably one of Allen & Overy’s most important, given how the firm is striving for market leadership throughout Europe. However, the UK team experienced a turbulent period during the Supreme Court proceedings.

Nicola Dagg, IP partner at Allen & Overy for 12 years, accompanied February’s oral proceedings in the Warner-Lambert v. Actavis case. A short time later, however, Dagg left the firm to begin a European patent group at the London office US firm Kirkland & Ellis.

November’s Supreme Court judgment was announced less than two weeks after her first day at Kirkland. It is not known whether Dagg will continue the proceedings for the US firm. Neither Allen & Overy or Kirkland & Ellis have commented on the proceedings.

Powell Gilbert has been involved with the litigation for Actavis, part of Teva and now subsumed under the Accord brand, since the case began in 2014.  The patent team at the London office of law firm Bird & Bird has also been involved with Actavis.

Working alongside the London office of Taylor Wessing in the above case was Jenny Sunderland, senior patent litigation counsel at Mylan, and Erwin Owusu-Gyamfi, patent counsel at Mylan. Taylor Wessing and Mylan have worked closely together over a long period, with Mylan a long-standing client of the law firm.

For Warner-Lambert
Blackstone Chambers (London): David Pannick
Three New Square (London): Thomas Mitcheson, Miles Copeland, Tim Austen
Allen & Overy (London): Nicola Dagg (now at Kirkland & Ellis), Mark Ridgway; associates: Jin Ooi (now Kirkland & Ellis), Tom Edwards

For Generics/Mylan
8 New Square (London): Adrian Speck
11 South Square (London): Kathryn Pickard
Blackstone Chambers (London): Pushpinder Saini
Taylor Wessing (London): Matthew Royle (lead); associates: Michael Henley, Josie Miller

For Actavis
8 New Square (London): Adrian Speck
11 South Square (London): Kathryn Pickard
Blackstone Chambers (London): Pushpinder Saini
Powell Gilbert (London): Tim Powell; Bethan Hopewell; associate: Siddarth Kusamakar

UK Supreme Court, London
Jonathan Sumption (presiding judge), Jonathon Mance, Robert Reed, Patrick Hodge, Michael Briggs


Parallel ongoing cases in Europe

Federal Court of Justice
(3 Ni 3/15): Patent revoked, appeal filed at Federal Court of Justice in 2017, no date for oral hearing announced.