Inventive step

UK Supreme Court finds ICOS patent invalid

A patent for the drug tadalafil has been ruled as invalid by the UK Supreme Court. Upholding a Court of Appeal decision, the patent EP (UK) 1173 181, owned by ICOS Corporation and licensed to global pharmaceutical company Eli Lilly, was found to lack inventive step. Going forward, the judgment sets out a series of guidelines for cases pertaining to the inventive step.

27 March 2019 by Amy Sandys

CIALIS, taladafil, ICOS, Eli Lilly, actavis Taladafil, marketed by ICOS as CIALIS, is used to treat erectile dysfunction. ©chagpg/ADOBE STOCK

The drug tadalafil, sold under the brand name CIALIS, is used to treat erectile dysfunction. Research by Eli Lilly found that tadalafil, when administered in 5mg doses, could be taken daily for chronic use. This gives it a technical advantage over other erectile dysfunction drug sildenafil, marketed as Viagra, which is used ‘on demand.’

Appeal upheld

A patent for the 5mg dosage was argued by Eli Lilly to be valid on the grounds that to trial such a small dose for erectile dysfunction was not obvious use. This was agreed in the High Court ruling in the first instance by presiding judge Colin Birss, who cited the regime as inventive.

Charlotte Weekes, partner, Pinsent Masons

Charlotte Weekes

However global pharmaceutical companies Actavis and Teva, and generics company Mylan, appealed the decision to the Court of Appeal based on obviousness.

The respondents claimed effectiveness of the 5mg dose should have been tested by Eli Lilly as a matter of course. The Court of Appeal reassessed Birss’ judgment of obviousness in the first instance and held that patent EP (UK) 1173 181 was invalid for lacking inventive step.

Eli Lilly then appealed to the Supreme Court. However, in November 2018, the Supreme Court judges led by Patrick Hodge unanimously dismissed its appeal and declared Eli Lilly’s patent invalid.

Ten steps

While the tadalafil case lacks the eminence of recent Supreme Court cases, such as in the pregabalin case concerning Warner Lambert and Actavis, one lawyer at a leading London patent firm says it is a useful blueprint for future inventive step cases. “It’s the Supreme Court saying, don’t get too tied up in the structural approaches of the EPO, or Germany or the UK. Ultimately, the question is about whether the invention is obvious or not to a person skilled in the art,” he says.

Another unique aspect of the case is the Supreme Court publishing ten points which provide a guideline for future cases concerning obviousness. In clarifying the theory behind inventive step, the Supreme Court provides parties with new guidance in approaching cases regarding obviousness.

Today’s judgment may therefore help guide patent owners and third parties through cases in which a patent is challenged on such grounds.

London calling

Several companies were involved as respondents against appellants Eli Lilly and ICOS, with the London offices of various firms acting on their behalf. This includes Pinsent Masons acting for Actavis Group, Teva UK and Teva Pharmaceuticals, Bird & Bird for Actavis UK and Taylor Wessing for Mylan Pharmaceuticals. It is thought that Allen & Overy acted for ICOS and Eli Lilly.

Matthew Royle, Taylor Wessing, partner

Matthew Royle

Taylor Wessing has a long-standing relationship with Mylan, having worked for the generics company for almost 20 years. Partner Matthew Royle led on the case, with Amanda Ebbutt and Josie Miller making up the Taylor Wessing team.

The firm also worked with Jenny Sunderland, senior patent litigation counsel, and Erwin Owusu-Gyamfi, patent counsel, both in-house for Mylan. Teva was introduced as a client to Pinsent Masons in 2010 by Clare Tunstall, practice head of the Pinsent Masons IP group.

However, the relationship between Pinsent Masons and Teva’s legacy companies extends over a decade prior to this.

Following the acquisition of Actavis by Teva in 2016, Pinsent Masons was instructed by Actavis on the tadalafil matter, with Actavis already party to the proceedings. Pinsent Masons partner Charlotte Weekes, and senior counsel Tamsin Cornwell, acted for Teva UK, Teva Pharmaceutical Industries and Actavis Group.

Tamsin Cornwell, Pinsent Masons

Tamsin Cornwell

Pinsent Masons also represented two of the interveners to the proceedings – Christopher Sharp for the British Generic Manufacturers Association (BGMA), and Catherine Drew for Medicines for Europe.

In-house, the lawyers instructing Pinsent Masons on the Supreme Court proceedings were Jules Fabre, senior legal counsel, and Alpha Indraccolo, vice president and general counsel of European IP and regulatory litigation. Both work for Teva.

Jennifer Jones and Elizabeth Wright, partner and senior associate respectively at Bird & Bird, acted for Actavis UK.

From Bristows, Myles Jelf and Alan Johnson, both partners, and Annsley Ward, senior associate, acted as interveners in the proceedings for the IP Federation. Nicole Jadeja, partner at Fieldfisher, intervened for the UK BioIndustry Association (BIA).

For respondents
8 New Square (London): Adrian Speck, Mark Chacksfield, Thomas Jones

For Actavis Group
Pinsent Masons (London): Charlotte Weekes (lead), Tamsin Cornwell

For Actavis UK
Bird & Bird (London): Jennifer Jones (lead); associate: Elizabeth Wright

For Teva UK
Pinsent Masons (London): Charlotte Weekes (lead), Tamsin Cornwell
In-house for Teva: Jules Fabre, Alpha Indraccolo

For Teva Pharmaceuticals
Pinsent Masons (London): Charlotte Weekes (lead), Tamsin Cornwell
In-house for Teva: Jules Fabre, Alpha Indraccolo

For Generics (Mylan)
Taylor Wessing (London): Matthew Royle (lead); associates: Amanda Ebbutt and Josie Miller
In-house for Mylan: Jenny Sunderland, Erwin Owusu-Gyamfi

For ICOS and Eli Lilly
Three New Square: Andrew Waugh, Thomas Mitcheson, Katherine Moggridge
Allen & Overy (London): no information

UK Supreme Court, London
Brenda Hale (president), Patrick Hodge, Brian Kerr, Jonathon Sumption, Michael Briggs