Actavis Group PTC EHF (a company incorporated under the laws of Iceland) and Another (Appellants in Appeal A3/2016/4110) (Respondents in Appeal A3/2016/4103) TEVA UK Ltd and Another (Appellants in Appeal A3/2016/4094) (Respondents in Appeal A3/2016/4103) Generics (UK) Ltd (t/a Mylan) (Appellant in Appeal A3/2016/4104) (Respondents in Appeal A3/2016/4103) ICOS Corporation (a company incorporated under the laws of the State of Washington, USA) and Another (Respondents in Appeals A3/2016/4110, 4094, 4104) (Appellants in Appeal A3/2016/4103)

JurisdictionEngland & Wales
CourtCourt of Appeal (Civil Division)
JudgeLord Justice Kitchin,Lord Justice Floyd,Lord Justice Lewison
Judgment Date01 November 2017
Neutral Citation[2017] EWCA Civ 1671
Docket NumberCase No: A3/2016/4094 & A3/2016/4104 & A3/2016/4110
Date01 November 2017

[2017] EWCA Civ 1671

IN THE COURT OF APPEAL (CIVIL DIVISION)

ON APPEAL FROM THE HIGH COURT OF JUSTICE

CHANCERY DIVISION (PATENTS COURT)

THE HON MR JUSTICE BIRSS

[2016] EWHC 1955 (Pat)

Royal Courts of Justice Strand, London, WC2A 2LL

Before:

Lord Justice Lewison

Lord Justice Kitchin

and

Lord Justice Floyd

Case No: A3/2016/4094 & A3/2016/4104 & A3/2016/4110

Between:
(1) Actavis Group PTC EHF (a company incorporated under the laws of Iceland)
(2) Actavis UK Limited
(Appellants in Appeal A3/2016/4110)
(Respondents in Appeal A3/2016/4103)
and
(1) TEVA UK Limited
(2) TEVA Pharmaceutical Industries Limited (a company incorporated under the laws of Israel)
(Appellants in Appeal A3/2016/4094)
(Respondents in Appeal A3/2016/4103)
Generics (UK) Limited (t/a Mylan)
(Appellant in Appeal A3/2016/4104)
(Respondents in Appeal A3/2016/4103)
and
(1) ICOS Corporation (a company incorporated under the laws of the State of Washington, USA)
(2) Eli Lilly & Company (a company incorporated under the laws of the State of Indiana, USA)
(Respondents in Appeals A3/2016/4110, 4094, 4104)
(Appellants in Appeal A3/2016/4103)

Adrian Speck QC, Mark ChacksfieldandThomas Jones (instructed by Bird & Bird LLP) appeared for Actavis UK Limited (instructed by Taylor Wessing LLP) appeared for Generics (UK) Limited (t/a Mylan) (instructed by Pinsent Masons LLP) appeared for Actavis Group PTC EHF, TEVA UK Limited and TEVA Pharmaceuticals Industries Limited

Andrew Waugh QC and Katherine Moggridge (instructed by Allen & Overy LLP) appeared for ICOS Corporation and Eli Lilly and Company

Hearing dates: 12/13 July 2017

Approved Judgment

Lord Justice Kitchin

Introduction

1

These appeals are concerned with the validity and infringement of a patent concerning tadalafil. Tadalafil is the generic name of a drug which is sold under the brand name CIALIS for the treatment of male erectile dysfunction ("ED") and benign prostatic hyperplasia, and under the brand name ADCIRCA for the treatment of pulmonary arterial hypertension. CIALIS has enjoyed considerable commercial success. In 2014 worldwide sales amounted to about $2.29 billion and UK sales amounted to about $99 million. In that same year UK sales of ADCIRCA amounted to about $1 million.

2

The patent, EP (UK) 1,173,181 (the "181 patent" or "the patent"), is owned by ICOS and exclusively licensed to Lilly. It relates to the use of tadalafil in a dosage form and is entitled "Compositions comprising phosphodiesterase inhibitors for the treatment of sexual dysfunction". It was filed on 26 April 2000 and claims priority from US application 132036P filed on 30 April 1999. It was granted on 15 October 2003. The form of the patent in issue is a B3 specification following centralised amendments made in the EPO on 25 March 2015. Tadalafil is also protected by an SPC (SPC/GB03/007) that expires in November of this year.

3

The claimants, Actavis, TEVA and Mylan, began these proceedings to revoke the 181 patent and so clear the way for the marketing of their own products. ICOS and Lilly, collectively "Lilly", defended the claim and counterclaimed that the claimants were threatening to infringe the patent.

4

The claimants sought the revocation of the 181 patent on various grounds. They contended first, that the matter disclosed in the specification extended beyond that disclosed in the application for the patent as filed; secondly, that the patent lacked novelty over three publications, WO 01/08688 (" Anderson"), WO 00/53148 ("Stoner") and WO 01/08686 ("Oren"); thirdly, that the patent was obvious in the light of another publication, WO 97/03675 ("Daugan"); and finally, that the specification of the patent did not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art.

5

The position in relation to the novelty citations was a little complicated but may be summarised as follows. Anderson, Stoner and Oren were all published after the filing date for the 181 patent but were available in support of an allegation of lack of novelty under s.2(3) of the Patents Act 1977 ("the 1977 Act") (corresponding to Article 54(3) of the EPC) if and in so far as they contained relevant matter which was entitled to a priority date earlier than that of the invention of the 181 patent. Anderson and Oren both had a priority date of 3 August 1999. Accordingly, if the 181 patent was not entitled to its claimed priority date, they were each relevant prior art for novelty purposes. Stoner was filed on 3 March 2000 and so, if the 181 patent lost priority, it too was relevant prior art for novelty purposes. However, Stoner claimed priority from a US filing on 8 March 1999 which is earlier than the claimed priority date for the 181 patent. It followed that, in so far as Stoner was entitled to this earlier priority date, it was citable for novelty purposes even if the 181 patent was entitled to its claimed priority date. Lilly did not suggest that the matter relied upon in Stoner might not be entitled to priority on substantive grounds but contended that the claimants had failed to establish that its owner was entitled to make the priority claim.

6

The action came on for trial before Birss J in June and early July 2016 and he handed down judgment on 10 August 2016 ( [2016] EWHC 1955 (Pat)). He found that all of the claims of the 181 patent, save claims 2 and 12, were entitled to their claimed priority date; claims 2 and 12 lacked novelty in light of the disclosures of Anderson and Oren; Stoner was entitled to its claimed priority date but none of the other claims lacked novelty in light of its disclosure; the allegation of obviousness in light of the disclosure of Daugan failed; and that the allegation of insufficiency fell away in light of the findings concerning the validity of claims 2 and 12. As for the counterclaim, the judge held that the claimants would infringe the 181 patent were they to launch their intended products.

7

I should also mention that there was before the judge a claim for the revocation of another Lilly patent, EP (UK) 1,200,092. The judge found that all of the claims of this patent were invalid. The appeal by Lilly against this finding has not been pursued and so I need say no more about it.

8

Upon these appeals, brought with the permission of the judge, the claimants contend as follows:

i) the judge failed properly to construe the claims of the 181 patent which are said on these appeals to be independently valid, namely claims 1, 7 and 10;

ii) the judge ought to have found that none of these claims is entitled to its claimed priority date;

iii) the amendments made to the claims mean their disclosure extends beyond the disclosure of the application as filed and the judge should have so held;

iv) the judge fell into error in failing to find that Stoner deprived the claims of novelty; and

v) the judge fell into error in approaching the issue of obviousness and ought to have found there was nothing inventive in any of these claims.

9

I will address each of these contentions in turn but must first summarise aspects of the technical background and consider, albeit briefly, the disclosure of the 181 patent.

The technical background

10

The technical background is set out in a technical primer, the contents of which were largely agreed by the parties before the trial. The following summary is sufficient to understand the issues arising on this appeal.

11

ED is an extremely common medical condition affecting a significant percentage of men between forty and seventy years of age. It may be caused by a considerable number of disorders, both physiological and psychological.

12

The penis contains smooth muscle. In the normal resting state, this smooth muscle contracts and so restricts the arteries supplying blood to the penis. The penis is, as a result, detumescent. When an erection is triggered, the smooth muscle relaxes and no longer restricts the supply of arterial blood. The penis then fills with blood and becomes tumescent.

13

Smooth muscle relaxation leading to an erection is the result of a cascade of complex biochemical reactions within the body. Sexual stimulation causes the release of the neurotransmitter nitric oxide ("NO") which enters the smooth muscle cells where it leads to an increase in the production of a second messenger, cyclic guanosine-3', 5'-monophosphate ("cGMP"). cGMP in turn binds to and activates an enzyme which regulates the activity of other intracellular proteins and leads to the relaxation of the smooth muscle. An increase in the intracellular level of cGMP, through NO production, therefore promotes smooth muscle relaxation, while a decrease in the intracellular level of cGMP tends to cause the smooth muscle to return to its ordinary contracted state.

14

The intracellular concentrations of cGMP and another second messenger, cyclic adenosine-3', 5'-monophosphate (" cAMP"), are regulated by a class of enzymes known as cyclic nucleotide phosphodiesterases ("PDEs"). By 1999 at least six PDE families had been identified, PDE1 to PDE6, but it was known that the most prevalent in the penis is PDE5. This binds cGMP and hydrolyses it to its non-cyclic form GMP so leading to a reduction in smooth muscle relaxation and the prevention of penile tumescence.

15

The first orally administered PDE5 inhibitor to be marketed for the treatment of ED was sildenafil which is sold under the brand name VIAGRA. By inhibiting PDE5, sildenafil prevents it from hydrolysing cGMP to the inactive GMP. As a result, cGMP levels remain elevated which promotes smooth muscle relaxation. This leads to greater arterial blood flow into the penis and results in penile tumescence. Tadalafil is another PDE5 inhibitor and it operates in essentially the same way as sildenafil.

16

As for the specificity of the PDE families known in 1999, PDEs 1 and 2 were known to act on...

To continue reading

Request your trial
5 cases
5 firm's commentaries
  • Actavis v Eli Lilly: The Impact On Patent Infringement Law In The UK Two Years On
    • United Kingdom
    • Mondaq UK
    • 24 July 2019
    ...Floyd LLJ), Regen v Estar [2019] EWHC 63 (HHJ Hacon); notable earlier commentary in Generics v Yeda [2017] EWHC 2629, Actavis v ICOS [2017] EWCA Civ 1671 (Kitchin LJ), Illumina v Premaitha [2017] EWHC 2930 and Liqwd v L'Oréal [2018] EWHC 1394). In other words, "normal interpretation" is the......
  • Actavis V Eli Lilly: Supreme Developments
    • United Kingdom
    • Mondaq UK
    • 2 January 2018
    ...v Yeda”), a first instance decision of Mr Justice Arnold; and Actavis Group & Others v (1) ICOS (2) Eli Lilly & Company [2017] EWCA Civ 1671 (“Actavis v ICOS”), an appeal heard by the Lords Justices Lewison, Kitchin and The first issue that has been considered is whether “normal int......
  • Actavis V Lilly: Supreme Developments
    • United Kingdom
    • Mondaq UK
    • 17 November 2017
    ...v Yeda”), a first instance decision of Mr Justice Arnold; and Actavis Group & Others v (1) ICOS (2) Eli Lilly & Company [2017] EWCA Civ 1671 (“Actavis v ICOS”), an appeal heard by the Lords Justices Lewison, Kitchin and The first issue that has been considered is whether “normal int......
  • Validity - Annual Patents Review 2017
    • United Kingdom
    • Mondaq UK
    • 19 February 2018
    ...Biotechnology Limited [2017] EWHC 395 (Pat) (3 March 2017) Henry Carr J Actavis Group PTC EHF & Anr v ICOS Corporation & Anr [2017] EWCA Civ 1671 (1 November 2017) Lewison, Kitchin & Floyd Accord Healthcare Limited v Research Corporation Technologies Inc [2017] EWHC 2711 (Ch) (7......
  • Request a trial to view additional results

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT