Actavis Group PTC EHF (a company incorporated under the laws of the state of Iceland) v ICOS Corporation (a company incorporated under the laws of the state of Washington, USA); Actelion Pharmaceuticals Ltd (a company incorporated under the laws of the st
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 10 August 2016 |
| Neutral Citation | [2016] EWHC 1955 (Pat) |
| Date | 10 August 2016 |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2014-000040 Case No: HP-2015-000048 Case No: HP-2015-000062 |
[2016] EWHC 1955 (Pat)
IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION PATENTS COURT
The Rolls Building
7 Rolls Building
Fetter Lane
London EC4A 1NL
The Hon. Mr Justice Birss
Case No: HP-2014-000040
Case No: HP-2015-000012
Case No: HP-2015-000048
Case No: HP-2015-000062
Adrian Speck QC, Isabel Jamal, Joe Delaney and Tim Austen (instructed by Bird & Bird LLP) appeared for Actavis and Actelion and (instructed by Taylor Wessing LLP) appeared for Generics (UK) (trading as Mylan) and (instructed by Pinsent Masons LLP) appeared for Teva.
Michael Tappin QC also appeared for Actelion
Andrew Waugh QC, Thomas Hinchliffe QC, Katherine Moggridge (instructed Simmons & Simmons LLP) appeared for the Defendant and Third Party.
Thomas Mitcheson QC also appeared for the Defendant and Third Party
Hearing dates: 15 th– 17 th, 20 th– 24 th, 29 th, 30 th June and 1 st July
Judgment Approved
| Topic | Paragraph |
| Introduction | 1 |
| The issues | 5 |
| The witnesses | 32 |
| Technical Background | 53 |
| The 181 Patent | 72 |
| The skilled person and the common general knowledge – | 72 |
| The 181 patent specification | 99 |
| Claim construction — 181 | 117 |
| Priority — 181 | 138 |
| The priority document | 143 |
| Is the Named Compound tadalafil? | 160 |
| What are compounds 1 to 5? | 192 |
| Ranges | 211 |
| Priority overall | 228 |
| Added matter — 181 | 235 |
| Novelty — 181 | 238 |
| Obviousness – 181 | 257 |
| Obviousness – the facts | 287 |
| Insufficiency — 181 | 343 |
| Infringement — 181 | 346 |
| The 092 Patent | 357 |
| The skilled person and the common general knowledge – | 357 |
| The 092 patent specification | 377 |
| Claim construction — 092 | 385 |
| Priority — 092 | 392 |
| Added matter — 092 | 395 |
| Novelty — 092 | 400 |
| Obviousness – 092 | 410 |
| Insufficiency — 092 | 459 |
| Claims limited by pharmacokinetic properties | 460 |
| Claim 12 | 468 |
| Claims 1 to7 – particle size distribution | 469 |
| Infringement — 092 | 490 |
| Conclusion | 491 |
| Annex 1 – relevant claims of the 181 patent | |
| Annex 2 – relevant claims of the 092 patent |
Introduction
These action is concerned with patents relating to tadalafil. Tadalafil is the generic name for a product sold under the brand name CIALIS for male erectile dysfunction and under the brand name ADCIRCA for pulmonary arterial hypertension. CIALIS is also sold for benign prostatic hyperplasia. The patents and exclusive licences are held by Lilly and ICOS. In these actions, the pharmaceutical companies Actavis, Actelion, Teva, and Generics (UK) (Mylan) are seeking to clear the way. The relevant SPC expires in November 2017. The commercial value of these proceedings is very high. Based on public IMS data, branded sales of CIALIS for 2014 in the United Kingdom come to about $99 million while sales of ADCIRCA were $1 million. The European sales amount to about $ 3/4 billion annually and Lilly's accounts for 2014 showed a figure of $2.29 billion for global turnover of CIALIS.
Two patents are in issue. EP (UK) 1,173,181, entitled "Compositions comprising phosphodiesterase inhibitors for the treatment of sexual dysfunction", was filed on 26 th April 2000 claiming priority from US 132036P filed on 30 th April 1999. The 181 patent was granted on 15 th October 2003. The form of the patent before the court is a B3 specification following centralised amendments made in the EPO on 25th March 2015. The 181 patent relates to dosing. The other patent in suit is EP (UK) 1,200,092 entitled "Beta-carboline drug products". It was filed on 1 st August 2000 claiming priority from US 147048P filed on 3 rd August 1999. The 092 patent was granted on 21 st April 2004. The 092 patent relates to drug formulation.
An important part of the context in this case relates to the famous drug VIAGRA. By the relevant priority dates (1999/2000), Pfizer had launched the compound sildenafil citrate under the brand name VIAGRA as a treatment for erectile dysfunction. It had attracted enormous public attention as well as attention in the pharmaceutical industry. VIAGRA was first launched in the USA after approval by the FDA in March 1998 so that by the earliest of the various possible priority dates it had been on sale for about a year. In fact at least in the industry it had attracted attention before launch. Sildenafil is an inhibitor of an enzyme known as phosphodiesterase 5 (PDE5). That enzyme acts in the corpus cavernosum tissue in the human penis and plays a role in maintaining erections. It is the inhibition of PDE5 which accounts for sildenafil's mode of action. Tadalafil is also an inhibitor of PDE5. Many of the issues involve considering the thinking of a person skilled in the art aware of sildenafil and considering tadalafil as another possible inhibitor of PDE5.
In the judgment I will refer to the two sides as "the claimants" and "Lilly". The claimants are Actavis, Actelion, Teva, and Generics (UK) (t/a Mylan)). In this judgment Lilly refers to both ICOS Corp. and Eli Lilly and Company. The proprietor of the patents is ICOS Corp. while Eli Lilly and Company holds an exclusive licence.
The issues
Claim 1 of 181 is in this form:
A pharmaceutical unit dosage composition comprising 1 to 5 mg of a compound having the structural formula:
said unit dosage form suitable for oral administration up to a maximum total dose of 5 mg per day.
The structural formula represents tadalafil. The other relevant claims of 181 are set out in Annex 1.
There is a debate about claim construction concerning the reference to a maximum total dose per day. There are also issues on infringement which relates only to Actavis and Mylan. One is about whether a threat to infringe has been established and this applies to 181 and 092. The other is about the terms of the marketing authorisation(s) for the generic products. Most of the time at trial was taken up with issues concerned with validity. Recognising that Actelion does not challenge the validity of the 181 patent, I will still just refer to "the claimants" as a whole unless it is necessary to distinguish between them.
The claimants contend the relevant claims are not entitled to priority from the priority document. If priority is lost then further citations become relevant prior art (see below). The priority issue for 181 involves two points. First the claimants allege that tadalafil is not identified in the priority document or at least not identified sufficiently clearly nor in the correct context to support the claims of 181. This is mostly an argument about chemical nomenclature. Second the claimants allege that other features of the claims of 181 (relating to the maximum daily dose and/or amounts in dosage forms) are not supported in any event.
Lilly denies these allegations. It maintains that tadalafil is the compound disclosed in the priority document and the claims are entitled to priority.
The claimants take two added matter points against the 181 patent. They are similar to the second substantive priority issue but this time focussed on comparing the claims in force with the disclosure of the application as filed rather than with the priority document. The application as filed is said not to disclose dosage forms of from 1–5mg and not to disclose a maximum daily dose of 5mg. Lilly denies the patent includes added matter.
Four prior art citations are relied on: WO 97/03675 ("Daugan"), WO 01/08688 (" Anderson"), WO 00/53148 ("Stoner") and WO 01/08686 ("Oren"). Daugan was published on 6 th February 1997 and therefore is full prior art with respect to the 181 patent.
Anderson , Stoner and Oren were all published after the filing date for the 181 patent and therefore can never be relevant for obviousness. However they all designate both GB and EP(UK), amongst other states, and so may be relevant as novelty-only prior art under s2(3) of the Patents Act 1977 (Art 54(3) EPC). That will depend on dates and priority.
Anderson was filed on 1 st August 2000 and claims priority from a US filing on 3 rd August 1999. Therefore to the extent the 181 patent keeps its priority date Anderson is not relevant prior art at all. However if a claim of 181 loses priority, then to the extent any matter in Anderson is entitled to its own priority claim, it is citable for novelty against that claim. In fact Anderson is the PCT application which led to the 092 patent. No point is taken by Lilly that the matter in Anderson is not entitled to claim priority from Anderson's priority document.
Stoner was filed on 3 rd March 2000 and so if 181 loses priority, the contents of the Stoner application are citable for novelty. Stoner claims priority from a US filing on 8 th March 1999 which is earlier than the claimed priority date for the 181 patent, however in order for the claimants to argue that Stoner would be be citable under s2(3) even if 181 kept its priority date, it would be necessary to establish that the relevant matter in the Stoner...
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