Hospira UK Ltd v Cubist Pharmaceuticals LLC
Jurisdiction | England & Wales |
Judge | Mr Justice Henry Carr |
Judgment Date | 10 June 2016 |
Neutral Citation | [2016] EWHC 1285 (Pat) |
Docket Number | Case No: HP-2014-000037 |
Court | Chancery Division (Patents Court) |
Date | 10 June 2016 |
[2016] EWHC 1285 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Rolls Building
Fetter Lane
London EC4A 1NL
The Hon Mr Justice Henry Carr
Case No: HP-2014-000037
Richard Meade QC and Isabel Jamal (instructed by Taylor Wessing LLP) for the Claimant
Andrew Waugh QC, Thomas HinchliffeQC andStuart Baran (instructed by Carpmaels & Ransford LLP) for the Defendant
Hearing dates: 21, 22, 25–29 April, 3, 5 and 6 May 2016
Introduction | 5 |
The issues | 5 |
The 417 Patent | 5 |
The 179 Patent | 6 |
The 047 Patent | 6 |
All Patents | 6 |
The 417 Patent | 7 |
The witnesses in respect of the 417 Patent | 7 |
Dr Ebert | 7 |
Dr Harding | 8 |
Dr Zeckel | 9 |
The Skilled Addressee | 10 |
Lilly's development history of daptomycin | 10 |
Conclusion in relation to the Lilly daptomycin trials | 14 |
Dr Zeckel's knowledge and Cubist's disclosure | 15 |
Common general knowledge | 16 |
Vancomycin and the need for new treatments for gram-positive infections | 16 |
Common general knowledge/what would have been found out about the Lilly trials | 17 |
Skeletal muscle toxicity | 21 |
Tolerance of side effects | 22 |
Advantages of once-daily dosing | 22 |
Concentration dependent killing | 23 |
Aminoglycosides and quinolones | 24 |
Post-antibiotic effect ("PAE") | 25 |
The pharmacokinetic and pharmacodynamic properties of daptomycin | 25 |
Paediatric dosing | 26 |
The 417 Patent | 26 |
The Claims | 29 |
Scope of the claims | 30 |
Legal principles and the effect of G 2/98 | 30 |
Disclosure of the first priority document | 33 |
The second priority document | 36 |
The Cubist Press Release | 37 |
Disclosure | 37 |
Anticipation by the Cubist Press Release | 37 |
Obviousness in light of the Cubist Press Release | 38 |
Legal principles | 38 |
Application to the facts | 39 |
Woodworth | 42 |
Disclosure | 42 |
Anticipation by Woodworth | 44 |
Obviousness in light of Woodworth | 44 |
Added matter/lack of clarity | 46 |
Legal principles | 46 |
Application to the facts | 47 |
Sufficiency – enablement across the full width of the claims | 48 |
The Purity Patents | 48 |
The witnesses in respect of the purity patents | 48 |
Dr Baker | 48 |
Prof Myerson | 49 |
Dr Kelleher | 50 |
The skilled addressee | 50 |
Whether a clinician would be included in the skilled team | 51 |
The relevance of the scale of the purification processes | 51 |
The 179 Patent | 52 |
The evidence of Dr Kelleher | 52 |
Dr Kelleher's first statement | 52 |
Dr Kelleher's cross-examination | 54 |
Common general knowledge of relevance to the 179 Patent | 56 |
Purity versus yield | 56 |
Fermentation and clarification | 57 |
Purification processes | 57 |
Multiple purification steps and modes | 57 |
AEC | 58 |
Purification techniques used on lipopeptides | 58 |
HIC and lipopeptides | 59 |
The use of AEC in combination with HIC | 59 |
The use of buffers and chaotropic agents | 60 |
Daptomycin | 61 |
Anhydro daptomycin and the β isomer of daptomycin | 61 |
The specification of the 179 Patent | 63 |
The claims of the 179 Patent as granted | 66 |
The disclosure of US 843 | 68 |
Obviousness over US 843 | 69 |
Motivation to improve US 843 | 71 |
Use of AEC | 71 |
AEC as the first step | 72 |
HIC followed by AEC | 72 |
Use of buffers and chaotropic agents | 72 |
Fair prospect of success | 72 |
The secondary evidence | 73 |
Conclusion | 73 |
Obviousness of the 179 Patent over common general knowledge alone | 73 |
Added matter | 74 |
Legal principles | 74 |
The starting sample of daptomycin and obtaining "purified daptomycin" in combination with the purification steps of claim 1 | 75 |
Claim 1 – list of chaotropic agents | 77 |
Claim 3 – "purified daptomycin" | 77 |
Enablement across the full width of the claims | 78 |
The 047 Patent | 78 |
The skilled team | 78 |
Additional common general knowledge of relevance to the 047 Patent | 78 |
Surfactants | 78 |
Lipopeptides as surfactants | 79 |
Primary structure of lipopeptides | 79 |
Daptomycin as a surfactant | 80 |
Tests to determine whether a lipopeptide is a surfactant | 80 |
Common general knowledge of surfactin at the priority date | 81 |
Formation of micelles | 81 |
The specification of the 047 Patent | 82 |
Claim 1 of the 047 Patent | 83 |
The disclosure of Lin & Jiang | 84 |
Obviousness of the 047 Patent in the light of Lin & Jiang | 84 |
Purification of surfactin and daptomycin | 84 |
Manipulating the CMC by altering the pH | 86 |
Assessment of obviousness in the light of Lin & Jiang | 86 |
Conclusions | 90 |
Introduction
The Claimant ("Hospira") seeks revocation of three patents ("the Patents") owned by the Defendant ("Cubist"), namely:
i) EP (UK) 1,115,417 ("the 417 Patent");
ii) EP (UK) 1,252,179 ("the 179 Patent"); and
iii) EP (UK) 2,264,047 ("the 047 Patent").
All three patents concern the antibiotic daptomycin, which was originally discovered by Eli Lilly ("Lilly") in the 1980s. Daptomycin is a lipopeptide, and lipopeptides are molecules consisting of a lipid (a naturally occurring molecule such as a fat) connected to a peptide (a short chain of amino acids).
Cubist has made an unconditional application to amend the 417 Patent. References to the claims of the 417 Patent in this judgment are to the proposed amended form. The 417 Patent claims a dosage regimen for daptomycin of between 3–10 mg/kg administered once every 24 hours, for treating a bacterial infection. It has a first claimed priority date of 25 September 1998 and a second claimed priority date of 24 March 1999. The 417 Patent was filed on 24 September 1999. The 179 and 047 Patents concern purification processes for daptomycin (collectively "the Purity Patents"). They rely upon the same priority documents and their earliest claimed priority date is 20 January 2000.
The validity trial of all three patents was heard at the same time. This did not prove easy, either for the parties' legal representatives or for the court. The 417 Patent raised different issues and involved evidence from different experts to the Purity Patents. It would have been preferable to hear the trial of the 417 Patent first, followed shortly afterwards by the trial of the Purity Patents. Generally speaking, three patents with different subject matter are likely to prove too many for a single trial.
To date, none of the Patents has enjoyed a happy life. The US equivalent of the 417 Patent was held to be anticipated by and obvious over prior art relied on in these proceedings. US patents with common features to the Purity Patents (although not identical claims) were also held to be invalid over prior art relied on in these proceedings. Those decisions were affirmed on appeal. The Opposition Division of the EPO held that the 417 Patent was not entitled to its first priority date and was invalid for lack of inventive step. The decision of the Opposition Division is under appeal to the Technical Board of Appeal. However, I have heard different evidence and different arguments, and in respect of the US judgments, I am applying a different system of law. Other than passages to which I expressly refer, I have not relied on those decisions.
The issues
The 417 Patent
The following grounds of invalidity are relied upon by Hospira:
i) That the 417 Patent is not entitled to either of its claimed priority dates. Cubist accepts that if the 417 Patent is not entitled to either its first or second claimed priority dates, then it is invalid.
ii) That, as a result of non-entitlement to the first priority date, the 417 Patent is anticipated or rendered obvious by a Press Release published on 1 March 1999 ("the Cubist Press Release").
iii) Irrespective of the priority attacks, that Woodworth et al., Single-Dose Pharmacokinetics and Antibacterial Activity of Daptomycin, a New Lipopeptide Antibiotic, in Healthy Volunteers, Antimicrobial Agents and Chemotherapy (1992) ("Woodworth") anticipates the 417 Patent or deprives it of inventive step.
iv) That the claims as proposed to be amended add matter over the application as filed and claim 2 as proposed to be amended lacks clarity.
v) That the claims of the 417 Patent are not enabled across their full width. This is advanced as a squeeze with the attacks based on the prior art.
The 179 Patent
The following grounds of invalidity are relied upon by Hospira:
i) That the 179 Patent lacks inventive step over US 4,874,843 ("US 843").
ii) That the 179 Patent lacks inventive step over the common general knowledge alone and/or is a non-inventive collocation of known purification steps.
iii) That the claims of the 179 Patent add matter over the application as filed.
iv) That the claims of the 179 Patent are not enabled across their full width. Again, this is relied on as a squeeze with the prior art, in that it is alleged that the claims are not enabled insofar as they cover methods which do not use the method described in US 843.
v) That the same objections to validity apply to the conditional amendments proposed by Cubist.
The 047 Patent
Hospira alleges that the 047 Patent lacks inventive step over Lin & Jiang, Recovery and purification of the lipopeptide biosurfactant of Bacillus...
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