Patents - Merck Sharp & Dohme Ltd v Wyeth LLC
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Patents Court (Mr Justice Meade) Merck Sharp & Dohme Ltd v Wyeth LLC  EWHC 2636 (Pat) (15 Oct 2020)
This was an action by Merck Sharp & Dohme Ltd ("MSD") for the revocation of European Patent (UK) 2,676,679 for formulations which stabilize and inhibit precipitation of immunogenic compositions which had been granted to Wyeth LLC ("Wyeth") on grounds of want of novelty, obviousness and insufficiency. Wyeth counterclaimed for infringement and also applied for the amendment of certain claims. The trial took place between 30 June and 10 July 2020 before Richard Meade QC as he then was. In a press release dated 4 Sept 2020, the Judicial Appointments Commission announced that Mr Meade had been elevated to the High Court bench with effect from 7 Sept 2020. His lordship handed down his judgment in this action on 15 Oct 2020 (see Merck Sharp & Dohme Ltd v Wyeth LLC  EWHC 2636 (Pat)). This is, therefore, one of the first if not the very first of Mr Justice Meade's judgments.
The abstract of the invention for which the patent in suit had been granted was as follows:
"The present invention addresses an ongoing need in the art to improve the stability of immunogenic compositions such as polysaccharide-protein conjugates and protein immunogens. The invention broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit particulate formation (e.g., aggregation, precipitation) of immunogenic compositions which are processed, developed, formulated, manufactured and/or stored in container means such as fermentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like."
S.125 (1) of the Patents Act 1977 provides:"For the purposes of this Act an invention for a patent for which an application has been made or for which a patent has been granted shall, unless the context otherwise requires, be taken to be that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification, and the extent of the protection conferred by a patent or application for a patent shall be determined accordingly"
"A. 1. A siliconized container means filled with a formulation which inhibits silicone induced aggregation of a polysaccharide-protein conjugate comprised in a siliconized container means, the formulation comprising
B. (i) a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5,
C. (ii) an aluminum salt and
D. (iii) one or more polysaccharide-protein conjugates
E. wherein the polysaccharide-protein conjugate comprises one or more pneumococcal polysaccharides
F. and wherein the one or more pneumococcal polysaccharides are a S. pneumoniae serotype 4 polysaccharide, a S. pneumoniae serotype 6B polysaccharide, a S. pneumoniae serotype 9V polysaccharide, a S. pneumoniae serotype 14 polysaccharide, a S. pneumoniae serotype 18C polysaccharide, a S. pneumoniae serotype 19F polysaccharide, a S. pneumoniae serotype 23F polysaccharide, a S. pneumoniae serotype 1 polysaccharide, a S. pneumoniae serotype 3 polysaccharide, a S. pneumoniae serotype 5 polysaccharide, a S. pneumoniae serotype 6A polysaccharide, a S. pneumoniae serotype 7F polysaccharide and a S. pneumoniae serotype 19A polysaccharide."
"Adding serotypes could risk the overall package, in particular prejudicing manufacturing feasibility for perhaps inadequate compensating gain in efficacy or cross-protection. Adding serotypes is not something that the skilled person would think could be done lightly or arbitrarily – indeed that is part of Wyeth's defence to obviousness – so there is a real rationale for the patentee to limit the claims to the precise combination of serotypes, which could be formulated (as the Patent shows) and is taught by the Patent (though not proved) to be useful clinically."
MSD opposed the proposed amendment of claims 2 and 17 on the ground of added matter. It argued that the limitation to a surfactant generally would be an impermissible intermediate generalization. Its contention is to be found in paragraph  of Mr Justice Meade's judgment. The argument in support of MSD's contention appears in paragraphs  to .
His lordship directed himself that the test for added matter was "whether a skilled man would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification" (per Lord Justice Iacob in Richardson-Vicks' Patent  RPC 568 at 576 approved by the Court of Appeal in Nokia OYJ (Nokia Corporation) v IPCom GmbH & Co Kg  EWCA Civ 567,  RPC 5). In relation to intermediate generalization, Nokia was also authority for the rule that "it is not permissible to introduce into a claim a feature taken from a specific embodiment unless the skilled person would understand that the other features of the embodiment are not necessary to carry out the claimed invention. Put another way, it must be apparent to the skilled person that the selected feature is generally applicable to the claimed invention absent the other features of that embodiment."
MSD alleged that the patent was obvious over an article entitled "Present and Future of the Vaccination against Pneumonia", Pediatrika 2004; 24(4): 147-155 known as de la Pena and an application for a patent for vaccines comprising aluminium adjuvants and histidine numbered WO 03/009869 known as Chiron.
b) Decide to use an aluminium salt adjuvant (filling in a gap, de la Pena is silent);
c) Decide to use a buffer (again, filling in a gap);
d) Decide to use a siliconized container (again, filling in a gap);
e) Add a surfactant to address silicone-induced aggregation; and
f) In order to make the decision to add a surfactant, the skilled team would have to observe that in the siliconized container, aggregation was occurring in the first place, since MSD's case is, as I have already said, that a surfactant would not be added unless there was a purpose for it."
Applying that methodology, his lordship concluded that all the claims are obvious over De la Pena.
He came to a different conclusion over Chiron largely because it was a formulation teaching and taught nothing specific about the immunological characteristics of the vaccine or vaccines for which it might be used.
"a) The allegation of infringement of claims 1 and 16 and all dependent claims fails.
b) I decline to decide the subsidiary allegation of infringement by equivalence since it is rendered irrelevant by my other conclusions.
c) Claims 2 and 17 do not add matter.
d) Claim 1 is anticipated by Hausdorff 381 (a conclusion against which Wyeth mounted no defence), but claim 16 is novel over it.
e) All the claims are obvious over de la Pena.
f) The allegation of obviousness over Chiron fails.
g) The insufficiency attack fails."
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