Patents - Merck Sharp & Dohme Ltd v Wyeth LLC

Electron Microscope Image of Human Blood
Photographers: Bruce Wetzel and Harry Schaefer




















Jane Lambert

Patents Court (Mr Justice Meade) Merck Sharp & Dohme Ltd v Wyeth LLC [2020] 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 [2020] EWHC 2636 (Pat)).  This is, therefore, one of the first if not the very first of Mr Justice Meade's judgments.

The Patent

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."

The Invention

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"

The claims in contention were claims 1, 2, 4, 16, 17 and c19

Claim 1

This was as follows:

"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."

The main issue of construction was whether integer F of claim 1 required precisely the 13 identified S. pneumoniae serotype polysaccharides, or required those 13 but permitted more.  Construing the claim grammatically, the judge preferred the former construction. Where the person who had drafted the claim had intended to include items in the specification other those he or she had mentioned, that person had used the verb "comprise".  Where that person had wanted to limit them he or she had used the verb "are". There was also a scientific consideration:

"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."

Amendment

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 [282] of Mr Justice Meade's judgment.  The argument in support of MSD's contention appears in paragraphs [284] to [296].

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 [1995] RPC 568 at 576 approved by the Court of Appeal in Nokia OYJ (Nokia Corporation) v IPCom GmbH & Co Kg [2012] EWCA Civ 567, [2013] 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."

Applying those principles between [297] and [303] the judge concluded that there was no difference in teaching between the application and the proposed claims.

Want of Novelty

Next, MSD alleged that claims 1 and 16 lacked novelty over WO 2006/110381.   Wyeth did not contest the argument over claim 1 but resisted in respect of claim 16.  The contention over claim 16 failed because two integers of those claims had not been disclosed in the international patent application.

Want of an Inventive Step

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.  

S.3 of the Patents Act 1977 provides:

"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2 (2) above (and disregarding section 2 (3) above)."

There was a dispute over who should be regarded as "persons skilled in the art" but the greater part of this judgment considered the matter forming part of the state of the art that was deemed to have formed part of the "common general knowledge" of such persons.

The judge decided that the "person skilled in the art" would be a team consisting of a vaccinologist and a  formulator.  MSD had contended that a vaccinologist would not be required because the patent contained no technical contribution relating to the choice of serotypes and that it would not therefore be of interest to a vaccinologist.  His lordship rejected that argument but concluded that in any event the patent would be of interest to a vaccinologist and a vaccinologist would be needed to implement it.  Notwithstanding its argument that the patent would not be of interest to a vaccinologist, both parties called vaccinologists as well as formulators as expert witnesses,  Wyeth also called Lakshmi Khandke who had been one of the inventors of the patented invention.  Mr Justice Meade considered what would be the common general knowledge of vaccinologists between paragraphs [88] and [134] of his judgment.  Between paragraphs [135] and l248]  he considered what would be the common general knowledge of formulators.

At paragraph [328] the judge directed himself as to the steps to be taken from De la Pena to the patent in suit thereby paraphrasing the Windsurfing/Pozzoli test as approved by the Supreme Court in  Actavis Group PTC EHF and others v ICOS Corporation  and another  [2019] UKSC 15, [2019] Bus LR 1318:

"a) Select the 13v vaccine for progression;
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.

Insufficiency

Applicants for patents are required by s.14 (3) of the Patents Act 1977 to "disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art." MSD argued that if the 13v combination was not obvious, there was nothing in the teaching to make it plausible that that combination would be efficacious or safe.  Mr Justce Meade regarded that argument as a "squeeze", a tactic used in patent litigation.  It can broadly be summarized as if the patent is not bad for obviousness it must be bad for insufficiency,  A case in which the tactic worked was Generics (UK) Ltd (t/a Mylan) and another nor v Yeda Research and Development Company Ltd  [2018] RPC 2, [2017] EWHC 2629 (Pat).  In this case, the evidence did not support the contention.

Infringement

Wyeth alleged that MSD's product V114 infringed the patent because it had all the features of claim 1 plus polysaccharides for 2 additional serotypes on top of the 13.  Had the judge held that claim 1 permitted additional stereotypes which might have been the case if the draftsman had used the verb "comprised" rather than "are" the counterclaim might have succeeded.  As he had reached a different conclusion on a grammatical construction, the infringement counterclaim failed.   The learned judge might have reached a different decision on infringement had he considered the equivalents but he saw little point in the exercise having found that the patent was invalid for want of novelty and want of an inventive step.

Conclusion

 Mr Justice Meade summarized his findings at paragraph [366] of his judgment:

"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."

Anyone wishing to discuss this article or patents generally may call me on 020 7404 5252 during office hours or send me a message through my contact page,

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