Merck Sharp & Dohme Ltd v Wyeth LLC (Rev 1)

In a patent action concerning vaccine formulations, a claim specifying that pneumococcal polysaccharides “are” a listed set of serotypes was construed as limited to precisely those serotypes. The ordinary meaning differed from the inclusive effect of “comprises”.

For obviousness, common general knowledge may include a specific application of a broader, established practice where the skilled team would regard it as an ordinary instance of that practice. The use of surfactants to address protein aggregation, including aggregation associated with silicone interfaces, was common general knowledge to the skilled team. Claims directed to a 13-valent vaccine and its formulation were therefore obvious over a document specifically identifying that vaccine, although a more general formulation document did not make the serotype combination obvious.

Merck Sharp & Dohme Limited sought revocation of European Patent (UK) 2,676,679. Wyeth LLC counterclaimed for quia timet infringement. The dispute concerned vaccine formulations containing pneumococcal polysaccharide-protein conjugates, aluminium salt, buffered saline and, in some claims, a surfactant.

The principal issues were whether the claims covered a vaccine containing additional pneumococcal serotypes; whether amended surfactant claims added matter; whether a use claim was anticipated by Hausdorff 381; whether the claims were obvious over de la Pena or Chiron; and whether the patent was insufficient.

1. Construction and infringement. The word “comprises” was inclusive, but integer F used “are” and therefore required precisely the 13 specified pneumococcal serotypes. The alleged product contained 15 serotypes and did not infringe claims 1 or 16, or their dependent claims (paras [251]-[270]).
2. Added matter. The test was whether the skilled person would learn anything about the invention from the amended specification which was not directly and unambiguously disclosed in the application as filed. An intermediate generalisation was permissible where the skilled person would understand that the selected feature was generally applicable without the other features of the specific embodiment. Reading the application as a whole, the skilled reader would understand that surfactants generally, not only polysorbate 80, were applicable to the disclosed formulations. Claims 2 and 17 therefore did not add matter (paras [278]-[303]).
3. Novelty. A use claim to an old product for a new use was not anticipated merely because carrying out the prior art inevitably achieved the technical result. The new use, or its objective and achievement, had to be disclosed. Hausdorff 381 did not clearly and unambiguously disclose a siliconized container or the use to inhibit silicone-induced aggregation. Claim 1 was anticipated, but claim 16 was novel (paras [304]-[317]).
4. Obviousness. The skilled team included a vaccinologist and a formulator. The formulator’s knowledge was not confined to vaccines and included relevant knowledge of therapeutic proteins. Surfactants could be used to address aggregation, and testing for physical stability and aggregation in the intended container was common general knowledge (paras [64]-[79], [136]-[160], [225]-[248]).
5. De la Pena specifically identified the 13-valent vaccine and gave the skilled vaccinologist a reason and motivation to progress it. The remaining formulation steps, including use of an aluminium adjuvant, buffered saline, a siliconized container and a surfactant to address silicone-induced aggregation, were routine. All claims were obvious over de la Pena (paras [318]-[346]). Chiron contained no sufficient pointer to the claimed 13-valent serotype combination, so the obviousness attack based on Chiron failed (paras [347]-[356]).
6. The insufficiency attack, advanced largely as a squeeze, failed. The standards for obviousness and plausibility-based insufficiency were distinct, and the claimed 13-valent combination was sufficiently plausible on the evidence (paras [357]-[365]). The equivalence issue was left undecided because it was immaterial to the conclusions.