A recent decision concerning GlaxoSmithKline and Wyeth Holdings has provided the High Court an opportunity to review what constitutes an “enabling disclosure” in the context of assessing novelty. In these proceedings, GSK had lodged a claim for revocation of Wyeth’s patent relating to a Meningitis B vaccine. Wyeth counterclaimed for infringement by GSK’s Bexsero vaccine. The novelty of Wyeth’s patent was questioned based on the prior use and prior description of vaccines that contained the same active ingredients. However, the High Court decided that neither the use nor the description constituted “enabling disclosures”. Ultimately, Wyeth’s patent was held to be valid, and GSK’s Bexsero vaccine was found to infringe.

Wyeth’s patent EP(UK)2,343,308 claims a composition comprising a 2086 protein, and additionally at least one PorA protein. This composition is effective as a vaccine to prevent meningitis caused by N. meningitides serogroup B, and claims 18-20 are directed to this use. It was known, prior to Wyeth’s filing, that vaccines containing PorA proteins did not provide broad protection against a sufficient variety of bacterial strains to be particularly effective. In contrast, Wyeth had found that inclusion of 2086 protein (also known as fHbp) provides compositions that elicit bactericidal antibodies to multiple strains.

In GSK’s claim for revocation, invalidity was asserted on the basis that certain claims of the patent lacked novelty. GSK relied upon prior use of a vaccine developed at the Finlay Institute in Havana, Cuba, which was being administered to patients before Wyeth’s first priority document. GSK also argued lack of novelty based on an abstract describing the antibody response of a vaccine developed from a Norwegian strain of Men B.

Both the Cuban and Norwegian vaccines included bacterial OMVs (outer membrane vesicles). These OMVs are released from the bacterium and thus contain associated proteins and lipids, some of which are strongly immunogenic. It was well known at the priority date that a major immunogenic component of OMVs was the PorA protein. However, the precise identity of other proteins of the OMVs was not known. It was later discovered that both the Cuban and the Norwegian vaccines did in fact include 2086 protein. In considering whether either of these earlier vaccines was prejudicial to novelty, the judge made some interesting observations as to what constitutes an “enabling disclosure”.

Concerning prior use of the Cuban vaccine, the judge posed four questions:

  1. Did the Cuban vaccine contain fHbp before the priority date?;
  2. If so, would the skilled person have been able to discover that fact?;
  3. Would it have been possible to reproduce the Cuban vaccine without undue burden; and
  4. In relation to claims 18-20, if fHbp was present, did it make any material contribution to the immune reaction produced by the Cuban vaccine?

Regarding Q.(i), GSK submitted that there was evidence the Cuban vaccine contained 2086 protein in 2009, and alleged that the vaccine would have had an equivalent composition before Wyeth’s priority date in 2001. It was however decided that due to the high degree of variation between batches of OMVs, on the balance of probabilities, it was not proven by GSK that the vaccine included 2086 protein at the priority date.

Turning to Q.(ii), Wyeth submitted that in order for the Cuban vaccine to anticipate as prior use, the skilled person must have been able to analyse it and identify the presence of 2086 protein at the priority date. GSK disagreed. In forming his decision, the judge referred to the principles set out previously in both Merrell Dow Pharmaceuticals Inc v HN Norton & Co Ltd [1996] RPC 76 and in Synthon BV v SmithKline Beecham plc [2006] RPC 10. In Merrell Dow, Lord Hoffman explained that anticipation requires clear communication of information to the public. It was expressly stated that “Acts done secretly or without knowledge of the relevant facts, which would amount to infringements after the grant of the patent, will not count as anticipations before”. In Synthon, it was further clarified that the skilled person “must be able to perform the claimed invention by using the matter disclosed in the prior art, read and understood together with his common general knowledge”. Applying these principles, the judge concluded that it was necessary for the skilled person to be able to identify the presence of the 2086 protein at the priority date, and since the techniques were not available to allow this, the prior use was not novelty-destroying.

Regarding Q.(iii) and (iv), the conclusions were relatively straightforward. For Q. (iii) it was considered that the required bacterial strain may have been obtainable in order to reproduce the vaccine. However, taken together with the prior conclusion that the 2086 protein could not be identified, overall the use of the Cuban vaccine did not amount to an enabling disclosure. In response to Q.(iv), it was considered that any 2086 protein would have been present in very low abundance and there was no evidence that this small amount would have contributed to the immune reaction produced by the Cuban vaccine.

With regard to the Norwegian vaccine described in the abstract, GSK alleged that this composition was within the scope of claim 1 of Wyeth’s patent, and that the skilled team could have determined the components of the OMVs using standard techniques. However, both GSK’s and Wyeth’s technical experts indicated that this task would have been “extremely laborious” and “very unlikely to work”. Furthermore, no specific method or growth conditions were disclosed in the abstract. Thus, it was not considered inevitable that OMVs produced based on the teaching would contain 2086 protein. On this basis, it was concluded that the abstract did not amount to an enabling disclosure.

In finding in Wyeth’s favour, this decision has reinforced the idea that for a prior disclosure to anticipate there must be sufficient transfer of information to the public. What is critical is what would have been known or achievable by the skilled person at the time of disclosure, regardless of what is learnt subsequently. Disclosure by prior use may be of particular interest in the field of biologics, where significant investment may be required to determine the active ingredients of a mixed composition. For those in this field, the decision is a positive one, since it confirms that even if the same composition was in use before, if the relevant information was unknown, a patent may still be granted on the basis of discovering the active ingredients and demonstrating their therapeutic effects.