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27/01/2009

Particularising common general knowledge
Tom Ohta

This article originally appeared in Bristows' Life Sciences e-newsletter, On The Pulse.
In the joined cases, ratiopharm v Napp Pharmaceuticals Holdings and Sandoz v Napp Pharmaceuticals Holdings[1], the High Court criticised the current practice of submitting pleas for obviousness based solely on common general knowledge, without further particularising the plea (except to the extent that it is later explained by the expert evidence). It is unclear whether the Court expects parties to particularise facts forming the common general knowledge at the time of pleadings, or whether such particulars are to be identified after pleadings have been submitted but prior to the exchange of evidence. Either way, this case is likely to lead to a significant change in practice upon when and how parties in patent actions should plead what amounts to common general knowledge.
The patentee, Napp Pharmaceutical Holdings, owned two patents concerning slow-release formulations of a known opioid painkiller, oxycodone. The case initially started as two actions by ratiopharm and Sandoz to revoke the patents, and for declarations of non-infringement for products that ratiopharm and Sandoz wished to market in the UK. Napp subsequently counterclaimed for infringement in both cases. The Court construed the asserted claims and held that neither patent was infringed by ratiopharm or Sandoz. In relation to the validity challenges, the Court held that both patents were valid.
The obviousness attack was primarily based on the common general knowledge. The Court therefore had to consider whether the inventive concept was obvious in light of the common general knowledge known to the notional person skilled in the art. The inventive concept was the provision of a controlled release version of oxycodone. However, it was disputed whether it was common general knowledge that oxycodone would be perceived as a substitute analgesic for patients receiving morphine. Sandoz and ratiopharm submitted that it did, and as morphine was available in a controlled release version, it would have been obvious to create a controlled release formulation of an alternative strong opioid, such as oxycodone, for the treatment of patients with moderate to severe pain.
The Court's approach towards assessing obviousness in this case is encouraging and refreshing as it demonstrates the Court asserting the importance of assessing the state of the common general knowledge without the benefit of hindsight. Mr Justice Floyd acknowledged that he had initially approached the case with an expectation of surprise if a controlled release version of a known drug, such as oxycodone, turned out to be inventive.  "After all," he said, "controlled release technology is a technology of potentially universal application... Unless there is some specific technical difficulty to overcome (and none is suggested here), why does making a controlled release version of a known analgesic warrant a patent?" However, such preconceptions did not colour the Court's assessment of the evidence before it. The Court concluded that oxycodone would not have been perceived as an alternative to morphine for development into a controlled release product. It held that at the priority date, there was insufficient information about the clinical performance of oxycodone as an oral analgesic in comparison to morphine to make it an obvious choice for development into a controlled release product.
This case is also likely to have a significant impact on patent litigation when submitting pleadings on what amounts to common general knowledge. The Civil Procedure Rules require a party in patent actions to identify the matter in the state of the art that is relied upon to support an obviousness attack on the patent's validity. However, it is common practice for parties to include a plea of obviousness based solely on common general knowledge without further particularising the plea. The Court criticised this approach, stating that, "the time has come when the matter which is said to be common general knowledge ought to receive some more formal exposition in advance of the expert evidence stage." The Court's rationale was that an adequate particularisation of the common general knowledge was a starting point for determining obviousness; without it, it was not possible to identify whether or not the inventive concept was obvious. It is unclear whether the Court expects parties to particularise facts forming the common general knowledge at the time of pleadings, or whether such particulars are to be identified after pleadings have been submitted but prior to the exchange of evidence. Either way, this case is likely to lead to a significant change in practice.


[1]
[2008] EWHC 3070 (Pat)


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