- The Patent in suit contains Swiss form claims to pregabalin in the treatment of pain (Claim 1) and in the treatment of neuropathic pain (Claim 3).
- Pain is difficult to define both clinically and in patent terms. Paragraph  of the Patent states that the invention is directed to chronic pain disorders. It then provides a list of conditions which the invention is said to include but not be limited to. Paragraph  of the Patent then refers to the invention as being the use of pregabalin in "the treatment of pain as listed above".
- The Patent refers to neuropathic pain as being that "which is caused by injury or infection of peripheral sensory nerves”. The patent does not draw a distinction between peripheral neuropathic pain and central neuropathic pain.
- The Patent contained data relating to animal models of inflammatory pain. None of these models were established models of neuropathic pain.
- Inflammatory pain contains a central sensitisation component which is present in neuropathic pain but not central neuropathic pain.
- The Defendants argued that Warner-Lambert must rely on the data in the animal models for the purposes of plausibility.
- Warner-Lambert responded that central sensitisation component provided the requisite link between the animal models and the claimed forms of pain.
- Mylan contended that not all forms of pain which fell within the claims contained a central sensitisation component. Furthermore, it was CGK that neuropathic pain included both peripheral neuropathic pain and that central neuropathic pain did not have a central sensitisation component.
- Warner-Lambert argued that the skilled person would in any event have understood claim 3 (i.e. to neuropathic pain) to have been limited to peripheral neuropathic pain.
although it is often said that a specification can act as its own dictionary, not every use in the specification of a term found in the claim will be understood by the reader to be a definition. On no basis can paragraph  or  or the two paragraphs read together be taken to be a definition of what the patentee means by the term "pain". They are statements exemplifying the broadest statement of invention, namely that pregabalin is suitable for the treatment of pain.
- In light of Kitchen LJ’s treatment of paragraphs  and , what is/is not to be recognised as a definition in a Patent? Claire considered that in light of this decision, Patent Attorneys must be particularly precise with definitions and the definitions must be reasonable based on the state of the art at the time.
- At what level of generality should the plausibility test be applied? In the event that certain embodiments of a claim are plausible at the priority date, should it be possible to “fill in the gaps” with later filed evidence (bearing in mind that pregabalin works in central neuropathic pain).
- Should evidence of technical effect only be rejected where nothing plausible is covered by the claim?
- Is it sometimes the case that having no data in your Patent is better than having the “wrong” data? Claire referred to the HGS v Lilly  UKSC 51 and Actavis v Lilly  EWHC 3294 (Pat) cases as examples of patents which did not have data in them and yet were found to be plausible.
(a) before a trial; (b) after trial, at which certain claims have been held valid but other claims held invalid, the patentee simply wishing to delete the invalid claims (I would include here also the case where the patentee wishes to re-write the claims so as to exclude various dependencies as in Hallen v Brantia  FSR 134. There the patentee is in effect continuing to claim which he had claimed before but in a much smaller way); and (c) after a trial in which all claims have been held invalid but the patentee wishes to insert what he hopes are validating amendments.
"we believe that whether or not a patentee's attempted reliance before this court upon a patent which has been amended pursuant to a central amendment application made after trial constitutes an abuse of process must depend upon all the circumstances, including whether it would be necessary to remit the case for retrial and, if so, what the consequences of that would be.”
- that Warner-Lambert had been the victim of procedural unfairness by the Defendants raising the peripheral/central distinction so late in proceedings;
- that the proposed amendment should not be considered to fall within Jacob LJ’s category (c) but instead was more akin to a category (b) amendment as it simply sought to excise invalid matter from an otherwise valid claim; and
- the amendments would not in any event require a retrial.
- Propose amendments at an early stage in proceedings, preferably before trial;
- Keep possible amendments in mind as the trial progresses; and
- carry out a mock trial with a view to unearthing any unexpected issues.
Stuart then turned his attention to the question of indirect infringement pursuant to s60(2). As s60(2) requires the supply of “means relating to an essential element of the invention,” it is necessary to consider what the invention in a Swiss form claim is. Stuart highlighted that s125 of the Patents Act states that an invention “shall, unless the context otherwise requires, be taken to be that specified in the claim.” As such, notwithstanding the wording of the claim, it is clear that the invention in a Swiss form claim is ascribing the novel therapeutic purpose to the medicament. The invention has nothing to do with “manufacture” or “preparation”. This is a case where the context does otherwise require. By adopting this approach, the Court of Appeal were able to reach a finding that there was no requirement for a downstream act of manufacture and as such, the ascribing of purpose by, e.g. the pharmacist in applying a label to the product, was relevant to the question of infringement.
- Alerting doctors/HAs/pharmacists in advance
- Avoiding supply through certain channels
- Avoiding oversupply vs. old indication market
- Steps to update clinical software; and
- Co-operating with NHS to issue guidance.