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| The IPKat and team watching last week's Supreme Court hearing... |
"Last week, the UK Supreme Court held a 4-day hearing in Warner-Lambert v Actavis et al., the latest (perhaps last?) installment in the long-running Lyrica® saga concerning the validity and infringement of Warner-Lambert’s (Pfizer) second medical use patent with Swiss-type claims covering pregabalin for the treatment of pain. The central issues in dispute in this appeal were the role of plausibility in the test for sufficiency of disclosure, the allowability of post-trial amendments, and the direct and indirect infringement of Swiss-type claims.
As readers may recall (see all previous IPKat posts here), the Court of Appeal had upheld Arnold J’s finding that inter alia claim 3 (to neuropathic pain, the only claim which is the subject of the Supreme Court appeal) of Pfizer’s patent was invalid for lack of sufficiency. The Court of Appeal had held that the data in the patent, which related to animal models of inflammatory pain, rendered it plausible that pregabalin would be effective in treating peripheral neuropathic pain but not central neuropathic pain. Whilst such data may have encouraged the skilled person to test the effectiveness of pregabalin in the treatment of peripheral neuropathic pain (rendering that invention plausible), the same was not true of central neuropathic pain and therefore not of neuropathic pain as a whole, rendering the claim insufficient.
The Court of Appeal also upheld the rejection of Pfizer’s application to amend the claim down to peripheral neuropathic pain after the first instance judgment had been handed down as being an abuse of process. On infringement, the Court of appeal provided obiter guidance, proposing a test for direct infringement based on the manufacturer’s knowledge or reasonable foreseeability of the ultimate intentional use for the patented indication, qualified by a caveat that the element of intention can be negated where the manufacturer has taken all reasonable steps to prevent infringement. On indirect infringement, the Court of Appeal reiterated that what is required is that means are provided which are for putting the invention into effect, but that there is no requirement for a downstream act of manufacture.
On appeal, the UK Supreme Court panel was composed of Lords Mance, Sumption, Hodge, Reed and Briggs. Tom Mitcheson QC argued Pfizer’s case on plausibility, and Lord Pannick QC took over the case on abuse of process and infringement, with both sharing issues of construction. For Actavis/Mylan, Adrian Speck QC made submissions on plausibility and infringement, with Pushpinder Saini QC dealing with the remaining issues of construction and abuse of process. Michael Silverleaf QC also made submissions on behalf of the Secretary of State for Health. A number of interveners also made written submissions that were occasionally referred to in the course of the hearing.
Our “Top 10” points of interest or questions arising from the submissions before the Supreme Court are as follows:
On plausibility
1. Is plausibility a disease that is spreading and which must tackled by the Court before it is too late, as argued by Pfizer?
2. Alternatively, should the test for plausibility and obviousness be the same (i.e. require a reasonable expectation of success), or must the patent show a direct effect on the mechanism of the claimed disease, as argued Actavis/Mylan?
On abuse of process
3. Should the patentee have a right to amend following them being made aware of the judicial decision, as is the case before the OD of the EPO and some other national courts?
4. Should the rules on partially valid patents apply to “partially valid claims”, as argued by Pfizer?
5. Is it disproportionate not to allow amendment post-trial where any prejudice could arguably be adequately dealt with in costs?
On construction
6. Pfizer suggested that the “validating principle” from contract law should be imported into patent law. Is it right to draw an analogy between a patent and a bilateral instrument such as a contract or deed, or a regulation which the court must interpret to ensure its validity?
On infringement
7. Does this issue require a judicial rewriting of s60 of the Patents Act, as initially argued by Pfizer?
8. Or is this simply a case of construction of the word “for”?
9. How important is the label in determining infringement?
Interveners
10. Is it relevant that patents with Swiss-form claims will disappear from the patent landscape in the future, as argued by the Secretary of State for Health?
At the end of the hearing, the panel thanked counsel for all parties for their submissions and announced that it would take “some time” to prepare the judgment. If last year’s Supreme Court case in Actavis v Eli Lilly is to be taken as a guide, the Court may take around three months to make its judgment available."