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Thursday, 22 February 2018

Top 10 issues from submissions before UK Supreme Court in Warner-Lambert v Actavis second medical use battle

The IPKat and team watching last week's Supreme
Court hearing...
Like many across the IP world, the IPKat was glued to his computer screen last week watching the drama unfold in the UK Supreme Court between Warner-Lambert and Actavis/Mylan.  The IPKat's friends, Katie Cambrook, Rachel Mumby and Claire Phipps-Jones of Bristows LLP, attended in person and, with the support of a team of other keen watchers in place each day, have summarized their Top 10 issues coming out of the hearing.  The IPKat expects that the very vocal panel of judges in the form of Lord Mance, Lord Sumption, Lord Reed, Lord Hodge and Lord Briggs will be grappling with these issues and much more in preparing their judgment. For those who missed the action, you can watch the recordings on the UK Supreme Court's website here.  Over to Katie, Rachel and Claire: 
"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? 
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."


Mr Blobby-Obvious said...

1. On plausibilty: This has not become a disease, but the usage of the word and the test has become appropriate on many occasions for good reasons. There must be some evidence, not necessarily data, that the invention will work. Pfizer admitted that armchair inventions are not appropriate, but sought to distinguish their case. I feel they failed on this. Although not having the written submission or the transcripts of the expert witnesses, it appears that at the priority date, it was common knowledge that neuropathic pain consisted of two sub-types. The test data was deemed predictive of peripheral neuropathic pain and the court will uphold this finding (I speculate), contrary to Actavis' assertions, which amounted to pretty feeble arguments and an attempt to pull the wool over the Court's eyes. Actavis must have thought these inexperienced judges were there for the taking, but I've been very impressed with how quickly they've understood the issues, and I would hire Lord Sumption as representative anytime. IMHO.

2. Actavis argues the tests should be the same, but failed to share the case law from the EPO that said otherwise. A little remiss? Did Pfizer include it in their written submissions? I haven't yet watched the final day replies. The test should be the same, I think. At least I did when I saw the EPO decision. Actavis didn't convince me my first thought was correct. It seems reasonable, although there may well be cases where an inventor has had an idea based on a prior disclosure, said idea being non-obvious without the benefit of hindsight, but once made known is clearly plausible based on the disclosure. My mind has changed, but not thanks to any argument from Pfizer. Again, something in their written submissions? IMHO.

It is a poor show that the statements of case and written submissions are not publicly available.

Mr Blobby-Obvious said...

3.4.5. There may well be a case to allow amendment once a claim has been determined partly valid. I suspect this may be allowed. Whether there is basis for a valid, useful claim is another matter.

6. Ain't gonna happen. Amendment is the way to go in this case.

7. Also ain't gonna happen. Shouldn't be wasting company funds arguing for the court to rewrite a law written in a self-contained statute. Not least because one of the judges has made public his belief that there shouldn't be any judge-made law.

8. No.

9. The label is of course important. The listing of a patented indication by the manufacturer is an admission of guilt. Its absence, however, exonerates no-one.

10. No, there is a long time to go yet. I would have like to have seen some better arguments on the scope of Swiss claims throughout this ongoing saga.
Clear failings on all sides. The European courts seem to have a better grasp.


Mr Blobby-Obvious said...

One other point on construction and claim scope: There was an argument along the line that, even if 'central neuropathic pain' utility was not plausible, the claim to neuropathic pain should stand as valid because it was sufficiently supported across its scope. The fact that the claim additionally covered some implausible embodiments should not invalidate the claim.

I am in agreement with this point and it is a very important issue for the Supreme Court to address. It is standard practice supported by EPO and national case law to allow a scope of protection that is reasonable based on the disclosure. Such extrapolation is rarely supported directly by evidence of the kind Actavis are arguing for, and it is also exactly the area where post-filed evidence is used to support the applicant's case.

In this case, I would argue that Pfizer have contributed a treatment for pain using pregabalin (the first such teaching) and they should be entitled to a claim scope that is reasonably supported by the evidence in the application. The evidence was found to plausibly support, inter alia, 'peripheral neuropathic pain' and the question of whether they can extend the claim to 'central neuropathic pain' is the 'reasonable extrapolation' argument. Personally, I do not believe the claim has been extrapolated too far.

BellBoy said...

"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?"

There is no such right before the OD of the EPO.

Mr Blobby-Obvious said...

Whilst generally supporting Pfizer's case, I must say they appear to be misrepresenting the EPO's position on the need for providing supporting data in the application. A very recent decision of the EPO supports the contrary view: T 1045/13.

We unfortunately suffer from poor decisions due to the inability of the parties to do their jobs sufficiently and provide both sides of the argument. By 'sufficiently', i do not mean stand up and present any case. The presented case must be plausible across the scope of the issues at stake.

I must apologise for being the solo commentator, apart from Bellboy.

Opportunities made available by Brexit said...

The Supreme Court have 2 great opportunities here: to rewrite the test for plausibility and for the infringement scope of a Swiss style claim. There is no reason for it to adhere to existing European case law, and it would be good for a de novo approach to be taken. There must be some upside to Brexit.....

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