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Thursday, 10 September 2015

BREAKING NEWS Full decision out in the Lyrica case, and it's a whopper

The judgment is a whopper, but not
a Whopper. Incidentally, the 81,423-word
judgment does not contain the W word ...
There has just fallen onto the desk of this Kat the judgment of Mr Justice Arnold at first instance following the full trial in the long-running case of Mylan and Actavis v Warner-Lambert.  It has just been posted on BAILII.  This has already been the subject of numerous preliminary judgments, including one from the Court of Appeal, and the trial took place over three weeks between 29 June and 17 July.  It has also been the subject of numerous Katposts (case management decision  here, Court of Appeal decision here and here,  and four first instance decisions  here,  here, here and here.)  This Kat thinks that it is the case of the year, concerning situation where there is a second medical use patent for a drug (pregabalin, sold by Pfizer under the trade mark Lyrica), and there are some authorised indications falling within the scope of the claims of the patent (neuropathic pain), and some that are not the subject of patent protection (epilepsy, general anxiety disorder).

Along the way, there has been argument about what a second medical use claim in the Swiss form actually covers - does an alleged infringer have to actively intend that their product be used for the patented indication (as Arnold J decided at first instance), or is it enough that they foresee that it will be (as the Court of Appeal decided)?  All have been agreed that a skinny label (where the package insert for the generic product does not mention the patented indication) is not of itself sufficient to avoid infringement, because neither the prescribing doctor nor the dispensing pharmacist is limited by the label.

Well, now the decision is out.

In one sense all is for naught since the patent has been found invalid in respect of the relevant claims (directed towards pain and neuropathic pain) on the ground of insufficiency.  (The inventive step of the claims was however upheld.)  So there is nothing to fight for.

However, Arnold J has nevertheless decided that Actavis does not infringe under the test put forward by the Court of Appeal as he understood it.  This test requires foreseeability, not intention, on the part of the manufacturer (Actavis), but it also requires intentional administration for the patented indication downstream, and Arnold J found that neither the doctor, nor the pharmacist, had the intention to administer the Actavis product Lecaent for pain.

He therefore granted declarations of non-infringement in respect of Actavis, wholesalers of Lecaent, doctors, pharmacists and patients.  He also found Pfizer liable for making groundless threats of patent infringement proceedings, albeit not in all the cases alleged by Actavis.

The decision is massive even by the standards of Mr Justice Arnold, running to 727 paragraphs and 174 pages.  This Kat will therefore post again when he has had a chance to study it.

This is probably not the end.  It is possibly not even the beginning of the end.  There will likely be an appeal, and possibly the case is even destined for the Supreme Court.


Thinking out Loud said...

I am wondering whether the insufficiency conclusion takes this test too far. The drug was known for epilepsy and the inventor discovered the compound could be used for pain. No link between the two. The test data in the application as filed demonstrated activity in inflammatory pain. It was also considered plausible that efficacy may be seen in peripheral neuropathic pain, but it was not considered reasonable to predict efficacy in central neuropathic pain. The claim (3) to 'neuropathic pain' therefore deemed to be invalid.

Pregabalin has subsequently been demonstrated to have efficacy in both peripheral and neuropathic pain.

I do not dispute the expert evidence (which I have not read) relied upon by Arnold, but I am concerned that undisputable scientific evidence was required to support the key claims. An inventor must be allowed to make a reasonable extrapolation based on the data disclosed. If Pfizer are not allowed even 'neuropathic pain' based on the application disclosure and subsequent evidence supporting efficacy, then what is the purpose or value in ever filing supporting data during examination?

I agree that pure speculation should never be sufficient and that there must be a reasonableness test. However, in this case I am concerned over the conclusion reached.

On another point, Arnold has dismissed certain infringing acts as being 'de minimis'. (paragraph 671). Where is the legal basis for this?

On the Swiss claim, there has been some assistance with the conclusion that 'for' includes an aspect of foreseeability rather than simply intent, but the decision could have given more consideration on the specific acts in the 'manufacturing' chain covered by a Swiss claim. I think this has been covered weakly.

Such a long decision to digest, so a lack of comments is unsurprising, and after further consideration I may change my views, which are certainly not set in stone on any of the points raised. I would be happy to hear other opinions, even those that are contrary to the above.

Ad Man said...

This is simply a profile raising comment to get this case back onto the front page. With just a teeny list of recent readers comments, important issues, such as those dealt with in this case, are surely worthy of additional comment.

Anonymous said...

To address the commenter above's question about I haven't read the full judgement either however the predecessor drug gabapentin had a well recognised effect on neuropathic pain. The two drugs work in very similar ways so it would be expected that it would have an effect on neuropathic pain.

Ad Man2 (the sequel) said...

I'm afraid I do not understand the connection you are trying to make. Are you saying gabapentin and pregabalin are so similar that the Warner Lambert invention was sufficient, but obvious.

You say the drugs work in very similar ways, but the judgement makes the statement "The mechanism of action of gabapentin was not understood." If the similar ways were mysterious ways then I may agree with you, but scientists may not.

Darren Smyth said...

Dear commenters

Thank you for your comments. I am working on a fuller post (or may be more than one post) but as you can imagine it may take some time. To answer some points raised so far.

1) Concerning the insufficiency finding, it is clearly established in the jurisprudence of England and Wales that the specification must make the technical effect plausible. If that plausibility is not present, it cannot be made up for by later evidence. I think this is consistent with the position at the EPO as well. Since the animal models in the patent could only demonstrate inflammatory pain and peripheral neuropathic pain, there was no plausibility for other kinds of pain (even if it may later have been found that pregabalin is in fact effective for central neuropathic pain). I don't see that "undisputable scientific evidence" was called for. Later evidence filed in examination is usually used to confirm the plausibility in the specification, or to support inventive step. It cannot replace the plausibility that the specification must have.

2) The de minimis principle is a fundamental principle of English law, and indeed many other legal systems, as far as I am aware. In this case, the combination of circumstances required for infringement to occur would be unusual, and so the judge was considering that those rare circumstances could not give rise to a finding of infringement as a whole.

3) I think the the acts of manufacturing are not considered because infringement was alleged only under Section 60(1)(c) and not 60(1)(b), so they were not relevant. The manufacture was conducted abroad. The judge was only concerned with the product of the process.

4) In response to Anon at 14:30 the judge specifically found that it was NOT common general knowledge (in the UK, which is what he decided mattered) that gabapentin could be used to treat neuropathic pain, so this could not be taken into consideration. As Ad Man2 poits out, he also stated that the mechanism of action was not understood.

Please carry on commenting on my next post!

Best wishes


Ad Man cometh soon said...


thanks for clarifying the law. However, the points were raised for discussion, not for your final word.

The question on de minimis appears to have asked for the legal basis. You merely state it is a fundamental principle. There is no provision in the Patents Act for such a conclusion and is this not where me must look for guidance? I would say 'de minimis' infringement (as a matter of fact) should be addressed by de minimis damages.

On sufficiency, you once again state it is established jurisprudence. If Arnold had determined X was not novel over Y, I guess you would state it is established jurisprudence that claims lacking novelty are not patentable either.

Both Sections 60(1)(b) and (c) refer to the process, so an assessment of 'the process' would be a reasonable requirement. What manufacturing is conducted abroad? The synthesis of the molecule? If this is 'the process', how can a patent application with a disclosure/claims directed to a method of treatment, and no disclosure of a chemical synthesis, provide basis for amendment of the method claims to Swiss-type claims?

When we all make this amendment are we all really saying the manufacturing process is inherently disclosed?

I would argue that the Swiss process claim can relate to many process acts, including the simple act of labelling a box of generic medicine with the patients details and dosage information and providing it to the patient for the treatment of the patented indication, intentionally, or foreseeably. This is a process.

Thinking out Loud said...

If later filed evidence is accepted to support plausibility, isn't that the point I made? If the invention is plausible based on the content of the specification, I fail to see the need to file additional evidence.

THE US anon said...

just catching up (so I have nto read through all the commetns) but this line struck me as cannot possibly be correct:

"An inventor must be allowed to make a reasonable extrapolation based on the data disclosed"

That's not possession of an invention.
That's possession of a planned, or even unplanned result.

Here in the States, there are far, far, far too many drug applications failing the FDA process to show possession of efficacy to merit an exclusive right on what turns out to be a non-possessed and merely desired end state of utility.

To say then that "must be allowed" is the very opposite of actually meeting one of the basic requirements (possession at time of filing).

Frank said...

TO US Anon,
That may be your opinion on what the legal position should be, but it is far removed from the actual legal position anywhere, even India, including Europe and the US.

THE US anon said...


Are you saying that possession is not a requirement?


Anonymous said...

It depends if you mean posession in the sense of A.60 or posession in the sense of A.83. In the case of the latter, no posession per se is not a requirement.


Frank said...

I am saying that reasonable extrapolation is required in the US. You must agree with me as you are so opposed to the current position.

Frank said...

By 'required', of course I meant 'permitted'.

THE US anon said...


Can you translate the A.60/A.83 references into blog-speak? I readily admit my limitations as to EP-ish.


You did not answer my question. I am aware of what you think that you are saying, but would like you to answer my question directly. Thanks. (btw, there is a U.S. case centering around "utility" that speaks to the "mere study plan" as not enough)

Frank said...

To US Anon,
I am saying that if a patent application claims, for example, 2 new compounds, it would be sufficient for the application to only describe the actual synthesis of one of those compounds and for there to be data demonstrating pharmacological activity of only the single compound. By means of reasonable extrapolation, it is reasonable to predict, therefore expect, the other compound to also have the claimed utility.

If this is not the case in the US, then I shall have to worry about the numerous patens I have had granted over the years.

If the US position is that the applicant is not in 'possession' of the unexemplified compound, then possession is clearly not a requirement.

THE US anon said...


Merely claiming "it is reasonable" does not make it so.

Take a look (again, for the first time?) at the number of FAILED FDA approval attempts.

That aside, you still have not answered my question as to the law.

(and yes, possession remains a bedrock requirement)

Frank said...

US Anon, As I pointed out in my first post, you are clearly unhappy with the fact that pharmaceutical patents are granted for compounds which fail to gain FDA approval. However, as I also pointed out, the fact you do not like the way the law is applied, does not alter the current legal position.

Regarding possession being a deadrock requirement, I defer to your knowledge on that point. Referring back to my previous example, in such an application the applicant must therefore be in possession of the unexemplified compound.

I am glad we can finish in agreement.

THE US anon said...

And Frank, as I have pointed out in my last post, you STILL have not answered my question.

There is no "fact" in my liking or not liking something. Law not applied (for whatever reasons) is not law applied. If on a general basis possession at time of filing is the law but has not been challenged, that lack of challenge does not change the law. Lacking possession of actual utility at the time of filing because no such utility exists does not - and cannot - change the law concerning possession at time of filing.

I think the only agreement we have "finished" with is that you are dodging a very simple and basic question.

Given the ultimate failure of something prophetic, one cannot say that one possesses the prophetic. Instead, all one possesses is a study plan and a desired utility.

Ad Man home alone said...

Comments on the case would be more of interest and more welcome and more appropriate. With the huge readership of this blog, I am a litle dismayed by the sparsity of challenging contributions.

Anonymous said...

astonishing Para 459-505...

Visitor said...

While most comments here focus on the nerdy details of law, this is in fact a very important decision in the broader context of patent and public health. Why so little has been discussed in this regard??

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