From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Monday, 3 April 2017

Tune in LIVE for tomorrow's Eli Lilly v Actavis Supreme Court showdown

Like any Kat, the AmeriKat prefers to view court hearings
from the highest vantage point
Almost a year ago, the AmeriKat reported that the Supreme Court had just published its list of cases that it would be hearing on appeal.  Among the list was Eli Lilly and Actavis.  Tomorrow, the Supreme Court will finally hear the dispute concerning Lilly's pemetrexed disodium product.

For those of you eager to hear what's going on you can tune in live online to the Supreme Court hearing where you can see the mighty Tom Mitcheson QC (supported by  Andrew Waugh QC and leading Stuart Baran) for Eli Lilly take on eloquent Danny Alexander QC (leading Thomas Raphael QC) for Actavis. The hearing is due to finish on Thursday.

The question, as summarized on the Supreme Court's website, is as follows:
Whether a new pemetrexed based cancer treatment produced by Actavis UK Limited and others infringes Eli Lilly and Company’s patent and its foreign designations either indirectly under s. 60(2) of the Patents Act 1977 (matter for appeal) or directly under a proper interpretation of Article 69 of the Europe Patent Convention 2000 (matter for cross-appeal).
If you do not wish to read all the myriad of decisions, the AmeriKat has re-summarized the 5 year (and then some) war between the companies as follows:

Dispute about the jurisdiction of DNIs
  • November 2012:  Mr Justice Arnold said he had jurisdiction to hear DNIs with respect of the foreign designations of the Lilly patent (see decision here and AdvoKat summary here)
  • May 2013:  A Court of Appeal consisting of Lord Justices Kitchin, Lloyd and Longmore upheld Mr Justice Arnold  (see decision here)
Decision on whether Actavis's proposed product would infringe
  • May 2014:  Mr Justice Arnold held that Actavis' proposed dealings would not amount to direct or indirect infringement (Justice Arnold in 2014  (see decision here and IPKat summary here)
  • June 2015:  A Court of Appeal consisting of Lord Justices Kitchin, Floyd and Longmore upheld Arnold J's decision in respect of direct infringement, but reversed the indirect infringement finding on the basis that if the products were reconstituted/diluted the saline solution would contain sodium ions in a ratio of at least 2:1. This would fall within the claims and thus the supply of Actavis's products would amount to indirect infringement (see decision here and IPKat summary here
The dextrose remission point
  • February 2016:  The case also saw a recent decision from Mr Justice Arnold on a point that was remitted from the Court of Appeal.  The issue was whether the supply of Actavis' products would constitute indirect infringement of Lilly's patent if marketed with instructions to reconstitute and/or dilute the products with 5% dextrose solution instead of saline.  Mr Justice Arnold held it was not foreseeable that Actavis's product would be diluted with saline.  The AmeriKat has not heard if the decision has been appealed to the Court of Appeal, but imagines it is likely (see decision here and AmeriKat summary here)
What's up for grabs in the Supreme Court?  

With both parties getting permission (see the table), the issue of direct and indirect infringement subject to the June 2015 Court of Appeal decision is up for grabs.  Stay tuned for how and what else the parties argue before the Supreme Court tomorrow.

7 comments:

Proof of the pudding said...

It will be interesting to see what the Supreme Court makes of the Court of Appeal's assumption (made without any reference to the literature or to expert evidence) that a solution containing at least 2 equivalents of Na+ ions and 1 equivalent of pemetrexed (2-) ions falls within the definition of "pemetrexed disodium".

I would have thought that there is at least an arguable point that a dissociated collection of ions cannot be accurately described as a particular salt form (particularly if there are other ions present in the solution).

Of course, it would be a harsh result for the patentee if infringement could be avoided simply by using a different salt form (especially when the distinguishing feature of the invention has nothing to do with the specific form in which pemetrexed is administered).

However, it seems to me that, to be consistent with its prior case law, the Supreme Court has no choice but to proceed by asking how those skilled in the art would understand the claim. It may just be that the psita would understand the claim to encompass various salt forms of pemetrexed (and not just the disodium form), or even to encompass a solution in which the ions are dissociated. But the question must surely be asked and answered (by persons skilled in the art) before the court can reach a decision on either option.

Anonymous said...

"Of course, it would be a harsh result for the patentee if infringement could be avoided simply by using a different salt form "

Not harsh. Fair.

The claims relate to "pemetrexed disodium" and only a negligent attorney would draft that believing it would provide exclusivity over the potassium salt. Arguing the point in infringement is a separate battle.

A solution containing ions of pememtrexed and sodium is not "pemetrexed disodium" by any stretch of the scientific imagination.

MaxDrei said...

If I remember right, Applicant, in prosecution, narrowed to sodium. Is the patent owner trying, after grant, to capture what was given up in prosecution?

And if so, is that "fair"?

Anonymous said...

Potassium and sodium are interchangeable and there must be direct infringement under the doctrine of equivalents, or rather the Protocol?

Is it therefore okay to replace a saline drip or saline solution of drug with a potassium chloride solution? Rather than use saline or dextrose, why can't Actavis use potassium chloride solution to make up there product for administration?

The use of sodium chloride instead of potassium may also be beneficial during lethal injections on death row?

Will the Supreme Court ask Lilly's Counsel to prove the equivalence live on TV?

Proof of the pudding said...

@Anon 3 April 16:49

"The claims relate to "pemetrexed disodium" and only a negligent attorney would draft that believing it would provide exclusivity over the potassium salt. Arguing the point in infringement is a separate battle"

I think that you have missed the point that I was trying to make. In case this is because I explained it poorly, I will have another go.

The claims are directed to the person skilled in the art. How the person skilled in the art understands those claims, and in particular how they interpret the extent of protection provided by those claims, is therefore the decisive factor.

You may speculate as much as you like regarding what the attorney drafting the specification thought about claim scope. You may also question the competence of that attorney. However, in view of the Supreme Court's ruling in Kirin-Amgen, neither of these points is particularly relevant to the determination of the extent of protection provided by the claims.

Anonymous said...

My point about negligent drafting was not meant to be an interpretation of law. The question of harshness may relate to Article 69, but I suspect it was a more general point.

The Lilly case being argued is solely in respect of direct infringement and they are not trying to argue on the construction. The judges have made clear in several remarks they are never going to construe 'sodium' as 'potassium', which leaves Lilly arguing (as planned) that 'potassium' is an 'equivalent of sodium' in the context of the invention.

Facts reasonable that the skilled person would appreciate potassium salt is an obvious non-material variant. However, that involves the skilled person understanding the 'invention' as opposed to simply reading the claims (and description) and coming to a view on the scope of protection. The skilled person can't be expected to digest the prosecution history as that would be contrary to the principle that prosecution history estoppel does not exist in the UK (Gibraltar anyone?) If it doesn't exist to limit the patentees scope, it can't be an aid to understanding their 'invention' either. Lilly are getting very close to relying on pith and marrow, although they 'only' mentioned it to aid an understanding of the history.

In the Lilly case, the 'invention' is said to be the combination therapy of pemetrexed and vitamin B12. The claim is written in the Swiss format. I am prepared to accept an argument that the skilled person may appreciate the 'invention' in this context and would therefore understand that sodium may be replaced by potassium. The specific claim wording may not be a great hindrance to this understanding.

However, there is also a counter argument to this, and there would be many other examples where appreciating the 'invention' will not be readily apparent, and it would be unjust to expect the skilled person to ignore the claim wording when determining the scope of protection. In the Lilly case, what if the alleged infringer was using an anti-folate other than pemetrexed, for example? Is it to be understood that the invention is a combination therapy of any antifolate with Vitamin B12? Seems reasonable that a third party would take the pith and marrow of the pemetrexed combination and use another, perhaps newly-developed anti-folate, in order to produce a marketable (non-patent protected) workaround.

While I can see the equivalents point and accept the Protocol wording, it is still necessary to apply the 'fair protection v reasonable degree of certainty criteria.

Therefore, of course, it would be a harsh result for the third party if infringement could be concluded when by clearly using a different salt form (especially when the salt form of the claimed invention is so clearly defined by the patentee, who had it within their power to draft more sensibly).

On an irrelevant note to the legal assessment, the patentee attempting to draft a claim to pemetrexed, not limited by sodium salt, but they were unable to do so because they had no basis in the application. A drafting error, or a change of circumstances and importance of pemetrexed. Either way, the law should not aid a patent to go back in time and re-write their case.

Anonymous said...

Lilly have argued that Actavis should have challenged validity so as to run the squeeze argument to limit the scope of the claim.

This cannot be a reasonable position. A third party has every right to market a non-infringing product and cannot be expected to take such court action. This goes beyond the 'clearing-the-way' position.

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