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Thursday, 29 January 2015

Dutch diverge with English as Novartis prevails on Zoledronic Acid in Netherlands

This Kat was delighted to receive from Katfriend Rutger M. Kleemans (Freshfields Bruckhaus Deringer LLP, Amsterdam) the following news:

Rutger Kleemans
On 27 January the Hague Court of Appeal (judges Kalden, Brinkman and Van Nispen) ruled in summary proceedings in a case between Novartis AG and Sun Pharmaceutical Industries BV. The case is about indirect infringement by a so-called skinny label. Novartis’s patent EP 689 is of the Swiss type and discloses the use of zoledronic acid for the treatment of osteoporosis, administered intravenously in a unit dosage form of 2-10 mg where the period of administration is about once a year. Sun was marketing zoledronic acid in an identical dosage form but approved only for use in Paget’s disease, which indication is not covered by EP 689. The Court of Appeal granted Novartis an injunction (4.38)
“given the justified interest of Novartis to act against indirect infringement of its patent rights” which amongst others”
forbids Sun to commit indirect infringement” on pain of an immediately eligible penalty sum. The same patent was previously held invalid by the UK Courts for lack of novelty as a result an invalid priority right in Novartis v Hospira (see [2013 EWCA 516 (Pat.) and [2013] EWCA Civ 1663). Concerning the UK decisions, the Hague Court of Appeal states (4.3): 
“Departing from the said criterion the Court of Appeal, other than the judge in summary proceedings and the English High Court and Court of Appeal, partly because of different insights (more in particular after reading of the priority document) and partly because of other arguments of parties…”.
Now this is jolly interesting, thinks this moggy. First, as mentioned above, the Dutch Court has disagreed with the Courts of England and Wales on the matter of priority entitlement and hence validity (for which see Katpost here for the first instance and here and here for the appeal judgment).  But also, the judgment appears in stark contrast to the case last week where Arnold J permitted Actavis to launch a product (pregabalin) with a skinny label without requiring further measures such as overpackaging that were demanded by Pfizer; whereas here the Dutch court finds Sun Pharmaceutical guilty of indirect infringement despite the skinny label referring only to Paget's disease and not osteoporosis.

In fairness, the prescribing and dispensing systems are different between the England/Wales and the Netherlands, and there are other factual differences between the cases. For example in the Dutch case Sun had won a tender to be the exclusive supplier of zoledronic acid 5mg/100ml for the healthcare insurer VGZ.   The different outcome is not therefore necessarily to be seen as indicative of a divergent judicial approach to the efficacy of skinny labels to avoid patent infringement.

You can read the Hague Court of Appeal decision here (in English) and here (in Dutch).

18 comments:

Anonymous said...

"dutch diverge with english"

"in fairness..systems are different"

Is the ipkat going to take over from The Sun?

Or worse; "Patent Certificate Spotted on the Moon".

Jeremy said...

Anonymous, thanks for your comment. You ask if the IPKat is going to take over from the Sun. I don't know if you spotted the name of the defendant in the Dutch proceedings ...

Darren Smyth said...

Anonymous - I think it is clear from the piece that the English and Dutch outcomes were different in one main respect - the issue of validity. The "systems are different" comment applied only to a remark comparing the outcome to another case involving a different patent. So I think the headline is actually completely accurate.

Anonymous said...

The difference is clear. The English High Court has made a bad job of claim construction and a totally flawed balancing of the convenience on the PI in the Pfizer Lyrica case. The Dutch Court has framed a decent judgment and sensible relief in a similar case.

a) The Dutch Court relied, in order to establish infringement, on "the required knowledge" on the part of the Defendant. No intention was needed. Remember Arnold J in England says it's all about subjective intent.
(b) The Defendant's argument that it was not its fault that the product it was supplying would be used for the patented indication was rejected by the Dutch Court. It was up to the Defendant to do everything possible to prevent infringement. Whereas in England it was fine, in Arnold J's eyes, if the Defendant did nothing.
(c) The Defendant's protestation that it did not intend to supply the infringing market was not adequate to avoid the injunction in the Dutch Court. Those same protestations by Actavis in the UK were accepted by the English High Court!
(d) The Court took into account that the Defendant had not made sufficient efforts to alter the tendering process of the third party. It had not cleared the path for itself so it was injuncted. In the UK, Actavis did not clear a path. In fact, they did nothing and the Court would not grant an injunction.

Let's hope these stark differences ( and frankly the poor judgment in England) can be sorted out on appeal.

Anonymous said...

Frankly, the only 'stark matter' is how can a comment misrepresent a decision to such an extent - intent was exactly what it was all about in this NL decision. And a 'decent' priority claim it was not.

Let's avoid hyperbole and discuss the actual cases. They are different.

Anonymous said...

Jeremy, that must be why my mind forced me to refer to 'the sun' rather than 'the sport' which I knew to be more appropriate for my 'found on the moon' comment.

For us Pharma boys & girls, these decisions are extremely important for our industry. Mr Justice Arnold threw a very damaging spanner into an engine that took many years in the making. Someone should have told him "The Ladybird Book of Patents" isn't considered a reference work.

Anonymous said...

If I'm reading the decision correctly it's about indirect infringement. Whilst there don't seem to be any comments about what direct infringement of the Swiss claim would be, surely supplying the product should be considered 'direct' infringement?So the court must be assuming the Swiss claim only covers manufacture, which must be wrong according to the previous way of thinking about the scope of these claims.

I suppose what's happening with Arnold's decision and the present decision is that the Courts have decided they can't live with an ambiguous scope for Swiss claims and have decided to interpret literally. That's fine but now we need very careful jurisprudence about what is needed to infringe the new interpretation of scope (directly or indirectly), such as how does 'intent' come into play.

Mike S said...

So the Dutch court thinks that the pharmaceutical formulation is "an essential part of the invention" and that Sun are indirect infringers of the patent claim.

As indicated in my post on the Warner-Lambert case, I think that this is the most interesting avenue to explore. However, it is a shame that the Dutch court did not provide any detailed reasoning in relation to interpretation of the claim - and why their conclusions follow from that interpretation.

Anonymous said...

The Pfizer case and this one are hugely important.

The Netherlands Court of Appeal has said that the use of the generic medicine for the patented indication was inevitable because the insurers had a policy that prescriptions for zolendronic acid would be supplied with the generic product. The Dutch Court of Appeal inferred the mens rea element on the basis of the inevitable use. That was enough to infringe ( but not in the mind of Arnold J who found that some subjective intention ( whatever that means) was required.

Anonymous said...

Mr Arnold should look at the video evidence and reconsider his mistake. It happens in football, so why not here?

Anonymous said...

I think the problem with the adversarial system in common law countries is that because it is about 2 sides arguing, the objective picture gets lost, and the judge must simply decide between the 2. Arnold decided on the claim construction/approach that he felt decided the case between the 2 parties. However in the process no one seems to have considered whether good law is being created (certainly the decision does not properly discuss how to interpret Swiss claims). There needs to be a way in important UK Court cases for third parties to submit arguments (just as the Bioindustry Association did on the HGS Lilly Supreme Court case). Then CIPA or other relevant organisations can chip in with other perspectives to help the judge understand the implications of the decision. This is now going to create a lot of uncertainty.

Anonymous said...

Lets keep CIPA out of this. It represents a very small group of like-minded private practice attorneys.

There is nothing to stop a judge such as Arnold objectively applying the law. His failure is not evidence of a failure of the system. it may represent a failure of a party to argue their case but then Pfizer has abandoned the UK so I don't expect them to be strong in battle.

The House of Lords has made some great decisions in pharma cases. the odd porker in recent years in biotech case.

Anonymous said...

Anonymous of 13:22 are you referring to Conor v Angiotech as the 'porker'?

Anonymous said...

Anonymous of 11.45, Lyrica for pain was invented in Cambridge in the UK by an Englishman. A British invention! Sales of Lyrica in the UK are more than $300 million a year and rising fast. This is hugely important for Pfizer and the lifesciences industry in the UK.

Anonymous said...

Well guessed 15:11. Your are very astute.

Unfortunately, 15:55, you are not so astute. I am aware of the facts, but they have nothing to do with my statement.

Anonymous said...

This was all discussed in Court in detail yesterday before Arnold J in the Pfizer ( Warner Lambert) case against Actavis on pregabalin/ Lyrica.
Arnold J seemed to totally ignore the Dutch Court of Appeal's views that the generic had an onus on it to take effective steps to avoid their product being used for the patented indication. Instead, he chose to focus on the lack of explanation or analysis in the Court of Appeal's judgment on the interpretation of the Swiss claim at issue and how it had a scope similar to an EPC 2000 claim.

In any event, it seemed as if Arnold J had made his mind up that he didn't like the Dutch Court's analysis. Let's see what the English Court of Appeal think!

Anonymous said...

Have Pfizer appealed? When will we know? How do I track the case?

Anonymous said...

I would also be interested in the information available on this case and follow up actions. Means for following cases can be quite archaic in Europe, I have found.

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