For the half-year to 31 December 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Rebecca Gulbul, Lucas Michels and Marie-Andrée Weiss.

Regular round-ups of the previous week's blogposts are kindly compiled by Alberto Bellan.

Wednesday, 28 March 2012

Teva Tigers v Astrazeneca Lions - obvious to sustain...?

This particular guest Kat was chuckling just yesterday over these elegantly understated words written by Sir Hugh Laddie while a Judge in the Patents Court, and quoted in the House of Lords decision in Conor v Angiotech:

 "A company which has spent millions of dollars on research and has produced a valuable new drug will be understandably irritated when, say, a court declares the patent invalid for obviousness, thereby opening up the market to competitors." 
Applying this dictum mutandis mutatis to drug formulations, the latest patentee to be “understandably irritated” is Astrazeneca. The ever-faithful BAILII has delivered into the paws of the IPKat Mr Justice Arnold’s decision of 22 March revoking for obviousness Astrazeneca’s patent on a sustained release formulation of the anti-psychotic drug quetiapine (marketed by Astrazeneca under the trade mark Seroquel).

The facts and the outcome have echoes of Actavis v Novartis (and indeed one of the expert witnesses was the same). In that case, it was a patent concerning a sustained release formulation of fluvastatin that was held to be obvious. However, Merpel reminds us that in the fluvastatin case the sustained release was claimed in rather broad terms:

A sustained release pharmaceutical composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combinations thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.

whereas in the quetiapine case only a single type of sustained release formulation was at issue, claim 1 being in the following terms:
A sustained release formulation comprising a gelling agent and [quetiapine] or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients.
Lions in the path?
The IPKat considers that both cases really come down to “expectation of success”, and this is always a difficult issue to decide. Arnold J addresses at the end of his judgement the tricky situation that, while he has considered the patent invalid, a Dutch court has recently considered the same patent to be valid. Gratifyingly for the IPKat, who is always happy to see his undomesticated cousins appearing in Patent judgements, this was expressed using the “lions in the path”/”paper tiger” language developed in Pozzoli v BDMO. In this agreeably feline language, the patentee argues that there were reasons why the person skilled in the art would not have expectation of success, the “Lions in the path”, and the applicant for revocation argues that these are illusory – mere “Paper tigers”.

Or paper tiger?
In the present case, the Dutch court apparently accepted that there were lions in the path including: high first pass metabolism that was a counter-indication for the development of a sustained release formulation; high serum protein binding; and pH-dependent solubility. The last two were not put forward in front of Arnold J, while the first was considered by him to be a paper tiger.

The IPKat wonders whether this very subjective determination is likely to become sufficiently predicatable that different courts in different countries with different procedures will come to similar conclusions.  Or will a Dutch lion always morph into a British tiger?  Merpel wonders whether national divisions of a unitary court will be any more homogeneous in their results.


1 comment:

Anonymous said...

These cases always turn on the facts and the interpretation of expert evidence. We wouldn't expect a judge to mark university exam papers, but we do allow them to make the big decisions in court. Nothing much can be done about that, except possibly using only court appointed experts. Problem there is, the interpretation of the facts is never straightforward and who is the best expert in each case?

I attended one trial as a neutral to listen to expert evidence and the written judgement showed that the judge was swayed more by the 'presentation' of one expert over the other as opposed to listening to what they actually said. The judge found the claim to be non-obvious, whereas if you ask many people skilled in the art they would have had the opposite view. I tested this by asking an expert what they would have done in the specific situation, without knowledge of the case or the invention, and they pointed me straight to the relevant textbook with the answer (the invention) that was cited in court.

When you listen to the arguments of some professional experts they will happily give a position that directly contradicts what they teach their undergraduates on a weekly basis.

I think the answer is to have an expert adviser to the judge who can understand better the arguments put forward by the expert witnesses.

When it comes to formulation cases such as those cited, an overturned patent may be an irritation to the pharmaceutical companies, but they are not unexpected and the value of such patents is given appropriate weight within the company. It would be a foolish in-house attorney who advises the business that a formulation patent provides market exclusivity. That is the sort of advice one expects to receive from a typical private practice.

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