|The name "Hospira" is, according to their website,|
derived from the words hospital, spirit, inspire and
the Latin word spero, meaning hope.
Given that Herceptin is a massive blockbuster for Genentech (attributing to about £5 billion in sales in Europe between 2010-2013 alone), it was no surprise that Genentech sought leave to appeal in relation to the dosing regimen patent (the '115 Patent) alone. However, last Friday Mr Justice Birss refused permission on the basis that Genentech was seeking to argue a new point in relation to the dosage regimen. Genentech's argument was that the claimed dosage regime of a 8 mg/kg loading dose followed by a 6 mg/kg three weekly maintenance dose was inventive despite that a skilled person would have arrived at a 7.1 mg/kg off the back of the FDA label. That is to say that there was some magic in the 8/6 dosing regimen. That, the judge held was a new point.
In the decision (not yet on Bailii, but sent to the AmeriKat by a dear Kat friend) Mr Justice Birss stated:
"Mr. Tappin submits it is not a new point and that I have misunderstood his case. I do not accept that, not just as a matter of personal pride but because I have a firm recollection of considering very carefully and asking counsel about the matter. My recollection is that it was clear that Genentech were not running that sort of case. Moreover I am not aware that there was any evidence to support it. Genentech were of course submitting that a three weekly 8 + 6 regime is not obvious over the prior art and were also submitting that Dr Earhart’s analysis based on figure 2 was not sound (as I accepted). These things are not in dispute. The question is whether there was anything inventive about selecting 8 + 6 by a skilled person who had made the step of thinking that a 500 mg dose administered three weekly was likely to be efficacious and safe. In my judgment Mr Meade is right about paragraphs 1 to 14 of the draft grounds."
Another interesting point raised by last Friday's decision was that on costs. Hospira argued that they were entitled to an order for indemnity costs against Genentech in relation to Hospira's declaration of non-infringement for the formulation patent. Early in the proceedings, Hospira wrote to Genentech seeking a declaration of non-infringement for various formulations which included levels of the acidic variants of the Herceptin antibody outside the claim, in the literal sense, because the claim limited the variants to below 25%. Of course, held the judge, one never knows exactly what the correct construction of the claim of that kind will be. Following the exchange of expert evidence, it transpired that although Hospira's expert had expressed the view that the boundary of the claim was 25.5 or 25.7%, Genentech's expert was of the view it was 24.5%. Hospria's expert then changed his mind on the boundary. Hospira argued that as a result Genentech should have conceded the boundary question earlier than it did. Then at the pre-trial review, Genentech sought to argue that the measurement methods used by Hospira to measure the level of acidic variants in the formulation were not appropriate. The outstanding points were minor and resolved at trial, but Hospira argued that all these events were delaying tactics and both issues should have been raised/conceded much earlier.
None of these events, held the judge, took the case outside of the norm which would warrant indemnity costs. He held:
|Mr Justice Birss|
"In particular, it seems to me that the court having made a declaration which includes detailed reference to the method by which the measurement is made, it would be quite unfair to criticise the Respondent to that declaration, i.e. the patentee, for delay in that respect. The declaration itself, in the form finally sought by the applicant, Hospira, contains wording arising from matters which were only dealt with at a very late stage in the proceedings.
I should also say that I do not accept Mr. Meade's submission that one can criticise Genentech for their position in relation to the meaning of the 25% level in the claim. Mr. Meade's submission might have been better if his own expert had not given a different opinion about the precise level of the boundary of this claim, but since Mr. Gottschalk's opinion put the boundary of the claim in a different place from the place where Genentech's expert put it, it does not seem to me to be legitimate to criticise Genentech."
|Hiss! The AmeriKat was sure these costs|
figures added up earlier!
"The fact that the explanation from Hospira has not been completely coherent in relation to how these costs are incurred leads me to wonder if, when a detailed assessment is made, it will turn out that these costs may fall outside recoverable costs. I cannot say, but I intend to take it into account.
|An adage to live by for |
everyone preparing costs
schedules for Pre-Trial Reviews
Accordingly, the sum I will award by way of an interim payment is 50% of 96% of £3.1 million less the £150,000 that dealt with the interim payment of the '632 costs before. The way the uncertainty has been taken into account is that I might otherwise have been prepared to award a higher percentage than 50% in this case, but for those reasons I will award 50%. I will not do the maths in my head. "In the AmeriKat's head that's about £1.3 million. Not a bad result for Hospira, but it could have been better. The take home lessons being (i) don't bother with seeking indemnity costs on the declaration of non-infringement on the basis of the facts in this case and (ii) make sure your pre-trial review costs are done accurately so you don't end up with potential smaller interim payment than you may have otherwise been entitled to.