UPDATE: Birss J refuses permission to appeal in Genentech's Herceptin battle

The name "Hospira" is, according to their website,
derived from the words hospital, spirit, inspire and
the Latin word spero, meaning hope.  
A few weeks ago, fellow Kat Darren alerted readers to the fact-packed judgment of Mr Justice Birss in Hospira's revocation action of two of Genentech's follow-on patents protecting its blockbuster cancer drug, Herceptin.  Readers will recall that the judge found both patents - one relating to a dosage regiment and one relating to a formulation (via chromatography  purification) - invalid courtesy of information primarily disclosed on Herceptin's own Food and Drug Administration (FDA) label.  The judgment peaked some readers' interests due its comments on the role of plausibility in sufficiency and priority (see the comments of our dear Kat readers on Darren's post here).

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."
As such, Genentech will have to, if it decides, seek permission from the Court of Appeal which for a drug as significant to its portfolio as Herceptin, would not be a surprise if they did.

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!
Although unsuccessful in their doomed indemnity costs application, Hospira nevertheless obtained a payment on account from Genentech under CPR 44.2(8). Hospira's actual costs billed in the entire proceedings was £3.1 million.  Genentech elected not to tell the judge what their overall costs figures were.  Although entitled to withhold these figures at this stage, this meant that Genentech could not take a point on the difference in expenditure between the parties at certain stages of the proceedings as the judge could not provide context to those disparities.  Genentech however did argue that Hospira's figures before the judge now did not match those figures produced at the pre-trial review.  Hospira excused these discrepancies on the basis that the figures produced for the purposes of the pre-trial review were "done on a quick basis" and "a high level approach was taken and they were not deliberately calculated in a conservative manner".   Nevertheless there was a figure of " bout £700,000 which does appear not to fit between the evidence of Mr. Cohen given at the PTR and the evidence being given now."  The uncertainty lead the judge to be more cautious than he might otherwise have been about the percentage figure to award,
"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.  

In the meantime, the Kats will be waiting with fishy baited breath to see of the Court of Appeal entertains Genentech's appeal.  
UPDATE: Birss J refuses permission to appeal in Genentech's Herceptin battle UPDATE:  Birss J refuses permission to appeal in Genentech's Herceptin battle Reviewed by Annsley Merelle Ward on Friday, May 23, 2014 Rating: 5


  1. "That is to say that there was some magic in the 8/6 dosing regimen"

    I really don't understand that comment. It sounds like Genentech were saying that the actual thing claimed has to be obvious. Isn't that what Conor says is required?

  2. I don't know how strict TRIPS is about circumstances when appeals should be allowed, but presumably its fair to not allow appeal when a new argument is raised.

    I suspect Genentech decided not to argue that 8/6 was special/magic at first instance because the spec had no data to support it, and with Birss focusing on plausibility of the spec, such an argument would not have worked anyway. However it would have been interesting to see how Birss would have handled a situation where the method gives a special result, but is obvious to try. Such things can succeed at the EPO, but not normally in the UK.

  3. "The judgment peaked some readers interests ..."

    I think you mean "piqued", unless it's a clever reference to the chromatography in the '455 patent.

  4. No, my Kat colleague meant "peaked" since it referred to the interest of readers, once piqued, reaching some form of climax or crescendo.

  5. I wonder if Birss is being influenced by Section 3D of the Indian Patents Act which prevents evergreening of pharmaceutical inventions by prohibiting patenting new forms of a drug unless it has enhanced efficacy. He may have secretly or subconsciously decided to be harsh on dosage regimen inventions as a result.
    [This is meant to be a light-hearted comment]


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