Friday 15 April 2016

Not a Clear Cut Case?

As regular readers will know, I have been keeping a watch on cases where a negative patent office opinion on validity has been issued since October 2014 when section 73 was amended to allow for revocation by the comptroller following an opinion under section 74A finding a patent to lack novelty or inventive step. So far, there has been only one opinion that has resulted in revocation, which I have written about here. Two others resulted in a decision not to revoke the patent, and at the time of writing there are six others that are at various stages awaiting a final decision, including one that in my opinion will inevitably be revoked. One of these six cases involved opinion 10/15, which related to whether the UK part of EP2124945B1 was valid over various documents filed by the requester. The examiner found that the patent was not valid because it lacked an inventive step.

In brief, the invention related to a method of treatment using pirfenidone to treat idiopathic pulmonary fibrosis, the treatment involving a specified escalating dosage regime [as an interesting aside, the very narrow scope of claim 1 of the patent defines the exact dosage regime described in the SPC information for Esbriet (pirfenidone)] . The examiner found that, since everything apart from the specific claimed escalating regime was already known and that there was no proof that the regime had any particular benefits or that there was any technical prejudice against it, the claimed regime was obvious. This finding applied to all of the claims in the patent (of which there were only four). In principle then, the patent stood to be revoked by the comptroller under section 73. The proprietor had, however, the opportunity to request a review of the opinion under section 74B before any action would be taken.

The patent was granted in the name of InterMune, Inc., which was acquired last year by Roche Products Limited in a deal worth apparently £5 billion, and relates to a drug that is a recommended treatment for idiopathic pulmonary fibrosis. It is not therefore surprising that the patent proprietor did not take the opinion lightly and decided to request a review rather than risking the patent being revoked. The result of the review was a decision that issued a couple of weeks ago, BL O/163/16. The proprietor argued that the examiner had got it wrong because he had misapplied the law on inventive step, and in particular by presuming that any new dosage regime would be obvious without there being a clear technical prejudice pointing away from it, referring to this paragraph of the 2008 Court of Appeal decision in Actavis v Merck, which stated that new dosage regimes would nearly always be obvious because it was standard practice to investigate appropriate dosage regimes, and that only in an unusual case, where there was a technical prejudice against the claimed dosage regime, could specifying a dosage regime confer validity on an otherwise invalid claim.

The hearing officer did think that the examiner was wrong in taking the presumption of invalidity as a starting point, but did not think that the opinion was clearly wrong because the examiner had correctly followed the multi-part Windsurfing/Pozzoli test and had carried out a multifactorial analysis based on the material before him. The opinion was therefore not set aside.

What happens now is the interesting question. Given how much money is at stake, the proprietor will presumably not give up and let the opinion stand. To do so would risk getting the automatic revocation process initiated. Instead, I expect they will appeal the decision, which will tie things up for a while. The appeal cannot itself result in revocation but only a final decision as to whether the opinion should be upheld or set aside. If it is upheld, the process could then start all over again, as the patent office will still have the option open to them of initiating revocation of the patent. I wonder though, whether the patent office would decide to do this, given that the patent is one that is clearly worth fighting over, even though it may be (and, I suspect, is) clearly invalid. I suspect the patent office will really not want to get involved in a dispute that could mean having to defend a decision and spend a lot of money doing so. Unfortunately, assuming an appeal is filed, they will be involved anyway. Someone at the patent office might now be thinking that automatic revocation was perhaps not such a good idea after all.

UPDATE 31 May 2016: The IPO has issued a decision stating that no action will be taken to initiate revocation proceedings under section 73(1A). Presumably this means that an appeal has not been filed against the decision to uphold the opinion, which is an interesting approach to take for a patent that is clearly worth a lot of money. Perhaps the patent proprietor managed to find out what the IPO's opinion was on whether action would be taken before they decided not to appeal. Although the patent might not be clearly invalid in the IPO's view, it is at the very least arguably invalid and the negative opinion is there for all to see. I wonder if anyone will now bother to file a proper revocation action?