Validity - Annual Patents Review 2017

This is the Validity chapter of Gordon Harris' Annual Patents Review 2017. For the other chapters of the review, please follow the links below or download the Annual Patents Review 2017 in full.

Introduction Infringement Validity Technical Matters and Procedure Competition Law, Settlement and Licensing Employee Inventor Compensation Summary and Conclusions 3. VALIDITY

(a) Common General Knowledge and the Skilled Person

Because of the importance of these items I have started, in recent years, to begin the validity section with a few cases dealing very specifically with the nature of CGK and the skilled person.

In FKB v Abbvie29, the question arose as to whether the cited prior art should be looked at on its own (including the references cited therein) or considered in combination with additional prior art found as a result of searches by Abbvie's representatives.

The judge said ([167]):

There may be material which is not common general knowledge, which nonetheless, as a matter of routine, the skilled person would look for and find when approaching a particular problem. Amongst other cases this is supported by the judgment of Arnold J in KCI Licensing at [122]:

"It follows that, even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge."

I consider that the skilled person interested in progressing a dosage regimen in D2E7 would look for and find the Additional Prior Art. Professor Edwards rightly accepted that this would be the case.

Once a door is nudged ajar, as it was by Arnold J in the KCI Licensing30 case, it is prone to be kicked further open, and Henry Carr J may have done that in FKB v Abbvie. Are we now going to be deploying mosaics of items for the purpose of assessing obviousness?

In Generics v Yeda31, Arnold J said, in relation to the person skilled in the art ([75]):

A patent specification is addressed to those likely to have a practical interest in the subject matter of the invention, and such persons are those with practical knowledge and experience of the kind of work in which the invention is intended to be used. The addressee comes to a reading of the specification with the common general knowledge of persons skilled in the relevant art, and he or she reads it knowing that its purpose is to describe and demarcate an invention. Purely for convenience, I will hereinafter refer to the skilled person as "he". He is unimaginative and has no inventive capacity. In some cases the patent may be addressed to a team of persons having different skills.

There was a "small, but nonetheless significant" dispute between the parties as to the identity of the skilled person. The judge ruled that the skilled person need not be an expert in neuroimmunology, the pathology of MS or the analysis of MRI results, because the patent did not assume any specialist knowledge of those topics or teach the clinician anything about them that he would not already know.

Finally in this section, in Accord v RCT32, Birss J, conducting his review of the position relating to inventive step said ([208]):

Having reached that conclusion I will also say that I was doubtful that the whole step by step analysis was indicative of obviousness. The series of steps from Le Gall involved a full literature search, the distillation of all that work, numerous other avenues which could be considered and the conception of the methoxymethyl compound as something to consider. Although they are all apparently easy steps and many of them are conventional individually, looked at as a whole they did not strike me as supportive of obviousness, but I did not decide the case on that point.

So the question of whether it is permissible for the skilled person to conduct a full literature search, distil it, and then interpret the pleaded prior art in the light of it, remains to be addressed on another day. That a literature search can be conducted is clear from FKB v Abbvie. That it might be a restricted process, emerges from Accord v RCT.

So there is nothing very new, but perhaps we are seeing the consolidation of the slightly concerning trend for prior art beyond a single citation and CGK to be used in the assessment of inventive step.

(b) Anticipation/Priority

"Legal" priority

The question of "legal priority" has raised tricky and time-consuming questions in recent years, and at times one could be forgiven for mistaking some of the guidance for a haha. In 2017, the courts appear to have bent over backwards to dismiss challenges to legal priority, perhaps reflecting a policy of discouraging such highly technical, time-consuming and costly aspects of disputes.

The right to claim priority is provided for by s.5 of the Patents Act, Article 87 of the EPC, Article 8 of the PCT and Article 4(A)(1) of the Paris Convention. In Edwards v Cook33, Kitchin J held that to make a valid claim for priority as successor in title, it was necessary to be a successor in title at the time of filing the application. A subsequent acquisition of title was not sufficient. In KCI v Smith & Nephew34, Arnold J rowed back a little from this when he held that "successor in title" included a person who was a recipient of the beneficial interest in the invention in circumstances where he did not own the bare legal interest; and also that when determining whether a person was a "successor in title", it must be the substantive rights of that person, and not his compliance with legal formalities, that mattered. In Idenix v Gilead (2016)35, Kitchin LJ expressed the provisional view that both KCI and HTC v Gemalto (in which Birss J followed KCI) were correctly decided.

This year Henry Carr J continued to develop the authorities, inFKB v AbbVie36, when he said ([34]):

I do not consider that Article 4A permits both the original applicant and his successor in title to enjoy a right of priority. In my judgment, where a right to claim priority has been assigned, the assignor cannot subsequently make a claim himself. The Article contemplates a claim to priority either by the original applicant or his successor in title, and not by both. Once the right has been assigned there is no reason why the assignor should retain a right of priority. This is consistent with ensuring certainty as to who is entitled to apply, as referred to by Kitchin J in Edwards Lifesciences.

FKB challenged AbbVie's legal entitlement to priority. The issue was whether Abbott Laboratories (Bermuda) Ltd ("Abbott Bermuda") the applicant for AbbVie's EP '656 patent, was entitled to claim priority from US patent '961. US '961 was filed on 8 June 2001 by the inventors, Dr Kempeni, Dr Fischkoff and Dr Weiss. The PCT application by which EP '656 was sought was filed on 5 June 2002 by Abbott Bermuda for "all designated states except the US", and by Dr Kempeni, Dr Fischkoff and Dr Weiss, for the US only, as inventor/applicants.

In view of the conclusion quoted regarding Article 4A, the fact that the inventors applied for the PCT application (in respect of the US) did not establish entitlement to priority because it was (by the time of the trial) common ground that the equitable interest in the invention had been assigned from the US inventors to another group company. Further, the "all designated states except the US" was the only part of the PCT application that was material to the priority claim in the present case. However this did not dispose of the legal priority issue.

It was common ground that the issue of which party held the relevant rights was to be determined in accordance with the law of the transaction which was said to have transferred such rights. But the factual matrix in the case was quite complex and the documentary record incomplete (to put it mildly).

In the end, relying upon the substantive position under German and US law, the judge concluded that there was chain of title from each of the inventors to Knoll AG in respect of the invention. (For Dr Kempini, under German law, Knoll GmbH (which became Knoll AG in March 2001), had at the relevant time the right to demand delivery of an Invention Report pursuant to statute and to claim the Invention. Knoll GmbH was, therefore, in substance, the owner of the invention. For Dr Fischkoff and Dr Weiss, both whom had signed Employee's Invention and Secrecy Agreements ("EISAs"), to be construed under US law, the judge was satisfied on the evidence that Knoll AG was the relevant group company's nominee to hold all rights resulting from international clinical R&D, including the invention in issue. At any time, Knoll AG could have compelled KPC to transfer legal title. Therefore, as a matter of US law, Knoll AG was the beneficial owner of the US inventors' rights in the invention.) In addition, it was the "concordant intention" of the parties to a later agreement to transfer all non-US rights in the relevant invention to Abbott Bermuda, and prior to the filing of the PCT application Abbott Bermuda could have compelled Knoll GmbH to claim the invention from Dr Kempini and then to transfer it to Abbott Bermuda.

It is notable here that it appeared to be AbbVie's case that US '961 would have been recognised as a US...