The team is joined by GuestKats Mirko Brüß, Rosie Burbidge, Nedim Malovic, Frantzeska Papadopolou, Mathilde Pavis, and Eibhlin Vardy
InternKats: Rose Hughes, Ieva Giedrimaite, and Cecilia Sbrolli
SpecialKats: Verónica Rodríguez Arguijo (TechieKat), Hayleigh Bosher (Book Review Editor), and Tian Lu (Asia Correspondent).

Monday, 5 March 2018

Monday Miscellany

The IPKat brings you its usual list of forthcoming events plus some interesting articles/papers/blogs to browse.


First of all, a reminder that UNION-IP is hosting Tim Moss CBE, Chief Executive, UK Intellectual Property Office at their spring dinner meeting on Thursday 8 March 2018 at the Royal Overseas League.  In this period of unprecedented change within the UK intellectual property system, Tim will offer his thoughts on the main issues facing the UK IPO and the UK professions, as well as an overview of what next year holds in store for the Office.  Full details and tickets can be obtained through EventBrite.

Kat's idea of a spring dinner
Also on 8 March 2018, the The British Literary & Artistic Copyright Association (BLA©A) will host the seminar “Cultural Heritage Institutions and Immersive Technologies: Monetisation and Copyright”. This seminar is part of a a project being conducted by Queen Mary, Univ. of London and Goldsmiths, Univ. of London, in collaboration with several UK heritage institutions. For more information on the seminar, see here.

The Centre for Intellectual Property and Information Law will host the Thirteenth Annual International Intellectual Property Lecture, delivered by Professor Jessica Litman, on the topic of "Copyright and Property-Think". The lecture will take place on Tuesday, 13 March 2018 at the Emmanuel College, Queen's Building Lecture Theatre. For more information and registration, see here.

On 14 March 2018, Oxfirst will host a webinar on the topic “Are Important Innovations Rewarded? Evidence from Pharmaceutical Markets”, presented by Professor Margaret Kyle. The talk will discuss the research, focussing on the “relationship between therapeutic value and different measures of market rewards (the number of patents, price, market share, and total revenues) of a new treatment.” For registration see here.

Maastricht University will host the event “Innov-AI-tion Law for Technology 4.0” which will focus on AI, its impact on society and the need for a regulatory framework. The event will take place on 6 April 2018 at the Maastricht University Brussels Campus, for more information and registration see here.


In June 2018, the first issue of the Stockholm IP Law Review is scheduled to be published! The review is a student-led publication, which will focus on issues of European Intellectual Property issues. If you are interested in reading or contributing to this project, you will find more information here.

The European Parliament published the extensive study by Dr. Jan Nordemann Liability of Online Service Providers for Copyrighted Content – Regulatory Action Needed?  See here for a full abstract and to download the paper.

Fellow IP Blog Solo IP: for sole and small IP , decided to stop its activities. With the post The Soil Never Sleeps  Barbara Cookson bids farewell to the blog’s readers. Best wishes from the IPKat to Solo IP for its future endeavours!

If you are interested in the Pregabalin issue, there are two interesting articles to look at. 
The first, The clinician impact and financial cost to the NHS of litigation over pregabalin: an economic impact analysis, by Richard Croker, Darren Smyth,  Alex Walker and Ben Goldacre (for full abstract and paper download, see here); the second, a blog post by The IP Alchemist Why were the SPCs for Pregabalin allowed to lapse? I have a theory…


Anonymous said...

I would like to reply to Darren's post, but unfortunately it cannot be anonymous. Troll! No. Employed? Yes. Obviously certain people cannot comment and for others it is unwise even if in no way involved. I speak as one having no knowledge of the Pfizer actions.

The priority issue is certainly plausible as a validity argument, but I think even Darren would agree it would fail as an attack. There is specific case law directly on the issue of enantiomer novelty with the same facts. In any case, this potential invalidity would not have stopped any right-thinking attorney from filing an SPC.

I agree also about the potential for a competition commission attack for obtaining an SPC on a knowingly-potentially-invalid patent, however, again, this would not be sufficient to warrant abandonment. The Italian decision on abuse is utterly ridiculous and Pfizer would not err in acting to protect their interests even in the face of such challenges.

At no time could Pfizer have been considered to enforcing knowingly invalid rights because the priority argument is too weak.

So, why abandon the SPC? As Darren noted, the applicant is Northwestern University. The applicant in the later-expiring neuropathic pain use case is Warner Lambert (Pfizer). If we assume there was no validity or competition law concerns, the answer must either be a simple commercial decision or a mistake. On both counts, Pfizer may wish not comment.

An SPC on the compound patent would have resulted in the extension of royalty payments to Northwestern. However, market protection was available without royalties by virtue of the use patent. The SPC would have expired May 2018, 10 months post-expiry of the use patent. Is it possible there was more profit for Pfizer in abandoning the SPC?

I am surprised the licence with Northwestern didn't require the SPC filing, but it is also possible a deal was reached. After all, the pain market was an unexpected bonus.

Another question relates to the lack of filing of an SPC on the use patent instead.

It is all very murky. Darren, I suggest you make a formal request of Pfizer for information.

Darren Smyth said...

Thanks for your comments, Anon. I am sorry that my personal blog is not suitable for anonymous comments, and I do appreciate the issue.

I agree that there is "specific case law directly on the issue of enantiomer novelty", but the cases I am thinking of (eg escitalopram) do not seem to me to have the "same facts". What case are you thinking of?

I am also not clear how the use patent could have formed the basis for an SPC since the first marketing authorisation was not in respect of pain, so at the time of the issuance of the first marketing authorisation, the use patent did not protect the product.

Your comments on ownership are very interesting and I shall ponder them. I cannot believe that it was a "mistake" as it is actually quite hard to abandon an SPC in multiple countries simultaneously.

Best wishes


Anonymous said...

I hadn't thought through the use SPC.

Anonymous said...

The economics of patents and the direct effect on the manufacturers are frequently measured in court cases with reimbursement to one side or the other commonplace. The direct effect on the NHS is also clear, although difficult to measure (in principle irrelevant, but the cost to Pfizer and the generics on losing has also been difficult to quantify).

The question I have is whether there is any basis for a claim from the NHS? I know they acted in some ways on instructions / recommendations from the courts, but where they a part to the proceedings that suffered damage? I see that Highland Health Board were a proposed defendant in the early case, but was this followed through?

Is there a tort applicable to this position?

Anonymous said...

It is the EPO case law which dominates in respect of selections and which would be followed by the UK courts. The founding cases are, as you know, all listed in the EPO Case Law book, one of which is that Pfizer again. My favourite selection cases from the courts are the olanzapine decisions (US, UK, DE). Nothing to do with enantiomers, but practically speaking, hugely significant. Enantiomers are nice to have, but new compounds essential. Novelty is the easy part.

Darren Smyth said...

To the Anon above who asks the basis for a claim from the NHS - that is a very good point. The decision granting the order to issue the prescribing guidelines (handily reported on IPKat and the judgment is on BAILII has this at para [24]:

As mentioned above, there was one issue between the parties, which concerned the ambit of the cross-undertaking in damages to be given by Warner-Lambert contained in Schedule 3 to the order. Warner-Lambert was content to give a cross-undertaking in favour of NHS England and the Department of Health. Actavis, Teva and Dr Reddy's requested that the benefit of the cross-undertaking should be extended to (i) the Actavis group of companies, (ii) the Teva group of companies and (iii) Dr Reddy's respectively. Warner-Lambert resisted this. Neither Mylan nor Sandoz nor Consilient requested that the benefit of the cross-undertaking be extended to them, but Mylan reserved the right to apply for this in the future.

So it is this cross-undertaking that would serve as a basis for any claim.

Subscribe to the IPKat's posts by email here

Just pop your email address into the box and click 'Subscribe':