January 19, 2018 by IPAlchemist
The patent litigation on pregabalin has been one of the most important UK patent stories of this century. It has raised important questions about the scope and meaning of second medical use patents, and has led to entirely new forms of court order (the Patents Court ordering NHS England to issue instructions on the prescribing of pregabalin by brand rather than generically). At the time, I wrote about the story extensively on the IPKat blog. (My last post is here; my posts on the main first instance decisions are here and here; links to earlier decisions are here.) I have been looking at the situation again because I am collaborating with Ben Goldacre and Richard Croker at the Department of Primary Care Health Sciences, University of Oxford on a study of the effect of the litigation on pregabalin prescribing and cost.
There was one recurring fact in the litigation that was often referred to but never explained. The Supplementary Protection Certificate (SPC/GB04/034) based on the original product patent for pregabalin (EP0641330) was applied for in October 2004, following the granting of the European marketing authorisation to Pfizer for their Lyrica brand pregabalin, and granted in February 2005. But then in May 2013 the renewal fees required to bring it into force upon expiry of EP0641330 were not paid, so that it lapsed. It is a vanishingly rare occurrence to allow an SPC to lapse in this manner, and it must have been intentional. The question is, why would Pfizer do this? Incidentally, the owner of the patent and SPC is not Pfizer, but Northwestern University. There is no licence recorded on the UK IPO register, but licences are often not recorded and I presume that Pfizer (or one of its subsidiaries) is actually a licensee under the patent.
While looking into the case, I noticed that the US application from which EP0641330 claims priority is a continuation-in-part of an earlier US application. This is often a signpost to a possible self-collision issue, and so I took a closer look.
EP0641330 is based on international patent application WO93/23383, and claims priority from US application number 07/886,080. (“Claiming priority” is a system where you can file an application up to a year later than the earlier application, but it is regarded for the purposes of considering patentability [novelty and inventive step] as having been filed at the earlier date. Such a priority claim is valid only if the subject matter of the claim in question is present in both applications, and also provided that the earlier of the two applications is the first application for that subject matter). However, 07/886,080 is a continuation-in-part of US application 07/618,692, and a PCT application WO92/09560 was also filed claiming priority from that earlier US application.
The timeline is as follows:
27 November 1990 US 07/618,692 filed
20 November 1991 WO92/09560 filed
20 May 1992 US 07/886,080 filed
11 June 1992 WO92/09560 published
18 May 1993 WO93/23383 filed
Now, if we consider the right to priority of the claim to pregabalin in EP0641330, the corresponding subject matter is present in 07/886,080 and therefore on the face of it the first part of the test for a valid priority claim is satisfied – the subject matter is present in both applications. On that basis, WO92/09560 is not available as prior art, because it was published after 20 May 1992. (If this were not the case, I would expect the EPO examiner to have noticed it).
The difference between WO92/09560 and EP0641330 is that in EP0641330 pregabalin is claimed as a single enantiomer – the S-(+) enantiomer. In WO92/09560, by contrast, while the pregabalin molecule is disclosed, it is only made and tested as the racemate. However, WO92/09560 also states:
“The compounds made in accordance with the present invention can contain one or several asymmetric carbon atoms. The invention includes the individual diastereomers or enantiomers, and the mixtures thereof. The individual diastereomers or enantiomers may be prepared or isolated by methods already well known in the art.”
There is a plausible argument that this passage, in combination with the disclosure of the racemic pregabalin, is sufficient to count as a disclosure of the S-(+) enantiomer. In that case, however, WO92/09560 (or its priority application 07/618,692) is the “first” application for that subject matter, and not 07/886,080. That would make the priority claim invalid so that the effective date for considering the patentability of EP0641330 would become the filing date of WO93/23383, namely 18 May 1993. Thus WO92/09560 would become novelty-destroying prior art, because it was published before the filing date of WO93/23383 and thus EP0641330.
Now, all of this is arguable both ways, and it is possible that a court would not accept the argument. It is also a fairly subtle point, and I can imagine an EPO examiner missing it. It does not surprise me that the patent was nevertheless granted – on the face of it if the priority claim of WO93/23383 is valid, then WO92/09560 is not prior art at all since it was never filed at the European Patent Office as a European application. (If WO92/09560 has been filed as a European application, it would have been considered by the EPO examiner as “novelty-only” prior art under Article 54(3) EPC as being filed before, but published after, the priority date of WO93/23383). It is only if the additional criterion, whether 07/886,080 is the “first application” in respect of the subject matter of the S-(+) enantiomer of pregabalin, is considered that a potential problem becomes apparent.
None of this would apply in the USA, where the rules about your own earlier applications counting as prior art against your own application are completely different from the rules in Europe.
Also, a possible reason why the patent might be invalid is not of itself a reason for Pfizer to drop the SPC. Pharmaceutical patents are often found to be invalid by national courts, and although obviously the proprietor then loses the patent case, there is usually no further adverse outcome.
However, in 2009 the EU Commission published the Final Report in its competition inquiry into the pharmaceutical sector, which raised a number of questions about behaviours that had previously been considered unproblematic. Then in July 2010 the General Court upheld a finding of abuse of dominant position against AstraZeneca in relation to Losec (omeprazole), for actions including providing incorrect information about the date of the first marketing authorisation when applying for supplementary protection certificates, and this was upheld by the Court of Justice of the European Union in December 2012.
Moreover, in January 2012, the Italian Competition Authority sanctioned Pfizer for abuse of a dominant position relating to latanoprost consisting of various aspects including basing an SPC on a divisional application. This was quashed by the Regional Administrative Court of Lazio in September 2012, but then reinstated in February 2014 by the Consiglio di Stato.
All of these events together created a perception around 2010-2012 that, at least in respect of an SPC (if not necessarily in respect of a patent), the proprietor might (under competition law if not under any intellectual property law) be under a kind of good faith obligation that was more extensive than had previously been the case in Europe, and that the EU competition authorities might regard breach of such a good faith requirement as constituting an abuse of a dominant position. That perception is perhaps less prominent now, but at the time such views were widely discussed. A person might therefore have had a concern that a patent proprietor applying for an SPC based on a patent that the proprietor knew or should have known to be invalid, because the reason for invalidity was their own prior art, might be found to be an abuse of a dominant position under competition law.
There is no clear authority that it is an abuse of a dominant position to apply for an SPC based on an invalid patent (even where the patentee should know it is invalid, for example because the prior art is their own related application), but it may well have seemed in 2013 that this was the direction in which competition law was heading. The EU Commission can fine an undertaking up to 10% of worldwide turnover, so the risks involved if competition law comes into play are very high.
By not bringing the SPC into force, it was pretty much guaranteed that there would never be any litigation under the patent, since it would expire before the end of the data exclusivity period. On the other hand, if the SPC were brought into force, there would inevitably be litigation with generic companies, and there would be a risk that the patent might be found invalid for this self-collision reason. Once that reason became public by reason of the litigation, there could then arise a concern that this would lead to EU Commission action under competition law.
I do not know why Pfizer decided not to bring the SPC into force. However, this priority issue leading to a potential self-collision provides a plausible reason (and I have not seen any other possible reason suggested) why someone might have decided that it was too risky to bring the SPC into force. I wonder whether anyone can tell me whether it is anywhere close to the real reason.
August 2, 2013 by IPAlchemist
Well would you credit it? Your very own IPAlchemist is now A Face of Chemistry! Those who said I had to choose – I could be a lawyer or a chemist but not both – well they were wrong.
Before I go on to explain what on earth I am talking about, I have to give the now-usual obligatory apology. It has been MONTHS since I posted here. It is not that nothing has been happening – far from it – but that what blogging time I have has been exclusively reserved for the IPKat (check out the Publications page for a periodically updated list of IPKat posts) with the only occasional foray as a guest blogger on the India-specialist Spicy IP blog. There have been some other writings as well, but for those too you have to peek at the Publications page as well.
Anyway, a little while ago those lovely people at the Royal Society of Chemistry (and I mean it – they really are lovely) asked if I would mind being filmed for the Faces of Chemistry series. You can check the RSC’s explanation of the series on the Faces of Chemistry microsite, but my understanding is that they are aimed at young adults, and that the intention is to encourage people to study chemistry to show what an amazing range of career opportunities it leads to. Well that is very much my bag, and I will do anything I can to further and improve the public image of chemistry, so of course I said yes.
We burbled around for a little while making all the arrangements, and then on the appointed day two wonderful people came from the RSC with a cameraman who brought with him all that impressive looking kit. The way they structured it was that the nice lady asked me lots of open questions, and then I was supposed to reply in such a way that when they edited out the questions, the answers by themselves would make sense. Well I soon got the hang of it and we were away. And then before I knew it they said they had enough material and that was it.
We had agreed that they would also film around the office, with me lecturing, working, discussing cases, and so on, and that they would also interview two other chemists in the firm – Fergus Tyrrell who is my trainee, and Robert Lundie-Smith who is an IP solicitor. This would give different perspectives on the topic.
It turned out that they had so much material that they made two films – one of me, and one of Fergus and Robert. So a little while later two draft edits appeared in my inbox.
Well, dear readers, I can tell you that although I can handle speaking in public and even being filmed, watching it back is quite another thing altogether. All three of us found it excruciating watching ourselves, and my toes curled with embarrassment. Why do I go “Ummm” so much? Why do I look shiftily to one side when I am thinking? Why did no-one tell me? And do I really sound like that? Not to mention look like that? Apparently I do. So I have watched the proofs twice for quality control purposes (in fact they were perfectly edited and I didn’t request any changes, and neither did my colleagues), and then never again. Well, maybe one day I will bear to look once more.
The IPAlchemist would like to thank the RSC for a great opportunity. It has been a joy and a privilege to be associated with this project.
October 24, 2012 by IPAlchemist
My current job.
I am a patent attorney, partner in the intellectual property law firm EIP, and head of its chemistry practice group, EIP Elements. This covers pharmaceuticals, food science, process chemistry, polymers, agrochemicals, batteries, inks, and all sorts of other fascinating things.
What I do in a standard “work day.”
A lot of reading of patent documents and other “prior art” (which can be journal articles, abstracts…). A lot of writing as well: huge volume of emails; drafting patent documents; writing letters to the patent office, or other patent attorneys in other countries; and of course writing to my clients giving opinions, advice, and reports.
Although the work runs the danger of being solitary, I make it collaborative by talking to my colleagues – getting second opinions, arguing over obscure rules of grammar or punctuation, or discussing knotty legal problems.
There is quite a lot of travelling – I get to go to Japan and the USA quite regularly, and Munich (the seat of the European Patent Office) often. My favourite place to visit has been Jurong Island in Singapore, which is a vast agglomeration of chemical plants and an amazing sight.
What kind of schooling / training / experience helped me get there?
The chemistry degree was essential – you cannot even train as a patent attorney in Europe without a science or engineering degree, and you can only practise in a technical field that you understand. It was probably also important that I was interested in topics outside science – English language and literature and other languages especially, as literacy is a key aspect of being an effective patent attorney.
I did a DPhil and a post-doc – these were not perhaps so essential, although I do think that it helps me as a patent attorney that I understand a little of what it is like to do actual research. In the long term, the most important thing about the post-doc was probably that it was in Japan, so I learned Japanese. Many people enter the patent attorney profession after an undergraduate degree.
How does chemistry inform my work?
It is there all the way through – in particular the nomenclature aspects – you cannot claim a class of compounds if you don’t know how to name them correctly. It was probably teaching 1st year organic chemistry to biochemistry undergraduates that really hammered nomenclature into my head. I rely on the inventors most of the time for the detailed technical input, but I have to have the general background knowledge to understand this.
Being in private practice (rather than working in-house in a particular company) I get a lot of variety in the technical fields that I work in, and I really love that. My main reason for moving away from the research path was the monotony.
Finally an anecdote
My entry into the patent world was by a series of accidents. I heard about it when I was a teenager when my mother had an idea (a heater for the windscreen wiper reservoir to prevent freezing) and consulted a patent attorney about it. I mentioned that I was interested in the patent attorney career to a student doing a DPhil in the same lab as me when he was planning to enter the profession, and when he left his job to emigrate, he contacted me to ask whether I would be interested in the vacancy. A partner was visiting Japan where I was doing my post-doc at the time, and the job was then mine! People nowadays are a bit more methodical about it all, I think.
September 13, 2012 by IPAlchemist
So, APAA is coming up. It will be my first time to visit. I have wanted to go for the longest time, but previously the “one observer per non-member firm” rule made it impossible for me. Of course, as a UK-based UK and European Patent Attorney, I am not eligible to be a member of APAA.
Never before will I have seen so many patent attorneys in one place, with the possible exception of a party that I went to at AIPPI in Geneva. So I am really looking forward to it.
Of course I am looking forward to meeting old friends from Japan, but the really amazing aspect is the opportunity to meet so many attorneys from countries which I have not had a chance to visit yet (which is all except Japan, Singapore and New Zealand, and my trip to NZ was a holiday, so I didn’t meet any patent attorneys… Actually the Singapore visits were both very brief, so I didn’t see much other than the fascinating Jurong Island.)
If you chance by my blog and are going to APAA, look me up and say hi to the IP Alchemist!