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  1. Teva v Gilead – C-121/17 provides some clarity on combination products

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    July 26, 2018 by IPAlchemist

    The CJEU gave its ruling yesterday in case C-121/17 in the case of Teva v Gilead. This concerns the SPC for the combination of tenofovir and emtricitabine (marketed by Gilead as Truvada ®), which was granted in the UK and which Teva and others were seeking to revoke. There was no SPC for the tenofovir alone, as far as I can tell, because the EU marketing authorisation for the mono product was granted within 5 years of the application date of the basic patent EP 0915894. Gilead has successfully argued that the patent, which did not mention emtricitabine, could serve as the basic patent for a combination SPC following authorisation of the combination, because claim 27 referred to:

    A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.

    In proceedings in the Patents Court, Mr Justice Arnold considered that the CJEU jurisprudence on combination SPCs was still insufficiently clear, so he referred yet another question on Article 3(a) of the SPC Regulation to the CJEU:

    ‘What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No 469/2009?’

    He offered a view – that it related to the inventive advice or technical contribution of the patent – stating at [97]:

    In my view, the answer is that the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent.

    The Advocate General disagreed and proposed that the criterion should be whether:

    “on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.”

    The CJEU has not gone with either of these proposals, but has instead set out a test which is a more nuanced version of the AG’s test and which I think, for the first time, is tolerably clear and can reasonably be applied to future cases.

    The ruling states:

    Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

    – the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

    – each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

    While emphasising that this is a matter for the referring Court, the CJEU makes clear how the test should be applied to the facts of the underlying case:

    In the present case it is apparent, first, from the information in the order for reference that the description of the basic patent at issue contains no information as to the possibility that the invention covered by that patent could relate specifically to a combined effect of TD and emtricitabine for the purposes of the treatment of HIV. Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent.

    Like theologians poring over the latest papal encyclical, SPC enthusiasts have leapt on this judgment to try and work out what it really means. Unlike the gnomic utterances in Medeva (“specified in the wording of the claims of the basic patent”) and Lilly v HGS (“the claims relate, implicitly but necessarily and specifically, to the active ingredient in question”), some clarity and method is beginning to emerge.

    What the CJEU is saying is that the active ingredient, or in the case of a combination product, each active ingredient in the combination, must specifically be indicated in the patent as being part of the invention. And by the “invention”, is not meant any consideration of the “clever bit” or inventive advance (as suggested by Arnold J) – the CJEU is relying only on the law that relates to the extent of protection and extent of invention – Article 69 EPC and Section 125 of the Patents Act. According to s125, the invention is “that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification”, and it is precisely that which the CJEU is referring to. The CJEU correctly rejected the AG’s opinion that focused on the claims alone, because Art 69 and s125 include the description and drawings as being part of the interpretative means. But the CJEU also said that the prior art can be taken into consideration, and it seems this would be relevant if the particular active ingredient in question was referred to in the patent indirectly in a manner that would lead the skilled person, in the light of the prior art, to the specific active ingredient.

    By “specifically”, the CJEU means that the particular active ingredient must be somewhere indicated, and not simply a generic description that did not lead to the specific compound. The indication might be in the claims, in the description, or possibly in the prior art if, for example, the compound was sufficiently well known. How specific is needed is still a little unclear – obviously “other therapeutic ingredient” as in the current case is not enough (at least if the compound was not already known, but probably in any case). I would expect that a broad functional term would also not be enough. A therapeutic class might suffice, but I would expect that this might depend on how broad the class was, and how well known the particular active ingredient was within it. Hopefully two further CJEU cases will clarify this – in both the question is whether the term in the claim is specific enough to support an SPC. In the case of Sandoz v Searle, the claim specifies a broad structural formula, but not the exact combination of substituents leading to the specific compound, which is not disclosed in individualised form in the patent. In the Sitagliptin case, the term in the claims is a functional term. Good judgments in those cases would serve to clarify the situation a great deal.

    So will patent attorneys now start adding lists of known drugs into patent applications for new chemical entities? And would this be effective to support a combination SPC? We may well see this happen, but I expect that if a whole pharmacopoeia of compounds is mentioned in the specification, the CJEU may ultimately rule that none of them is specifically disclosed as being part of the invention.
    For the avoidance of doubt, I disagree with all of the jurisprudence on this topic. My preference would be a simple infringement test – if the active ingredient, combination or otherwise, would infringe the patent, then it should satisfy Art 3(a). But that ship has long sailed, and even the Swiss courts have now moved away from the infringement test.  It seems that the best we can hope for now is clarity on the test that the CJEU intend to be used.


  2. The LGBT+ STEMinar 2018 – the conference for the future

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    January 23, 2018 by IPAlchemist

    I have been wanting to write a post about the LGBT+ STEMinar, but I was not really sure what I wanted to say.  Having a thought in my head that I want to get out is frequently my driver for blogging, and when I don’t have it, things tend to get a bit delayed.  In the meantime, others have written their accounts – you can see this on the website of the Royal Society of Chemistry (one of the several learned societies who sponsored the event) and this from my hero David Smith, a chemistry professor at the University of York.

    It was one of the most tweeted conferences that I have come across, and the hashtag #LGBTSTEMinar18 will take you to a multitude of tweets and pictures.  We were a trending hashtag on the day, and even attracted the attentions of a number of trolls, which most of us took as an affirmation of the significance of the event.

    I have just come back from the annual general meeting of IP Inclusive, and this has finally spurred me to express a few thoughts about why the LGBT+ STEMinar is such an important event for me, and, from what I can tell from talking to other attendees, for many other people as well.

    Firstly, although “interdisciplinary” is much talked about nowadays, it is extremely rare to attend an event that truly covers a whole range of disciplines within science.  The programme is at the link here, and you can see that just in the talks there is chemistry, microscopy, astrophysics, biology, atmospheric physics and more.  The posters were yet more diverse still.  It is so rare to see scientists actively engaged outside their own discipline, and just sharing their enthusiasm for what interests them.

    Secondly, the atmosphere at the conference was truly wonderful – people were respectful and engaged.  The applause at the end of each talk had a quality not just of “thank you for finishing” but “really, thank you for sharing that with us”.  There were no questions designed to show off the superior knowledge of the questioner, and people were respectful of their time allocations. And the socialising the evenings before and after the conference itself were great opportunities to chat to a whole range of fascinating scientists.

    Thirdly, both the keynote speakers Beth Montague-Hellen at the beginning and Tom Welton at the end reminded me of just how far rights for LGBT+ people in the UK have come on in rather a short period of time of just a few decades.  Being at the upper end of the age range of people attending, I am particularly conscious of this – not only was consensual sex between men decriminalised only the year before I was born, but also, when I came out at the age of 19, sex between men was still illegal for men of my age.  This reminder is on the one hand very heartening, but on the other very concerning – what has been given in a short time can be taken away in a short time as well, and we cannot afford to be complacent.  Many of these advances have taken place in only a few countries, and in much of the world LGBT+ people do not enjoy the freedoms that we do in the UK.  And in the UK, even with the great progress that has been made, there is still much work to be done to promote LGBT+ visibility and inclusion both within the workplace and in wider society.  It saddened me how many people present, a generation younger than me, spoke of less than full acceptance from their families and peers.

    So it was also handy that we had a number of workshops on public engagement (that because of time pressures had to be run in parallel), exploring what we can all do to counter prejudice, and to increase visibility.

    Presenting my talk (thanks @BatWarren for pic)

    This year, my second to attend the conference, I was delighted to have my talk proposal accepted. I was very nervous, because I was aware of how few slots there were for speakers and how many excellent proposals had not been accepted. I spoke about the patent litigation on pregabalin, and the effect on the drug reimbursement price – truly interdisciplinary even by the standards of this most diverse event.  I hope that I succeeded in my aim of communicating the fascination I have with how complex litigation unfolds and affects those involved, not just the parties to the litigation.

    Presenting IP Out Poster

    I also took along a poster about IP Out, and several people came over to talk to me about patents and about the work that IP Out is doing.

    On a more personal note, it was lovely to have the event in York – every time I go there I am struck afresh by quite what a beautiful place it is. But I grew up in Yorkshire, and I cannot say that my memories are entirely happy, as it was not a forgiving environment for a boy who didn’t entirely fit in.  So it is always with mixed emotions that I journey from London up the East Coast line.  The transportation was also not kind to us, as there were train delays both the day before and on the day of the conference.  Happily, though, I still made it.

    In my title I called this the “conference for the future”, as I think that the event gave the participants the space to be authentically ourselves.  We would like our environments, and especially our workplaces, to be like this all the time.  In the meantime, for just one day a year, we have this.  So I look forward to seeing everyone next year, which will be hosted by the Royal Astronomical Society and the Institute of Physics in London.

     

     


  3. Why were the SPCs for Pregabalin allowed to lapse? I have a theory…

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    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.

     


  4. Chemophobia and the Chemical-Free Bear

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    February 11, 2014 by IPAlchemist

    When I set up this blog, one of the things I said I would do with it is address Chemophobia.  That is, using the word “chemical” to mean “something that will kill or at least seriously harm you” (and its cognate, using “natural” to mean “safe and good for you”).  I have not done that much on it yet (although I have touched on it a couple of times here and here), but I was delighted last week to witness the creation of the Chemical-Free Bear, who in barely more than a week on Twitter as @ChemFreeBear has tackled more lazy chemophobia than most of us do in a year.  He clearly hit a chord with us chemical Twitterers because he attracted more followers in a week than any mere person that I have known.

    I was catching up on Dragon’s Den at the weekend and saw an episode that filled me with horror.  It is a pitch in Episode 8 beginning ca. 19 mins for “innovative sports recovery drink”, and if you are watching this soon, you may be able still to see it on iPlayer at:

    http://www.bbc.co.uk/programmes/b03tt4df

    Well, I straightaway informed my new ursine friend, and you will never guess what the splendid furry creature did – he started a blog!  So he duly now appears on my blogroll, and you can read his criticism of the item here:

    http://thechemicalfreewoods.blogspot.co.uk/2014/02/a-chemical-and-evidence-free-recovery.html

    If this makes you RAWR like the Chemical-Free Bear, then leave a comment below!

     

     


  5. The Oxford Chemistry Part II System

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    September 26, 2013 by IPAlchemist

    I just had a little Twitter conversation with @OxfordChemistry, and was asked for my advice for students starting the Part II year. Twitter being Twitter, I sent off my immediate thought: enjoy it and don’t skimp on the writing up time.

    Then I got to thinking a little bit more. The Part II system is the jewel of the Oxford chemistry undergraduate system. Certainly back in my day (which I do acknowledge was well back in the previous millennium), Oxford was the only university where the fourth year of the undergraduate chemistry course was given over entirely to research. It was what had attracted many of us to Oxford in the first place; and even if it wasn’t, it was what we said at interview.

    So what do I think is the best way to take advantage of this fantastic opportunity? In many ways, I think that the question I was answering earlier this afternoon came at the wrong time. By the time you’re starting your Part II, it’s too late to make the most of it. Because surely, the most important aspect is to select the right project and supervisor in the first place.

    So here is my advice to those harassed third years, thinking what to do for their Part II next year.

    The main thing is not to rush the decision. It’s really a terrible time to be trying to decide your fourth year, when the third has enough pressures of its own. So the temptation is to rush the decision and not devote enough time to exploring the different possibilities. But you only get one Part II year, and it is really important to give yourself the best opportunity to have a rewarding and productive year. Of course it’s always more fun when the research goes well, and that part you don’t have any control over. But working with people that you get on with, and in the field that you find stimulating, that part of the deal is in your hands.

    Don’t necessarily go for the position that you think will look best on your CV afterwards, or is the place that you think you ought to go to. You’re likely to be much happier, and therefore perform much better, if you choose it on the basis of your own taste and enthusiasm. Think carefully – do you prefer a large group or a small group; are you really interested in this area of chemistry, or do you just think you should be? The only piece of advice I was given at the time was – stay within the main chemistry department, unless you are absolutely certain that the alternative is really what you want. I took that advice – I have no idea what might have happened to me otherwise.

    On the other hand, I’m now a patent attorney, so draw your own conclusions as to whether my advice is worth anything at all.

    Any case, I wish you all the best.

    Oh, and I do stick by my Twitter advice, if that is where you are at now!


  6. Faces of Chemistry

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    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.

    Anyway you can go and watch them yourself on You Tube – Me and Robert and Fergus.  I will be very happy if you “like” it.

    Or if you prefer it embedded in the RSC website, see here  for the series, and the individual resources of me and Robert/Fergus.

    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.

     

     


  7. Stop Horsing Around With Our Food – RSC Public Lecture

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    April 18, 2013 by IPAlchemist

    On 14th March 2013 the IP Alchemist attended a panel discussion hosted by the Royal Society of Chemistry, entitled “Stop Horsing Around with Our Food”; the goal being to “tease out the issues to be tackled” in the wake of the recent horsemeat scandal and the progressively decreasing amounts of resources made available for food sampling and analysis.

    The event took the form of a brief talk from each panellist followed by a question-and-answer session. The panel of industry experts consisted of:

    - Dr Derek Craston, UK Government Chemist, Chief Scientific Officer at LGC and chair of the panel.

    - Gerald Heddell, Director of Inspection, Enforcement and Standards Division at the Medicines and Healthcare products Regulatory Agency (MHRA).

    - Dr Mark Woolfe, member of the RSC’s Analytical Methods Committee and formerly of the Food Standards Agency (FSA).

    - Liz Moran, President of the Association of Public Analysts.

    Dr Craston began proceedings by indicating that any food analysis or testing only usually takes place in relation to known issues, after a problem had been brought to light. Current resources are insufficient to test in areas where no issue has been identified.

    Dr Woolfe stated that he was “not that surprised” that food adulteration had taken place and that he was only surprised by the scale of the issue. He said that the food chain had become longer, because price pressure from supermarkets led suppliers to source food production from abroad. He added that any supply chain should be as short as possible to avoid any untoward contamination.

    Gerald Heddell looked at parallels with regulation of medical products. He stated that the answer cannot lie solely in testing but requires regulation of the supply chain: a poorly-regulated supply chain could not be compensated for by any amount of testing or analysis. He reported that 60% of adults have changed their shopping habits in the wake of the scandal, indicative of a collapse of confidence in the sector as a whole.

    Liz Moran, of the Association of Public Analysts, painted a rather bleak picture of the decline of the UK food analysis system which is currently “in the eye of the storm” with 30% of the UK’s food testing laboratories having closed over the last few years resulting in a significant loss of expertise. She went on to argue that labs need to be able to react quickly to problems that present themselves and help the FSA. This issue was not routinely tested for before, but now labs were working round the clock testing beef for equine and porcine DNA. She stated that laboratories must be prepared for the next issue that presents itself and that regulation via paperwork would be insufficient due to possibility of forgery.

    The floor was then opened to questions and contributions. Dr Chris Smart of Leatherhead Foods defended the industry and argued that food safety and traceability were taken very seriously. He pointed out that when fraud happens (of which there have been a number – orange juice, baby formula, olive oil) it can be hard to spot when it first happens, emphasising the importance of the integrity of the chain. When a question was raised regarding the acceptability of hiding cheap ingredients in processed food, he pointed out that one cannot simply “hide” ingredients and that doing so was illegal. He argued that there was nothing wrong with convenience food and that such products addressed a consumer demand. He pointed out that consumers have an expectation that products have good shelf life, but taking out emulsifiers, salt, and other ingredients can compromise this.

    On the question as to whether cheaper and faster testing was being developed, Dr Woolfe outlined the immense number of issues surrounding food analysis, indicating for example that the presence of methanol in drinks is easy enough to detect whereas determining the geographic origin of meat is far more challenging.

    One enquiry which aroused much interest from the panel was the question of how sensitive and specific the tests for horse meat were. Liz Moran immediately indicated that the last thing any lab would want to do is report a false positive result, and indeed that no lab would declare anything without undertaking repeat measurements. She went on to indicate that ELISA (Enzyme-Linked Immuno Sorbent Assay) tests are sensitive to 1% and PCR (Polymerase Chain Reaction) testing is sensitive to just 0.01 %, posing a further question as to what exactly constitutes an acceptable limit, pointing out that detection of equine DNA is not the same thing as establishing that the meat is horse meat as such.

    Mark Woolfe pointed out that surveys and investigation come from intelligence – often from within the food industry itself, while Gerald Heddell re-iterated that testing cannot rule out all risk and that supply chain management is also key.

    Ms Moran understandably criticised cuts to testing labs. When questioned, she explained that there have been cuts to DEFRA (Department for Environment, Food and Rural Affairs) but that local authorities also have responsibility for testing. The number of samples taken by local authorities has been declining in recent years and some have reported no testing at all to the FSA. Naturally these cuts were implicated in the fact that the horsemeat problem did not first come to light in the UK.

    The IP Alchemist very much enjoyed this evening and thanks the RSC for putting it on in a very short timescale. He did however feel that each of the speakers pretty much said what you might have them to say, given their current or previous affiliation, and pretty much the same went for the audience contributions (where their loyalties were stated). Cuts were blamed where expected, and the importance of consumer choice and demand were also emphasised by precisely those who would be expected as well.

    The IP Alchemist would like to thank his Twitter interlocutors, in particular @RSC_Comms, @chemical_ian, @melancholysci, and @chiara_ceci for enlivening the evening, and for creating a record on which this blog post could be based. The hashtag used for the event was #stophorsingaround. He is also enormously thankful to Fergus Tyrrell for assisting with the first draft of this report.

    The event was webcast live, and there is a promise that the recording will be made available, but as at the posting time this has not yet occurred.

     


  8. RSC Profile

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    April 4, 2013 by IPAlchemist

    Over the last year or so, I have been involved in a number of projects related to the public perception and understanding of chemistry, and also showing to current or aspiring chemists what possible careers are available for them, and what chemistry-related jobs might look like.

    On Twitter, we have had #RealTimeChem (see @RealTimeChem, organised by @DrGalactic, whose blog is on my blogroll).  The next event is going to be a week, not just a day, beginning on 22 April, so do all look out for that.  I shall be at BIO in Chicago that week, so I am hoping to tweet and blog from there.  It is my first time attending the BIO convention, so I am very excited about it.

    The other week I was also thrilled to be added to @JessTheChemist ‘s family tree of tweeting chemists (where everyone is connected via a current or former supervisor).  Her blog is on my blogroll, and the post with the family tree is here.

    On the blogosphere, See Arr Oh hosted a Chem Coach Carnival on his blog Just Like Cooking, also on my Blogroll, last October, which I participated in here.

    In a perhaps similar vein, the Royal Society of Chemistry has every month in RSC News, which accompanies Chemistry World, the magazine for RSC members, a profile of a chemist.  And I am in the April edition, which you can find here (the profile is on page 7) or on the RSC Blog The Reaction here.

    As it happens, there has been a bit of an intellectual property theme going on in the RSC News profiles recently, because just a few months ago the towering IP barrister Michael Edenborough QC was likewise featured – you can see his profile here.  I actually only found out quite recently that his background was quite so strongly chemical – barristers practise in a wider range of technical and legal fields than patent attorneys so have a diverse array of backgrounds.

    I hope that this little array may help any chemists out there who are considering what direction their career may next take.

     


  9. Genesis 2012 – Better late than never?

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    January 18, 2013 by IPAlchemist

    It is now over a month since Genesis, the UK’s flagship life science and healthcare networking conference. I had always intended blogging about it – I was very excited to attend the whole event for the first time, because in previous years the most that I managed was to pop in for a little while, or attend the dinner. The problem is that, after the event was over, nothing really came into my mind that I wanted to say. So the blog piece got put off, until now, at the one-month stage, I feel I really need to write it, whatever.

    Normally when I go to an event, I come away with something that I want to say, but on this occasion it didn’t really happen. It is not that I did not enjoy the event – I enjoyed it immensely. I met many interesting people for the first time, as well as running into various One Nucleus stalwarts that it was a pleasure to see again. There were of course many patent attorneys in attendance (although with some notable and noticeable absences), and it is rarely disappointing to meet a patent attorney. There were many interesting and stimulating discussions, as well as the formal presentations.

    In particular I attended the afternoon session on Antibody-Based Therapeutics which yielded many fascinating brief stories (although one, which I feel I should not name, was basically “We have great idea but it is so early stage we can’t tell you what it is yet. It might not work – we don’t know yet, but if it does it will be amazing”).

    In the morning I attended a case study on the deal between Astex, Cancer Research Technology and The Institute of Cancer Research relating, of course, to an anticancer compound. This revealed fascinating insights into how such complex deals come into existence and what drives the terms and the choice of partner.

    I also attended the morning plenary session and the afternoon plenary debate. And perhaps that is the issue. Annual events such as Genesis prompt a certain amount of navel gazing. The industry as a whole, in its widest sense including service providers and academia as well as pharmaceutical and biotech companies of whatever type, considers “are we in good shape”? And now seems a particularly troubling time to ask this question, because, as the plenary debate made clear, one can equally argue for optimism pointing to all sorts of wonderful positive signs, as for pessimism pointing to all the harbingers of doom. And I wonder whether it might not be better if the answer was clearly negative, because then we could agree that there is a problem and do something about it: I feel maybe that the lack of consensus is itself the reason for the feeling of unease.

    I will end on a harbinger of optimism, a fellow blogger that I have added to my blogroll, Lucy Robertshaw. Lucy was a model of optimism and enterprise, having moved from the UK to Sweden to set up her own consultancy company. She also cleverly worked out that if you get the right photo, you can do quite a short post!  That was my APAA strategy, but foolishly I took no snaps at Genesis.


  10. Making Sense of Scents – British Society of Perfumers

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    January 16, 2013 by IPAlchemist

    Can we really be two weeks into the New Year already? I intended to have a quiet December relatively free from social media activity, but that was supposed to be followed by an active January. It has not quite panned out that way. I have joined the IPKat as a permanent member, so my IP-blogging will mostly be done there. That leaves plenty of other things to write about here – it is, as usual, just a question of finding the time.

    On 10 January (nearly a week ago now!) I attended a fascinating event, again at the Royal Society of Chemistry, but this time in association with the British Society of Perfumers, and also supported by IFRA (the fragrance trade body) and basenotes (a website for fragrance enthusiasts). The format was not actually that clear from the advance information, but I attended because I have a long-standing interest in the chemistry of fragrance. Like many things, fragrance is underpinned by a lot of chemistry (a fact that perhaps escapes many people), and in a previous incarnation I used to do some patent work in this space.

    When I turned up, the event, entitled Making Sense of Scents, turned out to be a kind of question time, with pre-submitted questions, and further and follow-up questions from the audience, being put to a fabulous panel of experts, namely:

    John Bailey, current President of the British Society of Perfumers

    Steve Pearce, CEO and Founder of Omega Ingredients Ltd and Maverick Innovations Ltd

    Penny Williams, Perfumer and consultant, Orchadia

    Grant Osborne, Founder, basenotes

    Lisa Hipgrave, Director, IFRA

    Ruth Mastenbroek, Perfumer, Ruth Mastenbroek (eponymous niche perfumery)

    Will Andrews, Fragrance Scientist, P&G Prestige

    I didn’t keep detailed notes, which is why I should have written my blog post a lot sooner. But several points stuck in my mind.

    When asked whether perfumery is an art or a science, the panel responded unanimously and in unison: “Both”. Of course that is so. Even chemistry is an art as well as a science, so of course perfumery is also. It was noted that there are “no young Master Perfumers”, and that the acquisition of the necessary knowledge set takes a long time.

    I was happy to see it acknowledged that perfumery is a branch of the chemical industry, without equivocation. That means that it has not been untouched by the increasing regulatory pressures applied to chemicals generally. As I understand from what was said, the use of certain fragrance compounds has been banned, while others are permitted only at specified concentrations, depending upon the nature of the final product. Of particular recent concern is apparently the development of allergies to particular fragrance compounds, which is a two stage process – initial sensitisation, requiring exposure to a sensitising dose, after which the allergy can be triggered by the compound at a much lower level. IFRA in particular hope that this issue can be addressed by ensuring that the sensitising dose is never reached. Friends of the IP Alchemist will know my frustration over chemophobia, where “chemical” equals “something toxic” while “natural” equals “safe”, and will therefore not be surprised that I was reassured to note that it was acknowledged that certain flower oils (i.e. “natural” essential oils) are amongst those associated with allergic responses. Of course. I do not quibble at all with sensible regulations that in widely distributed products only compounds with appropriate safety profiles are used. But I do worry that a safety agenda is being driven by an ill-informed constituency, with poor understanding of risk, and fuelled by chemophobia.

    I enjoyed seeing the breadth of the fragrance industry, from the ultra-niche perfumer, to the fragrances that are put in household products such as cosmetics and cleaning products. The full breadth was represented on the panel, and their perspectives did not, so far as I could see, differ much on most of the key questions.

    The audience, perhaps surprisingly, could field only one person willing to identify themselves as a “perfumista”. The problem for such people apparently is that many fragrances are offered only in larger quantities than a collector wants – someone who wears only one fragrance may wish to buy 100ml bottles, but the person with a collection of 100 fragrances will want smaller unit sizes.

    There was an interesting opening question as to why smell is so evocative. Apparently that sense, unlike the others, feeds directly into the limbic system, a more primitive part of the brain than that responsible for the other senses. This was news to me, and makes a lot of sense (boom boom).

    There was an interesting discussion around marketing – surely more central to the fragrance industry than almost any other. In particular because of the rise of the internet and social media, it becomes possible to have a highly niche brand, or, indeed, an array of ultra niche brands. So some brands may choose to position themselves as actually unattractive to a large section of consumers in order to be more attractive to their very small target market (who don’t want other people to be wearing their fragrance). Thus, although mass market fragrances continue (and the even larger market of consumer items where the fragrance is incidental also thrives, despite those like the IP Alchemist and at least one other audience member who dislike such incidental smells), there is a burgeoning sector of niche scent. Grant Osborne referred to Etat Libre d’Orange as a fragrance house whose website proclaims:

    fragrance has been liberated from the traditional restrictions of the perfume industry, where even the most talented noses are subjected to the expectations of brands and are forced to conform to the demands of the marketplace.

    and whose perfumes are given names than many people might find unattractive or even offensive.

    There was a drinks mixer after the panel session, where I had the delight to meet another past president of the BSP, David Ruskin, as well as two of the panellists Grant Osborne and Ruth Mastenbroek. Ruth, pleasingly, is like me a chemistry graduate of Oxford University who also spent time in Japan – of course the best start to any career.

    I hope to attend and report back on further perfumery related events in due course. This should be a bumper year as the BSP is celebrating its 50th anniversary in 2013.