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  1. 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.

     


  2. 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!

     

     


  3. 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!


  4. 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.

     


  5. 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.

     


  6. Another RSC Policy Event – Synthetic Biology

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    November 15, 2012 by IPAlchemist

    Last night I went to the RSC for another of the series of events on chemistry policy, following the two last month that I wrote about on this blog. This time, the subject was “Synthetic Biology: challenges and opportunities for the UK”.

    It was another great event, but quite different from the previous ones. It was not about an individual project, unlike previously where each lecture had focused on a particular molecule (one pharmaceutical and one agrochemical). And the format was quite different too – a largish panel each spoke for about 5 minutes, and then there were a series of questions from the floor.

    I was very gratified that on this occasion Twitter was encouraged, and we were provided with a hashtag #synbio2012. (Usually, in the Chemistry Centre, we are told to turn off our mobile phones because they interfere with the sound recording equipment). If you want a blow-by-blow account of the event, a search on that hashtag should work well (for a while) as there were a number of professional reporters and writers present who are highly skilled in the art of real-time tweeting (unlike your humble servant).

    The event was technologically ambitious, being live-webcast, and having a live video link with a second audience at the University of Bristol. This impressive setup only failed slightly sometimes when there was a strong echo from the Bristol venue.

    The Biochemical Society has a better advance listing than the RSC, and I gratefully take my biographies of the speakers from their website.

    The impressive chairman was Dr Ehsan Masood – Editor, Research Fortnight.

    Ehsan is a science writer, journalist and broadcaster. Since 2009 he has been Editor of Research Fortnight and also teaches a course in international science policy at Imperial College London. As well as writing for Prospect magazine, The Times, Guardian and Le Monde, he writes and presents programmes for BBC Radio.

    The panel in London consisted of:

    Dr Lionel Clarke – Chairman, UK Synthetic Biology Roadmap Coordination Group

    Lionel chairs a group of independent experts who have set out A Synthetic Biology Roadmap for the UK. Its recommendations include investing in multidisciplinary centres, an annual forum, and funding competitions to support the development of novel applications. It emphasises responsible research to support the UK taking an internationally leading role. Dr Clarke joined Shell in 1981 and has been responsible for planning and delivering strategic research programmes there for more than ten years.

    Professor Robert Edwards – University of York and Chief Scientist, Food and Environment Research Agency

    Professor Edwards is the Chief Scientist for FERA and a Chair in Crop Protection in the Centre for Novel Agricultural Products (University of York). His research focuses on countering herbicide resistance in weeds, wheat biotechnology and biorefining. His group have discovered two new classes of plant glutathione transferases and identified their roles in soy, wheat and maize herbicide metabolism.

    Daisy Ginsberg – Synthetic biology writer and commentator

    Alexandra Daisy Ginsberg is a designer, artist and writer, interrogating science, technology and new roles for design in a biotech future. As Design Fellow on Synthetic Aesthetics, an NSF/EPSRC-funded project at Stanford University and the University of Edinburgh, she is curating an international programme researching synthetic biology, art and design, investigating how we might ‘design nature’.

    Helena Paul – Co-director, Econexus

    Helena is a co-director of EcoNexus, an organisation analysing developments in science and technology and their impacts on environment and society. She is also involved in the international negotiations of the UN Conventions on Biological Diversity and Climate Change. Dr Paul is currently monitoring UK research on synthetic biology, including consultation with the public and the conduct of scientists in connection with scientific uncertainty.

    Described as the “chair” in Bristol, but in the event acting more like a further panelist (which was welcome, as he spoke very well indeed) was Professor Dek Woolfson – University of Bristol

    Dek has been a Professor of Chemistry and Biochemistry at the University of Bristol since 2005. His research group’s focus is the prediction and design of protein folds and their application in bionanotechnology and synthetic biology. In 2011 Professor Woolfson won the RSC Protein and Peptide Science group’s Medimmune Protein and Peptide Science award, which is awarded in recognition of excellence in any area of protein and peptide science.

    It will probably be somewhat apparent from the biographies that all except Helena pretty much assumed that synthetic biology was A GOOD THING.  Their discourse focused on whether it would achieve what was hoped of it, whether it had been over-hyped, and how to foster public engagement and acceptance.  They were referring to (and buoyed up by) George Osborne’s speech from last week, on importance of synthetic biology to the UK, as for example reported in The Guardian.

    Helena was a lone voice advocating the precautionary principle.  While the others accepted that there was a serious public engagement issue to avoid a repeat of GM crops being labelled “Frankenfoods”, none of them to my mind seriously engaged with people who genuinely consider that with biological developments we need to set the bar of confidence that no harm can possibly result at a very high level indeed.  It seemed as though Helena and the others were simply taking part in parallel events that were not interacting with each other.

    To be clear, I do not agree with the precautionary principle being applied to developments in synthetic biology, but neither do I think that we can just carry on talking as though its proponents are not in the room.  So I used my question to ask:

    Is there any way to bridge gap between proponents of precautionary principle and those who do not espouse it?

    Even this did not really result in what I would regard as real engagement. There was some discussion of “what would have happened if the precautionary principle had been applied to motorised transport”, which is a good point, but, as Helena did point out, ultimately irrelevant as people who advocate the precautionary principle consider that there is an issue with organisms (which are replicating) that render them fundamentally different, and in need of a far, far higher level of regulatory caution than any other technology.

    My own “what if”, although equally irrelevant ultimately, is the story of CFCs.  They were brought in to replace the toxic and dangerous refrigerants that were used in domestic fridges, but turned out, completely unexpectedly, to harm the ozone layer.  But this was not an irreversible effect, and it is in principle possible to stop using them and return to something approximating to the status quo ante.

    Having squandered my question on this issue, I did not get a chance to talk about the IP issues, although I did tweet a little on the subject.  A sensible question was asked about the effect and role of IP on synthetic biology by Dylan Williams (@vitamindyl), but it did not really result in very informative answers, and I regret that I was not able to dive in.

    A particularly regrettable response was from Helena, who said that she worried that patents would be used by companies to tie up the technology and hide what they were doing.  Of course fundamental to the concept of patenting is disclosure, and so use of the patent system will actually help, not hinder, dissemination of the technology and publication of what is being done.

    There was some talk that the “biobricks” might be open source.  This may or may not turn out to be true – it might happen, but there would be no way to ensure that it happened universally.

    My expectation is that the basic rules of patenting – an invention must be new and involve an inventive step to be patentable, plus the requirements of disclosure and to be not contrary to morality, will turn out to be quite sufficient to deal with the issues presented by synthetic biology, and I do not see that the discipline presents any special new issues that would require dealing with in a different way.  I certainly don’t expect that it will need its own separate legal framework.  How then companies choose to use IP Law – in a collaborative way or in a proprietary way – or, as  is most likely, as a mixture of the two – remains to be seen.  But I am confident that the patent system will provide within itself the necessary flexibility to underpin whatever approaches are adopted.

    A final observation.  It is curious that no-one actually defined what they meant by “synthetic biology”.  While I heard “it is not genetic engineering”, and I heard various qualities attributed to it, no-one actually said what they considered the term to encompass.  Since the semantic meaning of the term is rather vague, if we are going to discuss issues like what will it do and how should it be regulated, I think we do need precision about the scope of the terminology.  I slightly formed the impression, although I could well be mistaken, that not all the panelists and question askers were assuming the same meaning.

    Final verdict – a fascinating evening and I look forward to another.