Earlier this week we teamed up with Alzheimer’s Research UK, our charity of the year for 2017, to deliver a webinar on the dementia R&D landscape in the UK.

The webinar highlights the various funding opportunities available to support the development of novel dementia treatments, and why working closely with industry and academic institutions is paramount to finding a cure. Withe speakers including Dr David Reynolds from Alzheimer’s Research UK, Dr Janet Brownlees from MRC Technology, Dr Rick Livesey from Gen2 Neuroscience and Dr Lee Dawson from Astex Pharmaceuticals.

Do you have a video you would like the sector to see? Contact us.

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Last week over 150 members gathered at Allen and Overy in London for this year’s BIA Committee Summit, to hear updates from the eight BIA Advisory Committees. Find out more in the blog below.

The BIA’s eight Advisory Committees are crucial mechanisms for highlighting the most relevant issues facing bioscience companies, covering areas from cell and gene therapy to intellectual property. Their work informs and guides BIA policy and priorities, ensuring that member needs are met.

Launched at the Summit, the Science and Innovation Advisory Committee (SIAC) is the newest of the BIA committees and was set up to identify and build on evolving science trends in the biotech industry that can give the UK competitive advantage.

The aims of SIAC are to:

  • Influence the policy of government and funders of UK science and technology through proactive engagement with key stakeholders to the benefit of UK life science companies
  • Encourage active networking between BIA member companies to facilitate communication, collaboration and sharing of best practice for mutual benefit
  • Improve translational science through more effective interaction between the academic research community, Tech Transfer Offices and BIA members
  • Address the identified science skills shortage in UK life sciences

Dr Mark Carver is the new SIAC Chair and told us the strong UK science base is going to be the catalyst for sector success. SIAC brings together specialists from across the BIA’s membership to help build on this competitive advantage by addressing issues that are key to sector growth, contact us if you want to know more.

Also announced at the Summit, the Synthetic Biology Advisory Committee has been renamed the Engineering Biology Advisory Committee. Speaking at the Summit, Chair of the committee, Dr Tim Fell highlighted how cheap DNA synthesis and new gene editing tools are transforming the biotechnology sector. At the same time, we are seeing increasing numbers of engineers, physicists, and computational scientists joining the field. Engineering biology is a more accessible term that better reflects the breadth of the field and we hope it will encourage potential new members into the committee for 2017.

Finally, the Communications Advisory Committee will be changing and becoming a more informally structured meeting, relaunching as the Communications Forum on Thursday 2 March.

The changes to our Advisory Committees reflect the changing needs of BIA members, who are key to ensuring that these vibrant expert communities can continue to flourish and drive forward sector wide success in 2017.

As part of the Summit, delegates also heard updates from our Cell and Gene Therapy, Finance and Tax, Intellectual Property, Manufacturing and Regulatory Affairs Advisory Committees. Click here to view the slides from the session, with details of all committee activity in 2016 and their areas of focus for 2017.

For more information on the BIA Advisory Committees, please visit the website.

Watch a slideshow of pictures from the day below.

 

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Marking Rare Disease Day 2017, our guest blog today comes from Jo Churchill MP, Chair of the All Party groups for Medical Research and Personalised Medicine.

Today hundreds of patient organisations from countries all over the world will host activities marking Rare Disease Day. While a disease may be rare, having a rare disease is not. A rare disease is defined as one that affects less than 1 in 2,000 people, however, 1 in 17 people, will be affected by a rare disease at some point in their lives. This equates to approximately 3.5 million people in the UK. Rare diseases are often chronic or life-threatening and 75% of them affect children. Despite the prevalence and severity of rare diseases, a significant proportion of patients do not have access to the best available care and treatment.

In 2013 the health departments of England, Scotland, Wales and Northern Ireland came together to publish the UK Strategy for Rare Diseases, to ensure that health and social care systems across the four nations provide those living with rare conditions with the highest possible quality of care and treatment, regardless of where they live in the UK.

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In October last year however, NHS England and the National Institute for Health and Care Excellence (NICE) published a consultation proposing changes to the way medicines are evaluated and funded, which, if implemented, would see patients with rare diseases in England being denied access to treatments available to patients with the same or similar conditions in Scotland, Wales and Northern Ireland. NHS England and NICE are yet to respond to the consultation, which closed in January, but the original document set out plans for the proposed changes to come in to force on 1st April this year.

Most concerning for patients with very rare conditions is the proposal to introduce a £100,000 cost effectiveness threshold for medicines evaluated via NICE’s Highly Specialised Technology (HST) programme. It is widely acknowledged that cost-effectiveness measures are not appropriate for evaluating medicines for very rare diseases, due to small patient populations and often limited data. In 2014 NICE established the HST programme to address these challenges. The programme provides an alternative evaluation process for medicines for very rare conditions, which gives less weight to cost-effectiveness criteria and considers the impact of medicines beyond their direct health benefits.

Many treatments for very rare conditions that are currently funded by NHS England have cost-effectiveness measures in excess of £500,000, including the three medicines that have been approved by NICE’s HST process to date – Soliris for Atypical haemolytic uraemic syndrome (aHUS) a blood disease; Vimzim for Morquio syndrome, a rare type of birth defect and Translama for Duchenne Muscular Dystrophy. Under the proposed changes, medicines which exceed the £100,000 threshold will be evaluated via NHS England’s prioritisation process. This process is not appropriate for assessing medicines for very rare conditions as it fails to take in to account broader factors such as unmet medical need, burden of illness and impact on patients and carers.  The new threshold will therefore, effectively stop the flow of new medicines reaching patients with very rare diseases.

Additionally, the consultation’s broader focus on economic thresholds will disproportionately disadvantage highly innovative, first-to-market drugs, which are often expensive to develop and produce but provide promising treatment options for patients with high unmet need, including patients with very rare conditions. By making it more difficult for patients to access these medicines, the proposed changes could inadvertently make the UK a less appealing prospect for companies considering where to invest and develop their medicines. This could mean fewer opportunities to discover new, potentially life-saving medicines in the future.

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The theme of this year’s Rare Disease Day is research. Rare disease research is crucial to providing patients with the answers and solutions they need. As Chair of the two All Party groups covering both Medical Research and Personalised Medicine, I am passionate about finding answers. I am concerned that we ensure collaboration across Europe, and beyond, to enable research into rare diseases, in which I include rare cancers, for patient benefit. I am currently trying to take a Private Members Bill through Parliament, putting the role of the National Data Guardian on a statutory footing. I firmly believe we need to concentrate on two strands; firstly the patient journey, including the support of family and, secondly, the use of consented data for research to find those answers.

I am acutely aware of the difference research can make, whether it’s providing a diagnosis, offering treatment options, or ultimately finding a cure. As the slogan for this year’s Rare Disease Day appropriately explains, ‘with research the possibilities are limitless’. However, this is only the case if research can be used to make innovative medicines and treatments that patients can access. If NHS England and NICE push ahead with their proposed changes they will limit the possibilities, and subsequently limit the treatment options available for patients with very rare conditions.

 

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I’m delighted that the BIA now has a new expert advisory committee, the Science and Innovation Advisory Committee (SIAC), set up to identify and build on evolving science trends in the biotech industry that can give the UK competitive advantage. It was the highlight of our Committee Summit last Friday where all eight of our Advisory Committees met, with over 150 BIA members attending.

Dr Mark Carver is the new SIAC Chair and told us the strong UK science base is going to be the catalyst for sector success. SIAC brings together specialists from across the BIA’s membership to help build on this competitive advantage by addressing issues that are key to sector growth, contact us if you want to know more.

There were further changes to the BIA’s committee’s announced at the Summit. The Synthetic Biology Advisory Committee has been renamed the Engineering Biology Advisory Committee, reflecting the breadth of this exciting area of biotechnology, as increasing numbers of engineers, physicists, computational scientists and the like are joining the field. And our Communications Advisory Committee will be changing and becoming a more informally structured meeting, keeping the elements that members value and will relaunch as the Communications Forum on Thursday 2 March.

The changes to the BIA Advisory Committees reflect the changing needs of our members, who are key to ensuring that these vibrant expert communities can continue to flourish and drive forward sector wide success in 2017.  For further information on the Committee changes, read the press release here or visit our website. We’ll have a blog from the Summit available later this week.

Last Thursday, as part of a £229 million industrial strategy investment in science, research and innovation, Business Secretary Greg Clark announced £103 million for a new national centre of excellence for life and physical sciences, at the Rosalind Franklin Institute in Harwell. The centre will build on the UK’s world-leading reputation in these fields and effectively bring together academia and industry. Facilitating collaboration between industry and our world-class academic science base is an important driver for innovation. This £103 million investment is testament to the prominent role of life sciences within the Government’s Industrial Strategy. Investments such as this new centre of excellence will play an important role in the UK becoming the third global biotech cluster.

Also on industrial strategy, on Wednesday I took part in the House of Commons Science and Technology Committee Industrial Strategy evidence session. I welcomed the Government’s green paper and especially the focus on life sciences through a “sector deal” but highlighted regulation and immigration as two key issues for our sector not addressed in the strategy.  We were the only industry voice among the six organisations giving evidence, which demonstrates the success of the BIA team in raising the prominence of our sector within Parliament. You can watch the session in full here.

Following last week’s announcement, you’ll have noticed across the trade press that EuropaBio’s Nathalie Moll will be taking up the position of Director General at EFPIA from April. Many congratulations to Nathalie, who we’ve worked very closely with during her time at EuropaBio. I wish her all the best and look forward to working with her in her new role at EFPIA.

A reminder that the latest update from the Medicines Manufacturing Industry Partnership is available to download here. We’ve also recently updated our webpage on the partnership so do take a look for the latest information, or join the LinkedIn group here.

Best

Steve

Next Tuesday, 28 February, is Rare Disease Day.

Rare Disease Day takes place on the last day of February each year. The main objective of the day is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives.

Watch the video below to find out more, or visit the website.

Do you have a video you would like the sector to see? Contact us.

Earlier this month, representatives from across the synthetic biology community gathered at the Royal Society to take part in an open discussion – Synthetic Biology: does industry get it? The conference, organised through the Royal Society’s Science, Industry and Translation Programme, was co-organised by BIA CEO Steve Bates, along with Professor Ben Davis FRS (University of Oxford) and Professor Paul Freemont (Imperial). Speakers discussed the potential of synthetic biology to address some of the key challenges of our time, as well as the barriers to fulfilling its full potential. Read on for our highlights from the day.

What is synthetic biology?

Synthetic biology is an interdisciplinary area that involves the application of engineering principles to biology. The field, in its broadest sense, is opening up a suite of possibilities for the design and redesign of biology to create new products and processes – advances in research and new toolkits could see the application of synthetic biology across a variety of industry sectors from pharmaceuticals to energy.

Improvements in the speed and cost of DNA synthesis in recent years have driven innovation at an exponential rate. Many international bodies predict that synthetic biology will have a significant impact on the economy, growth and jobs over the coming years, with the UK well positioned to play a leading role in the development of this burgeoning field.

A wealth of potential

Morning presentations from Professor Christina Smolke, Stanford University and Dr Jason Kelly, Ginkgo BioWorks both highlighted the strength of biotechnology as a manufacturing platform, offering nanoscale precision at continent scale production.

50% of our medicines are derived from nature, with 50% of those originating from plants – one obvious example being opioids. However, as explained by Professor Smolke, there are limitations to relying on nature directly to produce these and other products – a point also picked up by Jason Kelly when describing the manufacture of rose oil. Manufacturing with biotechnology has the potential to transform supply chains, providing a more cost effective and efficient route.

In an inspiring presentation, Dr Kelly shared his vision for the future: consumer biotech product launches (think Apple’s latest iPhone but for a synthetic spider silk shoe). From clothing made of bioengineered spider silk, to recreating the fragrance of extinct flowers, the falling cost of genetic engineering is opening new markets to biotechnology. And investors are interested – in the first half of 2016, over $900 million was raised by synthetic biology companies.

Synthetic biology also has the potential to catalyse the re-invention of industries and technologies. Presentations from Dr Andrew Phillips, Microsoft and Dr Jeremy Shears, Shell looked at applications from programming biology, to its role in the energy transition as we steer towards lower carbon and renewable energy sources.

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Credit: Royal Society

Does industry get it?

Across a multitude of sectors, there were some clear examples of uptake by industry on show at the conference. Multinational companies are becoming increasingly involved in the synthetic biology field, some funding research within their own companies but collaboration with SMEs and academia playing a more significant role.

Embracing this kind of disruptive technology can lead to great success for companies, but at a risk. Pfizer’s Dr Edmund Graziani emphasised the importance of driving internal innovation within a company – if not us, then someone else will capitalise on this opportunity. He sees collaborations as a useful way for larger companies to approach new technology and keep up with the rapid pace of innovation.

This was echoed by a number of the larger companies present on the day, including Dr Phillips, Microsoft who highlighted their work with BIA member company Synthace, and GE Healthcare who recently signed a collaboration with Synpromics, another BIA member. Dr Jeremy Shears also spoke to Shell’s network of research partnerships with universities, looking to academics for unique and experimental technologies.

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However, challenges to the wider uptake of synthetic biology by industry remain. These include the clear need to demonstrate profitability in order to displace existing processes; concerns over public perception and difficulties around the language and definitions used in the field. Critically, these barriers risk meaning that the full potential of synbio is not well understood.

So what else can we do to ensure the success of this flourishing industry? Persistence is key, it appears, when it comes to industry. And as synbio technologies begin to drip into the mainstream, building public trust through transparency, openness and dialogue from the beginning is paramount to its success – with companies such as the UK’s Oxitec already leading the charge in this area.

Find out more about the synthetic biology start-up scene in Europe here.

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Last week the Science Industry Partnership (SIP) launched their Strategic Skills Action Plan. This follows their Skills Strategy launched in 2016. Today’s guest blog from Malcolm Skingle, Chair of the SIP board, takes a look at the changing image of vocational education.

We are currently witnessing the most far reaching changes to further and higher education in decades – including to the funding environment (the Apprenticeship levy) and across technical education more broadly (The Post-16 Skills Plan). And the Government has also set a target for three million more apprentices “to deliver the skills employers need” in this Parliament.

Alongside this education reform, the Government is building its new Industrial Strategy and its Green Paper is out for consultation. One of the Paper’s 10 ‘pillars’ is to build a “proper system” of technical education.

The Science Industry Partnership has been working hard to influence all of this, and indeed has been very positive about what it sees as an unprecedented opportunity to position academic and technical qualifications on an equal footing. We want to ensure that, in future, technical and vocational education is a distinctive, prestigious, high-quality offer in its own right and a positive, informed choice for young people.

Our employer members have always delivered high-paid, high-skilled jobs; but in recent years, we have put out a clarion call for much better, higher quality, vocational education to meet the demands of our high skill STEM occupations.

Along with the BIA, the SIP recently responded to the Science and Technology Committee’s inquiry “Closing the STEM Skills Gap” to further build the evidence base around pressing STEM skill shortages and the need to reduce them. We set out, in our response, what our SIP Skills Strategy had told us – that there are a range of occupations where appropriately skilled people are in critically short supply.

And the solution? The continued pursuit of excellence in delivery of science vocational skills, supported by industry. The need to build greater capacity in the college and university system for evolving skill areas. And the appropriate funding to sit alongside this.

For example, new degree apprenticeships carry parity of value and esteem for both learners and employers.  They offer a fantastic route to a STEM career, creating a new type of graduate who becomes technically competent through undertaking advanced work-based learning while studying.

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Strategic Plan

The SIP has developed a Strategic Skills Action Plan that has a five year horizon. This sets out the cross sector collaboration with a range of key partners that is required in order to deliver on this high skill, vocational agenda.

A clear part of this plan is to create a network of vocational science Higher Education Institutes (HEIs) around the UK. HEIs have a critically important role to play, and some may have to depart from traditional frameworks of study and create even stronger relationships with employers, to ensure a fit-for-purpose curriculum supported by industry.

The newly announced Institutes of Technology are also set to play a key part in STEM education. These will bring supply and demand together, working across Further and Higher Education and in partnership with local employers to create community bodies that really add value.

Our “Trailblazer” employer group is playing a vital role too, in developing new Apprenticeship Standards and assessment of competence that are creating a clear, accredited route through to the top of the most advanced science professions. We know that the apprentices in our sector are ambitious to achieve professional status. We were delighted to announce recently that ten apprentices from leading science-based companies, Lucite and Pfizer, were the first to successfully complete the new STEM Trailblazer Apprenticeship Standards. They met the Standard across many different disciplines ranging from complex manufacturing of active pharmaceutical ingredients, drug product formulation design, synthetic organic chemistry and analytical research & development, all underpinned by an extensive training programme in the workplace.

Finally, while we are wholeheartedly supportive of this newly developing model of high quality, vocational education, we do continue to call for much more flexibility in the use of the levy. For example how might we make best make use of unused Apprenticeship Levy within the science sector to optimise employer engagement on training and to support upskilling of the workforce?

The forthcoming Industrial Strategy gives us an opportunity to work together to maximise this investment. We are developing a proposal for skills, as part of the “Sector Deal” for science, a much welcome invitation which was put forward from Government in its Green Paper.

The SIP recognises that all of this reform and change presents challenges and opportunities for science employers, and our members will continue to work, in conjunction with Government and its agencies, Trade and Professional Bodies, Providers and Higher Education Institutes to meet the skills challenges facing the science sector now and in future.

The power of the sector approach is here to stay.

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As well as the article 50 bill starting its passage through the House of Lords, the government has today responded to the Commons Science and Technology Committee’s report on the implications for science and research of leaving the EU. In its statement, the Government has reaffirmed its commitment to science and innovation and “making the UK the global go-to nation for scientists, innovators and investors in technology”. In particular, we welcome the acknowledgment that maintaining communication with stakeholders throughout the Brexit negotiations will be key, and we look forward to continuing the close working relationship we have with the Government and helping them to maintain confidence within the global life sciences community.

I had the opportunity to talk Brexit with Lord O’Shaughnessy, who recently assumed life science responsibilities in the Department of Health, in a meeting last week. We also discussed, amongst other things, the Industrial Strategy – a conversation I was able to continue this morning at a Life Sciences Industrial Strategy Stakeholder Reception with many BIA members in the impressive but chilly Durbar Court of the Foreign Office (see picture). For all of us attending (and thanks to those Members able to join at short notice) it was great to hear John Bell endorsing our goal of growing life science businesses to scale from the UK as a “grand challenge” and to discuss in detail ideas around financing and investment in life science, policies for the science base and regions and future of regulation. An unannounced appearance at the end of the event by NHS Chief Executive Simon Stevens was a positive sign of NHS England engagement with the process. We continue to advocate on this crucial area and the government hope to publish a new strategy by the end of next month.

Last week the US National Academy of Sciences and National Academy of Medicine published a report on human genome editing, “Human Genome Editing: Science, Ethics, and Governance”. The report outlines several criteria that should be met before allowing germline editing clinical trials to go forward. We welcomed the publication of this cautious but reasoned report and the continued international focus on enabling this pioneering area of biotechnology. With its renowned science base, and a world-leading regulator in the HFEA, the UK is well placed to lead in this innovative genetic revolution.

We are also blessed with expert institutions like the Royal Society, the Wellcome Trust, the Nuffield Council on Bioethics and numerous medical research charities, able to facilitate and contribute to the vital ongoing global public debate needed about the science, ethics and governance of human genome editing. The BIA hopes that a consensus position is reached between UK scientists, society and policy-makers that will enable businesses that may emerge from this frontier science to want to establish themselves in the UK as a supportive and properly regulated environment.

On Thursday we were at the BioHub Birmingham for their BioBrum event. It’s always useful to attend regional hub meetings, such as BioBrum, which provide valuable opportunities to engage with companies in the area. BIA COO Nick Gardiner spoke to delegates about our talent directory and growing desire to understand the education and vocational training environment and talent development available across the industry. Talent remains a key area of focus for the BIA and something our People Advisory Committee will continue to address, including at Friday’s Committee Summit.

Later that evening, back in London, the Science Industry Partnership (SIP) launched their Strategic Skills Action Plan. This follows their Skills Strategy launched in 2016. The Action Plan was set out to deliver the key skills activities needed to achieve the sectors’ skills ambition – including a requirement for  up to 260,000 skilled people out to 2025 – many in new technology-based scientific occupations. This projection includes up to 142,000 professional level graduate-entry jobs and up to 73,000 technical level apprenticeship-entry roles.

It is vital that there is a sustainable future pipeline of knowledge and skills to ensure that the sector can continue to grow and succeed. The Medicines Manufacturing Industry Partnership (MMIP) Advanced Therapies Manufacturing Taskforce (ATMT) worked in close partnership with SIP to align the ATMT action plan launched in November 2016 and the SIP Strategic Action Plan to support this shared goal.

If you’re interested in the skills agenda, read more about the work of our Manufacturing Advisory Committee and their bioproduction leadership initiative that launched in January. In the run up to our annual Committee Summit on Friday, we’ve also published a round-up of the focus of our Intellectual Property Advisory Committee, which has been following the increasing divergence between US patent law and that of other major jurisdictions around the world.

Looking forward to seeing you at the Summit on Friday

Best

Steve

Following the outcome of the UK’s referendum on membership of the European Union, the BIA has worked closely with members and stakeholders to identify the threats and opportunities for biotech post-Brexit and to represent the sector.

Our BIA Brexit Briefing webinars will provide a monthly update on government policy, progress of working groups, and how these will potentially affect companies in life sciences – particularly with regards to innovation, financing, regulation and people.

Catch up on last week’s webinar below, delivered by Steve Bates OBE, Chief Executive Officer, BIA.

Visit our website for details on future Brexit webinars.

Do you have a video you would like the sector to see? Contact us.

Last week, the BIA wrote to the US Patent and Trademark Office (USPTO) to raise concerns about the increasing divergence between US patent law and that of other major jurisdictions around the world.  The intervention is the latest action led by the BIA’s Intellectual Property Advisory Committee (IPAC), which has been following developments in the US closely to monitor how they might affect the UK biotech sector.

A widening schism in international patent law

Over the past six years, the US Supreme Court has issued a series of decisions – Bilski, Mayo, Myriad, and Alice – that have significantly impacted the legal definition of what is eligible for patenting and what is ineligible (see page 5 of this document for an in-depth background).

As a result, patents involving abstract ideas, laws of nature, and natural phenomena have become prone to challenge in the courts. In biotechnology, this has resulted in a range of diagnostic patents being declared invalid, and even the patent for Dolly the Sheep.

The BIA recently hosted a seminar with Dr Konstantin Linnik from US firm Nutter McClennen & Fish LLP. His slides are an excellent introduction to the implications of the Supreme Court’s decisions, with helpful guidance on how companies should write their patents to gain greater protection.

A consistent and harmonised patent eligibility framework across the globe allows inventors to determine with predictability whether to rely on patent protection (and therefore to disclose their inventions) or, instead, withhold their discoveries and rely on trade secret as an alternative form of IP protection. These two forms of protections are mutually exclusive – one cannot maintain a trade secret in one jurisdiction while obtaining a patent in another.

This can hamper innovation as ideas aren’t shared, and at worst can prevent innovations being developed at all – the risk of losing exclusivity to a technology puts off many investors, meaning companies can’t develop them. As the US is the largest market in the world for medical innovations, their laws will influence decisions made by biotechs and investors everywhere.

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BIA interventions in the US

This threat to innovation and the importance of the US market for UK biotechs has prompted the BIA to intervene in court cases across the Atlantic where there was opportunity for the case law to be better aligned with that of Europe and other jurisdictions.

In 2015, we petitioned – with support from Dr Linnik – the US Federal Circuit to reassess its decision in Ariosa vs. Sequenom, a case in which the case ruled that the PCR-amplified foetal DNA detected by Sequenom’s diagnostic test represented a natural phenomenon. The court didn’t change its view and so Sequenom sought review in the Supreme Court. The BIA submitted a friend of the court brief urging it to accept the review; this time we were joined by several other industry associations, illustrating the global importance of this issue: EuropaBio, AusBiotech, Swiss Biotech Association, HollandBIO, BIOTECanada, and Japan Bioindustry Association. Unfortunately, the Supreme Court didn’t accept the case and so the law remains at odds with that of other countries.

A potential new opportunity to address the schism?

The USPTO has recently launched a public debate exercise, calling for comments on “the legal contours of eligible subject matter in US patent law” and hosting public roundtables. They are also asking for feedback on guidance they have produced.

The BIA has now written to the USPTO raising our concerns and highlighting the international support that the friend of the court brief received from other biotech associations. We hope this demonstrates to the US authorities the importance of the issue not only to US innovators, but those around the world also.

The USPTO is only facilitating a public debate at this stage, but we hope it could be a useful step towards a process that can address the increasing schism in international patent law. The BIA’s IP Advisory Committee will continue to monitor the issue and look for further opportunities to ensure the UK and the international biotech community’s voice is represented in the US.