Archives for category: Intellectual Property

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.

Queens speech 2016

On Wednesday the Government set out its legislative agenda for the 2016-17 Parliament in the Queen’s Speech. It announced that bills will be introduced to reorganise the UK’s research and innovation funding system and to reduce unjustified patent challenges.

A reorganisation of research and innovation funding bodies

The UK’s research and innovation funding system is set to be reorganised by a new Higher Education and Research Bill this Parliament. It was the first bill introduced to Parliament following the Queen’s Speech.

The Department of Business, Innovation, and Skills also published a white paper last Monday setting out its intentions to bring the seven Research Councils, Innovate UK, and a new body called Research England under one umbrella called UK Research and Innovation (UKRI). The move follows a green paper and Sir Paul Nurse’s recommendations to improve coordination between funders in a similar way late last year. You can read the BIA’s submissions to both the green paper consultation and Nurse Review consultation here and here.

White paperThe nine Councils, as they will officially be called, will keep their branding, discipline-focus and separate budgets and leadership but many backroom functions will be merged, including grant administration. Research England will take over the university block grant funding, which includes support for technology transfer, from the Higher Education Funding Council for England (HEFCE), which is to be dissolved.

The nine Councils will be led by Executive Chairs – “high profile positions appointed by Ministers on the advice of UKRI’s Board and reporting to UKRI’s CEO”. The Chair of UKRI has already been announced as John Kingman, who is stepping down as Second Permanent Secretary to the Treasury in July. He will lead UKRI on an interim basis while it is being established. His appointment means someone who has shown a deep interest and support for UK bioscience translation is the new boss. The inclusion of the term ‘Innovation’ in the name of this new body is also a positive signal at the importance of translation.

The white paper is keen to highlight the importance and distinction of support for innovation in the new architecture. It states that Innovate UK’s business-facing focus will be enshrined in future legislation, which would replicate the functions in its current charter (this will also be done for the Research Councils). As now, the Secretary of State will allocate a hypothecated budget to Innovate UK and will also “consider the option” of nominating a member of the UKRI Board to lead in promoting and championing innovation and business interests and providing strategic support to the Innovate UK Executive Chair. The post holder would sit on the council of Innovate UK.

It’s positive to see that the Government has listened to BIA calls for the Research Councils and Innovate UK to keep their brands, autonomy, and distinct funding streams. We believe that such autonomy is essential to ensure they are led by and employ experts to manage the strategic and efficient use of public funds. However, the devil will be in the detail to assess whether this proposed structure is better placed than what we currently have to underpin the UK’s global competitiveness and attractiveness as a research destination.

From a business perspective, it is essential that Innovate UK retains its ability to support businesses to translate research and to innovate and scale up in order to generate wider economic benefit and is not seen as just a technology transfer office for the other Councils.

As these proposals are taken forward the BIA looks forward to working with Government, Parliament and wider stakeholders to ensure such optimal outcomes are delivered by these proposals.

Higher education reform

As the name suggests, the Higher Education and Research Bill will also make changes to the higher education system. These reforms make up the majority of the white paper in fact and are wide-ranging.

In brief, the Government’s intention is to create greater competition in the higher education sector by making it easier for new universities to be established and unsuccessful ones to close. It also intends to raise institutions’ focus on delivering high-quality teaching by linking performance to tuition fee rises, widen access to students from disadvantaged and under-represented backgrounds, and give students more power as customers.

Clamping down on unjustified patent challenges

An Intellectual Property (Unjustified Threats) Bill was announced in the Queen’s Speech and published the following day to reform the law around unjustified threats of infringement proceedings for patents, trademarks, and design rights. It is intended to provide greater clarity for right holders and third parties that become involved in IP disputes. The Government says that the bill will help create an IP environment that favours negotiation and settlement rather than litigation.

Threats can be made by organisations or individuals that believe their IP has been unlawfully used by another. However, threats can also be used to inappropriately intimidate others to gain an unfair competitive advantage. This can be a particular problem for smaller biotechnology companies that do not have the resources to fight large claims.

The legislation follows a detailed report and draft bill from the Law Commission. The bill will define what a threat is, create a “safe harbour” to discuss disputes, and provide protection to lawyers intended to allow them to better resolve disputes. It will also make a clearer distinction between approaches made to different parts of the supply chain, forcing the right holder to focus their allegations on the source of the alleged infringement.

The BIA’s Intellectual Property Advisory Committee will be assessing the proposed legislation and directing our engagement with the reforms.

The BIA’s eight Advisory Committees are crucial mechanisms for highlighting issues facing bioscience companies, debating and influencing sector and policy developments, and providing useful networking communities for BIA members in their respective areas of focus.

On 25 February 2016, the BIA is hosting its second Committee Summit, where all BIA members are welcome to attend and check out some of the Committee meetings. Registration closes shortly so do sign up today.

Ahead of the event we will be highlighting some of the Committee’s work and areas of focus on the blog. Today we shine a light on the Intellectual Property Advisory Committee.

Chaired by John Murphy of Skyepharma, the IP Advisory Committee (IPAC) brings together in-house legal advisers with lawyers and patent attorneys from private practice to provide expert advice to the BIA and its members on IP issues that impact the sector.

The blog, looking back over IPAC’s achievements in 2015, goes live as the BIA publishes two member briefing documents that the Committee has prepared on the respective issues of the Nagoya Protocol and the new patent system in Europe.

These guides are intended to help members navigate the impact of some fairly complex issues on their business. The Nagoya Protocol concerns the use of genetic resources in R&D and this paper gives a thorough yet concise briefing on what you, as a business working with genetic resources need to do to adhere with new compliance rules. The second briefing provides an overview of the new patent system being set up in Europe and the questions you should ask yourself in relation to future patent filing.

These are just two IP developments that the Committee has been involved with over the past year. In addition to the development of these papers, members of the Committee have also attended Defra-led stakeholder meetings on the implementation of Nagoya and inputted to the BIA’s consultation response on fee levels for the new Unified Patent Court.

The Committee keeps a watching brief on a wider variety of IP issues that have the potential to impact the sector, depending on the direction of travel from policy makers. Issues on the agenda over the past year have included grace periods, the Biotech Directive and Supplementary Protection Certificates. This latter issue will become a greater focus for the Committee in 2016 as the European Commission conducts a thorough review of SPCs as part of its review of the Single Market.

One of the highlights of IPAC’s work in 2015 was the submission of a well-received amicus brief in the US Ariosa v Sequenom case. The BIA’s brief highlighted the detrimental impact the original court ruling could have on R&D funding for innovate products, global trade, market access and consistent patent eligibility standards across the globe. As the case appeal is likely to progress for hearing at the US Supreme Court, the BIA intends to contribute again, heightening our international profile and contributing to key case law that has the potential to be incredibly impactful on the future of our sector.

Keen to learn more? Then do come along to the Committee Summit on 25 February and learn more about the work of the Intellectual Property Committee alongside the seven other areas of focus from our Advisory Groups – Cell Therapy and Regenerative Medicine, Communications, Finance and Tax, Manufacturing, People, Regulatory Affairs and Synthetic Biology.

blog_reportThroughout the year the BIA advocates for our members in the UK life science industry, engaging with decision makers and influencers in Westminster, Whitehall and across the science, health and business sectors, as well as with regulators in the UK and Europe. Our latest quarterly report, ‘Influencing and shaping our sector: BIA update July – October 2015’, sets out what we’ve been up to in the last few months.

You can download the report in full here. Highlights include:

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  • Our work ahead of the Government’s Spending Review on 25 November to illustrate why public funding for science and innovation is so vital. We’ve undertaken a range of activities on behalf of industry and in collaboration with the wider life science community. If you want to add your voice please do contact us!
  • Our activities across blog_labour tablethis autumn’s party conference season, including our joint roundtable discussions as part of Life Sciences UK (ABHI, ABPI, BIA and BIVDA) at the Labour and Conservative party conferences. We also review the new Labour landscape following the installation of Jeremey Corbyn as new Labour leader and his shadow ministerial team.
  • An update on Patent Box developments. Following the completion of talks at an international level by the G20 and the OECD on the Base Erosion and Profit Shifting (BEPS) project, HM Treasury has issued its consultation on the implementation of the reforms into the UK. Find out more about the changes and our efforts to demystify the policy and potential business implications, starting with the publication of an overview paper – Changes to the UK Patent Box: An Overview, October 2015 – which was prepared in partnership with Confluence Tax.
  • Details on the recently announced PRIME scheme – a new scheme, developed by the European Medicines Agency (EMA) and the EU Regulatory Network, to support development of priority medicines addressing major public health needs. The BIA will be inputting to the public consultation issued on 26 October on the key elements of the scheme, which is scheduled to launch in Q1 2016.

We’re always keen to hear from our members. Which policy areas do you care about; what’s impacting your business and R&D? Do you have a story that would help us to make the case for continuity in what works and to change what doesn’t?

To learn more about BIA’s policy, public affairs and regulatory affairs work, see our previous quarterly policy updates, our consultation responses, or email Zoë with any questions.

The BIA has eight established advisory committees who deal with a range of topics, from regenerative medicine to finance and tax. Meeting once a quarter, the committees are crucial mechanisms to highlight and explore key issues facing bioscience companies. Committee members include influential experts from across the sector. Their work informs and guides BIA policy and priorities, ensuring that member needs are met. 

This week we have updates on the activities of the Regulatory Affairs Advisory Committee and the Intellectual Property  Advisory Committee.

Regulatory Affairs Advisory Committee (RAAC)

Throughout this year, RAAC has continued to build upon a positive working relationship with the Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Authority (EMA). This has included collaborating on a number of successful events, for example the popular joint conference with MHRA in June on the opportunities and challenges in the regulation of healthcare innovation to stimulate innovation and accelerate patient access, which attracted over 130 delegates.

One upcoming event to note is the BIA Regulatory Dinner Discussion – Healthcare innovation and regulatory decision-making in the biocentury – with guest speaker Dr Ian Hudson on 22 October 2014. Dr Hudson will reflect on his first year as MHRA’s Chief Executive, supporting innovation as well as the challenges of regulation in the current environment.

The committee continues to advocate for a supportive environment for clinical research and innovation. Earlier in the year BIA produced a briefing paper on the new EU Clinical Trials Regulation, which explains the major changes brought in by the new legislation and provides some practical considerations until the Regulation is implemented. The BIA, together with EuropaBio, is taking an active role in influencing the development and design of the EU clinical trial portal and database. The committee has also been closely involved with the clinical trials transparency debate and contributed in May to the EMA’s targeted discussions with key stakeholders.

Collaboration with sister organisations has also been an important area in 2014. Back in June, BIA teamed up with the Association of the British Pharmaceutical Industry (ABPI) and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) to host a one-stop-shop event on the EMA’s adaptive licensing pilot project – you can read a write-up of the event here. In another joint effort with ABPI, BIA also developed communication materials on biological medicines, including biosimilars, to enhance prescribers’ and other stakeholders’ understanding of these medicines.

Intellectual Property Advisory Committee (IPAC)

This year IPAC has continued its focus on issues relating to intellectual property in the biotech sector. Ongoing discussion topics have included the implementation of the European regulation arising from the Nagoya Protocol on Access and Benefit Sharing, and the question of grace periods (the period of time within which, if an invention is disclosed to the public, it can still be the subject of a patent application). Grace periods exist in the US and Japan and there appears to be a move in various quarters, particularly arising from discussion on harmonisation, to consider bringing in grace periods in Europe where they do not currently exist.

IPAC provided comments and draft wording in relation to the Bolar Exemption in the Legislative Reform (Patents) Order 2014. Following on from last year’s introductory and update blogs on Supplementary Protection Certificates (SPCs), IPAC has continued its regular review of SPC legal cases and reviewed the Law Commission report regarding groundless threats.

Through regular bilateral meetings with the government’s Intellectual Property Office (IPO), IPAC remain updated on various issues including progress on the establishment of the Unitary Patent Court. Earlier this year IPAC members also met with the Minister for IP for a discussion to highlight the relevance of IP to the biotech sector.

For the remainder of 2014, IPAC’s priorities will continue to reflect some of these major issues. The Unitary Patent and the Unified Patent Court will remain a significant area for monitoring and input, and a close watch will be kept on the possibility of grace periods being introduced in Europe so that appropriate advice can be given to BIA members on how it might affect them. The Committee will also be keeping a watching brief on developments relating to recent US Supreme Court decisions regarding what is considered patentable subject matter – and subsequent USPTO guidance. The implementation of the Nagoya Protocol will be kept under review, taking action as and when appropriate to strive for proportionate enforcement and keeping adverse impact on patenting to a minimum

IPAC and RAAC are also considering areas of common interest where they might work together, such as exploring the regulatory and intellectual property aspects of personalised medicines.

TaylorWessingWhen the new system of unitary patents and a Unified Patent Court (UPC) is introduced, it will be the most radical change to the European patent landscape in a generation. This may happen as little as two years from now and so, given the nature of the changes to ownership and enforcement that will be made possible, and the revocation risks, it is imperative that those with patents now begin to consider how they can adjust to, and benefit from, this new system. This is particularly the case for patents held by multiple owners and licensees.

At present, the EPO grants a bundle of patents across Europe (European patents, or “classicals”). Each patent in the bundle protects one of the countries designated in the original application filed with the EPO. Aside from opposition at the EPO within the first nine months of grant, enforcements or challenges to the validity of these patents must be fought in the national courts of their respective designations. This can mean several national actions if infringements in more than one country are to be stopped.

In contrast, a unitary patent (full name “European patent with unitary effect”) will be a single, pan-European right protecting all the EU Member States (excluding Italy, Spain and Poland). This patent will be a new option for patent holders and will exist alongside the above classical European patents, together with the existing system of national patents.

Unitary patents are obtained in the same way as classical European patents, except that a request for unitary status must be filed with the EPO within one month of the date of grant. If this period is missed, the opportunity to obtain unitary patent status is lost and the patent remains of the classical European type.

At the same time that the unitary patent comes into force, the UPC will begin hearing disputes concerning unitary patents and classical European Patents (but not national patents). In the UPC, it will be possible to enforce or revoke, in one action, a unitary patent or a bundle of classical European patents simultaneously in all of the territories that they cover.

This pan-European nature of UPC decisions creates risks as well as benefits. On the one hand, a patentee considering obtaining unitary patents needs to be aware that such patents could be revoked across all the Member States protected, in one action. On the other hand, this risk might be outweighed by the potential to enforce a unitary patent across all these same states, also in one action. A patent holder does not have to request unitary status for a patent if they do not wish to. But, classical European patents become automatically subject to a potential action in the UPC, unless they are actively “opted-out”. Although for a transitional period of seven years classicals can be litigated in either the UPC or the national courts, they too are at risk of a pan-European revocation in the UPC. On the other hand, when opted-out, a classical European patent can only be enforced or revoked in the national courts, country-by-country, subject to the opt-out later being withdrawn. There are also cost savings to bear in mind. Although the renewal fees for a unitary patent are not yet known, potentially large legal cost savings are expected to come from the ability to enforce, defend or challenge in one set of UPC proceedings, rather than several national proceedings.

Opt-out requires the lodging of an application by the proprietor or, if it is co-owned, by all proprietors. Hence, co-owners must agree a common strategy on opt-out. Furthermore, whilst licensees do not need to consent to opt-out, given the potential consequences of this decision, particularly for an exclusive licensee, licensees are likely to want to negotiate to have a say in  the opt-out decision. Because of the risks of the new system, as well as the benefits, careful decisions about whether to obtain unitary patents and which patents to opt-out of the UPC are now pressing to be made before the court opens its doors for business.

Nicole_Jadeja_220_portraitNicole Jadeja is a Senior Associate at Rouse Legal and a member of the BIA’s Intellectual Property Advisory Committee. Following on from her previous blog about Supplementary Protection Certificate (SPC) FAQs, here Nicole has provided an update on recent developments in the Supplementary Protection Certificates (SPC) field. There have been several developments in the SPC field over the last month. A couple might be of particular interest. The first is a disappointing decision of the Court of Justice of the European Union (case C-210/13) which means SPC protection will not be available for adjuvants per se. The Court has essentially treated adjuvants in the same way as it does excipients and said that they are not ‘active ingredients’ for the purposes of the SPC Regulation. It, therefore, felt bound by one of its earlier decisions concerning polymeric, biodegradable excipients. It did not give credit to the fact that adjuvants can be innovative products, which act physiologically and are often the subject of extensive R&D. The disappointment extends to the fact that where you have a patent which protects an active ingredient, SPC protection is only available for the active ingredient itself and not a combination of the active ingredient with an adjuvant. The second is an opinion of the Advocate General in a case (C-484/12) where the primary question concerns whether you can get more than one SPC where your patent covers more than one product. Since the SPC Regulation came into force, many people have been proceeding merrily on the basis that you can. The AG’s opinion only addresses the ancillary questions in the case; the key question is yet to be resolved. However, some commentators consider that, by having answered the ancillary questions as the AG has, all indications are that another disappointing judgment is imminent (it is due this Thursday) – i.e. only one SPC will be available per patent. Procedurally though, it is not a surprise that the AG has only answered the ancillary questions; the Court said at the hearing that this was the approach it would take. There is hope that the Court will see sense on this one and I’m trying to stay optimistic that logic will prevail. However, given the CJEU’s approach to SPCs to date, I wouldn’t put money on it!

John Alty Formal photo_220_portraitOn 1 October 2013, the specialist Intellectual Property Court for England and Wales, the Patents County Court, was renamed the Intellectual Property Enterprise Court (IPEC) and given a new home, as a specialist listing within the Chancery Division of the High Court. Here John Alty, Chief Executive and Comptroller General of the Intellectual Property Office, outlines the implications of these changes for the bioindustry sector. 

The Court, which was originally introduced in 1990 as a court for lower value patent disputes, has undergone a dramatic transformation since 2010 and following a series of striking reforms is now a distinct forum for those businesses that are forced to take legal action to protect their patent, offering a lower cost, speedier option than the High Court.

The most important changes, for patent holders, are likely to be the introduction of a scale of recoverable costs capped at £50,000, a time limit of trial hearings of 1-2 days, and proactive case management.

The time limit on trials is significant as it not only means swifter judgements, but more importantly focuses the parties’ minds on examining the key evidence, reducing unnecessary testimony and document discovery. Before any hearing, at the case management conference, the judge himself is now able to state what evidence he would like to see at the trial, and what isn’t necessary. This process can dramatically reduce the cost of a trial, as well as its length, limiting the amount of legal work need to be carried out prior to and during the hearing.

This process has worked well in recent years, for example, in one case last summer the court was able to give a judgement in a patent trial in one day, and, as the Liversidge vs Owen Mumford Ltd case last year proved, the court is still capable of handling the complexity of a case from the bioindustry sector.

The court’s scale of recoverable costs allows businesses to prepare financially for the potential cost of legal action, providing them certainty on how much they could have to pay if they lose the case. This is particularly important for smaller businesses, who can be dissuaded from protecting their patent in the courts by the prospect of potentially paying for the other side’s expensive legal team. Alongside the cap on costs the court also carries a cap on damages of £500,000.

There will always be some patent cases that remain too complicated for these simplified processes and the Patents High Court remains an important venue for a lot of patent cases. However, the existence of a proven, viable low cost alternative for many of the bioindustry’s disputes is something that the IPO is keen to promote.

If you would like to know more about IPEC, there is comprehensive user guidance (along with contact details) on the Intellectual Property Office and the Ministry of Justice websites.

Nicole_Jadeja_220_portraitNicole Jadeja is a Senior Associate at Rouse Legal and a member of the BIA’s Intellectual Property Advisory Committee. Here Nicole writes about the Supplementary Protection Certificate Frequently Asked Questions document prepared for BIA members.

Supplementary Protection Certificates (SPCs) are an important part of the suite of intellectual property (IP) rights on offer to incentivise medical research and development. They are intended to compensate an innovative company for regulatory delays that can erode the exclusivity period provided by a patent.  Given the long development timelines for biopharmaceutical companies and the narrow window of exclusivity provided once marketing authorisation has been granted in some cases, SPCs can extend exclusivity for a further period of up to five years.

It is important for companies, small as well as large, to understand the SPC regime even if you do not yet have a marketed product. Given that for an SPC to be valid a number of criteria need to be met it is important for companies to consider the issue early and plan their IP strategy and management appropriately.

While the criteria for the grant of an SPC may appear simple on paper, there are a number of ongoing issues in the life sciences field, largely playing out through cases brought before the Court of Justice of the European Union (CJEU), affecting whether or not an SPC can or will be granted in certain scenarios.

The BIA’s Intellectual Property Advisory Committee (IPAC) monitors these substantive policy issues currently under debate and also, where appropriate, makes direct representations to the UK Intellectual Property Office (IPO) regarding specific questions before the CJEU when relevant. Given the complexities of application of the SPC regulation, especially in the life sciences field, opportunities for such comment are coming along more often than you might think.

Given the key policy issues under debate and the important practical considerations for bioscience companies to consider, the BIA’s SPC Frequently Asked Questions document provides a succinct introduction and overview to this important part of IP law. The document covers practical filing and qualification criteria, how SPC terms are calculated, and touches upon some of the issues currently before the Courts. If anyone would like to find out further information about SPCs or the Committee, please feel free to get in touch with Antonis Papasolomontos. Nicole attended the last hearing at the CJEU for the joined cases of Actavis (C-443/12), Georgetown University (C-484/12) and Eli Lilly (C-493/12) and would be happy to answer any questions people might have about this.