Our support for the KT sector

 

Health warning: this is an advert.

Anderson Law LLP has the largest and most experienced team of knowledge-transfer (KT) lawyers in the UK. Our 11 lawyers, between them, have many decades of experience of advising universities, research charities, NHS Trusts, government agencies and spin-out companies, as well as larger companies that collaborate with academic organisations.

Mark Anderson CLP, RTTP, EUKTS

As well as our main client base in the UK, we have recently received instructions from academic and commercial clients in Canada, Ireland, New Zealand, Spain, Switzerland, and the USA. Going back a little further, we have advised clients in Australia, Belgium, Denmark, Germany, and Norway.

Paul Maclennan

 

 

Through our membership of BioLawEurope FmbA, an association of lawyers (mostly in ‘boutique’ specialist firms) across Europe, and through our other contacts built up over 25 years, we can help you find legal advice in other countries.

Lisa Allebone

If you have enjoyed our contributions to the knowledge-transfer community, including:

  • Our PraxisUnico Guides, and our guides and templates for Knowledge Transfer Ireland;
  • Stephen Brett

    This blog, which has hundreds of articles on legal and practice issues that are relevant to the KT community;

  • Our other books and template agreements, including Technology Transfer (first published over 20 years ago; 4th edition in preparation);
  • Our contributions to PraxisUnico training courses (organising and speaking) over several years;
  • Our 5-day course on IP Transactions, held annually at UCL for the last 5 years; and
  • Mark Anderson’s chairmanship of the IP Law Committee of the Law Society of England and Wales, which lobbies for improvements in IP laws (e.g. the Intellectual Property (Unjustified Threats) Act 2017, which comes into force on 1 October 2017);

AnnMarie Humphries

why not consider instructing us, next time you need advice, support in negotiations, help with policy issues, mediation services, or a set of template agreements? Contact mark@andlaw.eu or on [44][0] 1865 858 878 for an initial, free discussion.

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Copyright in training materials: interpreting the assignment clause

On reflection, IP Draughts wonders whether the drafter of this assignment clause was making a distinction between IP and IPR – a distinction that he dislikes but sees in some contracts. If so, this probably supports the judge’s interpretation.

IP Draughts

Dr Susie Wilkinson

Picture the scene.  You have been conducting research on communications skills for medical professionals for several decades.  You have trained nurses in communication skills and written training materials for them.  You own the copyright in these materials, some of which are based on the contents of your PhD.  You are also a published co-author of an Oxford University Press book for healthcare professionals, and are or were an honorary senior lecturer at the Royal Free Hospital in London.

You are asked to participate in a joint bid to write training materials on the subject of communication skills in relation to the treatment of cancer patients.  These materials are to be used nationally by the UK National Health Service (“NHS”).  You are happy for the copyright in these materials to belong to the NHS, provided you do not lose ownership to your pre-existing intellectual property (“IP”).

The…

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Clinical trial agreements: thriving in ambiguity?

IP Draughts has recently advised several clients on clinical trial agreements (CTAs) and related contracts, including manufacturing agreements and agreements with clinical research organisations (CROs). The experience has left him reflecting about how this area of practice is an odd mixture of precision and vagueness, of formal procedures and finding ad hoc solutions, of strict regulatory compliance and muddling through the best one can, and where the scientific values of accuracy and taking a long-term view often run up against a commercial need to advance one’s product through trials ahead of the competition and before the development money, or investors’ patience, runs out.

In the UK, there is also sometimes a contradition, not found in some other countries, between the commercial aspects of running trials and paying fees to a hospital, and the non-commercial values and attitudes of National Health Service (NHS) hospitals and the people who work in them.

Instances of these contradictions include:

  1. Worldwide documentation. The need to comply strictly with national or regional (eg EU) regulations governing the conduct of trials, data protection and privacy, freedom of information, insurance and indemnities. But some of these regulations are complex, subject to change (eg EU data protection regulation), and vary between countries, while many clinical trials are conducted on a worldwide basis, using a single set of documentation wherever possible. Some of the language used in this documentation has clearly been designed under a different regulatory system to the one in which it is being used.
  2. Different skill-sets. The contracts that one encounters usually attempt to be in alignment with the regulatory system with which the drafter is familiar, at the time of drafting. But often they are drafted by non-lawyers and/or negotiated by non-lawyers, and used for several years without substantive review. They can and do end up with incorrect, misleading or outdated references to regulatory compliance, e.g. referring to guidelines rather than the relevant law, using terminology designed for a different type of trial, or a trial in a different country, or incorporating contradictions between obligations in documents designed for the same trial by different professionals, e.g. the Protocol (medical and ethical drafters), the Technical Agreement (regulatory and manufacturing drafters) and the CTA (financial, commercial and, one hopes, legal drafters).
  3. Poor source documents. This blog has previously commented on some of the oddities in the model NHS CTAs, e.g. the limit of liability for deliberate breach to twice the contract price. IP Draughts finds it difficult to believe that this strict limit, which he has never encountered in any other contract in over 30 years of practice, would be upheld by a court. Though he has no case authority directly to support this argument, he wonders whether a court would find such a limit unenforceable under the Unfair Contract Terms Act 1977, in view of the need for liability terms in written, standard terms of business to be reasonable. There are plenty of other examples of oddities in the NHS CTAs, which seem to be have been driven by commercial or financial priorities and to underplay the importance of clear, accurate, and legally-valid drafting. And yet he is told that the template CTAs in use in many other countries are much worse than the UK templates.
  4. Varying quality and availability of advisers. It is sometimes difficult for trial sponsors to find advisers and consultants who have significant experience of clinical trials and the associated legal issues in the jurisdiction in which the trial is taking place. For example, one of IP Draughts’ clients is currently looking for a legal adviser in Finland. Is any reader able to recommend someone suitable? A separate issue relates to CROs. Although he has not studied the subject in depth, IP Draughts has the impression that the market for CROs is dominated by a few international providers. He has heard stories of some large CROs taking weeks to respond to requests and being very bureaucratic in their approach.

The skilled clinical trials manager learns when to insist on strict compliance with the rules and when to bend, when to take one’s time and when to rush headlong, and when to stick and when to compromise in contract negotiations. It is not an easy task. In the UK we seem to have plenty of people who have these skills, and a thriving eco-system of life-science companies, service providers, hospitals, universities and regulators.

Whether this eco-system will survive Brexit is yet to be seen. There is a real danger of damage to the lagoon, its coral reef and its colourful species of fish.

 

 

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10 points to look for in a draft agreement

What is it about lists that makes them popular? Over the years, this blog has created a few lists, and this golden oldie from 2015 is one of them.

IP Draughts

once overYou are sent a draft agreement and asked to review it. No other instructions are given. You are expected to know what the client wants, without asking. In the case of technology-related agreements, perhaps they think you don’t need to know the subject-matter, or that you wouldn’t understand it.

Some people are willing to go along with this, and to advise as a ‘paper exercise’ without knowing anything about the subject-matter of the deal, what commercial discussions have already taken place, what are the client’s objectives and priorities, and so on.

IP Draughts is very reluctant to advise on this basis.

In IP Draughts’ experience, digging into the details and discussing the project with the client’s representative is usually essential, and is always efficient, if the agreement is to be well-drafted and protect the client’s interests. Persistence is sometimes required to coax useful instructions out of a client who may…

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