LICENSING EXECUTIVES SOCIETY

Britain and Ireland

NEWS EXCHANGE
Issue 71: February - March 2000

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Hasbro's Joanna Reesby Guest Speaker at the Annual Lunch on February 10th at the Café Royal

Joanna Reesby, Senior Vice President, Entertainment with Hasbro will be joining LES members and guests at the Café Royal to talk about the commercial exploitation of Hasbro's Intellectual Property.

Hasbro is a worldwide leader in children's and family leisure time and entertainment products and services. The company manufactures and designs traditional and high-tech toys internationally. Over the Christmas period its Pokemon products were disappearing from shelves as soon as they appeared in the shops. Joanna Reesby is currently the Senior Vice President, Entertainment at Hasbro as well as being responsible for acquisition of Sports and Character rights for Hasbro outside the USA. She originally joined Hasbro as their European Legal Counsel.
After working in private practice, first at Herbert Smith and then with Denton Hall, Joanna is now responsible for the commercial exploitation of Hasbro's intellectual property both licensed and proprietary.
We hope that many of you will take this opportunity to learn more about one of the world's more innovative companies. Further information about the lunch will be circulated to members.


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INDIA FALLS IN LINE

IN 2005, INDIA IS DUE TO COME IN LINE WITH MOST OF THE REST OF THE WORLD'S PATENT SYSTEM
Report by Christi Mitchell, LESI Healthcare Chairman, LES UK & Ireland Healthcare Chairman

The lack of a credible patent system in India has for a long time prevented the majority of Healthcare and Pharmaceutical companies from licensing technology into and from India. It has also prevented collaboration with Indian companies, together with any thought of setting up subsidiary companies able to conduct research and development. In the recent past it has proved financially worthwhile for a few companies to conduct limited clinical trials but the sentiment has been cautious.

India had, in the past, come to the decision that not having a 'modern' patent system would provide them with a better form of protection. The growing economic importance associated with licensing and Intellectual Property Rights throughout the rest of the world has shown that this really cannot be the case.

While licensing new technologies, I have worked with a majority of the top Indian pharmaceutical companies and found them to have excellent skills and facilities. I believe that this proposed change in policy would be of positive value to India and the rest of the world. While we may imagine that Indian pharmaceutical companies are better known for their ability to reproduce compounds discovered by others, I believe that we will also, with time, see a wealth of research and development skills that will be of value to us all.

Companies such as Rambaxy and Dr Reddy's Laboratories started investing in research in the early 90's and are now reaping their rewards in terms of companies abroad seeking clinical trial expertise, and also in selling and licensing their novel technologies.

The proposed patent system is now creating change within the industry. Dr Reddy's is setting up a new research centre in Atlanta and R & D spend is increasing rapidly. Rambaxy, India's largest pharmaceutical company, is increasing its research and other notable companies such as Wockhardt, Cipla and Torrent are making moves in the same direction.

India is a vibrant but challenging environment with a wealthy skill base. I believe that we must really look forward to their proposed patent system for 2005.


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Presidents Dairy


NHS IP>100!

Dr Tony Bates, Intellectual Property Advisor to the NHS, gave us a brilliant and topical start to our Millennium meetings programme in London. His talk attracted more than a hundred members and non-members to hear how the new policy framework for the management of IP, generated within the NHS, is being implemented. After Tony's most absorbing presentation, questions came thick and fast until we ran out of time. Our thanks are due to Council member, Michael Horlington for arranging for Tony to address us.

Back in December, we enjoyed a fascinating insight into the reasons behind Ireland's economic boom when Mary Swords, Yvonne McKeown and Emma O'Neill brought us up to date on Business and Licensing Opportunities in Ireland. Janet and I look forward to enjoying the company of our Irish members when we attend their Annual Dinner in Dublin on Friday February 18th.

In late January, LES B&I will be well represented by Vice-President Chris Goodman, and several members of Council, at the LESI Expanded Executive Committee Meeting in Vienna.

In February, Dai Davis, Head of IT Group (North), with Nabarro Nathanson will be giving our Manchester members an Overview of E-Commerce and on February 10th Nigel Jones has organised a half-day meeting at the Café Royal to discuss Recent Developments in UK and European Competition Law. This meeting will be followed at 12 noon by our Annual Lunch at which we are are delighted to welcome, as our Guest Speaker, Joanna Reesby, Senior Vice President, Entertainment with Hasbro. At the lunch we shall be making presentations to Michael Burnside and Jeremy Brown to mark their retirement from council after many years service to the Society at both LESI and LES Britain & Ireland level. We look forward to meeting you at these events. Please try to be with us!

Following the retirement of Reg Peplow as Editor of News Exchange, this is the first edition to be produced by Kudos. Tenders were invited, reviewed and submitted to council by an ad-hoc committee of Barry Quest, Kurt Deutsch and Michael Connor. It was a close run race and a difficult decision since a number of excellent submissions were received. We extend a warm welcome to Mary Elson who, as Deputy Editor, will carry out most of the duties formerly undertaken by Reg. Mary is well aware that Reg will be a hard act to follow!

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Controversy has long surrounded the genome project, should we really be afraid of the consequences of patenting our genes?

LICENSING IS IN OUR GENES

Gene research is providing interesting new opportunities for licensing - but is it ethical? Following the recent WTO conference in Seattle, this has been a matter of hot debate in the media. The latest criticism is the suggestion that human gene patenting is having an adverse effect on genetic screening in hospital and university facilities.

Commercialisation of biotechnology is an easy topic for the media to pursue as an ethical issue. Unfortunately it is often approached emotively and is frequently based on misguided or simply incorrect assumptions. It is, for example, common to suggest that patents for new or genetically altered life forms would necessarily lead to the production of 'designer babies' or 'Frankenstein foods' (although it is rarely explained how this could be a direct consequence of the patent system). It is also common to object to the patenting of naturally-derived drugs or modified agricultural strains, on the grounds that poor communities will be prevented from continuing to grow food and use traditional herbal remedies, based on the illogical misconception that the patent system allows patenting of 'inventions' which are already well known.

The patenting of gene sequences is another bête noir which, in truth, and leaving aside fallacies and misconceptions, does indeed raise difficult ethical issues. As part of the human genome project, the coded structure of genes in the human body is being progressively mapped. This has resulted in the identification of a significant number of human gene sequences, and attempts have been made to patent them. An existing gene could not be patented in terms of its usual host organism, because that already exists, but there is the possibility of obtaining protection for the sequence when it is first isolated and defined. This is essentially no different than, say, patenting isolated penicillin or insulin (which of course also occur in nature). The problem is that patents have been sought for gene sequences per se without thought of any practical utility, and the view has been expressed that this could have a serious obstructive effect on genetic research in general.

The European Biotechnology Directive and practice in European Patent Offices has sought to address this, by restricting protection where there is no clear current 'industrial application' for the sequence. However, matters have been taken somewhat further, particularly by developments of undoubted practical utility in the correlation between gene sequences and cancer. Certain gene sequences have been identified in which specified abnormalities have been shown, statistically, to indicate a predisposition to a particular form of cancer. In the USA, where the legal position is somewhat different, patents have already been granted for normal and abnormal gene sequences, and the use of these in diagnosis and treatment.

The national press recently picked up on a survey carried out in America, which revealed that clinical laboratory scientists are concerned that gene patenting by biotechnology firms is restricting the availability of certain genetic screening tests. One biotech company that has been granted patents for human gene sequences is Myriad Genetics of Salt Lake City, Utah. Interestingly, this area of the USA has become a focal point for genetic research owing to the vast collection of genealogical data compiled by the Mormon Church, which facilitates the establishment of familial relationships. Myriad's patents for genes linked to breast and ovarian cancers (for example, US Patent Nos. 5747282 and 5837492) give the company exclusive rights to tests used to screen patients for the presence of certain mutations in these genes that would greatly increase the likelihood of them developing cancer. This has upset a number of hospital laboratory scientists, who are no longer permitted to carry out the tests themselves, and must pay for samples to be screened at one of the handful of laboratories licensed by Myriad. The company is now also attempting to move into the European market, and has apparently already held discussions with the Department of Health and the NHS on the future of genetic testing in the UK.

It is still moot as to what we will be able to protect in Europe (and it seems that Myriad's corresponding European patent applications are all still pending), but the fact is that the door is open to commercial exploitation of gene sequence research. It goes without saying therefore, that the boundaries of protection will be vigorously pushed forwards and we will have to come to terms with this. From an LES point of view it can be argued that this is only to the good, insofar as it will encourage genetic inventors to provide full public disclosure (in their patent specifications) and enable them to accumulate funds sufficient to drive more research and find more practical applications. We may still feel uneasy about awarding monopolies for 'life' (although from a biochemical point of view DNA is not 'life', but a complex molecule that carries genetic information). The answer, as with other difficult areas, must surely be to regulate the exploitation (for example by compulsory licensing) rather than to restrict protection.


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In recent times the echoes of the roar of the Celtic Tiger have been heard through Europe and the USA. The expansion of the Republic of Ireland's economy has been hailed as one of the 'economic miracles' of the last decade and forecasts show that the high economic growth rate is to continue to grow at 5% or more annually over the next five years. So how has this been achieved? Dr Yvonne McKeown, Mary Swords* and Emma O'Neill were in London recently to tell LES members and guests all about it. Report by Reg Peplow

Technology transfer plays its part in Ireland's economic boom

Ireland has prospered by offering investors a stable, profitable, English-speaking base to serve the European market and beyond. As a result, the ratio of trade to GDP rose by more than 50 percentage points in the 1990s. That ratio - 160 per cent in 1998 - is one of the highest among all the members of the OECD. Ireland has experienced five straight years of stunning economic performance and today is a world leader in a number of aspects of economic performance.

Output growth has averaged over 9% per year on a GDP basis in the period 1994-1998. Half of that growth has been reflected in considerable employment gains and the rest in impressive labour productivity growth. There have been substantial increases in the labour force, thanks to Ireland's favourable demographics and to an important reversal in migration flows. Unemployment has fallen by nearly 9 percentage points to 6.4% and Consumer Price Inflation has remained below 2% over the past year.

The Economic and Social Research Institute, ERSI, estimates that the strong economic growth will continue to return high budget surpluses, giving the government scope for major investment in infrastructure, including roads, public transport and water services, fundamental elements which were once weak and off-putting to foreign investors.

Now over 1,200 companies have chosen Ireland as their base to serve the European market and beyond, including the top ten software companies in the world.

Amongst the factors contributing to the success of the Irish economy are two state organisations: IDA Ireland, responsible for overseas direct investment and, of special interest to LES members, is Enterprise Ireland.

This body is responsible for encouraging growth in Irish Industry. Its strategy involves driving investment in people and technology, development of equity and internationalisation of industry. Enterprise Ireland fosters strategic alliances and collaborative R&D between Irish and EU companies through various incentives and schemes, in particular the Technology Transfer Business partnership programme designed to help Irish and overseas technology companies to develop mutually profitable business alliances.

More than three hundred partnerships have been formed worldwide, using Enterprise Ireland's network of contacts. Around 40 new partnership/ joint venture agreements are signed each year. Participation is invited from a wide range of sectors including information and communications technologies, software, electronics, engineering, biotechnology, healthcare and food.

The programme is designed not only for growing Irish companies seeking partnerships or joint ventures with overseas companies but also overseas companies looking to access new markets and form new partnerships. When suitable candidates are identified the programme facilitates introductions and organises forums and face-to-face meetings. The services are available throughout the negotiation process if needed. Companies can also access Enterprise Ireland's solutions to other business needs: technical, commercial, intellectual property, legal, financial and marketing skills.

Further schemes allow companies to acquire technology to add value to their enterprises. The organisation will fund up to 50% of the costs of transferring the technology by way of a down payment or minimum payment.

Enterprise Ireland's Intellectual Property Assistance Schemes will provide advice on all IP matters, funding of patent costs and assistance with marketing.

* LES Ireland is keen to promote cross-border links and welcomes members from both the North and the South.


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Tony Blair would have been heartened to hear Tony Bates' excellent talk at the London meeting in January. Rather than being a constant drain on the Treasury, the NHS could be a financial asset! Report by Mary Elson

Management of Intellectual Property in the NHS

NHS R&D was established in 1991 and, even now, the UK has the only national healthcare system with its own R&D programme. Its annual investment in R&D runs at £425 million. Clearly its Intellectual Property needs careful management.

Tony Bates explained that the public has never been keen for the NHS to invest money in IP - 'spending money on inventions that may never bear fruit'. However, between 1990 and 1994 there were 135,880 biomedical papers published in the UK of which 31% had an identified NHS author. It is clearly beneficial for the patients, and the NHS, if the delivery of care is in a creative environment, developing new therapies and techniques, innovative products and processes and with the general approach: 'how can I do my job better?'

Prior to 1998 Intellectual Property in R&D contracts issued by the NHS Executive was owned by the Crown but there was little commitment to its management. IP has, belatedly, been recognised as a valuable asset, which needs to be exploited. The NHS is now working in partnership with many universities, not only in areas of research but with issues of technology transfer.

It would be foolish to think that this spirit of co-operation was without problems! Tony mentioned that difficulties arise when, for example, attempts are made to decide who owns the IP, university or NHS. He added that NHS contracts do not always address issues of ownership and confidentiality: 'preventing careless disclosures is sometimes a problem'!

In the past we have suffered, in this country, from undervaluing our creative ability. Innovations used routinely here, and not patented, have been observed by visiting colleagues from the US. Patents have subsequently been licensed to US companies, who have rights to manufacture the products thus requiring the NHS to pay royalties for its own inventions.

Tony quoted figures from the US (1998) showing how their commitment to research benefits the economy:

He stressed that the NHS has made great advances. Partnerships between NHS trusts and universities are becoming the norm. In the North West Region all NHS trusts are in partnership with universities and, so far, have 150 disclosures. Progress is evident in other regions too. He felt that the NHS should soon be seeing the benefit of the change in attitude towards its Intellectual Property.


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Kim Archer, Director of Research Services at the Royal Brompton & Harefield NHS Trust describes some of the difficulties encountered in managing NHS Intellectual Property:

With the implementation of the Culyer recommendations in 1997, those Trusts receiving significant research funding are now expected to account for exactly how such funding is spent and to demonstrate value for money. These changes have implications for management in areas not generally well developed in the NHS including sound costing and pricing, commercial contract management, risk and indemnity, and in the identification, protection and exploitation of intellectual property rights. Kim outlines a common scenario using factual examples of managing contracts in a NHS Trust.

NHS relationship with Commercial Sponsors: Friend, Foe or Partner?

Friend?
An NHS Consultant struggling with a heavy workload and limited NHS resources, keen to do research, receives regular visits from several different company representatives all too eager to help ease the way. The company representative relationship is with the individual researcher, working 'with him' in providing a range of persuasive support services such as seminar lunches, flights to conferences around the world and funding for a research fellow. The company representatives treat him well, recognising him as the scientific expert that he is. Funds are sometimes provided 'because of who he is' and to enable him to achieve greater flexibility in developing the research programme. He might be advised,

'… it's probably best to accept a cheque for £45k as a 'donation'… creates fewer problems that way… the researcher could put it into his Trust Fund for general research use…'

'Oh, by the way, that research fellow supported by the £45k … could he devote a day per week to working on a study? The rest of the time could be spent doing clinical work, a benefit to the NHS.'

'Yes, great!'

'Here's a standard form of agreement for you to sign in support of this project… don't worry, it's a standard form… several of your colleagues have signed exactly the same one…'

The research consultants are delighted!

Foe?
After years in which the consultants 'worked successfully with commercial companies, did great deals, brought serious amounts of money to the NHS, enabling a whole range of research activity'…along comes a manager. The manager creates more work, rules, bureaucracy and delays! No wonder the reaction is,

'The way this is going, no company will want to fund research.'

'Doesn't the manager understand that if we charge for all costs it will price us out of the market?'

'Doesn't the manager understand that the company will go elsewhere and I will lose the benefit of a range of resources and support that the NHS could never afford?'

The manager asks the consultant, who received the sum of £45k, whether any documentation had been agreed or signed. The paperwork is eventually produced, and reveals that the consultant had personally signed a contract in which:

  • it was warranted that he was an authorised signatory for the Trust and this had been accepted by the company
  • it was agreed that the NHS Trust would indemnify the commercial company, albeit that this was a study to test a new device not yet licensed for use in the UK
  • in several sections of the contract, the risk was assigned wholly to the NHS Trust
  • publication rights were severely curtailed and controlled
  • all IP was to be owned by the company, including any arising from all inventions and discoveries (not necessarily arising from the device study)
  • any claims were to be settled by arbitration in a country outside England
  • a clause stating that the payment as per schedule (salary only) enabled any and all NHS resources to be used in the course of the study

In a meeting between the manager, the Representative from the commercial company and the researcher, the company said they could only pay what had been agreed previously with the researcher - despite the fact that it did not even cover the full cost of the salary. The company could not pay any overheads.

'We have never had to do this with any other NHS institution.'

Value to the company was acknowledged, albeit reluctantly.

Partnership?
The policy guidance to NHS Trusts is clear. Subsidising strictly commercial research is not acceptable. In some circumstances, where significant benefit to the NHS can be clearly demonstrated, the NHS Trust has some discretion in supporting an undefined element of cost. Transparency in partnership must be the way for the future. Collaboration with industry is essential if we are to realise developments in the clinical products market. Greater recognition of innovation within NHS institutions is leading to increased identification, protection and efforts to exploit novel ideas successfully. These efforts will also depend on collaboration, both in risk and benefit, with commercial organisations. If costs are to be shared, benefits should also be shared.

Future contract management could lead to working together, and should include:

  • assessing full costs of study
  • assessing risk
  • assessing benefit
  • agreeing a reasonable contract for both parties, taking cost and benefit into account


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From Diana to Football - protection still found wanting (An update on personality character merchandising)

By Barry Quest

It is two years since we ran an article on what was then the hot issue of personality licensing. Matters had come to a head with the attempts to cash in on the name and distinctive image of Princess Diana. Protection was then found to be wanting. Events since then, and particularly a recently reported US case, suggest that little has changed. At that time there were also publicised issues concerning merchandising involving famous football players, and this is again very much in the news with reported attempts to derive licensing income from replayed footage of notable goals.

Traditionally, there has been nothing equating to a personality right in the UK. Famous personalities (real and fictional) stood little chance of establishing enforceable merchandising rights unless there was an existing reputation in commercial exploitation of relevant goods or services. This was put to test in cases involving Kojak, the Wombles and more recently Abba and the Spice Girls.

There have been developments in the law: the 1994 TradeMarks Act introduced changes to permit trademark registrations for purposes of licensing, and the courts have relaxed their attitudes towards what constitutes commercial reputation. The problem now however is that some personalities can be too famous to be protected. Without an existing established commercial reputation there is the possibility that the personality's name or image can be said to have become public property, open for all to use.

This was the difficulty encountered by the Princess Diana Memorial Fund in trying to obtain trademark protection for her name and image. It also featured in the recent Elvis Presley case in which, as in the older Tarzan case, there was found to be no general right to commercial protection in the absence of appropriate evidence of use of the name to sell goods. Similarly, problems have arisen in trying to protect the names of well-known football players in advance of actual commercialisation.

The position is however not necessarily the same in other countries. In particular, the USA has laws which protect personal rights irrespective of commercialisation. However, the two-year action pursued in California by the Memorial Fund against a Diana doll and decorated plates was unfortunately not successful. As reported in the press in the first days of the new millennium, despite the amazing 1M in legal fees spent by the Fund, the court declined to find that there had been a violation of local 'rights of publicity'.

The arguments will of course continue, if not on the US Diana case, then on others. It is simply a reflection of the change in commercial activity of developed countries. It is more productive for us to brand goods than make them. Just as we found it necessary to introduce the trade mark system in the 19th century to protect Manchester's textile industry against imitative (and cheaper) Indian imports, so we now need to ensure proper protection for our ephemeral products.

In line with this it is of more than passing interest that, as part of the current negotiations with the Football Association concerning the entitlement of football players to receive merchandising income, it has been suggested that video footage, for example showing notable goals, should be protected and licensed. It is common for such footage to be repeatedly used for promotional purposes and it could (or perhaps should) be registrable as a trademark.


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New Members

  • Ms Fiona Akers, Partner, Dickson Minto WS;
  • Ms Carin Burchell, Proprietor, Carin Burchell Trade Mark Services;
  • Mr Rufus Charles, Licensing Manager, Plant Bioscience Ltd;
  • Mrs Christina du Toit, Manager, Price Waterhouse Coopers;
  • Mr Nicholas Fenner, Associate, Watson Farley & Williams;
  • Mrs Sue Gold, Director, Legal Council, Warburgh Dillon Read;
  • Miss Sarah Lunt, Dennemeyer Software;
  • Dr Ian A McKay, Consultant, Retroscreen Ltd;
  • Mr Jeffrey Mills, Partner IP, Kirkland & Ellis;
  • Miss Helen Waugh, IP Manager, Heriot-Watt University;
  • Dr Gwilym Williams, General Manager NAVBC, Bioresearch Ireland;
  • Mr Walter Willigan, Director of Licensing, Price Waterhouse Coopers.

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NEWS Exchange is circulated as a service to members of the Society. Editorial contributions and advertising/insert enquiries are welcome and should be addressed in the first instance to the editor.

Editor: The Kudos Partnership Ltd,
Emerson Court, Alderley Road, Wilmslow, Cheshire SK9 1NX
email:s.ireland@kudos-uk.com


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