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Biotechnology Report 2009


Marks & Clerk Cover image: Cancer cell


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Foreword 4

Introduction 5

Executive summary 6

1. Funding challenges and the current economic climate 7

2. Protein biologics – from niche to mainstream 8

Biotechnology survey – key findings 12

3. Regenerative medicine and the US reforms 19

4. The EU Commission enquiry into the pharmaceutical industry 22

5. Industrial biotech – looking to the future 25

Marks & Clerk contacts 26

Contents


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Prof. Best is currently Entrepreneur-in-Residence at TVM Capital, Chairman of the Advisory Board of PAR Equity and a non-Executive Director of Polytherics Ltd. and Entelos Inc. He was previously Chairman of Ardana Plc. and Neuro3D SA, a Director of Avesthagen Pvt. Ltd. in Bangalore, India and a Director of Direvo Biotech AG. Prof. Best was the Chairman of the UK BioIndustry Association (BIA) from 2006-2007, the Vice-Chairman of BIO in the US from 1994-96 and a member of the Board and Chair of the Bioethics Committee from 1998-2005.

ForewordThe level of change facing the biotechnology sector at the current time is extraordinary. The scale of the global economic contraction has resulted in a prolonged flight from risk, leading to an unprecedented funding squeeze that has threatened the innovative R&D undertaken by the sector’s minnows. In Europe, an enquiry by the Commission into the pharmaceutical sector could result in considerable reform of the industry and the way it uses the intellectual property system, in order to drive down the costs of healthcare and promote greater generic competition. This is a vision likewise shared by the US administration. On a positive note, the US Government is also determined to remove the barriers facing regenerative medicine in lifting restrictions over cell lines, and has signalled its intention to commit public funds to the sector.

Undoubtedly, 2009 will be a watershed year for the industry, not least if some of the immediate economic pressures begin to show sign of abating. Changes in the mentality at the White House demonstrate a strong commitment in the US to its world-leading industries, and should create a more positive climate in which private investors feel confident to commit capital. This will have ramifications for our industry on a global scale.

Yet in this new environment emerging, there will also be a number of pressures to which the industry will need to adapt. For too long, Europe has struggled to replicate the commercialism that characterises US R&D. In a more competitive landscape, it is important that Europe rises to the challenge of this newfound US firepower, and that the balance is struck by policymakers (on both sides of the Atlantic), to support affordable healthcare while rewarding innovation.

At present, this balance is yet to be achieved. One of the key concerns that emerges from this research is an insufficient incentive structure to reward the R&D of innovator firms. And this concern comes at a time when the industry still faces many headwinds beyond immediate funding pressures. Certainty in the marketing approval process and timescales both for patent grants and drug approvals – all key to investment and the ability to make R&D commercial – are considered by those who took part in this research as having deteriorated over the last year.

These are important challenges that need to be addressed by those within the industry and by policymakers. In doing so, the foundations must be laid for the biotech industry to succeed in its aims and deliver the exciting drugs and regenerative therapies of tomorrow for the benefit of all.

Professor Simon G Best, OBE, FRSESerial entrepreneur and investor


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IntroductionWelcome to the 2009 Marks & Clerk Biotechnology Report.

It goes without saying that the last 12 months have been a challenging period for all sectors of the economy across the globe, not least R&D-intensive industries such as biotechnology. Against this backdrop, and following in the vein of our 2008 research report, we have carried out a worldwide survey focusing on key issues in the biotechnology sector.

Our intention was to assess the first-hand experiences and opinions of those people intimately involved in the biotech sector. Our survey primarily covered the following key areas: funding, biological therapies, regenerative medicines, the EU Commission inquiry into the pharmaceutical sector, and industrial biotech.

This 2009 report brings together the key findings of the survey, our own views on the specific issues, and the role of intellectual property – most significantly patents – to the biotech sector.

Over 360 executives, scientists, academics and investors responded to our survey. (For a breakdown of survey results and respondents see page 12). We would like to thank all those who took part in our research for their invaluable input.

Dr Gareth Williams Partner, Marks & Clerk LLP


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Executive summary

The Marks & Clerk 2009 biotechnology survey focuses on a number of key areas which are of particular relevance to stakeholders in the biotechnology industry – from entrepreneurs, to scientists, investors, and academics.

In our first section, on funding, respondents emerge as near unanimous in their view of the difficulties posed by the current economic climate, and believe that small biotechnology start-ups are likely to bear the brunt of the funding squeeze. 40 per cent anticipate significant levels of company failures. Some optimism is, however, reflected in the belief that the next 12 months may be less onerous on the industry than the year-to-date, and that the long-term case for investment in the industry remains strong. The emergence of large pharmaceutical companies willing to form strategic alliances or make acquisitions will prove essential in this difficult climate.

This theme is explored in full in our second section on protein biologics, where there have been several examples of recent alliances and acquisitions by big pharma. While 89 per cent are more convinced that big pharma can assist with commercialisation and scale-up of biological therapies, 83 per cent fear the loss of independence the involvement of big pharma may bring. The emergence of biosimilars presents an opportunity for the industry to exploit, but there is some concern that it may also represent a significant deterrent to investment.

One of the most significant areas of change in recent months has been in relation to regenerative medicine, which we explore in section three. This is an area of great topical interest in view of the recent reforms from President Obama. 81 per cent of respondents agree that the reversal of the ban on federal funding of hESC research comes “just in time” for the sector, but there is concern from Europe that it could be left behind. 84 per cent suggest that the changes may strengthen the US position over other markets. The positive attitude to the sector is also reflected by the FDA approval of Geron’s clinical trials. Alternatives to hESCs, such as iPS cells, are also seen as important, and such technical developments perhaps risk rendering the long-awaited EPO WARF decision largely irrelevant to the current state of the sector.

The EU sector enquiry into the pharmaceutical sector, considered in section four, is also a great source of concern for the industry. Possible abuse of the patent system was a key focus of the enquiry, and 58 per cent agree that reform of the patent system is likely. The establishment of a true single European patent is the most desired outcome, with 80 per cent believing that the industry would benefit from its creation whilst uncertainty remains as to whether it will materialise. Despite the appetite for some patent reform, our respondents were clear that the enquiry showed a clear lack of understanding of commercial and patenting reality by policymakers, and that a possible danger of patent reform is the deterrence of funding and innovation.

In our final section, we look to the future and the expanding role of industrial biotech, in particular so-called “black biotech” (replacements for fossil fuels). Over 89 per cent agree that the long-term economic case for this sector is equal to, or greater than, that for the health sector. However, one significant hurdle to overcome is public perception, with 76 per cent agreeing that public fears will need to be addressed to allow the sector to reach its full potential. As with regenerative medicine, the IP position needs to be clarified, perhaps through the creation of patent pools, to allow the sector to make its great leap forward.


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In our previous 2008 survey, we reported that 78 per cent of respondents believed the climate for innovation had deteriorated over the last year, while 82 per cent thought that this had encouraged risk-aversion from investors. 68 per cent of respondents asserted that a less risk-averse approach from regulatory bodies was needed to maintain investment.

Since then, industry and press commentators have been unanimous in their views of the state of funding of the industry. In a recent BIA UK survey of UK biotech companies, 37 per cent of those surveyed reported that they had failed to obtain any funding in the previous 12 months. The picture is likewise bleak in the US, a traditional source of funding for the biotech sector.

Our own research shows that the market has certainly become even more trying for the industry in 2009. Nearly all respondents – 93 per cent – believe that the overall climate for the biotech sector has become more challenging in the last 12 months. While the industry believes that access to funding and investor appetite for risk have deteriorated over the last year (at 86 per cent and 90 per cent respectively), more than half believe this deterioration to be “significant” (see figure 1). Further, 87 per cent of respondents consider that small biotech start-ups will bear the brunt of the funding squeeze and 85 per cent suggest biotech companies will need to turn to new sources of funding if the sector is to survive in the medium to long term.

The picture, however, is not all doom and gloom (see figures 2 and 3). While the industry believes that it will take over a year for current funding pressures to subside, 60 per cent assert that the outlook will improve within the next 12 months. Over 80 per cent of those surveyed argue that the long-term investment case for biotech remains strong.

Intellectual property is seen as a major factor when it comes to securing funding and minimising investor inertia. 68 per cent of respondents believe that IP systems across the globe should be adjusted to make the rewards of biotech inventive endeavour more generous. This is particularly the case where there are significant moves afoot both in the US and the EU to facilitate access to biosimilar products – see sections 2 and 4 concerning protein biologics and the EU Commission enquiry into the pharmaceutical sector.

There is no doubt that conditions remain weak for the biotech sector. Inevitably, there will be an increase in company failures as a result of the standstill, with 40 per cent of respondents predicting a “significant” increase in insolvencies (see figure 4). Sources of funding may need to change – traditional sources from the US may give way to other routes in the Far East. In the UK, this may include the $750 million Strategic Investment Fund for emerging technologies, including biotechnology, announced by Alistair Darling in his Budget on 22 April this year. Many believe that what happens today will shape the future of the biotech landscape – which will certainly be very different in the years to come.

1. Funding challenges and the current economic climate

85%of respondents suggest biotech companies will need to turn to new sources of funding if the sector is to survive in the medium to long term


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IntroductionBiologics are making an ever-increasing impact in the healthcare market. Long lauded as a panacea for the pharmaceutical industry, in recent years biological medicines have successfully made the transition from niche players to multi-billion blockbuster drugs. In broad terms, ‘biologics’ encompass a wide range of medicinal products derived from a living source, including cells; vaccines; serum and other blood components; tissues; antibodies; and hormones. Biologics are typically highly complex molecules or mixtures of molecules that cannot necessarily be readily characterised. In contrast to chemical-based pharmaceutical agents, typically identified by “trial and error” science, the attraction of biologic medicines lies in that they are often intrinsically understood to be of therapeutic use for treating specific conditions.

Hand-in-hand with this transition, the major pharmaceutical companies are adapting their business models to integrate ‘biologics’ products into their portfolio. Our research suggests that the current economic climate may make large pharmaceuticals move more aggressively still. 78 per cent of our survey respondents believe that the appetite of pharma companies to form strategic alliances and/or to make acquisitions has increased over the last 12 months (see figure 5). This view is reinforced by a number of key deals within the biologics market, such as Roche’s recent US$46.8 billion acquisition of the non-Roche owned equity of Genentech, and Eli Lilly’s late 2008 US$6.5 billion acquisition of ImClone, to name but a few.

It is likely that this appetite is being driven by the projected long-term increase in the market value of biologics and the attractiveness of current valuations. 87 per cent of those surveyed believe big pharma will “turn

the recession to their advantage”, taking advantage of low prices.

In this section, we focus on “protein biologics”, as exemplified by monoclonal antibodies (MAbs), cell receptors and hormones, since they have contributed significantly to the growth of biological medicines over recent years. Moreover, companies specialising in the production of protein biologics are the focus of much industry M&A activity, and patent law has particular relevance to how such products are best protected, allowing companies to reap the rewards of their innovation.

Protein biologics – review of the market Current state of the marketGlobal sales of biologics rose from $75 billion in 2007 to $87 billion in 2008 and sales are forecast to continue to grow. For protein biologics, the main categories of products include monoclonal antibodies, erythropoietins, insulins and interferons. The sales of monoclonal antibodies reached $33 billion in 2008 and of TNF blockers $18 billion (sources: IMS Health and Global Biologic Market Review 2008 – Krishan Maggon).

Most pharma companies have sought to contribute protein biologics to their drug pipelines from bespoke in-house R&D departments, wholly-owned subsidiaries, or via significant partnership arrangements/investments with biotech companies. For example, AstraZeneca has merged Cambridge Antibody Technologies (acquired by AstraZeneca in 2006) with MedImmune (acquired in 2007) to create a biologics division; Merck has established a biologics division, Merck BioVentures, to provide a pipeline of new and generic biologics; Novartis has strengthened its biologics capabilities by partnering with Lonza and MorphoSys.

Yet our research shows that the

2. Protein biologics – from niche to mainstream

Biotech deals to hot up?78 per cent of those who participated in our survey believe the appetite among big pharma to form strategic alliances or make acquisitions has increased in the last 12 months. 85 per cent believe the recession will hasten consolidation.

Already, we are witnessing considerable activity in the marketplace. Notable recent deals involving biologics include:

• Merck and Schering-Plough merging in a $41 billion deal

• Pfizer acquired Wyeth for $68 billion

• Eli Lilly acquired ImClone Systems Inc for $6.5 billion. ImClone are specialists in Monoclonal Antibody technology

• Roche completed the acquisition of Genentech for $46.8 billion

• Gilead Sciences completed the acquisition of CV Therapeutics

78%of respondents believe that appetite of pharma companies to form strategic alliances and/or to make acquisitions has increased over the last 12 months


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As discussed later in this section, patents play a crucial role in securing funding for biotech companies to develop protein biologics. What may emerge is that the R&D, or the patents on that R&D, become the battleground for finance. Notably, 93 per cent of respondents believe that in the current economic climate investors are increasingly securing their investment against IP rights or taking larger equity stakes. The climate is progressively becoming tougher – this figure has risen from 80 per cent of industry who felt this was a cause for concern in our 2008 report (see figure 6).

However, it has to be remembered that patents are monopolistic – their justification is that they encourage innovation. Though the marketplace for therapeutics is vast and ever growing, a contraction in the number of biotech companies coupled with a shortfall in investor cash could mean that monopolistic patent rights are held by a small number of cash rich companies. Will this scenario best serve society’s needs for developing new therapeutics? We have already seen initiatives like the “orphan drug” provisions. When the current recession is over, schemes to encourage innovation in narrowly profitable markets could become more frequent.

Marketing approval and biosimilarsProtein biologics are highly complex molecules produced via manufacturing processes that often use living biological material. In view of the complexity of the products and the fact that the manufacturing process can lead to heterogenicity, specific regulatory mechanisms have been adopted to ensure that protein biologics products meet necessary quality and safety criteria.

Striking the balance between safety and supporting drug development is essential. Notably, 89 per cent of our respondents

view from the biotech community – and the extent of the role larger pharmaceuticals should have vis-à-vis the independent biotech sector – is somewhat divided. Only 59 per cent of respondents assert that consolidation would be beneficial, meaning that a significant minority do not agree.

For protein biologics, this mixed message is likely to be based on two opposing views. Where consolidation leads to links between biotech and pharma companies, the interest of pharmaceuticals may be welcome in enabling biotech companies to become more commercial. Indeed, 89 per cent of respondents assert that traditional pharmaceutical companies can assist with manufacturing and large-scale commercialisation. Such partnering will, we expect, facilitate the translation of more protein biologics from the laboratory to the bedside.

Yet the enthusiasm for biotech to learn lessons from major pharma to bring their products to market is tempered by the realisation that this could lead to a loss of independence for the industry. 83 per cent of survey respondents consider that the combination of the current funding squeeze and the increased interest from pharma companies will shrink the independent biotech sector by the end of the recession. On the one hand, consolidation and partnering can speed route to market. On the other hand, consolidation leads to loss of independence, which could push the industry away from innovation towards conservative “me-too” products. Indeed, 85 per cent believe increased risk aversion will lead to the backing of more latter-stage drug development in place of more speculative R&D.

From this position, it is tempting to speculate on the effect of the recent M&A activity and the recession on R&D for protein biologics.

consider that greater certainty is needed for the approval of biologics, demonstrating that the regulatory mechanisms are not satisfying industry needs.

Moreover, in recent years, a number of major protein biologics have gone off-patent, opening the door to generic manufacturers to gain a share in the market. Biosimilars (or “follow-on biologics”) are copycat biologics drugs. The market for biosimilars is rapidly growing as a consequence of the lapse of patent rights, and also public policy in encouraging the development of cheaper alternatives to branded products. Encouragingly, our survey reveals that on balance 75 per cent of industry consider the emergence of biosimilars as a commercial opportunity, yet 71 per cent recognise in a climate already dogged by funding and regulatory woes, as well as increased political pressure, the emergence of generic competition is a growing challenge for originators. Notably, nearly three-quarters (72 per cent) argue that insufficient incentives are given to reward the R&D of innovator firms (see figure 7).

Due to the complexity of protein biologics and their manufacturing processes, there have been concerns that biosimilars may be significantly different to the original branded product. Accordingly, rather than allowing biosimilars to use generic drug authorisation frameworks, bespoke frameworks are being established. In Europe, the pathway to market is now established: the first biosimilar was launched in 2006 (Sandoz’s Omnitrope) and over 10 have now been approved. In the US, at the time of writing this report, the framework is still being established.

While our research shows huge optimism among the industry, with 81 per cent believing the rise of generics will result in more affordable healthcare, adequately compensating

93% of respondents believe that in the current economic climate investors are increasingly securing their investment against IP rights or taking larger equity stakes


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innovator companies emerges as a concern. 68 per cent believe the legislation should provide greater reward for protein biologics products than for traditional drug products, due to the longer time and greater expense in bringing these products to market.

Patenting of protein biologicsCurrent patent systemAs a result of the considerable delay and expense of developing new biologic medicines, in many cases the IP portfolios of biologics companies are often their main means of attracting investment, and indeed their main asset. Hence a strong patent system and a clear IP strategy are of key importance, particularly in the current climate.

Yet our research shows that respondents lack confidence in the IP systems in Europe and the US – the very frameworks used to reward innovation. Only 57 per cent describe themselves as confident in the patent system at a European level, rising to 64 per cent at the US level. What are the specific reasons for this lack of confidence? Is it the length of time taken to gain patent protection? The costs involved, especially with the current EP system? The quality of patents granted? Or inconsistencies that can arise in patent systems, both within and between jurisdictions?

Against this background, when asked about the establishment of a European Community patent system, a clear majority of 80 per cent of respondents indicate that the creation of a common patent would be beneficial for the biotech industry. Certainly, a European Community patent system should offer considerable cost savings over the presently fragmented (in some respects) route to obtaining patent protection throughout Europe. Were such a system coupled with a

centralised European Patents Court, then the cost of litigation would likely be reduced, though any benefit of “doubt and delay” for patentees would be minimised. Notably, little over a third (37 per cent) expect the common patent to become a reality, likely indicating a frustration between what the industry feels would be beneficial and achievable, and the level of development it expects at a co-ordinated European level (see figures 13 and 14).

There are also a number of areas in which specific problems can arise for patenting protein biologics. For example, differences can arise between the US and European patent offices’ judgement of the patentability of monoclonal antibodies (MAbs). In contrast to the US, at the EPO where there is an existing MAb to a known target, a patent claim to a further MAb to that target may be judged to be inventive by the applicant demonstrating that the new MAb has unexpected benefits over the known MAb. While the bar required for “unexpected benefits” can be low, this difference in the standards adopted could be significant for obtaining patent protection for “me-too” MAbs in Europe. Representatives from the US, European and Japanese patent offices meet too infrequently to review their approaches to patenting inventions in certain technology areas. Perhaps if they were to agree a more regular and co-ordinated approach, this would address some of the actual or perceived inconsistencies.

A frequent problem when patenting protein biologics is correctly judging the best time to file a patent application: is there sufficient information to show that the biologic has therapeutic activity? In general, the EPO recognises that given the time required to demonstrate the effectiveness of new therapeutics, it is not reasonable to require that a patent application show in vivo activity

57%of respondents are confident in the patent system at a European level


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in humans, and apply an “at least made plausible by the disclosure” standard. In practice, the standard of “plausible disclosure” can often be demonstrated by in vitro data. However, a principal issue is the need to ensure that the correct nucleic acid or amino acid sequence of a protein biologic is included in the patent application. The EPO interpret this provision very strictly, and hence it is very difficult to correct a non-obvious error in a European patent application. A similar issue arose with Myriad Genetics’ patents to the BRCA screening methods, which led to a reduction in patent scope.

59 per cent of those who took part in our survey assert that the timescales involved in patent grants have deteriorated in their opinion over the last 12 months. In view of the broader challenges facing the industry, from funding, to retaining the balance between promoting generic entry and rewarding innovators (particularly with the encouragement of follow-on biologics), policymakers need to tread with care. Protein biologics offer great hope in the development of highly-specific therapeutics, as well as gaining in importance as major revenue sources for the large pharmaceutical companies, but the needs of both generics and originators will need to be met in what is a very fragile market. Ultimately, it may be the case that pharma companies may play a key role here, offering the means to bring new protein biologics to market, to the benefit of all.

IP strategies for protein biologics Over two-thirds (68 per cent) of our survey respondents think that the IP system should more generously reward the biotech industry to compensate for the greater expense of bringing biotech products to market when compared to traditional drugs.

Indeed, given the very large delay in bringing new medicines to market, often a “first generation” patent covering a protein biologic will be heading for expiry not long after the product has established a firm market presence. Against this background, what strategies can be used to secure further IP protection?

A starting point is obtaining a patent term extension. In Europe, the Supplementary Protection Certificate scheme can give up to an additional five years of patent-like protection to compensate for delay in obtaining marketing authorisation for medicinal and veterinary products. Patent term extensions are also available in the US.

By implementing an IP strategy to continuously monitor the research required to bring the protein biologic from the laboratory to the marketplace, it will usually be possible to obtain further patents that protect innovative modifications. These are sometimes referred to as “patent thickets”, although the title can provoke unwelcome reaction (see section 4 on the EU Commission enquiry). For example, optimising protein function, enhancing MAb binding, or reducing immunogenicity may be covered by later filings. Also, cell lines used to produce the protein biologics could be patented, as could methods of manufacturing the protein. Any one of these subsequent patents could provide an invaluable further extension to patent protection, often when the protein biologic is in the marketplace and sales are close to peaking.

Finally, it is important not to overlook the protection afforded by regulatory bodies, referred to as data or marketing exclusivity. In certain countries, regulatory authorities are not permitted to reference data submitted by the original marketing authorisation holder for a prescribed period of time. This is relevant if a

generic or biosimilar manufacturer applies for abridged marketing authorisation. In certain countries, there may be further period of marketing exclusivity as well.

68%of respondents think that the IP system should more generously reward the biotech industry to compensate for the greater expense of bringing biotech products to market when compared to traditional drugs

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Within the next 6 months – 4.8%

Within the 12 months – 34.2%

Beyond the next 12 months – 58.1%

The worst is already over – 2.9%

There will be a significant increase in company failures – 40.1%

There will be a moderate increasein company failures – 55.1%

We will not see an increase incompany failures – 4.5%

We will see fewer company failures – 0.3%

2. At what point do you think current funding pressures will subside and investors will start to reappraise the sector?

4. Will more biotech companies fail as a result of the recession?

Biotechnology survey – key findings

Improvedsignificantly

Improvedslightly

Deterioratedslightly

Deterioratedsignificantly

1. In your opinion, have the following issues seen an improvement, or a deterioration, in the last 12 months?

Access to funding

Overall certainty of marketingapproval process

Drug approval timescales

Patent grant timescales

11.3%

35.5%

28.2%

38.1%

58.5%

65.2%

53.1%

52.3%

5.5%

5.5%

6.3%

33.9%2.5%

0.6%

1.2%

2.5%

3. Do you believe that the outlook for the biotech sector will improve or deteriorate over the next 12 months?

It will improve considerably – 7.6%

It will improve slightly – 52.4%

It will deteriorate – 36.7%

It will deteriorate significantly – 3.9%

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6. Belief that in the current climate investors are increasingly securing their investment against IP rights or taking larger equity stakes

2009

2008

93%

80%

Improvedsignificantly

Improvedslightly

Deterioratedslightly

Deterioratedsignificantly

5. In your opinion, have the following issues seen an improvement, or a deterioration, in the last 12 months?

Appetite of big pharma to formstrategic alliances

Appetite of big pharma to make acquisitions

43.8% 35%

46.2% 17.8% 3.7%

18.1% 3.2%

32.3%

Highly significant Significant Not that significant Insignificant

7. How significant a problem, if at all, do you believe the following issues are to biotech investors?

Political pressure to reduce healthcare costs

Uncertainty and time-scalessurrounding the marketing approval process

The growing challenge posed by biosimilars and other generic competition

Insufficient incentives to reward the R&D of innovator firms

Overall risk-aversion and reduced access to debt markets

27.7%

16%

20.3%

21.5%

33.8%

55.2%

62.6%

50.5%

52.7%

20.3% 3.9%

1.6%27.1%

16.8% 0.3%

27.3%27.3%

13.5%

0.6%

48.2%

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Highly confident Confident Not that confident Unconfident

8. How confident are you in the prospects for economic recovery in the following geographies?

USA

Europe (ex UK)

UK

Asia

21.8%

5.8%

5.2%

20.7%

51.8%

58.9%

54.6%

18.2% 1.9%

6.1%36.2%

32.7% 3.1%

21.4% 3.3%

58.1%

9. Confidence in the US

Confidence that proactive US stimulus will help restore economic climate

Likely increase in investment into regenerative medicine following Obama reforms

US public policy will create more affordable healthcare

Likelihood of stem cell reversal increasing attractiveness of US relative to other geographies

Extent to which European governments have done enough to support biotech in the current economic climate

Danger of Europe being left behind

58%

81%

96%

83%

15%

52%

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Yes – highly viable – 19.5%

Yes – viable – 52.1%

No – not that viable – 25.8%

No – not at all viable – 2.6%

11. Are stem cells derived from adult cells (iPS) a viable alternative to embryonic stem cells?

Highly confident Confident Not that confident Unconfident

10. How confident are you that intellectual property systems have managed to reward innovation adequately, and keep up with the needs of the industry?

At a European level

In the US

4.4%

9.4% 54.5%

40.4% 2.7%

33% 3.1%

52.5%

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12. Views on key aspects of the EU Commission enquiry

Strongly agree Agree Disagree Strongly disagree

Lack of awareness among politicians as to the commercial realities of the pharma sector

Patent system should be adjusted in favour of generics

Danger of weakening patent protection, deterring funding and innovation

Reducing healthcare costs is best tackled outside patent reform

Policymakers need to strengthen the rewards for innovator firms, not weaken them

Patent thickets should not be singled out within the pharma sector

Danger of undermining innovation by favouring generics to reduce healthcare costs

Gap between the expiry of the originator patent and the entry of generics is not indicative of anticompetitive practices

Recognising secondary patents is useful for encouraging and rewarding drug development

29% 15.6% 0.5%54.8%

2.1% 55.1% 17.6%25.1%

17.1% 27.8% 0.5%54.5%

27.7% 17.6% 1.6%53.2%

40.7% 11.1%48.1%

24.9% 15.7% 1.1%58.4%

43.9% 16.6% 3.7%35.8%

22.5% 11.2% 0.5%65.8%

19.1% 17% 2.7%61.2%

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Strongly agree – 29.9%

Agree – 50%

Disagree – 17%

Strongly disagree – 3.1%

13. To what extent do you agree that the industry would benefit from the creation of a European Community patent?

14. What do you think the likely outcome of the enquiry will be?

Significant reform of the patent system – 8.5%

Modest reform of the patent system – 49.2%

The creation of a European Community patent – 36.5%

Little or no reform of the patent system, but specific action taken against offending companies – 29.1%

Increased difficulty and uncertainty in securing follow-on patents – 25.4%

There will be no substantial consequences – 9.5%

Strongly agree Agree Disagree Strongly disagree

15. Views on outlook for industrial biotech

Long term economic case is as strong for industrial biotech as for medicinal biotech, and growth over the next 10 years will reflect this

Need to allay public fear about the possible application or misuse of industrial biotech

21.6%

15.8% 23.2%

10.8%

1.1%

67%

60%

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Breakdown of survey respondents

Biotechnology company(commercial) – 41.5%

Biotechnology organisation (academic/public sector) – 10.5%

Broader life sciences/pharmaceuticalorganisation – 20.6%

Venture capital, with biotech interest – 2.8%

Financial institution, with biotechinterest – 1%

Other industry, with biotech interest – 23.7%

16. Type of organisation

USA – 28.3%

UK – 36.2%

Europe (ex UK) – 18.3%

Asia – 9.3%

Other – 7.9%

Mainly originator drug development – 63.4%

Mainly generic competition – 4.8%

Both originator and generic drugdevelopment – 31.9%

17. Geography

18. Principal activity or interest


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President Obama’s reforms, at least as regards the biotech sector, have been swift and comprehensive. Less than a month into office, we have seen the reversal of Bush’s block on the use of federal money to fund research of human embryonic stem cell lines created after 9 August 2001, and the promise of committing specific funding in relation to regenerative medicine.

Optimism from the beleaguered biotech sector is clear, with 81 per cent suggesting the reversal of the ban came just when the sector needed it most. 41 per cent believe that increased investment into the sector will be considerable as a result of opening up more stem cell lines for federal funding.

Of course, embryonic stem cell research has been going on in the US before and during the Bush ban. However, there was a perception among the industry that such a ban has nonetheless affected research in the US, allowing other regions, including Europe and Asia, to forge ahead in terms of pioneering embryonic stem cell research. Is this all about to change?

Some 84 per cent of survey respondents appear to think so, suggesting that the reversal of the ban will strengthen the US in relation to other geographies. 96 per cent believe the reforms level the playing field once more with Europe, or may in fact trigger the revival of US regenerative research. Some 59 per cent believe that we may see an increased migration of talent to the US in the wake of Obama’s reforms, although this figure is perhaps slightly lower than some reporters have feared.

Overall, respondents are the most upbeat about recovery being staged within the US over other major geographies, and least confident about the prospects for recovery within the UK (see figure 8). Looking to Europe as a whole, 85 per cent

3. Regenerative medicine and the US reforms

express a lack of confidence in the actions of Europe’s policymakers, set against the commitment of US money to regenerative medicine. Taken in sum, a small majority of 53 per cent believe there is a serious danger Europe could now be left behind, rising to 75 per cent among the 103 UK-based respondents who took part in this research (see figure 9).

The position of Europe and IPPrevious biotech reports by Marks & Clerk have considered the patent landscape surrounding the stem cell arena, not least the lack of clarity in EP law in terms of what is/what is not patentable in the human embryonic stem cell area. Particularly in view of the attitude towards a revival of US biotech, it is notable that 64 per cent of those who took part in this year’s research are confident that the US IP system has kept up with the industry’s needs. Only 57 per cent believe this to be the case at a European level (see figure 10).

Importantly, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) has now finally issued its decision in relation to the patentability of stem cells in Europe. The EBA’s intervention came about during prosecution of EP0770125 to the Wisconsin Alumni Research Foundation (WARF) – a patent application providing methods for obtaining embryonic stem cells from primate embryos, albeit through the destruction of an embryo. Interest in this decision was huge, and the potential impact upon the commercialisation of stem cell related technology, significant. Yet rather unsatisfactorily, the decision issued by the EBA was somewhat limited and failed to impart the clarity and certainty required for workers in the field. The opportunity for clarity has, for now, been missed.

84%of respondents believe that the reversal of the Bush ban on embryonic stem cell research will strengthen the US in relation to other geographies


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Perhaps most disappointing, was the EBA’s reluctance to consider the wider issues which, from the numerous amicus curiae briefs received, it was evident were of real importance to the stem cell community. As such, while it is now perfectly clear that applications which only describe methods of obtaining products (for example stem cells) in which human embryos are destroyed will not be granted, we are still no closer to knowing for certain whether, for example, the EPO will ultimately allow claims to products obtained from established human embryonic stem cell lines, or other methods which do not “directly” involve the use or destruction of a human embryo. Rather frustratingly, the answers to these questions may only be finalised in response to further referrals to the EBA.

iPS cells: the solution?With the continued lack of clarity surrounding the law, it is not surprising that technology is swiftly moving towards alternatives to stem cells obtained from embryonic material. 72 per cent of those who took part in our research regard induced pluripotent stem (iPS) cells as a viable alternative (see figure 11).

The use of iPS cells may also help alleviate possible ethical or moral concerns surrounding human embryonic stem cells. Meanwhile, other scientists are looking to use embryonic stem cells not for therapy per se, but as platforms to assist drug testing and facilitate more conventional drugs getting to market. Certainly neither of these areas has the same controversy as the therapeutic use of embryonic stem cells and cells derived therefrom.

The iPS cell field is led by Yamanaka’s “Nuclear reprogramming factors” applications (derived from WO2007069666). Although a patent has been granted in Japan

(JP04183742), we are only in the early stages of prosecution in Europe. However, it is interesting to note that the Examining Division of the EPO has already raised doubts over the novelty and inventiveness of EP1970446 (the European application derived from WO2007069666). The objections focus on an earlier Yamanaka application (WO05080598), which describes methods of screening for somatic cell reprogramming factors.

In the light of this prior art, the examining division is of the initial opinion that one skilled in this field could readily identify and predict the effect of the factors claimed in EP1970446. Moreover, German chemical giant Bayer AG applied for a patent in Japan on June 15, 2007, just before WO2007069666 was published, for a technique to generate iPS cells, from human cells. Interestingly, the application was filed before Yamanaka was publicly able to demonstrate that his technique could work with human cells.

The industry will no doubt continue to monitor the prosecution of EP1970446, to see whether the preliminary objections can be overcome to yield claims which broadly protect an increasingly important platform technology and/or if the Bayer patent application complicates matters. The outcome as to who may have dominating patent rights will be extremely important to the iPS cell community.

The IP and regulatory landscape for regenerative medicineOf course, simply obtaining a suitable source of stem cells, be it embryonic or iPS, is unlikely to be sufficient in terms of their application. The cells will generally require some form of processing in order to produce sufficient cell numbers; suitable scaffolds within which the cells can grow and differentiate as necessary;

and/or be provided in a form in which they can be safely assimilated into the body.

Many of these issues have not yet been satisfactorily addressed, and to do so will pose a significant technical and clinical challenge. Meeting this challenge will require a multidisciplinary approach, with the input not only of biologists and clinicians, but also of materials scientists and engineers. Thus, the patent landscape in the regenerative medicine field is not merely restricted to the development of the cells themselves and covers many other areas. With the patent landscape expanding all the time, careful consideration of this is required by interested parties.

Undeniably, the potential therapeutic promise of regenerative medicine is extremely exciting. However, the fact that regenerative medicine therapies and products are very different from more conventional medicines that have gone before, may also challenge their development and acceptance, not least in terms of funding and public perception. The novel nature of these products also means that regulatory authorities lack suitable precedents by which to assess their safety, and they have tended to respond by establishing very strict criteria that set standards intimidatingly high (The Review and Refresh of Bioscience 2015: A Report to Government by the Bioscience Innovation and Growth Team). Notably, 71 per cent of survey respondents say that certainty in the marketing approval process across the biotech sector has deteriorated in the last year.

Taking all of these factors into account, do they contribute to provide a low appetite for this technology among investors, with a risk that a significant funding gap may develop, further slowing the translation of research into viable clinical products?

72% of respondents regard induced pluripotent stem (iPS) cells as a viable alternative to embryonic stem cells


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this could have a devastating effect on the field. The outlook remains finely balanced for industry.

Current global economic concerns are likely to affect all areas of biotechnology, but with the US funding that has been promised, and with the desire of the industry and public at large, the future for regenerative medicine looks promising. Those countries and organisations that take active steps to address these now are likely to take the lead in advancing this new field, and enabling it to reach its full potential.

available for regenerative medicine research (US Department of Defence: News Release 17 April 2008).

In the UK, the recent report from the Bioscience Innovation and Growth Team (BIGT) made the establishment of two UK centres for translational scale-up one of its recommendations to Government (The Review and Refresh of Bioscience 2015: A Report to Government by the Bioscience Innovation and Growth Team). In Europe, the Advanced Therapies Regulation is intended to provide a single regulatory framework that will apply to all member states. While these initiatives, and others like them, will all help to promote regenerative medicine, perhaps the most important change has nevertheless been the Obama reforms. That said, at the same time as this important change in policy, the world has entered a challenging economic climate, which will undoubtedly cause a significant degree of caution in the venture capital community before a recovery. It may be the case that it is one step forward and one step back.

However, another potential cloud for the field was also recently lifted when the FDA decided at long last to allow Geron to commence the first trial in the US using cells developed from embryonic stem cells. Whilst this may not be the first use of human embryonic stem cells in the clinic, it is nevertheless extremely important in terms of potential credibility and safety considerations, as the FDA and its practices are highly regarded worldwide. Many other regulatory authorities around the world are likely to be keeping a very close eye on the FDA and the results of the Geron trial. 76 per cent of survey respondents assert that the FDA decision was important not just to the stem cell area, but to the biotech field as a whole. But of course, if Geron’s trial is unsuccessful, or perhaps worse if the therapy is shown to be unsafe, then

Certainly, delays in the development of these much-vaunted new therapies may cause impatience among the public, which can then turn to cynicism and less motivation for their adoption. Furthermore, our survey ranks investor appetite for risk as the single biggest challenge across the biotech sector, with 90 per cent citing its deterioration in the last 12 months. Yet 65 per cent assert that the biggest barrier to investment is the economic climate directly, rather than the marketing approval process. This implies that it is the recession itself, and the reaction of policymakers, which will prove key going forwards.

This being the case, there may be cause for tentative optimism. Many commentators believe that the sea-change in the US is likely to make the field (and in particular those early stage companies), much more attractive to the venture capital community. Overwhelmingly, 96 per cent of our survey respondents believe that the Obama reforms are likely to encourage investment into the regenerative medicine field (see figure 9). Some 66 per cent of respondents believe the lifting of the “ban” will make the commercial realities of biotech easier to deliver by lifting the administrative barriers for biotech.

Public funding and the outlook for industry91 per cent of survey respondents believe European governments should follow the lead of the US and commit public funds to the biotech sector. That response may be needed swiftly, in order to retain Europe’s competitive position.

In terms of public funding, the need for action to combat barriers to regenerative medicine are being recognised, and steps taken to address the problems. In the US, for example, the Armed Forces Institute for Regenerative Medicine (AFIRM) will make more than $250 million

91%of respondents believe European governments should follow the lead of the US and commit public funds to the biotech sector


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An investigation which begins with dawn raids would seem unlikely to lead to agreement between the targets and the raiders on points of reform. And yet it appears that the will to reform is in fact a central outcome of the EU sector enquiry into the pharmaceutical industry.

Is the enquiry justified?The preliminary findings of the EU investigation into allegedly anticompetitive practices by the pharmaceutical industry were published in November 2008. The report criticises originator firms for perceived anticompetitive practices, questioning in particular the uses made of the patent system by originator firms.

Respondents to our survey are divided 50:50 on whether the enquiry and its criticism of originator firms are justified, but are more critical of some of the possible outcomes. 89 per cent believe rewards should be strengthened for innovator firms in the current climate, not weakened, while 84 per cent state that the enquiry highlights a lack of awareness among politicians as to the commercial realities of the pharmaceutical sector (see figure 12).

The EU Commission’s investigation was sparked by concerns over the cost of pharmaceuticals in the EU, and an alleged “decline in innovation measured by the number of novel medicines reaching the market, and instances of delayed market entry of generic medicines, as compared to what might be expected.” Improving competition is intended to reduce the cost of drugs. Consumers and governments want cheaper drugs – as noted by Lord Justice Robin Jacob, “before the invention of a new drug, we would willingly pay for it. After the risking and investment have produced a new medicine there is great temptation to say the price is

too high.” Generics can and do drive the price down, as a consequence of much reduced research costs.

Yet our research questions whether a gap between the expiry of market exclusivity and generic entry is really an indicator of anticompetitive practices, with 88 per cent of those who took part suggesting this is not necessarily the case. Further, is the current balance between public health and protection of investment wrong? Notably, while 81 per cent of biotech companies accept the aim of policymakers is to reduce healthcare costs, it is their belief that this is best tackled outside patent reform. The enquiry further leads to the question whether tinkering with this balance risks the law of unintended consequences – not only in the pharma sector, but in other fields. Use of the patent system to alter the balance would bring changes not confined to the industry, but would impact on all users of the patent system. While favouring generics may reduce healthcare costs in the short term, 80 per cent of respondents assert that it risks long-term problems by undermining innovation.

Tools to deter competitionThe enquiry comments, “one commonly applied strategy is filing numerous patents for the same medicine (forming so called “patent clusters” or “patent thickets”). Documents gathered in the course of the inquiry confirm that an important objective of this strategy is to delay or block the market entry of generic medicines”.

Yet patent clusters and evergreening are not new, and are not confined to the pharmaceutical sector – for example, the electronics industry has long lived with patent clustering. 83 per cent of those who took part in our survey believe that it is unfair to single out the use of patent clusters within the pharmaceutical

4. The EU Commission enquiryinto the pharmaceutical industry

84%of respondents state that the enquiry highlights a lack of awareness among politicians as to the commercial realities of the pharma sector


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rewarding drug development. In view of the many pressures on innovator firms – from funding conditions, to lack of certainty in the marketing approval process, to the rise of generic competition – arguably there is a case that the system needs strengthening. 73 per cent believe that the patent system does not need to be adjusted in favour of generic competition. 68 per cent go so far as to suggest that the rewards should be greater for innovator companies, in view of the expense of bringing biotech products to market.

Notably, our research further shows that originator companies have some support from their generic competitors. On the one hand, the figure that supports the EU Commission’s enquiry and its criticism of originator firms rises to 75 per cent (from 50 per cent) among only generics respondents. Yet two-thirds (67 per cent) of those who engage principally in generic biotech drug development support the view that tipping the balance in their favour could undermine innovation, and recognise that the gap between the expiry of the originator patent and the entry of generics does not necessarily mean anti-competitive practises are at play within the biotech sector.

ReformThe Commission’s report notes that “Generic companies and originator companies are in agreement over the need for a single Community patent and the creation of a unified and specialised patent judiciary in Europe”.

Ending the fragmented system has consistently been the call of industry of all sectors across the EU. Indeed, our survey shows that 80 per cent of respondents believe the industry would benefit from the creation of a true single European patent. Many past initiatives for the Community patent have withered on

sector as only one of the many R&D industries which deploy patent thicket strategies.

The Commission’s report also considers whether the use of the opposition system at the EPO deters competition, and finds that generic companies “prevailed in approximately 75 per cent of final decisions rendered by the EPO (including the Boards of Appeal) during 2000 to 2007, either by achieving the revocation of the patent or by having its scope restricted.”

On the face of it, this suggests that originator patents are weak, and that generic challenges are generally successful. However, the EU clearly uses a curious definition of prevailing – significantly, the statistics do not consider whether the final outcome led to the generic being free to market a competitor; a narrowed patent is not necessarily a loss for the patentee. There is also no comparison of whether the “approximately 75 per cent” victory of generics differs from equivalent figures in other sectors. The EPO’s 2007 Annual Report gives the outcome of 2,750 oppositions: the patent was revoked or amended in 68.5 per cent of the cases, which is little different from the 75 per cent figures quoted above.

The Commission’s report also comments on the perceived weakness of secondary patents (that is, those that do not protect a new chemical entity, or NCE, per se). While acknowledging that it “is generally accepted that innovation is often achieved in incremental steps, patents relating to second generation products are sometimes criticised as weak by other stakeholders who argue that they show only a marginal (if any) improvement or additional benefit to the patients”.

Yet our survey shows that 80 per cent of the industry believes recognising secondary patents is a good way of encouraging and

The EU Commission enquiry: negative perception of patentsDespite efforts towards harmonisation throughout the history of the EU, the relevant legal provisions relating to the pharmaceutical industry (or more importantly, the interpretation of those provisions) are by no means uniform across the EU. We would expect to see not only distortions in the single market, but also commercial moves to exploit, where possible, those distortions.

The pharmaceutical industry is a heavy user of the patent system. Since patents, by their nature, are monopolistic and potentially anticompetitive instruments, it should perhaps be no surprise that the Commission’s report focuses closely on the patent system, and suggests that “originator companies have designed and implemented strategies aimed at ensuring continued revenue streams for their medicines. Although there may be other reasons for delays to generic entry, the successful implementation of these strategies may have the effect of delaying or blocking such entry. The strategies observed include filing for up to 1,300 patents EU-wide in relation to a single medicine (so-called “patent clusters”)”

This headline figure of 1,300 patents has been roundly dismissed as hyperbole (it appears likely that the report considered each patent and application, in each of the 27 EU countries, as a separate patent). However, it serves as a touchstone for the generally negative view taken of the patent system by the report.

80%of respondents believe recognising secondary patents is a good way of encouraging and rewarding drug development


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the vine; perhaps as a consequence of this report the political will might soon be in place to achieve this goal. 58 per cent of survey respondents believe reform of the patent system is likely, with over one-third (37 per cent) suggesting that the creation of the Community patent is a likely outcome of the enquiry (see figure 13). As the Commission report notes, “a significant number of generic companies – and to some extent also originator companies – call upon the EPO to ensure that patents granted are of high quality and to effectively counter patent strategies that may result in unnecessary delays”. If the political will is there, this may be achieved.

We must be cautious, however, of the implementation. There are strategies in place at the EPO for “raising the bar” – among them the imminent reform of the system for filing divisionals, as well as requiring a response to be filed to objections raised against PCT applications entering the European phase. These reforms are controversial, and may not achieve their objectives. It is important to remember that a patent office can never prevent grant of all bad patents – they simply do not have the resources that a determined opponent or litigator can bring to bear. There is also the risk that “raising the bar” has the effect of easing workload for the patent office at the expense of an increased burden on users. If the balance is wrong, this may deter use of the patent system and further imperil investment in R&D.

Survey respondents are split on whether this is likely – although 72 per cent assert that there is a danger that significant weakening of patent protection would deter funding and innovation, only 9 per cent believe “significant” reform of the patent system is a likely outcome of the enquiry. One in four believe follow-on patents will become harder to secure,

and 29 per cent think there will be greater action taken against offending companies. What is clear is that change will come – only 10 per cent believe there will be no substantial consequences following the enquiry (see figure 14).

Although our survey makes clear the potential dangers of unfocused reform to the patent system, it is clear that some change is likely – and indeed certain changes, such as a single European patent, will be welcomed. We expect that, when mobilised, the voices of the legal and originator industries are unlikely to be outweighed by the interests of generics, and that the end result will be a watering down of the more extreme proposals. One could perhaps take a Machiavellian view that the preliminary report is intentionally extreme, so that the proposals of the final report are considered more modest; thus the necessary reforms can be achieved with political consensus from all parties.

Prices and time to generic entryThe report indicates that generic entry takes place “about seven months” on average after loss of exclusivity, although this can be quicker: “for the most valuable medicines it took about four months”. Generics represent a significant portion of the market: “Of the medicines in the sample that were the subject of further in-depth investigation and which had lost exclusivity in the period 2000-2007, about half faced generic entry within the first year after loss of exclusivity (EU average). Measured in value terms, these medicines represent about 74 per cent of sales (sales value in the year of expiry).”

This seems to indicate healthy competition. However, the report suggests that a further €3 billion saving could have been achieved had generic entry taken place immediately on expiry of protection. But is this realistic?

It takes time for new generics to prepare for market entry. Even after patent expiry, there is still the need for regulatory approval. Moves have been made recently to encourage earlier generic entry, in particular the “8+2+1” structure for data and marketing exclusivity, and the entry into force of “Bolar-type” provisions across the EU. These are perhaps too recent to have had an impact on the data analysed in the Commission’s report, and the report itself does not acknowledge that things may change without further intervention.

One further change which has been discussed is an FDA orange book style listing of patents, which would allow competitors to readily identify patents of relevance to a product. However, there seems to be little consensus on whether this is desirable or necessary.

80%of respondents believe the industry would benefit from the creation of a true single European patent


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necessary accompaniment to pools of algae.

However others, most notably Craig Venter in the US, see building synthetic genomes driven by a strong IP position as the necessary route to a truly biological industrial revolution. His company Synthetic Genomics, in conjunction with the J. Craig Venter Institute, intends to be a leader in this revolution. Relevant patent applications are now reaching prosecution at the EPO through Marks & Clerk. Watching their fate may prove defining for the sector. Will the public be won over by those involved with this technology, who are likewise seeking to be at the forefront of ensuring adequate safeguards?

Biotech is already expanding out of the healthcare field. A new industrial biotech age is underway, with biotech companies looking to breed faster than algae to address pressing problems of the world. 89 per cent of survey respondents believe the long-term economic case for industrial application of biotech is equal to that for medicine and that growth over the next 10 years will reflect this potential (see figure 15).

Increasing usage of terms such as ‘black biotech’ and ‘biotech’s green gold’ indicate that application of microbes and algae to assisting with the world’s future energy needs is seen as having immediate promise. It has drawn major investment from individual investors to major players in the current oil industry. With even the US Defense Advanced Research Project Agency (DARPA) recently handing out millions in the quest to bring green jet fuel to reality, industrial biotech looks set to be a continuing area for investment, regardless of the general financial climate.

Yet of equal interest, is who will end up owning the IP that matters? Moreover, will this exciting field of discovery engender the next controversy for the industry? 76 per cent of respondents consider that for the industrial biotech industry to reach its full potential, public fear about the possible application or misuse of this technology will need to be allayed.

This does not bode well for those who see it as essential to look to genome modification strategies to address global challenges from fuel to food. The UK Carbon Trust through its Algae Biofuels Challenge (launched in 2008) has sought to focus entrepreneurs on addressing the still very real problems of scaling up algae oil production, and has noted the public perception problem if GMOs are at the foundation of this drive. Behind such projects, pooling of IP and strategic alliances may well be a

5. Industrial biotech – looking to the future

89%of respondents believe the long-term economic case for industrial application of biotech is equal to that for medicine and that growth over the next 10 years will reflect this potential


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Marks & Clerk contactsIf you would like more information about the survey or this report, contact the lead authors from our bioscience group.

Dr Paul ChapmanPartner, European Patent Attorney Marks & Clerk LLPEdinburghT: +44 (0)131 221 7000 E: [email protected]

Dr Claire IrvinePartner, European Patent AttorneyMarks & Clerk LLPOxford OfficeT: +44 (0)1865 397900E: [email protected]

Dr David MartinAssociate, European Patent Attorney Marks & Clerk LLPLeeds OfficeT: +44 (0)113 389 5600E: [email protected]

Dr Gareth WilliamsPartner, European Patent AttorneyMarks & Clerk LLPCambridge OfficeT: +44 (0)1223 345520E: [email protected]

Mike GilbertPartner, SolicitorMarks & Clerk Solicitors LLPLondon OfficeT: +44 (0)20 7420 0250E: [email protected]

About Marks & ClerkThe Marks & Clerk group is a world leader in intellectual property. Clients and peers worldwide have nominated us for many awards and we consistently achieve top rankings in the major legal directories and IP surveys.

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