Life Sciences : An Introduction
Contributed by Powell Gilbert LLP
2010/11 was an eventful year in the life sciences field. The recent trend of pharmaceutical industry consolidation continued both with the USD20 billion acquisition of Genzyme by Sanofi-Aventis and Takeda extending its reach into emerging markets with the acquisition of Nycomed.
Patent litigation over generic pharmaceuticals continues to be of critical importance to the biotechnology and pharmaceutical industries. Following its 2009 enquiry, the European Commission published a further report on its monitoring of settlement practices. The report highlights an increase in the number of settlements overall, but fewer deals in which generic suppliers were paid not to commercialise their products. The Commission’s scrutiny of the industry continues.
SPC litigation
As key patents expire, the role of the Supplementary Protection Certificate (SPC) is attracting increasing importance. In 2010/11 a number of cases relating to SPCs were referred to the Court of Justice of the European Union (CJEU), with opinions of the Advocate General providing guidance as to the likely clarification to be offered by the Court.
One such case, the Merck reference, raised the issue of 'negative term' SPCs – patent term extensions that would not extend beyond the 20-year life of the underlying patent, but which are still valuable given the availability of a six-month paediatric extension. Applications for such SPCs have been the subject of divergent practice in Europe. In an industry-favourable opinion, the Advocate General indicated that negative term SPCs should be available, in order to give rise to the benefits afforded by the paediatric extension.
The Medeva and Georgetown references from the UK Court raised questions concerning combination products, in particular multi-disease vaccines. Here, the Advocate General concluded that a sub-set of a combination product’s components can qualify for SPC protection, another view likely to be welcomed by industry.
The CJEU (which usually follows the Advocate General's opinion) is expected to rule on these cases in 2011/12.
Biotechnology
Following the 2010 Monsanto case, the CJEU has been involved further in considering the European Biotechnology Directive over a case concerning the patentability of human embryonic stem cells and what constitutes a "human embryo" for the purposes of the Directive.
In the case of Professor Brüstle, the applicant was granted a patent for making neural precursor cells from human embryonic stem cells, a method with clinical applications in treating Parkinson’s disease. Greenpeace challenged the patent in the German Federal Patent Court, which found it invalid insofar as it involved isolating the precursors from human embryonic stem cells. On appeal, the German Court stayed the proceedings and referred questions to the CJEU, seeking clarification of the scope of the Directive’s Article 6(2) prohibition on the use of human embryos for industrial and commercial purposes, the concept of "human embryo" being undefined under European legislation.
In March 2011, the Advocate General noted the sensitivity of the question but rejected arguments that individual member states should be allowed to use their own discretion in the matter, given the Directive’s aim of harmonised protection for biotechnology inventions. The Advocate General observed that totipotent cells, capable of developing into a complete human being, represent the first stage of the human body and must therefore be unpatentable under Article 5(1), and must be classified as an embryo. Likewise the blastocyst stage of development. However, on that analysis, pluripotent stem cells, which are not capable of developing into an entire human being, fall outside the definition of embryo. Accordingly, the Attorney General considered that inventions based upon pluripotent stem cells can be patentable, provided that they are not obtained to the detriment of the embryo.
Whether the Court affirms the Attorney General’s opinion remains to be seen, but further clarification of what can amount to patentable subject matter in this field is to be welcomed given the investment in this area by the life science industry and the great potential for clinical applications.
Also in the biotechnology field, in 2011 the UK Supreme Court heard its first patent case, that of Eli Lilly v Human Genome Sciences (HGS). This was an appeal focused upon the issue of industrial applicability and the degree to which an applicant must describe the function of a gene sequence in a patent disclosing a novel member of a therapeutically relevant protein family. The UK Court of Appeal had previously revoked HGS’ patent, notwithstanding that it had been upheld by the European Patent Office. It is hoped that the Supreme Court will help to reconcile the approach to industrial applicability in the UK with that of the European Patent Office.
Clinical Trials and Patent Infringement: The UK IPO Consultation
The question of whether conducting clinical trials in the UK amounts to patent infringement is a concern for the life sciences sector, although it has so far been given only limited consideration by the courts. Although the UK Patents Act does offer research-based exemptions from infringement, their scope remains uncertain.
Specific "Bolar-like" provisions expressly exempt testing carried out for the purpose of obtaining marketing authorisations for generic or biosimilar medicinal products, but these provisions do not extend to trials of new active substances. Such trials must therefore be considered in light of the "experimental use" exemption, which provides a defence for acts carried out for "experimental purposes relating to the subject-matter of the invention." UK case law has traditionally considered the defence narrowly and does not provide clear guidance in the pharmaceutical context, so in 2011 the Intellectual Property Office issued a public consultation to investigate the impact of patent legislation on the conduct of clinical trials in the UK. The results of the consultation are expected in autumn 2011, with the hope that clarification of the position of such trials in the UK will be forthcoming.
This outstanding group of all-rounders commands strength across the board and boasts a team packed with high-quality practitioners. Its international reach is well recognised, with clients able to rely on the firm for assistance on cross-border work throughout Europe and beyond. Sources applaud the practice as "responsive, highly organised and great at communicating with clients." Recent highlights include acting for Baxter in relation to the alleged breach of a collaboration and licence agreement.
Commercial Awareness "It's important to have trustworthy people that bear our interests in mind. Issues affecting our UK operations can have worldwide repercussions, and they understand that."
KEY INDIVIDUALS Group head Trevor Cook continues to lead the way in advising high-profile clients on complex life sciences issues. Interviewees speak admiringly of his "unparalleled knowledge of pharmaceutical patents." Morag Macdonald holds an excellent track record in life sciences-related IP litigation, including successfully defending Edwards Lifesciences against patent infringement claims. Clients say she is "a human sponge, mastering the facts of a case and understanding all the moving parts of related litigation across different jurisdictions." Robert Williams remains one of the team's prominent patent litigators. He recently represented international biopharmaceutical manufacturer Synthon in the High Court. Gerald Kamstra, meanwhile, is able to draw on a strong scientific background to assist clients across a range of sector-related issues. Sally Shorthose is considered a "dedicated and highly able" partner who, thanks to her in-house experience, can provide a truly thorough service to major life sciences organisations.
Bristows offers a hallmark of quality across a number of life sciences disciplines and earns consistent praise from clients for the sheer strength of its team. It continues to bolster its already impressive market reputation largely through the expertise of its individual lawyers. The firm has been emphasising scientific understanding in developing the practice, leading sources to commend it as well equipped to handle even the most complex disputes.
Client Service "Well connected in various associations. They have demonstrated their commitment to the sector by co-sponsoring and organising major conferences."
Commercial Awareness "They understand the European market and are capable of co-ordinating litigation across borders."
KEY INDIVIDUALS Head of practice Edward Nodder has an excellent track record in patent litigation, both domestically and internationally. Clients say he is a "sensitive and intelligent guy with a strategic mind." Clients describe patent litigator Brian Cordery as "extremely knowledgeable and energetic," and express their appreciation for the lengths to which he will go to assist them. Maria Isabel Manley is known as a "hugely user-friendly lawyer" with expertise in life sciences regulation, EU law and judicial reviews. Laura Anderson has an impressive presence in terms of corporate and commercial life sciences work, recently advising UCL spin-out Pentraxin in relation to a licence and collaboration agreement with GlaxoSmithKline. Transactional specialist Mark Hawes recently advised AstraZeneca spin-out Albireo on its USD40 million financing exercise, underlining his expertise in this field.
This multifaceted firm has built itself up to feature prominently in covering a number of life sciences bases. It is especially strong on commercial issues, M&A activity and fund-raisings, and has also proven skilful in dealing with regulatory concerns. Recent highlights include assisting Sinclair Pharma in the raising of £19 million. Assessments of the group have led to it being labelled "responsive, business-minded and genuinely nice to deal with."
Commercial Awareness "They take a very commercial approach and will avoid spending money on trivial matters."
KEY INDIVIDUALS Ralph Cox is highly thought of by interviewees and regularly acts for major pharmaceutical clients on IP matters. He recently represented Omnipharm in seeking the revocation of two patents owned by Merial. Gary Howes is a transactional specialist with a wealth of experience in life sciences. Clients find him "a dream to work with - he doesn't have his own agenda or feel the need to over-exert his position." Charles Waddell is an expert in life sciences corporate financings who recently advised Ipsen over an equity investment in Syntaxin. Allistair Booth is new to the rankings this year, earning an appearance on the strength of his corporate life sciences work that includes fund-raisings for biotech and medical technology companies. Clients say he "goes out of his way to understand our company's needs and strategy, always turning things round quickly." Regulatory expert Paul Ranson heads the firm's life sciences group, attracting praise for the depth of his industry knowledge and swift response rates.
This broad-ranging team brings impressive depth to its work across life sciences transactions and patent litigation. Commentators are impressed with the team's flexible and creative approach, a feature that has attracted clients of the calibre of GlaxoSmithKline, Kymab and the Wellcome Trust.
Client Service "They are very good to interact with. Everything is delivered promptly and they are patient of clients with a limited understanding of life sciences law."
KEY INDIVIDUALS Stephen Reese heads the life sciences team, most recently leading the team's assistance with the establishment and USD35.4 million financing of Convergence Pharmaceuticals, a spin-out from GlaxoSmithKline. Clients appreciate the way he "makes clear recommendations, explains his advice and always understands the commercial dimensions." Michael Burdon impresses with his handling of complex IP litigation. His skills were put to the test when he guided Kinetic Concepts in a patent dispute relating to negative pressure wound therapies.
Powell Gilbert derives an outstanding level of expertise from its patent litigation practice, interviewees confirm. It is known for bringing a depth of sector-specific understanding to its efforts and has been building on its track record of recruiting lawyers with science backgrounds. One recent highlight led the team to acting for Human Genome Sciences in a patent revocation action and parallel EPO proceedings brought by Eli Lilly. Satisfied clients describe the group as "intelligent, prudent and committed."
Client Service "They are completely reliable whenever you need something completed."
Commercial Awareness "They get things done. They roll up their sleeves, talk to the other side and work to achieve a settlement."
KEY INDIVIDUALS Solicitor advocate Tim Powell has an excellent reputation for cross-border patent litigation, as evidenced by his recent work for Israeli client Yeda in a dispute spanning both the UK and Europe. Clients say he is "experienced, has a clear mind and is able to weigh up concerns from a commercial perspective." Penny Gilbert is well known to the market as an outstanding patent litigator. She led the team on the Eli Lilly proceedings and is felt by clients to "apply her experience of both the law and technical scientific issues to great effect." Zoë Butler is considered a talented litigator with a strong track record in life sciences. Feedback indicates that she is "bright, reliable and embodies the best qualities of the firm."
Simmons & Simmons has an exceptionally strong presence in the life sciences field, possessing the breadth and depth to handle work ranging from high-value transactions to complex patent litigation. An overseas network of offices gives it the capacity to handle cross-border work on a global scale, as reflected in a client list that includes the likes of Astellas Pharma, Bayer HealthCare and Sphere Medical. Clients say the team is packed with lawyers who "have an incredibly sound grasp of the big picture; they always strive to look beyond the horizon."
Client Service "Their support is very important - they're extremely proactive and their advice is always good."
Commercial Awareness "They clearly know the field and can be counted on to manage workloads without needing their hand held all the time."
KEY INDIVIDUALS Rowan Freeland is a tremendously experienced patent litigator with a reputation for obtaining the "right results with the minimum of fuss." Kevin Mooney is deemed an immensely senior figure in the market, with his expertise increasingly valued by European regulatory bodies just as by his pharmaceutical clients. Marjan Noor is a new arrival at the firm, helping to boost its offering in both patent litigation and regulatory work. She includes a number of major pharmaceutical players among her clients, and advises on litigious matters for companies based in Europe and the USA. Marc Döring recently represented Bayer HealthCare in patent revocation proceedings before the High Court, whilst Scott Parker is considered a talented litigator whose background in the biological sciences has generated an impressive track record of working with pharmaceutical clients. Charles Mayo heads the firm's life sciences offering in the UK and handles major M&A deals in the sector. Clients say he is "greatly switched on in terms of giving you a proposal and a product that makes both business and legal sense." Richard Binns is an IP specialist who recently assisted Genmab on a projected EUR38 million research and licensing agreement with H Lundbeck. Mark Curtis, meanwhile, injects his understanding of corporate transactions into handling major life sciences M&A deals, while Michael Gavey continues to build a fine reputation for IP and regulatory advice. Clients say he is "one of the most dedicated lawyers I've ever encountered, and forever available."
SJ Berwin's life sciences practice is known to interviewees as a team that is "full of thorough and tenacious lawyers that bring great vigour and commitment to their work." The London team covers both intellectual disputes and general transactional work, and works closely with colleagues in Germany to offer a pan-European service. One recent highlight saw the firm advise NicOx on a global licensing agreement with eye health company Bausch & Lomb. Clients include Actavis, Corporación Medichem and Resolution Chemicals.
Client Service "They communicate well with clients and are available when I need them, even late into the night or in the early hours of the morning."
KEY INDIVIDUALS David Rose heads the firm's IP group. Clients know him as "an adept litigator with a thorough understanding of the market - a true force to be reckoned with." Transactional expert Andrew Shindler recently advised NicOx on the extension of a worldwide agreement with Merck. Clients admire his work, claiming that he is a "responsive, adaptable practitioner with an expert grasp of licensing concerns. He will play whatever role you need – either the legal guy in the corner or a full-on negotiator."
This firm draws together an eclectic team of practitioners to cover the transactional, regulatory and litigation spheres of the life sciences field. It is traditionally strong in IP law and has built a reputation for acting on behalf of generic manufacturers. It is, however, one of the few teams that also acts for innovators in patent disputes. Clients are impressed with the range of services the firm offers, claiming that lawyers "are well versed in handling all types of commercial agreements from IP concerns to corporate and employment issues."
Client Service "We have not yet encountered another firm that sought to help us as much as they do."
Commercial Awareness "They have great expertise in the market and are impressively sympathetic to the needs of business."
KEY INDIVIDUALS Expert patent litigator Simon Cohen enjoys a strong biosciences background that he puts to good use in working for pharmaceutical clients. Commentators note that "he adds a sense of strategic direction that has proven crucial to our business." James Marshall is an IP specialist who impresses with his track record and output, according to sources. He recently advised Generics UK in a patent dispute against Cephalon. Malcolm Bates heads the life sciences group and brings a great deal of experience in biology and biotechnology to the table, having worked in these fields both academically and in-house. Clients appreciate his "great knowledge and expertise" and look to him for guidance on complex financing and collaboration agreements. Simon Walker specialises in venture capital matters and has provided input on a string of life sciences deals. He recently acted for Xention on an £8 million series D financing. Cambridge-based special counsel Susanna Stanfield is building an excellent reputation for her work on life sciences transactions. Clients say she is "highly responsive, organised and a real pleasure to work with."
Well-regarded
Jonathan Radcliffe recently joined Mayer Brown from Nabarro LLP. He is deemed a sharp patent litigator who has been heavily engaged in US-focused work. Regulatory expert
Anthony Warnock-Smith of Morgan, Lewis & Bockius LLP is lauded as
"pragmatic and relaxed; he takes issues as they come and doesn't get into unnecessary fights with the other side." His practice, which has a strong international element, also takes in transactional work.
Gareth Morgan recently arrived at Winston & Strawn to boost the group's regulatory understanding. He is known as an excellent communicator who is
"well structured in his approach and greatly knowledgeable on all relevant legislation." Andrew Edge of Stephenson Harwood is a transactional specialist who recently advised Mumbai-listed pharmaceutical company Piramol on a USD3.7 billion deal with Abbott Laboratories. Clients consider him
"an incredibly pragmatic lawyer, a great sounding board and the ideal partner for our business needs." Jane Hobson of Baker & McKenzie LLP is an expert in cross-border pharmaceutical M&A transactions.
"We can't sing her praises highly enough," details one source, adding that
"she's supportive and very clear in her advice." Janet Knowles of Eversheds LLP is known for her
"realistic, practical advice that allows clients to make informed decisions." A transactional specialist, she recently assisted Vertex Pharmaceuticals on a series of clinical trial agreements.
Chris Shelley of Manches LLP has a wide-ranging life sciences practice. Clients say he is
"one of those people that you have instant confidence in - you immediately get the sense that he really knows what he's talking about." Clare Tunstall of Pinsent Masons is an accomplished litigator who recently advised Teva on galantamine patent revocation proceedings against Janssen Pharmaceutical.
Rebecca Halford-Harrison of K&L Gates is building an excellent reputation through her work with such notable clients as Neuralstem, who sought her advice on a series of patent disputes. Clients say she is
"easy to work with, technically savvy and focused on the business goal as well as the legal details." Reading-based
Janita Good of Osborne Clarke is deemed an
"organised and able" transactional lawyer with a refined understanding of life sciences and a strong scientific background.
Graham Defries of Dechert LLP is felt to be a highly skilled cross-border M&A lawyer with an increasingly active profile in the life sciences sector. He recently advised Biocon on a USD350 million licensing and supply agreement with Pfizer. Clients say he is
"smart, business-savvy and a top negotiator." Sangeeta Puran of Mayer Brown International LLP is a
"highly effective and very well-organised" practitioner, sources reveal. She was recently promoted to the partnership and is much admired by clients for her work on the IP side of corporate life sciences deals.
Anne Ware of Kennedys sits at the top table of product liability experts and routinely advises clients on complex multi-jurisdictional issues.
Gary Moss has recently joined EIP. He is a tested litigator with many years of high-quality experience to draw upon in dealing with complex patent disputes.