The Osborne Clarke biotech and pharmaceutical team brings expertise that spans both the scientific and commercial worlds. Possessing technical qualifications and hands-on industry experience, our Europe-wide network of lawyers has built its reputation providing co-ordinated advice to international clients across the sector, as well as those who support biotech and pharmaceuticals with services and technology.
From complex patent litigation and licensing, manufacturing and supply agreements, and technical regulatory advice, through to cross-border mergers and acquisitions - we can help you negotiate the many legal intricacies and emerging complexities you face today.
More than that, our sector specialism can help you develop long-term strategic plans, built on the strongest possible legal foundations.
A selection of our experiences
Patent & Technical Disputes
Pfizerv Amgen and Amgenv Sanofi & Regeneron cases in the English Patents Court concerning cardiovascular diseases and alirocumab/Praluent®.
Takeda v Roche case Invalidating Roche's patent to fucosylated monoclonal antibodies which was asserted against Takeda's blockbuster vedolizumab treatment.
Advised GlaxoSmithKline, in defence of arbitration claims brought by the Department of Health in relation to the treatment of brand-equalisation deals under the Pharmaceutical Price Regulation Scheme.
Advised Amgen, multinational biopharmaceutical company, on proceedings concerning Amgen’s cholesterol-lowering anti-PCSK9 antibody in the English Patents Court (Pfizer v Amgen; Amgen v Sanofi & Regeneron), and co-ordination of the concurrent actions in Germany, France, Spain, Italy and the Netherlands.
Advising Amgen vs Regeneron and Sanofi on their litigation strategy in respect of the intensely competitive new clinical field of cholesterol-lowering antibodies for the treatment of cardiovascular disease.
Advising Santen in relation to the expired compound patent for its leading ophthalmic products for the treatment of glaucoma and high intra ocular pressure, TAPTIQOM® and TAFLOTAN® in Europe.
Advising a British multinational pharmaceutical company in assessing the risks associated with the launch of a generic medicine in Italy and in particular the actions it may or may not take before the patent or supplementary protection certificate of the original product has expired.
A German subsidiary of the market leader in transfusion medicine on the defence of an established patient support programme for chronically ill patients to avoid visits to the doctor for intravenous infusions.
Advising a leading pharmaceutical company on the entry into the market of a generic fixed-dose combination product in the light of the patent linkage provision set out in the Balduzzi Decree, as well as the new competition law under discussion in May/June 2022 by the Italian Parliament.
Regulatory & Compliance
Advised Ajinomoto, a Japanese food and biotechnology corporation, on the regulatory requirements in UK/EU for placing new stem cell culture product on the market.
Advised Daiichi Sankyo, global pharmaceutical company, on concerns over breaches of procurement law against NHS England, in relation to a contract award made for Direct Oral Anticoagulants. The issues were novel in light of the application of the exemption to the PCR due to COVID-19 pandemic.
Advised Amring Pharmaceuticals, privately held pharmaceutical company, on regulatory approval for a generic drug.
Advised Reckitt Benckiser, British multinational consumer goods company, on Brexit related medical regulatory requirements in their health division.
Advised OncoDNA, company specialising in precision for the treatment of cancer and other genetic diseases, on various key collaborations with distributors, academic centres, pharma and biotech companies in the field of DNA sequencing and molecular pathology, as well as SaaS services for personalised cancer management.
Advised Penn Pharmaceuticals, drug development and manufacturing company, on its standard terms and on bespoke agreements for the manufactureand supply of clinicaland commercial product. Penn Pharmaceuticals operates a purpose built high containment facility for the manufacture of oncology drugs and a wide range of API.
Advising Ajinomoto, a Japanese food and biotechnology corporation, on the regulatory requirements in UK/EU for placing new stem cell culture product on the market.
Advising Grifols Italia on the CE marking of Medical Devices and software solutions, applicable laws and obligatory requisites in order to start a post-marketing clinical trial regarding a medical device bearing the CE marking, and the implementation of transparency (sunshine) laws.
Advising Grifols on the implementation of its reporting channel in line with EU Regulations.
Advising Mahana Therapeutics on license agreement with pharmaceutical company on DiGA applications.
Advising Mallinckrodt and Therakos in France on regulatory, commercial and compliance (interactions with HCPs, HCOs and patients’ communities; French Regulatory "Exploitant License").
Reviewing advertising materials for a listed biotech company under Dutch regulations and industry requirements.
Advising a market-leading US based clinical trials company on its European expansion including advice on where to locate its European head office, corporate structure, workforce structure, data privacy and regulatory matters.
Advising a novel drug company on importing investigational drugs and delivery devices into the EU before further distribution for use in clinical trials.
Advising on the regulatory aspects surrounding the launch of a prospective study sponsored by
a rare disease's biopharmaceutical company.
Advising on industry interactions between a listed South Korean pharmaceutical company and healthcare professionals and healthcare organisations based in The Netherlands.
Advisory
Advised Grifols, multinational pharmaceutical and chemical manufacturer, on its day to day UK employment law advice, including advice in respect of business protection, senior executives and global employment policies.
Advised hVIVO plc, a leading services provider in viral challenge studies and laboratory services on its offer from Open Orphan plc, which constituted a reverse takeover, in relation to option arrangements.
Advised BioNTech, a German biotechnology company that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases, on Real Estate matters in Germany.
Advised Bone Therapeutics, bone cell therapy company, on key collaboration with Cerhum, 3D-Side, mSKILand IREC to develop personalised, tissue engineered bone implants.
Advised a leading medical technology company, on the use of AI pricing algorithms and collaboration opportunities.
Advised UK BioIndustry Association and biotech consortium, on the COVID-19 Antibody Taskforce, which is a consortium of leading antibody development companies in the UK (including Abcam, Alchemab, Iontas and Kymab) led by the BIA, and drafting related documentation to protect the output of the project. The goal of the Taskforce is to develop an antibody-based treatment for patients with COVID-19.
Acting for Aflofarm Farmacja (one of the biggest Polish OTC pharmaceutical manufacturers) as a lead legal adviser in relation to its updated business model, advising on the remodelled IP licensing schemes (trademarks and copyrights to advertising campaigns).
Advising Basecamp Research on various employment matters as well as advising on commercial arrangements and incentives.
Advising Epitopea on various consultancy agreements.
Advising Grifols in numerous jurisdictions on the leasing and acquisition of real estate, commercial contracts and employment issues.
Advising Miltenyi on the review of their T&Cs for sales and maintenance of connected medical devices.
Assisting Novo Nordisk on a daily basis with their employment law issues (individual and collective) as well as post Covid19 advice including assistance in the overhaul of its telework policy, the quality of life at work policy and the negotiation of an agreement on professional equality between men and women.
Advising Teva daily with their employment law issues (individual and collective).
Advising Therakos on their T&Cs for sales contracts of medical devices and negotiations with hospitals.
Assisting a Danish pharma company in the potential restructuring of its entities in the framework of the elections of the members of the H&S committee.
Advising a German biotechnology company on a range of contract law issues (in conjunction with IP) but also on issues relating to mechanical and plant engineering.
Advising a global biotechnology company headquartered in Germany on the review of terms and conditions of service (B2B), privacy and regulatory issues relating to the marketing of a class IIB medical device, which functions as an incubator for cells for diagnostic purposes.
Assisting an Italian pharma group with the restructuring of its sales team, triggering complex questions to avoid discrimination.
Advising the largest private blood donation facility in Germany on the implementation of a partially cross-company organizational structure, taking into account the risk of joint operation versus employee leasing; advising on the establishment of a new laboratory operation with simultaneous retraining of employees with the involvement of the works council.
Transactional
Advised Takeda, multinational pharmaceutical, on its investment in, and option to acquire, Adaptate Biotherapeutics, a biotechnology company spun-out of GammaDelta Therapeutics and focused on developing an antibody-based therapeutic modulation of γδ T-cells.
Advised Oxular, leading clinical-stage retinal therapeutics company, on its £27m financing led by Forbion Capital Partners with support from the company’s existing leading investors.
Advised Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, on its $53m (£38m) Series B financing round. The investment proceeds will be used to accelerate the company’s growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and to extend its proprietary TPD platform.
Advised RHYTHM AI, a British spin-out from St Bartholomew's Hospital focused on the treatment of Atrial Fibrillation, on the closure of a seed financing round.
Advised NeRRe Therapeutics Limited, British clinical-stage company, on its £20m Series B2 financing round which involved a syndicate of leading transatlantic life sciences investors.
Advising AviadoBio Ltd, a pioneering gene therapy company focused on developing and delivering transformative medicines for people living with neurodegenerative disorders, on its US$80m (£58.6m) Series A financing round.
Advising BioNTech on its £562m acquisition of AI start-up, Instadeep, its largest transaction to date.
Assisting BioSenic, a biotech company listed on Euronext Paris and Brussels, on its due diligence and reverse merger acquisition of the French company Medsenic.
Advising Bio-Sourcing in the acquisition of assets from Vitam Fero (animal health – vaccines R&D).
Advising Cambrooke Therapeutics on the acquisition of an Italian distributor of medical / nutritional products, Quaris.
Advising the shareholders of Genome Diagnostics (GenDx), a leading HLA diagnostics company, in the competitive auction process relating to the sale of GenDx to Eurobio Scientific for an amount of €135m.
Advising Grifols on the acquisition of Hong Kong's Tiancheng International Investment Ltd. to acquire 100% of the shares of Tiancheng Pharmaceutical Holdings AG, which holds approximately a stake of 89.88% of Biotest ordinary shares and 1.08% of Biotest preferred shares for approximately EUR1.1bn.
Advising Grifols on the acquisition of US medtech company Medkeeper – including further advice on its sale to Becton Dickinson (BD).
Advising Hadean Ventures and Sunstone Life Science Ventures on their investment in Step Pharma, a biotechnology company focused on the development of a new class of CTPS1-targeted nucleotide synthesis inhibitors.
Assisting ImmunXperts, an immunogenicity services company, on their vendor due diligence and sale to Canadian based Nexelis group.
Advising a large international biotech on all real estate, construction and tax aspects of an agreement for lease and lease and fit-out of new a HQ incorporating research laboratory and office space in Cambridge, England.
Advising a leading multinational pharmaceutical company on the transfer of its pharmaceuticals production facility at Bulciago (LC).
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