Our Life Sciences and Healthcare Sector Focus 2022
Our Life Sciences and Healthcare Sector Focus 2022
Our Life Sciences and Healthcare Sector Focus 2022
allenovery.com
2 Our Life Sciences and Healthcare sector focus | 2022
Contents
Introducing Allen & Overy 04
Full service, international support for
the life sciences and healthcare sector 05
M&A/corporate finance 06
Licensing and collaborations 09
Patent litigation 12
Regulatory 15
Dispute resolution/arbitration 16
Equity and debt financing 17
Restructuring 18
Key contacts 19
allenovery.com 3
Introducing Allen & Overy
Global leader
12% 40
The world’s leading transactional law firm
580
Partners We advised on 12% more deals than our Over 40 offices
nearest competitor in 2020 around the world
2,400
Data sources: Refinitiv and Dealogic. Based on data from the live
database on 1 February 2021 therefore figures could differ from
published press releases.
5,650
People
30 29 17 15 4
Advanced
3 2
Global presence
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M&A/corporate finance
The combination of our leading M&A practice and our Our expertise and local knowledge in the M&A market
specialisation in the life sciences and healthcare sector ensure that we deliver cost-effective, seamless, high-quality
differentiates us from other international firms in the M&A legal advice. Our strong teamwork and uniform approaches
market. We have a reputation for getting to the heart of are vital to ensuring that cross-border deals are managed
the most complex issues, focusing on strategy, structuring effectively. Efficient working practices and commercial
issues and minimising execution risk. Our team advises on pricing enable us to deliver ‘more for less’.
the full range of M&A transactions from smaller, mid-tier
transactions to cross-border, complex acquisitions. We have
experience advising on all forms of acquisitions, including full
business and asset sales, asset swaps and the acquisition
of stakes in companies.
Mediq
Bridgepoint Advisers Limited On its USD1bn public takeover by Advent International and
A UK private equity house, via its portfolio company subsequent delisting.
PharmaZell on their acquisition of French Groupe Novasep
from private equity houses Silver Point Capital and Blackrock.
We also advised on a transaction-related financing. BTG
On its GBP3.3bn takeover offer by Boston Scientific,
the U.S.-based medical technology company.
Q2 Solutions
A leading global clinical trial laboratory services organization,
and a wholly owned subsidiary of IQVIA, Inc. in connection Crucell
with the sale of Nexelis, a portfolio company of Ampersand On its EUR1.75bn public takeover by Johnson & Johnson.
Capital Partners.
Walgreens
A.P. Moller Holding On its acquisition of a USD6.7bn 45% stake in Alliance
On the acquisition of Unilabs, the leading European provider Boots, the leading international pharmacy-led health and
of medical diagnostics services. beauty group, with an option to acquire the remaining 55%
stake in three years.
Kiadis Pharma
Consort Medical
A Dutch clinical stage biopharmaceutical company, on
the EUR308m public offer by Sanofi, an international On the sale of its U.S. business, King Systems Corporation,
pharmaceutical company. to Ambu A/S, a Danish medical devices manufacturer.
Arseus
Biomet On its acquisition of U.S.-based Freedom Pharmaceuticals.
On the USD300m acquisition of Merck KGaA’s 50% stake
in the Dutch orthopaedics and biomaterials joint venture
BioMer C.V. between Biomet, Inc and Merck KGaA. Adamed Pharma
On the acquisition of shares in Pabianickie Zakłady
Farmaceutyczne Polfa, one of the largest state-owned
Grünenthal producers of pharmaceuticals in Poland. This was one of the
On its acquisition of AstraZeneca’s European rights to most significant over-the-counter privatisation transactions.
prescription Nexium and the global (excluding the U.S.
and Japan) rights to Vimovo for USD922m.
Circassia Pharmaceuticals plc
On its acquisition of Aerocrine AB and Prosonix Limited,
GE Healthcare both funded through a GBP275m placing and open offer.
On its agreement to acquire PAA Laboratories, a worldwide
distributor of cell culture products; on the sale of its patient
statement printing and mailing services business; on its BTG
acquisition of VersaMed; on its USD100m acquisition of the On the USD200m acquisition of the Targeted Therapies
assets of Dynamic Imaging; and on its acquisition of Wave division of Nordion (a Canadian-listed company which
Biotech’s bioreactor business. manufactures and markets Therasphere, a product used
in the treatment of liver cancer), and on the USD180m
acquisition of EKOS Corporation, (the U.S.-based
Nikko Principal Investments manufacturer and distributor of the EkoSonic Endovascular
On the disposal of its 80% partnership interest in UK Healthcare System, a differentiated interventional product for use in the
Limited Partnership. treatment of severe blood clots).
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rogress Medical
P EC de Witt
On its acquisition of 90% of the shares in OB Klinika, The UK subsidiary of U.S. firm CB Fleet, on the sale
a surgical clinic in Prague, offering medical services in by competitive auction of its European speciality
aesthetic, bariatric, orthopaedic, and dental and jaw surgery. pharmaceuticals business to Recordati España.
yntaxin
S JHI
A leader in recombinant botulinum toxin technology, on its The international arm of Johns Hopkins Medicine, on the
acquisition by Ipsen for an upfront payment of EUR28m and acquisition of a stake and a joint venture with Saudi Aramco
milestones with a potential value in excess of EUR130m. to establish a new healthcare provider for Saudi Aramco.
This is a significant deal as it represents the first time an
American institution has invested in healthcare in Saudi Arabia.
inetic Concepts (KCI)
K
On its USD485m acquisition of Systagenix
Wound Management. oho Global Health
S
A leading Indonesian pharmaceutical business, on the sale
of a strategic stake in its ethical pharmaceutical business to
Novartis Fresenius and the related joint venture arrangements.
On the disposal of its 43% stake in LTS Lohmann
Therapie-Systeme AG to dievini Hopp BioTech holding
GmbH & Co. KG. The disposal has been agreed in Sartorius Stedim Biotech
co-operation with co-investor BWK GmbH On the public takeover of TAP Biosystems Group.
Unternehmensbeteiligungsgesellschaft which is also
selling out to dievini.
Optos
On the proposed offer by Nikon Corporation for the entire
Novartis
issued and to be issued share capital of Optos.
On the USD1.7bn sale of its Emeryville California-based
Diagnostics Unit to Grifols.
Deb Group
A portfolio company of existing client Charterhouse
Russia Partners
Capital Partners, on Deb Group’s acquisition of the Stoko
On the acquisition of a 15% stake in Invitro Holding. Professional Skin Care business from Evonik Industries.
martPractice
S Kladis Pharma
The global leader in diagnostic patch test allergens and A Dutch clinical stage biopharmaceutical company, on
chambers for the diagnosis of allergic contact dermatitis, the EUR308m public offer by Sanofi, an international
on the acquisition of Epicutantest Hermal/TROLAB patch
pharmaceutical company.
test business from Almirall.
fizer
P GE Healthcare
On an innovative agreement with GlaxoSmithKline to create a On a number of licensing and collaboration agreements and
HIV joint venture, ViiV, and subsequently on the amendment separation issues in connection with the disposal of a group.
to this arrangement to bring on board the Japanese
pharmaceutical group Shionogi.
UCB
On strategic global collaborations with Biogen, ImClone,
Amarna Therapeutics Immunomedics, Amgen and Millennium regarding the
On several strategic collaboration agreements with investors research, development and commercialisation of various
and research institutions. products, including advising on the application of the
Hart-Scott-Rodino Act.
Cambridge Laboratories
On a number of pharma product, research, collaboration and fizer
P
licence agreements; and on the licensing of marketing and On a range of technical collaboration and funding
distribution rights for its drug Tetrabenazine. arrangements with PRC universities and research institutes.
A global healthcare company Biomet 3i
On its licence and manufacturing agreement with MolMed for On its termination of its collaboration with Renishaw in
viral vectors and gene therapy products. relation to the distribution of dental scanners.
erck Millipore
M Syntaxin
On the negotiation and drafting of a development agreement. On strategic development and licensing agreements with
Ipsen relating to the use of botox in a therapeutic environment.
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Janssen Pharmaceutica Consort Medical
On an outsourcing project of analytical development services On a collaboration with an international pharmaceutical
with a global leader in the testing, inspection and certification company for the development, and if development is
of products. successful, the manufacture and supply, of a new medical
device to be used for drug delivery. The agreement covers
extensive R&D, the building of a new plant and long-term
Mubadala/Cleveland Clinic supply commitments.
On a master services agreement with IBM in relation to the IT
infrastructure of the Abu Dhabi Cleveland Clinic facility.
Almac
On reviewing and amending a licence agreement with Aerial
Thrombogenics Pharma relating to the supply of products.
On a series of template IP collaboration agreements,
including a master services agreement and a clinical testing
services agreement. Multiplicom
A spin-off from the University of Antwerp which develops,
manufactures and commercialises genetic test kits based on
biobank institution
A the latest molecular diagnostic technologies, on a number of
On various commercial and IP issues, including the contracts with suppliers and customers.
negotiation of an agreement with a third-party provider of
gene analysis services and the drafting of a collaborative
research agreement. ill’s Pet Nutrition
H
On the creation of a template sponsorship agreement for use
when entering into sponsorship agreements with universities
elchim Crop Protection
B in the U.S. and Europe.
On various commercial contract and commercial law issues,
including distribution issues.
t. Jude Medical
S
On entering into a partnership with a major university in the
GN Resound Netherlands with regard to the development of new medical
On an agreement with Cochlear, pursuant to which GNR equipment for treating heart failures. St. Jude Medical received
licensed its wireless technology to Cochlear for use in a grant from the Dutch Government for this research.
connection with cochlear implants, and also agreed to We advised them on the entitlement to patents that were
undertake certain development work. applied for, and that could be granted with regard to the
results of the research. We carried out a general review of
the terms of the partnership, the scope of protection of the
ovartis Consumer Health Services
N relevant patents in relation to the research, and advised St.
Jude Medical on the best strategy for approaching this matter.
On its existing distribution arrangements in the context of
recently introduced regulations by the Qatari Health Authorities.
Exscientia
On a series of collaborations with pharmaceutical partners
for the deployment of Exscientia’s AI drug discovery
technology in relation to various drug discovery targets,
including its USD5.2bn strategic research collaboration
with Sanofi to develop an AI-driven pipeline of precision-
engineered medicines.
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Patent litigation
We act for the world’s leading companies in major multi- Frequently, a firm technical understanding is crucial to securing
jurisdictional and national patent disputes across all sections success: many of our lawyers have technical backgrounds and
of the life sciences and healthcare industry. We represent our industry experience and can advise clients with confidence in
clients in the many different courts and tribunals worldwide cases involving the most complex technology. This includes
which are important in patent matters. team members with degrees in natural sciences, structural
molecular biology and biochemistry.
Our Patent teams are adept at exploiting the different
procedural and tactical possibilities these forums offer. We also advise our clients on the interplay between patent
This includes, for example, securing evidence, obtaining fast litigation strategy and regulatory matters. This axis has
interim relief or obtaining a favourable hearing. This enables assumed increasing importance in the courts in recent years,
us to co-ordinate litigation and settlement strategies to particularly when dealing with Supplementary Protection
achieve the right outcome for our clients. Certificates, Paediatric Extensions and matters relating to
data exclusivity.
Chinese companies of the Beijing Genomics A global pharmaceutical and healthcare company
Institute (BGI) group On advising and representing the company in enforcing and
The main challenger in the field of genetic sequencing, defending validity of their SPC covering Losartan against
regarding a dispute against the market leader, Illumina generics of Losartan + HCTZ. This case was a premiere in
Cambridge. The patents at stake involve extremely complex Europe raising the issue of interpretation of Articles 4 and 5
DNA sequencing technology, including machines, reagents of the SPC Regulation on the scope of protection of SPCs
and nucleotides. and paediatric extensions.
fizer
P Abbott
In enforcing its second medical use patent for its blockbuster, In a number of patent disputes relating to vascular stents
Lyrica (pregabalin), against Actavis and a large number of in France, part of an international battle against Evysio
generic companies in the UK, France and Germany. and Medtronic with related cases in the U.S., the UK,
Germany, Ireland and the Netherlands, including obtaining a
declaratory judgment of noninfringement in France (a route
Novartis rarely used there).
On a multi-jurisdictional biotechnological patent dispute
(against MedImmune, part of Astra Zeneca) relating to
the blockbuster drug Lucentis. This involved detailed Abbott
understanding of molecular biology, antibody engineering On obtaining the first preliminary injunction in a patent
and phage display screening technology. infringement case in the history of the Beijing courts.
Novartis Ambu
On a case where we obtained, in less than 3 days, a On its pan-European strategy and advice in relation to
preliminary injunction against Sanofi’s generic, which parallel national patent infringement and nullity actions in
was launched three weeks before the expiry of Novartis’ connection with its market-leading medical device
supplementary protection certificate. This case was a (laryngeal masks).
premiere in France where an injunction was ordered on an
ex-parte basis, prohibiting the marketing of Sanofi’s generic
products in 24 hours. The ex-parte order was confirmed inter
partes upon appeal of Sanofi in 48 hours.
Beckman
global healthcare company
A In a patent infringement dispute with Oxford Gene
On global surveys and conclusions on patent erosion Technology over nucleotide chip devices, including an
in emerging markets and on criminal offences for appeal to the English Court of Appeal.
patent infringement.
Biomet
A global pharmaceutical and healthcare company On numerous cases in relation to patents covering prosthesis.
In an infringement action against Teva who launched its
generic before the expiry of the company’s supplementary
protection certificate. Degussa
In a dispute with Novus regarding the bio-efficacy of natural
methionine versus synthetic methionine.
Novartis
On obtaining a preliminary injunction against off-label use
that infringes Novartis’ patent by a generic company in Electro Medical Systems and Ferton
Beijing. This was the first preliminary injunction of this kind In several patent litigation cases in relation to technology
in China. covering dental cleaning devices and medical instruments for
treating biological tissue.
Novartis
As exclusive licensee of Genentech’s patent, we advised in Guerbet
relation to patent revocation and DNI proceedings brought In a dispute concerning patents covering medical devices.
by Regeneron/Bayer to clear a path for “Eyelea” in the UK,
France, Germany and Italy. We worked with Genentech’s
legal counsel on case strategy, with a successful outcome for Haselmeier
Genentech and Novartis both at first instance and on appeal.
In nullity and appellate proceedings initiated by Novo Nordisk.
Pfizer
Inverness Medical
In an action brought by Actavis in the UK to revoke Pfizer’s
On the cross-border enforcement of its patented rapid
patent protecting its extended-release formulation of
immunoassay technology.
pramipexole – a treatment for Parkinson’s disease.
We successfully obtained the key strategic objective of the
case by obtaining a stay of the English proceedings pending
KCI
the EPO Opposition. This has maintained the status quo
across Europe pending the outcome of the EPO Opposition. In a patent licence dispute against Dr. William Fleischmann
regarding patents in the area of medical devices for use in the
field of wound care, tissue repair and tissue engineering.
Regeneron Pharmaceuticals
On its global patent enforcement strategy. This includes A global pharmaceutical and healthcare company
initiating patent infringement proceedings in the UK (against
Advice and representation on nullity actions against the
Kymab and Novo Nordisk) and in the Netherlands (against M
company’s patent covering dosage regimen. This case was
erus) as well as assisting in the coordination of the global case
raised for the first time before the French Courts on the issue
(which includes litigation in New York and patent opposition
of patentability of dosage regime claims.
proceedings at the European Patent Office (EPO) in Munich).
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Novozymes A global pharmaceutical and healthcare company
In a patent infringement dispute against Danisco in relation On an English High Court patent action against Genentech
to enzymes for the production of second generation biofuels. to achieve freedom to operate and commerical certainty in
relation to the healthcare company’s anti-IL-17 antibody,
Taltz, in five countries.
Purac Biochem
On patent infringement proceedings in the field of
biodegradable polymers used for pharmaceutical purposes. A multinational genomics company
On a dispute with a major patent portfolio owner relating to
integrated systems for the analysis of genetic variation and
Pfizer
function. The dispute arises from the patentee’s attempts to
On the validity of its paediatric extension to its Supplementary seek licence fees in relation to a patent pool that it is party
Protection Certificate (SPC) for the world’s largest to with another major player in genetic sequencing. We have
pharmaceutical, Lipitor, in the UK and across Europe, been advising our client on strategy for defending these
in response to a challenge from Dr Reddy’s.
claims on a pan-European basis, as well as in Asia.
Millennium Pharmaceutical
CB Pharma
U On regulatory aspects for the supply agreement of certain
On a potential contractual dispute and the possibility of pharmaceutical products in Italy.
invoking the “not” exception for (pre)clinical trials.
Novartis
A global healthcare company On a global technology agreement with Cegedim Relationship
On regulatory, warehousing and distribution issues relating to Management, for the processing of data Novartis is required
their operations in Slovakia. to collect and submit regarding certain payments and items
of value given to physicians and teaching hospitals under the
Physician Payments Sunshine Act.
A global pharmaceutical and healthcare company
On various employment law issues and regulatory, Crucell Holland
advertising and compliance issues relating to new
A subsidiary of Janssen Pharmaceutica, on the contracts for
pharamceutical legislation in Slovakia.
the European Commission’s IMI 2 grant that it has received
for developing an Ebola vaccine.
Synthes
On the compliance and enforceability under Belgian law of Reckitt Benckiser
its corporate policies on relationships with doctors; also on
In relation to proceedings commenced by the ACCC in the
regulatory, advertising and compliance issues relating
Federal Court of Australia.
to medical devices.
fizer
P
On the reimbursement and distribution of vaccines.
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Dispute resolution/arbitration
We have extensive experience of advising on commercial and contract disputes.
In addition, we are seen as experts in advising board members and senior-level
executives in relation to corporate risk management. We actively pursue alternative
avenues of dispute resolution and advise on choosing the method most appropriate
to our clients and the requirements of a particular matter. We have significant
experience of mediation, arbitration and negotiation across our global network.
A pharmaceutical company
On a criminal complaint by a former manager who was .S. contract manufacturer
U
dismissed as a consequence of a whistle-blowing procedure. On an ICC arbitration over misappropriation of
patented technology and know-how and breach
of confidentiality undertakings.
IQVIA
An American multinational company serving the combined
industries of health information technology and clinical t. Jude Medical
S
research, in relation to a post M&A dispute before the Paris In several product liability matters including against multiple
commercial court. claims following a product recall of the Riata lead (a lead
which connects an implantable cardioverter defibrillator
(ICD) to the heart in order to monitor heart rhythms).
Biomet
In several dozen product liability cases in France and the
Netherlands including a product liability claim from a patient A manufacturer of medical devices
for a broken reamer and a potential counterclaim against the On litigation relating to the termination of a distribution
hospital regarding techniques used during the operation. agreement/refusal to sell.
NMC Health
The arrangers On its IPO on the LSE. This was the first premium listing of
On the debt financing supporting KKR, Bain Capital and an Abu Dhabi company on the LSE.
Merrill Lynch Global Private Equity’s USD33bn acquisition
of HCA (a hospital operator in the U.S.).
Société Générale
On the credit revolving facility for Ipsen.
A British multinational banking and financial
services company
As mandated lead arranger on the USD650m acquisition
financing of U.S.-based Decision Resources Group by
Piramal Healthcare of India.
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Restructuring
Our presence in the restructuring market is truly international. Restructuring advice comprises not only debt restructuring
Fielding one of the largest international teams, we are known but also corporate restructuring including employment.
as one of the few practices with the ability to advise on Our global Employment group is a market-leading practice
extremely complex cross-border transactions. We aim to with expertise of local and global issues for both advisory
bring pioneering ideas to our clients’ transactions, advising and corporate transactional work. We possess extensive
on every single part of the capital structure. This is important experience in wide programmes of change management,
as restructurings become more and more multi-faceted, including reorganisations and collective lay-offs, as well as
demanding wide market experience, deep knowledge of the specific expertise in HR constraints and ramifications in
sector and specialist legal knowledge. Restructurings within merger and acquisition situations.
the life sciences and healthcare sector require a specific
sense of the challenges related to this regulated context.
Germany Netherlands
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Netherlands Poland UK
UK Middle East
U.S.
U.S.
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22 Our Life Sciences and Healthcare sector focus | 2022
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Global presence
Allen & Overy is an international legal practice with approximately 5,600 people, including some 580 partners, working in more than
40 offices worldwide. A current list of Allen & Overy offices is available at www.allenovery.com/global_coverage.
Allen & Overy means Allen & Overy LLP and/or its affiliated undertakings. Allen & Overy LLP is a limited liability partnership registered
in England and Wales with registered number OC306763. Allen & Overy (Holdings) Limited is a limited company registered in England
and Wales with registered number 07462870. Allen & Overy LLP and Allen & Overy (Holdings) Limited are authorised and regulated
by the Solicitors Regulation Authority of England and Wales.
The term partner is used to refer to a member of Allen & Overy LLP or a director of Allen & Overy (Holdings) Limited or, in either case,
an employee or consultant with equivalent standing and qualifications or an individual with equivalent status in one of Allen & Overy LLP’s
affiliated undertakings. A list of the members of Allen & Overy LLP and of the non-members who are designated as partners, and a list of
the directors of Allen & Overy (Holdings) Limited, is open to inspection at our registered office at One Bishops Square, London E1 6AD.
GB
© Allen & Overy LLP 2022. This document is for general information purposes only and is not intended to provide legal or other professional advice. CS2109_CDD-65812_ADD-100036