life sciences Balancing innovation with the global industry legal landscape

the legal landscape

The life sciences sector has undergone significant transformation in recent years with large biopharma facing loss of exclusivity on blockbuster drugs, increased regulatory hurdles and costs to bring pipeline products successfully to market and a rise in price and product competition for market and healthcare payment share. Competition for investment is also growing and the industry overall has gone through a wave of consolidation and restructuring.

As the new industry landscape emerges, the drive now is to take an innovative approach to product development and business operations in order to emerge stronger, compete in the market and achieve success. However with a new focus on transparency across the industry, balancing innovation with ever evolving legal and regulatory pressures is a challenge.

02 | Life Sciences

transparency: With the reporting regulations on the US Sunshine Act finalised and the development across Europe of legal and policy issues concerning the disclosure of clinical trial data, transparency is a ‘hot’ topic for all stakeholders in the healthcare and life sciences industry.

consolidation & Restructuring: As a result of significant industry consolidation in the form of megamergers, acquisitions, spin outs and sell offs many organisations are restructuring their global operations to adapt and respond to the market.

new Business Models & strategic alliances: The anticipation of future industry challenges is driving a rationalisation of excess internal capacity in order to share the costs and risks associated with expensive activities such as R&D with others. However this is also driving the need for innovative collaborations and strategic alliances in order to achieve the most effective and efficient business models.

Regulatory compliance and investigations: The regulatory compliance burden on the industry, already significant, shows no signs of decreasing. Larger organisations are continually finding themselves at risk from being targeted for ABAC, anti-trust investigations and global law enforcement, requiring a holistic and international approach to compliance.

the growth of emerging Markets:

Continued investment into BRIC and G20 countries, is also bringing a renewed focus on patent protection and competition laws. Operating in these countries is increasing the level of exposure for companies to government oversight and enforcement, particularly in areas such as clinical trial governance and fraud.

innovation – generics/Biosimilars: The line of distinction between innovator and generic organisations is becoming blurred particularly the biologics/biosimilars field with many innovators funding biosimilars R&D.

pricing and Reimbursement/Routes to Market: The cost of getting products to market increases but pressure from healthcare payers is also intensifying with increased market access challenges, mandatory price cuts and broader use of reference and value based pricing models.

life cycle Management: The tension between IP rights and anti-trust laws continues and regulatory rights have also become an essential component of end of life product strategies. The current legal climate is having a significant impact on the implementation and risk of product strategies requiring them to be continuously reviewed to ensure they remain legally compliant.

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Whether you are a large global biopharma or med tech group with multiple operations worldwide, small and entrepreneurial biopharma or medical device company with a niche product offering or a research based institution seeking to develop the next new drug or diagnostic device, navigating the industry legal landscape successfully can be a challenge.

helping You navigate the industRY legal landscape

“Fantastic global reach and highly accommodating timely approach.” – chambers

Our team is organised around one principle: bringing the best talent to bear across the DLA Piper platform to handle any matter of importance to our life sciences clients via:

■ Our Global Reach – we can proactively support you wherever you need us through our extensive network of offices and relationships with third parties.

■ Our Sector Team – DLA Piper’s Life Sciences team is one of the largest and most active life sciences practices of any law firm in the world. Our Life Sciences team consists of more than 250 DLA Piper lawyers, across all practices, in 30 different countries who focus on biopharma and medical device matters.

■ Our Sector Experience – this is a global industry sector for DLA Piper and is supported via a team immersed in Life Sciences. We bring our scientific and medical knowledge, deep understanding of the sector and operating environments, and local knowledge to bear on the most important issues facing the sector. This exposure provides us with an insight to and an understanding of the business world in which you operate.

gloBal Reach local expeRience

AUSTRALIABrisbaneCanberraMelbournePerthSydney

AUSTRIAVienna

BAHRAINManama

BELGIUMAntwerpBrussels

BRAZILSão Paulo

CHINABeijingHong KongShanghai

CZECH REPUBLICPrague

FRANCEParis

GEORGIATbilisi

GERMANYBerlinCologneFrankfurtHamburgMunich

HUNGARYBudapest

ITALYMilanRome

JAPANTokyo

KUWAITKuwait City

MEXICOMexico City

NETHERLANDSAmsterdam

NORWAYOslo

OMANMuscat

POLANDWarsaw

EGYPTCairo

ETHIOPIAAddis Ababa

GHANAAccra

INDONESIAJakarta

IRELANDDublin

KENYANairobi

MAURITIUSPort Louis

QATARDoha

ROMANIABucharest

RUSSIAMoscowSt. Petersburg

SAUDI ARABIARiyadh

SINGAPORESingapore

SLOVAK REPUBLICBratislava

ALGERIAAlgiers

BOSNIA-HERZEGOVINASarajevo

BOTSWANAGaborone

BURUNDIBujumbura

CROATIAZagreb

DENMARKCopenhagen

DLA PIPER RELATIONSHIP FIRMS

SOUTH KOREASeoul

SPAINMadrid

THAILANDBangkok

TURKEYIstanbul

UKRAINEKyiv

UNITED ARAB EMIRATESAbu DhabiDubai

UNITED KINGDOMBirminghamEdinburghLeedsLiverpoolLondonManchesterShef�eld

MONGOLIAUlaanbaatar

NAMIBIAWindhoek

NEW ZEALANDAuckland Wellington

PORTUGALLisbon

RWANDAKigali

SOUTH AFRICACape TownJohannesburg

UNITED STATESAlbanyAtlantaAtlantic CityAustinBaltimoreBostonChicagoDallasHoustonLos AngelesLa JollaMiamiMinneapolis

New YorkNorthern VirginiaPhiladelphiaPhoenixRaleighSacramentoSan DiegoSan FranciscoSeattleShort HillsSilicon ValleyTampaWashington, DCWilmington

SWEDENStockholm

TANZANIADar es SalaamMwanza

TURKEYAnkara

UGANDAKampala

VENEZUELACaracas

ZAMBIALusaka

04 | Life Sciences

full spectRuM advice

“The excellent service leads to successful commercial outcomes.” – chambers

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to prosecutors in multiple jurisdictions

Patent challenges and enforcement

IP Strategy/lifecycle management and R&D investment

Anti-counterfeiting and trade marks

Social media presence and business operations

M&A and due diligenceLicensing and collaboration

agreementsVC/Private Equity and other

financing structuresSupply Chain agreements

Business restructuringData Privacy and Data

ProtectionGovernment affairs/

administrative lawHR

Product liabilityCommercialSecurities and derivative

litigation

Competition and antitrust advice

Clinical trial/investigation programmes

Drug device approvalsMarketing and promotion

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■ Advising a large international biopharma’s EU regulatory and public affairs team in Europe on a number of forthcoming changes to the pharmaceutical structure in Europe, including changes to pricing and reimbursement structures, the Transparency Directive and the pharmaceutical sector enquiry.

■ Conducting FCPA investigations in Japan, Korea, Indonesia, Thailand, and Taiwan for a large US based international pharmaceutical company.

■ Advised a company on its EU entry strategy for an Alzheimer’s treatment, including co-ordinating the patent, SPC and regulatory position in the UK.

■ Advising St Jude Medical on the EU plus 16 other CIS, Middle Eastern and African countries on managing changes to the registration of medical devices.

■ Acting for an Indian based pharmaceutical producer in the European Commission’s on-going investigation into ‘pay for delay’ pharmaceutical patent settlements.

■ Advised a leading medical technology organisation on its global litigation strategy, representing it in patent infringement and/or revocation actions across a number of European counties. The matter involved the management of complex inter-play of proceedings in multiple countries, leveraging procedural differences between jurisdictions and dealing with judicial decisions in different countries in order to achieve best overall outcome.

■ Acting for a large biopharmaceutical company with regards to a challenge to a patent covering a special crystal form of a particular drug. This involved ground-breaking legal issues in the US on “product-by-process” claims and crystal form claims.

■ Representing an international healthcare group in various parallel patent litigation cases in the US and Germany relating to surgical instruments and developed and implemented cross-border patent enforcement strategies.

■ Advising Aptalis Pharma on sales consultancy agreements for their EU operations that were addressing compliance issues including French transparency regulations.

■ Representing a global medical technology business in relation to product liability claims in respect of medical devices.

■ Advising a global biopharmaceutical company in relation to setting up its multi-jurisdictional compliance program. This involved setting up the program, drafting all related policies and procedures, reviewing and advising on promotional materials, various pharmaceutical regulations and rules on interaction with government officials, conducting due diligence of business partners and advising on clinical investigations.

■ Working with a major global pharmaceutical company on the rollout of 3 global, multisite clinical trial programmes across 15 jurisdictions. Providing a central team to coordinate and manage the overall implementation effectively and co-ordinating local DLA Piper lawyers to negotiate and advise on local law issues as required. Working in each case with the clinical trial team and CRO to develop appropriate clinical trial agreement templates, fall back positions and FAQs aimed at speeding up execution of clinical trial agreements (CTAs) across sites and, as far as possible, standardising the terms of the CTAs executed.

■ Advising a number of large international pharmaceutical companies on all aspects of numerous clinical trials, including drafting clinical trial agreements, advising on ICFs and advising on subject-injury payments issues, including obligations under the Medicines Australia’s Guidelines for Compensation.

■ Assisting one of the most innovative pharmaceutical groups in the world in the negotiation and execution of the agreements with Spanish leading hospitals and research institutions covering several series of clinical trials of new products.

■ Advising Incyte Pharmaceuticals on all the regulatory and commercial aspects of one of its key studies (or clinical trials). The clinical trial is being conducted over numerous jurisdictions including Australia, China, Hong Kong, Japan, Thailand and numerous countries in Europe. It is a significant study.

■ Providing advice to a Russian company and its group involved in organization of clinical trials (medical testing at preregistration phase) and operating in various jurisdictions across Eastern Europe and in the US, on various structuring issues in connection with the company’s contemplated expansion to Western European markets, including performance of a limited due diligence.

gloBal expeRience

06 | Life Sciences

■ Advising Austrian biotech company Intercell AG, in every phase of the negotiation, conclusion and implementation of pre-clinical and clinical studies.

■ Advising a leading university on their multi-million pound collaboration with a drug development company relating to a potential cancer treatment drug.

■ Advising global biopharmaceutical company with the commercialisation in the EU of a triple combination and anti-retroviral drug, including negotiation of joint ventures and various contractual arrangements for supply and distribution.

■ Acting for a global biopharmaceutical company on a joint venture with several of its competitors with regard to the manufacture and pan-European marketing and distribution of certain pharmaceutical products.

■ Advising GE Healthcare on a JV project related to import and distribution of pharmaceuticals in Russia, including advice on Russian pricing regulations.

■ Advising an innovative US-based pharmaceutical company in respect of the establishment of operations in France, including pharmaceutical establishment licensing regimes, ethics and compliance policies and data protection regimes.

■ Acting for Dentsply International, a global orthodontics company, in a cross border investigation and litigation involving the misuse of highly confidential information and a staff poaching in multiple jurisdictions. We acted for Dentsply in France, Germany, Switzerland, Japan and the UK to co-ordinate the forensic investigation, data privacy issues search orders and other legal action to protect Dentsply’s position in a market worth over US$200 million to the company. This case demonstrates how our international capability makes us a natural choice for big ticket employment litigation and shows our ability to deploy cross border multi-disciplinary teams.

■ Leading a multi-jurisdictional team advising a leading life sciences company, arising from the acquisition of a company across eight jurisdictions. The company purchased businesses across Asia Pacific and as part of that made offers of employment to a number of employees in countries throughout the region, including Australia, China, Japan, Singapore Thailand and New Zealand. This involved

navigation of differing regulatory and transfer of business procedures to achieve consistent and seamless transfer of employment.

■ Advising a large US Headquartered multinational biotechnology company on its multi-million dollar acquisition of an established provider of outsourcing services focused on the biologics sector.

■ Representing a US pharmaceutical company in connection with its acquisition of a pharmaceutical products line across multiple jurisdictions from a major French corporation.

■ Advised GI Dynamics on it’s A$80 million IPO and listing on the ASX. IPO market capitalisation A$305 million.

■ Advising the world’s largest spinal company, on establishing a subsidiary in Poland and ongoing legal services including corporate compliance.

■ Advising Novartis on setting up a EUR 80 million greenfield project in Special Economic Zone (SEZ) Novoorlovskaya, St Petersburg, including registration of a legal entity in St Petersburg, analysis of the SEZ agreement required for granting Novartis SEZ resident status, conducting a legal due diligence in relation to the land plot in order to detect key risks.

■ Advising Life Technologies on the divestiture of its global mass spectrometry business to a US-based company, Danaher Corporation.

■ Advising Berlin Pharmaceutical Industries on establishment of the group companies in Thailand.

■ Advising M.P. Biomedicals, a US pharmaceutical and diagnostic company, on the acquisition of a biomedical diagnostics company in Singapore and its regional subsidiaries.

■ Advising a global pharmaceutical group on data privacy issues arising from the outsourcing and consolidation of human resource services and financial transaction processing services in 72 jurisdictions.

■ Advising on the data privacy laws across EMEA in relation to the collection, processing, storage, cross-border transfer and disclosure/use of trial subject data and biological materials, and drafting informed consent documentation.

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DLA Piper is a global law firm operating through various separate and distinct legal entities.

Further details of these entities can be found at www.dlapiper.com

Copyright © 2014 DLA Piper. All rights reserved. | FEB14 | 2719963

www.dlapiper.com

Bonella Ramsay Partner Life Sciences Co-Chair EMEA t +44 20 7796 6028 bonella.ramsay@dlapiper.com

lisa haile Partner, Life Sciences Co-Chair US t +1 858 677 1456 lisa.haile@dlapiper.com

John dougherty Partner, Life Sciences Co-Chair US t +1 410 580 4140 john.dougherty@dlapiper.com

foR MoRe infoRMation

To learn more about our services to the life sciences industry please visit www.dlapiper.com or contact our Global Life Sciences Sector Co-Chairs:

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