Pharmaceuticals, Life Sciences & Medical Devices
Enabling Innovation

The business of pharmaceutical and medical devices is paradoxical. Science holds out the promise of breakthroughs, with aging populations fueling demand. Yet product pipelines are sluggish, pricing and margins are under attack, and regulatory, liability and competitive risks are growing.

To be successful, pharmaceutical, medical device and biotech companies are looking at things in new ways. Acquisitions, alliances and licensing are supplementing, and in some cases replacing, in-house discovery and development. Outsourcing, from product manufacture to clinical trials, is helping to improve performance, accelerate time-to-market and control costs.

At Baker & McKenzie, we help you get these and other innovative approaches right. We have been working with producers, distributors, researchers and regulators in the pharmaceutical and medical products industry worldwide for more than half a century. More than 250 lawyers in our pharmaceutical and healthcare practice concentrate their energies on the issues and opportunities of this dynamic and challenging market.

How We Can Help

• Advertising and marketing — We advise on regulations, standards and codes of practice relating to marketing and promotion of pharmaceutical products and medical devices.
• Biotech initiatives — We advise on financing, acquisitions, spin-offs, strategic alliances, joint ventures, licensing and other collaborations essential to biotech initiatives.
• Clinical trials — We work with clients on legal and regulatory issues through all phases of clinical trials and investigations.
• Competition and trade — We advise on the antitrust and competition law implications of mergers, joint ventures, and other complex transactions and investments.
• Commercial agreements — We negotiate and draft agreements covering matters such as distribution, outsourcing, franchising, marketing, licensing and consulting.
• Data privacy — We help assure compliance with data protection and privacy laws, including the observance of informed consent requirements and contractual implementation of confidentiality duties.
• Disputes and product liability — We help anticipate and avoid, or litigate, mediate or otherwise resolve commercial disputes and product liability matters and issues related to clinical trials.
• Intellectual property — We advise on all aspects of portfolio management, technology transfer and licensing transactions. We also conduct IP audits, provide patent validity and infringement opinions and assist with litigation.
• Market entry — We work with multinationals and their local subsidiaries to lobby for regulatory and legislative changes, and advise them on market strategies to take advantage of local market exclusivity protocols.
• Mergers & acquisitions — We help structure, conduct due diligence, negotiate, document and execute all types of transactions, strategic alliances and joint ventures.
• Private equity and securities — We advise on public offerings of shares, global depository receipts and other securities, rights issues, private placements and spinoffs.
• Professional ethics — We advise on all aspects of professional ethics rules governing the conduct of physicians who are cooperation partners of companies in the fields of marketing, advertisement and research.
• Promotion to professionals — We advise on permissible practices regarding marketing to and sponsoring of health professionals.
• R&D centers — We help establish R&D centers, including structuring IP ownership, setting up employment invention programs and developing local and cross-border tax and fiscal strategies.
• Regulatory compliance — We assist at all stages of compliance, from early stage general operations, licensure, research and clinical trials to marketing. We also defend enforcement actions and investigations.
• Reimbursement — We advise on the various schemes and health care plans in place in different jurisdictions and help companies gain, keep and defend the eligibility of their products for reimbursement and insurance coverage.
• Transfer pricing and tax — We devise and document defensible global transfer pricing and tax planning strategies and structures to help companies establish optimal longterm tax positions.