Life Sciences + Healthcare

They're very knowledgeable and practical, and they work with a lot of multinationals so they understand the issues we face.
— Client quote, Chambers USA 2021

Helping to Drive Innovation and Growth for a Healthier Tomorrow

The future of healthcare is the convergence of life sciences and technology. Advancements in biopharmaceuticals, medical devices, and digital health solutions are improving patient care and creating a more efficient, effective healthcare system. Whether you are developing the next blockbuster drug or are an emerging digital health start-up, you require unique and creative strategies to navigate the legal and regulatory hurdles on your way to commercial success. And no firm is better situated than MoFo to help you get there.

Our cross-disciplinary team of Life Sciences + Healthcare lawyers advises clients across the United States, Europe, and Asia. We work with innovators at every phase of their growth cycle, from conception to commercialization and exit, vigilantly protecting and enforcing your rights in a competitive market. We count among our clients some of the leading names in the biotechnology, pharmaceutical, and healthcare industries, and some of the fastest growing companies at the intersection of life sciences and data analytics. We focus on what drives your business and will help you develop the strategies that will lead to growth and commercial success.

We represent more than 500 private and public life sciences companies, research institutions, and the venture capital funds and investment banks that finance them. Our team includes attorneys and patent agents with more than 100 advanced scientific and engineering degrees, including 65 Ph.D.s in life sciences and related engineering disciplines. We have deep experience in technologies such as pharmaceuticals, biosimilars, diagnostics, precision medicines, genomics, gene editing technologies, medical devices, artificial intelligence and machine learning, medicinal chemistry, and vaccines, amongst others. We guide clients through all aspects of their business, including:

  • Emerging company and venture capital work
  • Corporate M&A and finance
  • Capital markets
  • Intellectual property strategy, prosecution, and enforcement/litigation
  • FDA regulatory and compliance
  • Privacy and data security
  • Complex transactions and licensing
  • Litigation, including product liability, class actions, securities, and white collar

Innovation is at the heart of the life sciences industry. As partner to some of the leading life sciences innovators, MoFo supports groundbreaking ideas and helps clients discover the real-world solutions that will bring those ideas to life.

Areas of Focus

Our areas of focus include:

Biotech and Pharma

Global demand in the biopharma sector shows no signs of slowing down, as new technologies pave the way for life-changing drugs and therapeutics. Research and development is moving at a rapid pace, investment in the industry is at an all-time high, and valuations are steadily increasing. Whether you are an early-stage biotech or an established publicly-traded pharmaceutical company, you need strategic legal and regulatory counsel to help propel your business forward. MoFo’s life sciences team bridges the gap between law and science, to develop legal strategies that align with your business objectives and help you maintain a competitive edge. Our technology experience is unmatched, with scientific backgrounds in small molecule pharmaceuticals, biosimilars, antibodies, cell and gene therapies, immunotherapies, regenerative medicines, and vaccines—just to name a few. Our patent team has played a significant role in the creation and protection of many landmark patent portfolios in the industry, working with some of the world’s most innovative biopharma companies. We have also played a critical role in some of the most anticipated litigation in the industry, including Sandoz v. Amgen before the U.S. Supreme Court, involving the Biologics Price Competition and Innovation Act, which provides a streamlined approval path for biosimilars.

We also help our biopharma clients navigate a challenging regulatory landscape with a strategic and comprehensive lifecycle approach. We counsel on compliance with FDA regulations throughout the entire product lifecycle and alignment between patent and regulatory exclusivities for drug products. We also advise on the vast regulatory requirements, ethical challenges, privacy issues, and practical concerns clients face in preclinical, clinical, and research settings. As clients seek to develop new products and accelerate R&D capabilities, our transactions and licensing team works closely with our M&A and corporate practices to structure build-to-buy collaborations, joint ventures, asset purchases, and merger arrangements. We also advise on in-license, out-license, and other development and distribution agreements.  

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Medical Devices and Diagnostics

The medical devices industry is undergoing rapid transformation. The application of software, artificial intelligence, and machine learning to traditional medical device and diagnostics manufacturing has opened the door to major advancements in medical products to treat and diagnose patients. However, increased regulatory scrutiny and rising R&D investments require strategic legal and regulatory strategies that address the evolving demands of the market. MoFo’s global full service team understands the industry and collaborates across practices and technical disciplines to provide seamless representation from concept to market and beyond. We protect and enforce valuable medical innovations, including cardiovascular devices, imaging technologies, diagnostics, implants, neurovascular treatment methods, orthopedic and surgical supports, vascular devices, test instruments, and veterinary devices and equipment. We represent clients in financings and exits in pursuit of growth, and we help structure commercial agreements to drive R&D strategy. Our team also advises on licensing and strategic collaborations to support commercialization.

From pre-product launch to post-market representation, we guide domestic and international clients on FDA product approvals and regulatory compliance, positioning products for maximum coverage and reimbursement and advising on evolving regulations and guidance that cover new technologies, including software as a medical device (SaMD). We also provide full lifecycle advice, addressing post-market issues including labeling and promotional campaigns, manufacturing quality programs, supply chain management and distribution controls, product safety and liability risk management, and indemnification.

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Digital Health and Data Analytics

As the technology, life sciences, and healthcare industries continue to collaborate and seize on market opportunities, both emerging innovators and established companies are entering the digital health market to improve the efficiency and effectiveness of patient care. The use of software, AI, robotics, data analytics, and blockchain to develop therapeutics, diagnostics, and medical devices has led to a new generation of legal and regulatory issues for companies to consider. At the forefront of both the life sciences and technology industries, MoFo is uniquely qualified to understand the challenges in the digital health industry and to help clients embrace analytics-driven insights to identify solutions to the most pressing issues they face in the marketplace. Our clients work in technologies that include:

  • Consumer health applications, including wellness, fitness trackers, and nutrition apps
  • Digital therapeutics
  • Electronic health records
  • Health applications and information technology
  • Personalized medicine
  • Predictive analytics
  • Remote patient monitoring
  • Telemedicine and virtual care platforms
  • Wearable devices and biometric sensors

We represent clients in emerging company counseling, venture capital financings, and mergers and acquisitions, and provide strategic patent counsel to protect digital health technologies, including patenting software and AI-related life sciences inventions and medical devices. We also understand the unique data privacy and security issues inherent to the industry, advising global digital health innovators on the legal and ethical use of health and medical data and developing compliance programs around health privacy and information security. We support clients in the FDA approval process and compliance before global regulatory bodies, including regulatory pathways for SaMD and telemedicine and telehealth platforms. We work across practice areas to provide strategic legal and regulatory counsel that leverages the power of data to maximize growth, mitigate risk, and help you realize the full potential of your digital health innovations.

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