McDermott Will & Schulte, a global law firm

Healthcare and life sciences companies operate under the most difficult circumstances. They face pressure to drive innovation and growth while navigating intense government oversight and stakeholder scrutiny. Our lawyers guide you through critical business decisions, complex regulatory frameworks, and evolving market pressures – so you can lead transformation in a highly regulated environment.

Year after year, we are named “Healthcare Practice Group of the Year” by Law360 and ranked by PitchBook as the #1 law firm advising healthcare private equity investors. As one of the top healthcare law firms in the US, we represent every major stakeholder in the ecosystem – from healthcare providers and health systems to life sciences companies and investors.

Our global team delivers integrated legal counsel across regulatory, transactional, intellectual property, litigation, and other business-critical matters. Having served in leadership roles both in-house and within government, we provide the legal, commercial, and regulatory guidance you need across health and life sciences law to shape the future of the industry.

Our health and life sciences lawyers have held senior roles across key government agencies including the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), Department of Health and Human Services (HHS), and Department of Justice (DOJ) – giving us unique insight into the enforcement challenges you face.

We don’t just understand how regulations are enforced – we know how healthcare policy is developed. Through McDermott+, our dedicated healthcare policy and strategic advisory arm, we help you navigate and shape the policy landscape that influences the industry. With a team that includes lawyers, physicians, policy professionals, data analysts, and veterans of Capitol Hill, we advocate for policies that support your healthcare mission.

Our lawyers also guide you across the life cycle of transformative deals, from formation and financing to commercialization, partnerships, and exit. We help you structure transactions that are aligned with market realities and designed to deliver long-term value.

From securing investment and commercializing innovation to scaling operations and protecting your market position, we support you at every stage of growth. Our team develops integrated legal strategies that help clear the path for your breakthrough technologies, next-generation therapeutics, AI-enabled healthcare solutions, and innovative care delivery models.

Whether you’re a global biopharma leader in medical devices and drugs, a cutting-edge digital health innovator, a clinical research organization or something completely new, our Food and Drug Administration (FDA) practice will help fuel your mission by guiding you through the complex regulatory and compliance landscape.

As the top-ranked law firm for health and a leader in life sciences, we are dedicated to our clients and passionate about the work we do together. We counsel clients on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA.

Our FDA regulatory lawyers offer deep industry experience, strategic legal advice, diverse perspectives and practical solutions that address the full scope of regulatory and compliance issues life sciences companies face. Our cross-border, cross-practice team will work collaboratively to help you clear your path to success on issues such as intellectual property, data privacy and security, litigation, pricing, reimbursement and healthcare compliance. We advise clients on the following:

• Current Good Manufacturing Practice (cGMP), Medical Device Quality System Regulation (QSR), Good Clinical Practice (GCP), internal compliance programs, internal and external audits, and standard operating procedures (SOPs)
• Marketing applications and other regulatory submissions, product labeling, advertising and promotions, and post-market surveillance
• Product regulatory status determinations, import-export compliance, and other pre- and post-market regulatory programs
• FDA inspection preparedness and responses to FDA Inspectional Observations (483s), warning letters and other regulatory communications
• FDA investigations, FDA consent decrees and other enforcement actions involving the FDA, the US Department of Justice (DOJ), state attorneys general, other federal and state agencies, the US Congress, and False Claims Act qui tam and other litigants
• Compliance program implementation, auditing and monitoring in accordance with OIG’s Seven Elements of an Effective Compliance Program and applicable PhRMA Code/ADVAMED industry standards and applicable laws and regulations
• Development and submission of citizen petitions, trade complaints and comments on FDA proposed rules and guidance
• Entry into the United States of non-US companies through clinical-study, approval, prelaunch, compliance-program and other initiatives

The McDermott Will & Schulte attorneys truly understand the science of our patents, give us personalized attention, and respond quickly to our questions.
– Chambers USA, Life Sciences

As a life sciences company, your intellectual property (IP) is your most valuable asset—it’s what propels your growth, drives your success and sets you apart from competitors. But it may also be your most vulnerable asset.

How you commercialize your innovation and gain compliance is crucial for the success of your business. As competitors constantly work to capture your share of the market, it is imperative that your IP is protected to maximize its value. Our business-first perspective makes us uniquely equipped to help our clients build formidable IP portfolios, maximize their value and enforce or defend them in litigation.

Our more than 140 multidisciplinary life sciences lawyers are here to help. In addition to legal experience spanning the world’s foremost life sciences companies to its most innovative startups, the majority of our IP lawyers hold advanced degrees in the life sciences fields including in cellular and molecular biology, chemistry and organic chemistry, biochemistry, biomedical engineering, chemical engineering, immunology, pharmacology and genetics, among many other areas.

We provide the full array of services to protect and leverage your IP assets:

• Patent protection and enforcement
  • Patent litigation, including Hatch-Waxman Act litigation
  • Patent portfolio management
  • Infringement, validity and freedom-to-operate opinions
• Trademark and brand management
  • Initial strategy and clearance, trademark registration
  • Portfolio management
  • Seeking and obtaining both brand and generic names, United States Adopted Names (USANs) and International Nonproprietary Names (INNs)
  • Domain name, social media, advertising, unfair competition and trade dress matters
  • Enforcement, including trademark, copyright and trade secret litigation
• IP monetization and transactions
  • Licensing and collaboration
  • M&A and finance
  • Outsourcing and licensing agreements

Let us help you go further.

Private equity firms operate in high-stakes environments where speed, execution, and risk directly impact investment returns. Our private equity lawyers advise sponsors and their portfolio companies throughout the investment life cycle. We help you execute transactions, manage risk, and address the legal, commercial, and regulatory issues that impact how your investment performs.

Our private equity team includes more than 150 lawyers in 20+ offices worldwide. Working across disciplines including finance, tax, antitrust, investment funds, restructuring, and litigation, we provide integrated guidance to support domestic and cross-border investments across industries and asset classes.

We advise you on acquisitions, dispositions, recapitalizations, carve-outs, minority investments, joint ventures, and other strategic transactions. Our private equity lawyers structure deals and negotiate terms to help you manage risk, create value, and support performance across all stages of your investment – from fundraising to exit.

Competing stakeholder interests often lead to disputes. Disagreements over governance, deal terms, and post-closing obligations can create significant exposure for private equity firms and portfolio companies. Our litigators work alongside deal teams to help you navigate disputes while preserving enterprise value. We represent you through mediation, arbitration, and litigation in state and federal courts, including the Delaware Court of Chancery.

With one of the most active transactional practices in the US, we understand how complex deals are structured, negotiated, and executed. By combining deep market knowledge with cross-disciplinary capabilities, our private equity lawyers help you mitigate risk and advance your strategic goals throughout the life cycle of your investment.