Life Sciences v2

Medical Devices

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Stephen Thau

Scott Iyama

We serve over 500 life science clients across all segments – biotech and pharma, digital health, research and laboratories, medical devices and diagnostics and tools. Regardless of where our clients are in the corporate lifecycle, we offer them solutions scaled to their needs:

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Jeanine McGuinness

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Jeanine McGuinness

LIFE SCIENCES

A top 5 global venture capital practice and a powerful network of resources for innovative entrepreneurs and private companies.

Global data privacy and cybersecurity and incident response support from a market leading team (Chambers band 1 ranked).

Patent strategy and prosecution support from a team that knows the science (and has the PhDs to prove it).

Digital Health

Research and Labs

Biotech and Pharma

Diagnostics and Tools

AREAS OF FOCUS

No sector will come out of the pandemic with greater momentum and clarity of focus than Life Sciences. Orrick is partnering with our clients to leverage this momentum by helping them expand their businesses, protect their IP, and address risk so they can focus on what matters: improving patients’ lives.

Regulatory, compliance, and public policy advice to mitigate risk from a team that is regularly on the front lines representing clients through internal and government investigations.

A sterling record of successful exits through sale, IPO or SPAC transactions.

IP licensing expertise, delivered through the practical, business-minded advice from a team that draws from decades of government, private, and industry experience.

500+

Life Sciences Companies

Biotech and Pharma

Orrick’s biotechnology and pharmaceutical clients range from cutting edge, market-disruptive start-ups to some of the largest pharmaceutical companies in the world. Our clients value our team’s creative, nimble counsel to help them formulate thoughtful regulatory strategies to navigate the myriad of rules and regulations that govern all aspects of their business, without losing sight of the core mission and value proposition of the business. Having extensively partnered with our clients for decades to help solve problems and allow them to focus on their critical (and in many cases, life-saving) work, our life sciences team understands this complex environment. We offer practical advice through all stages of a company’s life cycle, from critical early stage financing to guiding through a public listing to access new markets; from counseling on complex licensing and deal transactions to navigating through high-stakes bet-the-company litigation; from tailored regulatory advice through to defending the company from government scrutiny and enforcement actions. At its core, Orrick’s life sciences team provides the comprehensive and practical counsel to support our life sciences clients’ tireless work advancing the interests of their patients and other stakeholders.

With COVID-19 being the first pandemic in the digital age, technological advancements in healthcare have accelerated at an exponential pace. Healthcare digitization is transforming the industry by delivering new products and services to consumers that leverage AI, data, and new tech with unprecedented connective and mobile capabilities. The movement toward telemedicine and remote health solutions that bring care and monitoring within one’s home has similarly accelerated. The pandemic has highlighted the need and opportunity for high-quality, high-compliance healthcare that can seamlessly function amid physical distancing challenges. All the while, enormous quantities of sensitive personal and health data are being collected, handled, interpreted, used, and stored in a world where digital threats loom large and one significant event can upend operations or even present existential risk. Our Life Sciences team work with tech every day, we understand both the value digital health solutions are playing in the industry and the nature of the risks inherent in business models that are inextricably intertwined with data. From innovative growth strategies, to harvesting intellectual property and developing a sophisticated patent portfolio strategy, to complex licensing transactions, to international data transfer or data security advice, we offer a deep cross-sector experience and business-minded advice that guide clients to successful outcomes.

Digital Health

Research organizations and laboratories are at the forefront of the innovation that is driving quantum leaps in discovery, experimentation, and invention. Effective collaboration with partners in life sciences is key to longevity and success of these organizations and the solutions they enable. But successful collaboration necessitates careful definitions of roles and responsibilities, robust internal compliance and quality controls, and constant vigilance and clarity with respect to intellectual property. At the same time, the drive for rapid development on increasingly urgent timelines are pushing boundaries and creating risk. Companies need to balance these pressures against setbacks, obstacles, and regulatory (or worse, criminal) risks that are attendant to research and clinical activities. Orrick’s life sciences team offers decades of experience and a deep understanding of the industry, developed from working with, and advising, rich networks comprised of critical sector participants. Our team can help clients strengthen their market share, negotiate and enforce complex licensing transactions, investigate allegations of fraud or misconduct, and defend them in high-stakes government investigations, claims, or disputes.

Research and Labs

The medical device field is rapidly evolving, with companies leveraging mobile technology, robotics, and AI to innovate and offer healthcare solutions that are accurate, personalized, and connected. This evolution implicates complex regulatory challenges and risks, potentially driving change in operational standards for medical device developers and manufacturers and uncertainty for licensees. The ability of companies to respond strategically to these challenges will differentiate them and offers significant opportunities to optimize business processes and data management for improved compliance, innovation, and efficiency. At Orrick, we understand that for medical device companies improving healthcare delivery and quality of life for their patients are top priorities and we counsel on regulatory, IP, employment, corporate and transactional issues to help clients solidify their position in the marketplace. Health fraud, waste and abuse are rising issues in the sector with the False Claims Act (FCA), the Anti-Kickback Statute (AKS) and the Foreign Corrupt Practices Act (FCPA) being powerful tools used by the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC). We've assisted with federal FCA investigations and qui tam actions arising in federal districts throughout the country and have experience handling matters arising under state false claims statutes and have represented clients in connection with investigations and litigation concerning alleged violations of state false claims statutes in several states.

Medical Devices

Companies that develop, manufacture and license tools and diagnostic products are vital to the progression of the healthcare sector by enhancing patient care, improving efficiency, and lowering costs. It’s a complex market with numerous segments at various stages of growth, and to succeed life sciences companies must be able to adapt to emerging competitive threats, customer needs, regulatory requirements and technological changes. Orrick's tech focused practice and deep sector knowledge is built to help our clients thrive. We have our finger on the pulse of the life science market, and for our clients, that means they have a trusted advisor to guide them on a successful path through all the challenges and risks they will face. From concept to market and beyond, we have a global team that collaborates across practices and technical disciplines to provide effective guidance and support in this complex sophisticated sector.

Diagnostics and Tools

Employment Litigation Counsel

Orrick represents Genentech as litigation counsel in multiple single-plaintiff and class action litigations, with allegations ranging from wrongful termination to wage and hour claims.

False Claims Act and Anti-Kickback Statute Litigation

Orrick represented directors and officers of Cardiovascular Systems, Inc. in a securities class action and shareholder derivative action stemming from alleged violations of the False Claims Act and Anti-Kickback Statute. Our team obtained dismissal of the securities class action and convinced the shareholder derivative plaintiff to voluntarily dismiss her complaint on the grounds that a forum selection clause rendered her choice of venue improper.

FCPA Counsel to Multinational Medical Device Company

Orrick served as FCPA counsel for a multinational medical device company, representing it through a DOJ and SEC inquiry and FCPA monitorship that successfully concluded when the monitor certified its compliance program as effective.

Scaling with Twist Bioscience

Orrick has been advising Twist Bioscience since its inception and has counseled the company on multiple financing rounds, its IPO and follow-on offerings, as well as on various M&A transactions and matters involving employment, insurance, and privacy.

Johnson & Johnson’s Nationwide Talc-related Litigation Defense

Orrick has been the go-to firm for Johnson & Johnson in high-exposure talc-related matters, including defending thousands of personal injury lawsuits, product liability cases, major consumer class actions, and cases brought under Proposition 65.

PARTNERING WITH LIFE SCIENCES CLIENTS

5-patent ITC Investigation

Orrick successfully represented FUJIFILM Corporation and FUJIFILM North America in an ITC investigation and two district court actions in which competitors asserted claims against one another of patent infringement, antitrust violations, unfair competition, and business torts with respect to 3D digital mammography devices.

K Health’s Venture Capital Financings

Orrick has been advising K Health, a digital health company that offers free personalized healthcare, since its inception on multiple financing rounds, including its $132 million Series E round that brought its valuation unicorn status (+$1.5 billion).

Trade Dress Infringement Case

Orrick serves as lead trial counsel for Coorstek Bioceramics in a trade dress infringement case. We prevailed at trial in 2017 and secured a victory in the Paris Court of Appeals in 2021 preserving Coorstek Bioceramics’ right to use the color pink for ceramic hip implant components. The case is significant because color as trade dress is rarely litigated in the U.S. and the EU, and it sheds light on the intersection between trademark and patent law, particularly in the color mark context.

Bayer's Acquisition of BlueRock Therapeutics

Orrick advised Bayer AG, the Germany based global pharmaceutical company, on its $600 million acquisition of BlueRock Therapeutics, a leading company that develops, manufactures, and delivers engineered cell therapies in the fields of neurology, cardiology, and immunology.

Major Win for Pioneering Swiss Non-Profit Research Foundation EspeRare

Orrick successfully represented EspeRare Foundation, a Swiss non-profit supporting advanced clinical research in rare, so-called “orphan” pediatric diseases, in a Swiss Chambers international arbitration proceeding. The outcome validated EspeRare’s rescission, on grounds of fraud in the inducement, of an R & D collaboration agreement.

Data Privacy Compliance Advice

Orrick advised a Chinese technology developer and manufacturer on privacy compliance challenges for the launch of its social and well-being apps in Europe and the U.K. We advised on health data processing activities, potential regulatory agency interactions, international data transfer compliance and consumer privacy due diligence for acquisitions.

Clover Health's Merger with Social Capital Hedosophia Holdings Corp.

Orrick advised Clover Health, an innovative technology company committed to improving health equity for America’s underserved seniors, in its $3.7 billion merger with Social Capital Hedosophia Holdings Corp. II, a California based special purpose acquisition company (SPAC), resulting in Clover Health becoming a public company listed on the Nasdaq.

Special purpose acquisition companies (SPACs) have become an attractive alternative to the traditional IPO. The year 2020 saw an unprecedented surge in SPAC activity, igniting an upward trend of private equity firms, venture funds, and operators forming SPACs and private companies seeking to quickly access liquidity through a de-SPAC transaction.

Gia Lee, General Counsel at Clover Health, joined us for a discussion on SPAC transactions. We discussed Clover’s SPAC journey and why they decided to go the SPAC route, what was most surprising about the process, and the key takeaways that came about during the deal.

Litigation representation from a team that has navigated some of the biggest and messiest trade secret, patent, securities, mass torts, and class action employment disputes on record on behalf of some of the leading life sciences companies in the world.

A top 5 global venture capital practice and a powerful network of resources for innovative entrepreneurs and private companies.

A sterling record of successful exits through sale, IPO or SPAC transactions.

IP licensing expertise, delivered through the practical, business-minded advice from a team that draws from decades of government, private, and industry experience.

Global data privacy and cybersecurity and incident response support from a market leading team (Chambers band 1 ranked).

Patent strategy and prosecution support from a team that knows the science (and has the PhDs to prove it).

One of the most formidable appellate practices in the U.S. with a proven track record for winning - sometimes against all odds.

Compliance, government investigations, and public policy advice from a team that is on the front line with state and federal regulators and prosecutors on behalf of their life sciences clients every day.

WHAT YOU NEED TO KNOW

Biotech and Pharma

A special purpose acquisition company (SPAC), often referred to as a “blank-check company,” is a shell company formed to raise capital through an initial public offering (IPO). Once public, the SPAC targets a privately-held operating company or business to acquire, known as a “business combination” or “de-SPAC merger,” for the purposes of taking the private company/business public.

Biotech and Pharma

Orrick’s biotechnology and pharmaceutical clients range from cutting edge, market-disruptive start-ups to some of the largest pharmaceutical companies in the world. Our clients value our team’s creative, nimble counsel to help them formulate thoughtful regulatory strategies to navigate the myriad rules and regulations that govern all aspects of their business, without losing sight of the core mission and value proposition of the business. Having extensively partnered with our clients for decades to help solve problems and allow them to focus on their critical (and in many cases, life-saving) work, our life sciences team understands this complex environment. We offer practical advice through all stages of a company’s life cycle, from critical early stage financing to guiding through a public listing to access new markets; from counseling on complex licensing and deal transactions to navigating through high-stakes bet-the-company litigation; from tailored regulatory advice through to defending the company from government scrutiny and enforcement actions. At its core, Orrick’s life sciences team provides the comprehensive and practical counsel to support our life sciences clients’ tireless work advancing the interests of their patients and other stakeholders.

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Biotech and Pharma

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One of the most formidable appellate practices in the U.S. with a proven track record for winning - sometimes against all odds.

AREAS OF FOCUS

Orrick is advising fintech unicorn Dave, a leading banking app with 10 million customers, in its US$4 billion merger with VPC Impact Acquisition Holdings III, Inc., a special purpose acquisition company. Upon completion of the transaction, it intends to list under the ticker symbol DAVE.

Dave’s merger with VPC Impact Acquisition Holdings III, Inc.

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PARTNERING WITH LIFE SCIENCES CLIENTS

AREAS OF FOCUS

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Thora Johnson