Biotech
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One of the Largest Life Sciences Practices in the U.S.
Wilson Sonsini's Life Sciences practice is one of the largest in the U.S., with more than 275 professionals, including attorneys, patent agents, and scientific advisors.
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A Nationally Recognized and Ranked Life Sciences Practice
Wilson Sonsini is often ranked among the top life sciences firms in the U.S. by outlets including Law360 and LMG Life Sciences. For example, in July 2024, Wilson Sonsini was named a finalist for “Corporate Firm of the Year” in the LMG Life Sciences 2024 Americas Awards, an annual awards program that honors the top firms and legal professionals in the life sciences market.
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A Leading Strategic Partner to Innovators in Life Sciences
From Maxygen and Illumina to NantHealth and Pharmacyclics, Wilson Sonsini has worked closely with biotechnology innovators for more than 40 years.
Wilson Sonsini's leadership position in the life sciences sector was established through the firm's longtime representation of innovative biotechnology companies, the pioneering entrepreneurs that start them, and the sophisticated investors that finance them. In fact, Wilson Sonsini has been an active services provider to the biotech community since the formative years of the industry, when bold new companies started developing and commercializing scientific discoveries.
While the biotech industry grew and matured, our firm's attorneys forged strong ties to clients in the sector by becoming their strategic partners. Our attorneys not only have the expertise to assess the underlying technologies and formulate IP strategies, they have the experience to help clients assess the market and their prospects for financing, in the course of devising strategic and sophisticated business plans that best leverage IP assets.
Today, the firm's Life Sciences practice--one of the largest in the U.S.--is anchored by a multi-disciplinary team of more than 275 professionals, including attorneys, patent agents, and scientific advisors. A substantial number of our practitioners have advanced degrees in biology, chemistry, engineering, or other scientific fields. Similarly, a large number of our professionals have experience working in laboratory, medical, or research facilities. The team also includes attorneys who have served as in-house legal counsel for major life sciences companies, or have held senior positions at U.S. federal agencies, including at the United States Patent and Trademark Office (USPTO) and the Patent Trial and Appeal Board (PTAB).
The Industry Experience tab above includes a representative list of life sciences sectors in which our attorneys have experience. Our professionals have experience in nearly every field of medicine and health care, from biochemistry, digital health, and genetics to medical devices, therapeutics, and companion diagnostics/precision medicine. We represent more than 1,000 companies in the pharmaceutical, biotechnology, medical devices, digital health/healthcare IT and other healthcare sectors.
Wilson Sonsini has consistently represented biotech companies at all stages, from formation to exit. Our work with emerging biotech companies is typically focused on two areas that are vital to early-stage enterprises: intellectual property and finance. Our highly regarded IP practice helps growing life sciences companies achieve important milestones by securing, developing, and protecting their most vital IP assets, while also advising established companies responsible for advancing groundbreaking discoveries. In addition, we represent life sciences clients in regulatory and litigation matters, from antitrust and commercial disputes to FDA and export compliance issues. Additional services that our firm routinely provides to similarly situated clients include: FDA counseling services, trademark and advertising, licensing and partnering, post-grant review, and corporate finance and strategy. The tabs above provide additional details about the range of services we provide to life sciences clients.
In short, with more than 1,000 attorneys, Wilson Sonsini provides comprehensive representation to life sciences and biotech industry clients across a broad range of practices, including:
- Antitrust and Competition
- Capital Markets
- Corporate Governance
- Employee Benefits and Compensation
- Employment Litigation
- Intellectual Property
- Litigation
- Mergers & Acquisitions
- Real Estate
- Regulatory and Compliance
- Tax and Tax Equity
- Technology Transactions
Wilson Sonsini's leadership position in the life sciences sector was established through the firm's longtime representation of innovative biotechnology companies, the pioneering entrepreneurs that start them, and the sophisticated investors that finance them. In fact, Wilson Sonsini has been an active services provider to the biotech community since the formative years of the industry, when bold new companies started developing and commercializing scientific discoveries.
While the biotech industry grew and matured, our firm's attorneys forged strong ties to clients in the sector by becoming their strategic partners. Our attorneys not only have the expertise to assess the underlying technologies and formulate IP strategies, they have the experience to help clients assess the market and their prospects for financing, in the course of devising strategic and sophisticated business plans that best leverage IP assets.
Today, the firm's Life Sciences practice--one of the largest in the U.S.--is anchored by a multi-disciplinary team of more than 275 professionals, including attorneys, patent agents, and scientific advisors. A substantial number of our practitioners have advanced degrees in biology, chemistry, engineering, or other scientific fields. Similarly, a large number of our professionals have experience working in laboratory, medical, or research facilities. The team also includes attorneys who have served as in-house legal counsel for major life sciences companies, or have held senior positions at U.S. federal agencies, including at the United States Patent and Trademark Office (USPTO) and the Patent Trial and Appeal Board (PTAB).
The Industry Experience tab above includes a representative list of life sciences sectors in which our attorneys have experience. Our professionals have experience in nearly every field of medicine and health care, from biochemistry, digital health, and genetics to medical devices, therapeutics, and companion diagnostics/precision medicine. We represent more than 1,000 companies in the pharmaceutical, biotechnology, medical devices, digital health/healthcare IT and other healthcare sectors.
Wilson Sonsini has consistently represented biotech companies at all stages, from formation to exit. Our work with emerging biotech companies is typically focused on two areas that are vital to early-stage enterprises: intellectual property and finance. Our highly regarded IP practice helps growing life sciences companies achieve important milestones by securing, developing, and protecting their most vital IP assets, while also advising established companies responsible for advancing groundbreaking discoveries. In addition, we represent life sciences clients in regulatory and litigation matters, from antitrust and commercial disputes to FDA and export compliance issues. Additional services that our firm routinely provides to similarly situated clients include: FDA counseling services, trademark and advertising, licensing and partnering, post-grant review, and corporate finance and strategy. The tabs above provide additional details about the range of services we provide to life sciences clients.
In short, with more than 1,000 attorneys, Wilson Sonsini provides comprehensive representation to life sciences and biotech industry clients across a broad range of practices, including:
- Antitrust and Competition
- Capital Markets
- Corporate Governance
- Employee Benefits and Compensation
- Employment Litigation
- Intellectual Property
- Litigation
- Mergers & Acquisitions
- Real Estate
- Regulatory and Compliance
- Tax and Tax Equity
- Technology Transactions
The proceeds from the Series B will be used to advance the clinical development of Ona’s lead program, ONA-255, a first-in-class ADC initially focused on breast cancer, and to progress ONA-389, a second first-in-class ADC targeting colorectal cancer. ONA-255 is designed to address treatment-resistant tumor biology through a differentiated mechanism aimed at improving the therapeutic index compared to earlier approaches. ONA-389 will advance toward first-in-human studies, expanding Ona’s pipeline in indications with significant unmet need. Ona currently retains full worldwide commercial rights to all its assets.
The proceeds from the Series B will be used to advance the clinical development of Ona’s lead program, ONA-255, a first-in-class ADC initially focused on breast cancer, and to progress ONA-389, a second first-in-class ADC targeting colorectal cancer. ONA-255 is designed to address treatment-resistant tumor biology through a differentiated mechanism aimed at improving the therapeutic index compared to earlier approaches. ONA-389 will advance toward first-in-human studies, expanding Ona’s pipeline in indications with significant unmet need. Ona currently retains full worldwide commercial rights to all its assets.
Miranda advises life sciences clients in partnering and licensing arrangements, M&A, and other transactions.
Miranda advises life sciences clients in partnering and licensing arrangements, M&A, and other transactions.
Broad Life Sciences Industry Experience
Our attorneys represent companies in the following life sciences industry sectors, among others:
- Agricultural biotechnology
- Adoptive cell therapy
- Animal health
- Antibody therapeutics
- Biochemistry
- Bioinformatics software
- Biomedical sciences
- Biotechnology
- Catalysis and oil processing
- CAR-T cell therapies
- CRISPR gene editing
- Cell therapy
- Chemical engineering
- Digital health
- Diagnostics
- Genetic engineering
- Gene therapy
- Genetics
- Genome editing
- Genomics
- Immuno-oncology
- Medical devices
- Molecular biology, RNA-based medicines
- Nanotechnology
- Organic and medicinal chemistry
- Personalized medicine
- Peptides
- Pharmaceuticals
- Proteomics
- Solid state and inorganic chemistry
- Stem cell biology
- Small molecule therapeutics
- Synthetic biology
- Tissue engineering
- Virology
Broad Life Sciences Industry Experience
Our attorneys represent companies in the following life sciences industry sectors, among others:
- Agricultural biotechnology
- Adoptive cell therapy
- Animal health
- Antibody therapeutics
- Biochemistry
- Bioinformatics software
- Biomedical sciences
- Biotechnology
- Catalysis and oil processing
- CAR-T cell therapies
- CRISPR gene editing
- Cell therapy
- Chemical engineering
- Digital health
- Diagnostics
- Genetic engineering
- Gene therapy
- Genetics
- Genome editing
- Genomics
- Immuno-oncology
- Medical devices
- Molecular biology, RNA-based medicines
- Nanotechnology
- Organic and medicinal chemistry
- Personalized medicine
- Peptides
- Pharmaceuticals
- Proteomics
- Solid state and inorganic chemistry
- Stem cell biology
- Small molecule therapeutics
- Synthetic biology
- Tissue engineering
- Virology
Intellectual Property and Patents
As the largest and most highly regarded life science patent group in the U.S., we have a deep, skilled, and experienced bench of more than 180 patent professionals that are dedicated to establishing patent strategies for our life sciences clients. Our patents and innovation attorneys collaborate across the various disciplines of intellectual property (IP litigation, IP transactions and licensing, trademarks and advertising, and patent prosecution) to develop and execute IP strategies for business enterprises in the industries we serve including a strong focus in life sciences, precision medicine and digital health sectors.
We help companies build and implement successful new business models, devise value-creating IP strategies, structure and negotiate complex transactions, and develop and execute strategic litigation. Our deep knowledge of the industry sectors, together with our extensive experience advising clients on IP from product concept through launch and beyond, helps clients develop and leverage their IP to achieve their business objectives.
We create thoughtful IP portfolios that protect our clients’ most important assets: intellectual property. We also clear potential third party infringement risks—which is a critical process for growth-stage life science companies looking to maximize shareholder value. This two-pronged approach to IP strategy enables us to effectively advise companies and differentiates us from other law firms.
We also analyze product trends in the client’s industry, patent litigation in the client’s technology areas, and the client’s position in the market to anticipate potential patent disputes and advise on a patent filing strategy that will put the company in an advantageous competitive position.
We have an impressive track record of IP value creation, as members of our practice are responsible for the development of the IP portfolios covering such inventions as the DNA chip, healthcare IT solutions, companion diagnostic precision medicine technologies, cancer therapies, nanotechnology, cell-free genetic tests, medical devices, stem cell technologies, and next-generation DNA sequencing.
Please see our Patents and Innovations overview for more details about our experience in this area.
Intellectual Property and Patents
As the largest and most highly regarded life science patent group in the U.S., we have a deep, skilled, and experienced bench of more than 180 patent professionals that are dedicated to establishing patent strategies for our life sciences clients. Our patents and innovation attorneys collaborate across the various disciplines of intellectual property (IP litigation, IP transactions and licensing, trademarks and advertising, and patent prosecution) to develop and execute IP strategies for business enterprises in the industries we serve including a strong focus in life sciences, precision medicine and digital health sectors.
We help companies build and implement successful new business models, devise value-creating IP strategies, structure and negotiate complex transactions, and develop and execute strategic litigation. Our deep knowledge of the industry sectors, together with our extensive experience advising clients on IP from product concept through launch and beyond, helps clients develop and leverage their IP to achieve their business objectives.
We create thoughtful IP portfolios that protect our clients’ most important assets: intellectual property. We also clear potential third party infringement risks—which is a critical process for growth-stage life science companies looking to maximize shareholder value. This two-pronged approach to IP strategy enables us to effectively advise companies and differentiates us from other law firms.
We also analyze product trends in the client’s industry, patent litigation in the client’s technology areas, and the client’s position in the market to anticipate potential patent disputes and advise on a patent filing strategy that will put the company in an advantageous competitive position.
We have an impressive track record of IP value creation, as members of our practice are responsible for the development of the IP portfolios covering such inventions as the DNA chip, healthcare IT solutions, companion diagnostic precision medicine technologies, cancer therapies, nanotechnology, cell-free genetic tests, medical devices, stem cell technologies, and next-generation DNA sequencing.
Please see our Patents and Innovations overview for more details about our experience in this area.
Collaborations, Partnering Agreements, and Joint Ventures
Wilson Sonsini has extensive experience advising maturing biotech companies as they reach important developmental milestones. Dating back to some of the most significant, landmark collaborations and partnering deals between industry pioneers, Wilson Sonsini's attorneys have helped biotech clients structure and execute all manner of sophisticated, strategic transactions, working closely with each client to leverage their valuable intellectual property assets to achieve diverse market objectives.
The firm has advised life sciences companies on the structure of more than 100 major corporate collaborations. Our experience includes developing, negotiating, and implementing:
- Research and development agreements
- Strategic alliances
- Joint development agreements
- Co-investment agreements
- Cross-border agreements
In addition, our team has vast experience with a broad range of joint venture transactions involving our biotech clients. We have also recently introduced clients to novel, creative agreements—such as build-to-buy agreements—aimed at benefiting multiple parties.
Please see our Technology Transactions overview for more details about our experience in this area.
Collaborations, Partnering Agreements, and Joint Ventures
Wilson Sonsini has extensive experience advising maturing biotech companies as they reach important developmental milestones. Dating back to some of the most significant, landmark collaborations and partnering deals between industry pioneers, Wilson Sonsini's attorneys have helped biotech clients structure and execute all manner of sophisticated, strategic transactions, working closely with each client to leverage their valuable intellectual property assets to achieve diverse market objectives.
The firm has advised life sciences companies on the structure of more than 100 major corporate collaborations. Our experience includes developing, negotiating, and implementing:
- Research and development agreements
- Strategic alliances
- Joint development agreements
- Co-investment agreements
- Cross-border agreements
In addition, our team has vast experience with a broad range of joint venture transactions involving our biotech clients. We have also recently introduced clients to novel, creative agreements—such as build-to-buy agreements—aimed at benefiting multiple parties.
Please see our Technology Transactions overview for more details about our experience in this area.
Regulatory and Compliance
Regulatory approvals are critically important to growing biotech companies. Wilson Sonsini has a dedicated regulatory team that helps place biotech clients in a favorable position to clear regulatory hurdles and secure timely approvals. Our team also helps such clients remain in compliance with strictly enforced regulatory laws in the U.S. and international markets. Our healthcare regulatory attorneys help drug and medical device clients successfully manage complex regulatory issues related to:
- Negotiations with FDA; legal and administrative proceedings
- Compliance counseling and training with respect to state and federal anti-kickback laws, interactions with healthcare professionals, and reporting
requirements - Crisis management; responding to audits and other inquiries from FDA
- Assessing product development and regulatory approval options
- Advertising and promotional strategy and review; participating in advertising review committees
- Counseling on patient privacy protection laws
- Drafting and support for M&A, partnering, and commercial arrangements
- Clinical trial counseling and documentation – regulatory requirements, CRO agreements, CTAs, informed consents, HIPAA authorizations
Please see our FDA Regulatory, Healthcare, and Consumer Products overview for more details about our experience in this area.
Regulatory and Compliance
Regulatory approvals are critically important to growing biotech companies. Wilson Sonsini has a dedicated regulatory team that helps place biotech clients in a favorable position to clear regulatory hurdles and secure timely approvals. Our team also helps such clients remain in compliance with strictly enforced regulatory laws in the U.S. and international markets. Our healthcare regulatory attorneys help drug and medical device clients successfully manage complex regulatory issues related to:
- Negotiations with FDA; legal and administrative proceedings
- Compliance counseling and training with respect to state and federal anti-kickback laws, interactions with healthcare professionals, and reporting
requirements - Crisis management; responding to audits and other inquiries from FDA
- Assessing product development and regulatory approval options
- Advertising and promotional strategy and review; participating in advertising review committees
- Counseling on patient privacy protection laws
- Drafting and support for M&A, partnering, and commercial arrangements
- Clinical trial counseling and documentation – regulatory requirements, CRO agreements, CTAs, informed consents, HIPAA authorizations
Please see our FDA Regulatory, Healthcare, and Consumer Products overview for more details about our experience in this area.
Venture Finance
Wilson Sonsini consistently represents more venture-backed companies than any other law firm in the U.S. In fact, LSEG ranked Wilson Sonsini as the top law firm by number of venture capital rounds raised in 2024 in its “Global Private Equity Legal Advisory - Full Year 2024.” A large percentage of our clients that receive venture funding are biotech companies.
One reason for the firm's unmatched standing in the venture finance space is the long-standing relationships we have built working alongside innovative entrepreneurs to launch successful biotech companies. Another key driver of our success is our experience working with influential sources of funding: Wilson Sonsini represents more than 100 venture capital and private equity firms.
Please see our Emerging Companies and Venture Capital overview for more details about our top-ranked venture finance practice.
Venture Finance
Wilson Sonsini consistently represents more venture-backed companies than any other law firm in the U.S. In fact, LSEG ranked Wilson Sonsini as the top law firm by number of venture capital rounds raised in 2024 in its “Global Private Equity Legal Advisory - Full Year 2024.” A large percentage of our clients that receive venture funding are biotech companies.
One reason for the firm's unmatched standing in the venture finance space is the long-standing relationships we have built working alongside innovative entrepreneurs to launch successful biotech companies. Another key driver of our success is our experience working with influential sources of funding: Wilson Sonsini represents more than 100 venture capital and private equity firms.
Please see our Emerging Companies and Venture Capital overview for more details about our top-ranked venture finance practice.
Capital Markets: IPOs
Many of Wilson Sonsini's successful biotech clients have opted to enter the capital markets, most often through an initial public offering. In recent years, the firm has represented several companies in their IPOs including Denali Therapeutics, IGM Biosciences, Livongo, Silk Road Medical, Alector, Kodiak Sciences and Allakos.
In addition, Wilson Sonsini represents biotech companies in their follow-on public offerings. Examples include follow-on transactions completed for IRIDEX, China Biologic, Avinger, and Xenon Pharmaceuticals.
Please see our Capital Markets overview for more details about our experience in equity and non-equity finance.
Capital Markets: IPOs
Many of Wilson Sonsini's successful biotech clients have opted to enter the capital markets, most often through an initial public offering. In recent years, the firm has represented several companies in their IPOs including Denali Therapeutics, IGM Biosciences, Livongo, Silk Road Medical, Alector, Kodiak Sciences and Allakos.
In addition, Wilson Sonsini represents biotech companies in their follow-on public offerings. Examples include follow-on transactions completed for IRIDEX, China Biologic, Avinger, and Xenon Pharmaceuticals.
Please see our Capital Markets overview for more details about our experience in equity and non-equity finance.
Mergers and Acquisitions
An acquisition can often be an ideal exit strategy for a biotech company, because it can signal the continued viability of a developing product line, as well as broader, even global distribution options that may not have otherwise been available to the company. Wilson Sonsini has represented a number of biotech clients that reached a point in their development where either selling part or all of the company proved to be the best strategic option.
While Wilson Sonsini has represented biotech clients in hundreds of smaller M&A transactions and limited intellectual property asset acquisitions, the firm has also been involved in some of the largest M&A deals in the life sciences industry. For example, Wilson Sonsini represented Pharmacyclics in its 2015 sale to AbbVie for approximately $21 billion and more recently represented Peloton Therapeutics in its acquisition by Merck.
Please see our M&A overview for more details about our related experience and top-ranked transactions team.
Mergers and Acquisitions
An acquisition can often be an ideal exit strategy for a biotech company, because it can signal the continued viability of a developing product line, as well as broader, even global distribution options that may not have otherwise been available to the company. Wilson Sonsini has represented a number of biotech clients that reached a point in their development where either selling part or all of the company proved to be the best strategic option.
While Wilson Sonsini has represented biotech clients in hundreds of smaller M&A transactions and limited intellectual property asset acquisitions, the firm has also been involved in some of the largest M&A deals in the life sciences industry. For example, Wilson Sonsini represented Pharmacyclics in its 2015 sale to AbbVie for approximately $21 billion and more recently represented Peloton Therapeutics in its acquisition by Merck.
Please see our M&A overview for more details about our related experience and top-ranked transactions team.
Litigation
As biotech companies grow, they often become involved in a proportionately larger number of business disputes. Our attorneys have successfully represented biotech companies engaged in litigation with competitors, suppliers, service providers, employees, and other entities, with disputes ranging from employment-related lawsuits to high-stakes patent litigation. We have also successfully defended biotech companies in class actions, including antitrust, consumer, and securities litigation matters. In addition to representing companies in federal and state courts throughout the U.S., our attorneys represent companies in arbitrations and mediations.
Please see our Litigation overview for more details about our relevant experience in this area.
Litigation
As biotech companies grow, they often become involved in a proportionately larger number of business disputes. Our attorneys have successfully represented biotech companies engaged in litigation with competitors, suppliers, service providers, employees, and other entities, with disputes ranging from employment-related lawsuits to high-stakes patent litigation. We have also successfully defended biotech companies in class actions, including antitrust, consumer, and securities litigation matters. In addition to representing companies in federal and state courts throughout the U.S., our attorneys represent companies in arbitrations and mediations.
Please see our Litigation overview for more details about our relevant experience in this area.
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