Life Sciences

Our attorneys understand the unique laws and regulations governing your industry with a passion for the science behind your business. Let us focus on solving your legal needs, from IP and licensing to corporate and privacy law.

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Summary

Procopio’s Life Sciences attorneys bring you decades of law firm and in-house counsel experience—from life-saving pharmaceuticals to breakthrough biotechnologies—offering a unique understanding of your legal challenges and opportunities in your rapidly evolving, multidisciplinary industry.

Whether you’re an emerging company or an established multinational, we provide a wide range of legal services including corporate formation, financing and venture capital, intellectual property counseling and litigation, technology transactions and licensing, mergers and acquisitions and joint ventures, data privacy and cybersecurity, labor and employment, and real estate.

We counsel medical device designers and manufacturers, innovators in the biologics, genomic, diagnostic, e-health, digital health technologies and other life sciences companies.

Our molecular biology experience includes gene therapy, personalized cancer immunotherapy, TCRs, antibodies/peptibodies; antibody-drug conjugates (ADCs); protein therapeutics, cancer therapies, cellular immunotherapy, nucleic acids, as well as next-generation sequencing and modern genomics.

Our chemistry technical expertise includes pharmaceuticals, industrial biotechnology, organic chemistry and polymer chemistry, in areas as diverse as peptide pharmaceuticals, adhesives, drug delivery technology, and medical devices.

We are active in the Southern California Life Sciences community and support organizations driving innovation including BIOCOM, California Life Sciences, San Diego Venture Group, SABPA (Sino-American Biotechnology and Pharmaceutical Association), and Women in Bio. We also coordinate professional development and networking opportunities for established and rising industry leaders, such as our Life Science CEO Connection programs. These exclusive, invite-only and complimentary programs are held at our Palo Alto, Irvine and Del Mar Heights offices, and offer an unparalleled opportunity for select early-stage CEOs to engage in a vibrant, monthly, peer-to-peer forum. Learn more.

INTELLECTUAL PROPERTY

Our team includes experienced patent, licensing, trademark, copyright, and trade secret attorneys and patent agents with substantive technical experience in the life sciences industry. In addition, we provide counsel on identification, development, registration, licensing, protection and litigation of IP, including:

IP due diligence
Patent portfolio development, maintenance and lifecycle management
Patent prosecution and opposition strategies
Freedom to operate & patent landscape analysis
Patent portfolio management
License negotiations
Structuring and negotiation of technology options and licenses from public institutions
Non-infringement and invalidity opinions
Trademarks & copyright compliance and transfer
Technology licensing, collaborations, M&A and other IP-related transactions
Copyright registration, licensing, policing, enforcement, compliance and business transactions
Database law compliance
IP litigation

TECHNOLOGY TRANSACTIONS AND LICENSING

We have extensive experience providing advice on IP provisions for contracts and our tech transactions team are regularly involved in contracts involving the development, protection, licensing and transfer of intellectual property and associated rights. We also regularly draft and negotiate contracts governing the creation, transfer and use of data. We negotiate and draft licensing agreements to acquire, protect and license technology and license software development and other computer-related intellectual property rights. We also draft and negotiate agreements for research and development.

FORMATION AND FUNDING

We assist startups and emerging life sciences companies in all areas of corporate and securities, from initial incorporation through seed and angel investments, to mergers and acquisitions (M&A) services. We leverage relationships with premier angel investors, venture capital firms and other sources of debt and equity funding to bring together life sciences entrepreneurs and investors.

M&A AND JOINT VENTURES

Our Mergers & Acquisitions (M&A) attorneys have closed hundreds of deals totaling billions of dollars, from $5 million to more than $1 billion, offering the infrastructure to support smaller and mid-sized companies as well as multinationals. We work actively with Life Sciences clients to determine the best strategies for acquisition or sale, as well as possible strategic joint ventures.

CAPITAL MARKETS & SECURITIES

Whether you’re an emerging or established company, our Capital Markets and Securities attorneys are there to support your growth with a wide array of private and public financing and securities-related transactions.

FULL RANGE OF SERVICES

Procopio provides a full range of services to life sciences clients. Our Real Estate attorneys assist clients in acquiring and selling properties unique to the needs of medical research and production. Our Privacy and Cybersecurity attorneys work with life sciences clients to maintain compliance with the latest privacy laws, including the California Privacy Rights Act (CPRA) and HIPAA. And our Employment Law attorneys help growing life sciences companies stay on the right side of ever-evolving labor laws, particularly in California.

Led IP due diligence for Denali Therapeutics’ $250M initial public offering (IPO), follow-up offering, and subsequent licensing and collaboration transactions with Takeda and Sanofi.
Managed IP matters for Evofem Biosciences, Inc., including its merger with Neothetics, Inc.
Guided biotechnology company United Therapeutics in multiple large licensing and M&A transactions.
Strategic counselling leading to PTAB post-grant review (PGR) win for Paragon Bioteck in first-ever Orange Book patent upheld in a PGR proceeding.
Obtained patent infringement verdict of $5.5M, plus 10% royalty on behalf of manufacturer of polymer fibers, against importer and distributor of infringing products.
Represented pharmaceutical manufacturer in Abbreviated New Drug Application (ANDA) patent litigations relating to blockbuster cholesterol drug and colon cancer drug.
Represented biotechnology clients in patent disputes relating to humanized monoclonal antibodies and genetic testing.
Represented a global chemical products company in US ITC Section 337 Investigation relating to patent infringement claims regarding polyimide films.
Defended pharmaceutical manufacturer against claims of trademark and trade dress infringement, false advertising and related Lanham Act claims. Case settled on favorable terms.
Represented pharmaceutical company in trademark and trade dress infringement action relating to over-the-counter vitamins. Obtained favorable settlement during trial.
Earned a complete victory for Amneal Pharmaceuticals over Noven Pharmaceuticals in connection with Amneal’s ANDA for a therapeutic equivalent of the Minivelle® estrogen patch; at trial, persuaded Judge Stark of the District of Delaware to invalidate all asserted claims of all three Noven patents for failure to meet both the written description and enablement requirements of Section 112 of the Patent Act.
Persuaded the Federal Circuit entire panel, including Judge Newman, to affirm the decision of the PTAB that all claims of six patents were invalid as obvious; this victory over Jazz Pharmaceuticals helped pave the way for client Amneal Pharmaceuticals in connection with its bid to market a therapeutic equivalent of Xyrem® for the treatment of narcolepsy.
Persuaded the Federal Circuit to vacate a trial decision rendered against Actavis after being brought on for the appeal, with the Federal Circuit instructing the district court to enter judgment of non-infringement in favor of Actavis.
Secured complete victory for Allergan in first-to-file litigation over Beyaz® and Safyral® (Merck and Bayer), persuading a unanimous Federal Circuit panel to reverse and invalidate the patents under the on-sale bar.
Represented privately held San Diego medical device company in its Series B and Series C Preferred Stock financing in which $19M and $30M, respectively, was raised.
Represented San Diego-based medical device company in its simultaneous acquisition of three private companies.
Represented a pharmaceutical company in its Series B and Series C Preferred Stock financing in which $5M and $30M, respectively, was raised.
Represented two biotechnology venture capital funds (co-lead investors), investing in a drug development company in a $45M purchase and sale of Series D Preferred Stock.
Represented a life sciences medical diagnostics company in the negotiation and implementation of a long term development, collaboration and commercialization agreement with a large public pharmaceutical company for a companion diagnostic test necessary for regulatory approval by the FDA of a new cancer drug.
Represented biotechnology company in preferred stock sale, and concurrent licensing of ancillary technology, to a public technology company.
Complete victory for Amneal Pharmaceuticals over Noven Pharmaceuticals in connection with Amneal’s ANDA for a therapeutic equivalent of the Minivelle® estrogen patch; at trial, persuaded Judge Stark of the District of Delaware to invalidate all asserted claims of all three Noven patents for failure to meet both the written description and enablement requirements of Section 112 of the Patent Act.
Persuaded the Federal Circuit entire panel, including Judge Newman, to affirm the decision of the PTAB that all claims of six patents were invalid as obvious; this victory over Jazz Pharmaceuticals helped pave the way for client Amneal Pharmaceuticals in connection with its bid to market a therapeutic equivalent of Xyrem® for the treatment of narcolepsy.
Persuaded the Federal Circuit to vacate a trial decision rendered against Actavis after being brought on for the appeal, with the Federal Circuit instructing the district court to enter judgment of non-infringement in favor of Actavis.
Secured complete victory for Allergan in first-to-file litigation over Beyaz® and Safyral® (Merck and Bayer), persuading a unanimous Federal Circuit panel to reverse and invalidate the patents under the on-sale bar.
Scored a complete non-infringement victory for Watson before Judge Andrews in the United States District Court for the District of Delaware, obtaining a rare, expedited schedule and delivering a trial presentation so compelling that Judge Andrews announced his decision from the bench at the close of evidence, before any post-trial briefing.

Co-Leader

Goldstein, Helen

Senior Associate • Scottsdale, AZ

Life Sciences

Summary

Services

FULL RANGE OF SERVICES

Representative Matters

Goldstein, Helen

Yang, PhD, Xiaofan (Frank)

Campbell, Richard E.

Crawford, David

Doucette, Dennis J.

Edwards, Jeremy J.

Eigner, William W.

Femrite, Jason A.

Garrison, Brett

Gillespie, Noel C.

Jensen, Kaitlyn

Johnson, Paul B.

Johnson, PhD, Brent

Kim, Raph Y.

Kinkelaar, Michael J.

Kramer, James

Maddox, Steven A.

Mehta, Miku H.

Qashu, Ruba

Ramos, Robert "Bob"

Rawlins, Pattric J.

Sloss, Robert H.

Spence, PharmD, Erica

Sumida, Takeshi

Tidgewell, Kelsey

Turner, Gabriela L.

Winn, PhD, Blake

Wolmark, Aaron

Zhou, PhD, Yuefen (Jennifer)

Tony Chen, PhD

Founder and CEO of Eton Bioscience

Steven P. Richieri

President and COO, Banyan Biomarkers

Asa Nordgren

CEO & Co-Founder, Trice Imaging, Inc.

Inanc Ortac

Co-Founder and CTO, DevaCell

Life Sciences

Summary

Services

FULL RANGE OF SERVICES

Representative Matters

Goldstein, Helen

Yang, PhD, Xiaofan (Frank)

Campbell, Richard E.

Crawford, David

Doucette, Dennis J.

Edwards, Jeremy J.

Eigner, William W.

Femrite, Jason A.

Garrison, Brett