Overview

Fredrikson & Byron’s Life Sciences Group advises companies and investors through all stages of development. Our clients rely on us to take an integrated approach to their company’s growth strategy including corporate, intellectual property and regulatory issues. From industry leaders to emerging start-ups, our approach focuses on improving our client’s strategic position.

Fredrikson & Byron currently represents over 100 life sciences companies and many more companies on investment and strategic decisions related to the industry. We are at the center of key developments within the life sciences industry primarily due to our experience with and proximity to some of the most well-known and fastest growing companies in the industry. Our experience means Fredrikson & Byron’s clients receive extensive knowledge of the industry as well as a deep understanding of the business approach needed to deal with legal issues at every stage of development.

Our clients rely on our ability to navigate through the, sometimes complex, channels of the life science legal scene. Our team provides hands-on expertise and insight when assisting life science companies and believes the key to helping them reach their goals is developing great relationships.

Our ability to develop strong relationships is at the foundation of how we conduct business at Fredrikson & Byron. In order to have a great relationship, we understand that both parties need to be in synch with each other throughout the business and legal process, which is why we work closely with clients to establish a mutually beneficial relationship. 

Our relationship-focused approach includes:

• Superior responsiveness and service delivery
• Sophisticated, high quality work product
• Business network collaboration to get the deal done – beyond the legal work

Intellectual Property

At Fredrikson & Byron, we also help clients navigate through the channels of the intellectual property legal scene. We have become adept at getting up to speed quickly and effectively in a technical field. The thoughtful attention we pay to clients and their changing needs often leads us to recognize better ways of serving them. 

Our attorneys understand both the legal and technical issues involved. Many of our lawyers hold advanced scientific degrees and have industry experience in biotechnology and related fields. This background guides their work, from patent applications to venture capital financing, from licensing agreements to mergers and acquisitions, and from patent litigation or freedom to operate opinions to initial public offerings. All of our patent attorneys are registered to practice before the U.S. Patent and Trademark Office and each has at least one technical degree; many have advanced degrees. These attorneys work with our patent agents, paralegals, and staff scientists to provide high-quality, cost-effective protection.

We commonly look beyond a client’s immediate goal of filing a patent application; we take a global perspective as we balance the risks and benefits of various levels of protection and evaluate how patent coverage integrates with clients’ business needs. 

Venture

One key to any successful company is its financing which is why we advise and assist on matters of capital formation, including acquiring or working with venture financing or grant funding from public and private sources, mergers, acquisitions, and divestitures of all types. We leverage deep connections in the national and international venture market, and in particular, with those focusing on the medical technology market. The firm also represents companies and venture funds in strategic transactions and investments in the industry.

Regulatory Strategy

Life science companies look to us for our expertise on a full range of regulatory issues throughout the product life cycle. Our advice spans both FDA regulation and foreign governmental issues, such as the CE process in the European Union. We team with clients on the product approval process including interpreting statutory and regulatory requirements; setting approval strategies for NDAs, PMAs, and 510(k)s; and interacting with the FDA, including negotiating requirements, meeting with the agency, and attending advisory panel meetings. We advise on the process of obtaining clinical information, including advice on Good Laboratory Practices for pre-clinical studies; agreements for clinical trials, such as investigator and clinical research organization agreements; training of monitors and site study coordinators; and compliance advice, including handling of bioresearch monitoring inspections.

Our attorneys advise clients on the application of Good Manufacturing Practices to the entire life of drugs and devices, including Quality System Regulation advice for devices from the beginning of design controls to the delivery of product. We work with manufacturers on compliance issues such as inspections, warning letters, seizures, medical device reporting, recalls, the Application Integrity Policy, and criminal actions related to regulatory matters. We handle all post-approval regulatory issues, including import/export, post-market studies, and patent term extensions. We advise on promotion and advertising throughout the entire product cycle, as well as on related promotional materials.

Litigation and Regulatory Representation

We advise life sciences companies on a variety of legal disputes, including shareholder and partnership disputes, securities claims, intellectual property disputes, corporate investigations, and governance matters in both domestic and international jurisdictions. We analyze and manage disputes and potential disputes in connection with our due diligence activities.

Relevant experience

Fredrikson & Byron’s Life Sciences Group includes several professionals who have held high-level positions within life science companies. Our team’s deep connections within the industry, as well as the national and international venture markets, provide exceptional leadership for mergers, acquisitions, divestitures, joint ventures, strategic alliances, and licensing opportunities, as well as in identifying, valuing, and recommending growth opportunities. Our broad experience working with, for, and across the table from life science giants gives us a unique understanding of what small to medium sized companies can expect during transactions.

Fredrikson & Byron has closed over $20 billion in medical device transactions. We are an industry leader in this space and regularly represent our clients in the most sophisticated transactions against the largest law firms on the East and West coasts.

Bios

Primary Attorneys

Gail F. Brandt
Scott J. Dorfman
Emily E. Duke
Michael D. Ellwein
Kara K. Fairbairn
Philip M. Goldman
David C. Grorud
Bruce A. Johnson, Of Counsel
Ryan S. Johnson
Dean R. Karau
Robert J. Klepinski
Ann Marie Ladd
Ruilin Li
Keith A. Libbey
Christopher J. Melsha
Mia E. Mendoza
Brian G. Moore
Kurt J. Niederluecke
Robert K. Ranum
Alexander Rosenstein
Charles D. Segelbaum
Rhona E. Shwaid
James H. Snelson
Thomas F. Steichen
Peter Thomas
David C. West
John F. Wurm

Supporting Attorneys

Thomas B. Archbold
Michael J. Feller
Thomas S. Fraser
Sharon K. Freier
David M. Glaser
Matthew J.S. Graham
Steven E. Helland
Thomas R. Hipkins
Lisa Holter
Leigh-Erin Irons
Natalie D. Kadievitch
Patrick J. Kelly
Kimberly A. Lowe
Jessica D. Manivasager
John S. Parzych
Eric J. Snustad

Other Professionals

Kristi Nickles
Beckie Northrop
Julie Taylor