We bring our collective life sciences industry experience and insights to every engagement, providing exceptional value to entrepreneurs and inventors, venture-backed businesses and established industry leaders.
What We Do
Our understanding of your goals defines how we do business.
- Flexibility and creativity in pricing and no surprises in your legal bills.
- Superior responsiveness and service delivery.
- Sophisticated, high quality advice delivered in a way that lets business people make business decisions.
- Business network collaboration to get the deal done – beyond the legal work.
We know your industry. We represent over 150 life sciences and health care innovation companies, as well as investors and people who provide them financing and services.
- Over $20 billion in life sciences and health care innovations transactions.
- Negotiation of sophisticated deals opposite the largest law firms coast to coast.
- Exceptional guidance identifying and evaluating opportunities for growth by merger, acquisition, minority investment, joint venture, strategic alliance and licensing.
- Deep connections within the industry, including national and international venture investors and individuals in high-level leadership positions in the organizations at the forefront of the industry.
- Lawyers with in-house experience at leading life science companies like Medtronic and St. Jude Medical.
Subject matter experts in all areas impacting life sciences and health care innovation, including capital raising, securities compliance, governance, M&A, patents, licensing and tech transfer, trade secrets and non-competes, FDA regulation, supply chain and litigation.
We bring lessons learned from decades of experience. We’ve worked with the life sciences industry since its earliest beginnings, incorporating Medtronic out of a garage in 1957.
Here are a few recent examples of our work:
- General corporate representation of AGA Medical Holdings, Inc., including a $300 million recapitalization resulting from a shareholder dispute and the sale of the company to St. Jude Medical for $1.1 billion.
- Special representation of QuantaLife, Inc. in its $162 million sale to Bio-Rad Laboratories.
- General corporate representation of MinuteClinic, including its sale to CVS Pharmacy for over $100 million.
- General corporate representation of HealthFitness Corporation, including its sale to Trustmark Mutual Holding Company for $97 million.
- Representation of several biopharma development companies, including Cougar Biotechnology, Inc., Talon Therapeutics, Inc., and Nile Therapeutics, Inc., in connection with general corporate matters, securities compliance and several corporate financing transactions.
- General corporate and securities compliance representation of Techne Corporation, including strategic investments in numerous private businesses globally and its acquisitions of Tocris Holdings Limited for $124 million and Bionostics for $104 million.
- Corporate, finance and transactional representation for Cardiovascular Systems, Inc., including reverse merger/IPO and subsequent $16 million equity offering.
- General corporate and securities compliance representation, including key growth transactions such as $16.5 million IPO and subsequent $6.5 million equity offering for Kips Bay Medical, Inc.
- Representation of American Medical Systems, Inc. in several product line divestitures and strategic investments.
- Special representation of Galena Biopharma, Inc. in its 2011 acquisition of Apthera, Inc., an oncology-focused biopharma development company.
- Hundreds of growth transactions for Medtronic, the largest medical device manufacturer in the world, including mergers, acquisitions and divestitures; capital markets transactions; strategic investments involving preferred and common equity; secured, unsecured, and convertible debt; acquisition options; rights of first refusal/negotiation and distribution, manufacturing/supply and IP license agreements.
- Defense of AGA Medical in a licensing dispute with the son of a company founder, who sought more than $150 million. Based on a strong trial performance, the court rejected the plaintiff’s liability and damages theories, allowing AGA to negotiate a favorable settlement.
- Successful representation of Medtronic in patent and trademark infringement dispute against a competitor that tried to design around Medtronic’s patents in order to market a surgical drill tool that was visually indistinguishable from Medtronic’s drill tool. The parties negotiated an early settlement that required the competitor to exit the market.
- Representation of ACIST Medical Systems in enforcing its trade secret rights against a competitor after ACIST had shared a new product idea with a potential vendor under a non-disclosure agreement. After potential vendor announced plans to create a similar product, we filed suit on behalf of ACIST and negotiated a settlement that required the competitor to cease using ACIST’s trade secrets.
- Clinical trial advice including writing and negotiating investigator agreements, negotiating with FDA on IDEs, training and advising on trial compliance, advising on adverse event reporting, reviewing protocols for legal issues, and advising in clinical trial data reports.
- Preparation of marketing applications to FDA, and negotiation with FDA on approvals including training on advertising law and practices and reviewing promotional literature.
- Representation of Medtronic in numerous in- and out-licensing transactions, including negotiating Medtronic’s access to drugs and therapies of Abbott Laboratories and other drug manufacturers for use with Medtronic’s drug eluting stents and balloons.
- Experience in negotiating with universities, research institutions and government agencies, including the NIH.
- Representation of QuantaLife, Inc. in its licensing of critical patented technology from Japan Science and Technology Agency.
- Audited Techne Corporation’s key license agreements and revised its license templates.
- Developed and implemented the licensing arrangement for Surmodics, Inc. coating technology.
- Over 650 active U.S. and foreign trademark applications and registrations relating to life sciences products and services.
- Attorneys with in-house experience in advertising agencies.
- Successfully prosecuted and defended advertising actions before the National Advertising Division of the Better Business Bureau.
- Provide advertising clearance and regulatory advice relating to FTC and FDA matters.
News & Articles
February 15, 2017
Healthcare attracts some of the most innovative minds in the world, but there are legal speed bumps in the adoption of digital healthcare innovation. Inconsistent regulatory regimes, varying reimbursement models, potential litigation and the ethical concerns of protecting the privacy, life and health of patients mean the healthcare industry needs to move cautiously. As a result, some basic available technologies that could make healthcare more effective and efficient are still not widely adopted.
July 28, 2016
On July 20, a jury in Massachusetts convicted former Acclarent executives William Facteau and Patrick Fabian of 10 misdemeanor counts of misbranding and adulteration based on alleged off-label promotion of the Stratus sinus spacing device. They were acquitted of 14 related felony charges, but they have vowed to fight the misdemeanor convictions in future motions and appeals. The Facteau verdict contrasts with the clean sweep obtained by Vascular Solutions and its CEO, Howard Root, last February, when a Texas jury acquitted them of all counts of misbranding and conspiracy for allegedly promoting the Vari-Lase varicose vein device off-label. The two cases are different in significant respects, which may account for the disparate results. But they also bear many similarities, which provide a road map for medical device and pharma manufacturers to future off-label prosecutions in the wake of recent First Amendment precedents.Read More
Fredrikson & Byron Represents Bio-Techne Corporation in its Acquisition of Zephyrus Biosciences, Inc.
April 8, 2016
Fredrikson & Byron acted as legal counsel to Bio-Techne Corporation (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, in its acquisition of Zephyrus Biosciences, Inc.Read More
April 6, 2016
Fredrikson & Byron acted as legal counsel to Omnis International Co., d/b/a Omnis Pharma, in its merger with Magnis Therapeutics, LLC.Read More
March 7, 2016
On February 26, 2016, a jury in West Texas acquitted Minnesota-based medical device company Vascular Solutions, Inc., and its CEO, Howard Root, in a federal criminal case involving FDA alleged crimes. The indictment in the case charged Vascular Solutions and Mr. Root with misbranding and conspiracy based on allegations that Vascular Solutions marketed its Vari-Lase® device for off-label use and sought to conceal that activity from the FDA. The jury wholly rejected the government’s case and delivered a stunning defeat to the FDA and the Department of Justice (DOJ) by acquitting Vascular Solutions and Mr. Root on all counts.Read More
January 5, 2015
Courtney A. Hofflander Thompson has joined Fredrikson & Byron as an attorney in the Advertising, Marketing & Trademark, Data Protection & Cybersecurity, Life Sciences and Intellectual Property Groups.Read More
Don’t be Blacklisted: Be Aware of China’s New Anti-Corruption Regulations in the Healthcare Industry
October 2, 2014
By Ruilin Li
China’s heightened anti-corruption efforts are reflected in the recent adoption of several anti-corruption measures. This article will summarize each of these circulars as well as some action items companies may want to consider in order to ensure compliance under the new measures.Read More