Among the bright spots amidst all the bad news lately are the frequent reports of how scientists and engineers have been mobilizing to fight the COVID-19 pandemic with new tests, new treatments and new preventative measures. On March 28, 2020, Abbott Labs announced FDA approval for a new COVID-19 test that can be run in a doctor’s office and return results within 15 minutes.
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.
- 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.
- Over $25 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, private equity groups 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, Mayo Clinic and UnitedHealth Group.
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:
Closed more than 75 deals worth over $1.6 billion this past year. Notable relationships are described below:
- Represent Mayo Clinic in a number of investment and technology commercialization transactions. In addition, Mayo Clinic has referred us to several businesses commercializing Mayo Clinic technology.
- General corporate and intellectual property representation of Bio-Techne, including strategic transactions with numerous private businesses globally. Recent acquisitions include Zephyrus Biosciences and Advanced Cell Diagnostics ($250 million cash and $75 million contingent consideration).
- Represent 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.
- Represented Midwest Dental in 110 acquisitions in 17 states.
- Closed 23 acquisitions for Numotion as well as provided corporate, employment and regulatory advice.
- Represented AccuMed in the acquisition of business. Continued general corporate representation, including the refinancing of AccuMed’s senior and mezzanine debt and a product line divestiture to a strategic acquiror; exit at end of 2016.
- Corporate, finance and transactional representation for Cardiovascular Systems, Inc., including a public offering of common stock and its IPO in which CSI became a public company through a reverse merger with Replidyne, Inc.
- Represent Bioventus in several acquisitions, other strategic transactions and general corporate projects.
- Represent Medtronic, the largest medical device manufacturer in the world, on hundreds of growth transactions, 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.
- 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.
- 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.
- Represented Vascular Solutions’ CEO, Howard Root, and obtained complete acquittal in month-long federal jury trial based on alleged off-label promotion and conspiracy. The case is one of the first to establish clear limits on the FDA’s authority to prosecute off-label promotion, by drawing a distinct line between “truthful” and “misleading” speech.
- Represent Mayo Clinic and its physicians in litigation matters, including numerous malpractice cases and commercial disputes.
- 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.
- Represented 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.
Intellectual Property – Patents and Patent Litigation
- Intellectual property representation, including prosecution of several patent applications in global patent offices, assessments of patent infringement risk, negotiation and development of license agreements and trademark, copyrights and IP transaction matters.
- Represented a large medical technology, services and solutions company to investigate and quash the rampant infringement of its patent portfolio protecting its market-leading Slide-On Endosheath System. We successfully enforced U.S. patent rights to end infringement in the U.S. and then proceeded to enforce patents worldwide. In the latest of those proceedings, brought suit in France against Xmed S.p.A. and its French distributor Pouret Medical. Through settlement with Pouret Medical, stopped the infringing product from sale in France. We are currently working with French co-counsel to seek further enforcement of the client’s patent rights in France.
- Currently defending a large medical technology company in patent infringement litigation in the U.S. District Court for the Northern District of Illinois regarding infusion pumps. We’re defending the lawsuit on multiple fronts, including patentability challenges under the Supreme Court’s Mayo/Alice standard at the district court and coordinated inter partes review before the Patent Trial and Appeal Board.
- Represented a medical device provider in trademark enforcement and TTAB proceedings. In one recent case, the defendant changed the infringing advertising materials in response to our preliminary injunction motion.
- Represented a medical device company in a lawsuit to protect its trade secrets. Our client developed a new technology and entered into a non-disclosure agreement with a potential vendor. The vendor later applied for a patent that incorporated our client’s technology. We filed suit and achieved a settlement that keeps the competitor out of our client’s market.
Health Care and Regulatory
- Represent health systems, managed care organizations, medical device companies, single-specialty and multi-specialty physician groups, dental groups, practice management companies, pharmacies, ambulatory surgical centers and health care providers and suppliers on regulatory compliance advice on Stark, antikickback, HIPAA and Medicare and Medicaid reimbursement issues.
- 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.
- Represented 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.
- Represented QuantaLife, Inc. in its licensing of critical patented technology from Japan Science and Technology Agency.
- Audited Bio-Techne’s 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
January 13, 2020
Minnesota’s Medical Alley is a leading health care center anchored by world-class providers, technology companies and payors near Rochester, Minnesota.
Fredrikson & Byron Represents Bio-Techne Corporation in its Acquisition of B-MoGen Biotechnologies Inc.
June 17, 2019
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 B-MoGen Biotechnologies Inc.
October 26, 2017
Fredrikson acted as legal counsel to Celcuity Inc. in its initial public offering of 2.76 million shares of common stock with total gross proceeds of $26.2 million, before underwriting discounts and offering expenses.
July 18, 2017
Fredrikson & Byron’s Health Care Practice Group has been honored for its client relationships on the new BTI Industry Power Rankings: The Law Firms with the Best Client Relationships in 18 Industries.
May 17, 2017
Fredrikson & Byron acted as legal counsel to Medtronic, Inc. in its transaction with QT Vascular Ltd. for the option to acquire QT Vascular’s non-drug coated Chocolate® PTA.
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.
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.
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.
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.