PRESCRIPTION OTC DRUGS AND BIOLOGICS

Thompson Coburn, having represented drug and biologic companies ranging from emerging technology to specialty pharma to the larger companies in the industry, understands that these companies are constantly under scrutiny and often targets of product liability litigation. This portion of the life science industry is heavily regulated making the cost to get to market and maintain market share difficult. Complying with Good Manufacturing Practices, working with clinical trial sites and Institutional Review Boards, and achieving approval to market is time-consuming and costly.

Our attorneys work with clients to navigate the regulatory waters consistent with their business strategies. For emerging technology and specialty pharma, we negotiate sensible and fair licensing agreements, negotiate with capital sources and provide intellectual property counseling. We have assisted our clients in:

  • Filing New Drug Applications
  • Filing Investigational New Drug Applications
  • Filing for Orphan Designation
  • Drafting and reviewing clinical trial agreements, protocols and informed consents, as well as advising the client on IRB interactions
  • Complying with the Compounding Quality Act
  • Negotiating regional and global licenses
  • Reviewing BLA filings for sufficiency prior to filing
  • Negotiating clinical trial agreements
  • Negotiating tech-transfer agreements between research/academia and commercial entities
  • Implementing strategies related to the detention of regulated products
  • Responding to FDA 483 Inspection Reports and implementing corrective action plans where necessary
  • Civil investigations and disputes with the FDA and FTC, including fraud and marketing claims
  • Product liability cases regarding failure to warn, duty to warn, negligent manufacture and strict liability
  • DEA licensing/registration issues
  • FDA- and DEA-enforced pharmaceutical disposal matters
  • Negotiating tech-transfer agreements between research/academia and commercial entities
  • Compliance with the OTC monograph

Publications

Illinois legislature makes substantial limiting changes to state law on non-compete and non-solicitation agreements

EEOC issues new guidance on COVID-19 vaccinations in the workplace

Litigation fees may be tax-deductible, confirms new Tax Court ruling

Participate in standard-setting bodies? The enforceability of your patents could be affected

Criminal antitrust prosecutions still loom for employers with ‘no-poaching,’ ‘wage-fixing’ agreements

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

Supreme Court heralds tectonic shift in venue selection for patent suits

What to do when the government comes calling: A checklist for handling facility inspections

USPTO launches new proof of use audit program

The shifting standard for IPR estoppel: Where are we now?

5 tips for environmental due diligence in business transactions

D.C. appellate court strikes another nail in the coffin for the Frye test

What U.S. companies need to know about their IP rights post-Brexit

New OSHA reporting and anti-retaliation rules

USPTO publishes new (and largely improved) guidance for subject matter eligibility

Federal Circuit rules objective prong of willful infringement best decided by judge

TCLE

Better Together? Competition, Price Gouging and Other Antitrust Issues Raised by the COVID-19 Pandemic

Statutory Changes, New Regulations, and Compliance Deadlines Under the Food Safety Modernization Act

Blog Posts

Clearview AI class-action may further test CCPA’s private right of action

‘Aggrieved Persons’ can bring suit under Biometric Information Privacy Act

DOJ continues to investigate, seek recoveries over compounding pharmacy fraud

Fate of legalized cannabis hinges on key vote

FDA to step up enforcement of homeopathic medicine

Recreational marijuana shake-up: Sessions revokes Cole Memorandum

Clinical trials Part I: The upcoming clinical trials reporting rule

The FDA's new Digital Health Plan

FDA’s Health Software PreCert Program to fast-track innovation

FSVP compliance dates arrive, challenges to food industry increase

News

Jennifer Post talks to Business Insider about startup considerations before going public

Thompson Coburn releases first Ag Innovation Survey on the impact of COVID, future of the ag industry

Thompson Coburn supports agricultural growth through the Center for Soybean Innovation

Gain Executive Insights on trade developments with Thompson Coburn, Hispanic Chamber of Commerce

New Jersey jury awards $11 million to Thompson Coburn client in pet invention dispute

Agribusiness professionals enjoy hands-on farm simulation at Thompson Coburn

Thompson Coburn leads Missouri Soybean Merchandising Council to $600,000 jury verdict

Thompson Coburn earns corporate counsel recommendations five years running in national report

Jim Slear leads webinar on ‘Navigating the Russian and Ukrainian Sanctions Maze’

UMSL Research & Innovation Week to feature Tom Schlafly presentation

Steve Ritchey publishes article on patent basics for American Ceramic Society

Jeff Masson named ‘Influential Appellate Advocate’ for Monsanto Supreme Court win

Three partners named 2013 Up & Coming attorneys

Monsanto wins unanimous ruling from U.S. Supreme Court

19 Thompson Coburn partners named 2013 St. Louis Lawyers of the Year

Jeff Masson featured in AgProfessional magazine

Partner
St. Louis

Gordon is a highly experienced trial attorney who has achieved significant courtroom wins for clients in cases involving commercial disputes, white collar criminal defens...

Gordon is a highly experienced trial attorney who has achieved significant ...

Gordon Ankney
Partner
St. Louis

Matt represents major agricultural companies in business-critical disputes involving technology licensing, distribution channels, grain channeling, genetic testing, and p...

Matt represents major agricultural companies in business-critical disputes ...

Matt Bober
Partner
St. Louis

Matt is looked to for his thorough understanding of his clients’ business goals.

Matt is looked to for his thorough understanding of his clients’ business g...

Matt Braunel
Partner
St. Louis

Dan handles various types of complex litigation, including business, tort, product liability, intellectual property, and class action defense.

Dan handles various types of complex litigation, including business, tort, ...

Dan Cox
Senior Counsel
St. Louis

Chip's practice focuses on the representation of individuals, universities, and national and international companies in commercial transactions and counseling involving t...

Chip's practice focuses on the representation of individuals, universities,...

Chip Fendell
Partner
St. Louis

John represents domestic and international clients in complex litigation and multi-district litigation in some of the most challenging state and federal venues in the cou...

John represents domestic and international clients in complex litigation an...

John Galvin
Partner
St. Louis

Suzanne is a versatile litigator who finds creative solutions for clients facing difficult and protracted legal battles.

Suzanne is a versatile litigator who finds creative solutions for clients f...

Suzanne Galvin
Partner
St. Louis

Wil has a PhD in cellular and molecular biology and experience as research scientist working for a major biotechnology company.

Wil has a PhD in cellular and molecular biology and experience as research ...

Wil Holtz, Ph.D.
Partner
Washington, D.C.

Benjamin is a corporate advisor and business strategist for a wide variety of privately-held businesses, manufacturers, financial institutions, and nonprofits.

Benjamin is a corporate advisor and business strategist for a wide variety ...

Benjamin Hulsey
Partner
St. Louis

David strategically advises clients in a variety of intellectual property disputes including patent prosecution, IP litigation, brand protection, counterfeiting, Post-Gra...

David strategically advises clients in a variety of intellectual property d...

David Jinkins
Partner
New York

James serves as legal adviser to investors, entrepreneurs, investment advisers and investment bankers as they fund or invest in new companies, grow established private co...

James serves as legal adviser to investors, entrepreneurs, investment advis...

James Kardon
Partner
St. Louis

Tom is a veteran M&A and corporate finance attorney who provides clients with common-sense solutions to address complex transactional issues.

Tom is a veteran M&A and corporate finance attorney who provides client...

Tom Litz
Partner
St. Louis

Jeff is a litigator and ag insider who works with the country's largest agribusinesses to develop effective litigation strategies on a national and global scale.

Jeff is a litigator and ag insider who works with the country's largest agr...

Jeff Masson
Partner
St. Louis

Jonathan's practice includes nearly every aspect of intellectual property litigation.

Jonathan's practice includes nearly every aspect of intellectual property l...

Jonathan Musch
Partner
St. Louis

Chris is a valued strategic partner to emerging companies and the institutions and individuals that invest in them.

Chris is a valued strategic partner to emerging companies and the instituti...

Chris Reid
Partner
St. Louis

Steve advises clients on domestic and international patent applications and provides comprehensive counsel on licensing and technology transfer.

Steve advises clients on domestic and international patent applications and...

Steve Ritchey
Partner
St. Louis

Ben brings a background in electrical and computer engineering to his legal practice, which primarily focuses on the preparation and prosecution of patent applications.

Ben brings a background in electrical and computer engineering to his legal...

Ben Volk, Jr.