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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

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

Supreme Court comments on patentable subject matter in Prometheus decision

Blog Posts

University patents now immune to inter partes review: Will business come calling?

Food industry sees one of first whistleblower suits under FSMA

Food contact goods and the FSVP: Deciphering the FDA’s stance

Update: GMO labeling regs are back in limbo

FDA bans powdered gloves in human, animal medicine

What the FDA has in store for the food industry in 2017

Cannabis in animal supplements: A hazy proposition

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

The new look of FDA food facility registration: Human and animal food companies beware

5 legal trends food and agriculture companies need to know about

TCLE

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

Survival Tools to Protect Biotechnological Innovation

News

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

Betsy Haanes authors chapter on IP asset protection strategy

Jason Schwent, Kelly Simon named 2014 Up & Coming attorneys

Betsy Haanes co-authors article on obviousness-type double patenting

Thompson Coburn sponsors St. Louis ‘Inventor of the Year’ awards celebration

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

Dr. Betsy Haanes joins Thompson Coburn as a partner

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

Jason Schwent publishes article in Bloomberg BNA patent journal

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

102 Thompson Coburn attorneys featured in 2013 Best Lawyers list

Jeff Masson featured in AgProfessional magazine

Mizzou forums feature Thompson Coburn partners

Senator Kit Bond to kick off Missouri Technology Expo

Partner
St. Louis
314 552 6003

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
314 552 6408

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
314 552 6546

Senator Bond draws on his distinguished record of public service to represent clients on matters related to international trade, economic development, biotechnology, agri...

Senator Bond draws on his distinguished record of public service to represe...

Kit Bond
Partner
St. Louis
314 552 6106

Matt litigates all forms of intellectual property.

Matt litigates all forms of intellectual property.

Matt Braunel
Partner
St. Louis
314 552 6139

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 Patent Agent
St. Louis
314 552 6348

Wendy focuses her work with firm clients on patent prosecution in biotechnology and life sciences, especially in the fields of plant genetics and plant biochemistry.

Wendy focuses her work with firm clients on patent prosecution in biotechno...

Wendy Davis, Ph.D.
Partner
St. Louis
314 552 6528

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
Washington, D.C.
202 585 6920

Betsy offers 20 years of legal experience and 10 years as a professional researcher to firm clients, especially those in the life sciences industries.

Betsy offers 20 years of legal experience and 10 years as a professional re...

Betsy Haanes, Ph.D.
Associate
St. Louis
314 552 6512

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
St. Louis
314 552 6485

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
314 552 6304

David represents clients in a variety of intellectual property disputes, including patent prosecution, trademark, non-infringement and freedom to operate opinions.

David represents clients in a variety of intellectual property disputes, in...

David Jinkins
Partner
St. Louis
314 552 6072

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
314 552 6429

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
314 552 6547

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
314 552 6190

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
314 552 6232

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
Senior Patent Agent
St. Louis
314 552 6255

Charley draws on his 14 years of biotech industry experience and doctorate in biochemistry to serve clients in the biotech industry and university sectors.

Charley draws on his 14 years of biotech industry experience and docto...

Charley Romano, Ph.D.
Partner
Chicago
312 580 2224

Diane helps life sciences companies develop new products and bring them to market while proactively addressing the regulatory land mines that can delay or destroy the pat...

Diane helps life sciences companies develop new products and bring them to ...

Diane Romza-Kutz
Associate
Chicago
312 580 5060

Fred counsels clients in the life science and technology industries on a broad range of FDA and USDA regulatory compliance, data privacy and breach response matters and r...

Fred counsels clients in the life science and technology industries on a br...

Fredric Roth V
Partner
St. Louis
314 552 6291

Jason's practice is centered on technology with an emphasis on cybersecurity breach response and software and intellectual property licensing.

Jason's practice is centered on technology with an emphasis on cybersecurit...

Jason Schwent, CIPP/US
Partner
St. Louis
314 552 6338

Clyde prepares and prosecutes patent applications in mechanical and electromechanical arts.

Clyde prepares and prosecutes patent applications in mechanical and electro...

Clyde Smith
Partner
St. Louis
314 552 6352

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.