Why Leading Companies Turn to Axinn for FDA Counseling and Litigation

Axinn’s FDA Practice Group provides counseling, advocacy, and litigation services relating to the development, marketing, and approval of FDA-regulated products, including new and generic drugs, biologics and biosimilars, medical devices, human tissue and stem cell products, food and dietary supplements, and tobacco products. Axinn frequently represents clients before the Food and Drug Administration and in federal court, often in matters of first impression. By coupling the firm’s knowledge of the complex and shifting regulatory landscape with the firm’s in-house scientific capability and patent, antitrust, and licensing expertise, Axinn offers a comprehensive team to enable companies to bring regulated products to market and defend their market positions in the most efficient, competitive and profitable manner.

Axinn’s FDA Practice Group has experience in the following areas:

• Counseling and advocacy relating to approval standards for FDA-regulated products
• Federal court litigation regarding marketing exclusivities and approval standards
• Citizen petitions
• Commenting on rulemaking and guidances
• Formal and informal advocacy relating to obtaining, maintaining, and forfeiting the 180-day generic drug exclusivity period
• Assessing labeling carve-outs and proposing patent certification strategies consistent with approvable labeling
• Disputes arising under the Lanham Act and unfair competition law
• Formal dispute resolution
• Product lifecycle management strategies
• Regulatory due diligence
• Advising on and negotiating shared REMS programs and advocating for waivers of shared REMS requirements
• Review of settlement, licensing and distribution agreements
• Counseling and oversight of investigations
• Review of marketing claims
• Review of product packaging

In addition to representing clients before FDA, Axinn also litigates cases involving FDA law. In recent years, Axinn is one of the top firms to represent litigants in actions brought against FDA. 

Representative FDA litigation experience includes: 

• In what has been described as the first time a court has ordered FDA to approve a product, Axinn obtained summary judgement on behalf of Watson Laboratories in litigation against FDA in relation to 180-day exclusivity period for a multi-billion dollar product Actos^®.
• Successfully argued for FDA to approve Endo’s ANDA on the basis that another ANDA applicant had forfeited its exclusivity relating to valganciclovir (Valcyte^®) and subsequently intervened to defend FDA’s decision before the D.C. District Court.
• On behalf of Watson, won a challenge to FDA’s decision to grant 180-day generic drug exclusivity to another celecoxib (Celebrex^®) ANDA applicant before the Court of Appeals for the Fourth Circuit and obtained a judgment directing FDA to permit Watson to share in the 180-day exclusivity period
• Successfully intervened in a case to uphold FDA’s final approval of ANDA in a case involving antibiotic marketing exclusivity for Vancocin^®
• Intervened to defend FDA decision that approval of an ANDA was not blocked by orphan drug exclusivity relating to the multi-billion dollar drug Abilify^®
• Obtained dismissal of an action brought by Wyeth under the Lanham Act and state unfair competition law regarding Sun Pharmaceuticals’ labeling of its generic Protonix^®, arguing that Wyeth’s claims were preempted by FDA law

 Representative FDA counseling experience includes:

• Counseling relating to biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA), including the requirements for the demonstration of biosimilarity and the patent resolution provisions
• Advise on eligibility of complex innovator compounds for New Chemical Entity exclusivity
• Working closely with client’s regulatory and product development teams to navigate multiple FDA-issued deficiencies in order to devise the appropriate testing and obtain FDA approval
• Challenge refuse-to-file decision for drug application through the formal dispute resolution process
• Counsel on regulatory pathway for novel dissolvable energy strip product
• Review and revise marketing claims and Made-in-USA claims for smokeless tobacco product
• Provide solutions to issues pertaining to DEA’s proposed aggregate production quotas for controlled substances

News

• Axinn Successfully Advocates for Preservation of 180-Day Marketing Exclusivity for Carvedilol ER
• Axinn Defeats TRO, Enabling Immediate Launch of Generic Versions of AstraZeneca’s Blockbuster Crestor
• U.S. District Court Grants Summary Judgment for Axinn’s Client Zydus in FDA Case
• Axinn Protects Client Endo Pharmaceuticals Inc.’s Approval for Generic Valcyte^®
• Chad Landmon Named to Law360's Intellectual Property "Rising Star" List
• Chad Landmon Named to Law360's Life Sciences "Rising Star" List
• Axinn Obtains Favorable Decision in FDA Suit
• Axinn Obtains Summary Judgment Victory Against FDA
• Axinn Partner Chad Landmon Honored as Hartford Business Journal “40 Under 40” Winner
• View More ›

Articles & Newsletters

• FDA's Digital Health Technologies Framework Addresses Important Challenges
• Resistance or Defiance? The FDA and the 11th Circuit Spar Over Statute on Orphan Drug Statutory Exclusivity
• New U.S. Legislation Creates Momentum for Biosimilars
• FDA's Longtime Approach to New Chemical Entity Designations Now Codified
• Opinion: Purple Book Patent Listings Are Only a First Step
• Interview on the FDA’s Emergency Use Authorization Process for COVID-19 Vaccines
• The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
• Opinion: The Legal and Regulatory Year in Review
• Axinn FDA Update: Insights on the MODERN Labeling Act
• Axinn FDA Update: A Difficult Analysis Is Not Necessarily a Deferential Analysis
• FDA Extends Enforcement Discretion Period for Regenerative Medicine Products, but This Isn't a Green Light for Bad Actors
• FDA Informal Guidance Process
• Axinn IP Update: District Court Retains Subject Matter Jurisdiction But Grants Dismissal After Paragraph III Conversion
• ABA SciTech Brief Short Video on COVID-19: FDA Emergency Use Authorizations
• Insulin Under the BPCIA: Opportunities and Obstacles
• FDA’s Emergency Use Authorizations: Aggressive Action Taken to Combat COVID-19
• Virus Heightens Importance of Drug Shortage Reports to FDA
• FDA Emergency Use Authorizations
• Chevron’s Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference
• FDA Administrative Decision Challenges
• Open the Floodgates: The Potential Impact on Litigation Against FDA if the Supreme Court Reverses or Curtails Chevron Deference
• Can the FDA Salvage Interchangeable Follow-On Biologics?
• Fixing the Follow-On Insulin Regulatory Approval "Dead Zone"
• Recent FDA Court Decision Shows Potential Impact of SCOTUS Deference Decision
• How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy
• What High Court's Kisor Ruling Means for FDA Decisions
• FDA's Aggressive Enforcement Against Stem Cell Companies Starting to Ripen
• Axinn IP Update: FDA Issues Final Guidance on Interchangeability of Biologics
• FDA Doubles Down in Its Updated Biologics Naming Guidance
• Status Quo Maintained: FDA Reverses Course on Generic Product Labeling
• Stem Cell Companies Beware: FDA May Come Knocking
• Axinn FDA Update: SUPPORT for Patients and Communities Act
• Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second Edition
• FDA Focus: What Axinn's Practice Chair Is Watching
• FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users
• US FDA Postpones Celltrion's Remicade Biosimilar Review Meeting
• Scientific Speech Highlighted In SCOTUS Petition To Overturn CEO Conviction
• Attorneys React to High Court's Gene Patent Ruling
• 2012 Court Decisions Impact the Life Science Industry
• View More ›