
Chad Landmon, Chair of Axinn's Intellectual Property and Food and Drug Administration Practice Groups, is a first chair trial lawyer who guides clients in simultaneously clearing both patent litigation and Food and Drug Administration (FDA) approval hurdles, enabling clients to bring their products to market in the most profitable manner possible.
Recognized among the world’s leading patent litigators by IAM Patent 1000, Benchmark Litigation, and Law360, Chad has litigated more than 60 cases in the past decade alone. His experience includes leading a case described by media as the first in which a court has ordered the FDA to approve a product. Having advised on all of the top 10 generic drugs ranked by cost savings and nearly half of the top 100 generic drugs by sales volume, Chad has been lauded as a “Life Sciences Star” by LMG Life Sciences and a “Health Care/Life Sciences Trailblazer” by The National Law Journal.
Chad’s dual practice couples his litigation prowess with his adeptness in maneuvering through the complex FDA regulatory regime. He handles FDA citizen petitions and litigates cases involving marketing exclusivities, patent listings, certification and notification requirements, bioequivalence, labeling, and other issues relevant to the FDA drug approval process. He represents manufacturers of pharmaceuticals, biologics, medical devices, and human tissue products with billions of dollars in annual sales.
Additionally, Chad handles cases that intersect antitrust and patent law, such as matters arising from the settlement of patent and Hatch-Waxman Act exclusivity disputes, the Biologics Price Competition and Innovation Act, and other legislation impacting the life sciences industry.
Chad frequently speaks and writes about an array of issues relating to litigation in the life sciences industry, including skinny label litigation, the US regulatory landscape, and cell and gene therapies. He was active in local government in Southbury, Connecticut, for nearly a decade, including serving as an elected member of their Board of Selectmen. Additionally, Chad is a strong supporter of charity: water, a nonprofit that brings clean water to communities around the world.
Professional Activities
- Association for Accessible Medicines, Biosimilars Council (2017 – present)
- Food and Drug Law Institute, Annual Conference Planning Committee (2022 – 2023)
- Lexis Practical Guidance, Life Sciences Advisory Board Member
- American Bar Association, Section of Intellectual Property Law
- American Intellectual Property Law Association
- Connecticut Bar Association
- Connecticut Intellectual Property Law Association
- Hartford County Bar Association
- Food and Drug Law Institute, Medical Products Committee (2018 – 2021)
- Law360 Life Sciences Editorial Advisory Board (2018 – 2020)
Experience
Pharma Litigation
- Served as lead appellate and trial counsel in obtaining a decision from the United States Court of Appeals for the Federal Circuit, affirming a decision entered after trial by the United States District Court for the District of Delaware (with Federal Circuit Judge William Bryson sitting by designation), that patents covering Zohydro® (hydrocodone extended-release capsules) and asserted against Axinn client Alvogen Malta Operations Ltd. were invalid. The decision removed the patents as a barrier to Alvogen bringing its lower-cost generic product to market more than a decade before the patents were set to expire.
- Served as first chair trial lawyer, representing Norwich Pharmaceuticals Inc. in a patent infringement action filed by Salix Pharmaceuticals Ltd., Salix Pharmaceuticals Inc., Bausch Health Ireland Ltd., and Alfasigma S.P.A. The suit sought to stop Norwich from gaining approval to market a rifaximin 550 mg tablet, a generic of Salix’s Xifaxan®. Obtained judgment of invalidity on many of the asserted claims, which halted the trading of the plaintiff’s parent company’s stock after it plummeted following the decision. Axinn is currently handling the appeal in the Federal Circuit Court.
- Coupling patent litigation and FDA strategy, represented Zydus Pharmaceuticals in defending cases involving multiple patents for the blockbuster drug Abilify® (aripiprazole). Defeated a request for a temporary restraining order and obtained a favorable claim construction and noninfringement judgment at both the district court and the Federal Circuit. Also defeated a lawsuit by the brand company against the FDA seeking to exclude Zydus and others from going to market based on a claim to orphan drug exclusivity.
- Represented Sun Pharmaceutical Industries Ltd. in obtaining a dismissal of a Lanham claim brought by Wyeth relating to the blockbuster drug Protonix. The case, which alleged that Sun had engaged in false advertising for its generic product, was dismissed based upon an argument that the claims were preempted by FDA law.
- After successfully arguing claim construction, reached a favorable settlement with a patent license and supply agreement involving a billion-dollar product that was described by the client as “company-changing.”
- Following trial, obtained a favorable settlement enabling Actavis to bring its generic version of Shire's ADHD product Intuniv to market. During the litigation and after Axinn conducted aggressive fact discovery, Shire dedicated its core method of use patent to the public, removing it from further dispute in the litigation.
- Represented Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare in a Hatch-Waxman patent infringement action brought by Millennium Pharmaceuticals Inc. The litigation involved the drug bortezomib, which is marketed under the Velcade® brand. The patent at issue had previously been found valid by the US Court of Appeals for the Federal Circuit. Axinn developed a novel obviousness argument and aggressively litigated the case, leading to a favorable settlement on the eve of trial.
- Represented Alvogen and 3M in a patent infringement action filed by Noven Pharmaceuticals involving four patents and 48 asserted claims. Developed significant noninfringement and invalidity theories on behalf of Alvogen, which settled the case prior to expert discovery.
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Obtained favorable settlement following expert discovery in patent litigation concerning multibillion-dollar treatments for diabetes. Led and defended multiple fact and expert depositions.
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Successfully negotiated an extensive patent license and product distribution agreement relating to a blockbuster product on the eve of trial for a case involving complex patent, FDA, and business issues.
FDA
- In what has been described as the first case in which a court has ordered the FDA to approve a product, Axinn secured summary judgment on behalf of Watson Laboratories Inc. in litigation against the FDA in the US District Court for the District of Columbia. The case involved a dispute over the 180-day "first-to-file" marketing exclusivity for generic versions of the multibillion-dollar pioglitazone hydrochloride product Actos. The decision included an order enabling Axinn’s client to bring its generic diabetes drug to market.
- Represented Endo Pharmaceuticals Inc. in obtaining final FDA approval for its generic Valcyte® product after asserting a novel argument to FDA regarding the forfeiture of the 180-day exclusivity period by a third-party. Axinn then intervened in a lawsuit brought in the US District Court for the District of Columbia and successfully supported FDA’s decision that brought generic versions of Valcyte® and Nexium® to market, providing significant savings to consumers and payers.
- Obtained favorable decision from the US Court of Appeals for the Fourth Circuit to enable Watson Laboratories (now Teva) to bring its generic version of Celebrex® to market. Earlier FDA and district court decisions had effectively barred Watson and others from bringing their drugs to market. The Fourth Circuit reversed and remanded the district court’s decision and the FDA’s determination, finding that Watson and other companies were eligible to share in a 180-day marketing exclusivity upon the launch of their generic drugs because a reissued patent was not part of the same “bundle of rights” as an original patent.
- Obtained a favorable decision for Alvogen Inc. after intervening in an action against the FDA by a competitor seeking a preliminary injunction against generic versions of the antibiotic Vancocin. In less than a week, Axinn successfully moved to intervene, submitted opposition papers, and defeated the request for a preliminary injunction, allowing Alvogen's version of Vancocin to remain on the market.
- Represented Alvogen and affiliates in filing a suit against FDA regarding the forfeiture of the 180-day generic exclusivity period relating to buprenorphine buccal film (sold under the brand name Belbuca®). After aggressively pursuing the matter through /the filing of a motion for preliminary injunction, Axinn obtained a settlement with the generic company that had been deemed by FDA to be entitled to the 180-day exclusivity period.
Counseling
- Counseled a human tissue company on developing platform technology using adult stem cells. Guided client through designing around others' patents, securing its own patent protection, and negotiating a license in a critical technology area at a fraction of the demanded royalty.
- Provided patent and FDA counseling on numerous biosimilar products to assist clients with biosimilar product development efforts and to navigate patent and FDA approval issues under the Biologics Price Competition and Innovation Act.
Honors
- Benchmark Litigation, Connecticut Litigation Star: Intellectual Property (2020 – 2024)
- IAM Patent 1000, World's Leading Patent Professionals (2020 – 2023)
- LMG Life Sciences, Life Sciences Star (2019 – 2024)
- The National Law Journal, Health Care/Life Sciences Trailblazers (2020)
- Best Lawyers in America (2021 – 2024)
- Law360, Intellectual Property Rising Star (2013 – 2014)
- Connecticut Law Tribune, New Leaders in the Law (2012)
- Hartford Business Journal, 40 Under 40 (2011)
- Super Lawyers (2013 – 2020, 2023)
- Super Lawyers, Connecticut Rising Star (2009 – 2012)
News
- Nine Axinn Attorneys Named to the US District Court for the District of Connecticut 2023 Pro Bono Honor Roll
- Axinn Partners Named Life Sciences Stars by LMG Life Sciences
- Nine Axinn Partners Ranked in the 2024 Edition of Benchmark Litigation
- Axinn Attorneys Named to Best Lawyers 2024
- Axinn Shortlisted for Three 2023 LMG Life Sciences Americas Awards
- View More ›
Thought Leadership
- US FDA letting FTC Decide if Orange Book Listings ‘Improper’, BioWorld, November 17, 2023
- Axinn IP Update: District of Delaware Magistrate Judge Recommends Dismissal of Claims of Induced Infringement in Skinny Label Case, June 28, 2023
- Effects of GSK v Teva Ripple after SCOTUS Denies Cert, Life Sciences IP Review, May 23, 2023
- FDA's Digital Health Technologies Framework Addresses Important Challenges, Cell & Gene, Bioprocess Online, Clinical Leader, Med Device Online, Outsourced Pharma, and Pharmaceutical Online, May 16, 2023
- Axinn IP Update: Supreme Court Denies Cert. in Skinny Label Case, but the Impacts from GSK v. Teva Continue, May 15, 2023
- US Regulatory Landscape not Improving for Ultra-Rare Disease Therapies, March 2, 2023
- Resistance or Defiance? The FDA and the 11th Circuit Spar Over Statute on Orphan Drug Statutory Exclusivity, Clinical Leader, February 23, 2023
- The Regulatory Labyrinth of Stem Cell Treatments, Cell & Gene, December 20, 2022
- WTO's IP Waiver Reaches Final Stretch, BioWorld, May 4, 2022
- Being Proactive Could Cut U.S. FDA FOIA Load, BioWorld, February 7, 2022
- "Skinny Label" Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation, Pink Sheet, January 24, 2022
- Califf on Path to Win FDA Chief Role Despite Expected "No" Votes, Bloomberg Law, January 24, 2022
- Product Liability Regulation, Legislation to Watch: 2021, Law360, January 3, 2022
- The Center for Biosimilars Interview Series: Legal Perspectives in Biosimilars, The Center for Biosimilars, December 27, 2021
- Biden’s FDA Pick Califf to Face Senate Queries on Industry Ties, Bloomberg Law, December 13, 2021
- What the Moderna-NIH COVID Vaccine Patent Fight Means for Research, Nature, November 30, 2021
- Califf’s Return as FDA Head Will Give Drug Competition a Boost, Bloomberg Law, November 12, 2021
- "He'll Hit the Ground Running:" IP Attorneys Point to Stark's Experience Juggling Busy Patent Docket as Asset on Federal Circuit, Delaware Law Weekly, November 5, 2021
- Biden Names Delaware Judge Leonard Stark to Replace O’Malley on CAFC, IPWatchdog, November 3, 2021
- "Skinny Label" Case Gives Brands a "Blueprint" to Alter Use Codes in Patent Litigation, Pink Sheet, October 26, 2021
- U.S. FDA's PANDA Policy Could Pose Legal Problems for Biosimilars, Attorney Says, Pink Sheet, October 19, 2021
- Shutdown Threat Clogs FDA Workload as Vaccine Push Continues, September 29, 2021
- September Roundup: Biosimilar Policy Recommendations, Clinical Developments, and Interviews, The Center for Biosimilars, September 27, 2021
- USPTO Faces Growing Pressure to Enter Battle Over Drug Pricing, The Pink Sheet, September 23, 2021
- The Center for Biosimilars Interview: Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy, The Center for Biosimilars, September 22, 2021
- Questions About COVID-19 Boosters Bigger Than Adcom, BioWorld, September 15, 2021
- Capitalizing on Collaboration: The Effort to Sustain Pandemic-Partnering Momentum, PharmExec.com, August 2021
- U.S. Patent Community Responds with Shock and Surprise to O’Malley CAFC Retirement, IAM, August 9, 2021
- Skilled in the Art, Law.com, July 30, 2021
- Is Big Pharma’s Antidote to the COVID-19 Waiver a Viable Alternative?, Life Sciences IP Review, July 29, 2021
- Cost-Cutting Generics and Biosimilars Stuck in Legal Limbo, MedCity News, July 21, 2021
- Teva, in First-Ever CREATES Act Suit, Seeks Help with Fabry Disease Generic Development, Pink Sheet, July 14, 2021
- The Center for Biosimilars Interview: Axinn IP Chair Provides Analysis of Biden Biosimilars Initiative, The Center for Biosimilars, July 14, 2021
- Obamacare Ruling Paves Way for Fixing Flaws in Biosimilar System, Bloomberg Law, June 21, 2021
- Interview on the FDA Pipeline, Pharmacy Times, June 2021
- Biden Admin Backs Proposal to Suspend Intellectual Property on COVID-19 Vaccines, Angering Industry, FiecePharma, May 5, 2021
- IP and Collaboration, Pharmaceutical Executive, March 11, 2021
- Interview on the FDA’s Emergency Use Authorization Process for COVID-19 Vaccines, Pharmacy Times, March 2021
- Axinn IP Update: Where is the Federal Circuit Heading in the Skinny Labeling Case?, Axinn Update, March 4, 2021
- Skinny Labelling of Generics: The Beginning of the End for This Practice?, Pharmaceutical Technology, February 12, 2021
- Teva Patent Case Redo Spotlights Use of Generic ‘Skinny Labels’, Bloomberg Law, February 11, 2021
- Axinn IP Update: Federal Circuit Agrees to Reconsider Controversial “Skinny Label” Decision, Axinn Update, February 10, 2021
- To the Delight of Generic Drug Makers, Federal Appeals Court Tosses Controversial ‘Skinny Labeling’ Decision, STAT, February 9, 2021
- How President-Elect Biden’s Cabinet Nominations May Impact Pharmacy This Year, Pharmacy Times, January 15, 2021
- COVID-19 Could Factor Into Congressional Pricing Reforms, BioWorld, January 14, 2021
- The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021, Contract Pharma, January 5, 2021
- COVID-19 Vaccine Prices Are Likely to Remain Low in the Foreseeable Future, Scant Wiggle Room for Price Hike Postpandemic, Experts Say, GlobalData, December 21, 2020
- Biden to Nominate California AG Xavier Becerra as HHS Head, MedCity News, December 7, 2020
- What the Potential Elimination of the Biologics Price Competition and Innovation Act Means for Pharmacy, Pharmacy Times, December 1, 2020
- COVID-19 Pandemic Delays FDA Approvals, Causes CRL, BioWorld, November 23, 2020
- Axinn FDA Update: Insights on the MODERN Labeling Act, Axinn Update, November 20, 2020
- Legal Opinion: BPCIA is Likely to Survive Latest ACA Challenge, The Center for Biosimilars, November 11, 2020
- IP Under Biden: What Does the Future Look Like?, World IP Review, November 10, 2020
- Chevron Deference's Future in Doubt if Barrett is Confirmed, Law360, October 23, 2020
- Legal Experts Weigh in on BPCIA Severability, The Center for Biosimilars, October 22, 2020
- Eli Lilly’s and Regeneron’s mAb EUA Talk Trigger Expert Prudence on Available COVID-19 Data; Clinical Trials Likely to Be Affected if EUAs Come Through, GlobalData, October 9, 2020
- One Shot, Pharma Manufacturing, October 8, 2020
- California Gets Green Light to Produce Generics, Generics Bulletin, October 2, 2020
- California Dreamin’ of Being Generic, Biosimilars Player, BioWorld, September 29, 2020
- IP at the US Polls, Intellectual Property Magazine, September 29, 2020
- Could a COVID-19 Vaccine Gain EUA Without Sponsor Cooperation?, Pink Sheet, September 22, 2020
- Axinn FDA Update: A Difficult Analysis Is Not Necessarily a Deferential Analysis, Axinn Update, September 21, 2020
- Biopharma Opts for Collaboration, Not Patent Pools, BioWorld, August 25, 2020
- Expediting a COVID-19 Vaccine: FDA Approval Process, Contract Pharma, August 25, 2020
- FDA Extends Enforcement Discretion Period for Regenerative Medicine Products, but This Isn't a Green Light for Bad Actors, Cell & Gene, August 6, 2020
- FDA Informal Guidance Process, Lexis Practice Advisor, July 30, 2020
- Axinn IP Update: District Court Retains Subject Matter Jurisdiction But Grants Dismissal After Paragraph III Conversion, Axinn Update, July 8, 2020
- Amgen Ruling Could Prevent Slowdowns in Biosimilar Market Entry, Bloomberg Law, July 6, 2020
- Nabriva's Contepo NDA Derailed by COVID-19, BioWorld, June 22, 2020
- Open Source Patent Licenses: Pitfalls and Opportunity, Bloomberg Law, June 5, 2020
- Pharma Collaborations in the Covid-19 Era Come With Legal Risks, Bloomberg Law, June 5, 2020
- Gilead Gives Royalty-Free Remdesivir Licenses to Five Drugmakers, Bloomberg Law, May 12, 2020
- ABA SciTech Brief Short Video on COVID-19: FDA Emergency Use Authorizations, American Bar Association, May 8, 2020
- Gilead Under Gun to Mass-Produce Virus Drug or Risk Exclusivity, Bloomberg Law, May 5, 2020
- Seven Days in March: NDA-BLA and ANDA Approval Output Diverged As Coronavirus Teleworking Began, Pink Sheet, April 29, 2020
- Exploring the US FDA's Upcoming Complex Generic Product-Specific Guidance Lists, Pink Sheet, April 27, 2020
- FDA’s Emergency Use Authorizations: Aggressive Action Taken to Combat COVID-19, Contract Pharma, April 20, 2020
- Virus Heightens Importance of Drug Shortage Reports to FDA, Law360, April 2, 2020
- FDA Emergency Use Authorizations, Lexis Practice Advisor Journal, April 1, 2020
- US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want to Wait for In-Person Meetings?, Pink Sheet, April 1, 2020
- As a Global Pandemic Is Declared, What Effect Will the Virus Have on the IP Industry and Supply Chains?, Intellectual Property Magazine, March 27, 2020
- Gilead Abandons Orphan Drug Designation for COVID-19 Drug, BioWorld, March 25, 2020
- Opioid Trial, Other Pharma Cases Postponed in Wake of COVID-19, Pink Sheet, March 19, 2020
- Labrador to Offer Royalty-Free Licensing for Coronavirus Tests, Bloomberg Law, March 17, 2020
- Attempts to Flatten COVID-19 Pack Longer-Term Wallop, BioWorld, March 16, 2020
- FDA Halt of Foreign Inspections May Delay Some New Product Approvals, FiercePharma, March 11, 2020
- FDA Postpones Foreign Inspections Over COVID-19, Potentially Throwing off Product Approval Timelines, MedCity News, March 11, 2020
- FDA Postpones Meetings and Inspections, Grounds Staff to Combat COVID-19, BioCentury, March 11, 2020
- Chevron’s Hard-Hitting Footnote Nine Revived by Kisor v. Wilkie and Recent Decisions on Deference, FDLI, February 21, 2020
- Sanofi Ruling Makes Getting Drugs on FDA Approved List Trickier, Bloomberg Law, February 14, 2020
- Gilead Loses Challenge of Two U.S. Government HIV Patents (2), Bloomberg Law, February 5, 2020
- Revised MAPP Tightens FDA Scope for Prioritized Generic Drug Applications, Regulatory Focus, January 31, 2020
- FDA Administrative Decision Challenges, Lexis Practice Advisor, January 30, 2020
- Pharmaceutical Experience Matters in Defending Pharmaceutical Securities Cases, Axinn Update, January 2020
- The Patent Snatcher, Intellectual Property Magazine, January 24, 2020
- Open the Floodgates: The Potential Impact on Litigation Against FDA if the Supreme Court Reverses or Curtails Chevron Deference, FDLI, December 18, 2019
- Stephen Hahn Should Focus on Stability in First Days As US FDA Commissioner, Stakeholders Say, Pink Sheet, December 18, 2019
- Biosimilar Safe Harbors Need Record of Non- Commercial Use, Epogen Ruling Suggests, Pink Sheet, December 16, 2019
- USMCA’s Biologics Extension Provision Removed, Intellectual Property Magazine, December 12, 2019
- "Constitutional Issues" Over US Pharma Proposal, Intellectual Property Magazine, November 27, 2019
- Gilead’s HIV Patent Spat With HHS Could Keep Drug Prices High, Bloomberg Law, November 25, 2019
- U.S. Government Patent Enforcement: A Ripple or a Coming Tempest?, IPWatchdog, November 25, 2019
- FDA Pick Hahn Gets His Turn in the Senate Spotlight, Bloomberg Law, November 18, 2019
- Rare HHS Patent Suit May Impact HIV Drug Pricing, Access, Law360, November 14, 2019
- U.S. Government Accuses Gilead of Infringing HIV-Prevention Drug Regimen Patents, IP Law Daily, November 8, 2019
- Trump Administration Sues Drugmaker Gilead Sciences Over Patent on Truvada for HIV Prevention, The Washington Post, November 7, 2019
- U.S. Could Make Millions in Gilead HIV Prevention Suit, Bloomberg Law, November 7, 2019
- FDA Under Temporary New Leadership as Senate Considers Nominee, BioWorld, November 5, 2019
- New Calif. Pay-For-Delay Law May Hurt Those It Aims to Help, Law360, November 5, 2019
- Merck’s Patent Loss to Gilead May Have Big Impact on Drugmakers, Bloomberg Law, October 31, 2019
- Rarely Used Legal Tack Makes a Comeback in Pharma Patent Cases, Bloomberg Law, October 3, 2019
- Fixing the Follow-On Insulin Regulatory Approval "Dead Zone", BioSimilar Development, September 4, 2019
- Has the FDA Been Approving Some Drugs Without Proper Evidence?, MedCity News, August 20, 2019
- Recent FDA Court Decision Shows Potential Impact of SCOTUS Deference Decision, Bloomberg Law and Bloomberg Big Law Business, August 20, 2019
- What High Court's Kisor Ruling Means for FDA Decisions, Law360, July 16, 2019
- Ambiguity a Fact of Life at the FDA, so Is Agency Deference, BioWorld, July 5, 2019
- FDA's Aggressive Enforcement Against Stem Cell Companies Starting to Ripen, Bloomberg BNA Insights, June 27, 2019
- Congress to Vote on Amending Orange and Purple Books in Effort to Encourage Generics and Biosimilars, The Center for Biosimilars, May 8, 2019
- What’s Next for the Post-Gottlieb FDA, Medical Marketing & Media, April 19, 2019
- Court Considers How Much Deference FDA Should Get In Legal Challenges, BioWorld, April 2, 2019
- Justices May Be Ready to Narrowly Overturn 'Auer', Law360, March 28, 2019
- What to Know About New FDA Commissioner Sharpless, Law 360, March 21, 2019
- FDA Doubles Down in Its Updated Biologics Naming Guidance, The Center for Biosimilars, March 19, 2019
- Developers Call FDA Guidance on Suffixes a 'Direct Blow' to Biosimilars, The Center for Biosimilars, March 8, 2019
- Policy Reversal: FDA Will No Longer Require Suffixes for Older Biologics, Pink Sheet, March 7, 2019
- Gottlieb Leaves Vocal Legacy at FDA, Law360, March 6, 2019
- Gottlieb to Leave FDA After Two-Year Tenure, BioWorld, March 6, 2019
- Who Has The Chops to Succeed Scott Gottlieb as FDA Commissioner?, MedCity News, March 6, 2019
- FDA Chief Scott Gottlieb Has Resigned, Buzzfeed News, March 5, 2019
- Status Quo Maintained: FDA Reverses Course on Generic Product Labeling, FDLI Update, March 1, 2019
- Partisanship Outshouts Pleas for Unity on Drug Prices, Health Care Issues, BioWorld, February 7, 2019
- Stem Cell Companies Beware: FDA May Come Knocking, Bloomberg BNA Insights, January 28, 2019
- Axinn IP Update: U.S. Supreme Court Ruling Leaves On-Sale Bar Unchanged, Axinn Update, January 23, 2019
- US Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown, Pink Sheet, January 16, 2019
- How a 'Regulatory Dead Zone' May Be Holding Up Copycat Insulin, BioPharma Dive, January 14, 2019
- First Amendment Takes Center Stage in DTC Price Fight, BioPharma Dive, October 22, 2018
- 5 Questions on the Trump Admin's Bid to Mandate Prices in Drug Ads, BioPharma Dive, October 16, 2018
- Trump Administration's Push for Prices in Drug Ads Facing a Likely Legal Fight, Fierce Healthcare, October 16, 2018
- FDA Draft Guidance on Generic-Delaying Citizen Petitions a 'Warning Shot' to Industry, Lawyer Says, MedCity News, October 11, 2018
- A Growing Number of States Consider Legislation To Treat Pharma As A Utility, STAT, October 10, 2018
- Axinn FDA Update: SUPPORT for Patients and Communities Act, Axinn Update, October 9, 2018
- Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second Edition, ABA: Section of Intellectual Property Law, October 2, 2018
- Kratom Industry GMPs Target Swaying FDA By Exceeding Agency Standards, The Rose Sheet, September 19, 2018
- FDA Focus: What Axinn's Practice Chair Is Watching, Law360, September 14, 2018
- FDA to Form Work Group to Examine Drug Importation as a Solution to High Costs, FierceHealthcare, July 19, 2018
- Comments Roll in on Trump’s Drug Pricing Plan, POLITICO, July 16, 2018
- Judge Kavanaugh May Be Good US Supreme Court Pick For Pharma, Pink Sheet, July 10, 2018
- Kavanaugh Might Rein In FDA, Other Agencies’ Discretion (1), Bloomberg Law, July 10, 2018
- Wave Of FDA Suits Awaits If Kavanaugh Helps Trim Chevron, Law360, July 10, 2018
- Trump's Drug Pricing Plan Pushes for Increased Price Transparency, Greater Use of Generics, FierceHealthcare, May 14, 2018
- He's Handled More ANDA Cases Than Anyone, And Now He's Retiring, Pink Sheet, April 18, 2018
- Sun Pharma Gets Good News From FDA on Coreg CR Generic, Bloomberg BNA, April 17, 2018
- Big Money, Rare Jury Reversal: Gilead’s $2.54B Victory Over Merck, Bloomberg BNA Pharmaceutical & Life Sciences News, February 23, 2018
- White House Plan to Limit Generic Drug Exclusivity Could Backfire, Bloomberg BNA Health Care Blog, February 14, 2018
- White House Targets Generic Exclusivity to Lower Drug Prices, Health Care on Bloomberg Law, February 13, 2018
- New Normal Takes Shape After TC Heartland Shakeup, Law360, February 7, 2018
- 3 Places The Allergan Tribal Deal May Face Pushback, Law360, October 12, 2017
- Humira Biosimilar Settlement Could Be Model For Other Disputes, Pink Sheet, September 28, 2017
- Epogen Biosimilar Jury Verdict May Ignite New 'Safe Harbor' Battle, Pink Sheet, September 26, 2017
- Tribal Immunity Tested As Allergan Rewrites Patent Playbook With Mohawks, S&P Global Market Intelligence, September 14, 2017
- Humira Biosimilar: Boehringer Faces Same Launch Hurdles as Amgen, Pink Sheet, August 28, 2017
- Mylan Defers Product Launches Amid Regulatory Uncertainty, The Wall Street Journal, August 9, 2017
- Drugs and Biologics: New Administration, New Legislation, New Precedents, Update Magazine, Food and Drug Law Institute, May/June 2017, May 31, 2017
- Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers?, Pink Sheet, May 15, 2017
- Biosimilar Tentative Approvals Could Flow From US Supreme Court Case, Pink Sheet, May 12, 2017
- Five Things to Know About Trump’s FDA Lead Pick Gottlieb, Managed Healthcare Executive, March 24, 2017
- Gottlieb's Proposals Provide Possible Insight Into Upcoming Agency Reforms, InsideHealth Policy, March 3, 2017
- Generic Drugmaker Sues FDA to Get Its Exclusivity Back, Pharmaceutical Law & Industry Report, February 2, 2017
- Republic Congress, Trump Policies May Seek to 'Undo' FDA Device Safety Guidances; LDT Plan First To Go, Medtech Insight, November 21, 2016
- Euro Drug Pricing's Tradeoffs May Limit Appeal In US, Law360, September 8, 2016
- AbbVie Enters the Battle of the Biosimilars, Institutional Investor, January 15, 2016
- Actually, It's Not About The Patient – At Least When It Comes To Product Exclusivity, The Pink Sheet, October 26, 2015
- FDA's Abilify Smack-Down Boosts Imitator Drugs, Law360, October 9, 2015
- Ranbaxy Drops Appeal of FDA Actions Revoking Approval of Valcyte, Nexium Copies, Bloomberg BNA Pharmaceutical Law & Industry Report, October 7, 2015
- Using FDA’s Citizen Petition Process and Litigation to Achieve Market Success, Biotechnology Law Report, October 2015
- FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users, GxP Lifeline, August 2015
- Counsel’s Corner: Smart Approach to FDA May Lead to Faster Decisions, Savings, Bloomberg BNA Pharmaceutical Law & Industry Report, June 12, 2015
- Court OKs Pediatric Carve-Outs, BioWorld Today, May 28, 2015
- FTC's $1.2B Win Shows Pay-For-Delay Deals On Thin Ice, Law360, May 27, 2015
- Judge Won't Block FDA's Generic Abilify Approval, Law360, April 30, 2015
- Otsuka’s Battle to Block Abilify Generics Heats Up As Patent Expires, The Pink Sheet Daily, April 23, 2015
- FDA Beats Ranbaxy Suit Despite 'Serious' Approval Errors, Law360, March 11, 2015
- Ranbaxy Loses Bid to Block Other Firms' Nexium, Valcyte Generic Products, Bloomberg BNA Pharmaceutical Law & Industry Report, March 2, 2015
- ANDA Litigation: Patents Are Being Challenged Sooner, OxyContin Draws Most Fire, The Pink Sheet, November 6, 2014
- Copaxone Supreme Court Case Could Cut Relitigation of Patent Claims, The Pink Sheet, October 13, 2014
- Gilead could move to bundle recent Idenix patent disputes, likely to hinge on issues of prior art, invalidity – attorneys, BioPharm Insight, January 5, 2014
- FDA Announces Major Generic Drug Labeling Changes In the Wake of Preemption Decisions Involving Generic Drug Product Liability, Corporate Compliance Insights, November 21, 2013
- In Focus: Drug Sponsor and Contractor Relations, November 4, 2013
- Scientific Speech Highlighted In SCOTUS Petition To Overturn CEO Conviction, Inside Health Reform, August 21, 2013
- Attorneys React to High Court's Gene Patent Ruling, Law360, June 13, 2013
- 2012 Court Decisions Impact the Life Science Industry, Pharmaceutical Compliance Monitor, January 3, 2013
- The Rise of Precompetitive Collaboration, Life Science Leader, December 5, 2012
- Generic Drug Litigation: A Growing Practice Niche, Connecticut Law Tribune, November 19, 2012
- Axinn Partner Chad A. Landmon Interviewed for Law360's Q&A, Law360, July 12, 2012
- Innovative Procedures v. Premarketing Approval, Law360, September 20, 2011
- Final Word: Advocating for Biosimilar Approval Standards under BPCI, BioPharm International, September 1, 2011
- Viewpoint: Advocating for Biosimilar Approval Standards under BPCI, Pharmaceutical Technology, Vol 35, Issue 6, June 2011
- The Challenges of FDA's Nascent Biosimilars Regime, Law360, November 17, 2010
- Human Tissue and Stem Cell Therapies: Revolutionary New Therapies that Face Increasing FDA Scrutiny, FDLI Update, September 30, 2010
- Ask the Experts: Experts Discuss Effect of NJ Rules on Hatch-Waxman Litigation, Generic Line, February 4, 2009
- Ask the Expert: Impact of Federal DJ Jurisdiction Decision, Generic Line, September 3, 2008
- Federal Circuit Draws the Line on DJ Jurisdiction, Law360, August 25, 2008
- FDA's Exclusivity Forfeiture Saga Continues, IP Law360, May 15, 2008
- Ask the Expert: Caraco's Impact on Declaratory Judgment Actions, Generic Line, May 14, 2008
- Ask the Expert: Impact of FDA's Exclusivity Forfeiture Rulings, Generic Line, April 30, 2008
- Here Comes The Tidal Wave of Generic DJ Actions, IP Law360, April 3, 2008
- FDA Removes Teeth From Exclusivity Forfeiture, IP Law360, January 25, 2008
- Supreme Court Backhands Key Federal Circuit Test, IP Law360, January 10, 2007
- Fourth Circuit Rejects Another Authorized Generics Challenge, IP Law360, July 19, 2006
- On Demand: Focusing The Patent Scope, The Connecticut Law Tribune, May 8, 2006
- FDA's "Holding On The Merits" Test, IP Law360, April 21, 2006
- Recent Court Rulings Indicate That Patent Rights May Trump the Antitrust Laws, Intellectual Property Today, April 2006
- The "Narrowed Claim Conundrum" Resulting from Reissue and Reexamination Proceedings, Intellectual Property Today, October 2005
- The Impact of a Brand Generic Launch on the Recovery of Patent Damages, IPL Newsletter, Summer 2005
- Creation of a Less Perfect Union the Implications of General Motors Corp. v. Tracy for Commerce Clause Analysis of State Taxation, Connecticut Law Review, Fall 1998
Events
- Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies 2023
- GRx+Biosims Conference 2023
- FDLI Annual Conference 2023
- Subtle Defiance: FDA’s Catalyst Response and Strategies for Challenging FDA Decisions
- ACI 18th Annual Paragraph IV Conference
- ACI 40th Annual FDA Boot Camp
- ACI 39th Annual FDA Boot Camp
- 2022 FDLI Annual Conference
- ACI 17th Annual Paragraph IV Conference
- FDLI 2021 Advertising and Promotion for Medical Products Conference
- ACI Hatch-Waxman and BPCIA Virtual Proficiency Series
- FDA Boot Camp
- Pharmaceutical CEO Leadership: Collaboration in Pharma – Working Together
- Pharmaceutical CEO Leadership: Collaboration in Pharma – Innovation
- Pharmaceutical CEO Leadership: Collaboration in Pharma
- 2021 FDLI Annual Conference
- FDLI Webinar: Biologic and Biosimilar Litigation and IP Rights
- ACI 36th Annual FDA Boot Camp
- Celesq® CLE Program: FDA in the Year of COVID – How FDA Tackled the Pandemic and What to Expect from FDA in 2021
- If the BPCIA Should Fall – SCOTUS Decision Scenario Outlook
- The Potential Impact of the New Supreme Court Justice on FDA and FDA-Regulated Industry
- U.S. Election Special
- ACI Paragraph IV Disputes Virtual Conference
- Issues and Topics in Litigation Challenging FDA Actions Under the Administrative Procedure Act (APA)
- Virtual ACI 35th Annual FDA Boot Camp
- FDLI Virtual Program: What Patient Organizations Should Know to Interact with FDA During COVID-19
- ACI Paragraph IV on Virtual Trial COVID-19 Edition
- IP Issues in Responding to the COVID Emergency
- FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products
- IP Minds USA Summit
- The Future of Generic Drug Competition
- GRx+Biosims Conference
- Division of Labor and Divided Infringement: Unified Strategies for Personalized Medicine and other Medical Treatment Inventions?
- ACI 10th Annual Summit on Biosimilars Conference
- 2019 FDLI Annual Conference
- Barclays Credit Symposium
- Opioid Legislation – The Path Forward for FDA and DEA
- Expediting the Generic Drug Approval Process: FDA's New Initiatives on Drug Competition
- FDA: Past, Present, and Future
- 2018 FDLI Annual Conference
- Hot Topics and Issues in the Biosimilars Space: Part Two
- FDA Medical Device Approval Under the New Administration
- Connecticut Science Center Axinn Sponsorship
- Key Regulatory Issues in Biosimilars
- 2017 FDLI Annual Conference
- FDA's New Final Rule Implementing the MMA and Amending ANDA and 505(b)(2) Practice
- ACI 7th Annual Summit on Biosimilars
- Ploy or Policy Tool: A Look at the Citizen Petition Process
- ACI 27th Annual FDA Boot Camp
- Hot Topics and Issues in the Biosimilars Space: Part One
- ACI 6th Annual Summit on Biosimilars
- ACI 24th Annual FDA Boot Camp
- Marketing Exclusivities: Challenges, Opportunities and Current Controversies
- Hot Topics in Generic Drug Entry and Regulation
- FDA Intensive: Advanced Strategies for Navigating Key FDA Regulatory Hurdles and Responding to Heightened Government Scrutiny of Drugs and Devices
- International Congress on Paragraph IV Litigation
- 2013 ACI Biosimilars Conference
- ACI 7th Annual Paragraph IV Disputes Conference
- 2013 FDLI Annual Conference
- Bioequivalence: What Patent Lawyers Need to Know
- CBI 4th Life Sciences Congress on Paragraph IV Disputes
- ACI FDA Bootcamp 2012
- CBI 4th Annual Bio/Pharmaceutical Drug Safety Forum
- Non-Patent Marketing Exclusivities: Challenges, Opportunities and Current Controversies
- Patent Due Diligence - A Good Business Practice
- How to Align the FDA Approval Process with Paragraph IV Strategy: Tips, Best Practices and Case Studies to Optimize FDA Results
- AIPLA Mid-Winter Institute: Meeting of the Special Committee on the FDA: Discussion of the FDA Hearings on the Biologics Price Competition and Innovation Act
- Bioequivelance and Their Impact on FDA Approval of Generic Products
- ACI Paragraph IV on Trial: Litigator's Master Class on Paragraph IV Pre-Trial Preparation
- CBI Pharmaceutical Congress on Paragraph IV Disputes and Settlements: Workshop Leader on Assessing Paragraph IV Litigation Strategies
- Assessing the Patent and FDA Strategies for Follow-On Biologics to Maximize Success
- ACI Paragraph IV Disputes Advanced Master Class - Obtaining Optimal Terms and Mitigating Antitrust Concerns When Settling Paragraph IV Disputes
- CBI 3rd Annual Summit on Biosimilars
- ACI Paragraph IV on Trial: Litigator's Master Class on Paragraph IV Pre-Trial Preparation
- CBI Pharmaceutical Congress on Paragraph IV Disputes
- Navigating the FDA's New 180-Day Generic Marketing Exclusivity Rulings
- University of Connecticut School of Law - Patent Law, Pharmaceutical Industry, and Antitrust
- Collaborating Attorney to the Connecticut Intellectual Property Notes
Education
- JD, with honors – University of Connecticut School of Law (1999)
- BA, summa cum laude – University of Connecticut (1996)
Admissions
- Connecticut
- District of Columbia
- US Court of Appeals for the District of Columbia Circuit
- US Court of Appeals for the Federal Circuit
- US Court of Appeals for the Fourth Circuit
- US Court of Appeals for the Sixth Circuit
- US District Court District of Columbia
- US District Court District of Connecticut
- US District Court Eastern District of Michigan
- US District Court Southern District of New York
Spotlight
“He’s not just the lawyer who goes to court and who manages and runs the litigation, he also gives us strategy and direction.”
– Chambers USA
“Chad Landmon…has a wealth of trial experience.” – IAM Patent 1000, World's Leading Patent Professional
"Landmon's intellectual property acumen and FDA savvy… is rare"
– Law 360
2020 National Law Journal Health Care/Life Sciences Trailblazer