United States: Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

What Is Medical Upcoding? How Inflated Billing Can Trigger False Claims Act Liability

Medical upcoding is a form of healthcare fraud that involves billing for more expensive services than were actually provided.

United States Healthcare

MS

Miller Shah

The Shifting Senior Living Landscape: Adapting To Policy, Financial, And Competitive Pressures

The U.S. senior living industry is experiencing significant transformation as three major forces reshape the market landscape.

United States Healthcare

AC

Ankura Consulting Group LLC

Critical Medical Device Series: Part VII FDA's And FTC's Roles In MedTech Promotion And Advertising

As the second Trump administration ushers in changes across federal agencies, medical device companies must stay vigilant in their promotional and advertising practices.

United States Healthcare

AP

Arnold & Porter

Major Policy Changes Proposed For Medicare Payment, Accreditation, And Prior Authorization For DME Suppliers

Among other things, the Proposed Rule signals that a CMS announcement of the next round of the DMEPOS CBP is forthcoming, with significant overhauls of the policies that applied in prior rounds.

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

How A Pharma Business Transformed Its Batch Release With AI-Powered Document Mining

European Union Healthcare

AM

Alvarez & Marsal

Preparing For The Avalanche Of Uninsured Patients Survival Strategies Include Bold Initiatives

United States Healthcare

KM

Katten Muchin Rosenman LLP

Ninth Circuit Issues Landmark EKRA Decision: Key Takeaways For Healthcare Providers

United States Healthcare

D

Dykema

Potential Changes Coming To Medicare Provider Enrollment And DMEPOS Accreditation

United States Healthcare

KM

Katten Muchin Rosenman LLP

Can New State Licensing Pathways For Foreign Medical Graduates Reshape Physician Staffing And Recruitment Landscape?

United States Healthcare

FH

Foley Hoag LLP

CY 2026 Medicare PFS Proposed Rule: Telehealth Takeaways

United States Healthcare

FL

Foley & Lardner

U.S. Healthcare In OBBBA: A Patchwork Of Big Changes

United States Healthcare

FL

Fennemore

European Commission Approves Moderna's Updated COVID-19 Vaccine

European Union Healthcare

GP

Goodwin Procter LLP

New Florida Law Attempts To Provide Leeway For Certain Stem Cell Treatments

United States Healthcare

HK

Holland & Knight

Cultivated Meat Snapshot: Recent Federal And State Actions

United States Healthcare

PC

Perkins Coie LLP

New Montana State Income And Property Taxes For 2025 & 2026

United States Tax

PB

Parsons Behle & Latimer

From Copyright Case To AI Data Crisis: How The New York Times v. OpenAI Reshapes Companies' Data Governance And EDiscovery Strategy

United States Technology

NM

Nelson Mullins Riley & Scarborough LLP

Analysis Of The 2025 Federal Tax Changes Under The "One Big Beautiful Bill" Legislation

B

BakerHostetler

Business Tax Law Provisions Of The OBBA

United States Commercial

OK

Offit Kurman

AMTL's AICP Files Second Case Against TSMC, Its Advanced Memory Amends Against SK Hynix

United States IP

RC

RPX Corporation

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Highlighted Content

Plausibility At The EPO – An Update On G2/21

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In The United States Today?

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In Europe Today?

United States Healthcare

D

Dehns

How Good Does A Copy Need To Be?

United States Healthcare

D

Dehns

Supplementary Protection Certificates – European Patent Term Extensions

United States Healthcare

D

Dehns

How Much Experimental Data Is Needed For Patent Applications In Europe?

United States Healthcare

D

Dehns

The Silent Treatment: The EPO's Approach To Non-therapeutic Methods Encompassing Therapeutic Effects

United States Healthcare

D

Dehns

Implications Of The Genetic Technology (Precision Breeding) Bill On The Life Science IP Sector

United States Healthcare

D

Dehns

Protection For Plant Varieties In Europe And The UK Post-Brexit

United States Healthcare

D

Dehns

Best Practice For Invention Harvesting

United States Healthcare

D

Dehns

Food and Drugs Law

Congress Revisits The BIOSECURE Act: Risks For Biotechnology Collaborations With Chinese Entities

In the last Congress, the BIOSECURE Act (H.R. 8333, 118th) garnered significant attention despite not becoming law.

United States Government

AP

Arnold & Porter

FTC Settles With NextMed Over Deceptive Pricing, Hidden Material Terms, And Fake Reviews And Testimonials In Telehealth Membership Programs

The Federal Trade Commission (FTC) announced a settlement with NextMed parent company Southern Health Solutions, Inc., in response to allegations that the telemedicine platform offered deceptive claims and fake reviews...

United States Media & IT

GA

Global Advertising Lawyers Alliance (GALA)

How A Pharma Business Transformed Its Batch Release With AI-Powered Document Mining

Inefficiencies in batch release processes can tie up millions in revenue, delay the production of lifesaving medicines and create compliance problems. Alvarez & Marsal (A&M) helped one 400-millioneuro German pharma company...

European Union Healthcare

AM

Alvarez & Marsal

Claiming A Range, Watch Out For The Presumption Of Obviousness

United States IP

SM

Sheppard Mullin Richter & Hampton

New Florida Law Attempts To Provide Leeway For Certain Stem Cell Treatments

United States Healthcare

HK

Holland & Knight

Cultivated Meat Snapshot: Recent Federal And State Actions

United States Healthcare

PC

Perkins Coie LLP

MN Rewrote The MinnesotaCare Tax Rules — But Tax Committees Never Saw It Coming

United States Tax

JW

Jones Walker

Check's In The Mail: HRSA Tests A New Script For 340B

United States Healthcare

D

Dykema

Recent Federal Developments For August 2025

United States Energy

BC

Bergeson & Campbell

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Life Sciences, Biotechnology & Nanotechnology

Congress Revisits The BIOSECURE Act: Risks For Biotechnology Collaborations With Chinese Entities

In the last Congress, the BIOSECURE Act (H.R. 8333, 118th) garnered significant attention despite not becoming law.

United States Government

AP

Arnold & Porter

Critical Medical Device Series: Part VII FDA's And FTC's Roles In MedTech Promotion And Advertising

As the second Trump administration ushers in changes across federal agencies, medical device companies must stay vigilant in their promotional and advertising practices.

United States Healthcare

AP

Arnold & Porter

Antitrust Life Sciences Quarterly Update 2025 Q2

The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck's $3.9 billion acquisition of SpringWorks...

Worldwide Anti-trust

GP

Goodwin Procter LLP

European Commission Approves Moderna's Updated COVID-19 Vaccine

European Union Healthcare

GP

Goodwin Procter LLP

PTAB Discretionarily Denies Two Petitions, Refers A Third To The Board In Amgen v. Bristol-Myers Squibb

United States IP

GP

Goodwin Procter LLP

Dealmaker's Digest: A Top 10 Bulletin - August 2025

United States Commercial

RG

Ropes & Gray LLP

The FTC Goes All In On Head-To-Head Competition For Pipeline Medical Devices Merger Challenge

United States Anti-trust

KM

Katten Muchin Rosenman LLP

The Rise And Fall And Rise Again Of VC "Mega-Rounds"

United States Commercial

W

WilmerHale

Class Action Decisions Published April 2025

United States Healthcare

SH

Shook, Hardy & Bacon

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Healthcare

Congress Revisits The BIOSECURE Act: Risks For Biotechnology Collaborations With Chinese Entities

In the last Congress, the BIOSECURE Act (H.R. 8333, 118th) garnered significant attention despite not becoming law.

United States Government

AP

Arnold & Porter

What Is Medical Upcoding? How Inflated Billing Can Trigger False Claims Act Liability

Medical upcoding is a form of healthcare fraud that involves billing for more expensive services than were actually provided.

United States Healthcare

MS

Miller Shah

The Shifting Senior Living Landscape: Adapting To Policy, Financial, And Competitive Pressures

The U.S. senior living industry is experiencing significant transformation as three major forces reshape the market landscape.

United States Healthcare

AC

Ankura Consulting Group LLC

Court Blocks Medicaid Data From Being Used For Immigration Enforcement

United States Immigration

MP

Manatt, Phelps & Phillips LLP

Four Takeaways For CCPA-Covered Businesses From The Healthline Settlement

United States Privacy

SJ

Steptoe LLP

Major Policy Changes Proposed For Medicare Payment, Accreditation, And Prior Authorization For DME Suppliers

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

FTC Settles With NextMed Over Deceptive Pricing, Hidden Material Terms, And Fake Reviews And Testimonials In Telehealth Membership Programs

United States Media & IT

GA

Global Advertising Lawyers Alliance (GALA)

New Hampshire Adopts New Parental Medical Leave Law

United States Employment

MM

McLane Middleton, Professional Association

Preparing For The Avalanche Of Uninsured Patients Survival Strategies Include Bold Initiatives

United States Healthcare

KM

Katten Muchin Rosenman LLP

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Patents

The "Lead Compound" Approach To Obviousness And Obviousness-Type Double Patenting

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

United States IP

FL

Foley & Lardner

With Ultramercial Remand, Is The Supreme Court Telegraphing View On Patent Eligibility To Federal Circuit?

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

United States IP

FL

Foley & Lardner

GSK And Genentech Settle Cabilly Patent Lawsuit

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.

United States IP

BR

Beeser Ramamoorthy LLP

Supreme Court Holds That Generic Drug Manufacturers Can Challenge The Validity Of A Reference Drug’s "Use Code"

United States IP

BA

Bradley Arant Boult Cummings LLP

U.S. Supreme Court Allows Generic Drug Manufacturers To Challenge Brand’s FDA Use Codes

United States IP

VE

Vinson & Elkins LLP

Supreme Court Allows Generics To Challenge Orange Book Use Codes In Hatch-Waxman Litigation

United States Healthcare

PH

Paul Hastings LLP

Supreme Court Sides With Generic Drug Manufacturers, Closes Loophole In Hatch-Waxman Act

United States IP

PC

Perkins Coie LLP

U.S. Supreme Court Remands Myriad Case In Light Of Its Decision In Prometheus

United States IP

VE

Vinson & Elkins LLP

Federal Circuit Articulates Facts Establishing Jurisdiction In Declaratory Judgment Actions

United States IP

VE

Vinson & Elkins LLP

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Latest Videos

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Client Conversations With Patrick Krill (Video)

KG

K&L Gates LLP

Navigating FDA Compliance And Civil Litigation: Strategies For Food And Medical Product Companies (Video)

AP

Arnold & Porter

Artificial Intelligence In Healthcare (Video)

BI

Buchanan Ingersoll & Rooney PC

DSO Market Trends And 2025 Outlook ADSO Webinar Recording (Video)

B

Benesch Friedlander Coplan & Aronoff LLP

Preparing For Change: New CMS Survey Guidance Effective March 24, 2025 (Video)

SM

Sheppard Mullin Richter & Hampton

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