Social Media Ideas for Hatch-Waxman

ACI’s 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA

The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 20...

Practical Guidance for Pharmaceutical Method-of-Use Patent Claims After Teva v. Eli Lilly and In re Xencor

Pharmaceutical Method-of-Use Claims After Teva v. Eli Lilly and In re Xencor: Written Description, Enablement, and the K...

<![CDATA[Inside Pharma's Patent Battleground: The Policy Changes Reshaping Generic and Biosimilar Competition]]>

5th Circ. Backs FDA, Pharma Cos. In GLP-1 Shortage Fight

The U.S. Food and Drug Administration did not unlawfully remove blockbuster GLP-1 medications made by Eli Lilly & Co. and Novo Nordisk from the national drug shortage list, the...

A Costly 180: The D.C. Circuit Flips FDA’s Forfeiture Playbook

By Peter G. Dickos & Sara W. Koblitz & Kurt R. Karst —

A Prescription for Liability- Injunction in Gray-Market Drug Case Based on Material Differences

<![CDATA[MFN and New Rules of Global Launch Sequencing]]>

ITC Reinstates Sun Import Ban Win After Squires Intervention

The U.S. International Trade Commission has cleared a ban against Biofrontera dermatology device imports that infringe Sun Pharmaceuticals patents, following changes at the Patent...

Justices' Hikma Reasoning May Extend Well Beyond Pharma

The active steps framework announced by the U.S. Supreme Court in its Hikma v. Amarin decision, finding that Amarin failed to plausibly allege inducement of infringement, has the p...

PEPTIDE-L WAVE! PCAC Approves Four Bulk Drug Substances for the 503A List

By Karla L. Palmer & Charles D. Snow & Mary Bass —

When the Label Lags the Science: Using 505(o)(4) to Compel Labeling Changes

By Sara W. Koblitz —

AbbVie Seeks Block On Alkem Generic Constipation Drug

AbbVie Inc. and collaborator Ironwood Pharmaceuticals urged a New Jersey federal court to bar India-based generic drugmaker Alkem Laboratories from selling generic versions of thei...

FDA Must Revisit Xifaxan Generic Exclusivity, DC Circ. Says

The D.C. Circuit on Tuesday ordered the U.S. Food and Drug Administration to take another look at Norwich Pharmaceuticals' bid to bring a generic version of a prescription drug for...

Senate and House Lawmakers Unveil Competing 340B Reform Proposals

By Abdie Santiago —

FDA’s Expedited IND Pilot Comes Into Focus

By Sarah Wicks —

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Simtriyo]]>

Federal Circuit Affirms Non-Infringement Ruling in Lidocaine Patch Patent Dispute Over ZTlido Generic

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision Tuesday affirming a judgment of non-infringement entered by the U.S. District Court for the Southern Dist...

<![CDATA[Pharmaceutical Executive Daily: FDA Grants Traditional Approval to Novartis's Fabhalta]]>

USPTO Adopts Flexible Approach to Markush Group Language

One Atomic Substitution, Two Giant Hurdles of Disclosure and Efficacy

In Intra Cellular Therapies v. Controller of Patents, the Delhi High Court revisited two recurring fault lines in pharmaceutical patent law: the coverage disclosure distinction in...

The PEPTIDE-L Wave Rolls On! PCAC Adds Two More Bulk Drug Substances for the 503A List

By Charles D. Snow & Karla L. Palmer & Mary Bass —

7th Circ. Revives Teva Suit Over Eli Lilly Generic Drug Block

The Seventh Circuit on Monday revived a breach-of-contract lawsuit against Eli Lilly, ruling that an earlier legal settlement under which Eli Lilly agreed not to block the approval...

Mavyret Patent Abandonment Does Not Open the Field for Hepatitis C Generics

July 28, 2026 marked eight years of the National Viral Hepatitis Control Program (NVHCP). Launched under the National Health Mission, the program aims to eliminate Hepatitis C from...