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...

Amarin Ends 'Skinny Label' Patent Case Against Hikma

Amarin Pharma Inc. is dropping its patent suit over Hikma Pharmaceuticals USA Inc.'s generic version of a heart drug that uses a so-called skinny label, months after the U.S. Supre...

New Biosimilar Legislation Addresses Inflation Reduction Act Delay Provision

Key Update The Biosimilars Access and Affordability Act has been reintroduced in both chambers, which would create clearer criteria for delaying Medicare price negotiation of a re...

Chemical Structure, Formula, and Name Support Written Description of Pharmaceutical Genus

Do Not Let a Paperwork ‘Gotcha’ Sink Valuable Medicines

Congress is considering a bill that would let patents on prescription drugs be rendered unenforceable over an honest paperwork error, even when the underlying invention is genuinel...

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 —

Delaware Court Extends Hikma to Labels Without Carve-Outs

Key Takeaways In one of the first life sciences cases to address induced infringement after Hikma v. Amarin, the District of Delaware held that its affirmative-conduct standard ap...

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

340B Rebate Pilot — The Clock Starts Now

Teva, Apotex Don't Infringe Sleep Drug Patents, Judge Finds

Generic drugmakers Teva Pharmaceuticals and Apotex Inc. have secured an order from a Delaware federal court that they do not infringe patents asserted by Vanda Pharmaceuticals that...

<![CDATA[Naoki Okamura: Post-Patent Plan and Purpose]]>

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...

Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC

Fed. Cir. Docket Nos. 2024-2274, -2277, -2278 LOURIE, REYNA, TARANTO May 6, 2025 Avadel filed a 505(b)(2) “paper NDA” (AstraZeneca, FC 2010; Takeda, FC 2015) for its Lumryz product...

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...

Mylan Wants Del. Judge To Clear Wegovy Generic Drug

Mylan Pharmaceuticals Inc. has launched a lawsuit in Delaware federal court asking for a finding that its proposed generic version of Novo Nordisk Inc.'s blockbuster weight loss dr...

Pharma’s $500B patent problem will come in waves — not as a cliff

Merck is the most vulnerable to generic competition in the short term, but AbbVie, Johnson & Johnson, Sanofi and others will also grapple with patent losses in the years to com...

Dietary Supplement Innovation Act Aims to Address Drug Preclusion Concerns

Representative Diana Harshbarger (R-TN) recently introduced the Dietary Supplement Innovation Act (H.R. 10336), legislation that would amend the Federal Food, Drug, and Cosmetic Ac...

<![CDATA[What Do the New MFN Deals Lock In?]]>

USPTO Adopts Flexible Approach to Markush Group Language

Genentech, Novartis Sue Amneal Over Bid To Sell Xolair Copy

Genentech Inc. and Novartis Pharmaceuticals Corp. have filed a patent infringement suit in Delaware federal court, claiming Kashiv BioSciences' bid to sell a biosimilar copy of the...

CMS Gains Permissive Exclusion Authority: Implications for Pharma and Medical Device Companies

By Anne K. Walsh —

6 Ways Biotechs Can Manage Double Patenting Rejection Risk

The Patent Trial and Appeal Board review panel’s recent rejection of a Sanofi application signals that biotechnology and pharmaceutical companies should now take steps to mitigate...

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