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Regulatory Agenda Patents Regulatory Requirements

Smart & Biggar

Canadian Patent Office resumes granting of patents and is temporarily publishing list of pre-grant patents

Smart & Biggar on

The Canadian Patent Office (CIPO) has advised that as of January 14, 2025, it had granted patents for which final fees were processed in the old system. CIPO has started to process applications where final fees were paid in...more

Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

Smart & Biggar

New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations

Smart & Biggar on

As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® – September 2024: Expanding Horizons: Potential Expansion of IP Rights for High-THC Cannabis Varieties

In the United States, the intellectual property rights system for plants is multifaceted, encompassing utility patents, plant patents, trademarks, and Plant Variety Protection (PVP) Certificates. These mechanisms offer...more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Mintz - Antitrust Viewpoints

USPTO Issues Guidance on AI Use to Patent Professionals — AI: The Washington Report

Pursuant to President Biden’s October 2023 executive order on AI, on April 11, 2024, the United States Patent and Trademark Office (USPTO or Office) published “Guidance on Use of Artificial Intelligence-Based Tools in...more

Jones Day

The EU Pharma Incentives Review—Two Studies and a Legislative Proposal Released

Jones Day on

The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more

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