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Patent Infringement Compliance

McDermott Will & Emery

Small-Market Segment Can Satisfy Domestic Industry Requirement

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a US International Trade Commission finding, explaining that small-market segments can be significant and substantial enough to support the Commission’s domestic...more

Fuerst Ittleman David & Joseph

The GLP-1 Saga Continues: FDA Ends the Tirzepatide Shortage: Frequently Asked Questions

On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more

Smart & Biggar

Federal Court finds patent ineligible for listing against SNDS

Smart & Biggar on

In Bayer Inc v Amgen Canada Inc, 2024 FC 1849, the Court granted a motion brought by Amgen for a declaration that Canadian Patent No. 3,007,276 (276 patent) was ineligible for inclusion on the Patent Register and that the...more

Smart & Biggar

Update on biosimilars in Canada – March 2024

Smart & Biggar on

In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

Smart & Biggar on

On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Neal, Gerber & Eisenberg LLP

To Mark or Not to Mark? U.S. Patent Holders Should Take Time to Carefully Consider Their Patent Marking

It’s never a bad time for companies holding U.S. patents to assess their patent marking strategy and compliance. Patent marking is often neglected or relegated to the marketing team, but it shouldn’t be. Whether what and how...more

White & Case LLP

The Czech Competition Authority publishes new policy on compliance programs as mitigating factor when imposing fines

White & Case LLP on

In December 2023, the Czech NCA - Office for the Protection of Competition (the "Office") published its new Compliance Program Consideration Policy , which has taken effect from 1 January 2024 and which sets out the...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Smart & Biggar

Federal Court declines to grant injunction for infringement of HUMIRA formulation patent

Smart & Biggar on

On December 4, 2023, the Federal Court issued its public judgment and reasons in two patent infringement actions pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and two patent...more

Latham & Watkins LLP

German Draft Competition Law Amendment Includes Far Reaching Remedial Powers Absent Actual Infringements

Latham & Watkins LLP on

Under the draft law, the FCO could impose behavioural and structural remedies following a sector inquiry without finding an infringement of German or EU competition law. The German Federal Ministry for Economic Affairs...more

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