News & Analysis as of

Patent Infringement Compliance

Smart & Biggar

Update on biosimilars in Canada – March 2024

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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

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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

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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

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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

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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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