The US Food and Drug Administration is seeking to work with the Patent and Trademark Office on a variety of hot-button issues, but it seems unclear how much impact the collaboration will have on the intellectual property landscape for the pharmaceutical industry.
FDA Airs ‘Concerns’ Over IP Barriers
US Agency’s Patent Concerns Include Thickets, Product Hopping And Evergreening
Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’
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Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.
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A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.
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Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.
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The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.
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Teva is charting a new course under its ‘Pivot to Growth’ strategy, providing a memory aid for investors to better understand the firm’s financials going into 2025.