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I've been trying to understand the scope of protection for SPC's.

Let's say a drug company gets an MA in Europe for compound X for two different therapeutic uses, use A and use B. Let's say the company has two basic method of use patents, one for each of the therapeutic uses, and lets say both patents have the same expiry, and the company is interested in the +5 year extension conferred by an SPC. As I understand, only 1 SPC may granted to this company for compound X, so if the company chooses to apply for an SPC for the patent covering therapeutic use A, would a generic drug company still be able to market and sell into therapeutic use B (once patent B expires, but before the SPC on use A expires)?

Is there a way for the company to protect both therapeutic uses with only 1 SPC?

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  • What rule makes you think only one SPC is available per compound vs only one per patent?
    – George White
    Dec 11, 2023 at 16:29
  • I've read about that rule here: "while the same holder of several patents cannot be granted more than one SPC for the same product. This has become known as the “one SPC per product per patent holder rule”. patentblog.kluweriplaw.com/2018/12/07/spcs-under-friendly-fire Dec 11, 2023 at 21:12

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Apparently there was a case called Neurim in 2012 that ruled that if one uses was for humans and another use was for veterinary, use a second SPC was allowed. Also there was discussion that a second use where the action of the compound was different might also be allowed an additional SPC.

However, it was overruled in Santen in 2020. The “product” is the compound not compound+use.

One law firm’s analysis.

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  • Note that, as a retired US practitioner who never handled chemical or pharmaceutical cases, this info is from 20 minutes of googling.
    – George White
    Dec 11, 2023 at 22:18

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