by David Eyre | Feb 28, 2023 | UK
In this decision the Hearing Officer noted that a marketing authorisation is focused on what a product is rather than what it does. Consequently, a change in how the authorised product is used does not alter the basis of the original marketing authorisation....
by David Eyre | Sep 6, 2022 | UK
In the case of Neurim and Flynn v Mylan [2022] EWCA Civ 699 The Court of Appeal has issued a decision finding that the plausibility of a therapeutic effect can be demonstrated using subjective data obtained by questioning the users of a pharmaceutical product....
by Eddie Bishop | Apr 25, 2022 | US & International
Questions on the European SPC Regulation, in particular in relation to SPCs for combination products, have been raised at the CJEU many times over the years. It is therefore hoped that this newest referral may provide some much-needed clarity. Background For an SPC to...
by Sean HutchinsonEddie Bishop | Feb 8, 2022 | EPO
Background In our previous article, we discussed the expected referral to the Enlarged Board of Appeal in case T 116/18, wherein the Board of Appeal decided greater clarity was required concerning the use of post-published data when considering inventive step. The...
by Eddie Bishop | Oct 1, 2021 | Briefings, US & International
Belcher’s patent related to a high-pH formulation of L-epinephrine (L-adrenaline) and was granted with a claim to a formulation of pH 2.8-3.3. The formulation of L-epinephrine was also the subject of a new drug application before the FDA. Hospira, who were...
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