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...
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...
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...
In the present case the patentee wished to rely on documents dated after the filing date for their inventive step argument, stating that these documents in combination with data in the application as filed provided evidence of a synergistic effect between two...
Background The patent at issue in the present case was US7,772,209, claim 1 of which is shown below. Claim 1 A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount...
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