Wednesday, August 7, 2019

Tiotropium - EPO


EPO opposition / appeal decision:

Case number
Decision date
Online available
Patentee
Opponent(s)
Patent No.
Final Decision
T 1837/16
Jun 18, 2019
Aug 06, 2019
Boehringer Ingelheim
Teva / Actavis / Vossius & Partner
EP1496858
The appeal is dismissed

EP1496858 B1 (Forward pharma; Exp: Apr 02, 2023):

1. Inhalation kit consisting of an inhaler and an inhalable powder containing tiotropium in an amount of 0.001 to 5 %, in admixture with a physiologically acceptable excipient with an average particle size of between 10 to 500 µm, wherein the inhaler comprises a housing, containing two windows, a deck in which there are air inlet ports and which is provided with a screen secured via a screen housing, an inhalation chamber connected to the deck on which there is a push button provided with two sharpened pins and movable counter to a spring, a mouthpiece which is connected to the housing, the deck and a cover via a spindle to enable it to be flipped open or shut, and three holes with diameters below 1 mm in the central region around the capsule chamber and underneath the screen housing and screen, and further characterized in that the said inhaler displays a flow resistance of about 0.01 - 0.1 kPa min / l.

5. Inhaler suitable for the administration of an inhalable powder containing tiotropium in an amount of 0.001 to 5 %, in admixture with a physiologically acceptable excipient with an average particle size of between 10 to 500 µm, said inhaler comprises a housing, containing two windows, a deck in which there are air inlet ports and which is provided with a screen secured via a screen housing, an inhalation chamber connected to the deck on which there is a push button provided with two sharpened pins and movable counter to a spring, a mouthpiece which is connected to the housing, the deck and a cover via a spindle to enable it to be flipped open or shut, and three holes with diameters below 1 mm in the central region around the capsule chamber and underneath the screen housing and screen, and further characterized in that said inhaler displays a flow resistance of about 0.01 - 0.1 kPa min / l .

Summary: The patent was opposed under Article 100 (a), (b), (c) EPC on the grounds that its subject-matter lacked novelty and inventive step, was not sufficiently disclosed, and extended beyond the content of the application as filed.

The appeal lies from the decision of the opposition division to revoke the patent. The decision was based on the claims as granted as main request and 5 sets of claims filed as auxiliary requests 1 and 2 with letter of 26 February 2016, and filed during the oral proceedings of 28 April 2016 as auxiliary requests 3,4 and 5.

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