Citation: 4A_453/2019 E. B

B.a. Mit Eingabe vom 28. Januar 2019 stellten die Klägerinnen beim Bundespatentgericht folgende Massnahmebegehren: "1A. Respondents are to be prohibited by way of a preliminary injunction under threat of an administrative penalty of CHF 1000 per day according to Article 343 (1) (c) Federal Code of Civil Procedure (CCP), but at least CHF 5000 according to Article 343 (1) (b) CCP, as well as under threat of penalty for their officers according to Article 292 Penal Code (PC) in case of future violation, to import, export, store, manufacture, offer, sell or in any other way place on the market by itself or through third parties fixation devices for engaging mitral valve leaflets, with the following features described by reference to the illustration in Annex 1 hereto: a) the device comprises a pair of fixation elements, each composed of an outer paddle and an inner paddle, each fixation element having a first end, a free end opposite the first end and an engagement surface therebetween for engaging tissue, which engagement surface is located on the inner paddles; b) the first ends are movably coupled together and they are movable between (1) a closed position wherein the engagement surfaces face each other and (2) an inverted position wherein the engagement surfaces face away from each other, i.e., they are rotated by an angle of more than 90° with regard to a longitudinal axis of the device; c) the device comprises an actuation mechanism coupled to the fixation elements which actuation mechanism comprises a rod and is adapted to move the fixation elements between the closed position and the inverted position; d) the device comprises a pair of gripping elements, hereafter referred to as "clasps", each clasp being movable with respect to one of the fixation elements and disposed in opposition to the engagement surface of the respective fixation element so as to capture tissue therebetween; e) the clasps are movable from an undeployed configuration in which each clasp is separated from an opposing engagement surface, to a deployed configuration in which the clasp is adjacent to the opposing engagement surface; f) the outer paddles of the fixation elements have a concave inner surface directed towards the longitudinal axis; g) each clasp is at least partially recessed within the fixation element in the deployed configuration; i.e., in the configuration in which the clasp is adjacent to the opposing engagement surface. 1B. Respondents are to be prohibited by way of a preliminary injunction under threat of an administrative penalty of CHF 1000 per day according to Article 343 (1) (c) Federal Code of Civil Procedure (CCP), but at least CHF 5000 according to Article 343 (1) (b) CCP, as well as under threat of penalty for their officers according to Article 292 Penal Code (PC) in case of future violation, to import, export, store, manufacture, offer, sell or in any other way place on the market by itself or through third parties fixation devices for engaging mitral valve leaflets, with the following features described by reference to the illustration in Annex 1 hereto: a) the device comprises a pair of fixation elements, each composed of an outer paddle and an inner paddle, each fixation element having a first end, a free end opposite the first end and an engagement surface therebetween for engaging tissue, which engagement surface is located on the inner paddles; b) the first ends are movably coupled together and they are movable between (1) a closed position wherein the engagement surfaces face each other and (2) an inverted position wherein the engagement surfaces face away from each other, i.e., they are rotated by an angle of more than 90° with regard to a longitudinal axis of the device; c) the device comprises an actuation mechanism coupled to the fixation elements which actuation mechanism comprises a rod and is adapted to move the fixation elements between the closed position and the inverted position; d) the device comprises a pair of gripping elements, hereafter referred to as "clasps", each clasp being movable with respect to one of the fixation elements and disposed in opposition to the engagement surface of the respective fixation element so as to capture tissue therebetween; e) the clasps are movable from an undeployed configuration in which each clasp is separated from an opposing engagement surface, to a deployed configuration in which the clasp is adjacent to the opposing engagement surface; f) the clasps are arranged as shown in Annex 1 in the undeployed configuration. 1C. Respondents are to be prohibited by way of a preliminary injunction under threat of an administrative penalty of CHF 1000 per day according to Article 343 (1) (c) Federal Code of Civil Procedure (CCP), but at least CHF 5000 according to Article 343 (1) (b) CCP, as well as under threat of penalty for their officers according to Article 292 Penal Code (PC) in case of future violation, to import, export, store, manufacture, offer, sell or in any other way place on the market by itself or through third parties fixation devices for repairing mitral valve leaflets in a patient, with the following features described by reference to the illustration in Annex 1 hereto: a) an interventional catheter comprising a shaft having a proximal end, i.e. an end oriented towards a person operating the catheter, a distal end, i.e. an end configured to pass to a position within the heart adjacent to the mitral valve, and a longitudinal axis therebetween; b) a capture device detachably connected to the catheter comprising two extendable distal elements (hereafter referred to as "paddles") and two extendable proximal elements (hereafter referred to as "clasps"); c) each of the clasps and the paddles being disposed adjacent to the distal end of the shaft; d) each of the clasps and the paddles are moveable between a retracted position adjacent the shaft and an extended position extending away from the shaft; e) the two clasps and the two paddles are independently extendable, retractable and repositionable so that they are adapted to be extended or retracted by various amounts for protrusion of various distances from the shaft.