EPO - TEVA PHARMACEUTICAL INDUSTRIES v/ LES LABORATOIRES SERVIER
Date de la décision
Type de jurisprudence
EPO - Opposition Division
TEVA PHARMACEUTICAL INDUSTRIES v/ LES LABORATOIRES SERVIER
The company Les Laboratoires Servier, owner of a European patent on hydrates of arginine salts of perindopril and their therapeutic use, was represented by Gerard DOSSMANN and Murielle ROBERT LE MEUR, European Patent Attorneys.
The decision of the Opposition Division is entirely favourable to Laboratoires Servier and rejects the opposition engaged by Teva Pharmaceutical for insufficiency of description and lack of inventive step.
The company Teva Pharmaceutical Industries engaged an opposition against EP patent 1,354,873 owned by Laboratoires Servier on the basis of insufficiency of description and lack of inventive step.
The invention relates to an arginine salt of perindopril and its hydrates as well as pharmaceutical compositions containing them. This salt possesses a stability against heat and humidity higher than that of the tert-butylamine salt of perindopril currently in use.
Regarding the insufficiency of description, the opponent argued that the preparation of perindopril arginine salt as disclosed in the patent, referred only to standard techniques of preparation and that obtaining all polymorphs and all compositions able to satisfy all the criteria, in particular higher stability than that of the tert-butylamine salt of perindopril, were not disclosed.
In addition, the opponent argued that a skilled person would not have been able to prepare the hydrates of these arginine salts.
The Opposition Division notes in the decision that perindopril and its salts are known and commercially available. In addition, the Division emphasizes that none of the cited documents suggests the need to implement non-standard methods of preparation for the compounds of the invention. Moreover, according to the Division, the opponent has not shown the impossibility of preparing the salt of perindopril arginine by conventional methods.
The Opposition Division concludes that the skilled person would be able to prepare the compounds on the basis of the general knowledge in chemistry.
Concerning inventive step, the opponent cited a document disclosing a specific crystalline form of the tert-butylamine salt of perindopril as a stable form which can allow the storage thereof.
In addition, the opponent argued that several documents mention arginine among a reduced number of salts, as being able to improve the stability of pharmaceutical compounds.
Two other documents also disclose different specific crystalline forms of tert-butylamine salt of perindopril.
Based on the cited documents, the opponent tried to cast doubts not only on the existence of a problem to be solved as defined by the patent of Laboratoires Servier but also on the existence of evidence that the problem was actually solved.
On the basis of technical tests, the opponent argued that not only the stability of the arginine salt of perindopril seemed smaller than the corresponding tert-butylamine salt but also that the stability of the products appears to be related not to the product itself but to the composition and / or packaging of tablets that contain it.
Les Laboratoires Servier also filed technical tests showing the contrary.
The Opposition Division did not follow the opponent on these arguments and considered that the question is to ask whether the skilled person would have considered the arginine salt of perindopril as having superior properties to those of the corresponding tert-butylamine salt.
In addition, the Division noted that if comparative data between arginine salts and other salts are present in the documents cited by the opponent, these data pertain to compounds which structure is very different from that of the compounds of the invention.
Finally, les Laboratoires Servier having confirmed during oral proceedings that the compositions tested differed only in the nature of the salt used, the Opposition Division concluded that the tests are in agreement with the technical problem to solve.
The Opposition Division concluded by stating that the skilled person would have found in the documents no suggestion that could lead to unambiguously conclude that the selection of arginine salt from the list of possible salts presented a thermal and storage stability higher than that of the corresponding salt of tert-butylamine.
The Opposition Division therefore rejects the opposition and decide to maintain the patent as granted.