Today, I would like to provide a brief report on some ongoing pharma litigation in France, in connection with zoledronic acid.
Novartis AG is the proprietor of the French part of European patent No. EP1296689. This Swiss-type company was granted Swiss-type claims by the EPO.
More specifically, independent claim 1 is the following:
Use of 1-hydroxy-2-(imidazol-1-yl)ethane-1, 1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof in the preparation of a medicament for the treatment of osteoporosis in which the 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof is administered intravenously and intermittently and in which the period between administrations is at least about 6 months.
There is also an independent claim 5:
Use of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof for the preparation of a medicament for the treatment of osteoporosis wherein said medicament is adapted for intravenous administration in a unit dosage form which comprises from about 1 up to about 10 mg of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof, wherein the period between administrations of bisphosphonate is at least about 6 months.
I wonder how these claims are going to fare at the Paris Tribunal de grande instance (TGI) validity-wise, given the historical dislike of such claims by this court. But this is not today’s topic.
In December 2014, Novartis started patent infringement proceedings against Biogaran, Agila Specialties Polska SP and Sanochemia Pharmazutika AG. The exploitation of the generic Aclasta in France was considered by Novartis as an infringement of the patent.
The lawsuit was linked with other pending lawsuits, namely infringement proceedings against several Teva companies, as well as nullity proceedings initiated by Biogaran.
The decision discussed today is not a judgment on the merits, but rather a judgment on two preliminary objections filed by the defendant Sanochemia.
One of the preliminary objections was an alleged nullity of Novartis’ writ of summons. The other one was an alleged lack of jurisdiction of the Paris TGI. Such preliminary objections, or “exceptions” as they are called in French procedural law, are dealt with by the judge in charge of case management, before the trial in front of the full court. In this case, both were a bit of a long shot, and they were rejected by the judge on January 28, 2016. Sanochemia appealed, but the first instance decision was confirmed by the Cour d’appel de Paris on May 12, 2017.
Readers may be curious to know how the Paris TGI could possibly be considered as having no jurisdiction – according to the defendant. After all, we are talking about the alleged infringement of the French part part of a European patent, and this is the daily bread of the 3rd chamber of the Paris TGI.
Well, the argument presented by Sanochemia was very creative – although a long shot, as I mentioned.
Sanochemia is the manufacturer of the generic drug. The drug is manufactured in Austria. Then, it is imported into France and marketed in this country, and Sanochemia may or may not be directly involved in such activities – hard to tell based on the court’s ruling. At any rate, Sanochemia stated that it did not have any marketing authorization in France.
Now, remember that the patent at stake is a Swiss-type patent, and that the patent claims are accordingly directed to the use of an active substance for the preparation of a medicament for a particular treatment modality. My understanding is that Sanochemia considered that these claims exclusively protect a manufacturing process.
Since the manufacturing process was not carried out in France, Sanochemia argued that the alleged infringement in fact took place in Austria, and not in France. Sanochemia’s case was that they did not commit any act on the French territory. Therefore, they said, the Austrian courts had exclusive jurisdiction under the Brussels I jurisdiction.
As could be expected, the Paris Cour d’appel held that this theory did not hold water:
As noted by the judge in charge of case management, regulation No. EC 44/2011 of December 22, 2000 on jurisdiction provides that a person residing on the territory of a member state can be sued in another member state, and, in matters relating to delict or quasi-delict, in the courts for the place where the harmful event occurred.
Even if the act of manufacturing the product took place in Austria, the court for the place where the harmful event occurred is however not in Austria, since the drug alleged to be infringing is said to have been imported into France by Sanochemia. Therefore, the arguments presented by Sanochemia pertain to a defense on the merits and need to be examined on the merits. The judge in charge of case management thus rightfully rejected the exception of lack of jurisdiction filed by Sanochemia.
In summary, Sanochemia argued that they did not commit any act of infringement in France. However, the mere fact that infringement in France is alleged by Novartis implies that this question must be decided by French courts.
Whether Sanochemia is ultimately found to be guilty of infringement (assuming that the patent passes the validity hurdle) will be very interesting to watch, given the particular claims at stake, namely Swiss-type, dosage regimen claims.
According to article 64(2) EPC, “if the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process“. Thus, typically, a company that manufactures a product abroad according to a patented process and imports it into France can be declared guilty of infringement of the patent at stake.
But in the present case, the claims are not classical manufacturing process claims. The main part of the invention, or to be more precise the contribution of the invention to the art, lies in the dosage regimen (namely “administered intravenously and intermittently and in which the period between administrations is at least about 6 months” if we focus on claim 1), and this has in principle nothing to do with the manufacturing process.
In fact, one of Sanochemia’s arguments regarding the alleged nullity of Novartis’ writ of summons was that it was not clear from the writ whether the alleged infringement related to the manufacture of the drug or the manufacture of the leaflet, which contained dosage indications. The court found that the writ of summons was sufficiently clear – and the decision does not contain further details. But I would add that even the mere importation of a drug into France without any label or leaflet could possibly be an act of contributory infringement of a dosage regimen claim.
So, definitely a case to keep watching – today’s discussion being just an amuse-bouche.
CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, May 12, 2017, Sanochemia Pharmazutika AG v. Novartis AG et al., RG No. 16/05608.