Exforge is a blockbuster drug sold by Novartis for lowering blood pressure that combines two medications in a film-coated tablet It contains amlodipine, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin II receptor antagonist (ARB or A2RA); typically formulated as the benzenesulfonate salt.
The drug, whose patent protectiton expires on July 9, 2019, had a world turnover in 2016 of $926 million dollars.
TEVA successfully opposed Novartis’ patent application no. IL 140665 “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION” in Israel. However, they failed in their opposition to the corresponding patent in Europe.
On June 7, 2018, the Paris Court of First Instance (Judge Marie Courboulay) issued a preliminary injunction against Teva’s generic version of the drug on the basis of Novartis’ European Patent EP 2 322 174. The dispute was subject to parallel proceedings in several EU countries. In fact, an injunction was issued in Gewrmany on 14 December 2017, but injunctions were refused by the courts in Spain and Switzerland. After these earlier rulings, TEVA decided not to proceed with the planned commercialization of the generic version in Austria and Finland.
0n October 16, 2017, Novartis discovered that Teva was commercializing generic versions of the pharmaceutical in France. By February 2018, Teva had cornered 42% of the market.
Novartis sued for infringement of claims 1 and 2 of EP 2 322 174, while Teva counterclaimed alleging the invalidity of the patent based on double patenting, insufficiency, extension and obviousness. In a 42-page ruling, the Court reviewed and individually rejected all of Teva’s invalidity arguments which had also been rejected in the Opposition proceedings.
One central issue related to the sufficiency of disclosure. Teva claimed lack of sufficiency since the dosages used in the clinical trials on rats were not sufficiently specified and the exact dosages to be administered to humans were unclear. The Court clarified that the patent in question does not protect a second medical indication of a known substance, but rather the combination of two known substances with known medical indication. The inventive character of the specific patent lies with the clinical superiority of the combination itself. The Court found that clinical trials on rats were sufficiently documented and that it is well-known to persons skilled in the art that the dosages administered to humans are not the same as those administered to rats.
In its ruling, the Court ordered Teva to pay €5,846,628 to Novartis Pharma AG, the Swiss company which owns the patent, and €7,308,285 to Novartis Pharma SAS, the French licensee) as an advance on damages, prohibited further production of the generic medicines and required that Teva provide Novartis with the names and addresses of those involved in the production of the generics, information on the quantities produced, as well as to submit all relevant documentation related to the acts of infringement.