Apotex's Generic Version of Nasonex®: Non-Infringing -- May Conduct At Risk Launch (As To Other Patents)

So, the core patent legacy Schering-Plough claimed was violated by Apotex's generic -- the '353 patent -- has been held not to read on Apotex's reformulation, by a federal district trial judge in Newark. The judge specifically cited other, additional chemical structures in the Apotex formulation -- each of which surround the claimed compound, and in Apotex's reformulation(s) of Nasonex^®, change its character appreciably. This, it seems, was the core reason for the opinion of non-infringement. While this means Apotex could launch immediately, it is likely that Merck will appeal the ruling, and there is still a secondary patent, under which Merck claims (through Schering-Plough's legacy), a patent that is not due to expire until 2017, by its terms.

So we shall -- as ever -- see.

Here is the press release, and a bit from the full opinion (a 46 page PDF file):

. . . .In commenting on Dr. Matzger’s procedures, Threlfall stated "I would describe this as making scrambled eggs and then claiming you still had the eggs with the shells in the carton. . . ."

The issue is whether Schering met its burden of proof by a preponderance of the evidence with regard to the existence of monohydrate when the samples were shaken or vortexed to the extent that the material may have changed. Dr. Threlfall opined that Avicel “gels around the material . . . [and] in human terms [its] like swimming
through molasses.’ (T. 920, 6-9). Avicel is thixotropic, which means “not only does it thin when you shake it . . . but it continues to thin with more shaking.” (T. 921, 12-15). Accordingly, as shaken, “Avicel reduces its viscosity by a factor of 10,000.” (T. 921, 21-22).

Although Dr. Threlfall may have exaggerated some of his opinions through his colorful analogies, his demeanor was truthful. Dr. Threlfall connoted that Dr. Matzger overstepped the boundaries of a disciplined scientist. The Court gives weight to Dr. Threlfall’s testimony. With regard to the samples that were shaken or vortexed, Schering has not met its burden of proof by a preponderance of the evidence. If one places the evidence favorable to Schering on one side of a scale, and all the evidence favorable to Apotex on the other, the scale does not tilt toward Schering. As such, Schering can not meet its burden of proof on any samples that were shaken or vortexed. . . .

Do stay tuned. We will keep you informed.