English High Court invalidates Novartis’s Alzheimer’s patch patent

The English High Court has ruled that a patent covering Novartis’s transdermal patch treatment for Alzheimer’s disease, Exelon (rivastigmine), is invalid.

Novartis sued Focus Pharmaceuticals, Actavis and Teva for allegedly infringing its European patent 2,292,219, titled “Transdermal therapeutic system for the administration of rivastigmine”. The patent covers Novartis’s Exelon Patch product, which is available in 4.6mg, 9.5mg and 13.3mg dosages.

According to the judgment, handed down on Monday (April 27), 13 parties have opposed the disputed patent, and the Opposition Division of the European Patent Office is due to hear a case on its validity in December.

Focus, Actavis and Teva market their own versions of the Exelon Patch in 4.6mg and 9.5mg dosages, and in the same sizes as Novartis’s patch itself.

They denied that they had infringed the patent and counterclaimed to revoke it, arguing that it was invalid for obviousness.

In his opinion, Justice Richard Arnold found that there was no dispute that the defendants’ products are generic versions of Exelon Patches.

To prove obviousness, the defendants referred to US patent number 6,335,031, titled “TTS [Transdermal therapeutic system] containing an antioxidant”, as prior art. The US patent was granted to Novartis in 2002.

The ’031 patent teaches which dosage levels should be used for the transdermal patch, and recommends optimal contact area and the amount of active ingredient to be effective. Arnold found that the structure and composition of the TTS as recommended in the patent was the same as that in Novartis’s EU patent application.

He concluded that the patent was invalid for lack of inventive step.

Arnold also invalidated the patent on the grounds of added matter, and that Focus, Actavis and Teva did not establish that the patent is insufficient. If the patent were valid, he said, the defendants would have infringed it.

Paul England, a senior associated at law firm Taylor Wessing in London, told LSIPR that while the ruling has no binding effect on the other European litigation the patent is involved in, other courts might take note of the decision and its reasoning.

He added: “The interesting thing about this decision is that Arnold notes the ‘striking diversity’ of outcomes in the numerous other European courts in which decisions (mostly interim injunctions) have been made, with some courts and tribunals finding infringement and others not, on the same facts.

“It is exactly these differing results that the Unified Patent Court (UPC) is intended to sweep away, although many patentees say they would prefer to win in at least some countries around Europe rather than risk losing outright in the UPC.”

A spokesperson for Novartis said that the company was consulting with the appropriate parties involved and evaluating all of its options.

Focus, Actavis and Teva did not respond to LSIPR’s requests for comment.