Novartis Ag & Ors v Focus Pharmaceuticals UK Ltd & Ors

A patent claim defining a starting dose by reference to a specified patch is not thereby limited to patches having that patch’s structure or composition. However, that breadth adds matter where the application discloses neither the particular starting-dose use nor delivery of the dose by differently structured patches. For obviousness, prior art must be read as a whole and in light of common general knowledge. A dose may be obvious to try where routine testing, an expected tolerability benefit and a sufficient prospect of success justify a small clinical trial. The appeal was dismissed because the patent was invalid for added matter and lack of inventive step.

Novartis appealed against Arnold J’s decision in the Patents Court, reported at [2015] EWHC 1068 (Pat). The patent concerned rivastigmine administered through a transdermal therapeutic system for treating dementia or Alzheimer’s disease, with a starting dose defined by reference to a specified patch.

The judge construed the claim broadly, but revoked the patent for added matter and lack of inventive step. He rejected insufficiency and held that the defendants would have infringed if the patent had been valid. The infringement claims were later compromised, while Novartis maintained its appeal against revocation. The central issues were claim construction, added matter and obviousness.

1. Disposition. The appeal was dismissed. Floyd LJ and Hamblen LJ agreed with the judgment of Kitchin LJ. The patent remained invalid for added matter and lack of inventive step.
2. Construction. The claim was directed to rivastigmine administered by a transdermal therapeutic system, with the starting dose defined by the dose delivered by the specified 5 cm² reference patch. The words describing the starting dose did not require the treatment patch to have the reference patch’s structure or composition. The specification also indicated that patches with different structures could be used.
3. Added matter. The applicable question was whether the patent presented the skilled person with information about the invention that was not directly and unambiguously apparent from the application. The application disclosed a three-layer patch and broad pharmacokinetic ranges. Its only reference to a starting dose was qualified and did not disclose using the claimed dose therapeutically. The study data did not establish that the dose from the reference patch was suitable or better tolerated as a starting dose. The patent therefore introduced both the particular starting-dose use and the broader proposition that the dose could be delivered by structurally different patches. This was an intermediate generalisation and constituted added matter. The principles in Vector Corp v Glatt Air Techniques Inc [2007] EWCA Civ 805, Napp Pharmaceutical Holdings Ltd v ratiopharm GmbH [2009] EWCA Civ 252 and Nokia Corp v IPCom GmbH & Co KG (No 3) [2012] EWCA Civ 567 were applied.
4. Obviousness. The judge had erred in isolating one passage of US 031. The document had to be read as a whole and in light of common general knowledge, without hindsight. Nevertheless, the alternative obviousness case succeeded. The skilled team would be motivated to improve rivastigmine therapy, would regard transdermal delivery as suitable for once-daily treatment and smoother drug release, and would routinely conduct dose-titration studies. The expected tolerability benefits and the incentive to eliminate a sub-therapeutic titration step gave a sufficient expectation of success to justify trying the claimed starting dose in a small clinical trial.
5. Insufficiency. The respondents’ alternative insufficiency argument fell away because the finding of obviousness was upheld.

• Court of Appeal (Civil Division) — The appeal against revocation was dismissed. The Court upheld the findings that the patent was invalid for added matter and lack of inventive step.
• High Court of Justice, Chancery Division (Patents Court) — Arnold J, in [2015] EWHC 1068 (Pat), construed the claim broadly, revoked the patent for added matter and obviousness, rejected insufficiency, and held that infringement would have occurred if the patent had been valid.