Istituto Gentili SpA Merck & Co. Inc. v Teva Pharmaceutical Industries Ltd. & Ors

A patent claim lacks novelty where a prior publication, read by the skilled person with the relevant common general knowledge, gives clear and unmistakable directions which would infringe the claim. A step is obvious where the skilled person would regard it as sufficiently worthwhile to test in the light of the prior art and common general knowledge.

Patent claims must be construed purposively, by the description and in accordance with the Protocol approach required by the Patents Act 1977. An amendment is impermissible if deleting material adds a relevant teaching to the claimed invention, even if it narrows the claim. A claim in substance directed to a therapeutic dosing regime is excluded by section 4(2).

The appellants were patentees of two bisphosphonate patents. The first patent claimed pharmaceutical compositions containing alendronate or anondronate. The respondents alleged anticipation and obviousness, principally by a published European patent application known as Blum.

The second patent claimed the use of alendronate to manufacture an oral medicament for weekly treatment of osteoporosis. Jacob J revoked both patents on 23 January 2003. He held that the first lacked novelty and was obvious. He construed the second as claiming a dosing regime, refused to treat it as confined to a single 70mg dose, and held it invalid under section 4(2) of the Patents Act 1977.

On appeal, the central issues were whether Blum anticipated or made the first patent obvious, whether the second patent could be amended and how its claim should be construed, and whether that claim was a prohibited method of treatment.

1. The appeal was dismissed. The Vice-Chancellor gave the principal judgment. Buxton LJ and Laws LJ agreed.

2. The court upheld the revocation of patent 042 for lack of novelty. Applying the principles in The General Tire Company v The Firestone Tyre and Rubber Co Ltd [1972] RPC 457, Blum had to be read through the eyes of the skilled person at its publication date. Its direction to use the relevant bisphosphonates in pharmaceutical preparations was a clear direction to use them as active ingredients. The skilled person would understand that teaching against the known therapeutic use of related bisphosphonates. A pharmaceutically acceptable carrier or diluent followed as an ordinary consequence. The judge’s factual conclusion was therefore justified.

3. Although anticipation was sufficient to dispose of that part of the appeal, the court also upheld the finding of obviousness. Applying the structured approach in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59, the skilled person would place the C4 and C5 compounds high in a testing programme. The evidence established that testing C4 was worthwhile. There was no basis to interfere with the judge’s assessment of the competing expert evidence.

4. The proposed deletion from patent 292 was refused. If the deletion changed the claim so that a single 70mg administration became important, it added that teaching to the specification. It was therefore prohibited by section 76(3)(a) of the Patents Act 1977, notwithstanding that it restricted the claim. The court would also have refused the late and unexplained application as a discretionary matter.

5. The claim to patent 292 was properly construed as a claim to a weekly dosing regime, not to a single dosage unit containing 70mg. The specification expressly contemplated 35mg tablets and liquid formulations. A purposive construction under sections 125(1) and 125(3) did not permit the word “unit” to impose a single-pill requirement. On that construction, the claim was not novel and, applying Bristol-Myers Squibb v Baker Norton [2001] RPC 1, was for a therapeutic method excluded by section 4(2).

6. Buxton LJ additionally gave appellate-practice guidance. A challenge to factual and evaluative findings on anticipation or obviousness must identify the coherent and binding principle allegedly infringed. Merely disputing the trial judge’s assessment of technical evidence will not ordinarily establish an error of principle.

• Court of Appeal (Civil Division) Dismissed the patentees’ appeal and upheld the revocation of both patents.
• Chancery Division Jacob J revoked both patents by an order dated 23 January 2003.