[2009] EWHC 102 (Pat)

This case concerned a tit-for-tat revocation of two patents claiming the combinations of a particular anticholinergic with -agonists for treating respiratory illnesses.

The Claimant, Almirall, first brought proceedings before the UK Patent Court against Boehringer for revocation of Boehringer’s patent EP 1 651 270 (“270”) claiming that 270 was neither new, inventive nor did it sufficiently disclose the invention. Boehringer also made an application to amend 270 to limit the claims to certain - agonists.

Boehringer counterclaimed for revocation of Almirall’s later patent EP 2 419 819 (“819”) on the basis that it was also neither new nor inventive; relying on the same prior art as Almirall in respect of 270. Almirall accepted that should Boehringer’s patent be found invalid so would all the claims of 819, except claim 20 which claimed the “use according to any of one of claims 10, 18 and 19 wherein the patient is suffering from a preexisting heart condition or condition that would be aggravated by tachycardia”, claim 10 being in so-called “Swiss” or second medical use form. Boehringer, however, contended that this claim was also invalid as a method of treatment excluded by section 4A(1)(a) of the Patents Act 1977.

270 Patent

The 270 Patent related to the combination of a particular anticholinergic, the R-enantiomer of which is called Aclidinium, with certain 2-agonists to treat respiratory diseases such as asthma or COPD; the combination being described in the patent as possessing an “unexpectedly beneficial therapeutic effect”. The claimed anticholinergic (the Almirall Compound) was not limited to the R-enantiomer but extended to both racemates of and the S-enantiomer of the anticholinergic. The formula of the Almirall Compound, as well as the use of it with 2-agonists, had previously been disclosed by Almirall in a prior published patent application, which was one the pieces of prior art relied on by Boehringer, together with two posters which had been shown by Almirall at a conference prior to filing the 270 patent application.

819 Patent

The later filed 819 Patent focused on the R-enantiomer of the Almirall Compound in combination with 2- agonists and identified a clinical advantage associated with the second medical use claimed in claim 20.

270 Decision

The Court found that the prior art did not anticipate 270, as it did not specifically disclose the use of the particular 2-agonists claimed by 270. However, it did find the patent obvious in light of the prior art and the common general knowledge at the priority date of 270. The Court also found the patent to be insufficient as it did not disclose sufficient evidence for the statement that the combination had an “unexpectedly beneficial therapeutic effect” and it did not support the full breadth of the claims. In respect of the statement, the patent did not disclose any experiments suggesting a beneficial effect, on this Judge Fysh QC commented:

“In my judgment, the addressee would simply be left guessing. This is of course an unsatisfactory conclusion but since the public has a right to know what technical contribution has been made by the patent, this is no place for indulgence. Speculative statements, guesses and unsupported predictions are not good enough.”

A number of experiments were conducted by both sides to provide support for their respective positions regarding the effectiveness of the S-enantiomer. However, the Court heavily criticised Boehringer’s insistence on these experiments. Its main criticisms were that Boehringer knew before the experiments that the S-enantiomer was inactive, but failed to admit this, and that the experiments were of no real assistance and accordingly a waste of time.

819 Decision

The Court found that all the claims in 819, including claim 20, were also invalid for being obvious.

Claim 20 was also found invalid as covering a method of treatment. In coming to its conclusion the Court relied on old case law, which took a stricter approach (see Bristol Myers Squibb v Baker Norton [2001]) than the EPO in determining whether or not a claim consisted of a method of treatment. For example, such case law would have excluded patents for a new dosage regime for previously treated diseases. Recent UK case law, however, has followed the EPO in allowing such patents (see Actavis UK v Merck & Co [2008]). It is not clear why the Court did not consider Actavis v Merck.