Abbott Laboratories and Medinol

Coronary Stents and Invalidity

In November 2010, Mr Justice Arnold, one of the three specialist judges in the Patents Court in London, held three Medinol patents not to be infringed by Abbott Laboratories’ coronary stents.

It might be thought this would have been good enough for Abbott, but Abbott had also applied to have all three patents revoked for invalidity. Abbott relied on novelty over two separate references, obviousness over one of those, plus Common General Knowledge and added matter.

Arnold J. was not wholly convinced. Abbott had run a perfect squeeze argument between non infringement and anticipation on the main patent. As the Abbott stents did not infringe, the anticipation arguments did not succeed in invalidating the patent. The result was that one of those patents had to be amended by the patentee but was then declared valid, as was the second one. The third, the Judge found to be invalid based on a different argument for lack of novelty over one of the two citations.

On added matter, Abbott ran the argument that the scope of the claims had been extended between application and grant, an extension that was not supported by the disclosure of the specification. Indeed the specification itself had altered to, Abbott argued, better support that extension of the claim. By following the EPO approach to determining whether matter had been added when the change concerns the deletion or replacement of a feature from a claim, Abbott said that such changes meant that the patent must be declared invalid.

Medinol however, argued that the EPO test was inconsistent with the test for added matter set out by Jacob LJ in Napp v Ratiopharm ([2009] EWCA Civ 252 at para 98) and that, by applying this Court of Appeal authority, there could not be added matter. Arnold J pointed out that the EPO test was not put forward in that case so was not considered. Although he rejected the notion that the tests were inconsistent, he nevertheless accepted that he was bound by the Court of Appeal and found the patent valid.

At the same time all this was going on, Medinol had sued Abbott for infringement of the main patent in the Republic of Ireland, where Abbott manufactured these market-leading stents. Proceedings were also continuing on this patent in the courts of Germany and the Netherlands where Abbott has also been found not to infringe this patent, although for slightly differing reasons in each jurisdiction. It had become accepted wisdom, on both sides of the Irish Sea, that an Irish trial would be likely to follow the earlier outcome on the same patent in London.

When the trial came on in Dublin in January 2011, most of the English issues were re-run, and with the same expert witnesses as had given evidence in London. In March, Judge McGovern gave judgment on infringement, duly in favour of Abbott, the defendant. He also found that, on the construction of the claims proposed by Medinol, the patent would be invalid for anticipation. However, it was not until three months later that the Judge handed down a further judgment, this time on Abbott’s argument that the patent should be invalidated for added matter.

So far as Abbott was concerned, it was worth waiting for. With the Court of Appeal decision only persuasive authority in Ireland, Judge McGovern ignored the decision and preferred to show comity with the EPO approach on added matter, in line with the approach suggested by Lord Neuberger in Dr. Reddy’s v. Eli Lilly ([2010] R.P.C. 9 at paragraph 92). As such, he found, in robust and clear terms, that the patent was invalid. Whereas the patent application had disclosed a so-called “out-of-phase arrangement” of what the patentee had creatively described as “first meander patterns,” he held the patentee should not have tried to extend the claims of the granted patent so as to cover in-phase arrangements. So revoked for added matter.

Few patent cases have been decided in Ireland and as such, it is difficult to draw statistical conclusions from them. It has long been thought that the Irish court, faced with similar evidence, would be likely to follow any earlier English decision. However, after this case, it appears that Dublin is inclined to fit in with its continental brethren and be more independent of its bigger immediate neighbour.