Friday - 04 August 2017

Actavis v Eli Lilly: What does this mean for patent infringement in the UK?

Andrew White discusses the implications of the landmark Supreme Court decision.

https://www.linkedin.com/pulse/actavis-v-eli-lilly-what-does-mean-patent-uk-andrew-white?published=t 

Now that the dust has settled a little since the landmark Supreme Court decision in Actavis v Eli Lilly, we analyse what this means for patent infringement in the UK, and whether the position in the UK is now more in line with that taken across Europe.

Facts of the case

The claims at issue related to a class of medicament and in particular claim 1 explicitly recited “disodium”. Instead of disodium, the infringement used dipotassium, but otherwise the infringement was considered (with the help of expert evidence) to achieve substantially the same result in substantially the same way.

The rest of Europe

The patent at issue was also being litigated extensively across Europe. Perhaps with an eye to the formation of the future Unified Patent Court, Lord Neuberger looked to jurisprudence in the Netherlands, Germany, Spain and Italy. In particular, he noted that the previous precedent of the “Improver” case had been decided differently in the German, Dutch and Italian courts. He also seemed unhappy that the second Article of the Protocol on the Interpretation of Article 69 EPC (discussing how equivalents should be considered for the purposes of patent protection) was not adequately reflected in UK law.

How is infringement decided in the UK now?

Lord Neuberger noted that “our domestic law has long recognised that an immaterial variation does not get an infringer off the hook” and considered that a court should really focus on “the problem underlying the invention” or the “inventive concept”. He also considered that there should be some leeway from the language of the claims and that the previous approach incorrectly conflated the issues of interpretation and scope of protection.

With this in mind, Lord Neuberger arrived at a two-step test for deciding infringement:

· First, decide whether the item infringes “as a matter of normal interpretation”; and, if not,

· Second, does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial?

Result

Taking this new approach to assessing infringement, Lord Neuberger held that although the infringement didn’t use disodium (as explicitly recited in the claim), the dipotassium achieved substantially the same result in substantially the same way, and therefore the infringement was an immaterial variant. In so doing, he considered what happened during examination of the patent before the European Patent Office, and did not seem impressed that the amendment to explicitly write disodium into claim 1 was in response to an added matter objection raised by the European Examiner. Although Lord Neuberger did not rely on the file history in this case, as an example, he suggested it would be appropriate to refer to it in a situation where a patentee makes explicit statements about what the claim encompasses.

What does this mean for patentees?

This seems to be a patentee friendly decision. Importantly it means that if a patent is drafted carefully, a claim may encompass new (“immaterial”) variations as technology advances. Strict compliance with the language of the claims is no longer required. What really matters is how the invention works, and whether the infringement works in the same way.

On the other hand, this does make Freedom to Operate (FTO) work more difficult – Lord Neuberger indicated that patent litigation will increasingly rely on expert evidence.

What does this mean for patent attorneys?

There are steps as patent attorneys we can also take to help maximise the breadth of claim scope. For example, we can draft a patent specification to avoid listing too many unclaimed alternatives so that a judge doesn’t consider that “strict compliance with the language of the claim was nevertheless intended”. In the present case, disodium was listed in the patent as a specific form of a more general salt. Hierarchical drafting in this manner is common good practice to avoid an unwanted “intermediate generalisation” objection being raised by a European Examiner. However, in the present case, other specific forms of salt (such as dipotassium) were not listed. This led Lord Neuberger to consider that the other alternatives were not excluded, which in turn meant that the scope of protection was interpreted more broadly. On the face of it, similar reasoning helped the case in Germany, which Lord Neuberger referred to in the decision. This reasoning also seems consistent with the disclosure-dedication doctrine applied in the USA.

Finally, when we are making an amendment during examination or responding to objections raised by an Examiner, we should be very careful about what we say are the reasons for making the amendment. Many of us with an eye on US litigation were already mindful of this so it may really be a case of “business as usual”, but this decision does highlight why it may also be worth bearing in mind for litigation in the UK.

For more information about this article please contact Andrew White.