Actavis v Eli Lilly: UK Supreme Court reformulates patent infringement test

In a Judgment handed down today, the Supreme Court has reformulated the test for patent infringement in the UK, particularly insofar as it relates to infringement by equivalents.

The Patent and the declaration sought by Actavis

Eli Lilly owns a patent that claims the use of “pemetrexed disodium” in the manufacture of a medicament for use in combination with vitamin B12 for the treatment of cancer. Actavis sought declarations of non-infringement for its proposed products which included (a) pemetrexed diacid, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium instead of pemetrexed disodium.

Actavis sought equivalent declarations in respect of the UK, French, Spanish and Italian designations of Eli Lilly’s patent.

The Supreme Court has overturned decisions of the High Court and Court of Appeal and held that the Actavis products directly infringe Eli Lilly’s patent.

A New Infringement Test

Lord Neuberger has carefully considered Article 69(1) EPC 2000, and Articles 1 and 2 of the Protocol on the Interpretation of article 69, which provide the basis for interpretation for the scope of protection given to patent claims. The Protocol tries to strike a balance between the fair protection for the patentee and a reasonable degree of legal certainty for third parties but also directs that due account should be taken of elements that are equivalent to those specified in the patent claims. He considered that infringement is best approached by addressing two issues, each of which is to be considered through the eyes of the notional addressee of the patent. These are:

  1. does the variant infringe any of the claims as a matter of normal interpretation; and, if not,
  2. does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial?

If the answer to either issue is “yes”, there is an infringement; otherwise, there is not.

He considered that issue (i) raised a question of interpretation; whereas issue (ii) raised a question which would normally have to be answered by reference to the facts and expert evidence.

In relation to issue (ii) Lord Neuberger held that the three questions posed as a guidance as to whether a variant should fall within the scope of protection of a patent in Improver Corpn v Remington Consumer Products (the so called “Improver Questions” or “Protocol Questions“), which have been extensively used in the UK for infringement analysis, were helpful. However, he has now reformulated these questions, and in particular question 2, as set out below:

  1. Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e. the inventive concept revealed by the patent?
  2. Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
  3. Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

Applying the above three questions to Actavis’ products, the Supreme Court held that they directly infringe Lilly’s patent, and pointed out that the Court of Appeal took an approach which placed too much weight on the words of the claim and not enough on the Protocol.

Geoff Hussey, Litigation Partner, says: “The Supreme Court has effectively re-introduced a doctrine of equivalents into UK patent law, with the aim to reach a consistent approach to the interpretation of the scope of patent protection across Europe. It has achieved that by clarifying how the Protocol on the Interpretation of article 69 EPC 2000 should be followed.

This re-formed approach to infringement will broaden the scope of protection afforded to patents in certain circumstances but may make it more difficult to provide infringement analysis and perhaps less certainty for third parties attempting to work-around an invention.”

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