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S U P R E M E C O U R T F I R M LY
E S TA B L I S H E S U K D O C T R I N E O F
POSTED ON 19 / 12 / 17 IN BRIEFINGS
E Q U I VA L E N T S
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Significant changes in the way we determine claim scope in the UK.
PROTECTION
PATENTS In its decision in Actavis UK Limited & Others v Eli Lilly and Company [2017] UKSC 48 issued earlier this
FREEDOM TO OPERATE year, the UK Supreme Court made a significant move from the established principals of claim construction
and introduced a doctrine of equivalents into UK patent law. Here we review the details of the case and
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what the change means for patentees and those seeking to work around third party rights.
RACHEL WALLIS
Key takeaways:

 ✉ ⎙ 1. We now have a doctrine of equivalents that must be considered when assessing claim scope.
2. Claims may generally be considered to encompass unclaimed variants that differ immaterially
from and work in the same way as what is claimed.
3. Acts that didn’t infringe a patent before this decision might now infringe. Any conclusions drawn
on freedom to operate in the United Kingdom prior to this judgement should be reconsidered.

What happened?

The case concerned Eli Lilly’s European patent number 1313508 (“the Patent”), claims 1 and 12 of which
define:

“1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for
inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with
vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being
hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin
perchlorate, azidocobalamin, chlorocobalamin or cobalamin.”

and

“12. A product containing pemetrexed disodium, vitamin B 12 or a pharmaceutical derivative thereof said
pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin,
aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or
cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic
acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a
physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or
sequential use in inhibiting tumor growth.”

Actavis’ proposed products included pemetrexed compounds in combination with vitamin B12. The
products were for use in the treatment of cancer. The key difference between the Actavis products and
the medicaments defined in Eli Lilly’s claim 1 was the use of pemetrexed, pemetrexed ditromethamine, or
pemetrexed dipotassium, instead of pemetrexed disodium.

The positions of each party were summed up by Lord Neuberger in the judgement, stating:

“In a nutshell, the rival contentions are these. Lilly argues that the Actavis products infringe the Patent because
they are medicaments to be used as a treatment for cancer consisting of pemetrexed diacid, or a pemetrexed
salt, with vitamin B12, which represents the essence of the teaching and claim of the Patent. By contrast,
Actavis argues that their products do not infringe because the claims of the Patent are limited to a specific
pemetrexed salt, namely pemetrexed disodium, and the Actavis products contain either pemetrexed diacid or
different pemetrexed salts.”

Put simply, the question to be answered was whether pemetrexed disodium as claimed should be
construed to cover pemetrexed itself or other salts thereof, or whether it should be interpreted as
meaning pemetrexed disodium, specifically.

Claim construction

Prior to this judgement, the law on patent infringement in the UK had been shaped by three key decisions:
Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 (“Catnic”), Improver Corporation v Remington
Consumer Products Ltd [1990] FSR 181 (“Improver”) and Kirin-Amgen Inc v Hoechst Marion Roussel Ltd
[2005] RPC 9 (“Kirin-Amgen”). Those decisions established that, when assessing infringement, a
“purposive” construction should be applied to the claims, considering what a skilled person would have
understood the patentee to be using the words to mean.

Rather than simply applying purposive construction in this case, though, the Supreme Court returned to
first principles to decide how the claims should be construed. The law on claim interpretation in the UK is
based on Article 69(1) European Patent Convention, which states:

“The extent of the protection conferred by a European patent or a European patent application shall be
determined by the claims. Nevertheless, the description and drawings shall be used to interpret the
claims.”

If one simply applies the literal meaning of claims 1 and 12, the scope of protection would appear to be
quite clearly limited to pemetrexed disodium. Articles 1 and 2 of the Protocol on the Interpretation of the
EPC explains that it isn’t enough to just apply the literal meaning, though.

“Article 1

General principles

Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European
patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims,
the description and drawings being employed only for the purpose of resolving an ambiguity found in the
claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual
protection conferred may extend to what, from a consideration of the description and drawings by a
person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as
defining a position between these extremes which combines a fair protection for the patent proprietor
with a reasonable degree of legal certainty for third parties.

Article 2

Equivalents

For the purpose of determining the extent of protection conferred by a European patent, due account
shall be taken of any element which is equivalent to an element specified in the claims.”[1]

Lord Neuberger explained that Articles 1 and 2 of the Protocol mean that the scope of protection is not to
be limited by the literal meaning of the claims and that there is, potentially, a difference in interpreting a
claim and the extent of protection afforded by a claim. In assessing the extent of protection afforded,
equivalents must be considered.

Having reviewed the case law in the UK (Catnic, Improver and Kirin-Amgen) as well as the approach taken
in other EU jurisdictions, Lord Neuberger concluded that the problem of variants is best approached by
considering two questions, through the eyes of the person skilled in the relevant art:

“(i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not,

(ii) 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 explained that question 1 is a matter of interpretation, and can be achieved using the standard process
for interpreting documents. Applying that question to the current case, he concluded:

“In the present case, there is no doubt that, according to normal principles of interpreting documents, the
Actavis products do not infringe the Patent, as in no sensible way can pemetrexed free acid, pemetrexed
ditromethamine, or pemetrexed dipotassium mean, ie be said to fall within the expression, “pemetrexed
disodium” in claim 1 of the Patent…”

Turning to the second question, Lord Neuberger returned to the three questions provided by Hoffman J
(as was) in Improver. Whilst he found these helpful, he reformulated the questions, noting, though, that
they should be used as guidelines, rather than strict rules. The reformulated questions are:

“i) 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?

ii) 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?

iii) 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?

In order to establish infringement in a case where there is no literal infringement, a patentee would have to
establish that the answer to the first two questions was “yes” and that the answer to the third question was
“no”.”

Lord Neuberger applied the questions to the Actavis products, coming to an interim conclusion of direct
infringement. He stated that the products work in the same way as the invention and that it would have
been clear to the notional addressee, once informed that the variants do indeed work, that the variant
products would work in the same way. On the third question, he concluded that the notional addressee
would understand that the reason the claims were limited to pemetrexed disodium was that it was the
only salt on which the experiments described in the specification had been carried out, rather than to
exclude other salts from the scope of protection.

What about the file history?

The question of whether the prosecution history of the file should be considered was raised, Actavis
contending that the prosecution history made it clear that the Patent claims should be interpreted as
being limited to pemetrexed disodium. Lord Neuberger addressed this matter, stating:

“In my judgment, it is appropriate for the UK courts to adopt a sceptical, but not absolutist, attitude to a
suggestion that the contents of the prosecution file of a patent should be referred to when considering a
question of interpretation or infringement, along substantially the same lines as the German and Dutch courts.
It is tempting to exclude the file on the basis that anyone concerned about, or affected by, a patent should be
entitled to rely on its contents without searching other records such as the prosecution file, as a matter of both
principle and practicality. However, given that the contents of the file are publicly available (by virtue of article
128 EPC 2000) and (at least according to what we were told) are unlikely to be extensive, there will be
occasions when justice may fairly be said to require reference to be made to the contents of the file. However,
not least in the light of the wording of article 69 EPC 2000 [which is discussed above] the circumstances in
which a court can rely on the prosecution history to determine the extent of protection or scope of a patent
must be limited.

While it would be arrogant to exclude the existence of any other circumstances, my current view is that
reference to the file would only be appropriate where (i) the point at issue is truly unclear if one confines oneself
to the specification and claims of the patent, and the contents of the file unambiguously resolve the point, or
(ii) it would be contrary to the public interest for the contents of the file to be ignored. The first type of
circumstance is, I hope, self-explanatory; the second would be exemplified by a case where the patentee had
made it clear to the EPO that he was not seeking to contend that his patent, if granted, would extend its scope
to the sort of variant which he now claims infringes.”

He also confirmed that the contents of the prosecution file would not cause him to change his mind on
infringement of the Patent.

The judgement

Actavis’ products were found to directly infringe the Patent. Lord Neuberger also considered the issue of
indirect infringement, concluding that if the products didn’t directly infringe the Patent, they would
indirectly infringe. He further considered whether the French, Spanish and Italian designations of the
patent were directly infringed, again concluding that they were.

What does this mean in practice?

The (re)introduction of a doctrine of equivalents is one of the most significant steps in UK law in recent
years and it will take some time to see just how it is applied. One positive outcome is that the law appears
to be more closely aligned with the law of infringement in Germany. This might lower the chances of
inconsistency between cases in the UK and other European jurisdictions and between different courts
when the UPC comes into effect.

On first glance, the doctrine of equivalents appears to be particularly helpful to patentees, potentially
allowing the scope of protection afforded by a claim to be stretched to include variants that would not be
covered by a literal interpretation. Given the EPO’s preference for limiting claims to the scope for which
experimental evidence is provided, even though the limitation may not be required for novelty or
inventiveness, this may prove useful. Even though Lord Neuberger indicated that the prosecution history
should only be taken into consideration in very specific cases, it would be worth being especially careful in
the comments and arguments filed, particularly when limiting claim scope or deleting variants from a
claim. We would encourage patentees to not rely on the doctrine of equivalents, and avoid unnecessarily
limiting claims – ideally an infringement should be captured by the literal interpretation of a claim to avoid
any doubt.

There is some comment on the effect of the specification on the meaning of the claims in the judgement,
but it is insufficient to allow us to draw detailed conclusions on how the doctrine will affect the drafting of
specifications. We would still advise that, where possible, generic definitions are included for each
claimed element, along with any known equivalents. Further, we would recommend keeping the doctrine
of equivalents in mind when defining claim elements, to avoid causing any equivalents to be accidentally
excluded, because they are unnecessarily intimated to be material to the invention or because the
specification makes it clear that a narrow interpretation is intended. It also continues to be beneficial to
include more than one exemplified example for each element of the invention, so as to avoid having to limit
the claims unnecessarily.

More urgently, it may be necessary to reconsider any conclusions made on freedom to operate, based on
the old law. It is quite possible that acts that previously wouldn’t have infringed might now fall within the
scope of a claim if the doctrine of equivalents is applied.

If you would like further information on this, please get in touch with Rachel Wallis or your usual GB
contact.

[1] The Protocol had been amended to include Article 2 after Kirin-Amgen.

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