In this case, Lord Hodge identified ten relevant factors that should be considered in the assessment of obviousness, the last of
which was the nature of the invention. The invention in question was a dosage patent with claims in the Swiss-form or the EPC
2000 form. Lord Hodge dismissed the suggestion that there is a different approach or standard to assessing such patents, as
there is "no policy reason why a novel and inventive dosage regime should not be rewarded by a patent" and "[a] fortiori,
efficacious drugs discovered by research involving standard pre-clinical and clinical tests should be rewarded with a patent if they
meet the statutory tests". However, he also concluded that it was "no mystery" why Jacob LJ had concluded in Actavis v Merck
 1 WLR 1186 that "nearly always such dosage regimes will be obvious - it is standard practice to investigate appropriate
dosage regimes". It is because the target of the skilled person's research "is in large measure predetermined". In these
circumstances, finding additional benefits, such as the reduced side effects in this case, in the dose ranging studies did not
prevent the identification of the appropriate dose from being obvious.
The judgment of the Supreme Court emphasises a flexible, fact-specific approach to the statutory question of obviousness under
which the relevance and weight of various factors can change. This approach is designed to ensure that the assessment of
obviousness keeps in mind the patent bargain and the technical contribution made by the patentee. Whilst the Supreme Court
affirms that there is no prejudice against inventions based on empirical research or policy reasons against dosage regime patents,
it nevertheless revoked the patent in this case. For dosage regime patents, the routine nature of the research arising out of
regulatory requirements remains a relevant factor. Given this and the inability to rely on added (or surprising) benefits if these
inevitably arise out of such routine research that needs to be undertaken, it will be necessary to have several other relevant
factors that point against that dosage regime being obvious.
Please see our earlier issues for coverage of the Patents Court decision in August 2016 (here) and the Court of Appeal decision
in November 2017 (here).
Jonathan Turnbull, Partner and Katie Pryor, Associate (Australia)
2. Developments to equivalents: His Honour Judge Hacon's approach to the inventive core, numerical
claims, Formstein defence and more
Regen Lab SA v Estar Medical Limted & Ors  EWHC 63 (Pat), 18 January 2019
Technetix B.V. & Ors v Teleste Limited  EWHC 126 (IPEC), 29 January 2019
Marflow Engineering Ltd v Cassellie Limited  EWHC 410 (IPEC), 26 February 2019
The start of 2019 has been busy for His Honour Judge Hacon, who released three judgments applying and developing the law of
doctrine of equivalents in the UK before the end of February. These decisions follow the Court of Appeal's comprehensive
judgment in Icescape v Ice-World (see our summary in the December 2018 issue here), in which Kitchin LJ underlined the
importance of identifying the inventive concept/core of the patent and using this as a basis for assessment under the Actavis v
Lilly test for infringement by equivalents. Below are the key takeaways from His Honour Judge Hacon's recent decisions, including
guidance on numerical claims, multiple differences between the variant and the claims, and the 'hypothetical' Formstein defence.
Affirming the approach to assessing claim scope and infringement, and the importance of the inventive concept
In all three cases, Hacon HHJ affirms the approach set out in Icescape to determining infringement following Actavis v Lilly. The
first stage is to undertake a purposive construction assessment in determining the scope of protection conferred by the claims. If
an alleged infringer does not infringe on a purposive approach, the revised Improver questions in the Actavis v Lilly test are then
applied to determine whether there is infringement under the doctrine of equivalents. It is now clearly established that assessment
of claim scope under equivalents should be conducted separately from the assessment of scope according to the purposive
construction of the claim.
Hacon HHJ also highlights the importance of the inventive concept (used interchangeably with 'inventive core') drawn out in
Icescape in all three cases. The inventive concept of the invention is "the new technical insight conveyed by the inventionâ€”the
clever bitâ€”as would be perceived by the skilled person" (from paragraph 222 of Regen v Estar). When undertaking an
equivalents assessment in Technetix v Teleste, Hacon HHJ states: "the starting point for an argument of equivalence is the
identification of the inventive concept or core". This approach can be seen in practice in Marflow v Cassellie, where, as the first
step assessing infringement by equivalents, Hacon HHJ seeks to determine the inventive concept before moving on to answer the
revised Improver questions with the inventive concept as the point of reference.
In Regen v Estar, Hacon HHJ considered in detail how to apply the third Actavis question, ie, whether the skilled person, reading
the patent at the priority date, would have concluded that the patentee nonetheless intended strict compliance with the literal
meaning of the claim. Similarly, he approaches this question with reference to the inventive concept and asks whether the
relevant integer, that corresponding to the alleged equivalent, would have been regarded by the skilled person as an essential
part of the inventive concept. If there is no indication from the patent specification or the common general knowledge of the skilled
person that the relevant integer is part of the inventive concept, then the answer to the third question should be 'no'.
How to deal with multiple differences between a variant and the claims
In Regen v Estar, there were two separate features of the claim which were not present in the alleged infringer on a purposive
construction. This raised the question of whether multiple differences between the allegedly infringing process or product and the
claim should be assessed separately or as a single variant with all differences taken into account. This is a relevant consideration,
as a different result could be achieved depending on whether the equivalents are considered separately or together. Hacon HHJ
found that the allegedly infringing product or process should be assessed as a whole, taking all differences into account. Hacon
HHJ did acknowledge that it may be convenient to consider equivalents one by one as means of interim assessment, but there
must be a single overall answer.
Hacon HHJ also adopted this approach in Technetix v Teleste, where he disagreed with the defendant's suggestion that in order
to fall within the doctrine of equivalents each claim integer missing from the accused product or process must have a
corresponding and identifiable equivalent in the infringing product. Instead, Hacon HHJ again finds that the accused product or
process should be assessed as a whole. While no integer should be ignored, the missing integers are instead relevant to whether
the inventive concept has been exploited by the variant in substantially the same way to achieve substantially the same result.
How to deal with numerical claims
It has been postulated that numerical claims may be an exception to the application of the doctrine of equivalents. At the least, it
could be argued that the specification of a numerical range with certain levels of accuracy might indicate to a skilled person, under
the assessment of the third Actavis question, that strict compliance with the numerical claim was intended.
In Regen v Estar, Regen owned a patent claiming a method for the preparation of blood plasma enriched in platelets and other
factors, known as platelet rich plasma ("PRP"). One feature of the relevant claim required "a buffered sodium citrate solution at
0.10M" to act as an anticoagulant. The defendants argued that their method for production of PRP did not infringe, as their
anticoagulant had a molarity of 0.136, not 0.1 as specified by the claim.
Citing the Court of Appeal in Jushi Group Co. Ltd v OCV Intellectual Capital LLC  EWCA Civ 1416 (who in turn cited Smith
Nephew Plc v Convatec Technologies Inc  R.P.C. 32) that claims containing a numerical range were to be treated no
differently than another claim (see our report on the Jushi decision here), Hacon HHJ decided that Actavis did not change this
approach. Hacon HHJ did not consider there to be any reason to put numerical claims into a special class such that the doctrine
of equivalents does not apply to them. Instead, Hacon HHJ found that the accuracy to which the numerical claims are expressed
would be relevant as a matter of purposive construction, but that a variant assessed under equivalents may stretch the scope of a
numerical claim to cover the accused product or process.
In Regen v Estar, Hacon HHJ found that the molarity of the anticoagulant was not part of the inventive concept of the claim, and
thus the molarity of 0.136 would be an equivalent to the claimed 0.10. It will be interesting to see whether a very large difference
between a numerical claim (not part of the inventive concept) and the alleged infringer would affect this approach in some way. It
seems on Hacon HHJ's reasoning that, no matter how large the difference, if it is not a part of the inventive concept a large
numerical difference will not prevent infringement by equivalents.
The Formstein defence
In Technetix v Teleste, Teleste argued that if its product fell within the scope of the claim, it was entitled to a defence to
infringement if its product lacked novelty or inventive step over the prior art. As Hacon HHJ states: "It has long been a basic
principle of patent law in the United Kingdom that a patentee should not be able to prevent a person from doing what he or she
had lawfully been entitled to do before the patent was granted" (from paragraph 87 of Technetix v Teleste).
Hacon HHJ considers that this principle can be reconciled with the doctrine of equivalents if an accused product or process is
found to be an equivalent, but that equivalent would have lacked novelty or inventive step over the prior art at the priority date,
then it is deemed to fall outside the scope of the claim, thus providing a defence to infringement.
Both Germany and the USA address this concern with similar concepts. In Germany, the Formstein defence provides that a
contested embodiment does not fall within the scope of protection of a patent if it is anticipated in the state of the art or is obvious
from the state of the art. In the USA, the principle of 'ensnarement' provides that the range of equivalents cannot be so extended
as to ensnare the prior art. A similar defence is also provided for in Dutch law.
After canvassing the law in other jurisdictions, Hacon HHJ proceeds on the 'hypothesis' that a similar defence exists in UK law.
Characterising the inventive concept accurately is again seen to be important to determining the scope of the claim; if the
Formstein defence exists in the UK it provides a squeeze on infringement. Hacon HHJ found that "the simplicity of the inventive
concept or core tends to make the scope of the claim broader, [but] this will also increase the likelihood that the Formstein
defence will apply" (from paragraph 126 of Technetix v Teleste). Ultimately, Hacon HHJ found that had the patent been valid, it
would have been infringed, but that if there is a Formstein defence, the defendants would have been entitled to it.