Validity - Annual Patents Review 2017 - Patent

This is the Validity chapter of Gordon Harris' Annual Patents Review 2017. For the other chapters of the review, please follow the links below or download the Annual Patents Review 2017 in full.

3. VALIDITY

(a) Common General Knowledge and the Skilled Person

Because of the importance of these items I have started, in recent years, to begin the validity section with a few cases dealing very specifically with the nature of CGK and the skilled person.

In FKB v Abbvie²⁹, the question arose as to whether the cited prior art should be looked at on its own (including the references cited therein) or considered in combination with additional prior art found as a result of searches by Abbvie's representatives.

The judge said ([167]):

There may be material which is not common general knowledge, which nonetheless, as a matter of routine, the skilled person would look for and find when approaching a particular problem. Amongst other cases this is supported by the judgment of Arnold J in KCI Licensing at [122]:

"It follows that, even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge."

I consider that the skilled person interested in progressing a dosage regimen in D2E7 would look for and find the Additional Prior Art. Professor Edwards rightly accepted that this would be the case.

Once a door is nudged ajar, as it was by Arnold J in the KCI Licensing³⁰ case, it is prone to be kicked further open, and Henry Carr J may have done that in FKB v Abbvie. Are we now going to be deploying mosaics of items for the purpose of assessing obviousness?

In Generics v Yeda³¹, Arnold J said, in relation to the person skilled in the art ([75]):

A patent specification is addressed to those likely to have a practical interest in the subject matter of the invention, and such persons are those with practical knowledge and experience of the kind of work in which the invention is intended to be used. The addressee comes to a reading of the specification with the common general knowledge of persons skilled in the relevant art, and he or she reads it knowing that its purpose is to describe and demarcate an invention. Purely for convenience, I will hereinafter refer to the skilled person as "he". He is unimaginative and has no inventive capacity. In some cases the patent may be addressed to a team of persons having different skills.

There was a "small, but nonetheless significant" dispute between the parties as to the identity of the skilled person. The judge ruled that the skilled person need not be an expert in neuroimmunology, the pathology of MS or the analysis of MRI results, because the patent did not assume any specialist knowledge of those topics or teach the clinician anything about them that he would not already know.

Finally in this section, in Accord v RCT³², Birss J, conducting his review of the position relating to inventive step said ([208]):

Having reached that conclusion I will also say that I was doubtful that the whole step by step analysis was indicative of obviousness. The series of steps from Le Gall involved a full literature search, the distillation of all that work, numerous other avenues which could be considered and the conception of the methoxymethyl compound as something to consider. Although they are all apparently easy steps and many of them are conventional individually, looked at as a whole they did not strike me as supportive of obviousness, but I did not decide the case on that point.

So the question of whether it is permissible for the skilled person to conduct a full literature search, distil it, and then interpret the pleaded prior art in the light of it, remains to be addressed on another day. That a literature search can be conducted is clear from FKB v Abbvie. That it might be a restricted process, emerges from Accord v RCT.

So there is nothing very new, but perhaps we are seeing the consolidation of the slightly concerning trend for prior art beyond a single citation and CGK to be used in the assessment of inventive step.

(b) Anticipation/Priority

"Legal" priority

The question of "legal priority" has raised tricky and time-consuming questions in recent years, and at times one could be forgiven for mistaking some of the guidance for a haha. In 2017, the courts appear to have bent over backwards to dismiss challenges to legal priority, perhaps reflecting a policy of discouraging such highly technical, time-consuming and costly aspects of disputes.

The right to claim priority is provided for by s.5 of the Patents Act, Article 87 of the EPC, Article 8 of the PCT and Article 4(A)(1) of the Paris Convention. In Edwards v Cook³³, Kitchin J held that to make a valid claim for priority as successor in title, it was necessary to be a successor in title at the time of filing the application. A subsequent acquisition of title was not sufficient. In KCI v Smith & Nephew³⁴, Arnold J rowed back a little from this when he held that "successor in title" included a person who was a recipient of the beneficial interest in the invention in circumstances where he did not own the bare legal interest; and also that when determining whether a person was a "successor in title", it must be the substantive rights of that person, and not his compliance with legal formalities, that mattered. In Idenix v Gilead (2016)³⁵, Kitchin LJ expressed the provisional view that both KCI and HTC v Gemalto (in which Birss J followed KCI) were correctly decided.

This year Henry Carr J continued to develop the authorities, inFKB v AbbVie³⁶, when he said ([34]):

I do not consider that Article 4A permits both the original applicant and his successor in title to enjoy a right of priority. In my judgment, where a right to claim priority has been assigned, the assignor cannot subsequently make a claim himself. The Article contemplates a claim to priority either by the original applicant or his successor in title, and not by both. Once the right has been assigned there is no reason why the assignor should retain a right of priority. This is consistent with ensuring certainty as to who is entitled to apply, as referred to by Kitchin J in Edwards Lifesciences.

FKB challenged AbbVie's legal entitlement to priority. The issue was whether Abbott Laboratories (Bermuda) Ltd ("Abbott Bermuda") the applicant for AbbVie's EP '656 patent, was entitled to claim priority from US patent '961. US '961 was filed on 8 June 2001 by the inventors, Dr Kempeni, Dr Fischkoff and Dr Weiss. The PCT application by which EP '656 was sought was filed on 5 June 2002 by Abbott Bermuda for "all designated states except the US", and by Dr Kempeni, Dr Fischkoff and Dr Weiss, for the US only, as inventor/applicants.

In view of the conclusion quoted regarding Article 4A, the fact that the inventors applied for the PCT application (in respect of the US) did not establish entitlement to priority because it was (by the time of the trial) common ground that the equitable interest in the invention had been assigned from the US inventors to another group company. Further, the "all designated states except the US" was the only part of the PCT application that was material to the priority claim in the present case. However this did not dispose of the legal priority issue.

It was common ground that the issue of which party held the relevant rights was to be determined in accordance with the law of the transaction which was said to have transferred such rights. But the factual matrix in the case was quite complex and the documentary record incomplete (to put it mildly).

In the end, relying upon the substantive position under German and US law, the judge concluded that there was chain of title from each of the inventors to Knoll AG in respect of the invention. (For Dr Kempini, under German law, Knoll GmbH (which became Knoll AG in March 2001), had at the relevant time the right to demand delivery of an Invention Report pursuant to statute and to claim the Invention. Knoll GmbH was, therefore, in substance, the owner of the invention. For Dr Fischkoff and Dr Weiss, both whom had signed Employee's Invention and Secrecy Agreements ("EISAs"), to be construed under US law, the judge was satisfied on the evidence that Knoll AG was the relevant group company's nominee to hold all rights resulting from international clinical R&D, including the invention in issue. At any time, Knoll AG could have compelled KPC to transfer legal title. Therefore, as a matter of US law, Knoll AG was the beneficial owner of the US inventors' rights in the invention.) In addition, it was the "concordant intention" of the parties to a later agreement to transfer all non-US rights in the relevant invention to Abbott Bermuda, and prior to the filing of the PCT application Abbott Bermuda could have compelled Knoll GmbH to claim the invention from Dr Kempini and then to transfer it to Abbott Bermuda.

It is notable here that it appeared to be AbbVie's case that US '961 would have been recognised as a US asset and consequently would have been assigned to Abbott Biotechnology. Rejecting this, the judge noted Kitchin J's conclusion in Edwards v Cook that when considering Article 4A of the Paris Convention, "successor in title" means "successor in title to the invention". He said that the claimants' submission confused rights in the invention, including the right to claim priority, with rights in the US '961 application itself.

Accordingly, the judge concluded that there was chain of title from the inventors to Knoll AG in respect of the invention. Did the judge bend over backwards to prevent priority being lost due to intra-group admin?

Later in the year, in Actavis v ICOS (1 November 2017)³⁷, the Court of Appeal seemed to try to discourage the throwing of legal priority bombs into patent cases. A patent application ("Stoner") was relied upon by Actavis as novelty destroying, but it would only count as prior art by operation of section 2(3) of the Patents Act if it was entitled to its own priority date, namely the date of filing of US application 60/123,244. The applicants for Stoner were Merck & Co Inc and Ms Waldstreicher. The inventors of the US application were Ms Waldstreicher and Ms Stoner.

Merck, Ms Waldstreicher and Ms Stoner were not parties to the present case. There was nothing in evidence before the judge (Birss J) on the question of the legal priority of the Stoner patent application.

The Court of Appeal agreed with the judge that the contents of Stoner supported an inference that its priority date was indeed the filing date of the US application, and that the evidential burden had therefore shifted to Lilly to call evidence to rebut the inference of an entitlement to priority. Kitchin LJ said ([97]):

I accept that the legal burden of establishing that Stoner is entitled to a priority date earlier than its own date of filing lay on the claimants. But it does not follow that the evidential burden also lay on them throughout. The applicants for Stoner were Merck and Ms Waldstreicher and it carries on its face a reference to US application 60/123,244. The applicants for that US application are identified as Ms Stoner and Ms Waldstreicher, who are both said to share Merck's address in Rahway, New Jersey. Furthermore, the relevant subject matter in Stoner is disclosed in that US application. It is not suggested that Ms Stoner, Ms Waldstreicher or Merck had any relevant connection with the claimants or, indeed, with Lilly. In these circumstances and while it is of course possible that Merck was not the successor in title to Ms Stoner, it seems to me to be very unlikely. As a large pharmaceutical company with skilled legal advisers, it must have been well used to ensuring that the necessary formalities were complied with. In my judgment all of these matters were such as to raise a presumption or prima facie case that the claim by Ms Waldstreicher and Merck that Stoner was entitled to a priority date earlier than its own date of filing was properly and regularly made, in Merck's case as the successor in title to Ms Stoner. I am also satisfied the judge was both entitled and right to find that, although the legal burden of establishing that Stoner is entitled to the earlier priority date lay upon the claimants throughout, the circumstances were such as to shift the evidential burden on to Lilly to produce some evidence from which a lack of entitlement could be inferred. No such evidence was ever produced. Subject to the question of enablement, I therefore agree with the judge that Stoner is entitled to priority from the filing date of US application 60/123,244.

The following week, in Accord Healthcare v RTC³⁸, there was again an issue of legal priority - regarding RTC's patent, EP '289.

RTC worked, effectively, as the technology transfer office for a number of universities. There was a properly executed written agreement dated two weeks earlier than the application date of EP '289, on its face assigning the invention the subject of EP '289 from inventor Proessor Kohn to RTC. The assignment expressly included the right to claim priority (clause 5). However, Accord argued that in respect of the invention the subject EP '289, the procedures agreed between RTC and the University of Houston ("Houston") were not followed and as a result, at the time that the application for EP '289 was filed, the beneficial interest in the right of priority lay not with RTC but with Houston.

After noting that the Paris Convention is the origin of the international priority right legislated in section 5 of the Patents Act, and after considering the English authorities, Birss J said that the legal principles applicable to priority entitlement were settled at first instance, these being ([75]):

i) Usually the right to claim priority goes with the right to the invention. That is uncontroversial.

ii) The right to claim priority must be with the person making the patent application in which that right is claimed when they make that claim, i.e. when the application is filed. A later acquisition of that right cannot make good a lack of it on the relevant date. If the right was not in place at the time then the right is lost for all time. That is Edwards v Cook.

iii) But if the local law applicable to rights of the applicant and the patent application at the place and time when it was made allows for a splitting of property rights into legal and equitable interests, then it will be sufficient to establish an entitlement to priority if the applicant holds the entire equitable interest at the relevant date. That is KCI, HTC and FujiFilm and was held in the Court of Appeal in Idenix provisionally to be correct.

iv) A person with a legally enforceable right to call for the assignment of the legal title to a piece of property such as an invention (or a right to claim priority) has the equitable title to that property. When the cases refer to the applicant holding the substantive right and title to the invention, they are referring to this legal/equitable distinction.

Following on from these principles, Birss J said ([76]):

...a person who at the relevant time and under the relevant applicable law, acquired only the bare legal title to an invention and not the equitable title, when the equitable title is held by another, does not then hold the substantive right and title to the claim to priority.

This could present a problem, as Birss J chose to address quite directly, in comments which shadow the policy behind the courts' pattern of navigating through apparent difficulties with legal priority ([77]):

However I cannot help but observe that if priority is lost this patent would be revoked over a publication by the inventor in the period between the priority date and the filing date which I infer was assumed to be a safe thing to do because it was assumed by everyone involved that priority would be successfully claimed. There will be many cases like this. There is no obvious public interest in striking down patents on this ground, unlike all the other grounds of invalidity. The difficulty starts with the point that the title cannot be fixed retrospectively. If I may say so the reasons given by Kitchin J in Edwards v Cook are compelling reasons why that should be so. However the legal/equitable analysis chips away at that principle since what is happening in those cases is that the equitable owner's imperfect title on the relevant date is only perfected after the event. No doubt that is why, in the Court of Appeal, Kitchin LJ declined to get into the issue any further since he did not have to.

Birss J offered the following "tentative suggestions" ([78]):

One approach could be that the effect and devolution of the priority right has to be purely governed by a sui generis law applicable to priority rights in all signatory states to the Paris Convention equally and applicable in all those states regardless of whether those states recognise a legal/equitable distinction. Flaws in the title cannot be fixed retrospectively. That is one way of interpreting Edwards v Cook and there are good reasons for it. However it does not sit happily with the equitable/legal distinctions made in the later cases. An alternative could be to apply the same approach and the same applicable law to the priority claim as applies to ownership of the invention and the right to the patent. In a case in which there is some doubt about the claimant's title to the patent itself, that title has to be perfected by the judgment e.g. by assignment or the legal owner must be joined to the proceedings (see e.g. Baxter v NPB [1998] RPC 250). The moment the title to the patent matters is judgment. In this case the moment the priority claim matters could be said to be the judgment. As far as the applicable law is concerned, under English private international law, the law applicable to the devolution of the rights to the invention in Texas in 1996/97 is US law, which is in fact a mix of Federal and Texan state law. Nevertheless regardless of these tentative suggestions, I will apply the law as it is settled at this level.

Turning to the assessment of the facts, in the end, the judge was satisfied that according to the common law concept of a bona fide purchaser for value without notice (as codified in statute at 35 USC 261), RTC acquired good title to the invention including any priority right pursuant to the assignment. Any equitable interest in the invention which the university held before the assignment was destroyed or overridden by the assignment to RCT. Underpinning this was the judge's conclusion, on the evidence, that the university was aware of what was going on, that Prof Kohn was executing the assignment because he felt obliged to do so pursuant to his obligations to the university, and that RTC was not on notice of any possible conflicting interest held by the university.

Before reaching this conclusion, the judge declined, on the evidence, to draw inferences of fact necessary to support RCT's primary case that the procedure agreed between RTC and Houston (in 1966) had been complied with before the execution of the written assignment. He also concluded that he could not make the findings necessary to infer the existence of an "implied in fact" contract to assign the equitable interest, because here was nothing from which to infer that the university actually did intend that the lacosamide invention should be patented by RCT - there was no evidence the University thought about it at all.

Perhaps this year's batch of cases will now begin to turn the tide of challenges to legal entitlement to priority. The courts are clearly against such arguments, and the complexity of the legal and factual analysis, which generates trials within trials, may perhaps lead to bolder case management decisions on such issues in the Patents Court.

"Substantive" priority

Turning to the more conventional challenge to priority, that the claimed invention is not substantively entitled to its claimed priority, in Unwired Planet v Huawei (technical)³⁹, Floyd LJ gave some notable guidance on the legal test, comparing and contrasting it with the legal test for novelty.

Floyd LJ noted that in Samsung v Apple [2013] EWHC 467 (Pat), he endeavoured to set out a structured approach to the consideration of questions of entitlement to priority which he still believed to be correct. According to this approach, the task for the court is ([56]):

(a) to read and understand, through the eyes of the skilled person, the disclosure of the priority document as a whole;

(b) to determine the subject matter of the relevant claim;

(c) to decide whether, as a matter of substance not of form, the subject matter of the claim can be derived directly and unambiguously from the disclosure of the priority document.

To this, Floyd LJ added the following observations of general application ([71]-[72]):

A first, preliminary point concerns the correct approach to the determination of priority... Although the law [of] entitlement to priority shares with the law of novelty the common feature of assessing the disclosure of a document, it is important to recognise that that is where the analogy stops. A published document (or one treated as part of the state of the art for novelty purposes under Article 54(3)) will deprive a later claim of novelty if it hits the target, in the sense that something clearly disclosed by the document falls within scope of the claim: see Synthon v SmithKline Beecham [2005] UKHL 59; [2006] RPC 10. To put it another way, everything which falls within the claim must be novel. One does not assess priority, however, by asking whether everything which falls within the claim is clearly and unambiguously taught by the priority document. A test of that kind would make claiming priority impossibly hard. The exercise of determining priority involves asking whether the invention is directly and unambiguously derivable from the priority document, not whether every possible embodiment of the invention is so derivable.

A second preliminary point is that the priority document must not be read in a vacuum, but with the benefit of the common general knowledge which forms the factual matrix against which the technical disclosure is assessed. Viewed with that knowledge, the disclosure may mean something different to a skilled person than it does to someone reading the document without that knowledge. That observation has particular traction in a case where one is concerned not merely with what is made explicit by the document, but also with what is implicit in it, because both explicit and implicit disclosure may be taken into account for priority. None of that is the same thing as adding to the disclosure something which is obvious in the light of it, although the difference between the two may sometimes be difficult to pick apart on the facts. It follows that an appellate court must exercise caution when differing from a trial judge on the interpretation of a priority document where its meaning may be coloured by the common general knowledge. An alternative construction may seem more plausible in the drier atmosphere which prevails on appeal, than it did to a judge who has been soaked in the evidence of those skilled in the art.

It is hardly news, though it is certainly right, that when assessing priority, it is not the individual claims which are considered but the invention as a whole. The word "invention" is writ large throughout section 5 of the Patents Act.

Floyd LJ's comments may represent an attempt to moderate the volume of challenges based on lack of substantive priority. It was a rarely used weapon until quite recently and this might be a case of Floyd LJ putting it back in its box by easing the burden of establishing priority.

The method the subject of Unwired Planet's patent included the following steps:

...transmitting a sequence of data units or data unit segments to be received by the second node, the method further comprises the steps of:

counting the number of transmitted data units and the number of transmitted data bytes of the transmitted data units, and,

requesting a status report from the second node if the counted number of transmitted data units exceeds or equals a first predefined value, or the counted number of transmitted data bytes of the transmitted data units exceeds or equals a second predefined value.

The judge had construed the claim as not seeking to exclude the possibility of polling (and therefore counting) upon assembly i.e. just before the "protocol data unit" was transmitted, as opposed to when it had been transmitted. (The narrower construction would have meant that the claims did not read on to the LTE standard, and the patent would not have been "essential" to its operation).

The issue for priority was consequently whether this invention, interpreted in this way, was directly and unambiguously derivable from the priority document. Floyd LJ emphasised the need to consider the disclosure of the priority document as read by the person skilled in the art in light of their common general knowledge, without hindsight introduced by an understanding of the deemed scope of the later patent claim. He said that although the interpretation of the language of the priority document is for the court, the actual disclosure of a document, what it conveys to the skilled person, is a matter on which expert evidence is admissible.

Floyd LJ concluded that the interpretation which the skilled person would give the word "transmitted" in the priority document chimed perfectly with his common general knowledge, and the "invention" was directly and unambiguously derivable from the priority document.

The Court of Appeal's judgment in Actavis v ICOS (1 November 2017)⁴⁰ also addressed an issue of substantive priority. This concerned the entitlement of ICOS/Lilly's patent in issue to its claimed priority. Kitchin LJ gave his own view on the law, saying ([54]-[55]):

...In summary, the question is whether, as a matter of substance not form, the skilled person can derive the subject matter of the claim in issue directly and unambiguously, using common general knowledge, from the disclosure of the priority document.

There is a second requirement. The matter disclosed in the priority document must be enabling, that is to say it must disclose the invention in a way which will enable it to be performed by a person skilled in the art without undue effort.

The priority document is discussed at length by Kitchin LJ in his judgment. The priority document disclosed various dosages of tadalafil "between 1 and 20mg /dosage form". Preferably this was 5-20mg/day; more preferably 5-15mg; and most preferably 10mg.

Kitchin LJ agreed with the judge that this disclosed not just the administration of a total dose per day of 20mg, but also a total dose per day of 5mg. He also considered that lower total daily doses were disclosed saying ([75]):

It discloses, among other things, an article of manufacture for human pharmaceutical use comprising a package insert, a container and a dosage form containing 1 to 20mg of a selective PDE5 inhibitor...tadalafil. ...tadalafil is specifically identified as being one such inhibitor and ... as being especially prepared.

Enablement was addressed as a question of plausibility. Kitchin LJ agreed with the first instance judge, saying ([83]):

It is quite clear that a claimed invention will not be implausible if the inventor provides a reasonably credible theory as to why it will work. ... There is ample material in the priority document to satisfy this criterion. Tadalafil is specifically identified and is said to be especially prepared. The data in table 1 show that it selectively inhibits PDE5 and, as the judge observed, the skilled person would know that [the first orally administered PDE5 inhibitor marketed for the treatment of erectile dysfunction,] sildenafil works in this way. Example 4 shows that a 10mg dose of tadalafil is well tolerated and example 5 shows that a selective PDE5 inhibitor, as defined, is efficacious for the treatment of ED at doses of 5mg per day. In my judgment the requirement of plausibility is satisfied.

In Illumina v Premaitha⁴¹, a case heard and decided after the Supreme Court's judgment in Actavis v Eli Lilly, Henry Carr J compared the legal test for substantive priority with that for sufficiency.

Illumina had sued Premaitha and TDL Genetics for infringement of a number of patents regarding pre-natal tests; the defendants had challenged validity. Illumina accepted that claims of the "Lo 1" patent that were not entitled to the claimed priority were invalid. TDL argued that if the claimed detection method covered the approach adopted in the alleged infringing assay (the Harmony polymorphic assay), then since this approach was not enabled by the priority document, Lo 1 was invalid.

In addressing this squeeze, rather than considering the line of cases discussed and expanded upon by Floyd LJ in Unwired Planet v Huawei (technical), Henry Carr J plunged into Lord Hoffmann's statement of principle in Kirin-Amgen⁴² that "the disclosure must enable the invention to be performed to the full extent of the monopoly claimed".

In making this statement, Lord Hoffmann drew upon his own judgment in Biogen v Medeva⁴³, in which he said that a requirement for an "enabling disclosure" was common to the test for entitlement to priority (s.5(2)(a) of the Patents Act), the requirements of s.14(3) (disclosure) and s.14(5)(c) (support), and the test for insufficiency (s.72(1)(c)).

The Supreme Court's judgment in Actavis v Eli Lilly has thrown a spotlight on Lord Hoffmann's statement of principle. This is because it raises a question as to whether something found to infringe by the application of the doctrine of equivalents must be enabled in order for the patent to be valid, or whether, in such a scenario, there may be a difference between the reach of the claim for infringement purposes and the scope of the claim for the purpose of assessing its validity.

In Illumina v Premaitha, infringement was found in accordance with limb (i) of Lord Neuberger's test ("normal interpretation") rather than pursuant to limb (ii) (the doctrine of equivalents). Nevertheless, Henry Carr J took the opportunity to contribute to the Autumn's debate. He said ([138]):

The principle of enablement across the breadth of the claim is of considerable importance, but it is not absolute. It does not require a patentee who has claimed a principle of general application to anticipate inventive improvements which make use of that principle, nor future advances in technology, which would be an impossible task.

Turning to Lord Hoffmann's statement of principle in Kirin-Amgen, he said that he understood Lord Hoffmann's judgment as expressing in his own words, and not disapproving of, Aldous LJ's comment in the Court of Appeal that:

The law contemplates that patents will not lack sufficiency even though the claims cover inventive improvements. If the law were otherwise there would be no room for patents which disclosed a principle of general application unless the specification described how to carry out later inventions using the principle. ⁴⁴

Henry Carr J then turned to Lord Neuberger's first instance judgment (as Neuberger J) in Kirin-Amgen, and his reference in Actavis v Lilly to a lecture given by Netherlands Judge Rian Kalden, the Head of the IP Division in the Court of Appeal in the Hague, titled "Article 69 EPC - the Scylla and Charybdis of the European Patent Convention - Which route did the Dutch Courts take?". Lord Neuberger quoted the following passage:

Variants that are not foreseeable at the priority date may well, due to later developments, become an obvious variant at a later date. This may happen in case of a pioneer invention, where at the priority date the full breadth of the possible applications could or has not been fully recognised and therefore was not sufficiently taken into account when drafting a claim. Another possibility is that a new technique becomes available after the patent was granted, which makes available an obvious variant. It would be harsh and contrary to fair protection for the patentee to deny him the right to attack those, again provided such variant falls within the inventive concept and reasonable legal certainty is taken into account. So infringement by equivalence is not limited to foreseeable variants only.

Henry Carr J commented saying ([144]):

In summary, fairness to the patentee may require that unforeseeable variants, enabled for the first time by new technology, fall within the scope of protection, although the patentee is less likely to succeed where the variant was unforeseeable at the priority date. A variant which represents an inventive step may nonetheless infringe; Actavis v Eli Lilly at [63] - [64]. It would not make sense if, in those circumstances, the patent was found to be insufficient solely because such an inventive variant, which it did not enable, fell within the scope of its claims.

He considered the same principle to be "well-established" by EPO Board of Appeal decisions, in particular Genentech I/Polypeptide expression (T292/85) and Erythropoietin/Kirin Amgen (T0636/97). Finally, Henry Carr J concluded ([147]):

In summary, this case law establishes that a patentee may claim a principle of general application. He cannot anticipate future inventive improvements or future developments in technology which will fall within his claim. The fact that such improvements or developments fall within the claim, because they adopt the principle of general application, may well not mean that the patent is invalid for insufficiency. But this conclusion depends upon the facts of the case, including the nature of the invention and its technical contribution.

Turning to the facts, the judge said that the Lo 1 patent disclosed a principle of general application for detection of cell-free foetal DNA in maternal plasma and serum of a pregnant female. The method specifically disclosed was the standard one but the skilled geneticist would have appreciated that "insofar as new techniques for the detection or quantification of nucleic acid sequences were developed in the future, these could also be used to implement the general principle disclosed in the Lo 1 Patent and Priority document of using paternally inherited cell-free foetal DNA as the source material to be analysed".

TDL's squeeze between infringement and priority was therefore unsuccessful. However, amongst a number of other challenges to the claimed priority of the patents in issue, two were successful in respect of some of the claims of Lo 1. This was because the Lo 1 priority document represented that the plasma or serum based non-invasive prenatal diagnosis method according to the invention could be applied to the screening of Down's Syndrome and other chromosomal aneuploidies, suggesting two methods for doing this, but the evidence was that the skilled person would not have regarded it as reasonably credible/would have considered it implausible in practice. The claims in question were also broader than the disclosure of the priority document because they included a detection method which relied on a paternally inherited sequence not possessed by the mother for the detection of such conditions.

Anticipation

Generally speaking, confronted with the issue of novelty, judges cite the passage from Kitchin J's judgment in Generics v Lundbeck⁴⁵ as the basis for their analysis.

In the case of Edwards Lifesciences v Boston Scientific⁴⁶, HHJ Hacon added a small gloss ([139]):

I would add this. It is not essential that an item of prior art should expressly disclose all the features of an invention for that prior art to deprive the invention of novelty. It may be that one or more integers are disclosed by inference. But this must be an inevitable inference drawn by the skilled person reading the prior art.

In the case at hand, the necessary inferences were not inevitable, and so Boston's patents were not anticipated.

It is a little hard to assess whether Judge Hacon's comments represent a significant development. They are of course, only the comments of a first instance judge, and an IPEC judge at that. However, there may be a small element of blurring around the previously relatively bright lines which defined the scope of an assessment of novelty.

It is interesting though to note these comments in the context of Floyd LJ's general observations on the law regarding priority in Unwired Planet v Huawei (technical). Floyd LJ made it clear that, for the purposes of assessing substantive priority, it is not only what is made explicit by the original document, but also with what is implicit in it that can be taken into account. I had always considered that to be a differentiation between novelty in its purest sense, and a consideration of priority. It may be that the effect of HHJ Hacon's judgment is to move the novelty assessment closer to the assessment of priority; or it may be that Floyd LJ's comments in the Unwired Planet (technical) case rapidly over-rode any movement instigated by HHJ Hacon.

In Unwired Planet v Huawei (technical), the Court of Appeal confirmed Birss J's interpretation of Article 54(2) EPC, which says:

The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.

The prior art relied upon by Huawei as forming part of the state of the art (the "Ericsson TDoc") was uploaded to a publicly accessible server at 8:36 Central European Time on 8 January. This corresponded to 02:36 on the same date at the USPTO (EST). The priority document was filed in the USPTO at 16:59 EST, which was 22:59 CET. The priority document received a date of filing of 8 January 2008. Did the Ericsson TDoc form part of the state of the art?

Floyd LJ said ([161]):

...a publication is not part of the state of the art unless it was published before the priority date. The priority date is the 24 hour period of the day on which filing took place, in the time zone of the patent office where it was filed. The publication must occur before that day, on a time basis, by reference to the time zone of the patent office of filing.

So although the Ericsson TDoc was made available to the public 14 hours before the priority document was in fact filed, this was not "before the date of filing".

I have already made it reasonably clear in the section on the Supreme Court's Actavis v Lilly decision that there are implications in the field of validity.

In Generics v Yeda⁴⁷, Arnold J considered the construction of a patent claim for validity purposes and the interaction of the doctrine of equivalents with the tests for novelty and inventive step. He rejected Generics' case that prior art anticipated because it would (hypothetically) infringe pursuant to the doctrine of equivalents. So on Arnold J's approach, there seems to be a validity gap.

Perhaps the case with the clearest discussion of the implications of the Supreme Court's judgment is Fisher and Paykel v Res Med⁴⁸- a decision of Richard Meade QC sitting as the deputy judge in a dispute regarding ResMed's patent to a mask system.

The deputy judge openly discussed both the "infringement gap" which appears to follow Actavis v Lilly and the uncertainty as to how a patent claim should be interpreted for the purpose of assessing its validity. In view of the uncertainty, he proceeded to interpret the disputed claim language according to both its "literal" meaning and its "purposive" meaning. This could lead to different consequences.

For example, on a truly literal meaning of the word 'protrusions' in claim 12, prior art 'Geist' would not anticipate because it did not have protrusions on the collar, which was smooth and circular. However, on a purposive construction, the angled surface of the collar would achieve the same object as "literal" protrusions (which would cause a more abrupt change in the surface of the collar). Accordingly, on a purposive interpretation of the claim language, Geist would anticipate.

In the context of anticipation, there was a notable finding in respect of patient trials.

First, in FKB v AbbVie⁴⁹, FKB relied upon -

prior use for the successful treatment of two different patients at Guys and St Thomas' Hospital for the treatment of chronic plaque psoriasis and psoriatic arthritis, being the administration of adalimumab by subcutaneous 40mg administration every other week, and
disclosures made by the relevant doctors to these patients of the treatments and dosing regimens they were to receive (and subsequently did receive).

Henry Carr J concluded, on the witness evidence and corroborative evidence, that these prior uses had been established. The use made available the treatment to the public and so did the disclosures by the doctors to the patients.

This would seem to present an Achilles heel for any medical use patent in respect of which an early, otherwise unreported, patient trial has been conducted, if the challenger can obtain evidence of such use.

Finally, in Actavis v ICOS (1 November 2017)⁵⁰, the Court of Appeal considered the test for anticipation. The claims of the patent were concerned with unit dosage forms of tadalafil, for administration up to a maximum total dose of 5 mg per day for the treatment of sexual dysfunction.

Kitchin LJ said that the 'Stoner' prior art described a combination therapy for sexual dysfunction involving a cGMP PDE specific inhibitor together with an alpha-adrenergic receptor antagonist such as Melanotan-II. Among the cGMP PDE inhibitors described were PDE5 inhibitors such as sildenafil and tadalafil (identified as IC-351). Disclosed dosage levels were said to be between 0.001 to 50mg/Kg of body weight, preferably 0.005-25mg/kg, more preferably 0.01-10mg/kg. There was a specific disclosure of tablets containing 1, 2.5 and 5mg of each ingredient.

Kitchin LJ said that even the narrowest of these dosage ranges was "very much broader than that of the patent". The evidence was that it was so wide that in the absence of efficacy data, the skilled clinician would consider it speculative and effectively to provide no meaningful guidance. Moreover, the fact it was directed to a combination therapy would also affect how the skilled person would understand the disclosure.

Kitchin LJ agreed with the judge (Birss J) that the enablement criterion for novelty was not met by Stoner, saying that the skilled person would not regard it as plausible that, in combination with a centrally acting alpha-adrenergic receptor antagonist, administration of tadalafil in the claimed dosing range would be efficacious for the treatment of ED.

Further, and contrary to the judge's conclusion, Kitchin LJ expressed some doubt as to whether the claimed invention was even disclosed by Stoner. The judge had accepted evidence that a combination muddled the situation because the skilled person would not know whether the centrally acting agent (the adrenergic receptor antagonist) was going to modify totally the response of the patient to the PDE5 inhibitor. Kitchin LJ said ([100]):

In these circumstances it seems to me to be well arguable that Stoner does not make available to the skilled person as a technical teaching the subject matter of the claims of the patent; and further, that read through the eyes of the skilled person, Stoner does not disclose that it is possible to use the whole of the dosing range to which it refers.

However, Kitchin LJ said that it was not necessary to express a final view upon this in light of the conclusions of lack of inventive step.

(c) Obviousness

Historically, this has been the dominant section in this paper, but this year, mercifully, it takes a lower profile. There are just a handful of cases containing points worthy of consideration. Otherwise, the cases were largely resolved on their facts, and things had been heading in that direction for a number of years in relation to the law of obviousness.

It is always nice to open with a clear statement of the law, and one such was provided by Henry Carr J in FKB v AbbVie⁵¹. He said ([259]):

The legal principles of relevance to the present case are well-settled, and only require a brief summary:

(i) Obviousness must be considered on the facts of each case and the Court must consider the weight to be attached to particular facts in the light of all the relevant circumstances. These include the motive to find a solution to the problem that the patent addresses, the number and extent of possible avenues of research and the effort involved in pursuing them.

(ii) If a particular step is obvious in the light of the prior art, it is not rendered any less obvious merely because there are a number, and a perhaps a large number, of other obvious routes as well.

(iii) If the patentee chooses to advance broad claims, the inventive concept will be broadened in an equivalent way. The question to be answered is whether anything falling within the scope of the claims is obvious.

(iv)Where it is alleged that a step is obvious to try, the question is whether the skilled person would do so with a fair expectation of success; how much expectation depends on the particular facts of the case. Including something in a research project is not enough to establish lack of inventive step.

This is effectively the same test that he set out himself in the case of GSK v Wyeth⁵², but with (iii) added. It represents a caution that broad claims invite a broad assessment of obviousness.

Less conventional obviousness arguments

In Edwards Lifesciences v Boston Scientific⁵³, HHJ Hacon considered the question of obviousness. He opened with the obligatory citation of the Pozzoli⁵⁴ test, but the bigger issue here was an old favourite of mine - secondary evidence.

Boston's case on the secondary evidence was that in 2004 Edwards purchased Percutaneous Valve Technologies ("PVT"), a company that manufactured a device used in earlier celebrated work that formed part of the common general knowledge; but Edwards only included an outer skirt in a replacement valve device in 2014. Boston argued that if the skirt had been obvious to the skilled person in December 2003 (the priority date), then it would have been equally obvious to Edwards, who would have introduced it a good deal earlier than 2014. In Edwards' 2014 product, the outer skirt was advertised as eliminating significant leakage around the outside of the device ("PVL") and the addition of the skirt was seen by Edwards as a marketing advantage.

The trial took place in late January 2017. In July 2016 Boston sought disclosure from Edwards of documents, if any, showing earlier work done by Edwards on a skirt or other solutions to the problem of PVL. In correspondence Boston's solicitor said that in the absence of such documents, Boston would invite the court to draw an inference that it had not been obvious to Edwards at the relevant time to incorporate a skirt on a transcatheter heart valve ("THV"). The judge said that Boston's solicitor "was suggesting that Boston would rely on such an inference in support of their argument that Boston's inventions were not obvious".

Edwards' solicitor responded (in September 2016) saying that Edwards did not intend to rely on factual evidence of its own research. On this, the judge said ([173]):

It is difficult to see how documents revealing whether or not Edwards had given thought to a skirt on a THV, and if so when, would not be of assistance to the court. It does not follow that Edwards would have been required to give disclosure - other factors could have come in to play and there has lately been a shift in the tide regarding disclosure in patent actions... In any event, Boston did not pursue its application and the parties moved on. Edwards was on notice as to the inference that Boston was going to invite the court to draw and, as was Edwards' right, decided to live with it.

Two days before trial, Edwards' solicitor sent a letter stating that they understood from Boston's skeleton argument that Boston intended to advance an argument based on "secondary indicia of non-obviousness", and referring to some sentences in Boston's expert reports. The letter said that they expected Boston to put the case to Edwards' witness of fact (Senior Director of Valve Development and Testing at Edwards). He had signed Edwards' PPD but had not provided a witness statement.

The judge said it could not be correct that Edwards had only become aware of the argument because of the statements in the expert evidence. But more importantly, the suggested approach meant that Boston's counsel would have to cross-examine Edwards' fact witness without any idea of what the witness' views were on the topics.

On the third day of trial, Edwards sought permission to adduce a witness statement from their proposed fact witness. Permission was denied. The judge said ([178]-[179]):

Assuming that Mr Joseph had intended to outline 'other technical developments' required before Edwards could implement the idea of the skirt, Mr Meade would not have been in a position to test the accuracy and completeness of Mr Joseph's evidence regarding what Edwards' valve development team had done. That would only have been possible had Boston's legal team, at least, been given access to Edwards' research documents in due time. Mr Joseph was a technical man, but if he had also been intending to allude to marketing or other commercial factors he felt were relevant, Boston again were entitled to sufficient time to look into such factors in advance of Mr Joseph's giving oral evidence.

In short, in my view Edwards' application was far too late. Edwards took a strategic decision in August or September 2016 regarding how it was going to deal with Boston's argument on the secondary evidence and non-obviousness in this case, an argument that Boston had clearly signalled. Allowing Edwards to reverse that decision after the trial had started would have resulted in significant unfairness to Boston.

The judge concluded that on the available evidence, no clear technical reason had been established why Edwards' earlier THVs did not feature an outer skirt of the type subsequently used on the 'Sapien 3' device. Edwards were in "as good a position as the hypothetical skilled person" at the priority date; there was no reason to think that Edwards were the "victims of idiosyncratic prejudice or ignorance."

Previous authority (Jacob LJ in Schlumberger⁵⁵) indicated that secondary evidence can come into play only after alternative reasons for why an invention was not reached had been discounted. Edwards did not give alternative reasons in this case, even though they knew that the issue was at large. Consequently, this generated a suggestion, that was relevant but not conclusive, that the use of an outer skirt was not something the skilled person would have considered at the priority date.

The judge's decision to prevent Edwards submitting evidence at a very late stage, and to find relevance in Edwards' failure to use an outer skirt on a THV before the Sapien 3, is procedurally notable. It is worth bearing in mind the possible consequences of ducking a line of argument that is not necessarily fully pleaded, in the hope that it can be deflected on procedural grounds at trial. In most patent cases, secondary evidence, including disclosure from the patentee about what the inventor did, is a costly distraction but in a minority, it can be important.

In Varian v Elekta⁵⁶, Birss J addressed an interesting issue emerging in recent years - does the skilled person have the same qualities for all purposes?

The gist of the patent was that of combining MRI and radiotherapy technology. Radiotherapy is of course deployed as a direct beam, aimed at a tumour, to transmit radiation, with as little as possible being passed to adjacent tissue. The trouble is that people move, and they breathe. The idea of the patent was to have simultaneous MRI scanning to track the exact location of the tumour, and send a message to the radiotherapy technology to ensure that it is, at all times, accurately targeted.

Elekta put forward three cases of obviousness, and one comprised a squeeze with the question of insufficiency.

Giving a basic statement on the law of inventive step, the judge, Birss J, said ([282]):

As a matter of law, the skilled person is deemed to read any given prior art document with interest. That law exists to protect the public. However, the skilled person's reaction to an item of prior art will depend on the facts and circumstances, including their common general knowledge, what problems they may or may not be interested in, and what the document says. The fact a document is in a different field from their own is a relevant factor. It does not stop the skilled person from reading it with interest but it may mean they do so and then put it on one side. One legally appropriate outcome is for the skilled person to say: "I have read it with interest but I am not interested.

One item of prior art was known as 'Van Vaals'. This was an international patent application which proposed using MRI imaging to determine the movement or instantaneous position of the target region and then use that information to control an ultrasound source. Thus the ultrasound heating would be concentrated substantially within the moving target region and the tissue outside the target hardly heated.

Birss J found the patent in suit to be obvious in the light of Van Vaals and summarised his reasoning as follows ([313]):

A skilled team which involves an RT skilled person and an MRI skilled person interacting with each other does not involve hindsight. This is not a case like Schlumberger in which the invention brought two kinds of skilled people together. The two skilled people already interacted with each other. Accurate targeting in general and the problems of tumour movement were a major issue in the common general knowledge at the priority date. Van Vaals is addressed to this very problem and teaches the use of MRI imaging during treatment as a solution. It is not mentioned in Van Vaals but to an RT skilled person it would be obvious to think of applying this to external radiotherapy. The MRI skilled person would not dismiss the idea. They would think that it was a major challenge to combine the two machines but they would see the problems as matters which could be addressed using known techniques. The relevant claims are invalid.

Varian made the point that Van Vaals was a patent from the Philips company, which was engaged in radiotherapy as well as MRI and ultrasound at the relevant time and yet they appeared not to have come up with the invention. In around 1997, Elekta acquired the radiotherapy interests of Philips Medical Systems, and Elekta's development of a clinical system comprising a Linac and an MRI machine that could operate simultaneously had been in a consortium with Philips. So Varian's point on Philips was a rhetorical question - if it was obvious over their Van Vaals document, why was there no evidence Philips thought of it at the time? The judge said that there was some evidence that the idea only started to be taken forward by the groups now involved in the consortium some years after 1997, from 2000. But the judge was not persuaded on this. He said ([312]):

So I accept Varian have a point here as a form of secondary evidence but it is just as speculative to work out what Philips may or may not have done with Van Vaals as it is to speculate about why Varian themselves have not produced an MR-Linac since claiming the invention 20 years ago. This secondary evidence is not strong enough to carry sufficient weight in the obviousness analysis.

Elekta submitted that if the patent was sufficient despite the paucity of its disclosure, it must follow that the invention was obvious once the radiotherapist skilled person (having been presented with and read the prior art) spoke to the MRI skilled person. Birss J did not agree. He said ([308]):

That is because the position of the skilled person is not the same in the two situations and so the conclusion that if it is sufficient it must be obvious does not follow. One needs to examine the circumstances. On the other hand, evidence directed to one situation may be relevant to the other and this is reflected in the way each side puts its case on obviousness.

In Unwired Planet v Huawei (technical)⁵⁷, the question of secondary evidence raised its head again, albeit in a fairly diluted form.

Huawei contended that, at first instance before Birss J, on the primary evidence of the expert witnesses a finding of obviousness was effectively compelled, and that the judge had recognised this. What had made the difference was the secondary evidence, but on their assertion on appeal, this was not capable of amounting to persuasive evidence of non-obviousness.

On the law, Floyd LJ looked at a number of previous decisions including MedImmune v Novartis⁵⁸. In that case Kitchen LJ had noted the multi-factorial evaluation of evidence needed against a simple statutory test, which underpinned the reluctance of an appeal court to interfere with the judge's decision on the issue of obviousness. As long ago as 1997 in Biogen v Medeva⁵⁹, Lord Hoffmann had said that the need for appellate caution in reversing the judge's evaluation of the facts was because specific findings of fact, even by the most meticulous judge, were inherently an incomplete statement of the impression which was made upon him by the primary evidence. However, by reference to the judgment of Sir Robin Jacob in Teva v Leo⁶⁰, Floyd LJ noted that all this did not mean to say that obviousness was an appeal-free zone.

However, in this case, reviewing the evidence, Floyd LJ upheld Birss J finding ([114]):

I have to confess that I found the surgical division of the evidence into "primary" and "secondary" a rather unreal one on the facts of this case. The judge found that the relevant skilled person or team was a telecoms systems engineer who would be interested in the work of the standards body in the context of designing or implementing the RLC for the developing LTE system and would be interested in the inputs to standardisation meetings. An expert witness seeking to assist the court on the issue of obviousness would, as it seems to me, not be doing his duty if he did not make himself aware in general terms of the work of the standards body and, in particular, the technical discussions which were taking place. Failure to do so would leave him exposed to the accusation that the evidence he was giving was divorced from reality. In the present case it was not possible to insulate the primary expert evidence from the secondary evidence of what occurred in the standardisation meetings. Any experts were bound to rely on, or be asked to explain, the technical discussions which were going on at the priority date.

Floyd LJ noted that Huawei's approach demanded of the Court of Appeal a detailed review of the expert evidence to see whether it did indeed compel a finding of obviousness, before turning to the evidence of what happened in the committee itself and asking whether it could, on its own, support a finding of non-obviousness. Requiring in this way an almost complete review of the evidence, this amounted to "a serious inroad" into the approach identified to appeals on obviousness in the authorities cited.

Notwithstanding these comments, Floyd LJ did conduct a basic analysis of the expert evidence as given at the trial. He concluded ([133]):

Pulling this together, the judge made no error of principle in placing reliance on what the documents showed as to what occurred in the relevant standards-setting committee. There was ample material before him on which he was entitled to rely to reject the allegation of lack of inventive steps.

Dosing regimens

In Actavis v ICOS (1 November 2017)⁶¹, the first instance judgment of Birss J in the tadalafil case reversed by the Court of Appeal.

Birss J had agreed with Actavis that the skilled team, in the light of prior art called "Daugan" would undertake a "go no-go" Phase IIa study of a single dose of tadalafil in a relatively small group of patients using a 15mg dose. The skilled team would embark upon this with a reasonable expectation of success. Following successful results, a routine Phase IIb dose ranging study would be conducted in a larger group of patients, which would include 25mg, 50mg, and 100mg doses (but the judge concluded that the 10mg would not be included at this stage). The skilled team would not necessarily expect the lowest dose to be large enough to be clinically relevant, but the results would show that there was no difference in the efficacy end point between the three dosages. Rather than a dose/response curve, an efficacy plateau would be seen, whereas the side-effects would show a dose response curve. The judge then assumed that a further single dose ranging study would be conducted which included 5mg and 10mg doses as well as the higher ones. However, at this stage, the judge considered that the skilled team would not have had a reasonable expectation that the drug at the 5 mg dose would be a useful treatment, nor any expectation at all that the drug would produce a clinically relevant effect but with minimal side effects. They would be surprised by this. Stepping back and considering the factor articulated in Generics v Lundbeck⁶², Birss J concluded that claim 7 (the Swiss form claim) involved an inventive step. The other claims entitled to priority were similarly not obvious. Upon the evidence, the judge reached similar reasoning for chronic daily dosing also.

I have to say that I did find Birss J's reasoning hard to follow. It was hard to see the point in the process where the obviousness argument was lost and the trials became too remote in his view. The Court of Appeal duly disagreed with the judge. Quoting his own previous judgment in Novartis v Generics⁶³, Kitchen LJ said ([133]):

...In deciding whether the invention was obvious to the skilled but unimaginative addressee at the priority date the court will have regard to all the circumstances of the case including, where appropriate, whether it was obvious to try a particular route with a reasonable or fair expectation of success. What is a reasonable or fair expectation of success will again depend upon all the circumstances and will vary from case to case. Sometimes...it may be appropriate to consider whether it is more or less self-evident that what is being tested ought to work. So...simply including something in a research project in the hope that something might turn up is unlikely to be enough. But I reject the submission that the court can only make a finding of obviousness where it is manifest that a test ought to work. That would be to impose a straitjacket upon the assessment of obviousness which is not warranted by the statutory test and would, for example, preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable.

In the Actavis v ICOS case, Kitchin LJ continued ([134]):

I have no doubt that the judge had all these principles well in mind in carrying out his assessment. Furthermore, where no question of principle is involved, an appellate court will be very cautious in differing from a judge's evaluation. However, says [counsel for Actavis], in this case the judge did make errors of principle, failed to take into account relevant matters, asked himself the wrong questions and failed to distinguish relevant from irrelevant factors.

Going on to conclude that the patent was indeed invalid for obviousness, Kitchen LJ said ([152]):

The judge has lost sight of the fact that, on his own findings, the claimed invention lies at the end of the familiar path through the routine pre-clinical and clinical trials process. The skilled but non-inventive team would embark on that process with a reasonable expectation of success and in the course of it they would carry out Phase IIb dose ranging studies with the aim of finding out, among other things, the dose response relationship. It is very likely that in so doing they would test a dose of 5mg tadalafil per day and, if they did so, they would find that it is safe and efficacious. At that point they would have arrived at the claimed invention. In my judgment claims 7 and 10 are therefore invalid.

Floyd LJ agreed, though not entirely for the same reasons. Noting that it was difficult for the Court of Appeal to differ from a "very experienced patents Judge" he added a few comments of his own saying ([155]-[156]):

There is no difficulty about identifying the question which the court has to answer on the issue of obviousness of claims 7 and 10. It is whether it was obvious to the skilled team, in the light of Daugan, and without knowledge of the invention, that a 5 mg daily dose of tadalafil would be a safe and effective treatment, with minimal side effects.... If one notionally asks that question of the skilled team before it embarked on the investigations which Birss J chronicles in his judgment, the answer would be, of course, that it was not obvious. The skilled team would respond that it could not know without conducting appropriate tests what if any dose of tadalafil would achieve that goal.

The law, as it has developed at least in this jurisdiction, does not halt its enquiry at this point, however. If it did, this would have been a very short issue to decide. It is recognised that a patent will not be granted for an invention which, though not obvious in this a priori sense, is nevertheless an invention which would be arrived at by a line of routine and uninventive enquiry which would be carried out by a skilled team.

Floyd LJ went on to conclude ([172]):

It is true that the judge made a finding that the skilled team would be surprised by the result, namely efficacy at 5 mg/day. However it is a result which on his findings would be arrived at by the standard, routine enquiries into dose response which are required by Phase IIb clinical trials. The surprising result, once uncovered, does not make these routine enquiries inventive.

The third judge on the Court of Appeal panel was Lewison LJ. He added a few lines of his own saying ([180]):

This court has been at pains to warn against the over-elaboration of the "obvious to try" line of cases. While there are a number of factors which, depending on the circumstances, may bear on the question it is not always necessary for all of them to be ticked off as if on a checklist. As Kitchen and Floyd LJ have demonstrated, in a case which involves routine pre-clinical and clinical trials, what would be undertaken as part of that routine is unlikely to inventive.

Where does all this leave us? As usual, little further forward. Perhaps in some doubt as to the prospects of a patent for which the invention resides in a dosing regimen being found inventive. There is also perhaps a slight opening of the door on the question of secondary evidence, which clearly played a part in one case and may have done in another. However, the issues regarding the question of "obviousness to try" are still at large, and the very specific circumstances pertaining to most dosing regimen 'inventions' mean that the wider implications of the judgment are likely to be limited.

(d) Insufficiency

I once omitted this section completely on the grounds that it was "insufficiently interesting". My heart still sinks as I approach it, but unfortunately there is a lot at large and a couple of cases which need consideration.

Turning first to Edwards Lifesciences v Boston Scientific⁶⁴, this case involved two Boston patents, both of which were derived from the same parent application, claiming apparatus for endovascularly replacing a patient's heart valve (including the replacement valve). The patents referred to the use of a fabric seal to prevent blood flow around the valve when fully deployed.

Edwards ran an insufficiency squeeze: that in so far as Boston contended the inventions were not obvious because the skilled person would have been deterred from the skirt idea (since it would add to the delivery profile of the device), neither patent disclosed how to circumvent the difficulty.

However, Boston's arguments did not hinge on the delivery profile, and in any case it was not suggested that the skilled team would be unable to perform the inventions having read the patents. So the insufficiency squeeze did not succeed.

HHJ Hacon summed it up like this ([224]):

First, Boston's arguments did not hinge on delivery profile. Secondly, even if they had and to the extent that the delivery profile was discussed, it does not follow that the Patents failed sufficiently to disclose the inventions. It was not suggested that the skilled team would be unable to perform the inventions having read the Patents. If the skilled team had laboured under a technical prejudice in December 2003 regarding delivery profile, it would have been removed by the teaching of the Patents.

The case of Sandoz v Searle⁶⁵ touches on sufficiency in an interesting context. The patent in question was still alive courtesy of a Supplementary Protection Certificate. The challenge was to the SPC, and in particular, reference was made to article 3(a) of the SPC Regulation which stipulates that "the product is protected by a patent in force".

Article 4 of the Regulation states:

Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.

Various authorities have made it clear that the product must fall within at least one claim of the patent.

This case gave rise to a number of interesting issues.

The first involves the use of Markush formulae in the wording of patent claims. This has been established for some time, since the 1924 decision on the Commissioner of Patents in the USA in the case Exparte Markush. The UKIPO's "Manual of Patent Practice" includes the following commentary on Markush claims:

A claim whether independent or dependent, can refer to alternatives provided that this does not make the claim obscure or difficult to construe. However, such claim formulations should be avoided if, by reason of the large number of alternatives, the generality of the claim is impossible to search in its entirety. Markush claims are an example of this type of claim: such claims set out a number of alternatives (possibly using words such as "selected from the group consisting of ..."). They are often used in chemical cases as a way of setting out various functionally equivalent alternatives in one or more parts of the chemical compound being claimed.

For reasons which will become clear, the question of the presumption of validity of a patent was a relevant consideration in this case.

Arnold J said ([36]):

A granted patent is presumed to be valid until the contrary is shown. It is curiously hard to find clear modern authority for this obvious proposition, although it is long established...and was authoritatively stated to be the law under the Patents Act 1949 in American Cynamid v Ethicon. ....For the avoidance of doubt, presumption of validity simply means that the burden of proving that the patent is invalid lies upon a party asserting invalidity to do so by one of the procedures permitted under section 74 of the 1977 Act. It has no bearing on the standard of proof, which is the ordinary civil standard of the balance of probabilities.

In this case, the claimants put the validity of the SPC in suit, but not the patent itself, from which the SPC was derived.

The product which underpinned the SPC involved a compound known as darunavir. The claimants' contention, as described by the judge, was ([58]):

...that darunavir is not specified or identified in any of the claims of the patent: although darunavir falls within the claims due to their immense breadth, it is not specifically identified by name or structure in the claims or anywhere in the specification, nor is there any teaching in the Patent which points to darunavir, and in particular its novel and unusual P1 group. The Claimants say that a Markush claim does not specify or identify a product unless the skilled person would consider the product to be part of the subject-matter of the patent based on their reading of the specification and their common general knowledge as at the priority date without undue burden or further invention, and that this test is not satisfied in the present case. Accordingly, the Claimants contend that darunavir is not "protected" by the patent within the meaning of Article 3(a).

Pulling the threads together, Arnold J asserted that, in reality, the claimants' objection was that claim one of the patent was of excessive breadth because it encompassed a vast number of compounds which the skilled person could not make even a tiny fraction of and which it was not plausible would all be efficacious as protease inhibitors. If well founded, however, that was an objection to the validity of the patent. Arnold J said ([66]):

It amounts to saying that the claims are obvious on AgrEvo grounds or insufficient. But as I have already pointed out, the patent is presumed to be valid unless and until the claimants put its validity in issue, which they have not done.

Arnold J concluded that it was not necessary for the active ingredient to be identified in the claim by means of a structural formula: it was sufficient for the active ingredient to be covered by a functional description provided that the claims "relate, implicitly but necessarily and specifically, to the active ingredient". He said ([63]):

It is clear from this that the identification of the active ingredient in the claim by means of a structural formula is permissible, but not essential; that is not necessary for the claim individually to name or depict the active ingredient; and that it is not necessarily an objection that the claim in question covers a large number of other compounds in addition to the active ingredient in question.

This case could have fallen under the heading "Insufficiency" or "Supplementary Protection Certificates", but since I always steer clear of the latter in this talk, I have placed it here.

The last point in relation to insufficiency arises from the case of Generics v Yeda⁶⁶. Yeda's patent claimed a dosing regimen comprising "...three subcutaneous injections of a 40mg dose of glatiramer acetate every seven days with at least one day between each subcutaneous injection...", referred to as "TIW".

Generics ran a combined attack on the patent based on lack of inventive step for want of technical contribution (AgrEvo obviousness) and insufficiency. They also contended that, if the claimed inventions were not obvious over the prior art, then there was nothing in the patent which made it plausible that 40 mg TIW would be efficacious compared to placebo, or as efficacious as the known regimen of 20 mg subcutaneous injections daily ("20 mg QD") or more tolerable, because the patent contained neither any clinical data nor any theoretical justification for such a supposition beyond what was already known to the skilled person. Accordingly, the claimants contended that the claimed inventions made no technical contribution to the art and therefore did not involve an inventive step in accordance with the principles recently summarised by Floyd LJ in previous litigation between the same parties - Generics v Yeda (2013)⁶⁷. Alternatively they contended that the claims were insufficient in accordance with the principles summarised by Kitchin LJ in the Idenix v Gilead⁶⁸case. The comments in the judgment of Arnold J are worth capturing in full ([192]-[195]):

This contention is advanced by the Claimants by way of a squeeze. Counsel for the Defendants submitted that there was no squeeze, however, because the legal tests to be applied were different: obviousness required a fair expectation of success, whereas plausibility was a lower standard which merely required that the claim should not be speculative...

Counsel for the Claimants accepted that the legal tests to be applied were different. He submitted that this did not matter on the facts of the present case because all that the Defendants could rely upon to establish that the claimed conventions were not speculative was the skilled person's common general knowledge outlined above. If 40mg TIW was not obvious to try with a fair expectation of success in the light of the skilled person's common general knowledge, then the claim that 40mg TIW would be efficacious compared to placebo was speculative and the claim that it would be as efficacious and more tolerable than a 20mg QD was even more speculative.

Counsel for the Defendants submitted that this argument failed to take into account the need to provide pharmaceutical companies with an incentive to finance the huge cost of Phase III trials and the need for pharmaceutical companies to file patent applications before the results of such trials were known if the applications were to have any real prospect of leading to valid patents. I acknowledge the relevance of these policy considerations, but in my view they are already reflected in the legal tests applied by the courts. As is well known, the patent system does not always provide a satisfactory incentive for innovation. The remedy for such problems lies elsewhere.

In my judgment, if the claimed inventions were not obvious, then the claim that 40mg TIW would be efficacious compared to placebo was credible, but the claim that it would be as efficacious and more tolerable than 20mg QD was speculative. I therefore conclude that claim 3 would be invalid for lack of an inventive step and insufficiency, but not claim 1 as I have construed it.

(e) Added Matter

There is normally relatively little to say on this point, and that remains the case this year. However, there is one decision of some note, namely Varian v Elekta⁶⁹, a judgment of Birss J at first instance.

This is the case relating to the combined MRI/radiotherapy scanners.

Birss J explained the law by reference to two previous cases saying ([332]-[333]):

...the fact that an amendment increases the scope of what is covered does not make that amendment add matter. But it does not mean that increases in coverage get a free pass. If an amendment which increases coverage also has the effect of the patent disclosing new matter then that amendment is unlawful. Putting it another way - if all the amendment achieves is an increase in scope relative to what went before then it does not add matter, but the fact it increases scope does not mean it cannot also add matter (AC Edwards). That latter question just depends on the particular circumstances.

Sometimes the AC Edwards point arises from a generalisation. So in AC Edwards itself the application disclosed a coil spring and had been generalised to spring means. The latter is of wider scope but while it would cover a different kind of spring from a coil, such as a leaf spring, it does not disclose the idea of a leaf spring and so the wider scope does not add matter. Similarly in AP Racing the application disclosed a J shaped unit and had been generalised to an asymmetric unit. Asymmetric has wider scope than J shaped and might cover (say) F shaped or P shaped. However "asymmetric" does not disclose the idea of an F shaped or the P shaped unit and so the wider coverage does not add matter. If one asked the question - what would the skilled person build given the patent after amendment, the skilled person would still use a coiled spring in AC Edwards or a J shaped unit in AP Racing. So there was no added matter.

I am not entirely sure that I understand that approach.

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Footnotes

29. Fujifilm Kirin Biologics Company Limited v AbbVie Biotechnology Limited [2017] EWHC 395 (Pat) (3 March 2017) Henry Carr J

30. KCI Licensing Inc & Ors v Smith & Nephew PLC & Ors [2010] EWHC 1487 (Pat)

31. Generics (U.K.) Limited & Anr v Yeda Research and Development Company Limited & Anr [2017] EWHC 2629 (Pat) (26 October 2017) Arnold J

32. Accord Healthcare Limited v Research Corporation Technology Inc [2017] EWHC 2711 (Ch) (7 November 2017) Birss J

33. Edwards v Cook [2009] EWHC 1304 (Pat)

34. KCI v Smith & Nephew [2010] EWHC 1487 (Pat)

35. Idenix v Gilead [2016] EWCA Civ 1089

36. Fujifilm Kyowa Kirin Biologics Company Limited & Ors v Abbvie Biotechnology Limited [2017] EWHC 395 (Pat) (3 March 2017) Henry Carr J

37. Actavis Group PTC EHF & Anr v ICOS Corporation & Anr [2017] EWCA Civ 1671 (1 November 2017) Lewison, Kitchin & Floyd LLJ

38. Accord Healthcare Limited v Research Corporation Technologies Inc [2017] EWHC 2711 (Ch) (7 November 2017) Birss J

39. Unwired Planet International Limited v Huawei Technologies Co. Limited & Ors [2017] EWCA Civ 266 (12 April 2017) Gross LJ, Floyd LJ, Arnold J

40. Actavis Group PTC EHF & Anr v ICOS Corporation & Anr [2017] EWCA Civ 1671 (1 November 2017) Lewison, Kitchin & Floyd LLJ

41. Illumina, Inc & Ors v Premaitha Health Inc & Ors [2017] EWHC 2930 (Pat) (21 November 2017) Henry Carr J

42. [2004] UKHL 46 at [102]

43. Biogen Inc v Medeva Plc [1996] UKHL 18

44. Kirin-Amgen v Hoechst Marion Roussel Ltd & Ors [2002] EWCA Civ 1096 at [69]

45. Generics (UK) Limited & Ors v H. Lundbeck A/S [2007] EWHC 1040 (Pat) at [52]

46. Edwards Lifesciences LLC & Ors v Boston Scientific Scimed, Inc [2017] EWHC 405 (Pat) (3 March 2017) HHJ Hacon

47. Generics (U.K.) Limited & Anr v Yeda Research and Development Company Limited & Anr [2017] EWHC 2629 (Pat) (26 October 2017) Arnold J

48. Fisher & Paykel Healthcare Limited & Anr v ResMed Limited & Anr [2017] EWHC 2748 (Ch) (10 November 2017) Mr Richard Meade QC

49. Fujifilm Kyowa Kirin Biologics Company Limited & Ors v Abbvie Biotechnology Limited [2017] EWHC 395 (Pat) (3 March 2017) Henry Carr J

50. Actavis Group PTC EHF & Ors v ICOS Corporation & Anr [2017] EWCA Civ 1671 (1 November 2017) Lewison, Kitchin & Floyd LLJ

51. Fujifilm Kirin Biologics Company Limited v AbbVie Biotechnology Limited [2017] EWHC 395 (Pat) (3 March 2017) Henry Carr J

52. GlaxoSmithKline UK Limited v Wyeth Holdings LLC [2016] EWHC 1045 (Ch)

53. Edwards Lifesciences LLC & Ors v Boston Scientific Scimed, Inc [2017] EWHC 405 (Pat) (3 March 2017) HHJ Hacon

54. Pozzoli SpA v BDMO SA [2007] EWCA Civ 588

55. Schlumberger Holdings Limited v Electromagnetic Geoservices AS [2010] EWCA Civ 819

56. Varian Medical Systems International AG v Elekta Limited & Anr [2017] EWHC 712 (Pat) (6 April 2017) Birss J

57. Unwired Planet International Limited v Huawei Technologies Co. Limited & Ors [2017] EWCA Civ 266 (12 April 2017) Gross LJ, Floyd LJ, Arnold J

58. MedImmune Limited v Novartis Pharmaceuticals UK Limited [2012] EWCA Civ 1234

59. Biogen Inc v Medeva Plc [1996] UKHL 18

60. Teva UK Ltd v Leo Pharma A/S [2015] EWCA Civ 779

61. Actavis Group PTC EHF & Anr v ICOS Corporation & Anr [2017] EWCA Civ 1671 (1 November 2017) Lewison, Kitchin & Floyd LLJ

62. Generics (UK) Limited & Ors v H. Lundbeck A/S [2007] EWHC 1040 (Pat)

63. Novartis AG v Generics (UK) Limited [2012] EWCA Civ 1623

64. Edwards Lifesciences LLC & Ors v Boston Scientific Scimed, Inc [2017] EWHC 405 (Pat) (3 March 2017) HHJ Hacon

65. Sandoz Limited & Anr v G.D. Searle LLC & Anr [2017] EWHC 987 (Pat) (3 May 2017) Arnold J

66. Generics (U.K.) Limited & Anr v Yeda Research and Development Company Limited & Anr [2017] EWHC 2629 (Pat) (26 October 2017) Arnold J

67. Generics (UK) Ltd v Yeda Research and Development Co Ltd [2013] EWCA Civ 925

68. Idenix Pharmaceuticals Inc v Gilead Sciences Inc [2016] EWCA Civ 1089

69. Varian Medical Systems International AG v Elekta Limited & Anr [2017] EWHC 712 (Pat) (6 April 2017) Birss J

70. Epoch Company Limited v Character Options Limited [2017] EWHC 556 (IPEC) (22 March 2017) HHJ Hacon

71. Illumina, Inc & Ors v Premaitha Health Inc & Ors [2017] EWHC 2930 (Pat) (21 November 2017) Henry Carr J

72. Kirin-Amgen Inc & Ors v Hoechst Marion Roussel Limited & Ors [2004] UKHL 46

73. Aerotel Ltd v Telco Holdings Ltd & Ors [2006] EWCA Civ 1371

74. Symbian Ltd v Comptroller General of Patents [2008] EWCA Civ 1066

75. Zircotec IP Ltd v TWI Ltd [2017] EWHC 1075 (Ch) (8 February 2017) Sir Geoffrey Vos

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

UK: Validity - Annual Patents Review 2017