AIPPI (UK) Event: 2016's patent cases - all you really need to know

Like AIPPI's final talk of 2016, the AmeriKat is also
bristling - but instead of patent law issues, she is bristling
having spotted someone wearing socks with sandals
Right before the Christmas holidays, the UK Group of AIPPI held the annual session devoted to reviewing the year's patent cases.  This year Andrew Lykiardopoulos QC’s attempted the Herculean feat, summarizing a year’s worth of patent cases in a 90 minute presentation (and a helpful 60 page handout).   For those that were busy braving the dark London streets for last minute present buying instead, the ever succinct Steven Willis (Bristows) reports on the evening's festivities:

"Andrew recapped that in 2016, there were 18 Patents Court judgments on issues of validity and/or infringement.  Of those, two concerned issues of infringement only (both resulting in a finding of non-infringement).  Of the remaining 16, only four resulted in a patent that was valid and infringed. 

Andrew considered that Regeneron v Kymab [2016] EWHC 87 (Pat) represented the most technically difficult decision of the year, although he noted that Electromagnetic Geoservices v PGS would have run it pretty close had the case not settled.

Andrew considered that the cases before the English Courts in 2016 indicate that the UK is still considered one of the foremost jurisdictions in which to begin “clearing the way”; the English Courts are thorough and fast and an English Court judgment invalidating a patent may be a good way to avoid a German injunction.

In terms of the speed with which patent cases can be resolved in the English Courts, Andrew highlighted Napp v Dr Reddy’s, where (despite the Court requiring expert evidence and statisticians to resolve the question of infringement) final judgment that the patent was not infringed was made within 6 months according to the following timetable:

19 February 2016
Claim form issued
16 March 2016
Expedited trial ordered
7-8 June 2016
Trial took place
28 June 2016
Arnold J issued judgment finding patent not infringed ([2016] EWHC 1517 (Pat))
2 August 2016
Court of Appeal hearing took place at which the parties were informed of the Court’s decision to uphold Arnold J ([2016] EWCA Civ 1053)

Andrew challenged any other jurisdiction to match that.

Other highlights included Sir Robin Jacob’s final decision in Richter Gedeon v Generics [2016] EWCA Civ 410 and of course the battle of the judicial titans of 11 South Square in the pregabalin litigation.

Andrew approached the case law on an issue-by-issue basis (according to a Christmas-themed menu):

The Amuse Bouche
In Celltrion v Biogen [2016] EWHC 188 (Pat), Carr J made clear that parties should be thinking about trial dates from the beginning of litigation and should, in accordance with the Practice Statement, be seeking to list the trial within 12 months of the claim form being issued.  Carr J highlighted the motivation for the Practice Statement as being the need to speed up to avoid “falling behind certain other jurisdictions”. 
A Choice of Starters
Novelty – Standard of Proof
Can something probable be inevitable?  This was Andrew’s characterisation of the riddle faced by Birss J in Actavis v Eli Lilly [2016] EWHC 1955 (Pat).  The Judge was forced to grapple with the apparent tension between, on the one hand, the requirement that for a feature of a claim to be anticipated it must be the inevitable result of carrying out the prior art teaching and, on the other, the standard of proof being the balance of probabilities.  Birss J agreed with Floyd J in Actavis v Janssen [2008] EWHC 1422 (Pat) that the presence of another fairly remote possibility did not preclude a finding of “inevitable result”.  As such, the fact that it was “highly likely” that following the prior art teaching would result in a product with the claimed property was sufficient for the claim to be anticipated. 
De minimis and Quia Timet injunctions
Napp v Dr Reddy’s [2016] EWHC 1517 (Pat) provides a useful summary of the law relating to the application of the de minimis principle and of the interplay between de minimis and quia timet injunctions.  Arnold J’s consideration of the authorities (which included calculating that “trace amounts” of 5000 tonnes of soya bean meal in Monsanto v Cargill [2007] EWHC 2257 (Pat) equated to 250 tonnes of product carrying potentially infringing DNA) led him to reject the Claimant’s “a little can add up to a lot” argument.  In this case, the skilled person would not consider 0.01% of total production to amount to an infringement, even if this amounted to 200 patches (randomly distributed in a total of 2 million). 

Andrew also drew attention to Arnold J’s treatment of the Defendant’s argument that, for the purposes of obtaining a quia timet injunction, the Claimant needs to show a threat to infringe on a scale which would give rise to a sufficiently strong probability of harm to the patentee.  Although Arnold J confessed to being “initially attracted” by the submission, he ultimately held that it confused two concepts: “One is whether there is a sufficiently strong threat to justify the commencement of proceedings.  The other is whether the acts threatened will fall within the claim sufficiently often to amount to an infringement”.  Accordingly, “if there is a clear threat to do acts which fall within the claim sufficiently often that they cannot cannot be discounted as de minimis, then in my judgment that is sufficient to justify the bringing of proceedings on a quia timet basis.

Finally, Andrew referred to Arnold J’s obiter statement that even where the Claimant gets over the de minimis hurdle, it may still be “disproportionate and a barrier to trade” to award an injunction.  Andrew drew parallels with the availability of an injunction (or lack thereof) in cases involving second medical use patents (where the generic is entitled to sell for one or more non-patented indications) and cases involving Standard Essential Patents which are subject to a FRAND obligation, i.e. other categories of case where much of what the alleged infringer is doing is lawful. 
Post-trial Amendment
Andrew considered that Warner-Lambert [2016] EWCA Civ 1006 indicated that not much has changed since Nikken v Pioneer [2005] EWCA Civ 906 in relation to the potential to amend a patent post-trial.  Andrew suggested in particular that “re-writing amendments” should be proposed before trial (or in certain circumstances at the commencement of trial).  Andrew did not consider Arnold J’s rejection of Warner-Lambert’s attempt to amend its patent post-trial (and finding that such amendment would amount to an abuse of process) ([2015] EWHC 3370 (Pat)) or Floyd LJ’s upholding of the decision ([2016] EWCA Civ 1006) to be controversial.  Andrew considered that the days of proffering a raft of last minute amendments are over both in the UK and at the EPO. 
The Soup
Obviousness over the CGK Alone
Andrew highlighted two judgments from Birss J which suggest that he does not particularly warm to a pleading of obviousness over CGK alone.  Firstly, in Accord v Medac [2016] EWHC 24 (Pat), Birss J emphasised that relying on combinations of features that are said to be CGK “can pose a particularly acute hindsight problem” and furthermore indicates that the combination is “one which the person attacking validity has not been able to find as a pre-existing combination in the concrete prior art”.  Birss J rejected an argument that the invention was obvious over CGK in Unwired Planet v Huawei [2016] EWHC 576 (Pat) in similar terms: “the argument presented a combination of common general knowledge features which had been created with hindsight knowledge of the patent.

However, in Hospira v Cubist [2016] EWHC 1285 (Pat), Carr J suggested that he would have found Claim 1, which included the use of a standard buffer, a standard agent and a standard purification process, obvious over the CGK alone had he not already found it obvious over a piece of prior art.

Daniel Alexander QC’s judgment in Meter-Tech v British Gas [2016] EWHC 2278 (Pat) reiterates that, where a party alleges obviousness over CGK alone, it must clearly set out what it alleges the CGK to be in its statement of case.  Furthermore, Daniel Alexander QC held that the party must set out how the CGK differs from the invention and why the CGK renders the invention obvious.  However, Daniel Alexander QC also emphasised that the court “should be careful not to place undue forensic weight on the precise way in which such a pleading is done” suggesting that there may be a certain amount of scope to adopt a “wait and see” approach.

Researching the answer
In KCI v Smith & Nephew [2010] EWHC 1487 (Pat), Arnold J held that information that would be acquired by the skilled person as a matter of routine can, in addition to CGK, be taken into account in considering inventive step.  In Richter Gedeon v Generics [2016] EWCA Civ 410, Sir Robin Jacob upheld Sales J’s finding that such routine steps might include asking the author of a piece of prior art for clarification:  “I cannot see a logical distinction between a case where it is obvious to look something up and one where it is obvious to ask and clear that the answer would be given and would be clear.”  However, as Andrew pointed out, Sir Robin was careful to highlight the unusual facts of this case.  As such, it may be that the finding is confined to its facts rather than being a principle of broader application.

In GSK v Wyeth [2016] EWHC 1045 (Ch), Carr J agreed with Sales J’s attempt to “modernise” the concept of CGK in Teva v Astrazeneca [2014] EWHC 2873 (Pat) in view of the “procedure for the dissemination of scientific knowledge in the age of the internet”.  Carr J thus held that the CGK should be taken to include “material which the skilled addressee knows to be available on-line and which is generally accepted as a good basis for further action
Obvious to try
Carr J’s judgment in Actavis v Lilly [2016] EWHC 1955 (Pat) clarifies the test that is to be applied where an invention is said to be obvious to try.  In St Gobain v Fusion Provida [2005] EWCA Civ 177, Jacob LJ set the barrier at: “more or less self evident that what is being tested ought to work”.  The House of Lords in Conor v Angiotech [2008] UKHL 49 held that the test was whether there was a “fair expectation of success” with the degree of expectation required dependent on the facts of the case.  As Conor did not include reference to the test elucidated by Sir Robin in St Gobain, Carr J  felt able to find that “on the facts of this case I do not believe that the St Gobain way of putting the question is the appropriate one”.  Andrew suggested therefore that St Gobain can be considered confined to its facts and that the “more or less self evident” phrase has been put to bed.  
The Main Course
Construction and Infringement of Swiss Type Claims
Andrew reminded the audience of Arnold J and Floyd LJ’s 2015 judgments concerning the construction of Swiss-type second medical use claims.  In refusing Warner-Lambert’s application for an interim injunction in January 2015 ([2015] EWHC 72 (Pat)), Arnold J held that there was a requirement that the manufacturer subjectively intended (at the point of manufacture) that his medicament be used in the treatment of the patented indication.  As there was no such intention, there was no arguable case of infringement.  On appeal, Floyd LJ disagreed with Arnold J’s approach and suggested that the test should be one of objective foreseeability ([2015] EWCA Civ 556).  However, as Floyd LJ chose not to disturb Arnold J’s finding that the balance of convenience lay with the Defendants, the interim injunction was refused and his statements on construction remained obiter.  In his judgment on the merits of the action ([2015] EWHC 2548 (Pat)), Arnold J expressed serious reservations with Floyd LJ’s approach but resolved to attempt to apply it, nevertheless finding that the patent was not infringed (having also held the patent invalid). 

The parties appealed in relation to both validity and infringement.  In October 2016 ([2016] EWCA Civ 1006), Floyd LJ upheld Arnold J’s findings concerning the validity of the patent.  Noting Arnold J’s “profound reservations” with the correctness of the approach he had previously proposed, Floyd LJ nevertheless sought to provide some clarification on the construction of Swiss-type claims holding that “it is only essential that the manufacturer is able to foresee that there will be intentional use for the new medical indication”.  However, Floyd LJ suggested that it should be possible to “negative” that intention “where the manufacturer has taken all reasonable steps within his power to prevent the consequences occurring”. 

Once again Floyd LJ’s statements are obiter, but Andrew noted that two obiter statements, drafted in strong terms are likely to carry significant weight.  Andrew further noted that all is still to play for in relation to post-EPC 2000 claims. 
In Napp v Dr Reddy’s [2016] EWHC 1517 (Pat), the Court considered the construction of ranges for the first time since the Court of Appeal decision in Smith & Nephew v ConvaTec [2015] EWCA Civ 607.  Andrew noted that the Court’s decision in that case, where 0.77 was held to fall within a range of 1-25 raised a few eyebrows.  In Napp, Arnold J rejected the Claimant’s suggestion that a claim to a range of 10-15% would be understood by the skilled person to have been expressed to the nearest 5% and would therefore be understood to encompass a range of 7.5-17.5%:  “there is nothing in the specification of the Patent which sheds any light on the precision of this numerical limit.  On its face, it appears to be expressed as the nearest whole number.
Some Trimmings
Ambiguity leading to insufficiency
Birss J’s judgment in Unwired Planet v Huawei [2016] EWHC 576 (Pat) provides a useful summary of the law of insufficiency, including a detailed consideration of insufficiency resulting from ambiguity.  Birss J agreed with Arnold J in Generics v Yeda [2012] EWHC 1848 (Pat) in that this branch of insufficiency requires more than a “fuzzy boundary” at (as Andrew put it) the point that the claim ends and un-monopolised life begins.  Birss J noted that in the cases in which a finding of insufficiency by ambiguity has been found (Kirin Amgen [2004] UKHL 46 and Sandvik [2011] EWHC 3311 (Pat)), the determination of the scope of the claim turned on carrying out a technical test to find out if a product or process is within the claim or not.  In such cases “if the skilled person cannot know whether they are carrying out the right test, then the claim is truly ambiguous and therefore insufficient”.
Legal Priority
In Idenix v Gilead [2016] EWCA Civ 1089, Kitchin LJ gave the provisional view, obiter, that the transfer of equitable title in the priority year could be sufficient to render the transferee the successor in title for the purposes of the Paris Convention, which is in line with previous Patents Court jurisprudence on this point.

In Actavis v Eli Lilly [2016] EWHC 1955 (Pat), Birss J considered the extent to which a party relying on a novelty-only citation is required to prove that the third party patentee was entitled to priority.  He held that “the legal burden of proof lies on the party attacking validity… However, if sufficient evidence is available to support an inference that legal priority exists, an evidential burden will have shifted to the patentee to call evidence to rebut that inference”.  In this case, “the application taken at face value supports an inference that legal priority exists”.  However, the situation may be different if, as was the case in Idenix, the novelty-only citation was an application belonging to either side.
The Gravy
On to the gravy of this year’s AIPPI Christmas feast – plausibility – so-assigned because it has been “sloshed on everything” this year. 

One of the key issues in the law of plausibility is the extent to which experimental data is required in a patent in order to render it plausible.  In Accord v Medac [2016] EWHC 24 (Pat), Birss J referred to Carr J’s decision in Actavis v Lilly [2015] EWHC 3294 (Pat) as authority for the position that a patent does not need to contain experimental data in order to be plausible.  However, Accord was distinguishable from Actavis by virtue of the lack of “information and reasoning” in the patent which had been enough to render the patent in suit in Actavis plausible. 

In Actavis v Eli Lilly [2016] EWHC 1955 (Pat), Birss J emphasised that the requirement for experimental data will turn on its facts and also made clear that there is daylight between the tests for plausibility and for whether something is obvious to try.  Birss J went on to arguably impart a requirement for plausibility into the law of novelty by holding that a potentially anticipating disclosure will only be enabling if it is plausible.

In Warner-Lambert [2016] EWCA Civ 1006, Floyd LJ upheld Arnold J’s finding that Warner-Lambert’s claim to pregabalin in neuropathic pain was invalid for lack of plausibility.  The data in the patent related to inflammatory pain (which has a central sensitisation component).  The claim was plausible in relation to peripheral neuropathic pain (which also has a central sensitisation component) but not in relation to central neuropathic pain (which doesn’t).  Floyd LJ affirmed that there is no reason to align the tests for plausibility and obvious to try. 

In Idenix v Gilead [2016] EWCA Civ 1089, plausibility was dealt with under inventive step.  The scope of the monopoly must be justified by the technical contribution and the claimed technical effect must be plausible in light of the specification and CGK; it cannot be established solely by post-published evidence. 

Finally, in Merck v Shionogi [2016] EWHC 2989 (Pat), Arnold J emphasised that the assessment of plausibility/sufficiency is a two-stage enquiry.  It is not permissible for either party to rely on post-published evidence to determine whether the disclosure renders the claim plausible across its breadth.  In the event that the disclosure does render the claimed technical effect plausible, the next stage is to consider whether the evidence establishes that the claim cannot be performed across its scope without undue burden.  It is permissible to utilise post-published evidence for the second stage.

A Few Mince Pies
Submissions post-trial
In Regeneron v Kymab [2016] EWHC 87 (Pat), Carr J referred to the importance of drawing material omissions in a Patents Court judgment to the Court’s attention rather than “attempting to save up such points for the Court of Appeal”.
Preparation of Expert Reports
Arnold J was critical of both parties’ preparation of their experts in ASE v Rapiscan [2016] EWHC 756 (Pat).  The Claimant’s expert had been shown the prior art but not the Patent.  This did not enable the expert to consider whether the steps between the prior art and the patent would have been obvious.  The fact that the expert did not reach the invention when equipped with the prior art did not tell you whether it would have been obvious to the person skilled in the art to reach it.  On the other hand, the Defendant’s expert was not informed that he was not supposed to use hindsight knowledge of the invention when considering inventive step.

In Thoratec v AIS [2016] EWHC 2637 (Pat), the parties were criticised for failing to appreciate that an order to adduce evidence from two experts was intended to mean one expert from each of two technical fields (in this case a biomedical engineer and a clinician).  This should have been clear to the parties in light of it being “well established that the Patents Court does not permit duplicative expert evidence to be adduced”. 

Finally, in Merck v Shionogi [2016] EWHC 2989 (Pat), Arnold J was critical of the length of time spent in cross examination attacking the expert’s suitability for the task at hand.  Although it was “both legitimate and helpful to explore such matters as the witnesses’ qualifications and experience”, too much time spent on these issues was “unfair to the witness, unhelpful to the court and waste expensive time
Use of technical experts
On a more positive note, in Electromagnetic Geoservices v PGS [2016] EWHC 881 (Pat), Birss J was commendatory of the technical teach in provided to him by a neutral scientific adviser noting that in cases of significant technical complexity, such an additional step will often be useful and proportionate.  
Hot tubbing
Finally in the Unwired Planet v Huawei non-technical trial, Andrew reported that Birss J had asked the parties’ economic experts to consider a list of points, following which they were sworn into the box together where they considered the issues with the Judge.  The experts were then cross examined individually and the parties’ advocates were permitted to revisit issues that the experts had previously discussed with the Judge. 

Andrew ended the presentation with a look ahead to 2017.  He drew attention to the Unwired Planet v Huawei & Samsung litigation where judgment following a lengthy non-technical trial is expected to be handed down by Birss J in January 2017...[We await with bated breath, says Merpel]

Finally, there is the UPC, which was considered to be a topic for another day. "
AIPPI (UK) Event: 2016's patent cases - all you really need to know AIPPI (UK) Event:  2016's patent cases - all you really need to know Reviewed by Annsley Merelle Ward on Thursday, January 26, 2017 Rating: 5

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