It’s time again for a roundup of some recent decisions in the Patents Court, with the added bonus of one or two decisions from the Court of Appeal. Today we have refrigerators, HIV medication, heart valves and beer:
- Mexichem UK Ltd v Honeywell International Inc  EWCA Civ 473 (01 April 2020) on breadth of declarations.
- Genentech Inc. v The Comptroller General of Patents  EWCA Civ 475 (31 March 2020) on the scheme for payment of SPC fees.
- Master Data Center, Inc v The Comptroller General Of Patents (Costs)  EWHC 601 (Ch) (11 March 2020) on costs capping orders in appeals from costs constrained jurisdictions.
- Heineken Supply Chain BV v Anheuser-Busch Inbev SA (Rev 1)  EWHC 892 (Pat) (09 April 2020) on pandemic related alterations to trial timetables.
- Evalve Inc & Ors v Edwards Lifesciences Ltd  EWHC 514 (Pat) (12 March 2020) on pleading added matter, ‘technical success’, and pleading embodiments from within prior art.
- VIIV Healthcare Company & Ors v Gilead Sciences, Inc. & Ors  EWHC 615 (Pat) (10 March 2020) on the relevance of subjective intention to infringement by equivalents.
This case between Mexichem and Honeywell relates to six patents for refrigerant gases, in particular two refrigerant gases known as R-1234ze and R-1234yf. Mexichem is seeking declarations that the use of either of these compounds in mobile air conditioning systems was obvious by 25 October 2002 and/or 29 April 2004.
Those dates are the priority dates of the patents in suit, and also the priority dates for a further four divisional patents presently being sought by Honeywell. In the High Court Honeywell had applied to strike out the claims for the declarations sought but HHJ Hacon, sitting as a Judge of the High Court, refused to do so.
On appeal Lord Justice Floyd gave the leading judgment (handed down remotely). LJ Floyd dealt with the legal basis for such declarations brusquely:
A declaration in the form sought by Mexichem has come to be called an Arrow declaration because it was in Arrow Generics Limited v Merck & Co Limited  EWHC 1900 (Pat) that Kitchin J (as he then was) allowed the first such declaration to proceed to trial. Since then, the court’s discretionary power to grant Arrow declarations in appropriate cases has been reviewed by this court in two cases: Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie Biotechnology Limited and another  EWCA Civ 1; and in Glaxo Group Limited v Vectura Limited EWCA Civ 1496. It is now settled that such declarations may in principle be granted where justified by the circumstances.Paragraph 6 of LJ Floyd’s judgment.
Honeywell relied on two landmark judgments of the Patents Court to support its case. First, it relied on Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465 in support of the proposition that the grant of a declaration of obviousness should be tied to a particular product to be of utility.
The second case relied on by Honeywell was Technograph Printed Circuits Limited v Mills & Rockley (Electronics) Ltd  RPC 346. Honeywell said that Technograph supported the proposition that the assessment of obviousness should not be made on a step-by-step basis.
Lord Justice Floyd was not convinced by Honeywell’s argument that the declarations lacked utility given their breadth. This conclusion was founded partly on the basis that the wording of the declaration sought needed to be taken at face value: it said nothing about the inventiveness of any combinations of refrigerants or other variations, and would say nothing about the obviousness of products that used those combinations.
Lord Justice Floyd was more tempted by the argument that the court should avoid step-by-step analysis of obviousness. However, as the application was one for strike out Mexichem needed only to show there to be a real prospect of such a declaration being useful. Lord Justice Floyd considered that such a declaration may well serve a useful purpose, for two main reasons:
- in some cases a step-by-step analysis of obviousness might be permissible, for example where it reflected the way the skilled person would in fact undertake the research problem; or
- where the patentee was seeking to protect an inventive concept at the level of generality of the declaration sought.
Lord Justice Floyd, Lord Justice Lewison concurring, went on to uphold the judgment, allowing Mexichem’s declarations to continue to trial.
This judgment has already been covered by most patent firms in London. Expedited appeal hearings are rare, and this was one of the first hearings of the Court of Appeal to be conducted by video link. The substantive issue related to an application for an SPC that was accidentally filed for less than the maximum possible duration.
Dr Inga-Marlene Pietsch and Huw Evans of Gowling have posted a good summary on Lexology: https://www.lexology.com/library/detail.aspx?g=09c1c482-150f-4e21-9f43-5fc431419c6c
In short, the Court of Appeal considered itself bound by its earlier decision in Tulane Education Fund’s Supplementary Protection Certificate  EWCA Civ 890 and concluded the UK implementation of the SPC scheme to be in accordance with the SPC Regulation. On that basis there was no error or omission by the Comptroller that might justify the rectification of the error in the application for the SPC.
Also of interest is the admission by Master Data Center of twice failing to specify the appropriate term for an SPC before being saved by notification from the IPO. Perhaps time for the IPO to move to an all digital system with filers allowed to pick default rules.
3. Master Data Center, Inc v The Comptroller General Of Patents (Costs)  EWHC 601 (Ch) (11 March 2020)
In the same matter as the above the High Court had to consider whether to grant an application for a costs capping order. Costs capping orders are available under CPR part 52.19 where an appeal is made from a jurisdiction with limited, or no, costs recovery. For IP practitioners this includes the UKIPO and the IPEC.
Such orders are not commonly made but in this case Recorder Douglas Campbell QC, sitting as a judge of the Patents Court, decided that the court should grant the UKIPO an order capping the costs of the proceedings going forward. A key factor was the potential chilling effect on the UKIPO’s conduct of claims and appeals if it knew it had the possibility of footing a large costs award. The judge capped recoverable costs on appeal at £25,000 for each party.
This was a pre-trial review for a trial of the infringement and validity of two patents. The patents in question are owned by Anheuser-Busch relate to beer storage technology. In particular, those home keg contraptions that are probably as close as any of us can get to a pint of draught at the moment.
Heineken has worked on at-home keg technology for a long time, and the patents in suit date to 2007, not long after Heineken first introduced its at home keg concept to the market (Forbes).
New iterations use a system where an internal bag containing the beer is compressed to provide the supply, thereby minimising contact between the beer and air. Heineken now advertises a new system called ‘The Sub’ with refillable containers it calls ‘TORPs’ (Heineken’s product naming focus group clearly being dominated by 16 year-old military cadets).
The TORP is one of the products alleged to infringe AB Inbev’s patents.
The Judgment handed down by Daniel Alexander QC, sitting as a Deputy Judge of the Chancery Division, relates to directions for an amended trial timetable and hearing procedure in light of the Sars-Cov-2 pandemic.
The key thing to note in the judgment is that the court followed the approach of John Kimbell QC in Re Blackfriars Limited  EWHC 845. IN that case Mr Kimbell QC set out the guidance relating to remote hearings, and directed that a 5 week commercial trial should not be adjourned by virtue of the pandemic. Mr Alexander QC broadly follows that guidance, and took a relatively hard line approach on the parties involved.
The key message for litigators is that requests for additional time need to be detailed and specific. Lack of availability of a single member of a large team will not be enough. The need for access to justice and procedural fairness does not mean that a party is entitled to extra time to ensure every ‘t’ is crossed and every ‘i’ dotted.
This is the trial judgment of a major patent dispute relating to medical devices. The patents in question originate from Abbott’s work developing its ‘MitraClip’ product for treatment of mitral valve regurgitation. This occurs where the valve between the left atrium and left ventricle can’t fully shut, meaning that there is blood flow from ventricle back into atrium (this is very bad).
The allegedly infringing device is made by Edwards Lifesciences, and is called Pascal. The Judgment is by Mr Justice Birss. It is one of those judgments where you can see a direction of travel right from the start. I’ll give some choice quotes from the early sections:
- “The MitraClip has been a truly transformative advance in the treatment of this disorder. Before the MitraClip there was no effective transcatheter treatment available. The only effective treatments involved open heart surgery.”
- “Edwards sought to develop a transcatheter treatment… called MOBIUS… It worked in a different way from the MitraClip. The MOBIUS was taken into clinical trials but did not lead to an approved product… Now Edwards have produced a new product called PASCAL.“
- “Until close to trial Edwards also relied on a published application called Kuehn … much of the expert evidence was prepared starting from Kuehn”
- “Abbott also called evidence from Dr Stephen Kuehn, the inventor of the Kuehn patent application. From 1997 he led a project at St Jude to translate the Alfieri stitch procedure into a less invasive transcatheter system. The project was abandoned in 1999. Abbott relies on this as part of its answer to Edwards’ obviousness case. He was not cross-examined.”
To skip ahead, the Judge found the patent to be valid and infringed. There are many points of interest in what was clearly a hard fought case, below are three of immediate interest to other practitioners.
It is noteworthy that the Claimant’s intent to put prejudicial material before the Judge was transparent. Abbott did not run a case of commercial success, but openly said it wished to rely on the technical success of the MitraClip product. The Judge recognised at §49 that the main purpose of those submissions is prejudicial: “No judge wants to revoke a patent for a breakthrough”. The Judge warned that even where secondary evidence of inventiveness went to technical merit rather than commercial success the Defendant was entitled to ask the patentee for particulars of the case being put forward: what is the defect in the prior art? How was it overcome? This is necessary for the Defendant to be able to understand how the patentee’s product relates to the alleged invention.
Pleading Added Matter
The Defendants were criticised for the manner in which they put their case on added matter. The paragraphs of their pleading were described as opaque, and the allegation of intermediate generalisation advanced at trial was only permitted by the Judge where it was sufficiently foreshadowed in the statement of case on added matter he had previously ordered. Birss J stated:
“It is not accurate to plead a case of added matter by intermediate generalisation simply by alleging “feature A is not disclosed”. An intermediate generalisation case would be that feature A is disclosed but only in a context along with feature B whereas feature A in the claim is taken out of that context. “Time to go check your pleadings…
Working from Embodiments
A dispute arose at trial as to how to treat embodiments in prior art. This is a common issue with prior art in certain fields. Quite often only one embodiment in a prior art document presents a good obviousness attack: but is it the one the skilled person would be interested in?
Birss J turned to the authorities in Brugger v Medicaid, and the statement by Kitchin J (as he was then) in Lundbeck. In essence, to the extent a document presents multiple potentially promising avenues to the skilled person the defendant is entitled to rely on a particular embodiment as the starting point for an obviousness attack. However, this does not mean that the skilled person blindly pursues that embodiment. The skilled person considers the other embodiments, and their relative promise, as relevant factors in their assessment of the avenue(s) to follow.
Ultimately the Judge concluded that despite other aspects of the prior art being more attractive to the skilled team it would not be inventive for them to develop the embodiment in figure 18, as relied upon by the Defendant.
The Court’s judgment is also available in Evalve Inc & Ors Edwards Lifesciences Ltd  EWHC 513 (Pat) (12 March 2020), which is a separate trial relating to the public interest defence advanced by Edwards.
6. VIIV Healthcare Company & Ors v Gilead Sciences, Inc. & Ors  EWHC 615 (Pat) (10 March 2020)
This final judgment is an attempt by the defendants to strike out a pleading of equivalents. This is perhaps the most high profile equivalents case run since the Supreme Court’s judgment in Actavis v Lilly. Unlike many claims the infringement case is only advanced as a matter of equivalents.
The introduction from Birss J’s judgment reads as follows:
5. The claim is to a class of chemical compounds based on a heterocyclic structure, which has a carbamoyl-pyridone scaffold. It has a ring, referred to in the patent as the A ring, which is itself a heterocyclic ring. The claim requires certain alkyl substitutions on the A ring. It includes the DTG compound. BIC also has alkyl substitutions in the A ring, but they are ones which take it outside the normal construction of the claim. These substitutions form a bridge, as it is called, and that is the only difference from the claim. The remainder of the scaffold of BIC is within the claim.
6. The patentee contends that this bridge is one of the smallest possible changes to take the compound outside the literal wording of the claim. That is for another day.
7. The patentee also relies on a paper called Lazerwith which I understand was written by authors, all or some of whom are or were employees of Gilead. It was published in 2016. What the patentee intends to establish using Lazerwith is set out in paragraph 3 (iv), making two possibly distinct points. One is that the development of BIC started from and relied on knowledge of DTG and, the other is that the BIC was developed with the aim of maintaining the characteristics of DTG by the use of the similar structural features.
The dispute between the parties on the strike out application related to the question of intention. Is it legitimate for the patentee to plead and run a case where it asks the court to take into account the intention of the defendant?
Viiv relied in part on the classic passing off judgment in Slazenger & Sons v Feltham & Co (1889) 6 RPC 531. In the context of passing off the court will take it as a relevant factor that the defendant is trying to associate their goods with those of the claimant. Analogously, if the defendant is trying to produce something that works in the same way as a patented invention then that may be a relevant factor in considering equivalents.
Birss J warned some caution was justified in making the comparison with Slazenger. He warned that the court must keep in mind that the question to be answered was an objective one, but considered intention might have evidential value in the investigation of that question.
As an evidential issue, why does it need to be pleaded? Well, Birss J was quick to point out that the rule against inclusion of evidence in pleadings is outdated, and of more importance is setting out the case the other side has to meet.
More cynically, pleaded issues are the gateway to disclosure under the disclosure pilot. The idea of unearthing piles of prejudicial material must be appealing to Viiv. Given the value of this class of medicines expect this case to see appeal after appeal.
That’s all for now. Stay well!