Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 25 October 2024 - is below:

UK

Two RSV vaccine patents found invalid in Pfizer v GSK.

On 7 October 2024, Mr Justice Mellor handed down his decision in Pfizer v GSK [2024] EWHC 2523 (Pat). GSK were the proprietors of the patents in suit : EP (UK) 3 109 258 (EP 258) and EP (UK) 2 222 710 (EP 710), both of which described a strategy for vaccinating against respiratory syncytial virus (RSV) using a form of the “F” antigen of RSV which had been modified to stabilise it in its “pre-fusion” form.

Skilled team and CGK

Although the parties agreed that the skilled team would be led by a vaccinologist and the team would have expertise in immunology, virology and structural/molecular biology, they disagreed on whether the vaccinologist would have sufficient knowledge of molecular biology to avoid consulting an expert on the field. Pfizer contended that vaccinologist would consult a structural/molecular biologist who would be part of the skilled team when issues arose relating to protein structure. The Judge held that Pfizer’s submission was borne out on the evidence of how real-life research groups had operated at the priority date, and that the prior art and the patents both suggested that the skilled team should comprise a structural/molecular biologist. The Judge also criticised GSK’s approach whereby experts were “siloed” from each other and had not been able to share their views as a real skilled team would, leading to an “unduly narrow” approach to the CGK and the prior art.

Infringement

As a preliminary issue in the infringement analysis, the Judge had to rule on the definitions of “polypeptide”. Although GSK provided several examples of “polypeptide” being used interchangeably with “protein” and thereby encompassing structures containing more than one chain of amino acids linked by peptide bonds, the Judge held that these examples were irrelevant as they did not address the term as used in the claims of the patents. The Judge therefore preferred Pfizer’s construction, whereby “polypeptide” referred to a single chain of amino acids linked by amide bonds.

In light of his finding on the meaning of “polypeptide” the Judge held that since Pfizer’s product comprised two polypeptides linked by disulfide bonds (rather than amide bonds), it did not fall within the scope of the claim wording (present in both EP 258 and EP 710) of “a soluble F protein polypeptide comprising an F2 domain and an F1 domain” on the normal construction.

In considering infringement of by equivalence, the Judge preferred the evidence of Pfizer’s expert – by relying on a disulfide linkage between two polypeptides rather than a single polypeptide, the goal of stabilisation had been achieved in a 

substantially different way in Pfizer’s product over the method claimed in the patents. Also, in relation to the third Actavis question, the patents had described additional methods of stabilisation over those claimed – leading the Judge to find that the patentee had probably intended strict compliance with the claimed method.

Obviousness

One of Pfizer’s challenges to the validity of the patents was lack of inventive step. In this regard, Pfizer relied on prior art including the abstract published at an RSV symposium by Professor Ted Jardetzky (who also appeared as a fact witness in the case), together with the slides and the public oral disclosure made at that symposium by Professor Jardetzky (the Jardetzky Materials). Pfizer also relied on a Nature paper by Professor Jardetzky’s group on the structure of the F protein (Yin) and an abstract from the American Society for Virology (the ASV Abstract).

GSK sought to argue that the approach of the patents in suit was just one of many open to the skilled vaccinologist at the priority date. However, the Judge found that GSK’s contentions seemed to be directed to an unpleaded case of obviousness over the common general knowledge and did not address the prior art.

Applying the Pozzoli test which is commonly used to evaluate obviousness in the UK, the Judge found that the difference between the Jardetzky Materials and the patents was the virus whose F protein was stabilised – PIV (parainfluenza, like RSV a member of the Paramyxovirus family) rather than RSV. The Judge held that the skilled team would have been aware of the analogy between the two viruses and would consider it obvious that they could make a stabilised form of the pre-fusion conformation of the F protein of RSV as claimed by the patents.

Although the Judge considered the Jardetzky Materials the closest prior art, he also found the patents obvious over Yin and the ASV Abstract.

Secondary Evidence

In their closing skeleton argument, GSK introduced a case based on secondary evidence. GSK cited a large number of pre- and post- priority publications and sought to argue that, since none of those documents suggested that the pre-fusion form of the F protein in RSV should be stabilised in an effective vaccine, the invention must not have been obvious.

The Judge was unconvinced – the published literature cannot reflect everything that is going on in a particular field. Although there might not have been data produced on the approach of the patents for some years after the publication of the prior art, this was not sufficiently strong to rebut the Judge’s conclusion on obviousness. Additionally, Pfizer were able to provide certain Novartis patent applications filed during the period addressed by GSK which took a similar approach to that of the patents.

The Judge was also critical of GSK’s decision not to plead their case on secondary evidence before closing, as it had deprived Pfizer of a chance to properly address and respond to it with their own evidence. GSK had also failed to provide oral evidence from real-world workers whose words it had relied on, meaning that the secondary evidence was not, in the Judge’s view, sufficiently complete and testable to be of value to him.

Plausibility

A further challenge based on alleged lack of plausibility was rejected using the FibroGen approach. Pfizer argued that the examples of the patents had only made it plausible that the claimed modified antigens could be used for vaccinating against RSV in the presence of adjuvants. However, the Judge held that the demonstration of an immune response in the absence of adjuvants, even a reduced one, in some of the examples, was sufficient to render it plausible that the invention worked both with and without adjuvants and was therefore plausible across the scope of the claims.

Arrow declaration

Pfizer applied for an Arrow declaration on the grounds that at the priority date it was obvious to make an RSV antigen which resembled the pre-fusion state and to use that antigen in the treatment or prevention of RSV-associated diseases. The Judge referred to his findings on obviousness and granted the declaration, noting that making the declaration would have a useful purpose. The Judge agreed with Pfizer that the Arrow declaration would be useful as it would provide commercial certainty to Pfizer in light of GSK’s unclear strategy in relation to its other divisionals. There was also a public health interest in having Pfizer’s vaccine made available in the UK.

The decision is of particular interest because it demonstrates a rather sceptical approach to so-called secondary indicia of obviousness – e.g. contemporaneous reactions of people working in the relevant field at the time.  It also provides a further example of English Patent Court being willing to grant Arrow relief where the interests of justice would be served.

PORTUGAL

Supreme Court finds sitagliptin/metformin SPC valid.  

In a recent decision from the Supreme Court, a panel of three judges considered an appeal from the Lisbon Court of Appeal relating to Merck’s combination SPC for sitagliptin/metformin. While the Supreme Court considered a number of issues (including how the Court of Appeal had dealt with the evidence in the case) the core issue in the proceedings related to the validity of the sitagliptin/metformin SPC. At first instance this SPC had been found invalid as it did not fulfil the requirements of Art. 3(a), (c) and (d) of the SPC Regulation. At the Court of Appeal, this decision was overturned and the SPC had been held valid.

In its consideration of the validity of the sitagliptin/metformin SPC the Court looked at the requirements of Art. 3 of the SPC Regulation as well as the recent CJEU case law of Teva and Royalty Pharma on the interpretation of this article. The Portuguese Court considered that those cases assisted in understanding what earlier case law from the CJEU meant when it said a product is protected by a basic patent in force if the claims necessarily and specifically relate to that product, even where the product is not expressly mentioned. The Supreme Court found that as one of the claims of the basic patent upon which the SPC was based was to the combination of sitagliptin and metformin the test that the product is protected by a basic patent in force was fulfilled, Art. 3(a) was therefore satisfied. The Supreme Court then went on to consider Art. 3(c) and 3(d) of the SPC Regulation which require, respectively, that no previous SPC has been granted for that product and the MA relied on for the grant of the SPC is the first authorisation to place the product on the market as a medicinal product. It considered both aspects were fulfilled here, a previous SPC for sitagliptin alone not being for the same product and the combination MA for sitagliptin/metformin was the first MA for that medicinal product. The SPC was therefore held valid.

This case is part of the ongoing European dispute in relation to the sitagliptin/metformin SPC. There is currently a reference pending before the CJEU which seeks further clarity in relation to aspects of Art. 3(a) and 3(c). The Advocate-General’s opinion in that reference was given in June this year and a decision is awaited. The Appellants made the Supreme Court aware of the pending reference but on considering the facts in this case and the position under Portuguese law the Supreme Court considered that a stay was not justified. A stay can only be awarded under Portuguese law if there is a relationship of dependence and prejudice between two cases. The Supreme Court considered there was no prejudice here. A relevant factor in this decision by the Supreme Court was the abundance of case law from the CJEU on Art. 3 of the SPC Regulation which the Supreme Court considered would result in no risk in contradiction of the current decision with the CJEU case law.

USA

Court of Appeal for the Federal Circuit clarifies what software processes are eligible for patent protection.

On 9 September 2024, the Court of Appeals (CoA) for the Federal Circuit reversed the District Court’s decision to grant summary judgment to GoPro on the grounds that the asserted claims in the patent were ineligible under 35 U.S.C. § 101.

Contour IP Holdings (Contour) asserted U.S. Patent Nos. 8,890,954 and 8,896,694 against GoPro. The patents both related to point-of-view cameras that allowed a user to send real time information to a remote device. Lower quality videos were streamed to the remote deice to achieve real time playback without exceeding wireless connection bandwidth, and the higher quality was to be viewed later. In 2018 there was a Claim Construction Order holding that the word “generate”’ meant recording in parallel, distinguishing it from the prior art where high resolution video is generated first, then converted to a lower resolution for streaming.

GoPro sought summary judgment that the claims were directed to the abstract idea of taking two photos which is functional and an ‘abstract idea’. Adopting the Alice test, the CoA first asked whether the claims directed to an abstract idea. The claims require the parallel data stream to be recorded with the lower quality being transferred to the remote device. As decided in the Claim Construction Order, this is an improvement over the relevant technology. Accordingly, the CoA found that the claims are directed to a technological solution to a technological problem. The District Court had erred in characterizing the claims too generally in the context of assessing eligibility. The CoA held that the asserted claims are directed to patent eligible subject matter, reversing the District Court’s decision and remanding the case for further proceedings. 

UPC

Mannheim Local Division refuses r. 191 RoP Order.

On 20 October 2024, the Mannheim LD refused an Order for information by DISH. DISH had issued proceedings against Aylo for patent infringement relating to internet streaming services.

DISH requested an Order for information on the content delivery networks (CDNs) used to deliver the video files, where the servers were located, whether the files were stored on the CDNs, and how the files were encoded. It argued this information was reasonably required for the legal action. The Court refused to grant the Order, noting that it was not the Courts job to reduce applications to their core. It is therefore important for parties not to make their r. 191 requests too broad in the hope the Court will narrow it to what is reasonably required.

In relation to Art. 67 UPCA, r. 191 Alt. 1 VerfO, the Court found that an applicant cannot rely on this during ongoing legal proceedings where patent infringement has not been decided, unless there are special circumstances. The purpose of this provision is to identify further infringers in a distribution or supply chain following a finding of infringement. The Court offered no guidance on what could constitute a special circumstance. 

R. 191 Alt. 2 VerfO relates to requests for specified information where it is required for prosecution. It is not for information that a party might need to substantiate a claim or objection.

Assessing disputed facts is a matter for the Court. The Court said that it was not clear at this stage how Aylo will respond to DISH’s allegations so it was not apparent why the information was needed. The requests were also held to be too vague, and DISH had not exhausted all sources of information reasonably available to them.

UPC

Munich Central Division rules on validity and assesses jurisdiction of its own motion (UPC_CFI_252/2023).

In July 2023, NanoString Technologies Europe Limited (the Claimant) brought an action against the President and Fellows of Harvard College (the Defendant) in the Munich Central Division of the UPC, seeking the revocation of EP 2 794 928 (EP 928) (the UPC Action). In a decision dated 17 October 2024, the Central Division confirmed that it had jurisdiction to hear the revocation action and revoked EP 928 in its entirety with effect in the jurisdictions of Germany, France and the Netherlands.

As previously reported in Irides Weekly Update, a request for provisional measures in relation to EP 928 against two NanoString Technologies entities was rejected by the Munich Local Division in October 2023.

Jurisdiction

In July 2022, NanoString Technologies Germany GmbH brought a revocation action against the German national part of EP 928 in the German Federal Patent Court (BPatG). The BPatG revoked the German part of EP 928 in its entirety in May 2024. An appeal to the Bundesgerichtshof is ongoing.

In view of the ongoing German action, the Defendant lodged a Preliminary Objection (PO) challenging the jurisdiction of the UPC and seeking a dismissal or stay of the UPC Action in so far as it concerned the German national part of EP 928 (under Art. 29 and 30 of the Brussels I recast Regulation). The Defendant unconditionally withdrew the PO at the oral hearing and both parties asked the Central Division to accept jurisdiction. Nevertheless, under Union Law the Central Division was required to examine its jurisdiction under Art. 29-32 Brussels I recast Regulation of its own motion.

The Central Division held that Art. 29 (and, by extension, Art. 31) of the Brussels I recast Regulation do not apply in this case because the claimant in the German action, NanoString Technologies Germany GmbH, is not the same legal entity as the Claimant.  The fact that both entities belong to the same group of companies and have the same parent company is insufficient to conclude that their interests are identical and indissociable. No evidence was submitted to suggest that a judgment delivered against one of the entities would have the force of res judicata against the other. This decision is consistent with the approach of the CJEU and the UPC Court of Appeal in Mala Technologies/Nokia Technologies.   

The Central Division decided not to exercise is discretion under Art. 30 of the Brussels Regulation to stay proceedings where a ‘related action’ is pending before a national court (as was the case here). The Central Division concluded that in light of the specific circumstances of this case (which deviated from the circumstances before the UPC Court of Appeal in Mala Technologies/Nokia Technologies) the interests of the parties and procedural economy outweighed the risk that the Court of Appeal of the UPC and the Bundesgerichtshof proceedings may become pending in parallel. Those circumstances included:

• The parties had unanimously requested the Central Division to issue a decision to obtain legal certainty as soon as possible.
• The UPC Action was already at an advanced stage and therefore the procedural and economical benefits of a stay were limited.
• Proceedings before the Bundesgerichtshof are still at an early stage and no decision can be expected within the next year.
• Staying the UPC Action would risk preventing the parties from obtaining a decision with respect to French and Dutch national parts of EP 928.
• There is no risk of contradictory or conflicting decisions with respect to at least the BPatG decision since the Central Division reached the same finding on validity (see below).

The Central Division held that it would come to the same conclusion if it were to exercise its discretionary power to stay proceedings under r. 295(m) RoP.

Validity

The Central Division found that claim 1 as granted lacked novelty over a prior art citation called “Göransson”. In reaching its decision the Central Division applied the principles of construction established by the UPC Court of Appeal in NanoString/10x Genomics and VusionGroup/Hanshow (which apply equally to the assessment of validity), relying heavily on the description to interpret a number of claim features.

The Central Division went on to find auxiliary requests 1-8 to be invalid for lack of inventive step. The Central Division considered Göransson to be a ‘realistic’ starting point for the assessment of inventive step since it disclosed all the features of claim 1 as granted and had the same underlying problem as EP 928.

When addressing obvious next steps from Göransson the Central Division referred to the considerations outlined by the UPC Court of Appeal in NanoString/10x Genomics, in particular: 

• whether the skilled person would be motivated (i.e. would have an incentive) to consider and implement the claimed solution as a next step.
• whether the skilled person would have expected any particular difficulties in taking any next steps.
• a technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for inventive step, but a feature that is selected arbitrarily from several possibilities cannot generally contribute to inventive step.

The Central Division noted that it had come to the same conclusion as the BPatG on essentially similar grounds. Its decision was also substantially in line with the findings of the UPC Court of Appeal in NanoString/10x Genomics where many similar issues were addressed.

Late filed auxiliary request

Shortly (1.5 months) before the original oral hearing date the Defendant filed a second application to amend seeking a new auxiliary request 2. The Central Division refused to admit this request into the proceedings on the basis that the request could and should have been filed earlier. Citing preamble r. 7 RoP, the Central Division noted that the UPC is a front loaded system and that parties are obliged to set out their full case as early as possible. The Defendant argued that it had filed the request in response to a point of construction in the UPC Court of Appeal decision in NanoString/10x Genomics, and therefore it could not have set out its full case earlier. However, the Central Division found that the Defendant was aware of this issue of construction since at least November 2023 when the Claimant filed its Reply to Defence to Revocation.