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 - 20 December 2024 - is below:

CJEU

CJEU clarifies the approach to Art. 3(a) and 3(c) of the SPC Regulation.

On 19 December 2024, the CJEU issued its ruling in joined cases C-119/22 and C-149/22 concerning the interpretation of Art. 3(a) and 3(c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the SPC Regulation). The ruling, handed down almost 2 years after the hearing in early March 2023, has clarified aspects of the earlier decision in the Teva ruling in 2018 (C-121/17) on Art. 3(a) and also makes clear that the approach taken by the CJEU in the Actavis cases in relation to Art. 3(c) should not be followed. 

C-119/22 is a reference from the Finnish Court concerning Merck’s application for an supplementary protection certificate (SPC) to the combination of sitagliptin and metformin, based on a marketing authorisation (MA) to that combination. C-149/22 is a reference from the Irish Court also concerning a Merck SPC application – in this case to a combination of ezetimibe and simvastatin, again based on an MA to that combination. In each case, the patent on which the SPC is based is principally directed to one active ingredient – sitagliptin and ezetimibe respectively although each contains subsidiary claims to the use of these active ingredients in combination with metformin and simvastatin, respectively. Merck had previously obtained SPCs for sitagliptin and ezetimibe respectively based on the same patents and MAs for the single respective active ingredients.  

The combined references requested guidance on the criteria to be applied to determine when a product has not already been granted an SPC within the meaning of Art. 3(c) of the SPC Regulation and also the relationship between Art. 3(a) and 3(c). Clarification was also sought in relation to the ruling in Teva and the extent to which if a product is expressly mentioned in the claims of the basic patent, it also needs to be part of the invention to be “protected” by that patent for the purposes of Art 3(a).    

Departing from its earlier rulings in Actavis I (C-443/12) and Actavis II (C-577/13), and broadly following the Opinion of the AG issued on 6 June 2024, the CJEU ruled that a combination of active ingredients (e.g. A+B) is a different product from either of the individual active ingredients (e.g. A or B) and that Art. 3(c) does not preclude an SPC for A+B being granted where an earlier SPC has been granted for A or B. In relation to Art. 3(a), the Court ruled that it does not suffice that a product is expressly mentioned in the claims of the basic patent for it to be regarded as being protected by that patent.   It is also necessary that the product necessarily falls under the invention covered by the patent. Similar reasoning was used to answer a more specific question in the reference from the Irish Court. 

The operative part of the ruling in the joined references is as follows:

1. Art. 3(c) of the SPC Regulation must be interpreted as not precluding the grant of a SPC for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent.
2. Art. 3(a) of the SPC Regulation must be interpreted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, that that product necessarily fall, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, under the invention covered by that patent at the filing date or priority date.
3. Art. 3(a) of the SPC Regulation must be interpreted as meaning that a product consisting of two active ingredients (A+B) is protected by a basic patent, within the meaning of that provision, where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is an active ingredient in the public domain at the filing date or priority date of that patent, provided that the combination of those two active ingredients necessarily falls under the invention covered by the same patent.

It is interesting to note how far the Court’s interpretation of Art. 3(a) has come since the ruling in Medeva (C-322/10) on 24 November 2011 which many readers will recall held that to be protected by a basic patent for the purposes of Art. 3(a), the product had to be “specified in the wording of the claims”. The Medeva decision and those that followed in the years that followed almost certainly played a role in the interpretation of Art. 3(c) in the Actavis cases.  Now that Art. 3(a) has been reinterpreted, the Court seems to consider that the interpretation of Art. 3(c) can be more in-keeping with the actual language of the SPC Regulation and the definition of “product” need not be stretched too far.  

UK

Patents Court rules on the materials that can be used to identify the active ingredient of a medicinal product for the purposes of obtaining an SPC.

On 16 December 2024, Mr Justice Meade handed down a Judgment in the case of Halozyme v Comptroller of Patents. The Judge dismissed Halozyme's appeal against the UK IPO Hearing Officer's decision to refuse two SPC applications relating to recombinant human hyaluronidase (RHH) in combination with trastuzumab and rituximab, respectively.

The hearing before Meade J was an appeal from the decision of the UKIPO refusing Halozyme’s SPCs [see Irides update here].   There were two issues on appeal:

1. What materials are legitimate to consider in deciding whether RHH is an "active ingredient" under Art. 1(b) of the SPC Regulation, according to the test set out in Forsgren (C-631/13)?  At first instance, the UKIPO Hearing Officer had decided it was not legitimate to go beyond the MA documents (i.e. the SmPC and EPAR). On appeal, Halozyme sought to rely on the basic patent and scientific literature, whereas the Comptroller argued that the issue should be determined by reference to Section 2 of the SmPC only (i.e. the Qualitative and Quantitative Composition).
2. Based on the legitimate materials, whether RHH is, in fact, an active ingredient.

At first instance, whilst the Hearing Officer had favoured the SmPC/EPAR approach, he had also made factual findings that RHH is not an active ingredient even if the basic patent and scientific literature are taken into account. Accordingly, on appeal, Halozyme had to convince Meade J that the Hearing Office was wrong to reach those factual conclusions before the Court could assess which materials are legitimate to consider. In the UK, an appeal of factual findings is not a rehearing of the evidence; the appellate court need only consider whether it was reasonably open to the lower court or tribunal to reach its decision or, alternatively, whether it had failed to take something relevant into account or reached an irrational conclusion.

In this instance, Meade J held that the Hearing Officer had proper basis for his conclusions and therefore Meade J could not alter the findings. Halozyme's appeal was dismissed and no further deliberation was given to which materials would be legitimate to consider.  As a result, the position in the UK in relation to what is an "active ingredient" pursuant to Art. 1(b) of the SPC Regulation remains unchanged namely that the UK IPO will look to the SmPC/EPAR to make their assessment.

Interestingly, the advocate representing the UKIPO at the hearing before Meade J submitted that guidance would be welcomed by the UKIPO in relation to what materials are legitimate to consider for the purpose of assessing the active ingredient. Meade J expressed reluctance to comment on the topic without further evidence, in particular in relation to the test that the UKIPO currently applies when assessing the active ingredient(s)/excipient(s) and the potential effect that guidance could have on an applicant's right to appeal if it were to result in an automatic refusal of an SPC.

Meade J also noted that there is a pending CJEU referral in relation to Halozyme's Czech RHH/trastuzumab SPC application, the decision of which will not be binding on UK Courts but which “could well be persuasive".  He indicated that the question in the UK may be better assessed after the CJEU issued its decision and with the benefit of fuller argument, hinting at an appetite (at least amongst the lower UK courts) to remained aligned with the EU.

STOP PRESS - UPC

Munich Local Division hands down second substantive FRAND decision granting an injunction. (UPC_CFI_9/2023)

On 18 December 2024, the Munich Local Division gave a Decision in an action between Huawei v. Netgear relating to the infringement of Huawei’s patent relates to a method and device for transmitting information in a wireless local area network. The Court found that Netgear's Wi-Fi 6 products infringed the patent and ordered Netgear to cease the infringing activities, recall and destroy the infringing products and provide compensation to Huawei.

The key findings of the Decision are summarised below:

• CJEU in Huawei v ZTE: The CJEU judgment in Huawei v ZTE is not solely concerned with the determination of a FRAND licence. However, this may be one component of the overall decision. 
• Willingness of the Implementer: The willingness of the implementer must be assessed by considering both the initial and subsequent conduct of the implementer. This means that the implementer's behaviour throughout the negotiation process is crucial. 
• FRAND Offers by SEP Owner: If the Standard Essential Patent (SEP) owner has made several offers, at least one of these offers must be FRAND.  
• Offer Readiness: The offer from the SEP owner does not have to be ready to sign. It is sufficient if the offer provides a constructive starting point for further negotiations towards a FRAND licence agreement. 
• Security Provision by Implementer: Even if the SEP owner's offer is not FRAND, the implementer must provide security. This security acts as a safeguard for the SEP owner while negotiations continue. 
• Examination of SEP Holder's Offer: If no security is provided by the implementer, the examination of the SEP holder's offer may be completely omitted or, at best, cursory. 
• Amount of Security: The security must be provided at least in the amount of the counteroffer made by the implementer. Whether the security should be higher is left open.

USA

PTAB find that “First Available” Date Alone Is Insufficient Evidence of Disclosure. 

On 12 November 2024, the US Patent Trial and Appeal Boad (PTAB) denied Vectair Systems Inc.’s petition for an inter partes review of Fresh Products Inc.’s' patent (US 10 145 098). The patent describes a urinal assembly with a frame, posts, and openings, with the aim of the invention to reduce splashing and block large debris from entering the urinal.  

The PTAB denied the inter partes review petition because Vectair did not show a reasonable likelihood of prevailing on any of its challenges to the patent’s claims. Vectair’s challenges were on novelty (35 U.S. Code § 102) and obviousness (35 U.S. Code § 103) grounds.  

In an inter partes review, the petitioner can only refer to prior art of “patents and printed publications” when challenging patentability (35 U.S.C. § 311(b)). For something to qualify as a printed publication, it must have been publicly accessible at the relevant date. 

Vectair argued that the claims of the patent were anticipated by publicly available advertisements (through Amazon.com) for Fresh Products’ Wave 3D Urinal Deodorizer Screen, and that the Wave 3D product was on-sale, prior to the priority date of the patent.  

However, the PTAB determined that Vectair failed to establish a reasonable likelihood that the Amazon listings were publicly accessible before the priority date of the patent. The PTAB cited a previous PTAB decision which stated that “[t]he date that a product was listed as first available on a website . . . is not sufficient evidence that the content of the listing, including the photographs depicted therein, were published at that time”. This is because product listings may be updated over time and, therefore, a statement on a commercial website as to when a product was “first available” is insufficient evidence - without additional corroborating evidence that the listing itself has not changed. The PTAB did not believe Vectair provided sufficient corroborating evidence that any of the information or images depicted in the Amazon listings remained unchanged over time.   

In contrast, Fresh Products Inc. provided evidence, including in the form of witness testimony of its COO, which the PTAB found credible, that the Amazon listings offering the Wave 3D Urinal Deodorizer Screen for sale could not have existed prior to the priority date of the patent.  

It was therefore determined that Vectair had not demonstrated a reasonable likelihood of prevailing with respect to its novelty challenge.

UPC

Munich Local Division applies CoA decision and allows amendment to, amongst other issues, bring Romania into scope of claim.  (UPC_CFI_114/2024)

On 2 December 2024, the Munich Local Division gave an Order allowing Heraeus Electronics to amend its infringement action against Vibrantz Technologies Inc. relating to EP 3 215 288. The patent concerns metal sintering preparation.  

The permitted amendments allow the addition of Romania (which became a UPC member state on 1 September 2024) to the territorial scope of the action under r. 263 of the Rules of Procedure (RoP). Indirect infringement arguments based on method claims from the patent-in-suit (r. 263 and r. 333 RoP) were also permitted.  

The extension of the action to cover Romania was permitted by the Court as both parties had requested the same territorial expansion – with Vibrantz Technologies Inc. having applied for an extension of its respective counterclaim to cover Romania.  

Turning to the amendment to introduce a method claim, following a recent UPC Court of Appeal decision, the Court found this did not constitute an amendment to the action within the meaning of r. 263 RoP This is because, following the example given by the Court of Appeal, no further patent was being asserted and instead the allegation of infringement relating to the same product was merely being supported by a further patent claim. The Court therefore found in this instance that the method claim amendment did not require a party to apply for leave or permission under r. 263 RoP, and Heraeus Electronics’ extension of the action was consequently not objected to by the court. 

UPC

Paris Local Division revokes patent for lack of inventive step. (UPC_CFI_395/2023)

On 11 December 2024, the Paris Local Division issued its decision in Dexcom v Abbott, revoking EP 3 831 282 for lack of inventive step. The patent in issue relates to remote monitoring of glucose levels in people with diabetes, in particular a system that allows information to be shared with one or more remote monitor (allowing friends, family members or caregivers to receive information on the patient).  

Abbott sought to introduce added matter as a ground for revocation of the granted claims, following Dexcom having advanced arguments on the interpretation of certain claim features in its Reply to the Defence to Counterclaim. However, the Court found that  there was no legitimate reason for Abbott to raise the new ground at a late stage, when it had already set out its own claim interpretation in earlier pleadings.   

In relation to claim construction, interestingly the Court rejected Dexcom’s construction in relation to several features despite the Court finding that the proposed constructions was consistent with the description. According to the Court, adopting Dexcom’s construction would lead to incompatibility between several claim features, and the Court found that it would therefore go beyond using the description and drawings as explanatory aids.   

The Court’s finding that the patent lacked inventive step was based on a combination of two prior art documents referred to as Valdes and Goodnow. Valdes proposed to relay or share data with remote users but provided no concrete way of doing this. In particular, the presence of a server between the host and remote devices and the “invitation scheme” of the patent were not obvious based on Valdes alone. The court found that it was well-known in the field of healthcare applications at the priority date to resort to an architecture with servers for relaying health-related data between mobile phones, and this was adopted by Goodnow. Goodnow also proposed a scheme similar to the invitations scheme of the patent, to ensure that that data is shared only as authorized by the original user and is accepted by a sharing health care professional. Taken together, Valdes and Goodnow therefore rendered the patent obvious.