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 - 22 April 2025 - is below:
 

UK

Court of Appeal hands down written judgment in Glenmark v AstraZeneca.

As reported last week, the Court of Appeal overturned the High Court’s decision and granted AstraZeneca (AZ) an interim injunction against Glenmark on 9 April 2025 (at the appeal hearing), preventing it from launching its generic dapagliflozin product until the form of order hearing (FOO hearing) in the main validity action. The Court of Appeal handed down its written judgment on 16 April 2025 (Decision here).

By way of background, the High Court had refused the interim injunction on the grounds that any damages arising from the refusal of the interim injunction would be an adequate remedy for AZ because they could be calculated to a reasonably high degree of accuracy. By contrast, quantifying any damages payable under the cross-undertaking to Glenmark and the NHS (to which AZ agreed to give a cross-undertaking) would be significantly more difficult to quantify. Accordingly, damages would not be an adequate remedy for Glenmark or the NHS.

On appeal, AZ sought permission to present new evidence (in the form of a solicitor’s witness statement referring to letter correspondence) indicating that two other generic companies (Teva and another unnamed entity) were also preparing to launch in the UK. The Court of Appeal noted that this new evidence put “a different complexion on matters”. It established the risk that if the injunction was not granted against Glenmark, at least two other generic companies could enter the market prior to the FOO hearing. If AZ did not obtain an injunction against Glenmark, they would not be able to obtain an injunction against any other generic companies. The new evidence also showed that other generic companies were likely to enter the UK market more quickly than the High Court anticipated, potentially leading to a downward price spiral.

The Court of Appeal agreed with AZ that if multiple generic entry happened as quickly as indicated by AZ’s new evidence, AZ would be likely to reduce their price prior to the FOO hearing, and they would have serious difficulties in raising it again. However, this did not necessarily mean that damages would not be an adequate remedy for AZ. It would ultimately depend on the gap before the FOO hearing. The longer the gap, the greater would be the pressure on AZ to reduce their price.

The Court of Appeal also held that in considering the damage to AZ from a refusal of the interim injunction and Glenmark’s market entry before the FOO hearing, the High Court should have considered the damage to AZ not just in the period before the FOO hearing but also afterwards. Other generic companies entering the market before the appeal of the interim injunction application could be heard would inevitably prejudice AZ’s position making success on appeal less likely and therefore subjecting AZ to generic price erosion for a longer period. If AZ were to succeed in obtaining a final injunction following resolution of the merits, it would be far more difficult for them to raise the price again. As such, there was a real doubt regarding the adequacy of damages as a remedy for AZ.

Whilst there was some uncertainty as to which side (AZ or Glenmark) was more likely to be inadequately compensated by damages, given that the period of time until the FOO hearing is rather short, the Court of Appeal held that it would be prudent to preserve status quo and therefore injuncted Glenmark from entering the market.

The Court of Appeal criticised Glenmark’s strategy of launching during the proceedings without awaiting judgment and remarked that Glenmark had not cleared the path and instead “[jumped] the gun”.
 

UK

HHJ Hacon dismisses appeal against the refusal of a patent application for a lack of industrial application.

On 21 March 2025, HHJ Hacon of the English Patents Court dismissed an appeal (Decision here) by a litigant in person, Mr Klemz, against the refusal by the IPO of his patent application for an apparatus allegedly capable of generating force.  The Judge affirmed the decision of the hearing officer that the invention lacked industrial application under s. 1(1) and that it was insufficiently disclosed under s. 14(3) of the Patents Act, primarily due to contradictions with established physical laws.

In UK law, industrial applicability means an invention must be capable of being made or used in any kind of industry. This requirement is generally a low hurdle, however it is used to exclude inventions that operate in a manner that is contrary to well established physical laws. Appeals on this issue are rare.

Mr Klemz had sought a patent for an apparatus designed to generate force via electromagnetic principles without expelling reaction mass, primarily for spacecraft propulsion. In appealing the refusal, Mr Klemz argued that the invention was misunderstood by the hearing officer and that his experiments provided evidence of its functionality.

In outlining the relevant legal principles for the assessment of industrial applicability by the IPO, HHJ Hacon referred to the judgment in Blacklight Power Inc. v The Comptroller-General of Patents [2008] EWHC 2763 (Pat) and summarised the following:

a) The IPO should examine the material filed and assess whether the invention is patentable on the balance of probabilities. If yes, the application should be allowed to go forward to grant.
b) If no, the IPO should consider whether there is a substantial doubt about an issue of fact which could lead to patentability. If no, the application should be refused.
c) If yes, the IPO should consider whether there is a reasonable prospect that the invention will be found patentable if that issue of fact is fully investigated at a trial. Such a reasonable prospect must be based on credible material not the hope that something helpful might turn up.  The application should be allowed only if the answer is yes.

Having reviewed the evidence put forward, HHJ Hacon upheld the refusal of the patent application due to lack of industrial application, agreeing with the hearing officer's assessment that the invention was contrary to established physical laws (namely being inconsistent with the principle of conservation of momentum, Newton’s third law and Newton’s first law).  When considering if there were any doubts about an issue of fact that could lead to patentability, HHJ Hacon concluded that these inconsistencies were evident enough that even if relevant facts were to be explored at trial, and on the assumption that this could be done effectively, there was no reasonable prospect that the invention would be shown to be patentable.

As is permitted when assessing such an issue, HHJ Hacon noted the absence of support for the theory behind the invention from any experts in the scientific community.  If the applicant was correct that there was an inconsistency between the laws of electromagnetism and Newton’s law or the principle of conservation of momentum, one would have expected it to create a major impression in the scientific world.

Regarding the experiments presented by Mr Klemz, HHJ Hacon found that there was little confidence in the accuracy and reliability of the experiment. As such, very little could be deduced from what was seen and so this did not alter his conclusions.

For the same reasons of contradicting established physical laws, HHJ Hacon also agreed with the hearing officer that the invention was not disclosed in the application in a manner which is sufficiently clear and complete for it to be performed by a person skilled in the art.

Whilst this case may have been clear cut in its violation of physical principles, it does underscore the need for substantial evidence (and support from the relevant scientific community) when challenging such principles in the event of truly ground-breaking inventions.
 

INDIA

Delhi High Court rejects Roche’s PI against Natco for Risdiplam.

On 24 March 2025, the Delhi High Court (acting as the first instance court) handed down a decision rejecting Roche’s application for a PI against Natco Pharma concerning risdiplam (sold by Roche under the brand name Evrysdi) – a drug used for the treatment of Spinal Muscular Atrophy (SMA).

Given the debilitating nature of SMA and the high cost of Roche’s treatment, there was a significant public interest element to the case and an SMA patient group intervened in the proceedings, urging a rejection of the PI so that an affordable alternative medicine would be available.

The Court considered the following factors in deciding the PI application: (i) prima facie case, (ii) balance of convenience, (iii) irreparable damage, and (iv) public interest.

On prima facie case, the Court held that Natco raised a credible challenge to the validity of the patent on the grounds of novelty (anticipation by prior publication) and obviousness (given that the patent is a ‘selection patent’ and the modification made to the selected compound disclosed in Roche’s earlier patent would be obvious to the skilled person).

On the balance of convenience, the Court remarked that Roche does not manufacture the drug in India but imports it. By contrast, Natco intends to manufacture the drug in India and make the product available at a price of about 80 to 90% less than Roche's. Further, Roche’s Patient Assistance Program benefits only a small fraction of SMA patients in India. The Court also noted that the governmental aid given to patients of rare diseases would cover less than half of the annual cost per patient for Evrysdi. Therefore, the Court held that the balance of convenience was in favour of Natco.

On irreparable damage, the Court held that if Roche succeeds in the trial, Roche could be appropriately compensated by way of damages.

Finally, on public interest, the Court noted that risdiplam is the only approved drug for SMA (a rare disease) and is not available at reasonably affordable prices in India. The Court therefore held that "if a party is able to manufacture the drug and make it available at an affordable price, in such a case, the public interest would have to outweigh the need for grant of injunction”.
 

UPC

Court of Appeal gives ruling on territorial scope.
[UPC_CoA_169/2025]

In a procedural appeal, on 11 April 2025, the Court of Appeal has upheld the Helsinki Local Division's decision to allow the claimant to amend its Statement of Case to include new territories and a new defendant.

At first instance, following a jurisdictional challenge by the defendant TGI, the claimant, AIM, was successful with its requests under r. 263 and r. 305 RoP to amend its claim by adding TGI UK as new defendant, covering Germany and Spain as additional territories, and adding infringement by equivalence and liability based on the defendants acting as intermediaries. TGI appealed this procedural decision.

First, the Court of Appeal stressed that r. 263 and r. 305 RoP are discretionary powers, meaning the scope for an appellant court to review is limited. In this case, TGI failed to establish that the Helsinki Local Division went beyond the boundaries of its discretion.

The Court of Appeal found that the Helsinki Local Division took into account all of the required considerations when applying the relevant Rules of Procedure. In particular, AIM had only just become aware of the allegedly infringing acts in Germany of TGI UK, part of the same group as TGI. Furthermore, the infringements alleged to be performed jointly by TGI and TGI UK were based on the same patent and concerned the same product and the same pleaded facts. The existing proceedings could not be described as advanced given TGI had not served its Statement of Defence so there was little prejudice in allowing the amendments. The Court noted that the result could not be avoided in any event because AIM could just lodge separate proceedings if the order was refused and then apply to join the cases under r. 340 RoP. For the addition of Spain as a territory, it would not have been reasonable to include it earlier, given its inclusion was in anticipation of a change in the law in C‑339/22 Electrolux.

In rejecting the appeal, the Court of Appeal noted that allowing the amendments meant that the case was essentially restarted, and TGI had 3 months to file its Statement of Defence.
 

UPC

Düsseldorf Local Division clarifies approach to product-by-process claims and entitlement to damages under published EP applications.
[UPC_CFI_50/2024]

In a significant judgment from the Düsseldorf Local Division, the Court found infringement of EP 3 356 109 B1 (relating to a vehicle frame with structural foam components), dismissed a counterclaim for revocation, and provided guidance on the treatment of product-by-process claims under UPC procedure.

The claimants, Yellow Sphere Innovations GmbH and Erwin Härtwich, alleged that Knaus Tabbert’s “DESEO” and “AZUR” caravan models infringed the patent. The Court agreed, finding that the accused frames included foam components manufactured via a process falling within the product-by-process claims of the patent and coated with an external protective layer as claimed. That was the case notwithstanding that manufacturing involved two moulds, whereas the defendant had argued, based on prosecution history, that the claims required only one casting mould to have been used. The Court noted that the Court of Appeal had not yet decided on the relevance of the file wrapper to the interpretation of patent claims but in any event disagreed. The decisive  factor  is  whether  it is clear from the  patent  specification  that  the  use  of  the  process  described  is  essential  for  technical reasons  in  order  to  achieve  certain  features  of  the  product. The Court ordered Knaus Tabbert to cease the infringing activities, recall and destroy the infringing products, and provide financial compensation to the plaintiffs.

The Court reiterated that the technical content of the invention protected by product-by-process claims lies in the technical properties imparted to the product by the process, rather than the process itself. The process serves solely to define the product, but itself is not the subject of protection. The Court clarified that the relevant technical properties must be understood by a skilled person from the manufacturing method described and the conclusions drawn about the inventive nature of the product.

On damages for the pre-grant period (between publication and grant of the patent), the Court confirmed its competence under Art. 32(1)(f) UPCA and applied Art. 67 EPC, placing the burden on the claimant to explain the national requirements for each member state in question, in the absence of harmonised UPC provisions. Another time-related aspect of the decision was the Court’s confirmation that it is competent to consider the dispute in respect of acts committed before the UPC came into effect, and before the opt-out of the patent in suit was withdrawn.

In relation to the invalidity counterclaim, the chief battleground was novelty and inventive step, but the Court rejected the arguments on all fronts. Additionally, Knaus Tabbert argued it held the right to use the invention based on prior development agreements. The Court rejected this, finding no binding licence had been granted and no estoppel or exhaustion defence was available, despite past collaboration. The Court noted that the right of prior use requires more than the mere entitlement to use. In what amounts to requiring serious and effective preparations do the acts, the Court noted that the defendant must have made a firm and final decision to exploit the invention  commercially and they must have taken steps to prepare for the prompt implementation of that decision and have the intention to exploit the invention. On the facts of the present case, such preparations were held to be lacking.
 

UPC

Milan Local Division applies Electrolux and confirms the UPC’s long arm jurisdiction.
[UPC_CFI_792/2024]

On the 8 April 2025, the Milan Local Division confirmed the UPC's long arm jurisdiction to determine the validity of European Patents validated in non-UPC Countries. This is following the CJEU's decision in C‑339/22 Electrolux (reported here) that found that a national court has jurisdiction to hear and determine an infringement action of a patent granted in another European Member State if, in the context of that action, the defendant disputes the validity of that patent and the defendant is domiciled in that jurisdiction.

In this case, Dainese spa brought an infringement action of EP 4072364 (EP 364) in the "Territory for Relief", namely the UPC Contracting Member States and Spain, against six defendants. Alpinestars S.P.A, one of the defendants that is domiciled in Italy, filed preliminary objections under r. 19.1 RoP arguing that the UPC lacked jurisdiction to determine the Spanish infringement in Spain of the Spanish national validation of EP 364.

The Court noted that the UPC is "deemed to be a court of a Member State" under Art. 71 Regulation (EU) 1215/2012 (recast) as amended by Regulation (EU) 542/2014 and, therefore, it must apply the CJEU's interpretation as if it were a national court.

Applying the Electrolux decision, the Milan Local Division held that, due to Alpinestars being domiciled in Italy, it had “universal” jurisdiction over the infringement issues, including of the Spanish designation of EP 364. It does not lose jurisdiction just because the validity of the patent has been challenged.

The Court noted that applying any other interpretation would have the effect of recognising that the UPC has less territorial jurisdiction than a national court and would be contrary to Art. 71a.