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 - 16 February 2024 - is below:

STOP PRESS - UK

Permission to appeal to the Court of Appeal granted on the interpretation of art. 3(d) of the SPC Regulation

Following on from Irides Weekly Update 51/2023, Michael Tappin KC (sitting as a Deputy Judge of the High Court) has granted Merck Serono S.A. limited permission to appeal to the Court of Appeal following his decision on 19 December 2023 in which he refused to grant a Supplementary Protection Certificate (SPC) to Merck based on a patent for the use of cladribine to treat multiple sclerosis and a marketing authorisation for this use.  The SPC was refused on the basis that the application did not meet the requirements of art. 3(d) of the SPC Regulation because of a pre-existing MA to the use of cladribine to treat hairy-cell leukaemia. It is understood that permission has been granted on the basis that only the Court of Appeal has the power to depart from the CJEU case-law refusing to grant SPCs for second medical uses.  The Court of Appeal will now have the opportunity to examine whether to follow the CJEU case-law and not permitting second medical use SPCs or consider a different approach.

STOP PRESS - UK

Court of Appeal upholds Patents Court decision on “product” in the context of art. 3(a) and 3(b) of the SPC Regulation

In a decision handed down on 15 February 2024, the English Court of Appeal has dismissed Newron’s appeal against the refusal by the UKIPO and High Court to grant an SPC for safinamide for use in combination with levodopa/PDI. Giving the unanimous verdict of the court, Birss LJ held that the “product” of the SPC had to be the same for the purposes of art. 3(a) and 3(b) and although the basic patent protected the combination which was the subject of the SPC, the marketing authorisation was for safinamide only.  On this basis, art. 3(b) was not satisfied and an SPC could not be granted.  

INDIA

High Court of Delhi upholds Product-by-Process claims

On 7 February 2024, the High Court of Delhi handed down its judgment in a dispute between Vifor and MSN Laboratories, Corona Remedies and Dr Reddys upholding the validity of Vifor’s patent with “product-by-process” claims. 

Vifor is the proprietor of patent IN 221536 (the “Patent”) which discloses a water-soluble iron carbohydrate complex (Ferric Carboxymaltose or FCM) and a process for making it.  Claim 1 of the Patent is to a “water soluble iron carbohydrate complex obtainable from an aqueous solution of iron (III) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range[…]” (emphasis added). Vifor applied for an interim injunction in respect of the defendants’ FCM products. In July 2022, the interim judge refused to grant interim relief, on the grounds that claim 1, a “product-by-process” claim, was essentially a process claim. Since the defendants did not use the claimed process to manufacture their FCM products, there was no infringement. Vifor appealed the decision which was heard by the High Court of Delhi. 

The first issue for the High Court to determine was the correct scope of protection of “product-by-process" claims. The High Court rejected the approach taken by the interim judge that, in order to claim a product (and not just the process), a product-by-process claim must be described by its composition and structure and, since claim 1 failed to do this, the scope of protection was limited to the process only. Instead, the High Court held that a “product-by-process” claim relates to an inventive product whose unique attributes can only be explained with sufficient clarity by reference to its manufacturing process. This reasoning finds support in section 4.12 of the EPO Guidelines which provides that the technical content of the invention lies not in the process per se, but in the technical properties imparted to the product by the process. Therefore, product-by-process claims are permissible where the only way to explain the novel attributes of a novel product is by reference to the process of manufacturing it – this is the “rule of necessity”. They must, however, relate to a novel product to be valid. 

Further the language of product-by-process claims does not limit the scope of protection to merely the process. The High Court drew a distinction between process claims, wherein a product is “obtained by” the process and therefore performance of the process is required to establish infringement, and product-by-process claims, wherein a product is “obtainable by” the process. The latter pertains to a novel and inventive product described by reference to its process of manufacture, as opposed to merely a process for obtaining a product. 

On the facts, the High Court held that the interim judge had erroneously found the product of claim 1 to be anticipated, and therefore erred in its approach by only assessing infringement of the claimed process (being the “inventive part” of claim 1) and not the product. In fact Claim 1 did relate to a novel product, described by reference to a process, and therefore the question of infringement must be decided on the basis of the attributes of the claimed product, and not its process of manufacture. 

IRELAND 

High Court finds BMS compound patent for Eliquis® (apixaban) implausible

Following on from our Stop Press in Irides Weekly Update 6/2024, the High Court of Ireland has held Bristol Myers Squibb’s (BMS) patent to the compound apixaban insufficient and obvious due to lack of plausibility. This brings the Irish Court in line with decisions in England and Spain, but is contrary to the decisions in France, Sweden, Norway and a second instance PI decision in the Netherlands, which were distinguished by the Irish Court. The lengthy judgment also considered entitlement to priority.

By way of background, apixaban is an anticoagulant used for the treatment of thromboembolic disorders. Its anticoagulant properties are due to its ability to inhibit an enzyme in the coagulation cascade, factor Xa. For the purposes of plausibility, validity was assessed by reference to the application as filed (WO 652). WO 652 discloses a series of Markush formulae, lists of individual compounds and synthesised examples. Apixaban was included in one of the lists of compounds and as one the synthesised examples, as well as being one of the compounds included in claim 8 of WO 652 along with 74 other compounds. The only disclosure in WO 652 of the factor Xa activity of the compounds disclosed is that “a number of the compounds of the present invention were found to exhibit Ki ≤ 10 µM, thereby confirming the utility of the compounds of the present invention as effective Xa inhibitors”.

Norton (trading as Teva), challenged the patent’s validity on the grounds that it lacked priority, and that WO 652 did not disclose that apixaban was a factor Xa inhibitor and therefore the patent was insufficient and/or obvious over the prior art.

The judge considered the EPO Enlarged Board of Appeal’s decision in G2/21 but concluded that it did not affect the test for plausibility in Ireland, which was in these circumstances “whether the patent would give the skilled addressee a sufficient reason to think the new compound will work?”. The judge held that this requires “a reasonable technical basis for concluding that the patented molecule might well have the claimed effect” and therefore the question to be asked was “whether (i) what is found in the specification read in light of the common general knowledge; (ii) provides the skilled reader with information which gives him or her a reasonable expectation that the promise expressly held out by the specification (that some of the compounds disclosed are effective factor Xa inhibitors) will turn out to be true.” Applying this test, the judge held, inter alia, that there was nothing in WO 652 that supported that apixaban was an effective factor Xa inhibitor, let alone a factor Xa inhibitor with sufficient potency to be useful in therapy, and therefore the patent was not plausible.

Teva’s challenge to entitlement to priority was on the basis that BMS Co., the applicant for the international application that designated the European patent, did not have the right to claim priority. Instead, the priority rights had been assigned to BMS Pharma Co. In turn, BMS argued that BMS Co. was the beneficial owner of the right to claim priority. Ultimately, the judge held that BMS Co. was the equitable owner of the right to claim priority which was sufficient in the circumstances.

GEORGIA/EPO

Georgia and the EPO enter into validation agreement

On 15 January 2024, an agreement between the EPO and Georgia came into force which allows patentees to validate their European patent applications and patents granted by the EPO in Georgia under Georgia’s national law. These patents and applications will have the same effect and be held to the same standard as those national patents in Georgia. Patentees can now obtain protection in 45 countries via a single EP patent application.

UPC

Court of Appeal rules on members of the public requesting documents

On 8 February 2024, the Unified Patent Court of Appeal established that members of the public seeking access to the Register under Rule 262.1(b) must be represented. This decision arose from an appeal by Ocado Innovation Limited against an Order of the Nordic Baltic Regional Court granting access to a statement of claim to a member of the public, after redacting personal data.

The court clarified that the requirement for representation applies broadly within the UPC’s procedural framework, except where explicitly waived by the Rules of Procedure. Despite submissions by the member of the public that this requirement would impose an undue burden on individuals seeking access to documents, the court maintained that representation would ensure proper conduct and legal safeguarding in proceedings. The member of the public was given a 14-day period to appoint a representative and submit a Statement of Response.  The Court of Appeal is scheduled to hear the appeal of the order on 12 March 2024.