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 - 8 September 2023 - is below:
UK Court considers the interpretation of “product” under Article 3(b) SPC Regulation
On 16 June 2023, Recorder Douglas Campbell KC sitting in the High Court handed down his decision in Newron v Comptroller considering the interpretation of “product” under the SPC Regulation in the context of combination SPCs. Dismissing the appeal, the judge upheld the UKIPO’s decision to reject the SPC application on the basis that the combination SPC did not meet the requirements of art. 3(b).
Newron Pharmaceutical (“Newron”) is the proprietor of patent EP (UK) 1 613 296 B1 (the “Patent”), claim 1 of which is a Swiss-form claim to “The use of a first agent selected from safinamide from 0.5 to 1, 2, 3, 4 or 5 mg/kg/day in combination with levodopa/PDI I[Peripheral Decarboxylase Inhibitor], for the preparation of a medicament as a combined product for simultaneous, separated or sequential use for the treatment of Parkinson’s Disease.” Newron has a marketing authorisation (“MA”) for Xadago, which lists safinamide as the single active ingredient of the medicinal product but refer to the use of safinamide as an add-on therapy with levodopa and a PDI for the treatment of Parkinson’s Disease.
By way of reminder, the relevant articles of the SPC Regulation are as follows:
Article 1 - Definitions
(a) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product
Article 3 – Conditions for obtaining a certificate
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
The UKIPO refused the SPC application for the combination on the grounds that the “product” in the MA was limited to safinamide alone, not safinamide in combination with levodopa and a PDI. Therefore, the requirements of art. 3(b) were not met, as the MA wasn’t an authorisation to place the combination on the market, only the sole ingredient safinamide.
In the present case, the key question for the court was whether the interpretation of “product” under art. 3(b) should be limited to safinamide alone, or safinamide in combination with levodopa and a PDI.
First, on the definition of “product” more broadly, the judge rejected Newron’s submission that the definition differs across the limbs of art. 3. The definition of “product” in art. 1(b) applies throughout art. 3.
The next question to consider was whether the “product” (as defined in art. 1(b)) is restricted to safinamide alone, or to safinamide as an add-on therapy to levodopa and a PDI, in the context of art. 3(b). In considering the correct legal test, the judge confirmed Yeda v Comptroller General of Patents  EWHC 1733 (Pat) as the most relevant UK case (and supported by a line of European authorities). In Yeda, it was held that how a medicinal product is used does not form part of the identification of the product itself.
Newron argued that the two therapies will necessarily always be used in combination, because safinamide is an add-on therapy to levodopa, and so the “product” under art. 3(b) should be interpreted as safinamide with levodopa. Applying Yeda, the judge rejected this submission as such use in a combination was immaterial to the definition of “product” in art. 3(b). The MA only recited safinamide as the active ingredient, not the combination of safinamide and levodopa, therefore the test in art. 3(b) was not satisfied (i.e. the MA did not place the combination “product” on the market).
By way of final remark, the judge also rejected Newron’s submission that the language “levodopa/PDI” in the MA would be understood by the skilled person to require a PDI to always be used. Instead, this merely indicates that one possible use of safinamide is as part of such a combination.
This decision is important as it limits the scope for obtaining combination SPCs where, as in the present case, the MA does not recite a fixed combination medicinal product (A + B).The interpretation given by the Court in Yeda continues to apply.
Court of the Hague orders withdrawal of custom seizure following finding of patent invalidity
On 28 August 2023, the Court of The Hague handed down the latest decision in the ongoing multi-jurisdictional action between Edwards Lifesciences Corporation (“Edwards”) against Angiocare BV, Meril GmbH and Meril Life Sciences Pvt Ltd (“Meril”). The Court held that the patent was partiality invalid and as a consequence, Meril did not infringe the patent. The Court went on to consider the seizure of Meril’s allegedly infringing products by Dutch Customs. A copy of the decision is here.
By way of background, Edwards is proprietor to two patents relating to a leaflet attachment frame for a prosthetic valve. Meril have developed and manufactured an aortic valve prosthesis which Edwards alleged infringed its patents. Meril filed an opposition at the EPO in August 2020 and in a decision issued in August 2022, the EPO rejected that opposition and upheld the patent, finding that the EP 930 patent was novel over a related American patent application ("Lobbi") due to certain distinguishing features. Meril GmbH has appealed the decision, however the TBA has not yet reached a decision on the appeal. Proceedings were issued in the Netherlands in December 2021 via the accelerated regime.
After proceedings were issued, in May 2022, Edwards requested customs action based on EP 930 with regard to goods suspected of infringing the patent. This request was granted and subsequently, customs detained or suspended the release of specific products from Meril on several occasions based on this decision. These measures were opposed by Meril as being wrongly executed and constituting an abuse of rights.
At the hearing, the Court focused on the interpretation of specific features in claim 1 of the patent, particularly sub-features 1.2.7 and 1.2.8 and whether Lobbi disclosed these features directly and unambiguously. The main point of contention was the interpretation of sub-feature 1.2.7, which relates to the vertical orientation of struts. Edwards sought to argue that this feature necessitates strictly vertical and parallel struts, ensuring that flexible heart valve leaflets are clamped between them. In a decision which will cause many practitioners to call the celebrated case of Catnic to mind, the Court disagreed with this approach finding that the use of the term "oriented vertically," left room for interpretation that the patent did not explicitly require struts to be strictly vertical and parallel. The Court also noted that the patent's description and figures did not specify strict verticality as a requirement, allowing for some deviation in the interpretation. The figures within the patent served as illustrations rather than strict design requirements.
The Court concluded that claims 1 and 2, claims 4 to 7 (excluding those referring back to claim 3), claim 11, and claim 14 (excluding those referring back to claim 13) were invalid and the patent was partially revoked. On the basis of those claims being found to be invalid, Meril were found to not be infringing the patents in suit.
Turning to the customs action, the Court held that Edwards had wrongly sought the customs measures and as a result was ordered to pay compensation for the damage suffered by Meril. The Court ordered Edwards, with immediate effect, to withdraw the request submitted to Customs in writing seeking that they immediately cease execution of the decisions issued by Customs, immediately release all Meril products and pay a penalty of €200,000 for each day or part thereof that it violates the court's orders and prohibitions regarding customs measures, with a maximum total penalty of €10,000,000. Edwards was also prohibited from seizing or requesting seizure of the Meril products.
The European Medicines Agency publishes a draft reflection paper on the use of AI and ML in medicinal products
On 19 July 2023, EMA European Medicines Agency (EMA) published a draft reflection paper outlining the current considerations on the use of Artificial Intelligence (AI) and Machine Learning (ML) at any stage of a medicines lifecycle up to and including the initial drug discovery to the post-authorisation setting. The Reflection Paper addresses various applications of AI in the pharmaceutical industry, highlighting the importance of regulatory compliance and risk management at each stage. The principal aim of the paper is to reflect on the scientific principles that are necessary for the regulatory evaluation in utilising novel technologies to support a safe and effective development and use of medicines.
The Reflection Paper sets out that MA applicants and MA holders bear the ultimate responsibility for ensuring any AI/ML which are used meet the ethical, technical, scientific and regulatory standards as outlined in the GxP (GxP is an acronym whereby the G stands for “Good”, P stands for “Practice” and depending on the circumstances, x can stand for e.g. Manufacturing or Laboratory) standards and the current EMA scientific guidelines. The level of risk is dependent on a variety of factors such as the technology itself, the purposes of its use as well as the stage of the life cycle in the medicinal product and the EMA suggests risk-based approach should be taken when evaluating these applications. In certain cases, EMA will be involved in the assessment on whether the features of the device are sufficient to produce evidence in supporting an EU marketing authorisation. AI could be used with relatively low risk when it comes to drug discovery, but there are regulatory concerns if AI results are used in regulatory submissions and human supervision is required. The draft reflection paper is open for consultation to the public until 31 December 2023.