API and IP Newsletter
Contents
Approvals by USFDA in August 2024: 505 (b) (2)
We follow approvals by the FDA. This week, we analysed 505 (b) (2) approvals by the FDA in August 2024. In August 2024, there are five 505 (b) (2) approvals; details are below.
General information
What associates earn in German patent litigation practices
Salary continues to be a key factor in attracting associates to a career as a lawyer, and this is no less true for patent litigation practices. There is an ongoing race between law firms to outbid each other with high starting-salaries in Germany.
News here
UnitedHealth to remove AbbVie's Humira from some US drug reimbursement lists next year
UnitedHealth said patients will be able to get coverage for Humira until the preferred biosimilars on its plans are designated interchangeable by the U.S. Food and Drug Administration. This means they can be substituted for the original without consulting the prescriber. The FDA is expected to grant that designation in 2025, United said.
News here
Intellectual Property
Novartis Vs Celltrion- omalizumab
This write-up concerns the order of the Court of First Instance of the Unified Patent Court (Düss Division) delivered on 6 September 2024 regarding European Patent EP 3805248 B. The patent belongs to Novartis and Genentech and covers a specific formulation of the active ingredient omalizumab, which must be the marketed medication.
The two patent holders, Novartis and Genentech (henceforth Novartis), accused Celltrion of wanting to bring a biosimilar of Novartis’ XOLAIR onto the market despite EP 3 805 248 B still being in force. The patent holders applied to the Unified Patent Court for an injunction to prevent an actual infringement.
The patent application in the suit was published on 14 April 2021, and the patent grant was on 18 January 2023. Currently, the patent in suit is in force in all Contracting Member States of the UPC except for Malta.
Claim 1 of the patent in the suit reads as follows: “A pharmaceutical formulation of anti-IGE antibody rhuMAb E 25, characterised in that the formulation is: about 150 g/L of the anti-IgE antibody in 0.02 M histidine, 0.2 M arginine HCl, 0.04% polysorbate 20, pH 6.”
In August 2022, Celltrion publicly announced its intention to launch the challenged embodiment in the territory of Europe in 2024.
At the end of July 2023, Celltrion commenced proceedings in the UK seeking a declaration that the UK part of the patent in suit is invalid and a declaration of noninfringement.
In September 2023, Novartis filed a counterclaim seeking, among other things, an injunction restraining Celltrion from infringing the UK part of the patent in the suit. The trial is expected to start in October 2024.
On 16 October 2023, Celltrion filed EPO opposition proceedings against the patent in a suit.
In November 2023, a Celltrion official stated in a Korean healthcare news portal that Celltrion aims to be the first company to supply a XOLAIR® biosimilar to significant countries.
On 23 November 2023, Novartis sent a letter to Celltrion requesting that their rights be respected. Celltrion replied that it considered the patent in suit invalid and not infringed.
On 25 March 2024, Celltrion issued a press release emphasising its intention to launch the products on the European market as soon as possible after obtaining the authorisation.
At the end of March 2024, Celltrion participated in the Belgian Dermatology Days in Brugge with a booth displaying information about the challenged embodiment.
The European Medicines Agency market authorisation for the challenged embodiment was granted on 16 May 2024 to Celltrion.
On 24 May 2024, Celltrion issued another press release announcing the approval of the European marketing authorisation and its plan to expand its market share rapidly.
Novartis considered that the challenged embodiment infringed the patent in suit and challenged it in the Unified Patent Court (Düsseldorf Local Division).
Celltrion argued that their product falls outside the scope of claim 1 as the formulation contains a significant amount of histidine hydrochloride monohydrate and histidine.
The challenged embodiment is only based on XOLAIR® but not identical. Moreover, the patent in the suit should be interpreted as limited to the process. The challenged embodiment is not made using the process shown in the patent in the suit's description.
Novartis alleged that Celltrion had, on various occasions, already engaged in conduct that could, in any event, be considered an imminent infringement.
Every patent tries to solve a problem, and the “problem-solution” approach is critical in European proceedings.
The problem with the patent in the litigation is that improved processes are needed for preparing highly concentrated protein formulations, such as liquid antibody preparations and therapeutic products.
As a solution, the patent in suit provides the pharmaceutical formulation of claim 1. The claim can be structured by following features:
A pharmaceutical formulation of anti-lgE antibody rhuMAb E25, characterised in that the formulation is:
about 150g/L of the anti-IgE antibody,
in 0.02 M histidine,
0.2 M arginine-HCl,
0.04% polysorbate 20,
pH 6.
Celltrion argued that their formulation comprises histidine (0.009 M) and histidine-Cl (0.011).
Given the dispute, further explanation of feature 3 (i.e. “0.02 M histidine“) and the nature of a product claim is needed.
The skilled person will understand that 0.02 M histidine in feature 3 includes its protonated form with a counterion.
The wording of the claim is limited to the specific components as there is no indication that “is“ has a different meaning than “consists of“. Nor is there any indication in the description that other components are contained.
However, the skilled person will continue interpreting the philological meaning but will always consider the technical function of the feature as such and the features in the context of each other.
Therefore, it will not read every feature exclusively, but it must understand that the feature 0.02 M histidine must be seen in the context of the claimed pH of 6 (feature 6). Histidine is a buffer that protects a solution from change. It has an optimal buffering capacity at around the claimed pH 6. The skilled person commonly knows what chemical structure the components need to have to reach a certain pH. This means that for the claimed pH 6, histidine must be present in a more or less 1:1 mixture of neutral and protonated (1+) forms with a counterion.
The Court said claim 1 is undoubtedly a product claim and cannot be read as limited to the process. The wording is precise and final. Claim 1 protects the individual components of the pharmaceutical formulation, not the process steps for its manufacture.
Challenged embodiment infringes claim 1. Novartis stated that, as a biosimilar, the formulation of the challenged embodiment must be identical to their XOLAIR® formulation, which, according to the Court's interpretation, falls within the scope of claim 1 despite the presence of histidine (0.009 M) and histidine-Cl (0.011).
Celltrion has already obtained a marketing authorisation confirming that the alleged formulation is a biosimilar to XOLAIR®.
Celltrion has not substantially disputed that the challenged embodiment falls within the scope of claim 1 of EP 3 805 248 B and comprehends each feature. In the context of a product claim, it is irrelevant that Celltrion does not use the process.
The Court said,
Celltrion’s conduct does not yet constitute an imminent infringement.
Since claim 1 of the patent in suit is a product claim, the requirements for direct infringement are making, offering, placing on the market, or using a product that is the subject matter of the patent or importing or storing the product for those purposes. Only offering is seriously alleged in the present case, and the Court cannot find any of Celltrion's conduct that already constitutes an offering.
For a patent infringement to be considered imminent, there must be concrete indications in the overall circumstances that an infringement is imminent.
A situation of imminent infringement must be characterised by certain circumstances which indicate that the infringement has not yet occurred but that the potential infringer has already set the stage for it to happen. The infringement is only a matter of starting the action. The preparations for it have been fully completed. These circumstances must be assessed on a case-by-case basis. In this regard, the burden of presentation and proof lies with the Applicants, in this case, on Novartis.
It should be noted that the "Bolar exception" is not relevant in this case or related to an SPC or a generic drug case.
The question to be answered is whether Celltrion's conduct leads to the conclusion that they are more likely than not to intend to enter the market during the patent term without any further ado.
Novartis and Genentech are not required to accept a situation that would lead to renegotiating their contracts with their customers for their product in 2024 or affecting their ability to negotiate new contracts in 2025.
This would undoubtedly be the case if a concrete offer of the challenged embodiment were made to the market, which would constitute direct infringement.
It is sufficient for an offer if the act creates a demand for the product the offer will likely satisfy.
In the present case, this would be an advertisement that Celltrion could supply, in compliance with all the regulatory measures applicable to the medical market in the Contracting Member States, by mentioning a specific price if a potential customer wished to place an order.
It should be noted that potential customers are familiar with the pharmaceutical industry's practices. When regulatory measures, pricing, and reimbursement conditions have not been finalised, they are more likely to regard statements about future market entry as vague announcements.
In the present case, for an infringement to be imminent, all prelaunch preparations must have been completed so that an offer can be made at any time. Rather than looking at individual events in isolation, it is necessary to assess the activities overall.
The Court cannot find that Celltrion and Defendants have already completed all the pre-launch preparations.
The presiding judges have dismissed Novartis’ application for a preliminary injunction. The judges ruled that, at the time of the Court’s order, there was not yet sufficient evidence that the infringement was imminent.
However, the Judges also inferred that Celltrion’s formulation uses the technical teaching of EP 248 and that eight Celltrion subsidiaries are cumulatively liable for their actions.
A biosimilar of XOLAIR could be launched only after the expiration of EP 248, i.e. in September 2025.
Decision here
