API and IP Newsletter
Contents
Commission fines Teva €462.6 million over misuse of the patent system
FDA Approves Minocycline Hydrochloride Extended-Release Capsules for Individuals with Rosacea
FDA approvals in October 2024: 505 (b) (2).
We follow 505(b)(2) approvals on the FDA website.
The 505(b)(2) pathway enables investigators and/or manufacturers to apply for approval without repeating all the drug development work done for an innovative drug.
A 505(b)(2) applicant may rely on the FDA’s findings of safety and/or effectiveness for a listed drug only to the extent that the proposed product in the 505(b)(2) application shares characteristics (e.g., active ingredient, dosage form, route of administration, strength, indication, or other conditions of use) in common with the relied-upon listed drug/drugs.
In 2019, the FDA published guidelines for the industry on whether an applicant should submit an ANDA or a 505(b)(2) application. Here
This month, there are four 505(b)(2) approvals; details are below.
General information
Commission fines Teva €462.6 million over misuse of the patent system
The European Commission has fined Teva €462.6 million for abusing its dominant position to delay competition to its blockbuster medicine for treating multiple sclerosis, Copaxone. The Commission found that Teva artificially extended the patent protection of Copaxone and systematically spread misleading information about a competing product to hinder its market entry and uptake.
News here
FDA Approves Minocycline Hydrochloride Extended-Release Capsules for Individuals with Rosacea
Journal Medical Corporation has announced the US Food and Drug Administration (FDA) approval of minocycline hydrochloride modified release capsules 40 mg (Emrosi), formerly known as DFD-29. The drug is indicated for treating inflammatory lesions and erythema in adults with rosacea.
Doxycycline capsules, branded as Oracea and owned by Galderma, are the current standard-of-care treatment for inflammatory lesions from rosacea in adult patients.
Emrosi's pricing close to the launch would be "relatively in the same area" as Oracea's, which is around $950 monthly.
B. Riley's Patel estimates Emrosi to capture at least 50% of Oracea's market share and generate sales of at least $150 million at peak.
News here
News here
Intellectual Property
Unilever Vs Henkel AG
European patent EP3558224 was granted based on nine claims and issued to Unilever.
Claim 1 as granted related to:
"A process for preparing a composition comprising
i. a compound selected from resorcinol, phenylethyl resorcinol, 4-alkyl substituted resorcinol and mixtures thereof,
ii. a chelating agent, and;
iii. a cosmetically acceptable base comprising a water phase and an oil phase,
wherein, the process comprises the steps of
(a) combining a compound selected from resorcinol, phenylethyl resorcinol, 4-alkyl substituted resorcinol and mixtures thereof with a chelating agent in water,
(b) preparing a water phase and an oil phase,
(c) combining the water phase and the oil phase to prepare a cosmetically acceptable base, and;
(d) combining the adduct obtained in step (a) with the cosmetically acceptable base of step (c),
wherein the process does not comprise a combination of 4-hexyl resorcinol with ethylenediamine di-succinic acid."
Dependent claim 5 further defined:
"A process according to any one of claims 1 to 4 wherein, step (d) is carried out when the temperature of mixture obtained in step (c) is in the range from 40 to 50 C."
The patent was opposed because its subject matter lacked novelty and inventive steps.
Henkel AG opposed the patent, and the opposition was rejected in the first instance at EPO.
Henkel AG (the opponent) filed an appeal against the opposition division's decision to reject the opposition.
In its decision, the opposition division cited inter alia the following documents:
The patentee filed an auxiliary request 2.
The auxiliary request 2 introduced in claim 1 the feature that step (d) is carried out when the temperature of the mixture obtained in step (c) ranges from 40 to 50 C.
Let us discuss inventive step arguments.
The teaching in document D7/D8 aims to provide a hair dye composition comprising a two-component kit (of a first agent) containing an oxidising dye precursor and (a second agent) containing an oxidising agent with excellent storage stability. According to document D7/D8, the oxidising dye precursor's first agent may include a coupler such as resorcinol.
Document D7/D8 described, according to the English translation under the heading "Examples 1 to 2 and Comparative Example 1", the preparation of such a first agent in the form of an emulsion comprising in addition to oxidising dye precursors the chelating agent EDTA and resorcinol as follows:
"According to the composition ratio shown in Table 1, propylene glycol, sodium sulfite, EDTA.4Na, dimethicone copolyol, isopropyl alcohol, and sodium lauryl sulfate were added to purified water and heated to 80 C, followed by p-phenylenediamine, and Sorcinol, p-aminophenol, 4- amino-2-hydroxytoluene, and 2-methyl -5-hydroxyethylaminophenol were added and dissolved.
Put oleic acid and oleyl alcohol in a separate container, heat and dissolve to 80 C, mix and emulsify, cool to 40 C, add monoethanolamine, strong ammonia water (28%), and fragrance, and mix uniformly with the above solution. The first agent was prepared."
The composition ratio of the agents mentioned in paragraph [20] of document D8 is presented in the subsequent paragraph [22], which refers to Resorcinol instead of Sorcinol.
You can find a Google translation of D7 here. Examples 1 and 2 in the Google translation provide a fair idea about the reported prior art.
Taking account of the reference to resorcinol in paragraph [22], the first sentence of the cited paragraph [20] of document D8 thus discloses the separate step of combining resorcinol and a chelating agent with a variety of other ingredients in water to form a solution. This separate step corresponds to step (a) defined in claim 1 of auxiliary request 2.
Oleic acid and oleyl alcohol form an oil phase, and their emulsification requires a water phase. The instruction in the second sentence of the cited paragraph [20] of document D8 to prepare oleic acid and oleyl alcohol in a separate container and to emulsify at an elevated temperature of 80 C, therefore, corresponds to steps (b) and (c) as defined in claim 1 of auxiliary request 2.
The further instruction in the cited paragraph [20] of document D8 to cool after emulsifying oleic acid and oleyl alcohol in a separate container and to mix uniformly with the above solution corresponds to step (d) as defined in claim 1 of auxiliary request 2.
Accordingly, based on the English translation in document D8, the Board concluded that claim 1 of auxiliary request 2 does not include any distinguishing feature concerning the process described in document D7/D8.
The patent was revoked.
Decision here
