API and IP Newsletter
Contents- Recent DMF filings
- General information
- Abbott and DexCom settle glucose monitor patent disputes
- Generic Pharmaceutical Manufacturer Secures Precedential Win at U.S. Federal Circuit
- Intellectual Property
- T 1238/22 (Pharmaceutical Compositions having Desirable Bioavailability / ALCON) 13-11-2024
- Recent DMF filings
- General information
- Abbott and DexCom settle glucose monitor patent disputes
- Generic Pharmaceutical Manufacturer Secures Precedential Win at U.S. Federal Circuit
- Intellectual Property
- T 1238/22 (Pharmaceutical Compositions having Desirable Bioavailability / ALCON) 13-11-2024
Recent DMF filings
We follow DMF filings by Indian companies.
In September 2024, 139 DMF filings were made, with Chinese companies contributing more than 75. In comparison, Indian companies lagged, filing 52 DMFs.
MSN topped the list among Indian companies.
Some additional observations about products are listed below.
General information
Abbott and DexCom settle glucose monitor patent disputes
Abbott Laboratories and DexCom said on Monday they have reached an agreement to settle all patent disputes between them related to continuous glucose monitoring devices.
The agreement will dismiss all pending cases in courts and patent offices worldwide, along with a provision preventing legal action between the companies for patent and appearance disputes for the next 10 years.
News here
Generic Pharmaceutical Manufacturer Secures Precedential Win at U.S. Federal Circuit
Amneal had challenged five listed Teva device patents after being sued for infringement for its generic inhaler. The Federal Circuit agreed they should not be included in the Orange Book, as they covered device components but not the key active ingredient. This decision clears a path for Amneal’s product and also creates opportunities for similar challenges to other Orange Book listed patents.
News here
Intellectual Property
T 1238/22 (Pharmaceutical Compositions having Desirable Bioavailability / ALCON) 13-11-2024
The patent proprietor, Alcon (appellant), filed an appeal against the opposition division's decision, dated 1 April 2022, to revoke the patent in suit, EP 2265251.
This patent was opposed by
1. Pohlman, Sandra M.
2. Alfred E. Tiefenbacher (GmbH & Co. KG)
3. Generics [UK] Limited (trading as Mylan)
Three oppositions were filed against the patent on the grounds that its subject matter lacked novelty and an inventive step, that it was not sufficiently disclosed, and that it extended beyond the content of the application as filed.
In this write-up, we will discuss the Main request, inventive step
Claim 1 of the main request pertained to:
"An aqueous ophthalmic pharmaceutical composition, comprising:
a pharmaceutical vehicle suitable for topical application to an eye;
an amount of therapeutic agent;
an effectively low amount of surfactant; and
polyquaternium-1 with a number average molecular weight between 2,000 to 30,000 as a preservative;
wherein the therapeutic agent includes prostaglandin therapeutic agent and the surfactant includes hydrogenated and/or ethoxylated vegetable oil surfactant;
wherein the amount of prostaglandin therapeutic agent is at least 0.00001 w/v % but is less than 5 w/v % of the composition;
wherein the effectively low amount of hydrogenated and/or ethoxylated vegetable oil surfactant is at least 0.005 w/v % but is less than 0.3 w/v % of the composition;
wherein the composition is free of benzalkonium chloride; and
wherein the prostaglandin therapeutic agent comprises travoprost."
According to the patent (paragraph [0002]), the invention pertains to ophthalmic compositions with relatively low concentrations of surfactants that enhance the bioavailability of a therapeutic agent, such as travoprost. Further possible objectives are outlined in the patent (paragraphs [0003] and [0017]), including achieving a desired level of stability as well as antimicrobial or preservative efficacy.
A045 (WO 2008/052031) relates to the microbial preservation of ophthalmic, otic, and nasal formulations. In particular, A045 highlights several compositions on page 30 (formulations U-X) that include 0.004% Travoprost and 0.1% HCO-40, a hydrogenated and ethoxylated vegetable oil surfactant, without the presence of benzalkonium chloride (BAC). These formulations also incorporate 1-dodecyl-2-pyrrolidone (DDP) and zinc chloride.
The appellant, Alcon, contended that A045 is an inadequate starting point for evaluating the inventive step because it does not relate to bioavailability, and the compositions described in A045 are not distinctly identified as ophthalmic compositions.
The Board disagreed. The presence of travoprost in the described composition suggests that these formulations are intended for ophthalmic use. Additionally, the patent and A045 address the antimicrobial or preservation efficacy issue. Therefore, A045 pertains to the same purpose or effect as the patent in question and serves as a practical starting point.
The subject matter of claim 1 differs from the compositions in A045 solely by the inclusion of polyquaternium-1. No effect is demonstrated or claimed to result from the addition of polyquaternium-1. Therefore, the technical problem is to provide an additional BAC-free aqueous ophthalmic composition of travoprost.
A045 generally aims to meet the antimicrobial preservation criteria of the Pharmacopoeia. To this end, it provides compositions that include DDP as a preservative, combined with benzalkonium chloride, benzadodecinium bromide, a zinc salt, polyquaternium-1, or N-octyl-2-pyrrolidone (see page 4, lines 1-11).
In particular, the combination of DDP with polyquaternium-1 is emphasised in claim 20 of A045. A skilled person, starting from one of the compositions U-X of A045 and seeking an alternative BAC-free aqueous ophthalmic composition of travoprost, would consider either adding polyquaternium-1 to this composition or replacing the zinc salt component with the alternative polyquaternium-1 that is explicitly suggested in A045.
The appellant, Alcon, argued that a skilled person would not begin with formulation U of A045 due to its inferior preservative properties (pages 30, line 8 to 31, line 8).
In the Board's view, the formulation of U of A045 remains a realistic starting point. Given this formula, a skilled person would be even more likely to consider adding polyquaternium-1 as an additional preservative.
In this regard, the Board did not agree with the appellant's (Alcon) assertion that A045 suggests combining DDP with only one additional preservative (either zinc chloride or polyquaternium-1).
The appellant (Alcon) argued that formulations V-X already met the required antimicrobial standards and that a skilled person would not substitute the zinc chloride in these formulations with polyquaternium-1 without understanding its effect on ocular bioavailability.
The Board stated that this argument is not convincing, as A045 generally presents polyquaternium-1 and zinc chloride as equally suitable alternatives. Additionally, no evidence was provided to demonstrate that the claimed formulations are any better or worse than the formulations of A045. Since the issue is to provide an alternative, the skilled person requires no specific motivation to consider this exchange.
For these reasons, the Board determined that the primary request failed to satisfy the criteria for the inventive step.
The patent was revoked.
Decision here
