API and IP Newsletter
Contents
Pharmaceutical Research and Approvals: What's Trending in 2024
ORIC Pharmaceuticals gets grant for PLK4 inhibitors for treating cancer
DMF filings in February 2024
FDA publishes list of DMF filings in every quarter. On 10 April, FDA published the list of DMFs filed in 1st quarter of 2024. We analyse this list and evaluate DMF filing strategy of various Indian companies. This week we evaluated DMFs filed in February 2024.
In February, total about 53 DMFs were filed, Dr. Reddys filed 4 DMFs, Supriya, Viyash and Cipla filed 2 each.
Some of our other observations are as below.
General information
Pharmaceutical Research and Approvals: What's Trending in 2024
In the ever-evolving field of pharmaceutical research and development, staying abreast of the latest trends and advancements is paramount. This year, the pharmaceutical industry is marked by groundbreaking innovations, regulatory shifts and unprecedented challenges. From cutting-edge technologies to novel therapeutic approaches, pharmaceutical research, and pharmaceutical approvals in 2024 are redefining how we perceive health care.
News here.
ORIC Pharmaceuticals gets grant for PLK4 inhibitors for treating cancer
According to GlobalData’s company profile on ORIC Pharmaceuticals, Peptide pharmacophores was a key innovation area identified from patents. ORIC Pharmaceuticals's grant share as of February 2024 was 25%. Grant share is based on the ratio of number of grants to total number of patents.
News here
Intellectual Property
T 1318/21 (SYMRISE / ANTIMICROBIAL MIXTURE) 20-02-2024
EP 2774481 was issued to Symrise AG. The opposition division at 1st instance revoked the patent. Hence the patent proprietor Symrise AG appealed ("appellant") the decision of the opposition board.
Symrise AG develops, produces and sells fragrance, flavouring and food ingredients, cosmetic active ingredients and raw materials as well as functional ingredients and solutions that enhance the sensory properties and nutrition of various products.
The patent was opposed by Schülke & Mayr GmbH, who manufactures and supplies disinfectants, antiseptics, preservatives, biocides, medical skin care products, an active substance for deodorants, and system cleaners.
An opposition was filed invoking, inter alia, the ground for opposition under Article 100(a) EPC in combination with Article 56 EPC. The following documents were referred to, inter alia, during the opposition proceedings:
This is a very lengthy decision and there are several auxiliary requests. We will confine this write-up to discuss obviousness wrt below claim
Claim 1 of an auxiliary request 1 is identical to claim 1 as granted and reads as follows:
"1. An antimicrobial mixture comprising
(a) 4-Hydroxyacetophenone
and
(b) at least one second antimicrobial agent selected from the group consisting of 1,3-propanediol, methyl propanediol, 1,2-pentanediol, 1,2-hexanediol, 1,2-octanediol, ethylhexylglycerin, hexoxy-propan-1,2-diol, heptoxy-propan-1,2-diol, octoxy-propan-1,2-diol, 3-benzyloxy-propan-1,2- diol, 3-phenyl-ethyloxy-propan-1,2-diol, 3-phenylpropyloxy-propan-1,2-diol, 3-methylbenzyloxy-propan-1,2-diol, 3-phenyl propanol, 2-phenoxyethanol".
Closest prior art
Document D3/D3a discloses a mixture comprising 4-HAP stated to display virucidal, bactericidal and fungicidal activity. According to D3/D3a, this mixture is especially active against cultures of Candida albicans, Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa, i.e. cultures against which also the mixtures of the patent should display antimicrobial activity.
D3/D3a further discloses that the 4-HAP-containing antimicrobial mixture, due to its natural origin, low toxicity and low skin-irritating action, can be used for developing cosmetics and detergents.
Therefore, D3/D3a gives the skilled person a clear indication of the suitability of the disclosed antimicrobial mixture as a preservative in the above-mentioned consumer products.
The board considers D3/D3a a suitable starting point for the assessment of inventive step.
Distinguishing feature
It is common ground that when starting from the above disclosure in D3/D3a, the subject-matter of claim 1 of the main request differs from this disclosure in that the mixture further comprises at least one (b) compound, i.e. "at least one second antimicrobial agent selected from the group consisting of 1,3-propanediol, methyl propanediol, 1,2-pentanediol, 1,2- hexanediol, 1,2-octanediol, ethylhexylglycerin, hexoxy-propan-1,2-diol, heptoxy-propan-1,2-diol, octoxy-propan-1,2-diol, 3-benzyloxy-propan-1,2- diol, 3-phenyl-ethyloxy-propan-1,2-diol, 3-phenylpropyloxy-propan-1,2-diol, 3-methylbenzyloxy-propan-1,2-diol, 3-phenyl propanol, 2-phenoxyethanol".
Obviousness of the claimed solution
The appellant (Patentee) Symrise AG argued that even if no technical effect were ascribed to the inclusion of at least one of the (b) compounds mentioned in claim 1, the claimed subject-matter would still not have been obvious to the skilled person. There was no prompt in D3/D3a nor the remaining prior-art documents cited by the respondent Symrise AG to combine 4-HAP with another antimicrobial agent.
The board disagreed. When the objective technical problem merely lies in the provision of an alternative composition, no prompt or pointer towards the claimed solution is required. It is sufficient that the skilled person would have considered the claimed solution a reasonable alternative to the composition of the closest prior art
Antimicrobial compositions including more than one antimicrobial agent are well known to the skilled person. The board concurs with the respondent Schülke & Mayr GmbH that the compounds recited under (b) in claim 1 of the main request are well-known antimicrobial agents to be used alone or in combination, especially as preservatives in consumer products.
For example, D6 discloses cosmetic compositions comprising one or more alkane-diols as antimicrobial agent, thus pointing to e.g. the alkane-diols 1,3-propanediol, 1,2-pentanediol and 1,2-hexanediol. D7 discloses cosmetic preparations including 1,2-hexanediol as a preservative antimicrobial agent.
For these reasons, the board concluded that the subject-matter of claim 1 of the main request lacks an inventive step in view of D3/D3a taken as the closest prior art (Article 56 EPC). Therefore, the main request is not allowable and the appeal filed by the patentee was dismissed.
Decision here
