API and IP Newsletter
Contents
FDA approval in April 2022- Mavacamten
We follow FDA approvals. Mavacamten (CAMZYOS) was approved in April 2022 to treat certain classes of obstructive hypertrophic cardiomyopathy. Dosage form Capsules.
Mavacamten is a white to off-white powder that is practically insoluble in water and aqueous buffers at pH 2-10, sparingly soluble in methanol and ethanol, and freely soluble in DMSO and NMP. CAMZYOS is supplied as immediate release Size 2 hard gelatine capsules, containing 2.5, 5, 10, or 15 mg of mavacamten per capsule
WO2014205223 is compound patent family and WO2019028360 is method of use patent family.
Synthesis reported in example 1
Most of the raw materials are locally available, at first glance, chemistry also does not appear to be too difficult. So many Indian Generic companies will be working on this chemistry.
General information
API and University of Waterloo to develop coronavirus drugs
Applied Pharmaceutical Innovation (API) and a team of researchers from the University of Waterloo in Canada have collaborated on the development of potential therapies and drugs to prevent and treat coronaviruses.
The alliance will carry out research to develop potent small molecule therapies that can act on a protease enzyme essential for viral replication machinery in coronaviruses.
News here.
Cancer drug could be first treatment for recurring aggressive meningiomas
The drug is a newer cancer treatment called abemaciclib. The scientists demonstrated the effectiveness of the drug in select patients, mouse models, three-dimensional (3D) living tissue brain tumour (organoids) and cell cultures.
Investigators discovered meningiomas can be divided into molecular subgroups with different clinical outcomes and recurrence rates. This new method of classifying tumours allows scientists to predict recurrence more accurately than the current method of classifying the tumour.
News here.
Intellectual Property
T 1756/17 () of 3.3.2022
EP1959914B1 issued to DSM.
Huntsman P&A Germany GmbH and Merck Patent GmbH opposed. Merck appealed against opposition division’s decision.
This is not pharma case, but will cover key aspects of inventive step discussion in brief.
Main Claim (Claim1)
Cosmetic or dermatological compositions comprising multiply coated titanium dioxide particles, said particles having at least one inner inorganic silica coating and one outer organic coating and a water content of less than 1.5 %.
Prior art: WO 02/22098 (D3)
Decision of opposition division (1st instance)
On the issue of inventive step, the opposition division concluded that document D3 was the closest prior art.
The claimed compositions differed from D3 by the amount of water of the particles.
In view of the contradictory evidence on file, the problem of providing an improved cosmetic or dermatological composition could not be considered as credibly solved and was reformulated as to provide alternative multiply coated titanium dioxide particles.
The claimed solution, characterised by the required relative amount of water, would not have been obvious for the skilled person and was thus inventive.
Thus opposition division upheld inventive step argument of the patentee.
Merck appealed. The arguments of the appellant (Merck) were as follows.
If the claimed compositions were novel over those of D3, it would only be by virtue of the water content of the particles required by claim 1. This feature was not linked to any improvement, as shown by the experimental results.
The sole technical problem which could be considered credibly solved was to provide cosmetic compositions alternative to those of D3.
The claimed solution, characterised by the water content of the particles in the composition, would have been obvious to the skilled person in view of D3 and was for this reason not inventive.
The arguments of the respondent (DSM) were as follows.
Document D3 was the closest prior art.
It did not disclose a composition having particles with the required water content.
The problem underlying the claimed invention was to provide cosmetic compositions with an enhanced sun protection factor (SPF) and better stabilisation of Butyl Methoxydibenzoylmethane.
The problem was credibly solved as shown in the experimental report and test carried out by Merck. DSM said, could not show that the problem had not been solved as the results obtained were statistically relevant.
The claimed solution would not have been obvious for a skilled person and was thus inventive.
The Board’s decision:
The board said, It is not disputed that this technical problem has been credibly solved by the compositions of claim 1, having particles with a water content of less than 1.5%.
It remains to be decided whether the proposed solution to the objective problem defined above would have been obvious for the skilled person in view of the prior art.
According to document D3, the water content of the particles can be reduced by drying.
The skilled person, seeking an alternative, would thus have dried the particles used in D3.
No special effect has been shown for the moisture threshold set by claim 1. Therefore, when solving the problem of providing an alternative composition, the skilled person would have considered drying the particles below that moisture threshold of less than 1.5% and would thus have arrived at the claimed invention without inventive activity.
The compositions of claim 1 are hence not inventive.
The patent was revoked. Here
