API and IP Newsletter
Contents
ANDA approvals in February 2023
We follow ANDA approvals, especially of Indian companies. In February 2023 in total there are more than 70 ANDA approvals. Out of which about 20 are tentative approvals.
Eugia and Aurobindo received total 7 approvals. Zydus received total 5 approvals.
Ajanta, Hetero, Mankind received 2 each.
Some of our observations are as below.
General information
Handling HPAPIs safely – what does it take?
Here, Veranova’s Global Head of Analytical Research & Development, Dr Kishore Hotha, outlines safety considerations when manufacturing and handling highly potent APIs (HPAPIs).
Highly potent active pharmaceutical ingredients (HPAPIs) are used in formulations for high potent drugs, owing to their ability to target precise disease cells including cancer cells. These substances “are pharmacologically and biologically active at low doses,” Dr Kishore Hotha, Global Head of Analytical Research & Development at Veranova, explained.
In this Q&A, Dr Hotha offered expertise on the requirements and challenges of handling HPAPIs during manufacture.
He shared that the HPAPI market is expected to grow significantly in the next five years. Observing trends in the sector, Hotha noted: “the pharmaceutical regulatory space is shifting from traditional drug therapies to emerging targeted therapies that need specialised handling and considerations.”
News here.
Leading innovators in tyrosine kinase inhibitors for the pharmaceutical industry
110 innovations will shape the pharmaceutical industry
According to GlobalData’s Technology Foresights, which plots the S-curve for the pharmaceutical industry using innovation intensity models built on over 756,000 patents, there are 110 innovation areas that will shape the future of the industry.
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.
News here.
Intellectual Property
Sensile Pat AG Vs Eveon: Appeal Board decision at EPO
For a change let us analyze case for reconstitution device.
This is regarding EP 2822526. This patent was issued to Sensile Pat AG.
The patent was challenged by Eveon and it was upheld at the first instance. Eveon appealed.
Two main prior art documents discussed.
D3: WO 2007/074363 A2
D5: Micropumps for a Novel Combination Device: Lyo Reconstitution and Injection", Déhan C, EVEON France, Proceedings of the 2011 Parenteral Drug Association (PDA) Europe Conference in Basel, Switzerland, 8-9 November 2011, slides 1-16
In the appeal proceedings, Eveon argued that the subject-matter of claim 1 of the patent as granted was not inventive over D5 in combination with D3.
It is common ground that D5 discloses (slides 5 and 13 reproduced below) a drug reconstitution device with a disposable liquid transfer unit (disposable fluidics cassette on slide 13) including a pump engine, and a reusable control and drive unit (reusable device on slide 13).
The disposable liquid transfer unit includes a housing, a docking interface configured for coupling a first and a second constituent container to the housing, and a fluid flow system configured for transferring liquid from the first constituent container to the second constituent container.
The control and drive unit comprises a pump drive configured to removably couple and drive the pump engine.
The subject-matter of claim 1 of the patent as granted differs from the disclosure of D5 in that the pump engine is configured as a bi-directional rotary pump comprising a rotor rotatably moveable in a stator.
The appellant Eveon argued that claim 1 did not require the presence of two containers or the suitability of the reconstitution device for fluid being pumped back and forth between two constituent containers.
The Board did not share this view. Claim 1 specifically defined a drug reconstitution device comprising a fluid flow system configured for transferring liquid from a first to a second container. Moreover, the claim defined a pump engine for performing a pumping action. When interpreting the claim, the person skilled in the art will clearly understand that the pumping action has to be performed within the fluid flow system between the two containers, which is the only movement of liquid mentioned in the claim.
The description supported this understanding. Paragraph 0033 of the patent describes the effects of a bi-directional rotary pump as defined in the claim.
It explained that the bi-directional pump can be used to pump liquid several times from the first to the second container and vice versa.
This ensured that a poorly dissolvable lyophilised substance is completely dissolved. In this respect it is irrelevant what precise limitations are derivable from the terms "pump engine" and "rotary pump". The technical effect explained above results essentially from the fact that the pump is bi-directional.
Hence the objective technical problem solved by the distinguishing feature is not to provide a technical implementation of the micropump generally disclosed in D5, but rather how to obtain complete reconstitution of the drug conveniently and reliably.
According to D5, homogenisation and complete reconstitution may be obtained by recirculating the two constituents within a single container (slide 5).
It is common ground that D3 disclosed a bi-directional rotary pump (page 12, lines 29 to 31) for medical applications (page 1, lines 3 and 4).
However, there is no indication in D3 that such a pump should be used for solving the objective technical problem as formulated above.
There is no indication in D3 or D5 that a recirculation between the two containers should be implemented.
According to Eveon, the objective technical problem consisted of providing a concrete implementation of the schematic micropump disclosed in D5.
Formulating the objective technical problem in this manner does not take account of the technical effect of the bidirectionality of the pump as explained above.
Moreover, reconstitution of a drug from two components in D5 is achieved by recirculation within a single container, which does not need a bi-directional pump. Hence, contrary to the Eveon's argument, the person skilled in the art faced with the task of technically implementing the schematic micropump disclosed in D5 would have had no obvious reason to make it bi-directional.
Hence the Board confirmed that subject-matter of claim 1 is inventive over the combination of D5 with D3.
