API and IP Newsletter
Contents
Analysis of DMFs filed in October 2020.
General information.
In India’s pharmaceutical services sector, government and industry visions clash.
Artificial intelligence has the potential to identify the right pharmaceutical component in drug development
Intellectual Property.
Cabazitaxel (Jevtana)
Analysis of DMFs filed in October 2020
FDA publishes a quarterly list of DMFs filed by various companies. Recently Q4 2020 list is uploaded on FDA site. We would analyze this week DMFs filed by Indian companies in October 2020.
As usual, about 50% of total DMFs filed are by Indian API suppliers in October 2020.
Sidvim analysis is in below table.
General information
In India’s pharmaceutical services sector, government and industry visions clash
Despite a reputation for being a major source of pills and active pharmaceutical ingredients (APIs), India actually depends heavily on China to fulfil its pharmaceutical needs. (Read more)
Artificial intelligence has the potential to identify the right pharmaceutical component in drug development
Healthcare industry has rapidly embraced artificial intelligence into the working system. AI and its sub-technologies are helping the medical industry on a large scale. However, the pharmaceutical industry is still on the initial stage of leveraging digital technologies to accelerate the drug development process. (Read more)
Intellectual Property
Cabazitaxel (Jevtana)
Jevtana, which is Sanofi’s top oncology product by sales in 2018 and sales was about USD 500 million. It is approved by USFDA to treat certain prostate cancer patients in 2010. On 15 January 2021, Federal Circuit (CAFC) affirmed The Patent Trial and Appeal Board (PTAB) which found amended claims patentable over prior arts.
OB listed patents are as below.
US’592 is facing challenges in Courts and in Patent office (PTAB). US’592 relates to method of treating prostate cancer with combination therapy including Cabazitaxel and Prednisone/ Prednisolone.
The discussion in CAFC is about below claim:
27. A method of increasing the survival of a patient with a castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with Docetaxel, comprising administering a dose of 20 to 25 mg/m2 of Cabazitaxel, or hydrate or solvate thereof, to the patient in combination with Prednisone or Prednisolone.
The main issue was with respect to reasonable expectation of success in view considering the term ‘increasing survival’ in the claim.
TROPIC study which was cited as one of the prior arts. It is phase III protocol. The court said, such a protocol would have raised hopes but not the expectation of success. PTAB and CAFC granted the amended claim.
Generic launch of Cabazitaxel should be possible in 2021 but combination therapy/treatment with Prednisolone could pose some challenges in regulatory approvals of generic versions. (here)
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
