API and IP Newsletter
Contents
FDA approvals October 2021
We analyse FDA approvals each month. Avacopan is one of the small molecule approved in October 2021.
Step 5 of WO2016053890A1 represents Avacopan.
Avacopan, sold under the brand name Tavneos, is a medication used to treat anti-neutrophil cytoplasmic autoantibody-associated vasculitis. Avacopan was approved for medical use in Japan in September 2021, and in the United States in October 2021.
Jubilant Biosciences is ordering raw material for Avacopan , EHTYL 4-NITROBENZOYLACETATE (CAS:838-57-3) for development, Jubilant has ordered RM one year ago which means development must have started long ago, much before approval by FDA.
One can expect DMF filing by Jubilant soon.
General information
Without innovation Indian pharma cannot touch $130 bn by 2030: Industry
The leading names of the Indian pharmaceutical industry said that the target of touching a $130 billion size for the Indian drug industry by 2030 would not be possible without focus on innovation. India is a leading player globally when it comes to generic or copycat drugs, but has failed to move up in the value chain when it comes to innovative drugs.
News here.
Explained: CCI market study on pharma sector
The report found that manufacturers that concentrate their efforts on the creation of brand image and brand loyalty have been able to command a price premium on chemically identical drugs by striving “for the patronage of prescribing physicians,” adding that patients who are unaware of the attributes and substitutes for drugs simply purchase medications prescribed by physicians and dispensed by chemists.
The CCI also highlighted that the perception of difference in the quality of drugs by different manufacturers also feeds into brand differentiation
As evidenced by the formulation-level data on prices and market shares, market leadership position is often enjoyed by brands that command the highest or relatively higher prices,”, the competition regulator observed. The study cited the example of the highest selling anti-diabetic drug which costs Rs 9.97 per tablet, over six times the price of the chemically identical drug with the least market share which costs Rs 1.53 per tablet.
News here.
Intellectual Property
Ibuprofen Paracetamol decision by CAFC about invalidity and infringement of OB listed patents
Horizon, innovator of reference listed drug Duexis. According to IQVIA MAT July 2021, ibuprofen and famotidine tablets (reference listed drug Duexis) had an estimated annual sales of USD 765 million in the US
Federal Circuit (CAFC) affirmed District court’s decision of invalidity and infringement.
OB listed patents are as below.
Alkem filed ANDA in March 2018. Horizon sued Alkem. District court opined claims of US 8067033 (the ’033 patent) were invalid for obviousness and not infringed, and claims of US 8067451 (the ’451 patent) were not infringed. The district court relied in part on US 2007/0043096 A1 (“the ’096 publication”).
Horizon appealed.
Horizon argues that the district court committed legal error because the ’096 publication is not prior art to the ’033 patent.
CAFC said, there is no error in the district court’s finding that the ’096 publication is prior art.
The district court found that a prior art reference (“the ’671 publication”) disclosed tablet-in-tablet separation methods, like those recited in the ’033 patent, “to achieve greater stability” in pharmaceutical formulations containing drugs similar to ibuprofen and famotidine, under the same stability conditions claimed in the ’033 patent. The district court’s analysis is also supported by testimony from Alkem’s expert witness.
So, CAFC said there is no clear error in the district court’s findings regarding expectation of success.
About `451, CAFC opined, the prosecution history of the ’451 patent supported the district court’s construction.
Across multiple exchanges with the examiner, Horizon explained that it was amending the claims to “focus on an embodiment of the invention that uses Opadry® White (YS-1-7003) as a barrier layer,” acknowledged that the claims specified that “the barrier layer is Opadry White (YS-1-7003),” and distinguished prior art based on current claims with “the limitation that the barrier layer be Opadry White (YS-1- 7003).”
In view of this, CAFC did not find any error in the district court’s determination that Horizon unambiguously narrowed its claim scope to a barrier layer of YS-1-7003.
In conclusion CAFC affirmed the district court’s findings that claims 1, 8, 11, and 14 of the ’033 patent are invalid for obviousness and that claims 1–3 and 8–10 of the ’451 patent are not infringed by Alkem’s ANDA.
News 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.
