API and IP Newsletter
Contents
Patent applications filed by Nosch Labs Private Limited
In SIDVIM, we analyse IP (Patent) portfolio of small and medium sized companies. In past we analysed patent portfolios of big generic companies like Sun Pharma, Cipla and Glenmark too. We attempted to analyse their development strategies using combined analysis of Patent portfolio and import/export data. We further estimated development stages of molecules at their respective development centres. This week we looked at patent portfolio of Hyderabad based Nosch Labs Private Limited.
Comments:
Nosch as per their website is not known for their R & D capabilities. However, in past they did file some good IP, around processes, salts and polymorphs of APIs.
Patent applications are not filed in recent past and reasons to be investigated.
Most of the IP is abandoned or being prosecuted only in India.
General information
Mapping the RNA therapeutics R&D landscape in 2022
Over the last few years, the success of Covid-19 mRNA vaccines has reinvigorated not just big pharma’s interest in RNA research, but also seem to have widened the scope of RNA therapeutics and vaccines. The Pfizer-BioNTech deal was one of the most consequential ones in 2020 to show big pharma’s appetite to harness RNA research through collaborations. Researchers say this has impacted not just companies with clinical stage-products, but also individual academic labs, which will now likely result in more RNA-focused projects in the next few years.
There are less than a dozen FDA-approved RNA therapeutics, the bulk of which are antisense oligonucleotides (ASO) and small interfering RNA (siRNA) candidates for genetic disorders. A look at the planned studies in 2022, as per GlobalData, however indicate a broader landscape of RNA-focused vaccines and therapeutics that look at oncology, ophthalmology, and infectious diseases. Trials with more than two dozen novel RNA therapeutics or vaccines are expected to start in 2022
News here.
Amgen Extends Collaboration with Syngene International
Syngene International, a research, development, and manufacturing services company, announced on Dec. 16, 2021 that the company and Amgen have extended their long-standing multi-discipline research collaboration to the end of 2026.
The scope of the collaboration includes integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development. Under the extended contract, Syngene will build and operate a dedicated laboratory, which will enable the acceleration of R&D projects. Syngene currently operates the existing Syngene Amgen R&D Center (SARC) under the companies’ original collaboration deal.
News here.
Intellectual Property
Suboxone decision by CAFC
Suboxone had sales of around $1.86 billion in the US for the 12 months ended April 2018, according to market reports. here
DRL had already launched the product in 2019 based on earlier appellate Court decision. Sandoz launched Authorised Generics.
OB listed patents are as below.
This write-up is confined to US 9,687,454 patent. This litigation resulted from IPR which DRL had filed in November 2018 against US 9,687,454 patent, owned by Indivior. PTAB handed down the decision in June 2020 and held claims 1–5, 7, and 9–14 are unpatentable and claim 8 is patentable.
Both parties appealed. The ’454 patent issued as the fifth continuation of U.S. Patent Application 12/537,571 (the “’571 application”), which was filed in August 2009. This appeal involves the question whether Indivior could get the benefit of that 2009 filing date for the claims at issue.
Claims 1, 7, 8, and 12 of the ’454 patent are relevant, specifically polymer limitations.
Claim 1
1. An oral, self-supporting, A mucoadhesive film comprising:
(a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;
(b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;
(c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and
(d) an acidic buffer;…….
Claim 7
7. The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix.
Claim 8
8. The film of claim 7, wherein the film comprises about 48.2 wt % of the water soluble polymeric matrix.
Claim12
12. The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5; and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix.
The Board found that Tables 1 and 5 in the ’571 application disclose formulations from which a polymer weight of 48.2% could be calculated by a person of ordinary skill in the art (POSA).
Neither Table 1 nor Table 5 describes the claimed ranges.
It is true that in Table 1 there are four polymer components of the described formulations, polyethylene oxide, NF (MW 200,000); polyethylene oxide, NF (MW 100,000); polyethylene oxide, NF (MW 900,000); and HPMC, and when they are added up, each total is within the “about 40 wt % to about 60 wt %” range, but these values do not constitute ranges; they are only specific, particular examples.
For written description support of a claimed range, more clarity is required. Here, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the ’571 application to create an otherwise unstated range. That is not a written description of the claimed range.
The same shortcoming exists with Table 5, where four separate components are listed as “polymer.” Regarding claims 7 and 12, CAFC agreed with the Board (PTAB) that there is no written description support for the range of “about 48.2 wt % to about 58.6 wt %” in the ’571 application. This range also does not appear in the ’571 application.
Indivior argued, if one looks to Tables 1 and 5, plucks out the polymer components and creates a range from the percentage totals, then one has obtained the range recited in claim 7.
CAFC remarked, a written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.”
Federal Circuit said that Indivior failed to provide persuasive evidence demonstrating that POSA would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %. Hence, CAFC affirmed PTAB’s decision, opined claims anticipated by intervening prior art because patent fails to claim valid priority to the ’571 application.
Decision 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
