API and IP Newsletter
Contents
DMFs filed in September 2021
We analyse DMFs filed every month. In September there are about 65 DMFs filed. Many are of them by Indian companies.
Glimpses of our analysis is as below.
General information
With new drug molecules, cure in sight for psoriasis
A team of researchers from University of Hyderabad and DRL are working on target 12R-LOX
News here.
Domestic drug manufacturers seek Centre intervention to decriminalize errors by licensed manufacturers in D&C Act
In order to address the issue of menace of spurious drugs and as recommended by the Mashelkar Committee, the penalties under Section 27 were substantially enhanced and made more stringent vide Drugs and Cosmetics (Amendment) Act, 2008. However, the unintended consequence of the said amendment is that the licensed manufacturer’s unintentional non-compliances are also facing a lot of hardships. The prosecutions are even being filed for minor offences like labelling errors rendering the drug as misbranded.
According to Harish K Jain, Senior Vice President and Chairman, Regulatory & Technical Committee, Federation of Pharma Entrepreneurs (FOPE), “There is need to decriminalize the unintentional errors, non-compliances not having direct impact on the quality and are of lesser gravity, by the licensed manufacturing entities.
News here.
Intellectual Property
The decision of appeal board at EPO-CATALYST SYSTEM FOR THE POLYMERIZATION OF OLEFINS -T 1307/18 of 20.10.2021
The appeal of the opponent lies from the decision of the opposition division posted on 28 March 2018 rejecting the opposition against EP2794676. This patent was issued to Basell Poliolefine Italia SpA.
Claim 1 as granted read as follows:
A catalyst system for olefin polymerization comprising the product obtained by contacting
(a) a solid catalyst component containing Mg, Ti, halogen and at least an electron donor compound selected from phenylene aromatic diesters;
(b) an alkylaluminum cocatalyst and
(c) an ester formula R'OOC-(CR"2)m-COOR' in which m is an integer from 2 to 7, the R' groups, equal to or different from each other, are C1-C10 alkyl groups and the R" groups, independently, are hydrogen or C1-C15 hydrocarbon groups.
The decision of the opposition division was mainly based on document D1 (US 2009/0203863 A1). Patentee filed few auxiliary claims narrowing the scope, but are not outlined in this post to limit the size of this post.
D1 represented the closest prior art. Claim 1 of the main request differed from the catalyst system used in run O-0972 in Table 7 in that the external electron donor was a diester defined by the formula R'OOC-(CR"2)mCOOR' instead of the monoester isopropyl myristate. In the absence of an effect over D1, the problem solved was the provision of an alternative catalyst system suitable to produce polyolefins having reasonably high melt flow rate.
It would have however been obvious to the skilled person to replace isopropyl myristate in run O-0972 of D1 with any ester (c) according to claim 1.
Paragraph 62 of D1 described compounds identified as alternative activity limiting agents (ALAs) such as C1-4 alkyl diesters of aliphatic C4-20 dicarboxylic acids which overlapped with the definition of ester (c) as recited in claim 1.
These esters would have led to an alternative catalyst composition for the preparation of polyolefins having a high melt flow rate. The choice of an ester falling within formula (c) was therefore an arbitrary choice from the broad disclosure of D1, as no technical advantage was associated with this selection.
Appeal board opined, claim 1 of the main request lacked therefore an inventive step.
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.
