API and IP Newsletter
Contents
List of DMF filed in January 2021 by Indian Companies and our analysis.
General information.
Lonza to build mRNA and small-molecule plants in Visp.
Dr Reddy’s hits Amarin with antitrust suit over Vascepa.
Intellectual Property.
Section 3 (d) in Indian Patent Act for what is not eligible for patents and S. 415 in FDCA in US for what is not eligible for Data Exclusivity!!
List of DMF filed in January 2021 by Indian Companies and our analysis
We analyse DMFs filed by Indian companies and try to understand their strategies. In the below table, please find SIDVIM comments for more details.
General information
Lonza to build mRNA and small-molecule plants in Visp
Lonza says it will double production in Visp of the messenger RNA (mRNA) active ingredient that Moderna uses in its COVID-19 vaccine. Lonza will add three manufacturing lines to the three it has opened there since May 2020 when it and Moderna announced a 10-year collaboration to make the vaccine active ingredient. (Read more).
Dr Reddy’s hits Amarin with antitrust suit over Vascepa
Dr Reddy’s claimed that after prevailing in patent litigation in a district court in March 2020, it began preparations for the launch of its generic, only to find Amarin had “foreclosed all the suppliers of the Icosapent ethyl API who have sufficient capacity to support a commercial launch in a timely manner”.
“DRL contacted all potentially viable suppliers of Icosapent ethyl API in an attempt to obtain enough supplies to launch as soon as possible but its efforts were thwarted, the filing said. (Read more)
Intellectual Property
Section 3 (d) in Indian Patent Act for what is not eligible for patents and S. 415 in FDCA in US for what is not eligible for Data Exclusivity!!
First and foremost, this is not a like to like comparison. But is FDA and Congress thinking like the drafters of the Indian Patent Act?
As you would know, Section 3(d) in Indian Patent Act describes what are not inventions. In short, following are not inventions according to Indian Patent Act.
1. the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.
2. the mere discovery of any new property or new use for a known substance.
3. the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation –salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
Novartis case
Not going in to too many details of mailbox, EMR etc., and keeping the discussions confined to the topic, in 1993, Novartis filed first patent family for Imatinib, i.e. the basic patent family for the drug Glivec. An equivalent of it was not filed in India as India then did not offer product patent protection. In 1997, Novartis developed the beta crystalline form of Imatinib, Imatinib mesylate, which it found to have 30% more bioavailability than its non-salt form claimed in the basic patent (i.e., absorbed 30% more easily into the bloodstream). The company applied for second patent family in 1997. We know, Section 3 (d) prevented Novartis to claim beta crystalline form of Imatinib in India.
Roche Vs Cipla
In Roche Vs Cipla, Honourable Judge decided in favour of Cipla, stated, Cipla did not infringe Roche's Indian patent as their generic version Erlocip is the polymeric form B which is different from Roche's patented drug.
Maybe taking clue from this, US senate tweak HW Act and the definition of NCE.
FDA determined that:
1. Congress did not intend to award exclusivity for a very slight change to the chemical structure of an active ingredient that has no therapeutic significance.
2. The “active moiety” is essentially the core “molecule or ion” that is “responsible for the physiological or pharmacological action of the drug substance.”
To resolve any ambiguity between the statute and FDA regulations, on 11 March 2021 the Senate unanimously approved S.415, a bill that would amend the FDCA to replace the phrase “active ingredient (including any ester or salt of the active ingredient)” with FDA’s definition of “active moiety.”
The unanimous passage by the Senate suggests the bill has a strong chance to become law. News here.
For example, new esters or salts would not have NCE protection in US. However, please note, in US, though esters or salts would not qualify NCE protection by USFDA, there would be patent protection for the esters and salts by USPTO. In India we have no data exclusivity and patent protection would also be difficult by IPO!!
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.
