API and IP Newsletter
Contents
FDA approvals in March 2021.
General information.
Biocon's arm gets a GMP compliance certificate from UK's health regulator MHRA for the Bengaluru facility.
J&J seeks permission for clinical trial of single-shot Covid vaccine in India.
Intellectual Property.
Shilpa Medicare asked the US court for Novartis’ Gilenya profit!!
FDA approvals in March 2021
This week, we will continue providing information about FDA approvals in March 2021.
We will concentrate on small molecules mainly from synthesis of small molecules. We will not cover mechanism of action and other details.
This week we will cover synthesis of Tivozanib:
1. Tivozanib was approved in Europe in 2017. So, innovator samples must be available long ago, it could help generics to reverse engineer the product and be ready at NCE-1 date in March 2025.
2. WO2002088110A1 patent family could be composition of matter patent family and could be extended by five years in US and would expire in 2027 in US. In Europe, equivalent patent is extended till 26 April 2027.
3. WO2004035572A1 patent family covers specific compound and crystal form. Innovator has applied for SPC (Supplementary Patent Certificate for patent term extension) till October 2028.
4. Generally, innovator cannot apply for two SPCs and must give up one application. This issue to be investigated further.
5. The generic launch could be possible in 2027-2028 in US. If litigated, timelines will be governed by court case/(s) and driven by 30 month’s stay etc.
General information
Biocon's arm gets GMP compliance certificate from UK's health regulator MHRA for Bengaluru facility
The certificate, which includes manufacturing and packaging of tablets and capsules in the non-potent and potent blocks of the facility, was issued based on a remote inspection in the week of March 22, 2021. (Read more)
J&J seeks permission for clinical trial of single-shot Covid vaccine in India
Johnson & Johnson is partnering with health authorities and the world's best scientists to provide the safety and efficacy data necessary to support worldwide emergency use of the Janssen COVID-19 vaccine candidate. (Read more)
Intellectual Property
Shilpa Medicare asked US court for Novartis’ Gilenya profit!!
Fingolimod (Gilenya) was approved in September 2010. This is a blockbuster drug, generating sales above USD 2.5 bn/annum for Novartis.
Composition of matter patent of Fingolimod has expired, but there are composition patents and dosage regimen patents listed in OB, where expiration dates are till 2026 and 2027. These patents were upheld by the court.
Novartis has settled with Gxs and Gx launch will be before expiration of OB listed patents as per the settlement/agreements. OB listed patents are as below.
The objective of this write-up is not to provide old information about the settlement, lot of other blogs have covered that news earlier, here and here.
Interestingly, last week Shilpa Medicare, a company in Raichur Karnataka (Turnover about USD 130-140 mn) who owns polymorph patent US 9,266,816 for Fingolimod (Gilenya), sought damages from Novartis for infringing their IP (`816)! Isn’t it interesting?
Below are the claims of US 9,266,816
Claim 1: Fingolimod hydrochloride crystalline Form-β characterized by X-ray powder diffraction pattern comprising characteristic 2θ° peaks selected from the XRPD peak set of 3.54, 7.07, 10.66, 15.35, 20.52, 21.43 and 25.10±0.1 2θ°.
Claim 5: A process for preparing Fingolimod hydrochloride crystalline Form-β comprising the steps of—
As per the news article (I don’t have access to Delaware court document in PACER) Shilpa filed the complaint in the Court stating, Gilenya which is approved in September 2010, infringes their patent US 9,266,816, which has a priority date in November 2010. Please note patent application by Shilpa was filed two months after the launch of Gilenya. Isn’t it even more interesting?
Shilpa sought damages from Novartis, including cash compensation. Moreover, Shilpa wants to block sale of Gilenya until their patent US 9,266,816 expires, ie till 2031! Novartis had own polymorph patent family WO2010055028A2 (Priority date in 2008), covering several polymorphs.
We don’t have copy of the complaint filed by Shilpa. We have gathered the information about Shilpa’s patent by general Google search and search in patent database. There could be good inherency arguments. But interesting times ahead. Right? We would cover more details once Court documents are publicly available.
The brief news is 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.
