API and IP Newsletter
Contents
FDA approval: Fruquintinib
We follow FDA approvals of small molecules. Objective is to understand chemistry and IP around the molecule. Raw materials required to synthesise API and by analysing import-export database, try to make an educated guess about which generic companies who would be working on dossier development/ANDA.
FDA approved Fruquintinib on 8 November 2023.
Fruquintinib, sold under the brand name Fruzaqla, is an anti-cancer medication used for the treatment of colorectal cancer. Fruquintinib is a kinase inhibitor.
Fruquintinib is a white to off-white powder. Fruquintinib capsules for oral administration contain 1 mg or 5 mg of fruquintinib. The inactive ingredients are corn starch, microcrystalline cellulose, and talc. The 1 mg capsule shell contains FD&C Yellow No. 5 (tartrazine), FD&C Yellow No. 6 (sunset yellow FCF), gelatin, and titanium dioxide. The 5 mg capsule shell contains FD&C Blue No. 1 (brilliant blue FCF), FD&C Red No. 40 (allura red AC), gelatin, and titanium dioxide.
Process described in Example 1 of WO2009137797
To a solution of 4-chloro-6,7-dimethoxyquinazoline (1 equiv.) in 2ml CH3CN were added 6-hydroxy-N,2-dimethylbenzofuran-3-carboxamide (1 equiv.) and K2CO3 (1.5 equiv.). The mixture was refluxed under stirring for 10 hr. After the solvent was evaporated, the residue was washed with water, dried over MgSO4, filtered, concentrated, and purified by column chromatography to give the title compound in a yield of 85%.
WO2016037550A1 discloses and claims crystalline forms and solvates such as Form I, Form II, Form III, Form IV, Form VII, and Form VIII .
In September 2018, fruquintinib received its first global approval, in China, for use in the treatment of metastatic colorectal cancer.
Dr. Reddys (DRL) had spotted this and imported innovator samples from China; 1 MG and 5 MG capsules. DRL imported innovator samples even before FDA approval, hence they could be developing ANDA to file on NCE-1 date in US.
General information
UK Supreme Court has final say on Dabus as named inventor
In the long-running case over AI system Dabus, the UK's highest judicial instance has determined that a patent application cannot name AI as an inventor. But, while the decision aligns the UK position with the prevailing views of European courts, it has opened the door to debates on the future of AI patenting.
News here.
Anti-trust lawsuit against Natco Pharma over generic cancer drug dismissed in US
"The plaintiffs voluntarily dismissed Breckenridge Pharmaceutical Inc and Natco Pharma Ltd from the case. All claims against the company in the litigation have now been dismissed," Natco Pharma said in a regulatory filing. Breckenridge is the ANDA (Abbreviated New Drug Application) holder and front-end marketing partner for the Pomalidomide capsules generic product in the US, it added.
News here
Intellectual Property
Institute of Directors vs Worlddevcorp Technology And Business Solutions Pvt Ltd
This week, I could not find very relevant patent case to discuss and hence let us read one interesting trademark case decision handed down by the Delhi High Court.
Institute of Directors (Plaintiff) was aggrieved by the use, by the defendants Worlddevcorp Technology And Business Solutions Pvt Ltd , of the device mark. Worlddevcorp Technology has applied for registration of the said mark in for "education; providing of training; entertainment; sporting and cultural activities".
Mr. Jotwani, learned Counsel for Institute of Directors submitted that his client's grievance is essentially against the textual component of the impugned mark, which reads "Director’s Institute". He submits that the use, by Worlddevcorp Technology , of "Director’s Institute" is bound to result in confusion in the minds of the public, when seen vis-à-vis Institute of Directors's mark "Institute of Directors", especially as the marks are used for providing similar and allied services.
Mr. Jotwani has invited Hon. Judge’s attention to certain pages from the internet reflecting the use, by Worlddevcorp Technology, of the appellation "Directors' Institute", both as a phrase, as well as in the form of the logos.
Mr. Jotwani has no objection to Worlddevcorp Technology using any logo they want to, provided the logo does not contain the text "Directors' Institute" and "Director's Institute-World Council of Directors" and/or any other text which is deceptively similar to Institute of Directors's mark "Institute of Directors", as is likely to create confusion in the public.
Mr. Jotwani exhorted the Court to injunct Worlddevcorp Technology , pending disposal of the present suit, from use of the expression "Directors' Institute" as part of their mark or to refer to themselves as "Director's Institute".
Mr. Yashpal Singh, argued for Worlddevcorp Technology, submitted that the prayer of Institute of Directors is not sustainable as, while applying for registration of the device mark in Class 41, Institute of Directors, in response to an objection raised by the Trademark Registry under Section 9 of the Trade Marks Act, specifically responded on 08 December 2014 as below:
"We humbly submit that the mark IOD INSTITUTE OF DIRECTORS BUILDING TOMORROW'S BOARDS (DEVICE) of the Applicant is in the form of a device. It is pertinent to note that the words used in the mark are common English language words and are descriptive in nature and cannot belong to any one Proprietor. The Applied mark should be seen as a whole. It does not have direct reference to the characteristics like kind, quality, quantity or other characteristics of services.”
AAJ TAK case was referred. That was the case in which the Court held, while dealing with the mark "AAJ TAK" that, though, "AAJ" and "TAK", individually seen, were words of common usage, the word "AAJ TAK", once registered as a trade mark, was entitled to claim monopoly. That decision was rendered because of the distinctive use of the word "AAJ TAK", which was used as a specific device mark, over the whole of which monopoly was claimed. Even otherwise, that was not a case in which there was a representation made by Institute of Directors before the Trade Marks Registry to the effect that the words used in the mark were words of common usage, which did not belong to any one proprietor.
Trademark rights can be claimed only by the proprietor of the mark. The statement, in the response dated 8 December 2014, that the textual components of the device mark were English words of common usage, which could not belong to any one proprietor, prima facie defeats Institute of Directors's right to claim exclusivity over the words "Institute of Directors". Proprietary rights are a sine qua non for a claim to exclusivity to be sustained. Absent proprietary rights over a mark, there can be no exclusivity.
Obtaining of a registration in respect of a mark which consists of common English words is fraught with the possibility of its own adverse sequelae. While obtaining registration of such a mark, the registrant has to be conscious that, the mark being a combination of ordinary English words, and, in fact, as in the present case, being a mark as non-distinctive as "Institute of Directors", there is every possibility of a similar mark being used by another person. Commonly used words, or a non-distinctive combination of commonly used words, cannot be monopolised by any one person, so as to disentitle the rest of the world to the use thereof.
For all these reasons, therefore, the Hon. Judge opined, Institute of Directors's claim to exclusivity over the words "Institute of Directors" and, therefore, the prayer for a restraint against Worlddevcorp Technology' using the words "Directors Institute" cannot, prima facie, sustain.
Decision here
