API and IP Newsletter

 Contents

• Patent applications filed by Mankind

• General information

• District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA Infringement Suit

• Delhi High Court orders FranchiseByte to take down videos and content about Wow Momo from website, YouTube

• Intellectual Property

• Dosing regimen Remimazolam

Patent applications filed by Mankind

We follow patent applications filing strategy by Indian companies. This week we analysed patent application filings of Mankind Pharma. In last five years Mankind filed about 80 patent applications. General observations are as below.

1. Mankind identifies products for development very early, either in phase-III or in preregistration phase.

2. Many applications are related to amorphous APIs. 

3. Patent portfolio is good mix of old and new molecules and one could infer than Mankind is giving sufficient emphasis on Life Cycle Management (LCM) projects.

4. There seems to be lot of focus on backward integration at Mankind.

Some of our observations are as below

Publication Number	Comments
IN449934B	This invention relates to Preparing sugammadex and its sodium salt, involves adding gamma-cyclodextrin and halogenating agent in dimethylformamide and converting formed substantially pure crystalline halo-gamma-cyclodextrin to sugammadex and its sodium salt. There are many suppliers of sugammadex and over 4 dozen DMF filers, Mankind would be one of them. This invention deals with purification of sugammdex. Mankind filed DMF in July 2019 and this process could be representing Mankind’s DMF process.  Due to recent settlement launch in US would be possible in 2026.
IN428476B	Elafibranor (GFT505) is an experimental medication that is being studied and developed by Genfit for the treatment of cardiometabolic diseases including diabetes, insulin resistance, dyslipidemia, and non-alcoholic fatty liver disease (NAFLD).  This is not even approved in any key jurisdiction and Mankind had already started developing API. This invention relates to intermediate 2,6-dimethyl-phenyl ether derivatives used to prepare elafibranor. This indicates Mankind tries to be as backward integrated as possible right from the start of API development.
IN410862B	This invention relates to process of intermediate of atorvastatin. Preparation of 4-fluoro-alpha-(2-methyl-1-oxopropyl)-alpha-oxo-N-beta-diphenylbenzenebutanamide for preparing atorvastatin, involves coupling 4-methyl-3-methylidene-N-phenylpentanamide compound and halogen-substituted fluorophenyl compound. This indicates Mankind works on many LCM projects.  Mankind filed Atorvastatin DMF in June 2020 and this process could be part of the DMF.
IN201911052572A	Lanifibranor is a pan-PPAR (peroxisome proliferator-activated receptor) receptor agonist and is the first medication that targets PPAR-alpha, PPAR-beta, and PPAR-gamma simultaneously. As of today, it is in a phase III trial for nonalcoholic steatohepatitis; its advantage over other drugs that are in phase III trials for the same condition is that it has shown improvements in both steatohepatitis and fibrosis.  Mankind had already started working on API synthesis. This invention relates to New amorphous form of lanifibranor.
IN201911046561A	Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis.  Ozanimod was approved for medical use by USFDA in March 2020 in the European Union in May 2020, and by TGA in Australia in July 2020. Interesting to note patent application filed in November 2019, ie much before the approvals in key jurisdictions.  This patent application relates to substituted 2-isopropoxy-benzonitrile compounds useful intermediate for preparing ozanimod.  This hints how focused Mankind is on backward integration.

General information

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA Infringement Suit

As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal (here) without having access to the accused products when alleging infringement of Orange Book-listed patents. One recent District Court decision has clarified that non-Orange Book-listed patents are subject to the same pleading standard as listed patents in a Hatch-Waxman infringement suit 

News here.

Delhi High Court orders FranchiseByte to take down videos and content about Wow Momo from website, YouTube

A single judge bench of Justice C Hari Shankar in its October 20 order observed that by using the Wow Momo trademark “unauthorisedly”, FranchiseByte not only infringed on the trademark but had also defrauded people.

News here

Intellectual Property 

Dosing regimen Remimazolam

T 1161/22 (DOSING REGIMEN FOR SEDATION WITH CNS 7056 (REMIMAZOLAM)/Paion UK Ltd) 08-09-2023

EP 3492080 is filed by Paion UK limited and was under examination at EPO.

This application was refused by EPO. (This is a divisional application of granted EP 2637662).

The patent family relates to remimazolam, brand name Byfavo. 

Paion, a specialty pharmaceutical company with innovative drugs for use in outpatient and in-hospital sedation, anesthesia and intensive care.

Byfavo was approved by the European Commission in the EU (covering the European Economic Area (EEA) countries) in April 2023 for general anesthesia. 

Since 2021 it is already approved and available for procedural sedation.

With millions of procedures in the EU annually that require the use of general anesthesia, Byfavo and hence Paion believes it addresses a large market opportunity.

The some aspects of the product Byfavo seems to be covered by EP `080. As motioned earlier, this application was refused by EPO and hence patentee Paion appealed. 

According to the decision under appeal, none of the requests met the requirements of Article 76(1) EPC in view of the claimed combination of the features

What id Article 76(1) EPC?

This Article 76 (1) at EPC relates to divisional application and according to which, a European divisional application shall be filed directly with the European Patent Office in accordance with the Implementing Regulations. It may be filed only in respect of subject-matter which does not extend beyond the content of the earlier application as filed; in so far as this requirement is complied with, the divisional application shall be deemed to have been filed on the date of filing of the earlier application and shall enjoy any right of priority.  

This in case of EP `080, oral proceedings before the Board of appeal took place on 8 September 2023. During the oral proceedings, the appellant ie patentee Paion filed a new auxiliary request 12. 

Claim 1 of auxiliary request 12 read as follows, with the modifications vis-à-vis the main request shown in bold:

"1. 3-[(4S)-8-bromo-1-methyl-6-(2-pyridinyl)-4H-imidazo[1,2-a][1,4]benzodiazepine-4-yl]- propionic acid methyl ester (CNS 7056, remimazolam) of formula (I)

or a pharmaceutically acceptable salt or solvate thereof for use in sedation for colonoscopy, wherein CNS 7056 is given by intravenous administration in a fixed dose, wherein the term "fixed dose" relates to an amount of a drug given to a patient irrespective of his body weight, the fixed dose is 5 mg, 6 mg, 8 mg, or 9 mg and at least one 3 mg top-up dose of CNS 7056 (remimazolam ) is given."

With regard to the top-up doses, the Board notes that Table 18 discloses, when 0 μg of fentanyl is given, a constant top-up dose of 3 mg of CNS 7056 and an average number of top-up doses comprised between 4.205 and 4.338 (cf. the right hand column of Table 18), but does not give the actual number of top-up doses given. 

Hence, there is no disclosure of "at least one 3 mg top-up dose of CNS 7056 (remimazolam)" in the Table and this feature is also not derivable therefrom. For instance, there is no disclosure in Table 18 of one or two top-up doses.

The Board could in particular not agree with the patentee that dependent claim 2 of the parent application could serve as a basis for this feature; said claim recites indeed that "at least one top-up dose of CNS 7056 is given". 

Claim 2 is however dependent on claim 1 which relates to the combination of CNS 7056 (remimazolam) with an opioid, which is not the subject-matter of claim 1 of auxiliary request 12.

Consequently, the subject-matter of claim 1 of auxiliary request 12 is not derivable directly and unambiguously from the parent application and auxiliary request 12 does not meet the requirements of Article 76(1) EPC.

Decision here