API and IP Newsletter

 

Contents

• DMFs filed in May 2024

• General information

• Waltz Health debuts speciality pharmacy platform, partners with Reliance Rx to slash drug costs

• FDA Clears Omnipod 5 AID System for Type 2 Diabetes

• Intellectual Property

• Cesa Alliance SA

DMFs filed in May 2024

FDA publishes list of DMF filings every quarter. Second quarter list was published recently and since last week, we are analysing DMFs filed by the Indian companies. Last week we had looked at DMFs filed in April 2024 and this week we are analysing DMFs filed in May 2024. 

In the month of May 2024 there are about 70 DMFs filed. Indian companies had filed approximately 23 DMFs and Chinese companies filed 48 DMFs. First time we are noticing Chinese companies overtaking Indian companies in DMF filings with such a high margin. 

Some of the other observations are as below. 

HOLDER	SUBJECT	COMMENTS
MURLI KRISHNA PHARMA PVT LTD	DULOXETINE EC PELLETS 17.0% W/W	There're several duloxetine DMFs, but Murli Krishna is the first company to file DMF for duloxetine pallets. Nosch, Inventia and Titan are the major manufacturers and exporters of duloxetine pellets, but none of them filed DMF yet.
ALEMBIC PHARMACEUTICALS LTD	VILOXAZINE HYDROCHLORIDE	Viloxazine was approved in April 2021 and more than 9 DMFs filed already!  The drug was first marketed in 1976. FDA granted an orphan designation for cataplexy and narcolepsy in 1984. As per Wikipedia it was withdrawn from markets worldwide in 2002. The drug is repurposed by Supernus Pharmaceuticals as a treatment for ADHD and approved by FDA in April 2021. One could see many ANDA filings on NCE-1 date in April 2025.
TEVA PHARMACEUTICAL INDUSTRIES LTD	REMIMAZOLAM BESYLATE	This is a medication for the induction and maintenance of procedural sedation in adults lasting 30 minutes or less. Remimazolam is an old compound reported in WO2000069836 family first time in 1999. NCE-1 date would be 06 October 2024 and it would be interesting to note number of ANDA filers on NCE-1 date. There're already 9 DMF filers.
MSN LABORATORIES PRIVATE LTD	SORAFENIB	There are 20 other DMFs, but all of them are for tosylate salt. MSN had filed this DMF for sorafenib base. Maybe MSN is developing  sorafenib-loaded Poly (lactic-co-glycolic acid) PLGA polymeric nanoparticles for prolonged delivery of sorafenib for improved hepatic cancer treatment. Paper was published recently in Int J App Pharm, (Vol 16, Issue 4, 2024, 135-141), where MSN supported with API. Patent application also might have been filed and which is yet to be surfaced.  There is a technical disclosure from MSN about process and crystalline form of sorafenib base in April 2021.Here There’re already few generic launches in US. Current dose is 400 mg (2 tablets) orally twice daily without food. MSN might be trying to launch NDDS/new patient friendly formulation via 505 (b) (2) route.  We follow 505 (b) (2) approvals every month and if MSN seeks one for sorafenib, we will update readers of this newsletter.
SRI KRISHNA PHARMACEUTICALS	DIMETHYL FUMARATE USP	Dimethyl fumarate is approved for the treatment of multiple sclerosis. There're more than 30 DMFs filed. This will be very competitive market.

General information

Waltz Health debuts specialty pharmacy platform, partners with Reliance Rx to slash drug costs

A new specialty pharmacy program by digital health company Waltz Health has been created to lower costs for payers and provide better experiences for patients and pharmacies.

Waltz Health announced Waltz Connect, a platform that focuses exclusively on specialty drugs.

These drugs treat complex diseases and are usually much more expensive. 

News here

FDA Clears Omnipod 5 AID System for Type 2 Diabetes

The US Food and Drug Administration (FDA) has announced the expansion of indications for Insulet Corporation’s SmartAdjust technology, clearing the way for use of the Omnipod 5 Automated Insulin Delivery (AID) System in adults with type 2 diabetes.

Announced on August 26, 2024, the clearance makes the Omnipod 5 the first AID system to be FDA-cleared for both type 1 and type 2 diabetes management.

News here 

Intellectual Property 

Cesa Alliance SA

This is regarding EP patent application number EP2938337A1. This was filed by Cesa Alliance SA. This application was published as WO 2014/102090 and EP2938337A1.

The alleged invention concerns a chemical compound having the specific Formula (1) and its use as a medicament, in Alzheimer Disease. The compound is known at RVT: A7. 

Brief process mentioned in the application as filed is as follows: 

This application was refused by the examining division. 

Claim 1 of this request reads as follows.

"1. Compound having the Formula (1), presenting 1-30% of the isomer CIS and 70-99% of the isomer TRANS."

With its notice of appeal, the appellant Cesa Alliance SA requested, inter alia, to hold oral proceedings by means of a videoconference, should the decision under appeal not be set aside.

The appellant Cesa Alliance SA was summoned to oral proceedings to be held on 30 July 2024 at the premises of the boards of appeal.

In a communication under the Rules of Procedure of the Boards of Appeal (RPBA) issued on 17 June 2024 ("communication"), the Board expressed its preliminary opinion that the invention defined in claims 1 to 13 of the main request lacked sufficiency of disclosure (Article 83 EPC).

Oral proceedings took place before the Board in person on 30 July 2024 in the presence of the appellant Cesa Alliance SA. At the end of the oral proceedings, the Chair announced the Board's decision.

According to the application as-filed, the term "CIS" indicates that the aldehyde group and the hydroxyl group of the 6-membered carbonic ring lie on the same side of the ring plane ("isomer CIS"). By contrast, in the isomer named "TRANS" ("isomer TRANS"), these two ring substituents are oriented on opposite sides relative to the ring plane.

Claim 1 is thus directed to a mixture of the aforementioned two isomers CIS and TRANS in specified percentages ("CIS/TRANS mixture").

Sufficiency of disclosure of the invention defined in claim 1 (Article 83 EPC)

To meet the requirements of Article 83 EPC, an invention has to be disclosed in a manner sufficiently clear and complete for it to be carried out by the skilled person, without undue burden, on the basis of the information provided in the application as filed read by the skilled person with their common general knowledge in mind.

In the case at issue, the invention defined in claim 1 is directed to a mixture of two specific isomers of a compound of Formula (1) 

Contrary to the appellant's (Cesa Alliance SA ) position, depicting the formula of the desired compound in the application as filed and stating that it should be present as a specific mixture of its isomers is not sufficient to acknowledge sufficiency of disclosure. 

Rather, the application as filed must put the skilled person in a position that enables them to carry out the claimed invention, i.e. to prepare the claimed CIS/TRANS mixture of the compound, without undue experimentation.

In the Board's judgement, the application as filed fails to do so, the reasons being as follows.

1. Manufacturing methods are described on pages 8 to 10 of the application as filed. Specifically, page 8 discloses a scheme for the synthesis of a compound of Formula (1), referred to as "RVT:A7" and "A7". Page 9 provides details on the reactants for this synthesis. Page 10, lines 1 to 8, in turn, describes an example of the synthesis mentioned on page 8.

2. It is undisputed that the resulting product of the synthesis reported in this example is a mixture of several compounds including PBS and glycerol. 

3. This mixture is not further specified in the application as filed. In particular, the application as filed does not contain any information on whether this mixture comprises the claimed isomers CIS and TRANS and, if so, how to isolate these isomers from this mixture of components.

4. At the oral proceedings, the appellant Cesa Alliance SA argued that the final product of this synthesis did not include PBS and glycerol. Only the oil phase containing the molecule (i.e. A7) was used to produce the final product, i.e. the capsules. PBS and glycerol were used only to stop the reaction.

5. However, as explicitly observed by the Board at the oral proceedings, claim 1 is directed to a mixture of cis- and trans-configurations whereas in the formula of A7 (i.e. Formula (1) of claim 1) no stereochemistry is depicted. 

6. After having been made aware of this fact, the appellant conceded that the application as filed did not contain any statement on how to obtain the claimed CIS/TRANS mixture by means of the methods of synthesis described in pages 8 to 10.

7. It follows from the above that the application as filed lacks the necessary guidance on how to prepare the claimed CIS/TRANS mixture.

8. There is no evidence on file to show that this guidance may be found in the common general knowledge. Without such guidance, the skilled person has to resort to random trial-and-error experimentation to put the claimed invention into practice without any guarantee of success. 

9. Such trial-and-error experimentation places an undue burden on the skilled person, contrary to the requirements of Article 83 EPC.

Given these circumstances, the Board saw no reason to change its preliminary opinion and therefore concluded that the invention defined in claim 1 is not sufficiently disclosed (Article 83 EPC). Patent was not granted. 

Details here