API and IP Newsletter

 Contents


DMFs filed in January 2022



HOLDER

SUBJECT

SIDVIM comments

HONOUR LAB LTD

VILDAGLIPTIN

This is surprising and we need to find out more about this. Vildagliptin is not approved in US, we are not sure what is the rationale for filing DMF for vildagliptin. Of course this is not a first DMF of Vildagliptin and other 10 DMFs have been filed, but those are filed sometime back.

AUROBINDO PHARMA LTD

SORAFENIB TOSYLATE USP

Sorafenib will be generics soon in US. There are 14 other DMF filers. Small API market in terms of volume. 

NATCO PHARMA LTD

ERIBULIN MESYLATE

Many companies started filing DMFs for eribulin. It is a complex development and involve lot of column chromatography separations. 

VIRUPAKSHA ORGANICS LTD

ESCITALOPRAM OXALATE

Vanilla Generics. But Virupaksha could be fully backward integrated company to offer cost effective API to their potential clients.

MSN ORGANICS PRIVATE LTD

RIVASTIGMINE USP

There are many Gx launches, including authorised generics of Sandoz. Seven other DMFs filed. 

MSN LABORATORIES PRIVATE LTD

MIRABEGRON (a-FORM)

Alpha and Beta form of mirabegron are protected till 2022 in key jurisdiction.
In EU, SPC till 2023. So many Gxs will shift to alpha and beta forms in coming years.

MSN LABORATORIES PRIVATE LTD

GILTERITINIB FUMARATE

First DMF filed by MSN. Approval in November 2018. Though NCE-1 date is in November 2022, Gx launch in US could be challenging before compound patent expiration in 2031.


We analyze DMF filings by Indian companies. Some DMFs filed by the Indian companies and our analysis is as below. 



General information


Sandoz and Teva invalidate blockbuster apixaban patent and SPC


The UK High Court has invalidated a Bristol Myers Squibb patent, which covers a blockbuster drug and SPC for the treatment and prevention of blood clots. This month, the court is due to hear another revocation case brought by Teva, this time over four patents. Globally, sales of apixaban have grown due to the coronavirus pandemic.


The court invalidated the patent and corresponding SPC for lack of plausibility based on insufficiency. The court did acknowledge the amendments, but did not formally allow them as it would not “cure [the patent’s] invalidity”.

News here.



Novartis' Sandoz strikes AbbVie's popular eye pressure drug with generic launch

 

Novartis’ Sandoz is expanding its eye drug offerings, this time targeting a popular ocular hypertension med from AbbVie’s Allergan.

 

Sandoz has launched in the U.S. a generic version of AbbVie’s Combigan, a combo eye drop used to treat elevated eye pressure. As the most-dispensed branded combo glaucoma medication, the originator reeled in $373 million in U.S. sales last year.


The Sandoz version isn’t the first generic to Combigan. That title belongs to Apotex’s authorized generic version, launched in January before all patents around the drug expired.

News here.


Intellectual Property 


T 0798/19 (PRODUCING LIQUID DETERGENT/P & G) of 15.3.2022


The appeal is against the decision of the opposition division to reject the opposition against EP 2820114. The patent was issued to Procter & Gamble.

It was opposed by Henkel AG.

Patent was upheld at the first instance and it was under appeal. 


Claim: 

"1. A method for producing a liquid detergent product comprising from 5% to 15% by weight of the product of water using a vessel comprising an inlet, an outlet, an agitation device, and a microcapsule mixing zone disposed between the inlet and the outlet, characterized in that the method comprises the steps of:

a) introducing an unstructured liquid detergent precursor into the inlet of the vessel, said unstructured liquid detergent precursor comprising from about 10% to 90%, by weight of the precursor, of a surfactant, and from about 0% to about 15%, by weight of the precursor, of water;

b) mixing an aqueous slurry comprising perfume microcapsules and the unstructured liquid detergent precursor in the microcapsule mixing zone to form a combined microcapsule detergent;

c) adding a structurant to the combined microcapsule detergent downstream of the microcapsule mixing zone to form a liquid detergent product."

In its statement of grounds of appeal, Henkel only disputed the finding of the first instance that the subject-matter of claim 1 was not obvious in view of the prior art. 


The closest prior art

  1. It referred in this respect to D1 (WO 2011/120772 A1) in combination with common general knowledge or the disclosure of D3 (DE 10 2009 002 174 A1). 

  2. Henkel also submitted that, contrary to the opposition division's (1st instance) conclusion in the contested decision, the data in D7 (Expert declaration dated 20 March 2014) would not prove that a reduced aggregation of the perfume microcapsules occurred in the method for producing a liquid detergent product containing perfume microcapsules (PLDP method) defined in claim 1, vis-à-vis that occurring in the similar prior art method of D1.


Objective technical problem:


It was agreed that the patent addresses the technical problem of providing a method for producing a liquid detergent comprising perfume microcapsules that prevents the formation of large aggregates of perfume microcapsules 


Henkel argument

Henkel submitted that the subject-matter of claim 1 cannot solve the posed technical problem across its whole breadth because the patent itself showed substantial difference of dimensions of the aggregates of perfume microcapsules between the micrographs of liquid detergent products of the invention depicted in Figures 3 and 4. 

 

A picture containing text

Description automatically generatedA picture containing text, nature

Description automatically generated

The Boards of Appeal disagreed, said

  1. Henkel in its reasoning did not refer to any prior art or common general knowledge rendering predictable that the formation of large aggregates of perfume microcapsules can be disfavoured more effectively than in the PDLP method of D1, not to mention any prior art or common general knowledge rendering predictable that such improvement could be obtained in particular by adding the structurant not to the starting liquid detergent precursor, but rather to the composition obtained combining the slurry of perfume microcapsules with the liquid detergent precursor.

  2. Thus, it is apparent that the prior art does not render obvious to solve the posed technical problem by the modification of the closest prior art, necessary to arrive at the PLDP method of claim 1, that actually solves the posed technical problem.

Therefore, the subject-matter of this claim is found based on an inventive step and patent was upheld. Here









Popular posts from this blog

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic and Trademark case for J&J's ORS-L brand (Delhi HC decision)

API and IP Newsletter- Recent ANDA approvals and Roxadustat decision by EPO: T 0072/23

DMF filings by Indian companies in May 2025 and F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court decision