API and IP Newsletter

 Contents

• DMFs filed in March 2023

• General information

• Nestlé and Clextral revoke Ojah plant-based protein patent at EPO

• Industry-academia tie-up, a win-win for new drug

• Intellectual Property

• Delhi High Court refused to cancel the mark “Burger King” issued in favour of Burger King Co LLC

DMFs filed in March 2023

FDA publishes a quarterly list of DMFs filed by various API manufacturers. We analyse those. Type II DMFs.  We study DMFs filed by Indian companies. 

Generally, in the months of December and March, a greater number of DMFs are filed compared to the other 10 months. March 2023 is no exception. Total of 118 DMFs were filed. Some of our observations are as below.

HOLDER	SUBJECT	SIDVIM comments
BIOPHORE INDIA PHARMACEUTICALS PVT LTD	ELTROMBOPAG OLAMINE	There are 10 other DMF filers. Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag. A drug used to treat thrombocytopenia (a low blood platelet count). There is a specific compound patent for ethanolamine salt till March 2024. Many companies must be preparing for their generic launches.
GRANULES INDIA LTD	DASATINIB MONOHYDRATE	There are 5 other DMF filers. For US launch, API must be devoid of crystalline dasatinib monohydrate, which is protected till 2026.  There are a few Indian suppliers exporting to Europe and some other countries at USD 2900-4000/Kg. It will be interesting to know about the crystalline form of these exporters.
USV PRIVATE LTD	RIVAROXABAN USP (MICRONISED)	Rivaroxaban has only limited solubility in water, causing problems regarding the dissolution of the API from the pharmaceutical composition and the oral bioavailability. There are several patent families filed to address this issue, some are related to amorphous, and some are claiming crystalline modifications. So, though there are other 5 DMFs filed, USV's DMF with micronized API still could add value to the formulator.
MSN LIFE SCIENCES PRIVATE LTD	SUCRALFATE USP	Third DMF for Sucralfate in last 6 months. Due to CGT designation, there's a sudden surge in the requirement of sucralfate. There are few ANDA approvals and DMF filings in the last 6 months for this anti-ulcer drug.
DR REDDYS LABORATORIES LTD	LUMATEPERONE TOSYLATE	The first DMF filed, NCE-1 date is in December 2023. It is a first-in-class drug used for the treatment of schizophrenia. DRL had filed a patent application that relates to Lumateperone p-tosylate (1:1) in solid amorphous form. (WO2018189646A1). This could be the same grade of API claimed in the patent application.

General information

Nestlé and Clextral revoke Ojah plant-based protein patent at EPO

The EPO Boards of Appeal have revoked an Ojah patent covering plant-based protein technology. Nestlé, one of the main opponents throughout proceedings, is investing heavily in this increasingly popular segment of the food retail market. This growth, combined with developments around food technology and the manufacturing process, means future litigation over meat-substitute proteins is more than likely to occur.

News here.

Industry-academia tie-up a win-win for new drugs

A strong collaboration between academia and the pharma industry is a win-win situation as the strengths of each can be combined to develop a cost-effective drug,

News here

Intellectual Property 

Delhi High Court refused to cancel the mark “Burger King” issued in favour of Burger King Co LLC

For a change, we cover Trade Mark case this week. I must confess I am a patent lawyer, not a Trademark expert, but I like to read Trademark cases. In Trademark, since it is related to our day-to-day life, we understand the gravity of the issue quickly. Moreover, we form the first opinion based on our understanding of the registered marks. We need not be an expert in Trademark laws to form such an opinion.

The present rectification petition has been filed seeking cancellation/removal of the impugned mark, registered under no. 2052257 in class 43 in the name of respondent no.1, Virendra Kumar Gupta, from the Register of Trade Marks.

The trademark BURGER KING is registered in the name of petitioner Burger King Co LLC in over 122 countries worldwide. In India, the earliest registration of the trademark BURGER KING dates back to the year 1979. 

Burger King entered India in the year 2014 and opened its first BURGER KING restaurant in New Delhi on 9th November 2014. 

The annual turnover of Burger King in the year 2021 was 23,050 million US dollars. 

In August 2011, Burger King became aware that Virendra Kumar Gupta (respondent no.1) has applied for registration of the impugned trademark in class 43. 

The Registry advertised the impugned mark of Virendra Kumar Gupta in 2016 without informing Burger King and the impugned mark was registered in favour of Virendra Kumar Gupta.

In the year 2014, Burger King filed a suit for infringement against Virendra Kumar Gupta. 

On 25th July 2014, an ex parte injunction order was passed in favour of Burger King and against Virendra Kumar Gupta, restraining Guptas from using the trademark BURGER KING or any other mark similar thereto. 

The aforesaid injunction order was confirmed vide judgment dated 24th September 2018.

The Counsel for Burger King argued that the primary element of the impugned mark is identical to his client’s well-known trademark BURGER KING. 

He further submitted that the additional words in the impugned mark, i.e., “Family Restaurant” are descriptive in nature and have been written in a small font as compared to the words BURGER KING. He further submitted that the impugned mark has been registered in respect of services for providing food and drinks, temporary accommodation: café and coffee bar, restaurants including self-service, take away and fast-food restaurants, which are included in class 43 and are identical to the services provided by the petitioner Burger King under the BURGER KING trademark.

The Counsel of Burger King brought to the notice of the Court that his client is also a prior user of the trademark BURGER KING as compared to Virendra Kumar Gupta. Therefore, the registration ought not to have been granted in terms of Section 11 of the Trademarks Act.

The counsel for Virendra Kumar Gupta submitted that Guptas had filed an appeal against the judgment dated 24th September 2018 confirming the ex parte injunction granted on 25th July 2014, which is pending adjudication before the Division Bench of this Court. Hence, the adjudication of the present application may await till the decision of the Division Bench.

The Hon. Judge opined, 

1. the plant is clear that the mark “Burger King‟ was adopted in 1954 in the US, and thus, the evidence of transborder reputation, which is mentioned in the plaint, cannot be rejected at this stage 

2. The list of outlets at various airports shows that travellers from India would have had knowledge of Burger King. It cannot be disputed that there are thousands of outlets of Burger King across the world. 

3. Virendra Kumar Gupta’s explanation for the adoption being extremely unimaginative and the identical logo being an indication of dishonest adoption, the injunction already granted is liable to be confirmed. 

4. The manner in which Virendra Kumar Gupta and Company are soliciting enquiries and wanting to give franchisees for their outlets under the name Burger King poses a clear and imminent threat of extreme dilution of the mark. 

5. the injunction granted on 25th July 2014 shall stand confirmed. Guptas are thus injuncted from using the mark BURGER KING as also the infringing logo in respect of their food outlets or restaurants, in any manner whatsoever. 

6. Guptas are restrained from granting any franchisees or opening any new outlets under any name containing the mark BURGER KING. This, however, does not bar Guptas from using the mark/name “Burger Emperor”.

Decision here