API and IP Newsletter

 

Contents

• Analysis of FDA approvals. 

• General information. 

• Delhi HC rules in favour of Dr. Reddy’s in OMEZ trademark case. 

• The Latest Regulatory Guidance for Data Integrity and Regulatory Compliance. 

• Intellectual Property. 

• Sun Pharma Vs Cipla: Covid cannot be used as an excuse for Passing off (Madras HC) 

 

Analysis of FDA approvals

The below table summarizes FDA approvals in the month of September 2021. We will analyse approvals of small molecules. 

Drug Name	Active Ingredient	FDA-approved use on approval date
Livmarli	maralixibat	To treat cholestatic pruritus associated with Alagille syndrome
Qulipta	atogepant	To prevent episodic migraines
Tivdak	tisotumab vedotin-tftv	To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Exkivity	mobocertinib	To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations

Let us look at maralixibat in this newsletter.

 

SIDVIM comments:

1. Example 11 of WO2003022804 patent family describes the method of synthesising the compound. Similar seven member ring compounds are reported by Aventis in 1998 in patent family WO1999064410A1, so compound per say, might not be novel.

2. Innovator and now Gxs would generate lot of IP around processes, salts, polymorphs etc.

3. Analysing the patent filing and prosecution strategy adopted by Mirum Pharmaceuticals Inc, it seems maralixibat is going to be very US centric product.

4. Raymond James (analyst) estimated peak sales of $370 million for maralixibat in Alagille Syndrome (ALGS). ALGS is a rare and life-threatening cholestatic liver disease. 

5. Patent family WO2020167958A1 covers method of treatment for ALGS. The equivalents of this family are in US, Canada and Australia. If granted (in US it will be granted soon), it should able to protect the desired indication till 2040.

General information

Delhi HC rules in favour of Dr. Reddy’s in OMEZ trademark case

Dr. Reddy’s owns Trade Mark OMEZ. West-Coast Pharmaceutical Works offered same salt of omeprazole with Trade name OMES. Dr. Reddys sued West-Coast Pharmaceutical Works. Delhi HC opined in favour of Dr. Reddys and asked West-Coast Pharmaceutical Works to deposit Rs. 11100/- in PM National Relief Fund (PMNRF) for taking time of the Court and unnecessarily dragging Dr. Reddys in to this litigation.

News here.

The Latest Regulatory Guidance for Data Integrity and Regulatory Compliance

This article has focused on the section of the new PIC/S PI-041 guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments dealing with computerized systems. It is a good guidance with a wide scope and a lot of detail. In places, it veers from guidance with room for interpretation to a regulatory to-do list, especially for computerized systems. This may make it difficult for some organizations to implement fully.

News here.

Intellectual Property 

Sun Pharma Vs Cipla: Covid cannot be used as an excuse for Passing off (Madras HC)

This week, I could not find any interesting case for Patent dispute. However, few weeks ago there was headline in newspapers about Trademark case, Sun vs Cipla. 

1.  Cipla has an established market in the products viz Budecort Respules and Duolin Respules which are Budeonide Nebuliser Suspension BP and Levosalbutamol and Ipratropium Bromide Respirator Solution.

2.  The word “Respules” is a coined word has been registered and has been in use since 2013. These medicines were sold by Cipla with unique and colourful label and package.

3.  Using the mark ‘RESPULE’, Sun Pharma named its products as “Budefex Respules” and “Duoz Respules” which allegedly infringed Cipla’s registered trademark.

4. Sun argued, they have manufactured products valued Rs.1.5 crores and Rs.3.5 crores “Budefex Respules” and “Duoz Respules” respectively and be allowed to sell in the market. Sun promised to adopt a new package/label different from the one which has been currently used by them.

5.  Sun submitted, these products come with the expiry dates and therefore Sun may be allowed to sell the existing stock as these medicines are required for treatment of patients with Covid symptoms. 

6. The Court opined, it cannot allow a party to violate another person’s intellectual property rights viz copyright and trademark and remain a mute spectator where there also is an attempt to pass-off the goods although the country is facing unprecedented medical emergency.

7.   If Sun is allowed to release the products in the market, it will result in incalculable damage to the proprietary rights of Cipla and by permitting Sun to sell the good it will be allowing dilution of the proprietary rights of Cipla.

It is interesting to note, the Court has set a precedent here, even a medical emergency like COVID cannot be used as an excuse by the pharma-companies to infringe someone else’s IP rights.

Though this judgement states about Copyrights and Trademark infringements, could it be extended to patent cases?  

Decision here

Disclaimer

Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.