API and IP Newsletter

 Contents

• Analysis of patent applications filed by Alembic

• General information

• Catalyst (CPRX) Settles Patent Dispute Over Sole Marketed Drug Firdapse (amifampridine)

• EU court adviser says Servier's pay-for-delay deals were anti-competitive

• Intellectual Property

• Novo sued Sun Pharma alleging patent infringement of Saxenda and Victoza (Liraglutide)

Analysis of patent applications filed by Alembic

Alembic files a sizable number of applications every year. 

It is important to note, most of the applications are related to their ANDA filings and indicating towards their circumventing strategies of OB listed patents. 

Glimpses of our observations are as below. 

Publication Number	Sidvim comments
WO2022090953A1	Invention relates to solid dispersion of ponatinib. Ponatinib approved by FDA in December 2012, but later temporarily suspended sales on 31 October 2013 because of "the risk of life-threatening blood clots and severe narrowing of blood vessels". This suspension was partially lifted in December 2013 with  revised prescribing warning information. High price of treatment was also criticized in US. Only 2 DMFs filed so far. Alembic has not filed DMF!
WO2022079591A1	The invention relates to a solid oral pharmaceutical composition of lasmiditan, which is approved in January 2020 for treatment of migraine. In October 2020 Alembic filed patent application for composition. It means they must have developed API much in advance.
WO2020225738A1	The patent family relates to amorphous solid dispersions of venetoclax.   Venetoclax approved in 2026 for CLL and AML. Alembic filed ANDA and litigating with AbbVie and Genentech. In 2020 forecasted sales for venetoclax was US$1.48 billion!  OB listed patent US 8722657 claims venetoclax polymorphs, to circumvent this OB patent Alembic must have filed this patent application covering amorphous dispersion of venetoclax.

General Observations:

1. Alembic’s patent applications are mainly targeting small molecules.

2. Patent applications are filed for various formulation strategies and polymorphs. 

3. IP is generated around complex and hard to manufacture APIs

General information

Catalyst (CPRX) Settles Patent Dispute Over Sole Marketed Drug Firdapse (amifampridine)

Firdapse (amifampridine) was approved to treat Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients.

Per the terms of the settlement, CPRX will stop pursuing all claims related to patent litigation between the companies. In addition, Catalyst Pharmaceuticals will acquire certain intellectual property (IP) rights belonging to Jacobus, including the rights to develop and commercialize Ruzurgi in the United States and Mexico.

In return, CPRX will make an undisclosed cash payment to Jacobus, with the latter also being eligible to receive low single-digit royalties on net U.S. sales of amifampridine.

News here.

EU court adviser says Servier's pay-for-delay deals were anticompetitive

An adviser to Europe's top court said the court should back an EU antitrust decision which found French drugmaker Servier's pay-for-delay deals with generics rivals were anticompetitive.

Servier was fined 331 million euro ($332 million) after the European Commission said in a 2014 decision its deals with five generics rivals between 2005 and 2007 aimed to protect its best-selling blood pressure medicine perindopril from competition in the European Union.

News here.

Intellectual Property 

Novo sued Sun Pharma alleging patent infringement of Saxenda and Victoza (Liraglutide) 

OB listed patents are as below.

Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code
6268343	08/22/2022	DS	DP	U-968
6268343*PED	02/22/2023
7762994	05/23/2024		DP
7762994*PED	11/23/2024
8114833	08/13/2025	DS	DP
8114833*PED	02/13/2026
8579869	06/30/2023		DP
8579869*PED	12/30/2023
8846618	06/27/2022		DP
8846618*PED	12/27/2022
9265893	09/23/2032		DP
9265893*PED	03/23/2033
9968659	01/09/2037			U-2313
9968659*PED	07/09/2037

Novo sued Sun for four patents US 7,762,994 (the “’994 patent”), US 8,114,833 (the “’833 patent”), US8,579,869 (the “’869 patent”), and US 9,265,893 (the “’893 patent”), 

The claims 1-6 of the ’893 patent are directed to a push button connection for an injection device. 

Claims 1-8 of the ’994 patent encompass a mounting system for mounting two different needle arrangements. 

Teva, Mylan and Sandoz settled with Novo for launch date in June 2024. For Sun Pharma 30 Month stay will end later than June 2024 and it will be interesting to see whether Novo settles with Sun and what could the launch date for Sun, provided there are no other regulatory challenges.

Here

Novo also filed similar complaint for Saxenda. 

Saxenda and Victoza contain the same active drug, but only Saxenda is approved to help with weight loss. Victoza isn't approved for weight loss. Some people who take Victoza for type 2 diabetes may lose some weight with the drug. But Saxenda is used in a higher dosage than Victoza.