API and IP Newsletter

 

Contents

• List of Off-Patent, Off-Exclusivity Drugs (Capsules) without an Approved Generic

• General information

• Moderna takes first win in UK trials with Pfizer and BioNTech

• Local division Düsseldorf grants first ever injunction against bathtub manufacturer

• Intellectual Property

• Abbott Vs SiBio- Continuous Glucose Monitoring device

List of Off-Patent, Off-Exclusivity Drugs (Capsules) without an Approved Generic

Last week, we discussed the list of off-patent, off-exclusivity drugs published by FDA. 

In short, the FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. 

The FDA updates this list every six months (in June and December). More details could be found here.

Also, last week’s API and IP Newsletter, we had identified tablet dosage forms from the FDA lists, where there’re approved NDA drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA. 

This week we looked at Capsule dosage forms. The list for capsules is as below. 

Ingredient	Approved NDA	Dosage Form
AURANOFIN	N018689	CAPSULE
CARBAMAZEPINE	N021710	CAPSULE, EXTENDED RELEASE
CHOLIC ACID	N205750	CAPSULE
CITALOPRAM HYDROBROMIDE	N215428	CAPSULE
CYCLOSPORINE	N050625	CAPSULE
DISOPYRAMIDE PHOSPHATE	N018655	CAPSULE, EXTENDED RELEASE
ESTRAMUSTINE PHOSPHATE Na	N018045	CAPSULE
FENOFIBRATE	N021612	CAPSULE
HYDROXYUREA	N016295	CAPSULE
LEVOTHYROXINE SODIUM	N021924	CAPSULE
LOMUSTINE	N017588	CAPSULE
MESALAMINE	N020049	CAPSULE, EXTENDED RELEASE
MILTEFOSINE	N204684	CAPSULE
NABILONE	N018677	CAPSULE
OLSALAZINE SODIUM	N019715	CAPSULE
ORLISTAT	N020766	CAPSULE
PENTOSAN POLYSULFATE Na	N020193	CAPSULE
PHENDIMETRAZINE TARTRATE	N018074	CAPSULE, EXTENDED RELEASE
PROCARBAZINE HCl	N016785	CAPSULE
PROPRANOLOL HCl	N021438	CAPSULE, EXTENDED RELEASE
SERTRALINE HYDROCHLORIDE	N215133	CAPSULE
SODIUM IODIDE I-131	N021305	CAPSULE
SUCCIMER	N019998	CAPSULE
THALIDOMIDE	N020785	CAPSULE
TIPRANAVIR	N021814	CAPSULE
TRAMADOL HYDROCHLORIDE	N022370	CAPSULE, EXTENDED RELEASE
VERAPAMIL HYDROCHLORIDE	N019614	CAPSULE, EXTENDED RELEASE
ZOLPIDEM TARTRATE	N215721	CAPSULE

We tried to analyse products which would be of interest to the generics for their potential development project. Some of our observations are as below. 

Ingredient	Approved NDA	Dosage Form	SIDVIM comments
AURANOFIN	N018689	CAPSULE	It seems from public domain information that auranofin is not available in US market.  Recently, Auranofin was tried for repurpose drug for Glioblastoma, CLL, (N)SCLC, ovarian, primary peritoneal and fallopian tube cancer. However, since the drug is barely used for the original indication (rheumatoid arthritis), and hence is removed from most the markets (except from e.g. Canada), which complicates supply for clinical trials and may delay/hinder clinical adoption.
CARBAMAZEPINE	N021710	CAPSULE, ER	Carbamazepine Tablets is a major market in US ie about USD 120 mio. Capsules are not common and hence must be very low sales in US.
CHOLIC ACID	N205750	CAPSULE	This product is now offered by Mirum Pharmaceuticals. As per public domain information sales of capsules in 2023 was less than $ 23 mio.  Mirum acquired Travere’s rights to Cholic acid capsules ie Cholbam® which is indicated for the treatment of bile acid synthesis disorders.
CITALOPRAM HBr	N215428	CAPSULE	The only approval for citalopram HBr capsule in OB is for Almatica Pharma. The approval of citalopram 30mg Capsule provided an additional dosing option between 20 mg and 40 mg, for the treatment of major depressive disorder. US sales data for capsule is not available in the public domain.
CYCLOSPORINE	N050625	CAPSULE	This is Sandimmune capsules from Novartis. This is marketed by Sandoz. Though total sale of Sandimmune is reported about $ 250 mio, it must be comprising all dosage forms, only capsule sale is not available in the public domain.

Few of above products should qualify for GCT exclusivity. We covered information about CGT exclusivity in our last week’s write-up. 

General information

Moderna takes first win in UK trials with Pfizer and BioNTech

The UK High Court found Pfizer and BioNTech are infringing a Moderna patent with their COVID-19 vaccine Comirnaty and owe the US company damages. However, the court also declared a second Moderna patent invalid.

News here

Local division Düsseldorf grants first ever injunction against bathtub manufacturer

German bathtub manufacturer Bette faces the UPC's first ever injunction in an infringement case. The company may no longer sell shower trays in seven UPC countries. Germany, the domestic market of plaintiff Kaldewei and high-end competitor Bette, is not affected.

News here 

Intellectual Property 

Abbott Vs SiBio- Continuous Glucose Monitoring device

This is regarding European patent EP2713879, relates to analyte sensor devices, connections, and methods. This patent is issued to Abbott and would be valid till 2032. 

Essentially this granted patent would cover continuous glucose monitoring (“CGM”) device. Abbott has been a developer, manufacturer and marketer of continuous glucose monitoring (“CGM”) devices since 2007. Its series of devices is called FreeStyle Libre. Since 2014, these devices have comprised an applicator (i.e. an insertion device), an on-body unit consisting of an analyte sensor (for glucose) and sensor electronics as an integrated unit, and a display device (such as a reader or smartphone) with proprietary software.

The Chinese newcomer SiBio and its distribution partner Umedwings, are relatively young players in the CGM market. SiBio had launched its SiBio-KS1 CKM product last year.

Abbott filed three PI (Preliminary Injunction) proceedings against SiBio and Umedwings in April 2024 in Europe, two with the local division The Hague and one at the local division Düsseldorf. Abbott is also taking action against various SiBio companies, Umedwings and other European distributors across Europe.

According to Abbott, SiBio utilizes the technology disclosed in the granted patent EP2713879. 

Abbott is the main supplier of CGM products in the Contracting Member States. In Europe, Abbott serves over 1.3 million patients with its FreeStyle Libre products and has a market share of approximately 80%. 

Sibio also manufactures CGM systems. Since 2021, Sibio has been marketing a CGM device in China. Recently, at the end of 2023, Sibio entered the European market with its CGM device, called GS1. 

Umedwings and together with Sibio importing GS1 device in Europe.

A Chinese company, Shenzhen Sibionics Co. Ltd, filed a Protective Letter concerning the patent on 29 September 2023. In the protective letter, the company argued that it (or a member of the group) would not infringe the patent by providing the GS1 devices in the Contracting Member States. It is the understanding of this Court that Shenzhen Sibionics Co. and Sibio Technology Limited belong to the same group of companies.

Finally, Abbott lodged the application for a preliminary injunction and other provisional measures on 20 March 2024 at the UPC Local Division The Hague. 

Abbott contends that its patent is valid and that both independent claim 1 and dependent claim 4 of EP2713879 are infringed by Sibio, among others through the offering for sale of the GS1 Devices on Sibio’s website sibionicsshop.com, which is targeted at Europe. 

Abbott therefore requested that the Court, for the Contracting Member States in which the patent is in force to grant a preliminary injunction for direct infringement of the patent by prohibiting Sibio. 

In their objection, Sibio c.s. did not rely on the defence presented in the protective letter, nor did they challenge the validity of the patent or the alleged infringement. They also did not dispute the urgency of the application or the competence of the court. Instead, the Defendants Sibio  and Umedwings  provided a unilateral cease-and-desist declaration with certain undertakings concerning the withdrawal of the GS1 device from the market in Germany, France and The Netherlands. 

In response to criticism from Abbott, Sibio c.s. amended their cease-and-desist declaration on 15 May 2024. Sibio c.s. argued that the application has therefore become devoid of purpose and that there is no longer any need to adjudicate on it.

Decision:

The court granted a preliminary injunction for direct infringement of European patent EP2713879, prohibiting Sibio and Umedwings , individually and jointly, from infringing this patent, with immediate effect after service of this order, by making, offering and / or placing on the market the GS1 Device, or importing or storing the GS1 Device for the commercial purposes in accordance with claim 1 or 4 of European patent EP2713879 in Germany, France, The Netherlands and Ireland.

The Court ordered the Defendants Sibio and Umedwings to comply with the orders, subject to a recurring penalty payment of up to EUR 10,000.00 for each violation of, or noncompliance with, the order, or up to EUR 100,000.00 for each day, or part of a day counting as an entire day, that the violation or non-compliance continues.

Decision here