Friday, January 11, 2013

Apotex, Watson, Sandoz and Hi-Tech Pharma Sued for Filing ANDA

Plaintiff: Allergan

Defendant: Apotex, Watson, Sandoz and Hi-Tech Pharma

Case Number: 1:13-cv-00016

Date Filed: January 08, 2013

Court: North Carolina Middle District Court

Patent-in-Suit: US8263054

The patent US8263054 involved in suit is currently assigned to Allergan (as per face page). The patent entitled Method of enhancing hair growth was issued on September 11, 2012 and expires[i] by January 15, 2023. The patent describes a method of increasing eyelash growth in a human including length, thickness and darkness of the eyelashes, the method comprising administering bimatoprost to an eyelid margin of the human.

About the Parties:
Allergan is a pharmaceutical company. Their product range includes ophthalmic pharmaceuticals, dermatology products, and neurological products. It also develops and commercializes prescription and non-prescription eye care products. 

Apotex is a pharmaceutical company engaged in the research and development, manufacture, and distribution of generic pharmaceuticals. It offers products in various dosage forms, such as liquids, ophthalmics, nasal sprays, and injectables. Apotex Inc. operates as a subsidiary of Apotex Pharmaceutical Holdings Inc.

Watson pharmaceuticals is engaged in the development, manufacture, marketing and distribution of generic pharmaceuticals in a number of therapeutic categories and specialized branded pharmaceutical products that are focused on urology, women’s health and pain management. Watson also distributes generic and branded pharmaceuticals through Anda, Inc.

Sandoz a division of the Novartis is a generic pharmaceutical company with key product groups such as antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnologically active substances and anti-infectives. 

Hi-Tech Pharma develops, manufactures and markets products in three categories, generics, prescription brands and OTC brands. It produces a range of products for various disease states, including glaucoma, asthma, bronchial disorders, dermatological disorders, allergies, pain, stomach, oral care and other conditions. Its generic products are primarily prescription items and include oral solutions and suspensions, topical creams and ointments, as well as nasal sprays. 

As in Complaint:
Allergan is the current holder[ii] of New Drug Application (NDA) no. 22-369 for bimatoprost ophthalmic solution, 0.03%, sold under the Latisse® brand (source: Maxval’s Patent Marker) that is approved by FDA. Latisse (see Fig. 1) is a prescription treatment for hypotrichosis (inadequate lashes) to grow eyelashes longer, fuller, darker. Plaintiff alleges that defendants seeks FDA approval to market a generic version of Latisse with the Abbreviated New Drug Applications (ANDA) no. 201894 (Apotex), 202719 (Sandoz), 203051 (Hi-Tech) and 203749 (Watson) that infringe the above patent.
Other Cases Filed:
Plaintiff has recently filed cases against the below companies:

Case Number
Date Filed
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[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[ii] Patent Marker provides an online environment for patentees to virtually mark products and search for patent related information.

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