Watching the Pot™

GW Pharma, now a subsidiary of Jazz Pharmaceuticals, is no stranger to patent litigation. It previously found itself on the receiving end of a patent infringement lawsuit after being accused by Canopy Growth of using its patented extraction technology in 2020. That suit was dismissed last year. This year, it brought its own litigation, at the core of which is Epidiolex, the first cannabis-based therapeutic to receive approval from the FDA.

First approved in 2018, Epidiolex is indicated to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. Like typical pharma products, Epidiolex owns a bevy of Orange Book-listed patents. As well as the exclusivity afforded by those patents, Epidiolex has been granted New Chemical Entity (NCE) exclusivity from the FDA.

An approved therapeutic can receive NCE exclusivity if it contains an active ingredient that has never before been approved by the FDA. Being the first cannabis-derived product approved by the FDA, Epidiolex received the 5-year NCE exclusivity in September 2018. That means that any pharma company wanting to file an Abbreviated New Drug Application (ANDA) to seek approval for a generic version of Epidiolex had to wait until September 2022 to do so – the well-known “NCE-1 date” that allows for ANDA filing one year prior to expiration of the NCE exclusivity. It seems many companies filed ANDAs, as evidenced by a complaint filed earlier this month in the U.S. District Court for the District of New Jersey against more than a dozen ANDA filers. Those ANDA filers include: Teva Pharmaceuticals, Inc. Apotex Inc., Padagis US LLC, InvaGen Pharmaceuticals, Inc., Cipla Ltd., Cipla USA, Inc., API Pharma Tech LLC, Lupin Ltd., Alkem Laboratories Ltd., Taro Pharmaceutical Industries Ltd., Ascent Pharmaceuticals, Inc., MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., Zenara Pharma Private Ltd. and Biophore Pharma, Inc.

The Orange Book-listed patents at the core of the litigation number 25 and have expiration dates that span from June 2035 through March 2041. When a pharma company files an ANDA, it must certify to any patents listed in the Orange Book. Companies may certify that they will wait and not launch a generic product until after the patents expire. Others will certify that the listed patents are not infringed by the generic product, are invalid, or both. Such certification is known as a paragraph IV (PIV) certification, from the portion of the statute it relates to. Filing an ANDA with a PIV certification is an artificial act of infringement that allows the patent owner and NDA holder to sue the ANDA filer. If they sue early (within 45 days of receipt of a Notice Letter explaining the ANDA filer’s stance on the patents), there is an automatic 30-month stay (can be extended up to 42 months because this is an NCE-1 case) of regulatory approval of the ANDA.

Most pharmaceutical companies are no stranger to this type of litigation, but this is the first one of its type for a drug product derived from marijuana. We will report further as the litigation unfolds.

This article appeared in the January 2023 issue of MarkIt to Market®. To view our past issues, as well as other firm newsletters, please click here.