API and IP Newsletter
Contents
Patent applications filed by Zydus Lifesciences
We follow patent application filings by Indian Pharmaceutical companies. This week we analysed patent portfolio of Zydus Lifesciences Limited for last 5 years.
There are about one dozen PCT families filed in last five years by Zydus.
Some of our observations are as below.
General information: Two Recent Trademark Cases
Delhi High Court restrains Capital TV from using TV Today’s marks “To The Point”, “Halla Bol”, “Special Report”, “Black & White”, “Kismat Connection” Marks For News Programmes
The plaintiff filed the present suit seeking protection in respect of the programs run on its television channels. The plaintiff runs and broadcasts well known TV channels namely ‘AajTak’, ‘AajTak HD’, ‘India Today Television’ and ‘Good News Today (earlier known as Tez)’. The plaintiff had businesses in broadcasting, publishing, e-commerce, etc. and was part of the leading media group ‘India Today Group’, which also published the famous magazine ‘India Today’ amongst various other well-known magazines.
News here.
Delhi High Court Restrains Manufacturer From Selling Biscuits Under ‘Good Time Butter Cookies’ Mark In Suit By ‘Good Day’
The Delhi High Court has asked cookie-maker, Amar Biscuit, to stop selling or manufacturing Good Time butter cookies, following a complaint by Britannia, that sells and manufactures the popular Good Day cookies. Britannia dragged the cookie-maker to the court due to identical packaging.
News here
Intellectual Property
Zogenix, Inc Vs Apotex: Dispute on Skinny label.
Zogenix, Inc. and Zogenix International Ltd. (Zogenix) sell Fintepla (Brand name) for the treatment of seizures associated with Dravet syndrome. The active ingredient in Fintepla is fenfluramine hydrochloride ("fenfluramine")
U.S. Patent Nos. 10,478,441 (`441 ), 10,478,442 (`442) and U.S. Patent No. 11,406,606 (`606) are listed in the FDA's Orange Book for Fintepla among others.
These patents are directed to methods of treating patients with Dravet syndrome by administering a combination of stiripentol and reduced dosages of fenfluramine. Dravet syndrome is a rare, genetic epileptic encephalopathy that gives rise to seizures that don't respond well to seizure medications.
In this write-up we will cover discussions related to `606 patent in this case.
In October 2021, Apotex Inc. and Apotex Corp. ("Apotex") notified Zogenix that they had filed an ANDA seeking FDA approval to market a generic version of Fintepla
Apotex submitted a section viii certification for these patents, representing that the methods of use claimed in those patents are carved out from the label.
Apotex argued that its ANDA directed to Fintepla (fenfluramine) does not induce infringement of `606 because Apotex's ANDA contained a section viii statement to the '606 patent and a corresponding skinny label (label carving) that removed references to administering fenfluramine with stiripentol.
On 21 September 2022, Zogenix asserted causes of action against Apotex for infringement of the '606 Patent. The matter was before District Court For The District of Delaware. A prior report ie Report & Recommendation (R & R) of a United States Magistrate Judge was put before the District of Delaware.
Magistrate Judges have the authority to make recommendations as to the appropriate resolution of a motion. However, the Court conducts a de novo review when determining whether to adopt a Magistrate Judge's report and recommendation on a dispositive motion.
Coming back to this specific case, the asserted claims of the '606 Patent require the use of fenfluramine in combination with stiripentol. The Report of Magistrate recommended that the District Court Judge to grant Apotex' motion to dismiss Zogenix' induced infringement claims. In short, according to the Magistrate there’s no induced infringement by Apotex.
Asserted claim 15 of the '606 Patent recites a method of reducing or controlling seizures in a patient by "reducing a dosage of fenfluramine ... by 30% to 60% based on the patient being treated with a therapeutically effective amount of stiripentol, whereby the dosage of fenfluramine ... is reduced as compared to an amount of fenfluramine ... without stiripentol."
Zogenix objected to the Magistrate Judge's conclusion that Apotex' complaint does not plausibly allege that Zogenix' ANDA label encourages or instructs an infringing use.
Zogenix argued, the R&R erroneously applied its own interpretation of Apotex label instead of crediting Zogenix' allegations, which concerned how a prescribing physician would read the label.
Specifically, Zogenix contend that the Magistrate Judge improperly focused on individual sections of Apotex label in isolation, whereas a prescribing physician would read the label as a whole.
When read as a whole, Zogenix said, the label implicitly encourages an infringing use namely, the co-administration of fenfluramine and stiripentol.
Zogenix highlighted Section 2.3 in Apotex’ label which instructs a 20 mg dosage of fenfluramine for patients on strong CYP inhibitors not taking concomitant stiripentol. However, in later paragraph it directs physicians to prescribe fenfluramine dosage for patients taking strong CYP inhibitors and another AED (anti-epileptic drug).
Based on these statements in label Zogenix argued infringement of `606 and Apotex disagreed.
The Distric Court Judge agreed with Apotex that Zogenix' argument that the phrase another AED means stiripentol would be far fetching argument.
The Judge did not find it plausible that a physician would understand another AED (anti-epileptic drug) to mean anything other than another AED, and even Zogenix did not dispute that multiple AEDs exist besides stiripentol. (identifying clobazam and valproate as AEDs that are also frequently used in the treatment of Dravet syndrome).
Notably, every explicit reference to stiripentol in the dosing instructions at issue describes the administration of fenflurarnine without concomitant stiripentol.
Such language hardly constitutes encouragement to prescribe fenfluramine in conjunction with stiripentol.
The Hon. Judge adopted the recommendation of the Magistrate to dismiss the complaint because the proposed skinny label does not encourage or instruct an infringing use.
Although Zogenix attempted to rely on the warnings section in Apotex's label, the Hon. Judge found that warnings are not instructions.
Hon. Judge opined that the label could not induce infringement when, at most, it had information relating to both infringing and non-infringing uses.
Decision here
