API and IP Newsletter
Contents
DMF filed in the month of September 2022
We analyse DMF filings by Indian companies. This week we analysed DMFs filed in the month of September 2022.
Total 58 DMFs were filed in September 2022.
General information
FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug User Fee Amendment (GDUFA III) program.
News here.
Pharmaceutical Manufacturers Fight Fake Drugs with Intelligent Supply Chains
Eliminating counterfeit drugs in the legitimate supply chain is just the beginning of what’s possible in a fully digitalized life sciences supply chain. Pharmaceutical companies will be able to bring in and ramp up new, trusted suppliers faster. Intelligence will only grow with greater automation for business and patient value.
News here.
Intellectual Property
Delaware district court opined Slayback and Apotex's NDAs are non-infringing Eagle pharmaceutical’s OB listed patent for bendamustine product.
Bendeka/Treanda (bendamustine): North America sale, $415 million. It seems sales of Bendeka and Belrapzo decreasing. (here)
Bendeka was approved in April 2018 in US.
As per the exclusive license agreement between Eagle and Teva, Teva is responsible for all U.S. commercial activities for the product, including promotion and distribution of Bendeka.
Granted U.S. Patent No. 11,103,483, “Formulations of Bendamustine,” issued to Eagle Pharmaceuticals, which has been listed in the Orange Book for bendamustine formulations viz BENDEKA® and BELRAPZO®
This patent infringement case arises out of separate filings of NDAs by Slayback and Apotex with FDA for approval to manufacture and sell bendamustine hydrochloride drug products based on data from bioavailability and bioequivalence studies contained in the approved labelling for Eagle Pharmaceuticals, Inc.' s BELRAPZO® (bendamustine hydrochloride) Injection, 100 mg/ 4 mL (25 mg/mL).
Eagle alleged that Slayback and Apotex's NDAs constitute infringement of claims 2 and 4 of US11,103,483 (#483)
Claims of #483 patent
Claim 2 recites: The ready to use liquid bendamustine-containing composition of claim 1, wherein the antioxidant is lipoic acid, thioglycerol, propyl gallate, methionine, cysteine, a metabisulfite, sodium formaldehyde sulfoxylate, a phenol-containing aromatic compound, a phenolcontaining aliphatic compound, dihydrolipoic acid, or a mixture thereof.
Claim 4 recites: The ready to use liquid bendamustine-containing composition of claim 1, having less than about 5% peak area response of total impurities resulting from the degradation of the bendamustine, as determined by HPLC as a wavelength of 223 nm after at least 15 months at a temperature of about 25° C.
The Court said, analyzing infringement involves two steps. The first step is to construe disputed patent terms consistently with how they would be understood by an artisan of ordinary skill.
The second step is to determine whether the accused products or methods infringe the patent by comparing those products or methods to the construed claims.
The first step in the infringement analysis is a question of law; the second is a question of fact.
A patentee bears the burden of proving infringement by a preponderance of the evidence.
The only disputed infringement issue is whether Slayback and Apotex's ' proposed products meet the "ready to use" limitation of the asserted claims of the #483 patent.
The parties stipulated, and the Court therefore concluded as a matter of law, that "ready to use" means "able to be dispensed with minimal if any effort or preparation; prepackaged."
Eagle conceded that Slayback and Apotex's proposed products are not prepackaged.
Eagle also failed to establish by a preponderance of the evidence that Slayback and Apotex's proposed products can be dispensed with only minimal if any effort or preparation.
Accordingly, Eagle has failed to establish that Slayback and Apotex's filing of their NDAs constituted infringement of the asserted claims of the #483 patent.
So the court opined Slayback and Apotex's NDAs are non-infringing as their products are not “ready to use”.
Decision here.
