API and IP Newsletter
Contents
ANDA approvals in September 2022
We analyse ANDA approvals every month.
In September there are about 90 approvals and about 5% of those were tentative approvals.
General observations:
MSN was far ahead than others in August 2022 in seeking FDA approvals. There are overall 6 approvals, including two tentative approvals.
At second place are Gland and Zydus. There are 3 approvals each.
General information
Govt not to impose anti-dumping duty on Chinese chemical
India will not impose anti-dumping duty on a Chinese chemical used in pharma industry as the finance ministry has not accepted the recommendations of DGTR for imposing the levy. The commerce ministry's investigation arm DGTR had conducted a probe into the alleged dumping of "(4R-Cis)-1-1-Dimethylethyl-6-cyanomethyl-2, 2-dimethyl-1, 3-dioxane-4-acetate" from China, and in August it recommended the imposition of the duty.
News here.
Honeywell Introduces Manufacturing Excellence Platform, Driving Digital Transformation In The Life Sciences Industry
Honeywell today introduced its Manufacturing Excellence platform, which provides real-time end-to-end production visualization and dashboards for multiple user roles from operators to management, process unit timelines, detailed equipment status, and trends of critical process parameters. The Manufacturing Excellence platform, built for Life Sciences applications, puts actionable information in context in one interface.
The solution digitizes paper-based batch records, work instructions, and logbooks to ensure consistent compliance with standard operating procedures. Visibility of batch progress and alerts on critical process parameters enable users to respond quickly if batches start trending toward excursion beyond golden batch or expected limits, therefore saving batches and improving quality.
News here.
Intellectual Property
Delaware Court denied Allergan’s motion to strike down “unclean hand” arguments
Sun Pharma claims that AbbVie Inc.'s Allergan unit misused confidential information to prosecute patents for a formulation of eluxadoline. The drug is used to treat irritable bowel syndrome.
OB listed patents are as follows
Allergan sued Sun for patent infringement in the District of Delaware in 2019. This is mainly related to two OB listed patents US 11,229,627 and US 11,311,516. These two are later expiration patents (2033) than composition of matter patent which will expire in 2029.
Sun counter sued, claiming Allergan had unclean hands because it used information learned during the litigation with Sun to obtain these new eluxadoline patents. Sun claims that Allergan misused Sun's confidential information to prosecute the '516 Patent and then asserted that patent against Sun.
Sun alleges that prior to the date suit was filed in 2019, Allergan consistently prosecuted patent applications that recited "colloidal silica" or "colloidal silicon dioxide" as a required limitation in "each and every claim."
Sun alleges that after Allergan "had accessed Sun's confidential information regarding its ANDA Product formulation," Allergan eliminated the limitation requiring "colloidal silicon dioxide" from claims in the patent application that led to the '179 Patent
Sun alleges that Allergan later used Sun's confidential information to draft claims in the '516 Patent to "not explicitly require colloidal silica in an improper attempt to cover Sun's ANDA Product Formulation, which Allergan did not invent.
Sun alleges that Dr. Tim Costello, one of the inventors named on the '516 Patent, has stated "that he never invented any eluxadoline composition that did not include colloidal silica."
Allergan asserts that Sun's counterclaim for unclean hands sounds fraud. Allergan argues Sun's unclean hands counterclaim must be pled with particularity as required by the Federal Rule of Civil Procedure 9(b) standard. here
Sun contends that its unclean hands counterclaim is based on unconscionability (Unconscionability is a doctrine in contract law that describes terms that are so extremely unjust, or overwhelmingly one-sided in favor of the party who has the superior bargaining power, that they are contrary to good conscience) and bad faith. Sun argues it only needs to meet Federal Rule of Civil Procedure Rule 8's less-demanding requirements for pleading its counterclaim because it does not sound in fraud. here
The Court found that Sun's affirmative defense of unclean hands is properly pled. The pleading standard for an affirmative defense is less demanding than that of a claim or counterclaim.
Sun states a plausible claim that the '516 Patent is unenforceable due to the doctrine of unclean hands. This Court agreed. Court also denied Allergan’s motion to strike other defenses such as Prosecution History Estoppel and Patent misuse raised by Sun. So far, this case is moving favourably for Sun.
Decision here
