Generic exclusivity by alternate means – Teva sues 7 generics over Carvedilol
The Carvedilol story took another interesting turn recently, when on 21 June, Teva sued 7 pharmaceutical companies (Dr Reddy’s, Ranbaxy, Lupin, Orchid, Cadilla, USV & Warnbury) for infringement of 4 of its synthetic process patents.
News reports from the Indian Financial Express state that Teva had contacted the companies in May requesting details of their synthetic processes, and on receiving nothing, commenced suit before the District Court of New Jersey.
Not a bad way to make everyone else flinch on the brink of generic launch.
What’s interesting to me (and let me know your thoughts) is how Teva’s attorneys can be complying with Rule 11 in the complete absence of any factual information about the defendant’s processes…
(Rule 11(b)(3) of the US Federal Rules of Civil Procedure states:
By presenting to the court (whether by signing, filing, submitting, or later
advocating) a pleading, written motion, or other paper, an attorney
or unrepresented party is certifying that to the best of the person’s
knowledge, information, and belief, formed after an inquiry reasonable
under the circumstances,
(3) the allegations and other factual contentions have evidentiary support or,
if specifically so identified, are likely to have evidentiary support
after a reasonable opportunity for further investigation or discovery;…)