Recent Cases

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• UT represented a 505(b)(2) filer against a brand company represented by one of the world’s largest law firms, in a series of lawsuits involving a total of 13 patents (and counting). We pushed back and a few patents were later dismissed during the three-year litigation. UT was ready for trial in the District of Delaware on four patents when the plaintiffs filed for bankruptcy. The cases were stayed due to the bankruptcy proceeding and subsequently dismissed by party agreement. The UT clients were the only defendants in these cases. 

 

• UT helped a specialty pharmaceutical company satisfactorily resolve a long-running dispute with a much larger pharmaceutical company represented by a large law firm. This case stemmed from commercial competition and involved intricacies of FDA regulations on DESI and “identical, related, or similar” drug products, allegations of false advertisement and antitrust violation, and a trip to the ITC (which resulted in the dismissal of the large pharma company’s complaint in that forum). We helped this client in the ITC and two different district court actions. 

 

• UT represented an ANDA filer in a Hatch-Waxman Act litigation in the District of Delaware. The case was dismissed during expert discovery. The plaintiffs asserted multiple patents purportedly covering different aspects of the reference listed drug product, including chemical compound, API crystal form, method of treatment, and off-label use of the drug. 

 

• UT represents an ANDA filer in a Hatch-Waxman Act litigation in the District of Delaware. The plaintiffs asserted multiple patents purportedly covering different aspects of the reference listed drug product, including chemical compound and formulation. UT has filed a dispositive motion on the client’s behalf to remove the patent-in-suit with the longest expiry.

 

• UT represents an ANDA filer in a Hatch-Waxman Act litigation in the District of Delaware.  The plaintiffs asserted multiple patents in this and related cases purportedly covering different aspects of the reference listed drug product, including chemical compound, API crystal form, and formulation.

 

• We helped a client recently with regulatory strategy that allowed the client to file a Section viii Statement instead of a Paragraph IV certification, which every other ANDA sponsor filed. Because we convinced the FDA to permit the Section viii Statement, our client got final ANDA approval before everyone else and without any litigation spend.