Stand your Ground
On Nov. 30, 2020, the US District Court for the District of Delaware on remand upheld the validity of various patents of Tris Pharma relating to Quillivant XR® (methylphenidate HCl aqueous extended release oral suspension) and found Actavis’s product infringing. Court found all the asserted patents/claims valid, and Actavis directly infringe, contributorily infringe, and induce […]
Nov 2020, the European Commission (EC) has fined Teva and its now subsidiary Cephalon 60.5 million euros for agreeing to delay the generic version of Modafinil. A series of EU antitrust investigations begun in the year 2009 into ‘pay-for-delay’ drug deals. The drugs involved were Citalopram of Lundbeck, Fentanyl of Johnson & Johnson, Perindopril of […]
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) established a framework for FDA approval of biosimilars. It also provided a system for litigation of patent disputes involving those products. Recently on November 19, 2020, FDA issued guidance entitled, “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition […]
Most of the companies obtain an agreement from employee to assign any patents developed while working on the employer’s business at the beginning of employment itself. And later make the inventors sign invention-specific confirmatory assignments with each potentially patentable invention. Even if that is not the case, the employer still may compel the employee to […]
The introduction of modified versions of original products, is used as a strategy by pharmaceutical companies to switch patients from an original product to a follow-on product that benefits from further patent protection or new product exclusivity and may help circumvent Medicaid rebates on established products. The Innovator pharmaceutical companies take advantage of their market […]
Focus of generic pharmaceutical company is mainly on navigating the innovator’s intellectual property and not necessarily on developing a patentable product. Products are developed irrespective of whether they are patentable or not. Once developed (or development strategy is finalized), it is reviewed, and a patent application is filed. Here the value of patent/application primarily lies […]