U.S. District Court Confirms Validity of Patent For UCB Pharma’s Vimpat®
UCB Pharma, a Belgian pharmaceutical company, announced on 14th August 2016 that the U.S. District Court for the District of Delaware confirmed the validity of its U.S. reissued patent RE38551 related to anti-epileptic drug Vimpat® (lacosamide). The patent challenge was brought by generic drug makers who had questioned the validity of the UCB’s patent which […]
Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation
In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § […]
Monsanto’s Patent on Method of Producing Transgenic Plants refused by IPAB
Monsanto’s Indian patent application 2407/DEL/NP/2006 on transgenic plants with heat/salt/drought tolerant plants is rejected by IPAB. The subject patent application is directed to a method of producing a draught/stress/heat/salt/drug-tolerant transgenic plants by inserting a recombinant DNA molecule that expresses a cold shock protein CspA or CspB. The subject patent application was rejected by the Controller […]
Understanding Gene Patenting
We are sure that all of you must have learned about the latest US Supreme Court decision in Association for Molecular Pathology V. Myriad Genetics on June 13, 2013, which has ended the long brawl of 5 years. Yes! the sole provider of BRCA1 and BRCA 2 tests, Myriad Genetics Inc., has lost the battle. […]
Bruce N. Saffran Vs Johnson & Johnson and Cordis Corporation
Introduction A patent infringement suit filed by Bruce N. Saffran, a New Jersey Radiologist (“Plaintiff”) against Johnson & Johnson (J&J) and Cordis Corporation (“Defendants”) claiming that defendants directly infringed U.S. Patent No. 5,653,760 (filed Aug. 9, 1995) (the `760 patent;) entitled “Method and Apparatus for Managing Macromolecular Distribution”. Defendants’ accused products are the Cypher drug-eluting […]
Roche’s Struggle Over its Patents in India – Two suits, Two oppositions
The struggle between innovator pharmaceutical companies (mostly in the Western world) and developing world Generic companies have been lately played out in India and especially for the last 2-3 years in the form of litigations and oppositions. Here I would be discussing the specific case of Roche (a Swiss Pharma Company) showcasing its journey of […]
Ortho-McNeil Pharmaceuticals v. Lupin Pharmaceuticals and Photocure ASA v. Kappos
Ortho-McNeil Pharma v. Lupin Pharma and Photocure ASA v. Kappos Two recent cases decided before the U.S. Court of Appeals for the Federal Circuit (CAFC) on May 10, 2010 upheld two Patent Term Extensions (PTE) under 35 U.S.C. § 156. In the first case, Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., Lupin challenged the USPTO’s […]
Bayer Vs Cipla
BAYER Vs CIPLA & UNION OF INDIA Does a combined reading of the Drug Control Act and the Patents Act lead to an inference that no marketing approvals can be granted to a third party for a drug/formulation for which a patent exists? This was a primary question before the Delhi High Court in a […]