By Michael Young Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent. After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that…
By The Petrie-Flom Center Reforming Brazilian Pharmaceutical Patent Policy: Lessons from the Past and the Road for the Future April 23, 12:00pm Wasserstein Hall 1010, Harvard Law School, 1585 Massachusetts Ave. In this lecture by Pedro Paranaguá, he will discuss the report issued by the Brazilian House of Representatives in 2013 as part of an effort…
By The Petrie-Flom Center We are pleased to announce that Rachel Sachs will be joining the Petrie-Flom Center later this summer as an Academic Fellow for the 2014-2016 fellowship term. In 2013, Rachel earned her J.D. magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both…
By Julian Urrutia Gilead Sciences has developed a new drug (Sovaldi) that cures hepatitis C. This is a huge deal: about 150 million people world wide are chronically infected with the hepatitis C virus (HCV); according to the CDC 60-70% of people with chronic HCV will go on to develop chronic liver disease, 5-20% will develop…
By Michael Young In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs,…
By Nicholson Price Finishing up the event today is Tom Kowalski from Vedder Price, giving a US perspective on section 101 on patentable subject matter. This post will encompass his presentation and general questions afterward. Kowalski starts with a brief review of patentable subject matter, and states his view that after Prometheus and Myriad, “the…
By Nicholson Price Third up is Dr. Maaike van der Kooij, discussing medical use claims at the EPO. In general, methods of medical treatment aren’t patentable under Art. 53(c) of the EPC, but the way around is to claim a relevant product either for medical use (if the substance is known but not medically used…
By Nicholson Price Next up is Dr. Anja Schmitt, comparing Myriad and Mayo to EPO practice, and describing gene patents and diagnostic method patents in the EPO. Human gene patents The basic question of human gene patents–as will be familiar to those who followed the Myriad litigation–is whether isolated DNA is a product of nature/mere discovery, or…
By Nicholson Price I’ll be liveblogging today’s panel on Hot Topics in European Bio-Patent Law (co-sponsored by the Broad Institute), with several guest speakers from the European Patent Office (EPO). Ben Roin, Heiken Assistant Professor of Patent Law here at HLS, is moderating. Speakers will be Dr. Aliki Nichogiannopoulou on stem cells, and Dr. Anja Schmitt…
By The Petrie-Flom Center Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More April 2, 2014, 12:00 PM Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on…
