There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more
Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more
2/11/2016
/ Abbreviated New Drug Application (ANDA) ,
Antitrust Violations ,
Biologics ,
Clinical Laboratory Testing ,
Corporate Counsel ,
Food and Drug Administration (FDA) ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
REMS ,
Research and Development ,
Young Lawyers
Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more
10/14/2015
/ Biotechnology ,
BRACA Genes ,
BRCA ,
DNA ,
Human Genes ,
Myriad ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
SCOTUS ,
USPTO
With the enactment of the Leahy-Smith America Invents Act (AIA), the U.S. patent system moved to a “first inventor to file” approach for examining all applications having an effective filing date on or after March 16, 2013....more
With the enactment of the Leahy-Smith America Invents Act (AIA), the U.S. patent system moved to a “first inventor to file” approach for examining all applications having an effective filing date on or after March 16, 2013....more
With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo...more