Member Articles

Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...

On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013).  This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...

One way to change the law fast is to amend or repeal statutes in budget legislation.  That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...

On June 13, 2013, in a seminal case on the patentability of the genetic code, the U.S. Supreme Court unanimously held that “naturally occurring DNA … is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”  See Association for Molecular Pathology v. Myriad Genetics Inc. (2013) ...

A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...

The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...

Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...

On May 5th, 2011 Chile joined the Budapest Treaty on the International Recognition of the Deposit of microorganisms for the Purposes of Patent Procedure. In Chile, this treaty will enter into force on August 5th, 2011 ...

Is a recession good for innovation? History seems to suggest that it may be and numerous notable inventions have emerged from recessions, for example James Dyson's vacuum came out of the last recession in the 1990s. Innovation is a key priority for the Scottish Government in these difficult times and politicians have described innovation as "essential" to create a more successful Scotland through sustainable economic growth ...