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35 Biotechnology L. Rep. 1 (2016)

handle is hein.journals/bothnl35 and id is 1 raw text is: Select Developments in Biotechnology Law and the Biotechnology Industry By STEVEN J. ZWEIG U.S. FDA APPROVES GENETICALLY MODIFIED SALMON Recently, the Food and Drug Administration (FDA) approved genetically modified salmon for human consumption in the United States. The AquAdvantage Salmon, created by Massachusetts- based AquaBounty, grows twice as fast as non- engineered salmon-that's its only difference from salmon found in nature (i.e., it has the same taste, same nutritional value, etc., as non-engineered fish). And because there are no material differences between AquAdvantage and non-advantaged sal- mon, the FDA will not require that the fish be la- beled as engineered, though the FDA will release guidelines and wording for retailers who voluntarily choose to label the salmon. According to AquaBounty its fish could hit super- market shelves in two years (which is how long it takes their salmon to grow to full size). Two years is short compared to how long the AquAdvantage salmon have already waited: the Obama Administra- tion had delayed approval for five years, due to con- sumer concerns about genetically modified foods. It's been a long, upstream swim for the fish, but it looks like its finally reached calm waters. IP AUSTRALIA RELEASES EXAMINATION GUIDELINES FOR APPLICATIONS WHICH MAY BE AFFECTED BY THE D'ARCY V. MYRIAD GENETICS DECISION IP Australia administers Australia's intellectual property system. In the wake of the Australian High Steven J. Zweig is the Managing Editor of Biotechnology Law Report. Court's decision in D'Arcy v. Myriad Genetics, IP Australia is releasing Examination Guidelines to take effect (that is, to be incorporated into the Exam- iner's Manual of Practice and Procedure) on January 11, 2016. These guidelines, which take a narrow inter- pretation of the D'Arcy decision, provide a framework for examiners considering submissions which may be affected by that case's holding. Highlights include: 1. Isolated naturally occurring DNA or RNA is excluded from patentability. 2. Synthetic nucleic acids (which includes cDNA) would be excluded only if they merely replicate the genetic information of a naturally occurring organism. 3. Subject matter which may be subject to D'Arcy, but which is not expressly ex- cluded from patentability, will be evaluated case by case, looking at the following cri- teria or considerations: a. The substance (not form) of the claim; b. Whether the subject matter was made or changed by human effort; c. Whether the claimed invention has eco- nomic utility; and d. Whether the claimed invention represents a new class of claim. 4. The following remain patent eligible: re- combinant or isolated proteins; pharma- ceuticals and chemical substances; treatment methods; methods for applying herbicides; computer technology applica- tions. EN BANC REHEARING OF ARIOSA V. SEQUENOM DENIED Sequenom petitioned the Federal Circuit for an en banc rehearing of the court's decision in Ariosa v. Sequenom, which had held that Sequenom's U.S. 1 35 Biotechnology Law Report 1 Number 1, 2016 © Mary Ann Liebert, Inc. DOI: 10.1089/bir.2016.29001.sjz News Briefs

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