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33 Biotechnology L. Rep. 1 (2014)

handle is hein.journals/bothnl33 and id is 1 raw text is: Selected Developments in Biotechnology Law and the Biotechnology Industry AUSTRALIAN HIGH COURT HOLDS THAT METHODS OF TREATMENT REMAIN PATENT ELIGIBLE In the case of Apotex Pty Ltd. v. Sanofi-Aventis Aus- tralia Pty Limited, the Australian High Court affirmed the nation's prevailing standard that methods-of-treat- ment claims comprise patentable subject matter. The case examined the validity of a method directed to a new use for an off-patent drug, leflunomide (using it to treat psoriasis). On December 4, 2013, the High Court concluded that the claim-and method-of- treatment claims more generally-describes an artifi- cially created state of affairs providing economic utility, which is the threshold standard for patentability in Aus- tralia. In so holding, the High Court has settled the mat- ter, barring legislative action or future reconsideration by the High Court itself. The decision keeps Australian law in this regard aligned with that of the United States, although divergent from European law (where method of treatment or diagnosis claims are not patentable). AUSTRALIAN COURT AFFIRMS THAT ISOLATED GENES MAY BE PATENTED-FOR NOW A Federal Court in Australia also held, in Cancer Voices Australia v. Myriad Genetics, that naturally oc- curring genes that have been isolated from the body (but not otherwise manipulated or altered) may be pat- ented, as an artificial state of affairs that gives rise to economic utility. However, the decision is being appealed to the full Federal Court, so the matter cannot be viewed as settled. The Australian Court's decision stands in contrast to the decision of the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, which held that isolated, naturally occurring DNA is not patent eligible. U.S. SUPREME COURT DENIES APPEAL BY BIOTECHNOLOGY EXECUTIVE IN FRAUD CASE W. Scott Harkonen (whose name unfortunately in- vokes that of Baron Harkonnen, the heavyweight- in every sense of the word-bad guy from Frank Her- bert's Dune) was Intermune's CEO in 2002, when the company put out a press release that included state- ments from him that the company's drug Actimmune was the only available treatment shown to have clin- ical benefit against idiopathic pulmonary fibrosis. The press release also stated that Actimmune had re- duced the death rate from the disease by 70% for pa- tients with mild to moderate cases. Unfortunately, the drug's clinical trials had not shown any effect on the difficult-to-treat disease. Harkonen was accused of knowingly misstating the results of the trials and was convicted in 2009 of wire fraud for putting out the press release. Harkonnen was fined $20,000 and sentenced to 6 months of home confinement; Intermune has paid $37 million to settle claims growing out of its mar- keting of Actimmune. Harkonen has steadfastly maintained his innocence, but the Supreme Court's decision now closes off his last avenue for proving it. Harkonen's appeal was supported by an industry trade group, the Pharmaceutical Research and Manufacturers of America. 2014 RULING EXPECTED FROM EUROPEAN COURT ON HUMAN RIGHTS ON THE STATUS OF THE HUMAN EMBRYO In the case of Adelina PARRILLO v. Italy (No. 46470/11), the European Court on Human Rights (ECtHR; now there's an acronym that doesn't exactly roll trippingly off the tongue!) is expected to rule in 2014 on the status of human embryos. The factual con- text is that an Italian couple had five embryos fertil- ized and frozen for future implantation; before that happened, however, Adelina Parrillo lost her husband and also her desire to have the embryos implanted. Under Italian law, human embryos may not be destroyed (including for medical research), which means that Parrillo would have to keep the embryos frozen indefinitely, or at least until they naturally be- came nonviable. Understandably dissatisfied with that state of affairs, she appealed to the ECtHR, claim- ing that her property rights over the embryos and her right to a private life have both been breached by this Italian law. 1 33 Biotechnology Law Report 1 Number 1, 2014 ( Mary Ann Liebert, Inc. DOI: 10.1089/bir.2014.9995 News Briefs

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