Tag:Myriad

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Methods of genetic testing still patentable (Meat & Livestock Australia v Cargill decision)
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Australian Patent and Plant Breeder’s Rights Year in Review
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The Australian Patent Office Once Again Allows Claims Directed to Nucleic Acids
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Nucleic Acids Remain Patentable in Australia
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The USPTO and Laws of Nature, Natural Products and Natural Phenomena

Methods of genetic testing still patentable (Meat & Livestock Australia v Cargill decision)

On Friday 9 February, the Federal Court handed down its highly anticipated decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51. The matter has attracted substantial media attention in Australia and generated debate about whether patents claiming methods which use genetic information should be allowed.

The principal claims of the application in suit involve method claims for identifying a trait of a bovine subject from a nucleic acid sample. In particular, the invention made use of single nucleotide polymorphisms (SNPs).

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Australian Patent and Plant Breeder’s Rights Year in Review

K&L Gates has prepared the first edition of Patent and Plant Breeder’s Rights Year in Review which examines the significant judgments, development and events effecting patents and plant breeder’s rights in Australia.

The Review looks at a number of cases over the year including the Australian High Court’s decision in D’Arcy v Myriad Genetics Inc in the biotech industry, whether an Australian affiliate of an international pharma company was an exclusive licensee and whether it had standing to sue, and the Productivity Commission’s “IP Arrangements” Inquiry Report plus other updates. Click here for the summary or click here for the ePublication.

By: Simone Mitchell, Veg Tran, Michael Christie, Alex Dunlop, Jillian Lim, Jamie Wolbers and Jessica Mandla

The Australian Patent Office Once Again Allows Claims Directed to Nucleic Acids

In Commonwealth Scientific and Industrial Research Organisation v BASF Plant Sciences GmbH [2016] APO 83, the Australian Patent Office has once again confirmed that nucleic acids are patentable in Australia.[1]

The opposed application relates to methods of producing polyunsaturated fatty acids in the seeds of transgenic plants. The application included claims directed to a recombinant nucleic acid molecule comprising nucleic acid sequences coding for a polypeptide with Δ6-desaturase activity, a polypeptide with Δ5-desaturase activity, a polypeptide with Δ6-elongase activity and a polypeptide with Δ5-elongase activity, as well as one or more copies of a promoter and a terminator.

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Nucleic Acids Remain Patentable in Australia

A recent Patent Office decision in Arrowhead Research Corporation [2016] APO 701 (“Arrowhead”) has confirmed that nucleic acids can still be patented in Australia.

Following the High Court of Australia’s ruling in D’Arcy v Myriad Genetics Inc [2015] HCA 352 (“Myriad”), the Australian Patent Office has been broadly objecting to claims that encompass isolated nucleic acids.  This practice has frustrated applicants and their attorneys who consider many of the objections to be reactionary, and not consistent with the facts and principles set out in Myriad. In a very recent decision, the Patent Office has confirmed that nucleic acids remain patentable subject matter in Australia by allowing claims directed to interfering RNA compositions.

In Myriad, the High Court clearly stated that it would not be concerning itself with “gene patents” generally, but with the disputed claims specifically (at [37]). Those claims defined isolated nucleic acids per se that were useful in the detection of breast cancer. While acknowledging that the claims defined a product created by human action, the High Court considered that the “substance” of the claims was information, which could not be the subject of a valid claim.

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The USPTO and Laws of Nature, Natural Products and Natural Phenomena

New Approach to Patentable Subject Matter

The United States Patent Office periodically issues guidance for examiners often in response to a recent court decision or new statute.  These guidelines (the Guidance) do not have the force of law but nevertheless establish the specific procedures that the Examiners apply during examination of patent applications.

Examination guidelines were issued on 4 March 2014  to address two  recent court decisions related to the subject matter eligibility of certain claims under 35 U.S.C. § 101. Examiners will use tests described in the Guidance to determine the patent eligibility of any claim related to laws of nature, natural phenomena and natural products. Read More

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