News & Analysis as of

BRCA Life Sciences

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

Knobbe Martens

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Knobbe Martens on

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Subject Matter Eligibility Guidance -- Example on Screening for Gene Alterations

Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

Mintz

UPDATE: Subject Matter Eligibility under 35 U.S.C. § 101 – Life Sciences

Mintz on

The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35...more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post: Coalition for 21st Century Medicine Comments on Expected Ariosa Cert Petition

The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is...more

McDonnell Boehnen Hulbert & Berghoff LLP

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

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