Diagnostic Method

News & Analysis as of

Patent Profile: Patent Issued for Method of Differentiating Pancreatic Cancer from Benign Pancreatic Disease

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods." The '983 patent, which is assigned to the Van Andel Research...more

Patent Profile: National Tsing Hua University Receives Patent for Method for Early Diagnosis of Liver Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis." The '920 patent, which is assigned to National...more

Salient Lessons For Australian Applicants Of US Diagnostic Patent Applications

In the latest decision concerning diagnostic method claims a US Court1 has provided some guidance to the diagnostics industry on the interpretation of the recent Supreme Court decisions in Mayo v Prometheus2 (Mayo) and AMP v....more

Patent Claims for Prenatal Diagnostic Method Invalidated as Ineligible Subject Matter

The U.S. District Court for the Northern District of California found Sequenom's patent claims on a prenatal diagnostic method to be invalid and not infringed by Arisoa Diagnostic's Harmony Test product, because the asserted...more

Risk-Sharing and Reimbursement of Diagnostic Tests

Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more

Expanding Access to, and Development of, Personalized Medicine

In a July 8th, 2013 letter to the Centers for Medicare & Medicaid Services (CMS), the Personalized Medicine Coalition (PMC) advised that proposed reimbursement schedules for diagnostic medicine will threaten the development...more

GAO Calls for Action to Address Rise in Self-Referrals of Anatomic Pathology Services

The U.S. Government Accountability Office (GAO) recently published the results of a study examining trends in the number of self-referred anatomic pathology services and the impact on Medicare spending. Anatomic pathology...more

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories,...more

News from Abroad: Australian Federal Court Upholds Myriad's BRCA1 Gene Patents

In a significant win for Myriad, and their licensee Genetic Technologies Ltd, the Australian Federal Court on Friday upheld Myriad's method patents used in cancer screening for mutations in the BRCA1 gene. This decision will...more

Personalized Medicine Patenting Update

Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Courts Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the...more

Top Stories of 2012: #8 to #11

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Protection of diagnostic inventions in the USA - implications of PerkinElmer, Inc. v Intema Limited

On 20 November 2012 the US Federal Circuit handed down a decision in PerkinElmer, Inc. v Intema Limited1 relating to the patent eligibility of diagnostic method claims. In what appears to foreshadow future decisions regarding...more

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