News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Federal Court Issues Ruling in the Gene Patent Case Involving Myriad Genetics and the Association of Molecular Pathology

Many in the clinical laboratory and pathology industry will hold their breath as Myriad seeks to derail gene patent challenge by attacking standing of sole remaining plaintiff

There’s news regarding the widely-watched federal lawsuit that challenges the gene patents owned by Myriad Genetics  (NASDAQ:MYGN). On September 13, a Federal Circuit panel denied the ACLU’s Petition for Rehearing in this case. Clinical laboratory managers and pathologists following this controversial lawsuit will be interested in this latest development.

Since early this year, there have ongoing legal maneuvers by both sides in this case, which is officially titled: Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office et al. 09-civ-4515. It is a high profile lawsuit because of its potential to establish important new legal precedents in how and when genes may be patented. (more…)

Medical Lab Testing Company Myriad Genetics Acquires Rules-Based Medicine for $80 Million

Pathologists take note! Companion diagnostics is the driver in this transaction.

Genetic testing giant Myriad Genetics, Inc. (NASDAQ:MYGN) will pay $80 million to acquire Rules-Based Medicine (RBM) of Austin, Texas, a privately-held companion diagnostic company in a deal announced last week.

Myriad Genetics, best known to pathologists and clinical laboratory managers for its portfolio of predictive genetic cancer tests, believes its purchase of Rules-Based Medicine will give it a faster entre into companion diagnostics. RBM is a life sciences company that has well-established relationships with key therapeutic drug companies.

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Federal Appeals Court Hears Arguments in the Myriad Genetics’ Gene Patent Case

At issue is ability of biotech companies to hold patents on genes that might be used in clinical laboratory testing

Patents involving human genes have always been controversial among pathologists and clinical laboratory managers. This is one reason why many in the medical laboratory testing industry are following the progress of the well-publicized lawsuit that challenged certain patents involving human genes that are held by Myriad Genetics, Inc. (Myriad), of Salt Lake City, Utah.

In the trial, which was conducted last year, a federal judge ruled against Myriad Genetics. The company filed an appeal and, on April 4th, the United States Court of Appeals for the Federal Circuit (Court of Appeals) heard oral arguments in the case of Association of Molecular Pathology (AMP) (plaintiffs) versus United States Patent and Trademark Office (USPTO) (defendants). This lawsuit was originally filed on March 29th, 2010, in the United States District Court Southern District of New York (District Court).
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Federal Judge Invalidates Myriad’s Patents for BRCA Genes

Pathology labs would generally benefit if Judge Sweet’s ruling is upheld on appeal

It was positive news for many clinical pathology laboratories when a judge ruled against Myriad Genetics and the University of Utah Research Foundation in the federal suit attacking its patents for the BRCA1 and BRCA2 genes. The suit was brought by a group of patients, medical organizations and the American Civil Liberties Union (ACLU).

In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc.,  (NASDAQ:MYGN) of Salt Lake City, Utah.

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Pathologists and Patient Groups Challenge BRCA1 & BRCA2 Gene Patents in Court

Court case will directly affect future development of new pathology and molecular tests

In New York’s Southern District Court, a trial is underway that tests the legality of patenting genes. In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., of Salt Lake City, Utah.

Many experts believe this lawsuit has the potential to produce new case law that addresses the ability of individuals and companies to hold patents on human genes. A ruling in favor of either party in the lawsuit will directly affect the clinical laboratory testing industry and diagnostic tests that utilize gene-based technologies.

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