Pathologists and clinical laboratory managers can expect to see an expansion of genetic testing in the wake of the Supreme Court’s decision in the Myriad case
Pathologists and clinical laboratory professionals got a major victory on June 13. That’s when the United States Supreme Court (SCOTUS) ruled 9-0 to end the 30-year-old practice of awarding patents on human genes. The unanimous decision invalidates certain hotly contested patents held by Myriad Genetics, Inc., (NASDAQ: MYGN) on the BRCA1 and BRCA2 genes.
Moreover, this Supreme Court decision also opens the doors to other medical laboratories to develop their own diagnostics around the BRCA genes and compete for breast-cancer testing market share. (more…)
Pathologists and clinical laboratory managers will likely learn next year whether Myriad’s gene patents will stand
In the ongoing debate about gene patents, the nation’s highest legal authority is about to weigh in on the question. The Supreme Court has agreed to hear the Myriad Genetics patent case in the upcoming term. The case turns on whether human genes can be patented.
Will Clinical Labs Need to Pay Royalties for Using Human Gene Patents?
How the high court rules on this matter has significant implications for clinical laboratories and pathology groups throughout the United States. That’s because holders of patents on human genes require medical laboratories to pay royalties for the clinical testing they perform. (more…)
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…)
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).