SAN DIEGO, CA--(Marketwired - Jun 19, 2013) - In Association of Molecular Pathology v. Myriad, the U.S. Supreme Court struck down BRCA1 and BRCA2 gene patent claims. It is important for the diagnostic community to note that the limits of the Myriad decision applies only to patents on genes and portions of genes themselves, 'compositions of matter' that already exist in nature. In contrast, Invivoscribe Technologies, Inc. and its testing subsidiary, LabPMM, have a different patent protection: claims based on new methods of molecular and genetic testing and diagnosis. The continued viability of Invivoscribe's claims, after last week's ruling, is a victory for patients, and will enable the further development toward harmonized, consistent genetic testing worldwide.
Taking a closer look at the Court's ruling, it is limited to two specific issues: (1) are isolated segments of naturally occurring DNA patent-eligible; and (2) is cDNA produced from naturally occurring genetic material patent-eligible. The answers were "no" and "yes," respectively. The Court emphasized the limited scope of its decision:
"It is important to note what is not implicated by this decision. First, there are no method claims before this Court. . . . [T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . . . Many of [Myriad's] unchallenged claims are limited to such applications."
In short, by its very language, the Supreme Court made no changes to the patentability of method claims flowing from genetic discoveries. This means that there is no negative impact on Invivoscribe's comprehensive patent position covering testing for FLT3 ITD mutations. The Court then went further, indicating to the lower courts and to the public that patents still provide protection in the genetic testing area.
"It is and always has been Invivoscribe's view that patents should be used as intended; to incentivize discovery and innovation; to incentivize quality product development and validation; and to provide a window of exclusivity and an opportunity to provide quality tests for our customers," said Jeffrey Miller, CEO of Invivoscribe Technologies. "To this end, we are currently developing, in partnership with a pharmaceutical company and with FDA oversight, what will be the best characterized signal ratio FLT3 assay in the world; one that will be required by the FDA to direct treatment for the next generation of targeted treatments for patients with acute myeloid leukemia."
The cost of developing high quality molecular tests requires both an investment of millions of dollars and years of concerted work by a group composed of dozens of scientists, technicians, and regulatory experts. These dedicated resources would not be available without the short-term protection provided by the patent system.
"We are aware that to remain a leader in molecular diagnostics we must provide highest quality, reliable tests to our customers in a timely manner and at fair prices. Otherwise, once patents expire, customers will seek other options for their testing," Jeffrey Miller continued. "The development and validation of quality tests and reagents has been and will remain our focus."
The benefits of standardizing molecular diagnostic tests cannot be overstated. In this exciting new age of molecular medicine and gene-targeted therapies, both academic experts and regulatory authorities clearly understand that tests need to be both consistent and accurate. "A bad test is as dangerous to a patient as a bad drug," as Dr. Richard Schilsky (President: American Society of Clinical Oncologists; University of Chicago) recently stated.
Looking forward, Invivoscribe is developing, refining, validating and preparing for regulatory approval a harmonized and consistent FLT3 mutation test that can be used worldwide to direct targeted drug treatments for AML. This investment in harmonized FLT3 testing simply would not have been possible in the absence of patent protection. And that patent protection continues.
About Invivoscribe Technologies, Inc.
Invivoscribe Technologies, Inc., a privately held company, is a world-leading provider of PCR and NGS-based molecular reagents, CE-marked IVDs, Analyte Specific Reagents, and RUO testing products and controls targeting the fields of hematology-oncology and hematopathology. Invivoscribe and its subsidiaries provide worldwide access to clinically validated, personalized molecular diagnostic products used to identify, classify and monitor leukemias, lymphomas and other lymphoproliferative diseases. Results from these tests enable doctors to optimize treatment for their patients.
Invivoscribe manufactures all of their products at their cGMP facility in San Diego, CA. Exclusive licensed patents protect a majority of Invivoscribe's products. Invivoscribe products are sold to more than 500 customers in over 50 countries directly from Invivoscribe (USA) and Invivoscribe SARL (France), as well as through a network of distributors worldwide.
About LabPMM LLC and LabPMM GmbH
Invivoscribe's CLIA- and CAP-accredited laboratory, LabPMM LLC (San Diego, USA), and LabPMM GmbH (Planegg-Martinsried, Germany) are the only reference laboratories in the world (ex-Japan) holding licenses to perform mutation testing for both the FLT3 and NPM1 biomarkers, which are covered by two different sets of patents. LabPMM clinical reference laboratories, both in the US and in Germany, use cGMP products manufactured by Invivoscribe for testing.