The Salt Lake Tribune’s Tom Harvey reports that Utah-based genomics firm Myriad Genetics is back in court defending its patents related to genes linked to breast and ovarian cancer from a challenge by two competitors hoping to compete with Myriad in lucrative area of genetic testing.
Harvey notes that a bit less than three months after a June 13 U.S. Supreme Court decision invalidated several parts of Myriad patents related to the so-called BRCA1 and BRCA2 genes, Myriad was back in a federal courtroom last week asking a judge to prohibit the two competitors from offering diagnostic DNA tests that detect mutations related to a high probability of contracting hereditary breast and ovarian cancers.
Deliberations leading to the high court’s decision in “Association For Molecular Pathology v. Myriad Genetics” which overturned three decades of intellectual property policy on gene patenting practiced by the U.S. Patent and Trademark Office, were in play long before actress and celebrity Angelina Jolie’s public revelation last May that she had undergone a prophylactic double-mastectomy, even though she has no breast cancer thrust the issue into the public spotlight.
The ensuing publicity Ms. Jolie’s example generated, resulted in greater numbers of women at least considering gene testing for BRCA1 or the related BRCA2 anomaly, which about one in 400 women reportedly carry. Many discover, to their shock, that in the US, to be genetically tested for BRCA1 or BRCA2 would cost in the range of $3,340, plus an additional $700 if a related genomic-rearrangement test is included in the analysis. And while in instances where there was a clear family history of breast or ovarian cancer, health insurers would most likely to pay for the procedure, where no such risk had been identified the individual would be expected to foot the bill. One reason for the hefty price of the testing was that Myriad Genetics (MYGN) held a patent on the test for BRCA1 and BRCA2 mutant genes that Ms. Jolie had undergone.
Myriad Genetics counter-argued that “Because of the incentives provided by patents, companies invest millions of dollars in clinical studies that are essential for obtaining insurance coverage.” The company maintains that “For Myriad tests, approximately 95% of all appropriate patients have access to breast cancer susceptibility testing through private insurance, Medicare, Medicaid or Myriad’s Financial Assistance Program. Under our Financial Assistance Program, we test low-income, uninsured patients at no charge and have provided free testing to over 5,000 patients just in the past 3 years.” Myriad implied that should the high court rule in the ACLU/PUBPAT’s favor, it would set a precedent that could dismantle the profitability of the human gene patenting industry.
However, the high court found that the patents on human genes are invalid, which represents a major shift in patent law and overturns current Patent Office policy. “The court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA,” observed Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit.
One of Myriad’s aspiring competitors in gen testing, Houston-based Gene By Gene, Ltd., which currently processes BRAC1 and BRAC2 testing, as well as testing for several other genes that can diagnose different disease conditions for patients in Israel, says it can process the same tests for less than a third of the cost of what Myriad Genetics had been charging, which should enable concomitant significant reductions in health insurance costs.
“We’re pleased to make this important testing more widely available and accessible in the United States,” said Gene By Gene President Bennett Greenspan in June. “Our highly automated CLIA-registered lab and efficient processes enable us to make genetic and genomic testing more affordable and accessible to more individuals, in the U.S. and worldwide. And that’s our company’s mission, in a nutshell.”
DNATraits has processed testing for the BRCA1 and BRCA2 genes for individuals living outside the U.S. since 2012. Those genes are processed at the company’s Genomic Research Center in Houston, a CLIA-registered lab that has processed more than 5 million discrete DNA tests from more than 700,000 individuals and organizations globally using traditional Sanger DNA sequencing, which the company says is considered the gold standard for DNA analysis. In addition to the BRCA gene tests, DNATraits offers a pre-natal array that covers 111 population specific diseases, as well as other not population-specific diseases, like Duchene Muscular Dystrophy.
However, on July 9 Myriad Genetics, along with with co-plantiffs the University of Utah, the University of Pennsylvania, the Hospital for Sick Children, and Endorecherche, filed a lawsuit in the United States District Court for the District of Utah sueing Gene by Gene and Aliso Viejo California based gene testing firm Ambry Genetics in separate suits after the two companies’ respective announcements immediately following the Supreme Court decision that they would offer competing diagnostic tests for BRCA1/2. Gene By Gene, Ltd. responded by announcing that would team up with Ambry Genetics to defend against Myriad Genetics’ patent infringement lawsuits against both companies, and that both companies are also countersuing Myriad for alleged violations of the Federal Antitrust Act. “The Supreme Court was very clear that gene sequences, even when isolated, cannot be patented,” said Gene By Gene President Bennett Greenspan in an August release at the time Gene By Gene filed a declaration with the court outlining the details of its BRCA1/2 test, which it will continue to offer to the public. “In light of this ruling we are pleased that we can now offer Americans the benefit of this more affordable test that we have already successfully offered to overseas clients.”
Ambry Genetics filed an antitrust counterclaim against Myriad Genetics in response to the patent infringement lawsuit Myriad and other plaintiffs filed against Ambry on July 9, 2013, and announced that it would vigorously defend itself against University of Utah Research Foundation, et al, v. Ambry Genetics Corporation, United States District for the District of Utah, Case No. 2:13-cv-00640-RJS.
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Ambry’s antitrust counterclaim alleges that:
Myriad’s lawsuit is in violation of the Sherman Antitrust Act because the asserted claims against Ambry are invalid under two Supreme Court decisions and Federal Circuit authority. In bringing this patent infringement lawsuit, Myriad continues a practice of using overreaching practices to wrongfully monopolize the diagnostic testing of humans’ BRCA1 and BRCA2 genes in the United States and to attempt to injure any competitor who challenges Myriad’s monopoly, including Ambry. This includes conduct by Myriad of falsely representing to genetic counselors and payers as to the accuracy of Ambry’s BRCA1 and BRCA2 diagnostic products.
Due to Myriad’s anticompetitive conduct, customers must pay significantly higher prices for Myriad’s products in the relevant market, often nearly twice as high as the price of Ambry’s products and those of other competitors.
Myriad’s illegal enforcement of the asserted patents has ensured that customers have virtually nowhere to turn but Myriad and its monopoly-priced products.
Ambry CEO Charles Dunlop also issued a statement affirming that “Ambry Genetic supports the Supreme Court’s decision and will vigorously defend its position. We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing and Ambry is fully committed to supporting our clients and patients moving forward. ”
“Being sued for patent infringement a month after the Supreme Court ruled 9-0 unanimously against Myriad is just wrong,” Dunlop contends. “As alleged in our counterclaim, Myriad Genetics is also wrongfully depicting Ambry’s variants of unknown significance (VUS) statistic to be as high as 30% when it actually is approximately 5% for BRCA1/2 diagnostic testing. Tactics like this have no place in the medical field, especially cancer, as it will take a collabortive, industry wide effort to further understand the disease and find cures.”
The Salt Lake Tribune’s Harvey reports that in its suits, Myriad is asking U.S. District Court Judge Robert J. Shelby to issue an injunction requiring Gene By Gene and Ambry Genetics to immediately halt their testing programs, alleging that they infringe on parts of Myriad’s patents that were not invalidated by the June ruling from the Supreme Court, and that the two competitors have counter-argued that Myriad’s tests rely on genetic material that is not eligible to be patented under that decision and that their tests are based on new knowledge, methods and technologies not available when Myriad received its patents nearly 20 years ago. Harvey cites Myriad’s lead counsel David Mangum maintaining that the Gene by Gene and Ambry tests are still dependent on a synthetic genetic material called a primer on which Myriad still holds patents. arguing that under the provisions of the Supreme Court decision, Myriad’s primers are indeed eligible for patents because they are not performing functions that occur in nature.
Under the June high court decision, synthetic DNA, also known as complementary DNA, or cDNA, remains patentable. Thus, the court’s ruling lifted the patent obstacle to offering genetic diagnostic testing. In a release, Myriad Genetics affirmed in June that the Supreme Court of the United States had upheld its patent claims on cDNA, while ruling that five of Myriad’s claims covering isolated DNA were not patent eligible, and that following the June 13 decision, Myriad still has more than 500 valid and enforceable claims in 24 different patents conferring patent protection for its BRCA Analysis test. More Importantly, Myriad said, the Court noted that many of the firm’s unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes, and while these method claims were not at issue in this case, the Court highlighted Federal Circuit Judge Bryson’s opinion that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge.”
William G. Gaede III, an attorney jointly representing Ambry and Gene by Gene, is quoted by The Salt Lake Tribune’s Harvey insisting that Myriad’s primers contained a sequence of natural genetic material, making them ineligible to receive patent protection under the Supreme Court decision that such DNA isolated from the body remains a natural substance that cannot be patented, also arguing that Ambry’s tests incorporate the whole human genome and not just the segment where the BRCA1 and BRCA2 genes occur, as opposed to Myriad’s test, which he says looks only at those sequences and uses discoveries made long before the entire human genome was published.
Harvey reports that Judge Shelby says no decision will be forthcoming until the sides have a chance to file additional materials and then make final arguments at a second hearing.
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