Earlier this month, Myriad Genetics filed patent infringement lawsuits against Ambry Genetics (on July 9th) and Gene-by-Gene (on July 10th). Filed with the complaint in the Ambry lawsuit was a Motion for Preliminary Injunction, and the brief supporting this motion sheds light on the arguments Myriad will assert in its lawsuit (against Ambry and, presumably Gene-by-Gene as well).
In its introduction, Myriad reminds the Utah District Court what is at stake: that the company had invested "over $500 million dollars" in developing and commercializing its BRCA1 and BRCA2 genetic diagnostic tests. These tests have "revolutionized patient care and provided medical diagnosis and treatment options never thought possible," providing a test "of superior reliability and accuracy" and that "has saved, and continues to save, countless lives." Myriad continues to have many claims in its franchise (515 in 24 patents), including the ones specifically recited in its complaint. Finally, Myriad takes the position (one not completely supported by the Supreme Court's express language) that the Court "found that, unlike isolated human genes, synthetic DNA is man-made and is not a product of nature. Plaintiffs' remaining patent claims covering BRCA1 and BRCA2 gene testing, including those at issue here, pertain to synthetic DNA or methods-of-use, which were not affected by the Court's decision, and remain valid and enforceable."
The Statement of Facts provides access to the company's background on its website and recites one important aspect of Myriad's business: as a result of its 16 years and one million patients tested, Myriad has "an extensive database of genetic variant information . . . [that] has allowed Myriad Genetics to further improve its test quality by ensuring that over 97% of the patients tested with BRACAnalysis®, who receive a report identifying a genetic variation, will be informed as to the clinical significance of the variant." And the company emphasizes the pioneering nature of its work:
Myriad Genetics has also invested heavily in creating from scratch the market for breast/ovarian cancer genetic testing, including conducting extensive clinical studies in support of medical industry guidelines regarding hereditary cancer predisposition testing, developing a market of insurance reimbursement, both public and private, for such testing, and promoting physician and patient education surrounding the importance of hereditary cancer awareness and testing.
This section of the brief also references Ambry's activities specifically relevant to Myriad's patented technology (in particular, four tests identified as BreastNext, BRCAPlus, CancerNext and OvaNext) and Ambry's announcement that it would begin to provide BRCA testing. This announcement contained the information that Ambry would offer its BRCA tests for $2,280 (compared with Myriad's $4,040), a "significant" price drop, and asserted that "[w]hile Ambry's tests do not offer the accuracy, quality and reliability of Myriad Genetics' integrated BRACAnalysis® test, they present a significant competitive threat as third-party payors, rather than patients and their health-care providers, frequently decide where testing will be performed and such payors are often not well-informed about the competitive quality of such tests."
Turning to the nature of the testing, Myriad tells the District Court that the difference in its claimed probes and PCR primers are that they comprise "synthetically created complementary DNA molecules" that differ from the genomic DNAs claimed in the claims invalidated by the Supreme Court because "they are not naturally occurring,[ r]ather, they are synthetic, laboratory-created DNA carefully designed by man to achieve specific performance metrics." (While this is one interpretation of the Court's decision it is not the only one; indeed, the Court's basis for distinguishing patent-eligible cDNA and patent-ineligible genomic DNA was not on the basis of it being synthetic versus naturally occurring but that cDNA cannot be found in nature, a subtle but real difference.) Nevertheless, Myriad contends that "[c]reating synthetic DNA sharing sequence similarity with any particular gene requires an application of detailed knowledge from the discovery of that gene's structure," thereby placing its primers in that portion of the opinion that indicates that "applications" of the knowledge of the BRCA genes may be patent-eligible.
The legal section of the brief sets forth the requirements for obtaining a preliminary injunction: that there is a likelihood (not a certainty) that the patentee would be successful on the merits of the patent infringement suit; that the harm the patentee would suffer from infringement would be "irreparable" and not adequately compensated by money damages; that the balance of the hardships between the parties favors granting the injunction; and that the injunction would be in the public interest. The brief proceeds to set forth arguments for each of these prongs (albeit thinly for the hardship balance).
Myriad's arguments for the likelihood it will succeed on the merits depend in large part but not entirely on Section III of the Supreme Court's decision regarding the availability of patent protection to Myriad based on applications of its discovery of the human BRCA genes:
[T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson [of the Federal Circuit] aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications." Id. at 2120 (citing Ass'n for Molecular Pathology, 689 F. 3d at 1349) (emphasis added).
Other arguments include reference to its earlier (in the 1997 timeframe) "cease and desist" activities against the University of Pennsylvania and other academic labs, and that those earlier enforcement efforts "settled within a year of filing." "Not one of those infringers raised a serious contention as to the validity of Myriad's patents, and their quick exit from the market is indicative of the...
