The Federal Circuit Court of Appeals has applied the Supreme Court’s test for unpatentable abstract ideas to patents covering methods to determine a person’s likelihood of getting certain types of cancer.
In University of Utah Research Foundation v. Ambry Genetics Corp., 2014 U.S. App. LEXIS 23692, decided by the Federal Circuit on December 17, 2014, the court addressed the patentability of two types of claims: compositions and methods. The composition claims were directed to single strands of DNA called “primers” that correspond to the double-stranded DNA of a gene. The method claims were directed to diagnostic methods used to determine whether a patient carries a particular gene mutation that carries an increased risk of breast and ovarian cancer.
The plaintiffs were Myriad Genetics, University of Utah, and others. They discovered the BRCA1 and BRCA2 genes that, when mutated, cause breast and ovarian cancer. Myriad developed diagnostic test kits to detect the presence of the mutations. Myriad patented the natural gene sequences, synthetic primers, and medical test kits.
In 2013, the U.S. Supreme Court held that Myriad’s claims to the natural gene sequences were invalid. Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013). The Court found that the gene sequences were not patent-eligible subject matter, but were instead ineligible natural phenomena.
After the Supreme Court’s decision, Ambry Genetics began selling its test kits for the BRCA1 and BRCA2 genes. Myriad sued Ambry Genetics for infringement of the claims to the primers and the diagnostic methods. The district court for the District of Utah denied Myriad’s motion for preliminary injunction, holding that the claims covered patent-ineligible subject matter. The district court found that the primers and the methods were products of nature, essentially the same as the natural DNA of the gene, and therefore patent-ineligible.
The Federal Circuit affirmed. The court held that the primer claims were patent-ineligible as products of nature, even though they were synthetic, as they were identical in structure to the natural DNA. As to the method claims, the court explained that it did not need to decide if the method claims were patent-ineligible as laws of nature, but instead applied the Supreme Court’s test for claims that are directed to abstract ideas. That test was set forth in a business method case, Alice Corp. v. CLS Bank, International, 134 S. Ct. 2347 (2014). Under the Alice Corp. test, a court must first determine whether the claim covers a patent-ineligible idea. If so, the court must then determine whether the remaining claim elements transform the claim into patent-eligible subject matter (i.e., whether there is a further “inventive concept” that makes the claim patent-eligible).
The court applied the two-part Alice Corp. test to Myriad’s method claims. According to the court, the first part of the test was met because the step of comparing the gene sequences of the patient’s DNA to the normal DNA of the BRCA genes was an abstract idea. The second part of the test was met because the remaining steps of the claims did not add an “inventive concept” to transform the claim into patent-eligible subject matter. The court found that these steps were “routine and conventional activity.” Because both parts of the test were met, the court held that the method claims were patent-ineligible.
This decision was in the best interest of patients. Myriad’s claims to the diagnostic methods are invalid. This means that Ambry Genetics and other competitors will be able to offer their own diagnostic test kits to patients, and the price of the kits will drop. More patients will be tested, and that’s a good thing.