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Are Genes Patentable - The Final Word?


Greetings from D.C. A three-member panel of the Court of Appeals for the Federal Circuit (CAFC) has just ruled (August 2012)—again—on a case with implications for the patentability of genetic materials. The case, AMP v. Myriad Genetics, was initially ruled on by the CAFC last year, but was remanded by the Supreme Court after its subsequent ruling on a related case (Mayo v. Prometheus) in spring 2012. The bottom line? The recent CAFC ruling is essentially the same as the original, with some variations in the opinions.

As highlighted in this column last September, the Myriad case involved Myriad’s patents of two genes associated with increased risks of breast and ovarian cancers, and used in genomic-based diagnostics. The patents were declared invalid in a lower court ruling. The CAFC then rejected that lower court’s holding last fall, and many waited to see what would be the next step—an appeal, the case picked up by the Supreme Court, or what implications other cases the Supreme Court may take up would have on this decision. It was the latter that occurred.

In fall 2011, the Supreme Court accepted Mayo v. Prometheus, revisiting the issue of patentable processes following Bilski. In spring 2012, the Supreme Court unanimously held that the process claims in the Mayo case are not patent-eligible subject matter, a decision that many suggested could have far reaching implications on other cases. The ruling essentially noted that patents should not be allowed on optimal dosages for medicines since the body’s reaction to that medicine is a fact of nature. And, as expected, less than a week after the Mayo decision, the Supreme Court ordered the lower court to reconsider its ruling in the Myriad case in light of Mayo—to assess whether the validity of the Myriad gene patents were impacted by the Mayo decision.

That ruling came in August and, as noted, essentially follows the initial ruling. As Dennis Crouch wrote on the Patently-O blog, "The key results: 1) Affirmed: The courts properly have jurisdiction over the declaratory judgment case; 2) Reversed: Myriad’s composition claims to isolated DNAs, including cDNAs, fall within the scope of Section 101 patentable subject matter; 3) Affirmed: Myriad’s method claims directed to comparing or analyzing gene sequences are not subject matter eligible; and 4) Reversed: Myriad’s method claim to screening potential cancer therapeutics via in vitro changes is subject matter eligible."

Time will tell whether this is the final word on the matter. According to Crouch, “In my estimation, this case is not over. There is a strong possibility of either an en banc rehearing by the full 12-member Federal Circuit and/or a grant of certiorari by the U.S. Supreme Court.”

Much is at stake, and one presumes that every action available to all parties will be taken before it is over.

Much of this information was taken from the Patently-O blog and the Chronicle of Higher Education online.

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