This is a guest post from Donald Chisum and Janice Mueller.
On August 12-14, 2015, the Chisum Patent Academy held a three-day seminar at the historic Mayflower Park Hotel in downtown Seattle, Washington to discuss and debate current developments in U.S. patent law. The roundtable seminar group was limited to ten persons; sessions were led by treatise authors and educators Donald Chisum and Janice Mueller.
The recap of takeaways from the seminar can be found here:
Sequenom’s Petition for Rehearing En Banc – Panel Ignored “Inventive Concept” in Combined Steps of the Claimed Method
For any of us practitioners encountering increasing numbers of s. 101 rejection rejections of diagnostic claims based on Mayo and the March 2014 PTO Guidance – and that is pretty much any life sciences patent attorney – this brief is a “must read.” (A copy of this brief is available at the end of this post.) This brief puts it all out there, both criticizing the panel, proposing a new rule for method claims incorporating natural phenomenon and illustrating how the panel’s application of the Mayo Rule threatens method of medical treatment claims as well as diagnostic method claims.
If I start trying to summarize the Brief, I will not be able to stop. Instead of arguing that the Mayo Supreme Court decision was wrong, the Brief distinguishes the regimen claims in Mayo from the Sequenom claims – that were based on the discovery of cffDNA in maternal serum which, in turn permitted the non-invasive determination of the condition of the fetus. The opinion of the Brief’s authors is that the Sequenom claims adhere to the rationale of Diehr, a decision ignored by the panel. I will quote two paragraphs below, but picking just one to quote is like having to stop after eating a single M&M or one potato chip – nearly impossible:
CAFC Decides Akamai v Limelight–Holds For Infringement By Limelight–Defines Criteria For Directing And Controlling Customers’ Performance
In Akami Technologies v. Limelight Networks, App. No. 2009-1372, -1380, -1416, -1417 (Fed. Cir., August 13, 2015), the court, sitting en banc after a remand from the S. Ct., set out the requirements for direct infringement involving acts by two or more parties under s. 271(a). The unanimous ruling held that an entity is responsible for others’ performance of method steps (1) where that entity directs or controls the acts of another, or (2) where the actors form a joint enterprise. (A copy of this decision is found at the end of this post.)
The court explained:
“… we have held that an actor is liable for infringement under s. 271(a) if it acts through an agent … or contracts with another to perform one or more steps of a claimed method. See BMC, 498 F.3d at 1380-81. We conclude, on the facts of this case, that liability….can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance…. In those instances, the third party’s actions are attributed to the alleged infringer such that the alleged infringer becomes the single actor chargeable with direct infringement.”
PatentlyO recently posted a nearly final draft of a paper writer by Professor Rebecca Eisenberg that will be published in the Journal of Science and Technology Law (note to author – fix fn 23). (A copy can be found at the end of this post.) She and I have been on the opposite side of issues such as patents for genes at various times, but she nails the purposeful and logically unsupportable rationales of the Fed. Cir. and the Supreme Court that she believes have already ended patent-eligibility for claims directed to diagnostic methods. While I have argued that, even post-Ambry and Ariosa, there should be room for focused claims to diagnostic methods based on the discovery of naturally-occurring correlations, this paper suggests that “It ain’t over ’til it’s over” is hopelessly optimistic.
In some of my earliest posts, pre-Myriad and pre-Prometheus (“Mayo”), I argued that the Metabolites Labs. dissent by Justices Breyer, Stevens and Souter conflated the in vivo existence of cobalamin and homocysteine in the blood with the human act of correlating an elevated level of one with a deficiency of the other. On April 27, 2009, I wrote:
“Justice Breyer, I respectfully submit that nature may contain [the basis for] correlations but it does not analyze, much less correlate, anything. Nature doesn’t care if your homocysteine level is low or high and what consequences may befall you if it is too high or low. Just as nature doesn’t care what your PSA level is, even though it is certainly a natural phenomenon that men have PSA in their blood. But a claim: ‘Human blood containing PSA’ does not anticipate a claim to a method of detecting prostate cancer by assaying blood for PSA and correlating an elevated PSA level to the presence of prostate cancer. Good thing those patents have expired; they yielded workable life-saving test before they expired.”
