Although the jury found the claims valid, and the Fed. Cir. affirmed, this decision, which found that the claims were not insolubly ambiguous, was revisited by the Fed. Cir. While there are pages on issue preclusion, in the end, the Fed. Cir. took the appeal and reversed its original position. Here there were four possible methods to measure the parameter “stretch hardening” of the claimed polymer, and the specification did not identify which one was used. Following Teva, in which three methods of measuring molecular weight led to the Supreme Court’s imposition of the “reasonable certainty” standard for determining if a claim satisfied s.112, the Fed. Cir. had little choice but to invalidate the claims that recited this parameter. I have always resisted the mantra that would require lots of definitions of claim elements, but the writing is on the wall, and this new “easy-to-use” mode of claim invalidation will only gain momentum.
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.”