December 16, 2020

Top Section 101 Patent Eligibility Stories of 2020

Holland & Knight Section 101 Blog
Anthony J. Fuga
Section 101 Blog

Light a fire, pour yourself some glogg (21+) and find a comfy corner to read about the biggest Section 101 stories of 2020 because we're gonna have the hap-hap-happiest time since Bing Crosby tap-danced with . . . Well, you know the rest. It's going to be fun.

Before we get to the list, here are a few honorable mentions:

No. 3: Section 101 Continues to Develop for Pharmaceutical and Life Science Patents

In a pair of decisions earlier this year, the U.S. Court of Appeals for the Federal Circuit applied the two-step Alice framework to life science patents. While the Boehringer v. Mylan ruling felt like a straightforward decision following Vanda, the later Illumina v. Ariosa case provided significant discussion, along with a Circuit Judge Jimmie Reyna dissent. In that decision, the court ultimately held that while the claimed methods utilize the natural phenomenon discovered by the inventors, they employed a physical process step to selectively remove fragments of cell-free fetal DNA and were therefore patent eligible under step one of the Alice/Mayo test, and step two of the Alice test need not be considered.

The appellate court determined that the claimed methods include specific process steps of selectively removing larger DNA fragments to change the composition of the mixture from the naturally occurring ratio in the mother's blood and that doing so achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon. The court used this basis to distinguish the instant claims from the invalid ones previously considered in the Mayo, Athena and Cleveland Clinic decisions, which were all directed to simply detect a natural phenomenon.

Read more: Section 101 Update: Pharmaceutical and Life Sciences March 2020

No. 2: U.S. Supreme Court Continues to Ignore Section 101

There was much discussion this year about whether Section 101 would be reformed or reimagined. With the U.S. Congress having its hands full this year, much of the focus was on the U.S. Supreme Court, specifically whether the highest court in the land would take on a Section 101 case. They didn't.

Read more:

No. 1: American Axle v. Neapco (Again)

This was No. 2 on last year's list and, somehow, it not only made this year's list but moved to No. 1! This year, the focus was on American Axle's petition for rehearing en banc being denied with an evenly divided six-to-six vote.

This split en banc ruling, along with the concurring opinion and three separate dissenting opinions, only underscored the disagreements within the court. Chief Judge Sharon Prost, along with Judges Timothy Dyk, Evan Wallach, Richard Taranto, Raymond Chen and Todd Hughes, all joined in the denial of the en banc petition, while Judges Kimberly Moore, Alan David Lourie, Pauline Newman, Kathleen O'Malley, Jimmie Reyna and Kara Farnandez Stoll dissented from the denial.

Once again, Judge Moore offered a blistering dissent, arguing that the majority followed a "chimeric approach to § 101 which is inconsistent with precedent, a vast expansion of § 101, and bound to cause confusion in future cases."

Read more:

Did I miss a top story? Have a good glogg recipe? Let me know at

As always, thank you for reading the blog this year. I hope you and your families have a great holiday season. We'll be back in 2021!

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