Federal Circuit Issues Decision in AMP v. USPTO

By Kevin E. Noonan --

The Federal Circuit handed down its long-anticipated decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office (the Myriad case).  In an extensive and thorough opinion by Judge Lourie (only appropriate in a case where the District Court's opinion reached 156 pages), the Court affirmed the District Court's decision on standing, reversed the decision regarding isolated DNA claims, and affirmed the decision of unpatentability for method claims reciting merely "comparison" steps, on the grounds that these claims failed the machine or transformation test from Bilski.

Judge Moore wrote a separate concurring opinion, explaining her decision to join Judge Lourie (with regard to the isolated genomic DNA claims) on the grounds that, at this late date it is up to Congress, not the courts, to extend the "laws of nature" exception to isolated DNA.

Judge Bryson dissented from the majority's decision to reverse the District Court on the genomic DNA claims, based (in part) on his understanding that such claims would inhibit whole genome sequencing, and that these claims were analogous to earlier (albeit non-binding) precedent and (in his view) consistent with Supreme Court decisions.

Patent Docs will provide further analysis in upcoming posts.

Comments

[ACLU Bites the Dust]

"affirmed the decision of unpatentability for method claims reciting merely "comparison" steps, on the grounds that these claims failed the machine or transformation test from Bilski"

Great result here. And hopefully soon the Supreme Court will explain why the mere step of "transforming" a tissue sample to obtain the DNA sequence, using old, standard techniques, does not suffice to render a method of thinking about data eligible under 101.

[6]

Lulz, "ACLU gets closer to their USSC decision they wanted from the get go" is what I think you meant to say.

[EG]

Kevin,

Very interesting decision. Lourie actually has one his better and more understandable opinions (compared to Ariad and Prometheus). I definitely agree with his analysis on the isolated gene sequence quesiton. And can sort of go along with his analysis on the method claims. And I can live with the view of the entire panel on the standing issue which is a significant "kick in the gut" for the ACLU's PR-inflated and disingenuous "broad standing" view.

Judge Moore's concurring is also interesting in that she recognizes the reality of of overturning what the USPTO has done for 30 or so years in granting patents to isolated gene sequences. She's definitely "growing-up" as a Federal Circuit judge and I applaud her for that

I not happy that the panel held all but one of the method claims patent-ineligible using the M or T test (I don't agree with their view, but I at least understand where the current demarcation line is between patent-eligible and patent-ineligible for such method claims). Given ruling that Claim 29 of the '282 patent ("A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and compar-ing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.") is patent-eligible as being transformative in at least the "growing" step, Claim 29 (assuming there's no en banc Federal Circuit or SCOTUS ruling that suggests otherwise) should give us patent attorneys/agents a pathway to how to write such claims to be compliant with 35 USC 101.

Judge Bryson is apparently in Judge Dyk's camp on the isolated gene sequence issue. Their view mystifies and annoys me from the standpoint of ignoring the science, chemistry, molecular biology, and more significantly, the reality here.

Overall, this decision should be viewed favorably by the biotech world. Let's hope there's no en banc Federal Circuit (or even worse, SCOTUS ruling) that messes this decision up.