Can AMP v. Myriad Revive Diagnostic Method Claims?

At the end of the Supreme Court’s Opinion, Justice Thomas makes it clear that the Court was impressed by Judge Byson’s dissents in the Fed. Cir. Myriad opinions. Although Judge Bryson was on the Intema panel that sank claims to pre-natal screening for Down’s syndrome, the Supreme Court’s opinion makes his position in Myriad sound like a progressive one that will lead the way to patent-eligible claims:

“Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that ‘[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.’ 689 F.3d at 1349.”

Well, to what applications is Justice Thomas referring? Remember, Judge Bryson had no problem with Judge Lourie’s nearly summary disposal of the method claims that were on appeal. Also, in Intema, a panel that included Judge Bryson wrote: “The stricken [process] claims [in Myriad] are indistinguishable from those before us [in Intema]…The claims were not over an application of the mental process of comparing [a sequence in a tumor sample with one from a non-tumor sample]. ‘Rather, the step of comparing two DNA sequences [was] the entire process that [was] claimed. [citing to Myriad].’”

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Association For Molecular Pathology V Myriad Genetics – An Isolated Local Difficulty?

Paul Cole, Professor of Intellectual Property Law at Bournemouth University and European Patent Attorney at Lucas & Co, Warlingham, Surrey, UK discusses yesterdays Myriad ruling by the Supreme Court.

How does yesterday’s Supreme Court decision match international opinion on the patentability of biological material? From a European and indeed from an Australian standpoint it can be said with some confidence: not so well.

The USPTO has now made its policy clear in a letter from Andrew H Hirshfeld, Deputy Commissioner for Patent Examination Policy to the Patent Examining Corps:

“As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101. Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible. Other claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.

The entire commentary can be downloaded here:  Myriad Commentary.

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Supreme Court Rules In Myriad On Patentability Of DNA

Today, the Supreme Court ruled that a naturally occurring DNA sequence is a product of nature, and not patent-eligible simply because it has been “isolated.” (A copy of the ruling can be found at the end of this post.) However, the Court “split the baby” and held that cDNA is patent eligible, because it is not naturally-occurring, e.g, is sufficiently man-made. The core rationale was that Myriad did not create a composition of matter “with markedly different characteristics from anything found in nature,” taking language from what commentators consider dicta in Chakrabarty.  In other words, genes, though they can be defined by their chemical structure, are not “new…composition(s) of matter” under s. 101.

The Court rejected the Fed. Cir.’s two opinions  (e.g.,  authored by Judge Lourie) that severing chemical bonds “that bind gene molecules together” yielded new compounds and, oddly to this ex-chemist, stated that “[t]he claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the  isolation of a particular DNA section” but instead “focus on the genetic information encoded in the BRCA1 and BRCA2 genes”[Emphasis added].  In other words, the Court bought the somewhat metaphysical argument made by the ACLU attorney representing AMP et al (or the one professor found to have standing) that DNA molecules are simply repositories and transmitters of information. Maybe we practitioners are lucky the Court didn’t rule that they also were patent-ineligible as abstract ideas – a popular category these days.

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CLS Bank International v. Alice Corporation: Poison Apple

This is a guest post from Ron Schutz of Robins, Kaplan, Miller & Ciresi.

Move over Snow White.  A deeply-divided Federal Circuit in CLS Bank Int’l.  v. Alice Corp. Pty. Ltd., issued a per curiam opinion that dwarfs the scope of patent-eligible subject matter under § 101―and turns business method software into the saddest (former) patents of them all.  Because the majority could not agree on a rationale for its conclusion that the method and computer-readable medium claims at issue lacked subject matter eligibility, the seven-opinion decision (it seems no one was Bashful) has no precedential weight.  A not-so-Happy dissenting Judge Moore stared into the magic mirror and asked if CLS Bank may be “the death of hundreds of thousands of patents, including all business method, financial system, and software patents as well as many computer implemented and telecommunications patents.”  Any hope of a happily-ever-after for those patents now hinges on whether the Supreme Court bestows a reviving, certiorari-granted kiss or, instead, wickedly tells patent holder Alice Corporation (and the rest of the majority software industry) to kiss off.

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