Archive for the ‘Patentable Subject Matter’ Category

Myriad Settles – Questions Remain

Tuesday, January 27th, 2015

Yesterday, Myriad announced it has settled the BRCA assay litigations that had been ongoing—and not going well– with Pathway Genomics, Invitae and Gene by Gene (and I assume….Ambry and Labcorp). Although I was just about at the brink of shouting “Stop The Madness” – the settlements mean that the IP community will not learn if Myriad had any patent-eligible claims in any of their assay patents. Would claims directed to mutations at specific positions of the BRCA1 or 2 genes have passed muster as that elusive “inventive concept” that both the Fed. Cir. and the S. Ct. extracted from Mayo as the standard by which to judge assays reciting abstract ideas or natural phenomena (which one is it?)?

You can read an article about the settlement on the GenomeWeb page by clicking here.

The “Top Ten” IP Stories of 2014 (Most “Definitely”)

Tuesday, December 30th, 2014

I don’t think I can recall a more action-packed year for intellectual property law in my career, much less during the almost six years that I have been writing this blog. I am trying to write this while in transit, so there will be few footnotes or cites, but they are easy enough to find in my past posts, or online. I am not even sure that I outlined ten stories before I started typing, but here goes — in no particular order.

1,2,3 and 4. Mayo meet Alice meet Myriad - The Tortuous Path of s.101.

Although only Alice was decided in 2014, the excitement really started with the unexpected release of the PTO “Life Sciences” Guidelines in March (No. 1 Story). The draft Guidelines directed Examiners to reject claims to products of nature unless they were significantly different in structure from the products in their natural states, and declared that simple “If A, then B” diagnostic claims were patent-ineligible as attempts to patent natural phenomena.

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Mayo Meet Alice Meet Myriad – Fed. Cir. Appreciates “Abstract Art”

Thursday, December 18th, 2014

On December 20th, a panel of the Fed. Cir. of Judges Dyk, Clevinger and Prost – Dyk writing – found that six claims in Myriad’s dwindling arsenal of BRACA1 and 2 patents were invalid as claiming non-statutory subject matter. (University of Utah Res. Foundation et al. v. Ambry Genetics Corp., Appeal No. 2014-1361, -1366 (Fed. Cir., Dec. 20, 2014)). (A copy of the decision is found at the end of this post.) The decision makes more sense than some commentators have given it credit for, but it still reads like the plot of the last Matrix installment.

First, the panel invalidated four composition of matter claims directed to ssDNA segments useful to amplify the BRACA genes or portions thereof, when used as PCR primers, or to identify specific areas of the genes if used as probes. These were claims in US Pat. Nos. 5,747,282 and 5,837,492.

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Revised 2014 Interim Guidance on Patent Subject Matter Eligibility Released by PTO

Tuesday, December 16th, 2014

On Monday, December 15th, the Patent Office released revised “Guidance” on the evaluation of subject matter patent-eligibility under s. 101. (A copy is available at the end of this post.) The “Guidance” is an attempt to unify the analyses that were set forth in earlier Guidelines post-Mayo and post-Alice, and apply to all classes of inventions. After stripping away the introductory material, and the case law summaries, there are only a few pages of substantive guidance.

The most important change to the notorious March 4th “Life Sciences Guidelines” is summarized in the Flowchart on page 9 and in section 3B. If a composition is a “nature-based product,” it is analyzed in step 2B to see if it is “markedly different” from “its naturally occurring counterpart in its natural state.” However, the revised Guidance pointedly drops the requirement that the product be structurally different. Now “markedly different characteristics can be expressed as the product’s structure, function and/or other properties and will be evaluated based on what is recited in the claim on a case-by-case basis.” That is a big “or”:

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