Posts Tagged ‘Prometheus v. Mayo’

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Top 2011 IP Stories on Patents4Life

Saturday, December 31st, 2011

I spent a day or two looking back over the breaking IP news that resulted in posts on Patents4Life. I wrote most of them, but want to take a pause to thank regular contributors Paul Cole, Ron Schutz and Stefan Danner for their help. Patents4Life was originally intended to be a “blawg” focused on IP developments affecting the Life Sciences and, as 2011 comes to a close, I have put together a “top ten” list of stories to which attention had to be paid – by all of us in most cases – litigators, prosecutors and tech transfer professionals in the U.S. and abroad. The single most-apparent trend in IP last year was the increasing globalization of IP law – consider inter-office work-sharing and the prosecution highway. But I don’t want this column to go on into 2012, so here, in reverse order, are the “legal events” that dominated the netwaves in 2011. (I apologize for what I hope will be minor errors of fact and spelling – I am writing this from notes I made while back-tracking through the year.)

10. The Stem Cell Suits. In Sherley v. Sebelius, the district court finally dismissed the suit which had resulted in a ban on Federal funding for stem cell research, after the Court of appeals reversed its initial decision. (See Post, July 28th). However, in October, the Court of Justice of the EU ruled that claims to embryonic stem cells or even to cells that could become sources for embryonic stem cells were not patentable. (See post, Oct. 18th). Some types of gene therapy were indicated to be allowable. The future of embryonic stem cells is cloudy with a chance of further retreats like Geron’s.

9. On October 18th, Saint-Gobain petitioned for cert., urging the Supreme Court to answer a burden of proof question that comes down to: “Does holding a patent on an improvement on a patented invention that does not literally infringe insulate the accused infringer from infringement under the doctrine of equivalents?” This question has been simmering under the surface of infringement law for decades, the Fed. Cir. is clearly divided and the Supreme Court might bite. See Post of March 8, 2011 as well as October 14th post.

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Oral Argument in Mayo v. Prometheus – Why Mayo Will Lose

Friday, December 9th, 2011

On December 7th at 10:05 a.m., the Supreme Court heard oral arguments (transcript at end of this post) in the “Prometheus case,” presented by Stephen M. Shapiro of Meyer Brown (Mayo) and Richard P. Bess of Latham & Watkins. Solicitor General Verrilli also argued.  In earlier posts on this appeal, e.g., on November 7th, I noted that Mayo’s brief de facto asks the Court to follow the “LabCorp dissent” (548 U.S. 132, 136). In this dissent from a dismissal of cert. as improvidently granted, Justice Breyer, joined by Souter and Stevens, urged the Court to consider that all simple diagnostic tests that correlate a level of a chemical marker (like homocysteine) to a pathology (like a vitamin deficiency) are no more than impermissible attempts to patent natural phenomena: “[T]he process is no more than an instruction to read some numbers in light of medical knowledge.”

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Prometheus’s Brief – Don’t Confuse Us With “LabCorp”

Monday, November 21st, 2011

It took me a while to get around to reading Prometheus’s brief to the Supreme Court in Mayo v. Prometheus Labs., No. 10-1150 (S. Ct. Oct. 31, 2011), because I was pretty sure how it would read and, in fact, there are no major surprises. Prometheus argues that their claims must be considered as a whole, and that section 101 does not categorically exclude processes that end by providing useful information – what I called a “thinking step” in an earlier post. Prometheus argues that “Mayo’s categorical rule that all claims must end with an action step would just multiply byzantine claim drafting…This Court has routinely recognized that patents can properly leave ample room for ‘the judgment of the operator.” Res. Brief at 35. Prometheus also reaches into the Bilski opinion for one of the few helpful quotations: “Nothing in Bilski was intended to ‘create uncertainty as to the patentability of …advanced diagnostic medicine techniques.’ [130 S. Ct. at 3227[ let alone all processes provided valuable information.” Res. brief at 36.

Prometheus also takes the reader along the well-worn path of Morse, Benson, Flook and Grams to argue that the monitoring patents do not preempt all practical use of any “relevant principle” but then neatly circles back to Tilghman, 102 U.S. at 709, to argue that the patent in question “wholly preempted the ‘natural phenomenon’ that water applied at high temperature and pressure would have the stated effect on fatty bodies. But it did not preempt the broader natural principle that high temperature and pressure tend to break chemical bonds, and it did not preclude the use of other methods to separate fat acids and glycerine from fatty bodies, such as sulfuric acid distillation or steam distillation.”

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Mayo’s Brief Goes Back To A (Non-Precedential) Future

Thursday, November 3rd, 2011

You all may be suffering from Prometheus v. Mayo fatigue by now, but this remains the most important IP case before the Supreme Court, and may well alter the course of life sciences patenting for the foreseeable future. I know I am falling behind in posting on the appeal, but each party has now filed 59 page briefs. I recently finished Mayo’s brief (a copy provided at the end of this post along with Prometheus’ brief) and I wonder if they really want to clear the high legal fences they are “swinging for.”

The heart of their legal (vs. “This will hurt patients and inhibit research” policy) arguments are that Prometheus’ claims to administering to a patient having an immune-mediated g.i. disorder a drug providing 6-TG (the metabolite), measuring the levels of the metabolite wherein a level under x “indicates a need to increase” subsequent doses and a level over y “indicates a need to decrease” subsequent doses, improperly embed a law of nature or natural correlation with one or two information gathering steps that should be accorded no patentable weight.  (I disagree with the testimony of Prometheus’ expert as summarized by Mayo at page 25, that the doctor who receives the results would infringe even if they were not read. This summary ignores the claim limitation “indicates a need,” which is recognized as functional by Mayo at page 22 of the brief: “[The patents] advise physicians to think about the need for dosage adjustments when metabolites reach certain levels….” For more about “thinking” as a claim element, see below.

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