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« R+L Carriers, Inc. v. Qualcomm, Inc. (Fed. Cir. 2015) | Main | Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Novartis AG »

September 22, 2015

Comments

Paul,

Always appreciate your insights on our patent and court system from across the Pond. As you're likely aware, I don't always agree with them, but please understand that doesn't detract from their value for thoughtful discussion and debate.

What you argue for in your request would do much to help sort out the currently chaotic situation we have here in the States on the patent-eligibility issue under 35 USC 101. Unfortunately for your arguments, as well as the "rule of law," our patent law jurisprudence is currently being dominated by judges and especially Justices of SCOTUS who are making policy judgments which should be reserved to our Congress. In short, we have judicial activism where determinations on patent-eligibility are being made without trying to understand the facts (i.e., the technology being claimed) or the relevant patent statutes (i.e., 35 USC 101) which leads to mind-boggling nonsensical court decisions that are little more than judicial fiat. Wish it were otherwise.

Paul Cole: "[the Office] has a history of over-broad interpretation of Supreme Court and other decisions, which has created widespread difficulty for patent applicants and hence widespread adverse comment from both individuals and organizations."

Actually the exact opposite is true but Paul Cole isn't exactly the most forthcoming person in the room. Ever.

EG: "we have judicial activism where determinations on patent-eligibility are being made without trying to understand the facts"

Of course "EG" suffers from a well-documented difficulty in understanding what is a "fact" and what is not a "fact."

Here is a fact: Prometheus stated in open court that its claim covered the steps of (1) obtaining data using an old technique and (2) thinking a "new" thought about that data.

It doesn't take much intelligence to see where a patent system that allows such claims to be granted and enforced is headed. And yet many people -- including EG and many other self-identified "experts" -- have apparently chosen to "not understand" that simple fact for many years.

Now we yet have another case dealing with a class of incredibly broad claims with the potential to dramatically affect the public's rights to fundamental diagnostic facts. Specifically, we have the situation where X uses a well-known detection method to determine a natural fact, and then attempts to monopolize that fact by broadly claiming "A method wherein said method comprises the use of old technology to detecting [insert fact here]."

On an earlier thread dealing with this topic, Paul Cole was asked to directly address the implications of his position reqarding Sequenom's claim and he simply refused to do so. It's safe to assume that Paul Cole either does not understand the facts about Sequenom's claim (and claims like it) or Paul Cole simply does not want to discuss those facts because they make him uncomfortable (can anyone guess why?).

But here's the deal: those facts aren't going away. They didn't go away before Prometheus v. Mayo when the exact same crowd of cheerleaders tried to make the bad facts go away. And they didn't go away when before Myriad when the exact same crowd of cheerleaders tried to make other equally bad facts go away.

Here again is the hypothetical and questions that were asked on the previous thread. Maybe one of the defenders of Sequenom's claim will step up this time and answer them.

Hypothetical:

Biologist uses PCR to identify a new uncultured bacteria that lives in soil. Biologist claims "use PCR to detect [insert name of new species here]".

Question: Is that claim eligible? If so, why? If the claim is eligible, could the claim be made any simpler (i.e., broader?) including specific reference to all additional known methods?

If the claim isn't eligible, why is that the case and how does it differ from Sequenom's claim? What could/should be added to the claim to make it eligible?

Many thanks for your summary. I have one small quibble.

I spent several not so happy days studying the BRCA1 patent which I confess I view with the eyes of a chemist rather than a biotechnologist.

As you rightly say the patent listed the full length cDNA sequence. I did not find an example reporting the actual isolation of the cDNA as a physical molecule, and suspect that the experimental work had not progressed beyond probing various libraries for partial sequences and the computer reconstruction of the complete cDNA sequence from these partial sequences. However, my understanding is that once this stage had been reached the production of physical BRCA1 cDNA was a trivial step, and have learned that this cDNA is now a commercially available product.

The situation regarding wild-type BRCA1 is quite different. The patentees had indeed found the exons and knew both their sequences and their relative positions in the wild-type gene. However, they had sequenced only 27,000 of the 80,000 or so nucleotides in BRCA1, and there were regions listed as vvvvvvvvv which did not impress Judges Moore and Bryson in the Federal Circuit. Isolation of full length BRCA1 as a physical molecule was not reported in the patent, nor did the patent contain detailed directions for doing so.

“Isolated DNA” as construed by Judge Sweet at first instance meant a segment of DNA nucleotides existing free from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome. In their reply brief to the Supreme Court Myriad argued that isolation required separation of the specific DNA of interest from the rest of the DNA in the body and even from the rest of the fragmented DNA that might be present in a test tube outside the body. In their subsequent respondent’s brief Myriad argued that the specific isolated BRCA1 and BRCA2 molecules, once defined, are either separated from surrounding genomic and cellular matter at precise locations chosen by the Myriad inventors or assembled in a laboratory in the case of cDNA.

If Myriad were arguing that their BRCA1 patent described the separation of wild-type BRCA1 at precise locations of their choice, then my understanding is that argument is based on falsehood, which it appears was detected both by Judges Moore and Bryson in the Federal Circuit and by Justice Thomas in the Supreme Court who was well aware of the limitations of what had been disclosed in the patent and alluded to those limitations in his opinion.

The point, in my view, is not a question whether the disclosure of the BRCA1 patent sufficed under 35 USC 112 to support a claim to the wild-type gene (which I suggest is not proven) but whether Myriad's representatives insofar as the disclosure of the patent was concerned were presenting a falsehood to the Court which I think they were. Non-technical judges may not fully understand molecular biology, but they are good at detecting falsehood when they see it and did so here.

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