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Supreme Court Remands In Myriad Appeal

Monday, March 26th, 2012

Today, as predicted by many commentators, the Supreme Court set aside the ruling by the Fed. Cir. that claims to isolated DNA sequences that are the BRCA 1 or 2 gene, or fragments thereof, are patentable subject matter. The Supreme Court ordered the Fed. Cir. to reconsider its 2-1 panel decision in view of its recent opinion in Prometheus that assays to optimizing drug efficacy based on measuring metabolite levels were no more than attempts to patent natural phenomena.

It is not entirely clear what guidance the Prometheus opinion provides for the appealed DNA claims in the Myriad decision. After all, the claims closest to the invalidated Prometheus claims were the claims to a method of locating mutations in a subject’s BRCA DNA by comparing it to a benchmark, or wild-type BRCA sequence. In the Supreme Court’s opinion, Justice Breyer contrasted the claims at issue with claims to a new compound:

 “Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the [Promethus claims] do not confine their reach to particular applications of those  [natural laws].”

To invalidate claims to isolated DNA sequences, the Fed. Cir. and the Supreme Court would have to specifically interpret Chakrabarty to require that, to be “new” under section 101, a compound must exhibit a utility not possessed by the compound pre-isolation, even if the compound pre-isolation is structurally different than the compound post-isolation.  If the Fed. Cir. were simply to rely on In re Bergy, as I and others have suggested in previous posts on Myriad, it is difficult to imagine the Fed. Cir. reversing itself on this issue.

Even if gold in a streambed is not different from gold in a Krugerrand, isolated DNA in a “test tube”  is different from a DNA sequence that is one part of chromosomal DNA. However, the Supreme Court just added a “something more” requirement to a claim to optimizing a drug regimen, and the Court may be poised to put a “something more” requirement on a structurally novel chemical compound. I just hope that if the judges or justices go down this path, and hold that isolated DNA is a “natural product,”  they give us some hint of how to meet the “something more” requirement, going forward. They might also consider what “going forward” means.

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Supreme Court: Evidence Of Invalidity Must Be “Clear And Convincing”

Friday, June 10th, 2011

On June 9, 2011, the Supreme Court rejected Microsoft’s contention that a preponderance of the evidence should be sufficient to establish patent invalidity in an 8-0 (Roberts abstained) opinion, which affirmed the Fed. Cir.’s opinion (for a change). (The decision can be found at the end of this post.) The Court interpreted Congress’ intent in 35 USC 282 to preserve the presumption of validity of a patent claim unless an attacker can meet the burden of presenting “clear and convincing” evidence of invalidity.

The Court also rejected the notion that some sort of “fluctuating standard of proof” should apply in situations in which the evidence relied upon was not considered by the PTO during prosecution. Even if the primary rationale behind the clear and convincing standard, that the PTO applied its expertise correctly, “seems much diminished’ (citing KSR 550 US 398), the Court held that Congress “codified the common-law presumption of patent validity and, implicitly the heightened standard of proof attached to it” and that standard of proof must still be met. The Court suggested that, in such cases, the jury could be instructed that it could give weight to the fact that the evidence before it is “materially new” when determining if clear and convincing evidence of invalidity had been presented.

See my post of March 25 on this case

10-290_supremecourt_microsoft

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Federal Court Hears Myriad Gene Case This Morning

Tuesday, April 5th, 2011

The following is a guest post from Professor Ann McCrackin. 

I attended oral arguments at the CAFC on Monday for Association for Molecular Pathology v. Myriad Genetics, Inc.   The three-judge panel included Judge Bryson, Judge Lourie and Judge Moore.  Most of the questions came from Judges Bryson and Moore.  The arguments were directed to three issues:  jurisdiction, patent eligibility of the composition-of-matter claims, and patent eligibility of the method claims.

Myriad’s attorney, Gregory Castanias, argued that there was no case or controversy for declaratory judgment jurisdiction.  Judge Moore seemed troubled that the District Court’s standing criteria would allow consumers to challenge patents just because they desired a cheaper product.  On the merits, Castanias argued that  isolated DNA is structurally distinct from naturally occurring DNA and therefore does not exist in nature.  Judge Bryson asked whether Myriad’s claims would cover the entire human genome.  Judge Moore noted that the claims do not cover the entire chromosome, but wanted to know how isolated DNA is different from a mineral which is extracted from a rock.   Judge Lourie noted that a gene is structurally different when it is isolated, but a mineral is not structurally different when it is removed from the rock.  Castanias also argued that the method claims are patent-eligible, but was questioned by Judge Lourie regarding whether the steps of “comparing” in the claims were just a thought process.  Castanias also mentioned the Federal Circuit’s post-Bilski decision in RCT v. Microsoft.

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Microsoft V. i4i – Prosecution And The “Variable Proof Regime”

Friday, March 25th, 2011

The Government recently weighed in on this important appeal with its amicus brief, signed by Neal Katyal, Acting Solicitor General. (A copy can be found at the end of this post.) The question posed is simply: “Whether, when the defendant [here Petitioner i4i] in an infringement suit asserts as a defense that the relevant patent is invalid, the defendant must prove invalidity by clear and convincing evidence.”

The major portion of the brief argues “clearly and convincingly” that both precedent and legislative history compel a finding that the clear and convincing (C&C) standard is the appropriate burden of proof for the defendant to meet, even when the defendant introduces evidence of invalidity that was not before the PTO during the examination process – even though the new evidence may “carry more weight and go further toward sustaining the attacker’s unchanging burden.” American Hoist & Derrick Co., 725 F.2d 1350, 1360 (Fed. Cir. 1984).

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