Posts Tagged ‘Myriad’

Justice Breyer to Diagnostic Test Patentees – “Abandon Hope All Ye Who Enter Here.”

Friday, April 29th, 2016

danteKevin Noonan recently posted an article entitled “The Fantastical World of Justice Stephen Breyer” that demonstrates, via Breyer’s quotes during various oral arguments, his suspicion that the patent system is, for example, issuing broad, hard to understand, claims that lead to “national monopolies” and encourage trolls to  harass “small businessmen.” Breyer certainly appears to be leading the court in this area – he authored Mayo after all. No matter what Dr. Noonan thinks about his rhetoric, his anti-patent bias is clear, and has been for some time.

Noonan’s article encouraged me to re-read Breyer’s dissent from the Court’s refusal to decide whether or not the diagnostic claim at issue in Laboratory Corp. of Amer. Holdings v. Metabolite Labs., Inc. was patent-eligible under s. 101. (Breyer’s “Metabolite Labs. Dissent.”) (A copy can be found at the end of this post.) This remand occurred in 2006. The Fed. Cir. was still using the “useful, concrete and tangible result” test of State Street Bank, which morphed into the machine or transformation test by the time Bilski was decided. Both “tests” were urged to be applicable to the diagnostic claim at issue, but Breyer found no transformation recited in the claims and no precedent in the u-c-t test.

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Myriad vs. Mayo – Detection vs. Processing at the Fed. Cir.

Tuesday, April 26th, 2016

iStock_000005967663_SmallRapid Litigation Mgmt v. CellzDirect: Splitting Detection of a Natural Phenomenon from its Application to Yield a Product.

Courtenay G. Brinkerhoff at pharmapatentsblog.com summarized the oral arguments at the Fed. Cir. (App. No. 15-1570) conducted on April 5, 2016 in Rapid Litigation Mgmt Ltd. v. CellzDirect, Inc. (You can download an MP3 of the oral arguments here.) The district court invalidated claims directed to a method for isolating hepatocytes that can survive more than one freeze-thaw cycle as a patent-ineligible law of nature (US Pat. No. 7,604,929):

1.    A method of producing a desired preparation of multi-cryopreserved hepatocytes….comprising:

(A)  Subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,

(B)  Recovering the separated viable hepatocytes, and

(C)  Cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and the second cryopreservations, and wherein greater than 50% of the hepatocytes of said preparation are viable after the final thaw.

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Genetic Technologies Affirms Ariosa/Myriad With An Introduction By The Sequenom Petition for Cert.

Monday, April 11th, 2016

iStock_000067055603_SmallOn April 1st, Lilly filed an amicus brief in favor of Sequenom’s petition for cert. seeking to reverse Ariosa, that caused a lot of buzz in the IP community. (A copy is available at the end of this post.) To summarize, it argued that the courts’ attempts to interpret and define the judicial exceptions to s. 101 patent-eligibility was leading them to an unwarranted expansion of these policy-driven exceptions that threaten concrete technological advances that would otherwise be eligible for patent protection under the patent statute. In other words, the brief argued that the proper application the strictures of ss. 102 (requirement for physicality), 103 (inventiveness), 112(a)(WDR) and (f)(means plus function claiming) are sufficiently developed so that the court should abrogate the judicial exceptions that presently exclude what I will refer to as PAIN (phenomena of nature, abstract ideas and natural laws). (I checked that definition of “abrogate” and it does mean “do away with or to abolish by formal of official means.”)

I have written numerous posts in the last six years about the rise in importance of the written description requirement, as well as the evolution of s. 103 and I am willing to accept Lilly’s arguments. For example, the s. 102 requirement for novelty is sufficient to guard against issuance of patents on natural phenomena like fire, since fire is in the prior art. Pure concepts like blocking the NF-kB signaling  pathway to treat a condition ameliorated by blocking the NF-kB pathway would fail the written description requirement. Mental steps are permissible in a claim, but the claim cannot be entirely mental steps or disembodied functional language (See 112(f)). (This brief is worth reading just for its discussion of the mental steps doctrine at pages 18-21.)

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Patenting “Natural Products” Down-Under Post-Myriad

Wednesday, December 16th, 2015

iStock_000063710003_SmallAlthough the Australian High Court held that claims to naturally occurring DNA (e.g., BRCA1 nucleic acid) were not patent eligible because they were not a “manner of manufacture,” since the encoded information therein was not “made” by human action, in contrast to the USPTO, the Australian Patent Office issued “Examination Practice” guidelines dealing with the requirements to patent products of nature. The Guidelines generally left their Bergy-like examination standards intact outside of the nucleic acid arena. A copy of those guidelines can be found at the end of this post.

Naturally occurring nucleic acid molecules derived from genetic material or synthesized, including fragments thereof like primers, probes and iRNA, as well as cDNA are not patent-eligible since they “merely replicate the genetic information of a naturally occurring organism.”

More encouraging is the reaffirmation by the Australian PTO that “technical subject matter” including recombinant or isolated proteins, pharmaceuticals, methods of treatment and “applications of computer technology” remain patent-eligible, as do plant and microorganisms. The key factor seems to lie in determining whether or not the substance of the claims was “made” – created or modified by human action – or is “artificial.” Merely “artificial” is a bar, but it appears to include inspecting the claim for replicants – Dolly? — or synthetic versions of naturally occurring materials. While the physical difference between the claim and the material in its natural state is one factor to be weighed, the heartening sentence is that “[i]solation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.”

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