Posts Tagged ‘biotechnology’

New (and Improved?) PTO Guidelines on Biotech Patent-Eligibility

Friday, May 6th, 2016

new-improved-means-development-to-upgrade-product_f1xCRmPdThe PTO has released a new set of life sciences’ examples to teach Examiners how and when to reject claims and, hopefully, teach the patent bar how to write allowable claims. (A copy if found at the end of this post.)

The Guidelines have examples on vaccines, diagnostics, methods of medical treatment and BRCA-type Myriad claims. There are some surprises. Although Ariosa was decided about a year ago, the Guidelines approve of a claim to detecting a marker indicative of a certain disease by detecting whether the marker is present when a plasma sample is contacted with an anti-JUL-1 antibody and detecting any binding (e.g., an ELISA-type assay). The Guidelines justify this position by noting that the steps do not recite any recognized exceptions to s. 101, citing Mayo. This hypothetical claim could have come from Ariosa, which the Office must have made a hard decision to ignore.

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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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