USPTO Patent Eligibility Guidelines – A Step Too Far For Natural Products?

March 7th, 2014

Guest Post from Paul Cole, Lucas & Co., UK

New Prometheus/Myriad guidance appeared on the USPTO website on 4March under the weighty title 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products. A profound, and it is submitted unjustified, change is introduced in Example B of that guidance which concerns chemical substances purified from nature.

In 1900 Dr Jokichi Takamine succeeded in isolating and purifying adrenalin in fine crystalline form from the adrenal glands of sheep and oxen, for which he was granted US Patent 730176 in June 1903. The new product was said to be storage stable when dry and when injected into an animal to bring about a rise in blood pressure. A number of product claims were granted of which the following is representative:

“A substance possessing the herein described physiological characteristics and reactions of the suprarenal glands, having approximately the formula C10H15NO3 and having an alkaline reaction.”

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PTO Releases Guidelines On Patenting “Natural Phenomena And Natural Products”

March 6th, 2014

On March 4, 2014, Andrew Hirschfield, the Deputy Commissioner For Patent Examination Policy, released a “Memorandum” entitled “Guidance for Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” in view of the Myriad and Mayo (“Prometheus”) Decisions. (A copy is available at the end of this post.) The Guidance is intended to “assist examiners in determining whether a claim reflects a significant difference from what exists in nature and thus is [101] eligible, or whether a claim is effectively drawn to something that is naturally occurring, like the claims found ineligible by the Supreme Court in Myriad.” The Guidelines include a number of examples, including the analysis that is to be followed in deciding if they meet or do not meet the exceptions to s. 101.

The Guidelines do not apply to the examination of claims reciting an abstract idea, which are to be analyzed using MPEP c. 2106(I). However, the examples in these Guidelines include the analysis that Judge Lourie applied to conclude that claim 1 of the Myriad ‘857 patent was patent-ineligible as an abstract idea. Interestingly, these Guidelines do not include an analysis of claim 2 of the ‘857 patent which was directed to a method for diagnosing a predisposition to develop cancer by comparing the sequence of a subject’s BRACA1 DNA to a reference sequence and determining if there were alterations in the subject’s DNA sequence. The Office seems to want to ignore not only that “comparing and concluding claim” but also do not provide an analysis of any simple “If marker A, the disorder B” claim, such as the claim analyzed, and found wanting by Justice Breyer in the “Metabolite Dissent.” (Judge Rader’s criticism of that “dissent” is reproduced in my recent post noting the 5th birthday of this blog.)

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Happy Birthday To Us – Patents4Life Is Five!

March 4th, 2014

Which actually seems a bit surprising, since this life sciences blog is pretty much the observations of one patent attorney – me -  on developments in IP law. I do want to take the time to thank my fairly regular guest commentators – particularly Stephan Danner, Bill Bennett, Ron Schutz and Paul Cole.  But, apart from Bryan Ness and Mary Hirsch here at SLW, who do a great job of getting posts up there quickly, often before some of “bigger” blawgs can react, I am pretty much the only “journalist”—as one young interviewer called me—on the staff.

I was thinking of how to summarize the last half decade of IP law in a few paragraphs, but it’s really not possible. Most of the important judicial decisions, as well as the AIA, have amounted to cut-backs – or at least, sequestrations – of patent rights. I think that the PTO does not want to be judged or legislated out of business, and I have to give them credit for not over-reacting to largely policy driven decisions like Bilski, Mayo, and Myriad. But give a workman, or a bureaucrat, a new tool and they are probably going to use it. Ariad is such a tool and both the PTO and the courts have been using the WDR like Thor’s hammer to crush patents with both “mechanism of action” claims and ill-defined elements. Of course, a bright spot among this carnage was the Thersense decision that obliterated Rule 56(b) – but where are the final rules? The administration of the PTO is on hold as 2014 begins.

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GlaxoSmithKline v. Banner Pharmacaps – Written Description Requirement 101

March 3rd, 2014

In a short opinion dated February 24, 2014 (App. Nos. 2013-1593, -94, -95, -98), a Fed. Cir. panel made short work of the defendants’ attempt to invalidate a Glaxo claim in U.S. Pat. No. 5,565,467, to dutasteride “or a pharmaceutically acceptable solvate thereof” on the basis that the term “[dutasteride] solvate” failed to meet the written description requirement (“WDR”). The district court construed a “solvate” of this steroidal drug to mean “a complex formed by dutasteride in which dutasteride is reacted or from which it is precipitated or crystallized.”

While the parties agreed that dutasteride “is the molecule identified before ‘or a pharmaceutically acceptable solvate thereof’,” the panel noted that the defendants failed to argue that there was an inadequate description of “pharmaceutically acceptable” – this term had been construed to mean “suitable for use  when administered to the recipient thereof as a pharmaceutical”- and hinted that its ruling might have been different had the defendants adopted this approach, rather than arguing simple lack of an adequate disclosure of enough species to support the genus of dutasteride solvates.

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