Posts Tagged ‘biotechnology news’

USPTO Guidelines Blur “Natural” And “Novel” Products

Friday, March 21st, 2014

I seldom comment on fellow bloggers’ posts, but Kevin Noonan’s recent article in PatentDocs deserves some attention. He basically has taken the recent PTO Guidelines to their “logical” extreme. The Guidelines contain an example that suggests that the Myriad ruling should be applied to “natural products” other than isolated pieces of genomic DNA. In Kevin’s view the roof has fallen in on isolated, purified natural products of any kind. In other words, if a substance like insulin or quinine occurs in nature so that its isolation does not change its chemical formula, it is not patent eligible. To be fair, the example directs examiners to reject claims to natural products, such as “purified amazonic acid” since “there is no structural difference between the purified acid in the claim and the acid in the leaves [of the tree from which it is obtained].”

That simplistic standard, if taken to its extreme would, as Kevin writes, render almost any purified natural product patent ineligible. But there are some brakes that can be applied to halt this runaway train of rejections. As Hal Wegner has argued in detail, In re Bergy, 596 F.2d 952 (1979) was never vacated or reversed by the Supreme Court when it took up Chakrabarty. After the holding of Bergy was reaffirmed by the CCPA in a consolidated decision with Chakrabarty, the Commissioner sought certiorari, and the writ was granted as to both cases. Before the decision, Bergy was dismissed as moot “leaving only Chakrabarty for decision.” 447 U.S. at 306. Judge Lourie’s analysis of the posture of Bergy in the August 16th Myriad decision (fn. 11) is just incorrect. Bergy is precedential; the second CCPA decision was not vacated by the Supreme Court.

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

Thursday, 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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Stories I Missed In 2013

Thursday, January 16th, 2014

Some IP Stories Do Not Have Much “It” Factor.  Just like there used to be, and I guess still are, “It Girls” in showbiz and fashion, there are “It Issues” in IP law. I know these decisions/controversies are very important to the parties involved, but I just couldn’t get enthusiastic about these stories. However, since you may wish to investigate them further, I thought I would send out a short list.

1.  The legality of Michelle Lee’s appointment as Acting Deputy Director of the PTO (or whatever her title will turn out to be). More interesting would be the story of why Terry Rea was not offered the position (if she even wanted it).

2.  What “and/or” means in a patent claim. Although the PTO usually does not object to its use, it is probably better to write something like “at least one of A or B”, or “A or B or a combination thereof”.

3.  In case you have not noticed, prosecution history estoppel can limit the scope of a design patent. ‘Nuff said.

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Senator Leahy Urges NIH to Exercise “March-in” Rights on Myriad’s Tests

Wednesday, July 17th, 2013

The Bayh-Dole Act of 1980 grants universities the right to elect to take title in any patent application and patent that was made by their researchers with the support of the Government, e.g., NIH. 35 USC s. 200 et seq. This clears the path for universities and other non-profit institutions to license the patents, potentially exclusively, to commercial entities (like big Pharma) that, hopefully will fund further research and eventually bring a drug to market. Prior to 1980, the Government kept title, and was responsible for licensing such technology. However, due to a lack of resources and red tape, most Government-funded inventions never saw “the light of day.”

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