Posts Tagged ‘biotechnology law’

USPTO Forum to Discuss the Guidance on Subject Matter Eligibility of Claims Reciting Laws of Nature

Wednesday, April 16th, 2014

On May 9th the Patent Office is hosting a forum to receive public feedback from organizations and individuals on the “Guidance”(link below). As followers of Patents4Life are well aware, I have not been shy in posting my opinions regarding patenting inventions based on a number of the “Laws of Nature.” Below is my attempt to summarize some of the points of my commentary as written feedback to the PTO. If you invent or prosecute in this arena, you are already aware that Examiners are locating laws of nature, natural products, etc. in claims of all sorts, stripping away the other claim elements as conventional procedures and rejecting the claims as attempts to monopolize “natures handiwork.”

The Guidelines Contravene Decisions of the Fed. Cir./CCPA That Should Guide the Patenting of “Natural Products”

The extension of the Myriad Supreme Court decision barring patents on fragments of DNA isolated from the human genome did not require the formulation of PTO Guidelines barring patents on “Natural Products” unless they are structurally altered from their condition in nature (e.g., in their natural source). In re Bergy and In re Bergstrom make it clear that isolation alone can impart s.101 novelty to natural products that are isolated and purified from their natural sources. (Bergy is precedential, Judge Lourie’s opinion notwithstanding, as can be ascertained from the description of the history of the Bergy and Chakrabarty cases as it is reproduced in Chakrabarty. What the Office should be “measuring” in the extent in change in physical properties and/or practical utility that results from the isolation/purification. A gold nugget may be minimally changed from its physical properties and/or practical utility when it is panned out of a stream. However, the microorganisms in question in Bergy and the prostaglandins in Bergstrom were of no practical use in their natural state, but became valuable biofactories or drugs following extraction and purification. (The ACLU also conceded that the isolation of a drug that occurred in a very low concentration in a tree could render it patentable, since a controlled dosage could be given.)

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Cert. Granted In Teva V. Sandoz (“April Fool” Lightning Ballast!)

Wednesday, April 2nd, 2014

On Monday, the Supreme Court granted cert. in the somewhat overlooked panel decision, Teva Pharm., Inc. v. Sandoz, Inc., 727 F.3d 1363 (Fed. Cir. 2013)(Sup. Ct. 13-854) (a copy can be found at the end of this post). Most commentators had predicted that the Supreme Court would review the en banc decision in Lightning Ballast, but it is not to be.

The panel, Judge Moore writing (who at least has taken some chemistry courses), reviewed a district court decision that had found two groups of claims from eight Teva patents on Copaxone valid. Defendants in this Hatch-Waxman litigation had argued that both the Group I and Group II claims failed s.112(2) as insolubly ambiguous due to multiple definitions of the molecular weight in the specification. The district court, construed the term “molecular weight” as determined by a single methodology and so disagreed as to both sets of claims.

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USPTO s.101 Guidelines – How to “Eviscerate Patent Law”

Thursday, March 27th, 2014

On March 19th, the USPTO released 93 slides as training materials to help Examiners navigate the lengthy ”Guidelines for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature,” et al. (A copy of the slides is available at the end of this post.) Although multiple law review articles and blog posts will surely be written about various features of these Guidelines and Training Materials, I would like to focus, fairly briefly I hope, on the two most ambitious, and egregious aspects of these materials.

The first is the unprecedented (literally) expansion of the definition of “natural product” to require that the claimed natural product must be structurally different from the product as it occurs in its natural source, and not simply be functionally changed or improved. See, e.g., slides 48-56. This heightened patent-eligibility requirement appears to have been extracted from Chakrabarty, which described the altered bacterium as having “markedly different characteristics from any found in nature, and one having the potential for significant utility.” However, I don’t see any requirement that the new bacterium be markedly structurally different than its naturally occurring cousins. In Myriad, the isolated genomic DNA was unquestionably structurally different, but the Court based its holding on its opinion that its primary data storing and transmitting properties were unchanged. The Court minimized the import of the structural changes: “Myriad’s claims…[do not] rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”

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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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