Posts Tagged ‘biotechnology news’

FDA Accepts First Biosimilar Application for Review

Monday, July 28th, 2014

In an important step forward for the introduction of “generic biological,” the FDA announced that it has accepted Sandoz’s application to market a generic version of Amgen’s Neupogen®, which stimulates white blood cell production. As you may recall, about two years ago, the FDA was authorized to permit generic biologicals in a section of “Obamacare” (the Affordable Care Act), but final rules have not yet been promulgated. Since Neupogen is not “under patent” or NCE exclusivity in the U.S. this can roughly be analogized to a Para. III ANDA filing. With many other applications in progress, we will have to see how rough this gets.

Read more here.

PTO s. 101 Forum – Thumbs Down on Practitioners

Monday, May 12th, 2014

The USPTO held a four hour public forum on the new, disruptive s. 101 examination guidelines on Friday afternoon. The forum featured ten speakers from the patent bar, including Hans Sauer of BIO, Leslie Fishcher from Novartis, Barbara Fiacco (for the AIPLA), Greg Cox (speaking for the ABA IPL Section) and your truly (speaking out for justice, of course – my slides are attached). There were also three break periods where the studio audience or webinar participants asked questions.

There were brief opening remarks by Deputy Director, Michelle Lee, but the Forum was presided over by Drew Hirshfeld, who is Deputy Commissioner for Patent Examination Policy (He has Steve Kunin’s old job) and who signed off on the Guidelines. Jerry Lorengo, the relatively new Director of 1600 was present, but did not have a big role in the proceedings. Mr. Hirshfeld’s Legal Advisor, Raul Tamayo, made the PTO’s position on compound and composition claims clear: “The Supreme Court has never held that a claim reciting a natural product eligible unless it was structurally different from what occurs in nature.” The PTO clearly intends to fill that gap in jurisprudence, and has taken the position that a functional difference cannot per se meet the requirement for a structural difference.

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Isolated DNA and the “Hand of Man”

Monday, April 28th, 2014

Editors Notes: Apart from a fine survey of the case law on patent-eligibility of not-so natural products, Paul Cole suggests that, in view of the incomplete and/or indirect description of the BRACA sequences that Myriad claimed, there may well be isolated, purified and sequenced fragments of the human genome that would meet the test of being markedly changed in character from their state as a portion of genomic DNA. In other words, perhaps this is not the time to throw in the towel on patenting probes and primers.

Whether or not there is a need for modification of the proposed USPTO natural product eligibility guidelines (a PDF is provided at the end of this post) depends on the interpretation of four Supreme Court opinions, Funk Brothers, Chakrabarty and Myriad which relate to products and Mayo which relates to treatment methods.

Inclusion of an example based on Funk Brothers is arguably unwise having regard to the internal conflicts within the majority opinion, the divisions within the Court and conflict with a number of earlier Supreme Court decisions. The majority opinion is arguably in conflict with Hartranft v.Wiegmann, cited in both Chakrabarty and in Myriad, and supporting the proposition that a product is likely to be regarded as involving human ingenuity if it has been put into a new form and new utility results. The evidential nature of a new effect or result has been known since at least 1822 in Evans v Eaton, see also Webster Loom v Higgins and Carnegie Steel v Cambria Iron, and the primary reason for rejection of that new result evidence in Funk Brothers was on the arbitrary ground, that what had been achieved was “hardly more than an advance in the packaging of inocculants” and a commercial rather than a technical benefit.

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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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