Posts Tagged ‘biotechnology news’

Ignorance is Bliss – for Teva

Monday, August 4th, 2014

I did not pay much attention to the fairly recent panel decision in Bristol-Myers Squibb Co. v. Teva Pharma. USA, 757 F.3d 967 (Fed. Cir. 2014). It seemed like a fairly routine panel affirmance of the district court’s finding that Bristol-Myers’ patent (5206244) on the nucleoside analog entecavir was obvious in view of a structurally similar nucleoside analog, 2′-CDG. The unexpected results asserted by B-M had been found insufficient to overcome a strong case of structural obviousness.

But when the IPO made the decision to file an amicus brief supporting B-M’s petition for rehearing en banc, my prep/pros radar sounded a warning and I read both the brief closely and the original opinion more closely. [A copy of the opinion and brief can be found at the end of this post.]

The district court found that the POSA would have been motivated to select 2′-CDG as the closest prior art molecule and to make the relatively small structural modifications required to arrive at entecavir, summarizing the law (correctly): “Obviousness, and expectation of success, are evaluated from the perspective of a person having ordinary skill in the art at the time of invention [e.g., the filing date of the B-M patent].”

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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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