Archive for the ‘Obviousness’ Category

NOVARTIS A.G. v. UOI – What is Novelty in Indian Courts?

Monday, April 8th, 2013

Can everything old be made new again?  Lots has been written about the Indian Supreme Court rejecting a patent application claiming a crystal modification of imatinib mesylate (Gleevec), which is used to treat CML.  Novartis’ attempt to “evergreen” Gleevec with this patent – which will not expire until May of 2019 – failed in India.  I think the below linked newsletter account of the rationale of the court, from Lakshmikumaran & Sridharan, a leading Indian law firm, is the best I have encountered so far, so I won’t try to summarize it.

IPR Amicus Newsletter


Otsuka v. Sandoz – Motivation Trumps Structure

Wednesday, May 9th, 2012

The recent decision of the Fed. Cir. in Otsuka v. Sandoz, App. No. 2011-1126, -1127 (Fed. Cir. May 7, 2012) continues the courts admirable work in defining obviousness post-KSR. This case revisits the standards involved in making out a prima-facie case of structural obviousness. What is particularly interesting in this decision is the weight – or lack thereof – that the court gave to evidence of therapeutic utility of the closest prior art compound. In fact, the court applied the fairly obscure maxim of patent law articulated forty years ago In re Steminski, 444 F.2d 581 (CCPA 1971). John L. White, in Chemical Patent Practice, summarized the holding of Steminski as part of his discussion of the “Hass-Henze Doctrine”:

“The [CCPA] concluded that because the characteristics normally possessed by members of a homologous series [e.g., differing by only one methylene group] are principally the same, varying gradually from member to member [e.g., methyl, ethyl, propyl, butyl, etc], chemists knowing the properties of one member of a series would in general know what to expect in adjacent members so that a mere difference in degree is not the marked superiority which will ordinarily remove the unpatentability of adjacent homologs of old substances. Contra, where no use for the prior art compound is known [citing Steminski].”


Eurand v. Mylan –A “School Of Obviousness”

Friday, April 20th, 2012

How to teach preschool children/>When I read the April 16th decision (App. No. 2011-1399, -1409 (Fed. Cir. April 16, 2012)) (a copy is available at the end of this post) in which a Fed. Cir. panel of Newman, O’Malley and Reyna reversed a district court’s finding that two Aptalis patents on a controlled-release form of a muscle relaxant were obvious, I expected a routine recitation of the KSR “standards” and not much more. Therefore, I was pleasantly surprised to find that Judge O’Malley had authored one of the clearest and most thorough explications of the obviousness inquiry that I have ever read in an opinion. Every patent attorney should read this decision and so should every examiner.

The claims in question are thick with “pharmacokinetic values” and the question confronted by the court was whether or not it would have been obvious to “ascertain the correct pharmacokinetic/ pharmacodynamic (‘PK/PD’) profile” wherein the “determination of a PK profile is a quantitative exercise. The determination of PD, or therapeutic effectiveness, however is a qualitative exercise.” Of course the holding was ultimately “no,” and the panel may have been a bit snowed by the technical arguments, but the explanation of the s. 103 standards mandating reversal are what gives this opinion its force.


Obviousness Objections Based On Combinations Of References – Consistent Warnings From The CAFC

Wednesday, August 31st, 2011

By Paul Cole, Professor of Intellectual Property Law, Bournemouth University; Lucas & Co, Warlingham, UK

Those prosecuting patent applications before the USPTO, the EPO and other examining patent offices confront on a daily basis objections of the kind: “A is known from X, B is known from Y; there was no invention in combining A with B.” Such objections are time-consuming to counter and often seem to a prosecuting attorney and his or her client less than reasonable. A sequence of recent decisions from the CAFC provides a clear indication that objections of this kind are being made too freely and too often.

In re Arnold G. Klein decided 6th June 2011 was a unanimous opinion of Judges Newman, Schall and Linn. It concerned a jug for mixing nectar having two compartments separated by a movable divider. Sugar (presumably in granular form) could be placed in one compartment and water in the other, after which the divider could be removed and a correct mixture for hummingbirds and other specific creatures that it was intended to feed could be obtained. The USPTO Appeal Board held that the claimed subject matter lacked inventive step having regard inter alia to various primary references disclosing office drawers with movable partitions using as secondary reference admitted knowledge in the prior art of the appropriate sugar to water ratios for the creatures that it was intended to feed. The CAFC unequivocally rejected the cited primary references as analogous art on the ground that they were neither within the field of endeavour of the invention nor reasonably pertinent to the problem with which the invention was involved. In a footnote the Court rejected the proposition that the problem with which the inventor was concerned could be arbitrarily redefined to support an obviousness rejection and went on to comment that: