Archive for the ‘Obviousness’ Category

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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K/S HIMPP v. Hear-Ware Technologies, LLC – Splitting a KSR Hair

Monday, June 2nd, 2014

In KSR, the Court seemed to encourage the broader use of the “logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference” to resolve the obviousness question.  587 F.3d at 1324. In my opinion, this unleashed Examiners to reject claims as obvious if all or part of the invention “would have been no more than the predictable use of prior art elements according to their established functions.” (Another regular and maddening rejection is that the invention or part of it would be well within the ordinary skill of the art. Even the MPEP rejects this boilerplate as a ground for rejection. See Ex parte Levengood.)

The Board in a reexamination of a hearing aid patent obtained by Hear-Ware found the claims unobvious because HIMPP had not provided evidence that an element in two dependent claims (which seems to be just a plug in connector) were known ‘prior art’ elements.

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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].”

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