Archive for the ‘Obviousness’ Category

Vanda v. Roxane Labs. – Are Two Natural Laws Better Than One?

Monday, September 26th, 2016

iStock_000007770475_SmallAs you will recall, in Prometheus v. Mayo, the Supreme Court held that a claim reciting a natural law had to have other non-conventional steps to pass muster under s. 101. The natural law in Mayo was the correlation between the concentration of the metabolite of the immunosuppressive drug and the efficacy of the drug – unpleasant side effects at the high end of the recited range and lack of efficacy at the low end. The Mayo Court wrote: “We need not, and do not, decide whether were the steps at issue here less conventional, these features of the claims [the administering, determining and recognition steps] would prove sufficient to invalidate them.” It was unnerving that the invalidated claims were method-of-treatment claims.

In his opinion in a Hatch-Waxman litigation involving the anti-schizophrenia drug Iloperidone, Vanda Pharms., Inc. v. Roxane Labs., Inc., Civil Action No. 13-1973-GMS; 14-757-GMS (D.Del., 2016), Judge Sleet upheld the validity  of the compound and the method claims in Reissue Patent No. 39,198 and US Patent No. 8,586,610. (more…)

D. Mass Court Extends Myriad to Peptide Panels

Tuesday, September 6th, 2016

Bacterial infection tuberculosisIn a great leap backwards for patenting life sciences, Magistrate Judge Cabell invalidated claims in a number of patents licensed to Oxford Immunotec that are directed to e.g., “A kit for diagnosing infection in a human host by, or exposure of a human host to, a mycobacterium that expresses [protein/antigen] ESAT-6 comprising a panel of eight [ESAT-6 peptide fragments] represented by SEQ ID NOS 1 to 8.” (U.S. Pat. No. 7,632,646).

The Report was issued on August 31, 2016, in Action No. 15-cv-13124-NMG in Oxford Immunotec, Ltd. v. Qiagen, Inc. et al.

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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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