Archive for the ‘Obviousness’ Category

In re NuVasive, Inc. – Explain Yourself!

Monday, December 12th, 2016

In re NuVasive Emphasizes the Importance of Reasoning in the Obviousness Question.

Business Man Holding Contract Agreement Vector Illustration Signed Treaty PaperSince KSR, 127 S.Ct. 1727 (2007), repudiated as “rigid and mandatory” the Federal Circuit “rule” for obviousness –  that the prior art must provide a teaching, suggestion or motivation (TSM) to combine references so as to arrive at the claimed invention. Since then, it is my opinion that reliance on secondary considerations to support obviousness determinations has steadily increased. Such considerations include unexpected results, long-felt need, failure of others, teachings away from the invention, commercial success and the like. Likewise, Examiners have increased their reliance on factors such as common sense and routine optimization.

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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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