It Isn’t Good: Dx Case Outcomes

October 4th, 2016

slidimageThis is a guest post from Dr. Leslie Fischer.

The following slides are from her presentation at the Bio IP & Diagnostics Symposium.

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

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. Read the rest of this entry »

UCB v. Yeda R&D Co. – No “Safe Harbor” for Unamended Claims

September 20th, 2016

Ugavel3CB sued Yeda for a DJ of non-infringement of US Patent No. 6,090,923 [Appeal No. 2015-1957 (Fed. Cir. September 8, 2016)].The main claim in question was directed to “A monoclonal antibody which specifically binds a human cytotoxin [having X properties].” The specification only disclosed murine Mabs (the priority document was filed in 1984). During prosecution, Yeda had limited the claims to murine Mabs, and then later removed that limitation.

The Examiner rejected that claim as non-enabled as to the different species that were encompassed. Yeda argued that the claim should be read to encompass humanized and chimeric Mabs and put in a declaration that other species could be used to obtain the Mabs. The Examiner withdrew the non-enablement rejection but rejected claims that recited chimeric Mabs as unsupported new matter.

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McRO v. Namco – Fed. Cir. Reverses s. 101 Invalidation of Animation Method Patents

September 16th, 2016

I firsAnimated Moutht posted on this case in September 2014, and urge you to find the post and the district court’s opinion in the Archives. It provides a good – well, adequate– description of the patented technology, which is a method to automatically animate lip synchronization and facial expression of 3D animated characters. This art area has as much jargon as biotech, and I am not going to try to explain what a morph target, a phoneme or a visme is. The claimed method, which used pre-set “rules” to get animated characters to speak with the appropriate facial expressions, was certainly a great advance over using artists to adjust these activities by hand across a wide range of facial expressions and voices.

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