Archive for the ‘Litigation Issues’ 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…)

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

Tuesday, 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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Apotex v Wyeth Explores Structural Obviousness

Thursday, September 1st, 2016

Lately, I’ve been feeling that the only case law engaging enough to write about has involved S. 101 issues, so it was a welcome break to comment on some classic principles of organic chemistry.

iStock_000002291402Small(2)Apotex filed an IPR petition that Wyeth’s U.S. Patent No. 8,879,828 was obvious in view of four references. The Board granted the petition but went on to find that the antibiotic compositions claimed in the patent were not obvious. The Fed. Cir. agreed that the Board’s final decision was supported by substantial evidence  (Appeal No.  2015-1851 (Fed. Cir., August 6, 2016)  —Judges Lourie, Wallach and Hughes, Lourie writing).

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Limelight Networks v. Akamai Tech. – Cert. Denied

Monday, April 18th, 2016

Today the Supreme Court declined to hear Limelight’s petition for cert. on the question of whether an accused infringer may be held liable for direct infringement of a claim to a method where multiple parties perform the steps of the method.

On August 13, 2016, the S. Ct. remanded the en banc decision of the Fed. Cir. that set forth the law of divided infringement under s. 271(a), and found that Limelight directly infringed U.S. Pat. No. 6,108,703. The court held that an entity will be found responsible for others’ performance of method steps “(1) where that entity directs or controls others’ performance, [or] (2) where the actors form a joint enterprise.”  (more…)