Will The Celsis Appeal Put An End To 101 Rejections Of Laboratory Method Claims?

On April 5, 2016, the Federal Circuit heard oral arguments in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., where the U.S. District Court for the Northern District of Illinois held invalid claims directed to a “method of producing a desired preparation of multi-cryopreserved hepatocytes.” While it is never a safe bet to predict the outcome of an appeal based on the judges’ comments at the oral hearing, the Federal Circuit judges hearing this case appeared to have little patience for the application of Mayo to the type of method claims at issue. Continue reading this entry

Amneal's IPR Challenge Of The Jazz Xyrem + Valproate Patent

In decisions dated April 12, 2016, the USPTO Patent Trial and Appeal Board (PTAB) denied institution as to claims 1-18 of Jazz’s U.S. Patent 8,772,306, finding that neither Ranbaxy Inc. nor Par Pharmaceutical, Inc. had shown a reasonable likelihood of establishing obviousness. Amneal Pharmaceuticals LLC also has filed a petition for IPR of the ‘306 patent. Will the PTAB find its petition more convincing?  Continue reading this entry

Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute proceedings for claims 19-34 of the ‘306 patent, claims 1-18 may be more relevant to the Xyrem® prescribing information, and may present a more significant hurdle to generic competition seeking the same labeling.   Continue reading this entry

Court Can't Review Policy Behind Patent Term Adjustment Statute

In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon which relief could be granted. Ms. Singhal challenged the “RCE carve-out” on policy grounds, but federal courts lack authority to re-write statutes on that basis. Continue reading this entry

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35 USC § 101. Although Judge Dyk found the claims at issue to be similar to claims held invalid in other Federal Circuit decisions, the finding in Genetic Technologies Ltd. v. Merial LLC seems to go one step further down the road of ineligibility. Continue reading this entry