Everything Compliance-Episode 63, the Novartis edition
Episode 150 -- Novartis Settles False Claims Act and Anti-Kickback Cases for $729 Million
Daily Compliance News: July 2, 2020-the Novartis Pays More edition
Compliance into the Weeds: Episode 178-the Novartis FCPA Enforcement Action
Episode 148 -- A Review of the Novartis and Alcon FCPA Enforcement Action
On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more
Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., Appeal No. 2018-2273 (Fed. Cir., April 23, 2020). Argentum and other petitioners filed IPRs against Novartis’ patent related to methods of treating...more
Addressing issues of procedural due process and obviousness, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision to invalidate a patent in an inter partes review (IPR),...more
Addressing issues of motivation to combine and whether the Patent Trial and Appeal Board (PTAB) is bound by district court decisions of obviousness, the US Court of Appeals for the Federal Circuit found that the PTAB is not...more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Alcon Research, Ltd. PTAB Petition: IPR2017-01053; filed...more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Mylan Pharmaceuticals, Inc. v. Cosmo Technologies Ltd. PTAB Petition: IPR2017-01034; filed...more
Parallel District Court and PTAB Proceedings - In Douglas Dynamics, LLC v. Meyer Prods. LLC, No. 3:14-cv0886-JDP (W.D. Wis. April 18, 2017), the district court for the Western District of Wisconsin drew a clear line...more
On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were...more
In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more
Can a prior art reference that does not contain a teaching sufficient enough to allow it to be used in an obviousness combination nevertheless be used as a background reference for evidence of motivation to combine? ...more
As we have previously discussed on this blog, when considering an issue of patentability such as definiteness under section 112, the PTAB and a district court may properly reach opposite conclusions. In Tinnus Enterprises LLC...more
The Federal Circuit affirmed the PTAB’s final written decisions holding that claims directed to Novartis’s dementia drug compositions containing Exelon were obvious in Novartis AG v. Noven Pharm. Inc., No. 2016-1679 (Fed....more
About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more
The Federal Circuit affirmed the PTAB’s final written decision holding that claims directed to Novartis’s multiple sclerosis drug Gilenya were obvious in Novartis AG v. Torrent Pharmaceuticals. Ltd., No. 2016-1352 (Fed. Cir....more
The US Circuit Court for the Federal Circuit issued an important decision last week regarding the interplay of court litigation and inter partes reviews (IPRs) at the US Patent and Trademark Appeals Board (PTAB) on the issue...more
In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more
Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more