In an IPR on remand from the Federal Circuit on appeal of a motion to amend, the PTAB considered the scope of briefings of the parties in view of the Federal Circuit’s recent en banc decision Aqua Products v. Matal. The PTAB ordered that the remand be limited to the Federal Circuit’s remand instructions on reevaluating the original PTAB decision, without reconsidering all issues overturned in Aqua Products.

On April 2, 2018, Irish biotech Alkermes revealed that it had received a Refusal-to-File letter from the FDA regarding its depression drug ALKS 5461.  The announcement caused Alkermes shares to drop 22.4%, and adversely affected the performance of biotech stocks and exchange-traded funds on Monday.[1]

Before Newman, Clevenger, and Wallach.  Appeal from the Patent Trial and Appeal Board.

Summary: The USPTO has standing to intervene to defend its decision, even when the requestor has withdrawn.

The PTAB ruled that the Saint Regis Mohawk Tribe could not assert sovereign immunity in IPRs of patents that Allergan had assigned to the Tribe relating to Restasis®.  See The Saint Regis Mohawk Tribe is not entitled to Sovereign Immunity at the PTAB. Following the PTAB’s dismissal of the Tribe’s sovereign immunity defense, the Tribe filed a notice of appeal and request to the PTAB to stay the IPR proceedings.  IPR2016-01127, Paper 134 (PTAB March 8, 2018).  The Tribe argued that its appeal divested the PTAB of jurisdiction.  Id. at 3-7.  The PTAB denied the Tribe’s motion to stay and stated that the Tribe’s interlocutory appeal does not divest the PTAB of jurisdiction, because the IPR proceedings can proceed against Allergan alone.  IPR2016-01127, Paper 137 at 4 (PTAB March 22, 2018).  The Tribe then filed a motion with the Federal Circuit to stay the IPR proceedings.

Before Lourie, Reyna, and Taranto.  Appeal from the Patent Trial and Appeal Board.

Summary: A prima facie case of obviousness is established where the claimed range abuts a range disclosed in the prior art and there is no evidence of a meaningful distinction between the two ranges.

Before O’Malley, Plager and Taranto. Appeal from the U.S. District Court for the Northern District of California, Judge William H. Alsup.

Summary: Historical findings of fact relevant to copyright fair use can be resolved by a jury, but the district court must resolve all inferences drawn from those facts and the ultimate conclusion of fair use. 

Before Newman, O’Malley, and Reyna. Appeal from the Patent Trial and Appeal Board.

Summary: When resolving an obviousness challenge, the PTAB cannot invoke “ordinary creativity” of a skilled artisan to supply a missing claim limitation, without reasoned analysis and evidence.

On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a subject’s risk of developing specific cancers. 23andMe already sells diagnostic kits by mail that determine a variety of gene profiles from a consumer.

Lundbeck Pharmaceutical Company, headquartered in Denmark, recently announced the acquisition of Prexton Therapeutics B.V. for $1.1 billion (U.S.)[1].  Lundbeck is a publicly traded company focusing on psychiatric and neurological disorders[2]. 

Before Moore, Reyna, and Taranto.  Appeal from the Patent Trial and Appeal Board.

Summary: A party in an inter partes review proceeding may not present new evidence or arguments at oral argument.