Here’s the latest.

Federal Circuit’s O’Malley: Supreme Court doesn’t have stomach for another 101 case

Reported by Richard Lloyd at IAM

In an interview at IPBC Connect, Judge Kathleen O’Malley doubted that the Supreme Court will take up a case to reform the eligibility standard in the near future. Richard Lloyd discusses Judge O’Malley’s remarks which refer to a couple of cases (albeit not by name) that the Supreme Court declined to hear.

“The problem is that between covid, debates on the stimulus, a possible government shutdown before the election and then the election, I am afraid that IP reform is way down to the totem pole for Congress right now,” [Judge O’Malley] commented.

Judge O’Malley also remarked on the ability of patent owners in the United States to obtain injunctive relief. Judge O’Malley points to the Supreme Court decision in Ebay Inc. v. MercExchange, L.L.C. as the reason for the decline of injunctions issued.

“District courts have read it to mean that injunctions should not only not be the norm but should be the rare case and I think we have moved so far away from injunctive relief that we have gutted the system in large measure,” [Judge O’Malley] asserted.

An Argument for Mandatory Production of Limited Secondary Consideration Evidence by Petitioners in Inter Partes Review

Reported by Kristin Doyle at IP Watchdog

The PTAB is not currently required to examine secondary consideration evidence i.e. “evidence of long-felt need, failure of others, unexpected results, commercial success, industry praise, and copying.” In her recent article, Kristin Doyle argues that it should. The Federal Circuit placed extreme value on this evidence in Mintz v. Dietz & Watson, Inc., but patent owners in inter partes review do not get the benefit of a required disclosure of this evidence as a part of routine discovery. Additionally, the PTAB has not often granted requests for this evidence under additional discovery. Doyle ultimately concludes that this evidence should be disclosed as routine discovery.

It seems manifestly unjust that a petitioner can publicly condemn a patent as obvious, yet not be forced to disclose evidence documenting that, behind closed doors, the petitioner behaved in a manner (i.e., copied/applauded the patented technology) that suggests a contrary belief.

What We Learned About Biologics on Summer Vacation

Reported by April E. Weisbruch, Christopher M. Bruno, and Gilbert T. Smolenski at AJMC: The Center for Biosimilars

The Federal Circuit issued opinions in three cases concerning biologics over the summer. April E. Weisbruch, Christopher M. Bruno, and Gilbert T. Smolenski review these opinions and other trends in biologic litigation and regulation. In Baxalta Inc. v. Genentech, Inc., the Federal Circuit confirmed that common terms will receive broad constructions in patent claims. In Immunex Corp. v. Sandoz Inc., Immunex almost invalidated their own patent portfolio by licensing related patents through the doctrine of statutory double patenting (meaning a patent is invalid if it covers identical subject matter to another patent owned by the same entity). However, the Federal Circuit ruled that the original patent owner retained the right to sue which indicated that Immunex was not the rue owner. Forthcoming regulation from the FDA may also change the landscape of the licensure of biologics and subsequent litigation.

From basic statutory interpretation to antitrust issues, the legal and business landscape for biologics continues to evolve at a rapid pace. Companies must remain adaptable and continually take appropriate measures to position themselves for future success.