Declarations as New Evidence to Overcome § 325(d)

By Bing Liang, Ph.D. and Cary Miller, Ph.D.

We have published other blog postings relating to 35 U.S.C. §325(d), including a blog posting that addresses the PTAB’s October 24, 2017 notice designating three of its decisions as informative (here).  Recently, the PTAB instituted an inter partes review of US Patent No. 7,049,328 (the “’328 patent”) issued to Apotex Technologies, Inc. (IPR2017-01446) in view of a reference the USPTO had already considered during prosecution.

The ’328 patent is directed to using deferiprone, an iron chelating drug, to treat patients who require regular transfusions of red blood cells by stabilizing or reducing iron overload in their hearts.  Claim 1 is illustrative of the challenged claims and recites:

1. A method of treating iron induced cardiac disease in a blood transfusion dependent patient experiencing an iron overload condition of the heart, said method comprising administering to the patient a therapeutically effective amount of deferiprone or a physiologically acceptable salt thereof sufficient to stabilize/reduce iron accumulation in the heart resulting from being transfusion dependent.

The Petitioner contended, among other arguments, that the challenged claims are unpatentable as anticipated by a prior art reference, Hoffbrand.  It asserted Hoffbrand discloses treating iron-overloaded regularly transfused patients with deferiprone and that some of the treated patients had a liver iron content above 15.0 mg/g dry weight.  Hoffbrand does not explicitly mention an iron overload condition in the heart.  However, the Petitioner supported its inherent anticipation position by including an expert declaration stating —“Hoffbrand discloses that ten patients had a liver iron content above 15.0 mg/g dry weight, which falls in the range of iron content that has been associated with cardiac disease due to iron overload,” thereby connecting the liver iron content in Hoffbrand with the claimed “iron overload condition of the heart” or “iron-induced cardiac disease” required by independent claims 1, 2, and 4-10.

The Patent Owner urged the PTAB to exercise its discretion and decline to institute this ground under 35 U.S.C. § 325(d) because “Hoffbrand was expressly considered, on numerous occasions, by the Examiner during prosecution of the ’328 Patent.”

The PTAB decided that while it has discretion to reject the request under § 325(d) because the same or substantially the same prior art or arguments were previously presented to the USPTO, it was not persuaded by the Patent Owner’s argument after considering all of the relevant facts and circumstances in this case.  In coming to its conclusion, the PTAB reasoned that “[p]etitioner relies on a declaration…, which Patent Owner does not allege is duplicative of evidence previously presented to the Office”, and cited to Tandus Flooring, Inc. v. Interface, Inc., Case IPR2013-00333at *2 (PTAB Dec. 9, 2013) to support its decision.

Take away:

An expert declaration can provide new evidence to persuade the PTAB to institute an IPR over a previously considered prior art reference.  Patent Owners will want to carefully address such expert declarations in their preliminary responses, and should consider arguing that the information in the declaration is duplicative of information already considered by the USPTO.