Senate Confirms Andrei Iancu as New USPTO Director

On Monday, February 5, 2018, the Senate unanimously (94-0) confirmed Andrei Iancu to become the Director of the United States Patent and Trademark Office. Most recently, Mr. Iancu served as managing partner of Irell & Manella LLP, where he was a member of the intellectual property and litigation practice groups.

Upon review of Mr. Iancu’s answers during his Senate confirmation hearing, and upon review of articles of which he is a named author, some of his positions are apparent, notably those relating to  patent subject matter eligibility and post-grant proceedings before the PTAB

35 U.S.C. §101

During his confirmation hearing, Mr. Iancu was asked for his opinion on the Supreme Court’s jurisprudence regarding subject matter patentability. Mr. Iancu asserted his position that the Supreme Court “has introduced a degree of uncertainty into this area of law.” In response, Mr. Iancu publicly vowed to issue further guidance regarding §101, if necessary. Additionally, Mr. Iancu agreed with Senator Coons (DE) that the USPTO’s reported error rate of 32% on 101 rejections is, if true, unacceptably high.

In one publication, Mr. Iancu and his co-authors concluded that software claims, for example, can satisfy the requirements of 101, but may need legislation to save them from unclear Supreme Court jurisprudence. In this regard, Mr. Iancu thus seems to take a more pro-patent position, at least insofar as software patents are concerned.

Althought Mr. Iancu’s experience is primarily in the realms of telecommunications and software, he has played a part in a controversial biotech case in recent years. During his time with Irell & Manella, Mr. Iancu represented Ariosa Diagnostics in its suit against Sequenom, Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Ariosa sought a declaratory judgment after Sequenom threatened an infringement action. Claim 1 of Sequenom’s patent (U.S. 6,258,540) is directed to a method for detecting fetal abnromalities using cell-free fetal DNA (cffDNA) circulating in maternal plasma (i.e., cell-free blood). On appeal, the Federal Circuit held that Sequenom’s claims were invalid, despite representing “a significant contribution to the medical field.” Claim 1 of the ‘540 patent recites:

1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises: amplifying a paternally inherited nucleic acid from the serum or plasma sample anddetecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

The Federal Circuit reasoned that Sequenom’s claims posed a significant risk of preempting naturally occurring, paternally inherited cffDNA. This sparked criticism from the biotech community and concerns that Congressional intervention would be necessary to save diagnostic method claims.

Patent Trial and Appeal Board (“PTAB”)

Mr. Iancu co-authored a commentary on post-grant proceedings before the PTAB, which addressed the issue of deciding claim indefiniteness in inter partes review (“IPR”). Mr. Iancu and his co-authors set forth a model framework for the PTAB to adopt. In particular, Mr. Iancu and his co-authors suggested that both parties be afforded the opportunity to brief the panel regarding the issue of indefiniteness. During Mr. Iancu’s confirmation hearing, Senator Grassley (IA) asked whether Mr. Iancu believes that indefiniteness should be addressed by the PTAB even though it is not a ground for instituting IPRs. Mr. Iancu responded that the current body of law is unclear as to whether the PTAB may “push these decisions [of indefiniteness] into the trial phase of the IPR as opposed to deciding the issue at the institution phase, and [whether] the PTAB [has] the authority to issue a final written decision regarding indefiniteness once an IPR has been initiated.”  Mr. Iancu concluded that he would “work with USPTO leadership, Congress, and the stakeholder community” to determine whether action must be taken regarding this ambiguity.

Additionally, Mr. Iancu identified “the amendment process, the claim construction standard, the process used to reach institution decisions, and the conduct of the hearing itself” as aspects of the post-grant program that may need addressing.
When asked specifically if he would not “undermine Congressional intent and the goal of the AIA to provide a viable, faster and less expensive alternative to district court litigation” by drastically modifying or eliminating post-grant reviews, Mr. Iancu assured that he would work to ensure that post-grant reviews meet their statutory goals.

Where do we go from here?

It is unclear at this time what changes, if any Mr. Iancu will implement as USPTO Director. Although Mr. Iancu agrees that the Supreme Court has blurred patent subject matter eligibility doctrine, it is unclear where exactly Mr. Iancu would draw the line between eligibility and ineligibility, and whether it would differ based on the technology.

For patent owners who wish to take advantage of the streamlined PTAB proceedings, Mr. Iancu’s responses before the Senate and his past commentary both suggest that he does not wish to eliminate IPRs or PGRs. However, Mr. Iancu may seek to modify them in an effort to improve patent quality.