On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must submit to the Food and Drug Administration (“FDA”) and FDA must publish in the “Orange Book.”[1] See H.R. 1503, 116th Cong. § 2(a)–(d) (2021). The amendments require “manufacturers to share complete and timely patent information with the . . . (FDA), ensure that periods of exclusivity listed in the Orange Book are promptly updated, and clarify that patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed from the Orange Book promptly, but not before time for appeal has expired.” H.R. Rep. No. 116-47, at 3–4 (2019). The amendments also require FDA and the Comptroller General to submit reports to Congress about the types of patents that should and should not be listed in the Orange Book. See H.R. 1503 § 2(e)–(f).
Continue Reading Orange Book Transparency Act of 2020 Signed Into Law

Today, the PTO’s Patent Trial and Appeal Board (PTAB) issued a final rule related to trial proceedings under the America Invents Act.  The final rule goes into effect 30 days after publication in the Federal Register (scheduled for December 9, 2020); it makes changes to institution practice and sur-replies, and eliminates an evidentiary presumption in favor of a petitioner on certain institution-related fact issues.
Continue Reading PTAB Publishes Final Rule on Institution and Presumption in AIA Trials

To guide and inform the public about the Patent Trial and Appeal Board’s practice surrounding post-grant proceedings, the Board periodically designates certain of its decisions as precedential or informative.  As noted by the PTAB:

precedential decision establishes binding authority concerning major policy or procedural issues, or other issues of exceptional importance, including constitutional questions, important issues regarding statutes, rules, and regulations, important issues regarding case law, or issues of broad applicability to the Board. Standard Operating Procedure 2, 2-3, 11.

An informative decision provides Board norms on recurring issues, guidance on issues of first impression to the Board, guidance on Board rules and practices, and guidance on issues that may develop through analysis of recurring issues in many cases. Standard Operating Procedure 2, 9.

Relatedly, the Patent Office uses a Precedential Opinion Panel “to decide issues of exceptional importance to the Patent Trial and Appeal Board (e.g., issues involving agency policy or procedure).”  That Panel is composed of the Director of the Patent Office, the Commissioner for Patents, and the Chief Judge of the PTAB.

Recently, the U.S. Patent and Trademark Office announced that it established two online portals, to facilitate submitting 1) requests to designate precedential and informative decisions, and 2) amicus positions regarding requests for Panel review.
Continue Reading PTAB Adds Online Public-Submission Forms

Since the start of post-grant proceedings, the Patent Office has published a Patent Trial Practice Guide to provide a framework for conducting those proceedings, including setting out the structure and times for taking action in each of the new proceedings (e.g., Inter Partes Review and Post Grant Review). The first Trial Practice Guide issued in August 2012, and updates were issued in August 2018, July 2019, and November 2019 (Consolidated Trial Practice Guide).  To guide post-grant practice, the Patent Office has also designated more than 40 decisions as precedential or informative. A topic of continued interest is the Patent Office’s practice surrounding its decision whether to institute a post-grant proceeding after a petition is filed.

Recently, the Patent and Trademark Office issued a Federal Register notice regarding a Request for Comments on Discretion To Institute Trials Before the Patent Trial and Appeal Board. The full text of the notice can also be found in PDF format here and here.
Continue Reading PTAB Seeks Comments On Its Approach To Institution Decisions

On October 13, 2020, the Supreme Court granted petitions for certiorari filed by the United States (in No. 19-1434), Smith & Nephew, Inc. (in No. 19-1452), and Arthrex, Inc. (in No. 19-1458) regarding the appointments of the administrative patent judges of the Patent Trial and Appeal Board.  No date has been set to argue the cases, but the Court consolidated them and allotted one hour for argument time.  Because the Court consolidated the cases for briefing and oral argument, it noted that “future filings and activity in the cases will now be reflected on the docket of No. 19-1434.”  On December 31, 2020, the Court set oral argument for March 1, 2021.

The various petitions were granted only to the extent of “Questions 1 and 2 as set forth in the July 22, 2020 Memorandum for the United States.”  See Orders List at 2.

Question 1 asks “[w]hether, for purposes of the Appointments Clause, U.S. Const. Art. II, § 2, Cl. 2, administrative patent judges of the U.S. Patent and Trademark Office are principal officers who must be appointed by the President with the Senate’s advice and consent, or ‘inferior Officers’ whose appointment Congress has permissibly vested in a department head.”

Question 2 asks “[w]hether, if administrative patent judges are principal officers, the court of appeals properly cured any Appointments Clause defect in the current statutory scheme prospectively by severing the application of 5 U.S.C. § 7513(a) to those judges.”

Links to the briefs, and details of the briefing schedule, are below. [Updated 1/8/2021, to reflect most current filings, and argument date]
Continue Reading Supreme Court grants certiorari in PTAB Appointments Clause cases

It has become a significant open question in inter partes review proceedings what a petitioner must do to establish a reference as a printed publication. In a decision designated Precedential on December 20, 2019 (Hulu, LLC v. Sound View Innovations, LLC, IPR2018-1039) the Patent Trial and Appeal Board (“the Board”) provided practitioners with guidance regarding “what is required for a petition to establish that an asserted reference qualifies as a ‘printed publication’ at the institution stage.” Paper 29 at 6. The decision held, inter alia, that at the institution stage the “reasonable likelihood” standard applies to printed publications, and that the inquiry, as during other stages of the proceedings, is based on the totality of the evidence. Id. at 14-17.
Continue Reading PTAB states the “reasonable likelihood” standard applies to demonstrating public accessibility at the institution stage

As we noted previously on the blog (see here, here, here, and here), issues proving up prior art during inter partes review proceedings arise regularly at the PTAB.

Our colleagues, Miguel Bombach and Brandon White, reviewed the current state of PTAB rulings, and synthesized their findings in a short research paper, now available, entitled Inter Partes Review Practice: Challenges in Proving Up Publications as Prior Art. [PDF]
Continue Reading Challenges in Proving Up Publications as Prior Art During IPR

Today, the PTAB’s Precedential Opinion Panel issued a precedential decision holding that even a deficient pleading triggers the one-year IPR filing period.  GoPro, Inc. v. 360Heros, Inc., IPR2018-01754 (PTAB Aug. 23, 2019) (Paper 38)
Continue Reading PTAB Issues Precedential GoPro Decision That Even Service Of “Deficient” Complaint Starts IPR Time Clock