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.” 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
As part of the post-grant proceedings created in 2012 by the America Invents Act, a Patent Owner can choose to file a motion to amend its patent when that patent is challenged. See 35 U.S.C. § 316(d) (“Amendment of the patent.”); 37 CFR § 42.121 (“Amendment of the patent.”). For example, a Patent Owner may file a contingent motion to amend in lieu of filing a Patent Owner Response after institution of an inter partes review, cancelling the original, challenged claims. Or, the Patent Owner may file a noncontingent motion to amend with its Patent Owner Response, which allows the Patent Owner to argue that both the proposed and the original claims are patentable. However, the Petitioner in an instituted review can challenge the patentability of any proposed amended claims, arguing, for example, that the claims were anticipated by the prior art, or would have been obvious, or fail the requirements of 35 U.S.C. § 112. See Aqua Prods., Inc. v. Matal, 872 F.3d 1290, 1315 (Fed. Cir. 2017).
After several years of experience with post-grant proceedings involving motions to amend, the PTAB studied various aspects of the practice surrounding these motions. The PTAB then proposed two major changes to the motion to amend process, and implemented them in March 2019 in a Motion to Amend Pilot Program. The PTAB’s changes provided:
- A Patent Owner can request “preliminary guidance” from the PTAB regarding the patentability of proposed amended claims, when filing a motion to amend; and
- A Patent Owner can file a revised motion to amend regardless of whether the Patent Owner requests preliminary guidance.
Now, Tyler Bowen and Katherine Nesler, Ph.D., have published a short research paper entitled The Impact of the PTAB’s Motion to Amend Pilot Program [PDF], examining how the Pilot Program affected motion to amend practice. Tyler and Katherine’s research identified proceedings that involved a motion to amend, among the nearly 5,000 trials completed by March 31, 2020, and characterized and compared the outcomes of motions filed before versus after the Pilot Program began. In their paper, Tyler and Katherine identify trends in the data and provide practical tips, for both Patent Owners and Petitioners, regarding the motion to amend process.
We encourage you to download the paper, and hope you find the authors’ insights informative and helpful.
On December 4, 2020, the Board designated three cases from October as precedential. Together, the rulings help understand the Board’s approach to both serial challenges to issued patents and application of 35 U.S.C. § 315’s limitations on proceedings. Two of the newly precedential decisions address the real party in interest (“RPI”) requirement and the third concerns follow-on petitions and joinder motions. See RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 (P.T.A.B. Oct. 2, 2020) (“RPX”); Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9 (P.T.A.B. Oct. 28, 2020) (“Apple v. Uniloc”); SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 (P.T.A.B. Oct. 6, 2020) (“SharkNinja”).Read more about these decisions below. Continue Reading PTAB designates three precedential cases on Section 315’s time-bar and estoppel provisions
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:
A 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
On August 3, 2020, the Federal Circuit (Judges Lourie, Moore, and Reyna (dissenting)) (“the Court”) granted a petition for panel rehearing and issued a modified opinion (“Mod. Op.”) that maintained its prior patent-eligibility determination in Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419. Specifically, the modified majority opinion again held that the challenged claims of U.S. Patent Nos. 9,580,751 (the “’751 patent”) and 9,738,931 (the “’931 patent”), generally directed to methods of preparing cell-free fetal DNA from maternal blood for genetic analysis, are not invalid under 35 U.S.C. § 101 as directed to a natural phenomenon under the Alice/Mayo test, and are differentiated from other cases where the Court held claims ineligible. Continue Reading Method Claims Relying On A Naturally-Occurring Phenomenon Are Patent-Eligible Where They Recite “Human-Engineered Parameters”
The Patent Trial and Appeal Board (“Board”) recently designated two decisions as informative regarding discretionary denials of institution: Apple Inc. v. Fintiv, Inc., Case IPR2020-00019, Paper 15 (May 13, 2020), and Sand Revolution II, LLC v. Continental Intermodal Group – Trucking LLC, Case IPR2019-01393, Paper 24 (June 16, 2020). These decisions show how the Board applied the Fintiv factors established in its recent Precedential Order to determine whether co-pending district court litigation should result in a discretionary denial of institution under AIA 35 U.S.C. § 314(a). Continue Reading New PTAB Informative Decisions: Applying the Fintiv Factors in View of Parallel District Court Litigation
In Uniloc 2017 LLC v. Hulu, LLC, No. 2019-1686 (Fed. Cir. July 22, 2020), the Federal Circuit considered whether the AIA permits the PTAB to reject substitute claims proposed during an IPR for patent ineligibility under § 101. Continue Reading Federal Circuit confirms that the PTAB can consider the patent eligibility of substitute claims proposed during an IPR